Bearberry GF 13. Stinging nettle leaves GF XIII FS.2.5.0019.15. Procurement and storage of raw materials

Ministry of Health Russian Federation
State drug quality standard
Published 03/19/2014

Collected during the flowering period from May to August and dried leaves of wild and cultivated perennial herbaceous plant large plantain - Plantago major L., fam. plantain – Plantaginaceae.

Authenticity

External signs . Whole raw materials. Whole or partially crushed leaves, simple, leaf shape broadly ovate or broadly elliptical, rounded at the base, apex pointed or blunt, petiole winged, glabrous, of variable length. In the place where the petiole breaks, long remains of thread-like veins are visible. The leaf margin is entire or slightly toothed, the venation is arcuate; the leaf surface is bare on both sides, the length of the leaves with petiole is up to 24 cm, the width is from 3 to 11 cm. The color is green or light green, the smell is weak, the taste of the aqueous extract is slightly bitter.

Crushed raw materials. Pieces of leaves various shapes passing through a sieve with holes with a diameter of 7 mm. The surface of the leaf pieces is bare. The color is green or light green, the smell is weak, the taste of the aqueous extract is slightly bitter.

Powder green, passing through a sieve with holes 0.16 mm in diameter. The smell is weak, the taste of the aqueous extract is slightly bitter.

Microscopic signs.Whole and crushed raw materials. When examining a leaf from the surface, polygonal epidermal cells with straight side walls are visible on the upper side of the leaf blade. Cells of the lower epidermis (B) with slightly convoluted walls. The cuticle forms folds in places. The stomata on both sides of the leaf are anomocytic type (A4), round, surrounded by 3-4 epidermal cells. Trichomes are simple and capitate (A1, A3). Simple conical hairs with an expanded base, multicellular, smooth, rare, often torn off. There are two types of capitate hairs: on a unicellular stalk with an elongated two-cell head - found over the entire surface on both sides of the leaf; capitate hairs on a multicellular stalk with a spherical or oval unicellular head are less common. At the sites of hair attachment (A2), epidermal cells form a rosette of 6-9 cells.

Powder. In the powder, fragments of the epidermis with stomata, rosettes and capitate hairs are visible; simple hairs or their fragments are less common.

Figure – 1 Large plantain leaf. Surface preparation

A – epidermis top side(magnitude × 400): 1 – simple hair,
2 – place of hair attachment, 3 – capitate hairs,
4 – stomata of anomocytic type; B – epidermal cells of the lower side (magnitude × 400)

Figure - 2 Medium plantain leaf. Surface preparation

A B (magnification × 400) – epidermis of the upper side of the leaf blade,
B (magnification 100×): D – epidermis of the underside of the leaf blade.
1 – stomata, 2 – capitate hair, 3 – simple, delicately warty hair, with a collapsed cell.
D (magnitude × 160) – epidermis of the underside of the leaf blade (vegetal hairs)

Figure –3 Plantain lanceolate leaf. Surface preparation

(magnitude × 400): A – epidermis of the upper side of the leaf blade,
B – epidermis of the lower side. 1 – stomata, 2 – parastomatal cells.
3 – place of attachment and base of a simple hair,
4 – articulation of simple hair cells. 5 – capitate hair.

Determination of the main groups biologically active substances

1. UV spectrum

Absorption spectrum of test solution A (see section " quantitation» 2. Total flavonoids). 0.5 ml of solution A is placed in a 25 ml volumetric flask, 95% ethanol is added, mixed and adjusted to the mark. The optical density is measured using a spectrophotometer in a cuvette with a layer thickness of 10 mm, in the wavelength range from 250 to 450 nm. The reference solution is 95% alcohol. The absorption spectrum should have maxima at wavelengths of 288±3 nm and 333±2 nm, minimum at a wavelength of 303±2 nm (flavonoids).

1. Thin layer chromatography. 5 ml of solution A (see section “Quantitative determination” 2. Total flavonoids) is evaporated to dryness in an evaporation cup, then the dry residue is dissolved in 1 ml of alcohol
   70%. A starting line is applied to a sheet of chromatographic paper measuring 12x12 cm at a distance of 4 cm from the bottom edge. Apply 0.05 ml of the resulting extract in portions to the central point of the start line and dry. A “tongue” measuring 1.5x1.5 cm is cut out in the center of the starting line and folded down along the starting line. The chromatogram is placed in a chamber consisting of two Petri dishes of the same diameter with a solvent mixture of acetic acid-water 15:85 and chromatographed for 50-80 minutes. When the solvent front passes from the start line to the finish line (7 cm), the chromatogram is removed from the chamber and dried at room temperature.

In UV light at a wavelength of 360 nm, colored adsorption zones are visible on the chromatogram. Adsorption zones with Rf 0.25; 0.42 and 0.54 – dark; With Rf 0.88 – blue-blue and Rf 0.95 – greenish-blue.

After processing the chromatogram with vapors of an ammonia solution, the adsorption zones with Rf 0.25 and 0.42 change color to yellow-green, zone Rf 0.54 – to dark yellow-green. After developing the chromatogram 5% alcohol solution aluminum chloride zone Rf 0.25 fluoresces bright yellow-green, adsorption zone with Rf 0.42 – dark yellow-green, zone with Rf 0.54 remains dark (flavonoids). Adsorption zone with Rf 0.88 enhances fluorescence when treated with vapors of ammonia solution (phenolcarboxylic acids).

Adsorption zone with Rf 0.95 is stained with Stahl's reagent in a blue-green color (iridoids).

Note.

Preparation of Stahl's reagent :

3.0 g P-dimethylaminobenzaldehyde is dissolved in 100 ml of 95% alcohol and 5 ml of concentrated hydrochloric acid is added.

1. To 10 ml of solution A (see section “Quantitative determination”. 1. Polysaccharides) add 30 ml of 95% alcohol and mix; flaky clots appear that precipitate when standing (polysaccharides).
2. The solution with the precipitate is filtered through a POR-16 glass filter, the precipitate from the filter is transferred into a 50 ml flask using sodium hydroxide solution (0.1 mol/l). Add to 1 ml of the resulting solution
   0.25 ml of carbazole solution 0.5% and 5 ml of concentrated sulfuric acid, stirred and heated in a boiling water bath for 10 minutes; a red-violet color appears (galacturonic acid).

Note

Preparation of carbazole solution 0.5%. 0.5 g of carbazole is dissolved in purified alcohol 95% in a 100 ml volumetric flask and the volume of the solution is adjusted to the mark with the same alcohol.

Preparation of purified alcohol 95% . To 1 liter of 95% alcohol add 4 g of zinc dust and 4 ml of concentrated sulfuric acid. The mixture is left for 24 hours, stirring occasionally. The alcohol is then distilled. To 1 liter of distilled alcohol add 4 g of zinc dust and 4 g of potassium hydroxide, mix and distill again.

Numerical indicators. Whole raw materials. Polysaccharides not less than 12%; extractive substances extracted with water, at least 35%; extractive substances extracted with 70% ethyl alcohol, at least 20%; the amount of flavonoids in terms of cinaroside is not less than 0.6%; humidity no more
14 %; total ash no more than 20%; ash insoluble in hydrochloric acid no more than 6%; particles passing through a sieve with holes with a diameter of 1 mm, no more than 5%; leaves that have changed color no more than 5%; flower shoots no more than 1%; organic impurity no more
1 %; mineral impurity no more than 1%.

Crushed raw materials. Polysaccharides not less than 12%; extractive substances extracted with water, at least 35%; extractive substances extracted with 70% ethyl alcohol, at least 20%; the amount of flavonoids in terms of cinaroside is not less than 0.6%; humidity no more than 14%; total ash no more than 20%; ash insoluble in hydrochloric acid, no more than 6%; particles that do not pass through a sieve with holes with a diameter of 7 mm, no more than 10%; particles passing through a sieve with holes measuring 0.5 mm, no more than 7%; browned and blackened pieces of leaves, no more than 5%; pieces of flower arrows no more than 1%; organic impurity no more than 1%; mineral impurity no more than 1%.

Powder. Polysaccharides not less than 12%; extractive substances extracted with water, at least 35%; extractive substances extracted with 70% ethyl alcohol, at least 20%; the amount of flavonoids in terms of cinaroside is not less than 0.6%; humidity no more than 14%; total ash no more than 20%; ash insoluble in hydrochloric acid, no more than 6%; particles that do not pass through a sieve with holes measuring 0.16 mm, no more
1 %.

Note

1. The content of the amount of polysaccharides and extractive substances extracted by water is determined in the leaves of the great plantain, used as a medicine and in the raw materials intended for the production of the drug "Plantaglucid".

1. Other types of plantain found in raw materials as an impurity include:

a) medium plantain ( Plantago media L.) leaf blade is elliptical, pubescent, especially along the veins and leaf margins. Under a microscope, when examining the epidermis, numerous simple, multicellular hairs are visible, without an expanded base, with a smooth or gently warty surface, thin-walled, often with collapsed segments. Capitate hairs with a single-cell stalk and an elongated two-cell head.

b) lanceolate plantain ( Plantago lanceolata L.) leaf blade is elongated-lanceolate, pubescent along the veins. Under a microscope, when examining the epidermis along the veins and edge of the leaf, pointed, long, thick-walled hairs are found, having one short basal cell and 2-3 long terminal cells with their peculiar articulation. Capitate hairs have a unicellular stalk and a multicellular (8-10 cells) head.

quantitation.

1. Polysaccharides. An analytical sample of raw materials is crushed to a particle size that passes through a sieve with holes 2 mm in diameter. About 10 g (exactly weighed) of crushed raw materials or powder is placed in a flask with a ground section with a capacity of 500 ml, 200 ml of purified water heated to a boil is added. The flask is connected to a reflux condenser and boiled with stirring on an electric hotplate for 30 minutes. The extraction is repeated 2 more times, adding 200 and 100 ml of water.

The aqueous extracts are combined and filtered into a 500 ml volumetric flask through 5 layers of gauze placed in a glass funnel and pre-washed with purified water. The filter is washed with water and the volume of the solution is adjusted to the mark (solution A). 25 ml of solution A are placed in a 100 ml conical flask, 75 ml of 95% alcohol are added, stirred, and heated in a water bath for 30 minutes. The contents of the flask are filtered through a pre-dried and weighed ashless paper filter. The filter cake is washed successively with 15 ml of a solution of 95% alcohol in purified water (3:1), and 10 ml of a mixture of ethyl acetate and 95% alcohol (1:1). The filter with the sediment is dried first in air, then at a temperature of 100-105 ° C to constant weight. Polysaccharide content ( X) is calculated using the formula:

m 1 – filter mass, g;
m 2 – mass of the filter with sediment, g;
m– weight of raw materials, g;
W- humidity, %.

1. Total flavonoids. An analytical sample of raw materials is crushed to a particle size that passes through a sieve with holes 1 mm in diameter. Near
   1 g (exactly weighed) of crushed raw materials or powder is placed in a flask with a ground section with a capacity of 150 ml, 80 ml of 70% alcohol is added. The flask is connected to a reflux condenser and heated in a boiling water bath for 30 minutes. The hot extract is filtered through cotton wool into a 100 ml volumetric flask. Add 70% alcohol twice 10 ml each to the contents of the flask and filter into the same volumetric flask. The extract is cooled, adjusted to the mark with 70% alcohol and mixed (solution A).

In a 25 ml volumetric flask place 2 ml of solution A and 2 ml
aluminum chloride alcohol solution 2% in 95% ethyl alcohol. Bring the volume of solution to the mark with 95% alcohol. After 40 min. measure the optical density of the solution on a spectrophotometer at a wavelength of 385 nm in a cuvette with a layer thickness of 10 mm. As a reference solution, use a solution consisting of 2 ml of extract, 1 drop of diluted acetic acid and brought to the mark with 95% alcohol in a 25 ml volumetric flask.

A– optical density of the test solution;
A– mass of raw materials, g;
W- humidity, %;

361 – specific absorption indicator of the complex of a standard sample of cynaroside with aluminum chloride at a wavelength of 385 nm.

3.Extractives. An analytical sample of raw materials is crushed to the size of particles passing through a sieve with holes measuring 1 mm. About 1 g (exactly weighed) of crushed raw materials or powder is placed in a conical flask with a ground section with a capacity of 200-250 ml (hereinafter referred to as the General Pharmacopoeia Monograph “Determination of the content of extractive substances in medicinal plant raw materials”

Heavy metals. The determination is carried out in accordance with the General Pharmacopoeia Monograph “Determination of the content of heavy metals and arsenic in medicinal plant materials and medicinal herbal preparations.”

Radioactivity. The determination is carried out in accordance with the General Pharmacopoeia Monograph “Determination of radionuclide content in medicinal plant materials”.

Pesticide residues. The determination is carried out in accordance with the General Pharmacopoeia Monograph “Determination of the content of residual pesticides in medicinal plant materials and medicinal herbal preparations.”

Microbiological purity. The determination is carried out in accordance with the General Pharmacopoeia Monograph “Microbiological Purity”.

Packaging, labeling and transportation. Carried out in accordance with the requirements of the General Pharmacopoeia Monograph “Packaging, labeling and transportation of medicinal plant materials.”

Storage. Storage of medicinal products is carried out in accordance with the requirements of the General Pharmacopoeia Monograph “Storage of medicinal plant raw materials and medicinal herbal preparations».

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

GENERAL PHARMACOPOEIAN ARTICLE

Leaves OFS.1.5.1.0003.15

FoliaInstead of Art. GF XI

In pharmaceutical practice, leaves are called medicinal plant materials, which are dried or fresh leaves or individual leaves of a complex leaf. Leaves are usually collected when they are fully developed, with or without a petiole.

External signs

Whole and crushed raw materials. Preparing objects for analysis:

- small and leathery leaves are examined dry;

- large, thin leaves (usually crushed) are softened in a damp chamber or by immersing them in hot water for several minutes;

— fresh leaves are examined without pre-treatment.

The leaves prepared for analysis are laid out on a glass plate, carefully straightened, examined with the naked eye, using a magnifying glass (10×) or a stereomicroscope (8×, 16×, 24×, etc.). Pay attention to the following anatomical and diagnostic signs:

1. Structure(simple, complex - odd-pinnate, pair-pinnate, doubly-pinnate, doubly-unpaired-pinnate, palmate, trifoliate, etc.) and dimensions of the leaf blade.
2. Leaf blade shape(round, elliptical, broadly elliptical, narrowly elliptical, oblong, ovoid, broadly ovoid, narrowly ovate, obovate, rounded-ovate, broadly obovate, lanceolate, heart-shaped, arrow-shaped, spear-shaped, sickle-shaped, needle-shaped, etc.).
3. Depth of section of the leaf blade(palmate, pinnately, trifoliate, palmate, pinnately divided, trifoliate, palmately dissected, pinnately dissected, trifoliately dissected) .
4. Nature of the foundation(round, wide-round, narrow-round, wedge-shaped, narrow wedge-shaped, wide wedge-shaped, truncated, notched, heart-shaped, etc.) and tops(sharp, round, blunt, notched, elongated, etc.) leaf blade.
5. Character of the leaf edge(solid, serrated, doubly serrated, jagged, crenate, notched) .
6. The presence of a petiole, itssizes.
7. The nature of the surface of the petiole (smooth, ribbed, grooved, etc.).
8. Presence of vagina, stipules(free, fused), characteristic, sizes.
9. Pubescence of leaves and petiole(abundance and location of hairs).
10. Leaf venation(in monocots - parallel, arcuate; in dicots - pinnate, palmate; in ferns and primitive seed plants (gingko) - dichotomous).
11. Presence of essential oil glands and other formations on the leaf surface or the presence of containers in the mesophyll.

Dimensions determined using a measuring ruler or graph paper. Measure the length and width of the leaf blade, the length and diameter of the petiole.

Color determined on both sides of the sheet on dry material in daylight.

Smell determined by rubbing.

Taste determined by testing dry raw materials or aqueous extracts of leaves (only for non-poisonous objects).

For crushed leaves, determine grinding- the size of the sieve openings through which the mixture of particles passes.

Powder. Examine with the naked eye, using a magnifying glass (10×) or a stereomicroscope (8×, 16×, 24×, etc.). The color of the mixture of particles (the total mass and individual inclusions), the shape of the particles, the origin of the particles and their nature (if determined) are noted. When examined under a magnifying glass or stereomicroscope, attention is paid to the pubescence of the fragments and the nature of the surface (smooth, rough, covered with glands, etc.). Determine smell and taste (similar to whole and crushed leaves). The fineness (the size of the sieve holes through which the mixture of particles passes) is determined.

Microscopy

Whole and crushed leaves. Microslides are prepared in accordance with whole leaves or pieces of a leaf blade with an edge and vein, pieces of a leaf from the base and apex, pieces of a petiole (if the leaf has a petiole), examining them from the surface. When analyzing thick and leathery leaves (eucalyptus, bearberry, lingonberry), cross sections and “squashed” micropreparations are prepared. If necessary, transverse sections of the petioles are also prepared.

Pay attention to the following anatomical and diagnostic signs:

1. Character of the cuticle top and bottom epidermis(smooth; wrinkled, including longitudinal-wrinkled, transverse-wrinkled, radiant-wrinkled; streaked; comb-shaped, etc.).
2. Cell shape top and bottom epidermis(isodiametric - round, square, polygonal; polygonal - rectangular, oval, diamond-shaped, spindle-shaped, combined, etc.); cell wall tortuosity top and bottom epidermis(straight, curved, wavy, zigzag, jagged, etc.), degree tortuosity; thickening of cell walls top and bottom epidermis(uniform, clear-shaped).
3. Presence of stomata, their shape (round, oval), size, frequency of occurrence on the upper and lower epidermis.
4. Type of stomatal apparatus:

- anomocytic type (randomly cellular) - anomocytic (or ranunculoid) - stomata are surrounded by an indefinite number of cells that do not differ in shape and size from the rest of the epidermal cells;

- diacytic type (two-celled) - stomata are surrounded by two parastomatal cells, the adjacent walls of which are perpendicular to the stomatal fissure;

- paracytic type (parallel cell) - on each side of the stomata, along its longitudinal axis there are one or more parastomatal cells;

- anisocytic type (unequal cell) - stomata are surrounded by three parastomatal cells, one of which is significantly smaller than the other two;

- tetracite type - the stomata is surrounded by 4 symmetrically located parastomatal cells: two cells are parallel to the stomatal fissure, and the other two are adjacent to the poles of the guard cells;

- hexacite type - the stomata is surrounded by 6 parastomatal cells: two pairs are located symmetrically along the guard cells, and two cells occupy polar positions;

- encyclocytic type - secondary cells form a narrow ring around the guard cells;

- actinocyte type - characterized by several subsidiary cells radiating radially from the guard cells.

1. Availability water stomata(distinguished by their large size and are usually located at the top of the leaf or clove, above the hydathode).
2. Immersion of stomata in the epidermis(protruding above the epidermis, immersed in the epidermis).
3. Presence and structure of hairs on the upper and lower epidermis (simple and capitate, single- and multicellular, single-, double- and multirowed, fasciculate, branched and unbranched), their sizes, features of the places of their connection(availability of socket), wall thickening(thick, thin walls), nature of the cuticle(smooth, warty, streaked).
4. Presence of glands on the upper and lower epidermis, their structure, size.
5. Presence of secretory canals, laticifers, receptacles(in the parenchyma under the epidermis).
6. Presence and structure of crystalline inclusions(single crystals of various shapes, drusen, raphides, styloids, cystolites, crystalline sand, etc.), their localization(in the parenchyma under the epidermis, in the parenchyma in the form of a crystalline lining around conducting bundles and groups of fibers, rarely in epidermal cells), dimensions.
7. Availability of spare inclusions nutrients : mucus, inulin, etc. (in the parenchyma under the epidermis, less often in the cells of the epidermis).
8. Mesophyll structure(cell shape, homogeneity, location, presence of aerenchyma).
9. Leaf structure(dorsoventral, isolateral).
10. Structure of the conduction system sheet(shape of the main vein; number, shape, location of vascular bundles in the vein; structure of vascular bundles - location of phloem and xylem, presence of mechanical tissues).
11. Presence of mechanical fabric(collenchyma, sclerenchyma fibers, stone cells, bast fibers, etc.).
12. Petiole structure: on a cross section of a leaf petiole, indicate its shape in the middle, basal and apical parts (round, triangular, grooved, crescent-shaped, slightly winged, broad-winged), number and location conductive bundles, presence of mechanical tissue (collenchyma, sclerenchyma).

Powder. Prepare micropreparations of leaf powder in accordance with. In micropreparations of powder, fragments of leaves with the main and secondary veins, fragments of leaves with the edge of the leaf blade, fragments of the leaf apex, fragments in cross section, fragments of the petiole are examined. In the studied powder particles, all the manifesting anatomical and diagnostic signs listed for whole and crushed leaves are noted. Pay attention to the fact that a number of elements (hairs, glands, crystals, druses, etc.) can be separated from leaf particles; in the powder there are many tissue fragments and individual elements: hairs and their fragments, glands, individual crystals of calcium oxalate and fragments of the crystalline lining, mechanical cells - fibers, sclereids, fragments of secretory canals, receptacles, lacticifers, etc.

In a powder with a particle size of more than 0.5 mm, in the fragments under consideration, almost all the features characteristic of whole and crushed raw materials can be distinguished. Some elements of the epidermis may be in the form of fragments of hairs, glands, etc.; due to cell destruction, individual crystals, drusen, etc. may occur.

Even more difficult is the identification of anatomical diagnostic signs in powder of medicinal plant raw materials with a particle size less than
0.5 mm. There may also be fragments of various parts of the leaf epidermis, however, if possible, more attention should be paid to single elements: individual hairs, glands, crystals, cell features, etc.

In the powder of medicinal plant raw materials with a particle size of less than 0.5 mm, attention is paid to the structural features of the cells and the presence of single elements of the epidermis and mesophyll of the leaf - individual hairs, glands, their fragments, crystals, etc.

A description of the main diagnostic signs should be accompanied by illustrative material.

Fluorescence microscopy

Consider dry powder, less often a cross-section of a sheet, prepared from whole or crushed raw materials after preliminary softening in a humid chamber. The raw material's own (primary) fluorescence is observed in ultraviolet light. The brightest glow is found in the cuticle, cell membranes of mechanical tissues, xylem elements, hairs, the contents of individual cells or tissues of the mesophyll, leaf epidermis, depending on their chemical composition. The leaves of some plants are characterized by a bright and specific glow of the contents of the glands, secretory channels and receptacles, depending on the chemical composition of the contents.

Qualitative microchemical and histochemical reactions

Qualitative reactions

carried out with extraction from leaves according to the methods given in pharmacopoeial monographs or regulatory documentation.

Chromatography

The extracts are analyzed using various chromatographic techniques using standard samples. Most often, the components in extracts from leaves are determined chromatographically essential oils, flavonoids, etc.

Spectrum (UV spectrum)

The analysis is carried out in extracts from leaves if there are appropriate instructions in the pharmacopoeial monograph or regulatory documentation. A reference to the “Quantitative Determination” section is permitted. A description of the conditions for recording the spectrum is given, indicating the wavelengths at which the absorption maximum(s) and minimum(s) should be observed.

In whole, crushed raw materials and powder the following is determined:

— it is possible to determine extractive substances in accordance with the requirements;

— humidity in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of humidity of medicinal plant raw materials and medicinal herbal preparations”;

— grinding and impurity content

Weight of package contents

must meet the requirements.

Pest infestation of stocks

Radionuclides

The determination is carried out in accordance with the General Pharmacopoeia Monograph “Determination of radionuclide content in medicinal plant raw materials and medicinal herbal preparations.”

Heavy metals

The determination is carried out in accordance with.

Pesticide residues

The determination is carried out in accordance with the stage of the production process.

Microbiological purity

The determination is carried out in accordance with the requirements.

quantitation

Determination of the content of active substances (individual substances or the sum of substances in terms of individual substances) is carried out using various chemical, physico-chemical or other validated methods of analysis in accordance with the requirements of pharmacopoeial monographs or regulatory documentation.

An indirect method of quantitative determination is the determination of extractive substances extracted by an extractant specific to the raw material, in accordance with the requirements.

Package

According to requirements.

Marking

According to requirements. The labeling of secondary packaging must include the indication “Product passed radiation control.”

Transportation

According to requirements.

Storage

According to requirements. In a dry place, protected from light.

Best before date

The shelf life must be justified by actual data determining stability for all quality indicators of medicinal plant raw materials stored in each type of packaging.

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Rice. 7.1. Common bearberry - Arctostaphylos uva-ursi (L.) Spreng.

Bearberry leaves-folia uvae ursi
— Arctostaphylos uva-ursi (L.) Spreng.
Sem. heather—Ericaceae
Other names: bear ears, bear grapes, bearberry, torment, bearberry, drupe, bearberry

Strongly branched, low-growing evergreen shrub with prostrate shoots up to 2 m long (Fig. 7.1).
Leaves alternate obovate, wedge-shaped at the base, gradually turning into a short petiole, small, slightly shiny, leathery.
Flowers whitish-pink, reminiscent of bells, collected in drooping short apical brushes.
whisk pitcher-shaped, clepalatal with a five-toothed limb. Stamens 10.
Pestle with a superior five-locular ovary.
Fetus– coenocarpous inedible mealy drupe of red color, with 5 seeds.
Blooms in May - June, fruits ripen in July - August.

Spreading

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Spreading. Forest zone of the European part, Siberia and the Far East of Russia, as well as in the Caucasus and the Carpathians. The main harvesting areas where productive thickets are found are Lithuania, Belarus, Pskov, Novgorod, Vologda, Leningrad and Tver regions of Russia. Behind Lately thickets were identified in new areas: Krasnoyarsk Territory, Irkutsk region and Yakutia.

Habitat. Mainly in dry larch and pine forests (pine forests) with lichen cover (white moss), as well as in open sandy areas, coastal dunes, rocks, burnt areas and clearings. Light-loving plant. Occurs scatteredly, does not form large thickets.

Medicinal raw materials

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External signs

Rice. 7.2. Lingonberry (A) and bearberry (B):
1 – escape; 2 – sheet (bottom view); 3 – sheet (top view).

Whole raw materials

Leaves small, leathery, dense, brittle, entire-edged, obovate or oblong-obovate in shape, rounded at the apex, sometimes with a small notch, wedge-shaped narrowed towards the base, with a very short petiole (Fig. 7.2, B). Leaves length 1-2.2 cm, width 0.5-1.2 cm.
The venation is reticulate. The leaves on the upper side are dark green, shiny, with clearly visible depressed veins, on the lower side they are slightly lighter, matte, glabrous.
Smell absent. Taste strongly astringent, bitter.

Crushed raw materials

Pieces of leaves of various shapes from light green to dark green, passing through a sieve with holes with a diameter of 3 mm.
Smell absent. Taste strongly astringent, bitter.

Microscopy

When examining the leaf from the surface, polygonal epidermal cells with straight and rather thick walls are visible. The stomata are large, round, with a wide open stomatal fissure, surrounded by 8 (5-9) epidermal cells (encyclocytic type). Large veins are accompanied by a lining with calcium oxalate crystals in the form of prisms, their intergrowths and drusen. Slightly curved 2-3-cell hairs are often found at the base of the leaf (Fig. 7.3).

Rice. 7.3. Microscopy of a bearberry leaf:

epidermis of the upper (A) and lower (B) sides of the leaf from the surface:
1 – epidermal cell;
2 – stomata;
B – hair;
D – prismatic crystals along the vein (in the sheath cells).

Numerical indicators.Whole raw materials. Arbutin, determined by iodometric titration, not less than 6%; humidity no more than 12%; total ash no more than 4%; ash, insoluble in a 10% solution of hydrochloric acid, no more than 2%; no more than 3% of leaves that have turned brown and darkened on both sides; other parts of the plant (twigs, fruits) no more than 4%; organic impurity no more than 0.5%; mineral impurity no more than 0.5%. Crushed raw materials. Arbutin not less than 6%; humidity no more than 12%; total ash no more than 4%; ash, insoluble in a 10% solution of hydrochloric acid, no more than 2%; browned and darkened pieces of leaves no more than 3%; particles that do not pass through a sieve with holes with a diameter of 3 mm, no more than 5%; organic impurity no more than 0.5%; mineral impurity no more than 0.5%.

Procurement and storage of raw materials

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Preparation. The leaves should be collected in two periods: in the spring - before flowering or at the very beginning of flowering (from late April to mid-June) and in the fall - from the moment the fruits ripen until they fall off (from late August to mid-October). After flowering, the growth of young shoots begins; leaves collected at this time turn brown when dried and, in addition, contain a small amount of arbutin. When preparing raw materials, leafy shoots (twigs) are cut off with a special knife or chopped off with a hoe. The cut off branches are collected, shaken off sand and moss and transported to the drying site.

Apical shoots (Cormi Uvae ursi) 20-30 cm long are allowed for harvesting, which are cut with a knife or scissors, which increases the productivity of pickers. However, in pharmaceutical practice this type There are practically no raw materials available.

Security measures. Breaking branches and pulling out plants by hand is not allowed. In order to preserve the thickets, it is necessary to alternate collection sites, using the same array no more than once every 5 years. It is advisable to create reserves for bearberry.

Drying. IN natural conditions: in attics or under a canopy. The raw materials are laid out loosely, in a thin layer, and stirred periodically. Dried branches are threshed, selected, stems and blackened leaves are discarded. The crushed raw materials and mineral impurities are winnowed on a sieve. The yield of dry raw materials is 50% relative to freshly harvested. Artificial drying is allowed at a temperature not exceeding 50 °C.

Standardization. GF XI, issue. 2, Art. 26 and Changes No. 1, 2.

Storage. In a dry, well-ventilated area, packed in bags. Shelf life: 5 years.

Composition of bearberry

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Chemical composition. The active substance is the phenologlycoside arbutin, which is beta-D-glucopyranoside hydroquinone (8-16%). The leaves are rich in tannins of the hydrolyzable group (from 7.2 to 41.6%). Smaller quantities contain methylarbutin, hydroquinone, galloylarbutin, as well as triterpenoids - ursolic acid (0.4-0.7%), flavonoids, catechins, phenolcarboxylic acids - gallic, ellagic. Bearberry leaves contain a lot of iodine (2.1-2.7 mcg/kg). The glycoside arbutin is hydrolyzed into hydroquinone and glucose under the influence of the enzyme arbutase.

Qualitative reactions. An aqueous decoction of the leaves is used: the decoction (1:20), when shaken with a crystal of ferrous sulfate, gradually forms a dark purple precipitate (arbutin); A decoction of bearberry leaves when adding a solution of ferroammonium alum gives a black-blue color (tannins of the hydrolyzable group), and a decoction of lingonberry leaves gives a black-green color (tannins of the condensed group).

Properties and uses of bearberry

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Pharmacotherapeutic group. Diuretic, antiseptic.

Pharmacological properties. The antiseptic effect of bearberry leaves is due to hydroquinone, which is formed in the body during the hydrolysis of arbutin and is excreted in the urine. The urine turns green or dark green. The diuretic effect of bearberry preparations is also associated with hydroquinone. Tannins contained in bearberry decoction have astringent action in the gastrointestinal tract.

Application. A decoction of bearberry leaves is used for diseases urinary tract(urolithiasis, cystitis, urethritis) as a disinfectant and diuretic. When taking large doses, vomiting, nausea, diarrhea and others are possible. side effects. Bearberry leaves are somewhat irritating to the epithelium of the urinary system, so they are combined with plants that have anti-inflammatory, hemostatic and diuretic effects.

Medicines

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1. Bearberry leaves, crushed raw materials. Diuretic, antiseptic.
2. As part of diuretic collections (diuretic collections No. 1-2; urological collection (diuretic); Brusniver-T collection; Herbafol collection) and the anti-alcohol collection Stopal.
3. Uriflorin, tablets 0.3 g (bearberry leaf powder). Diuretic, antiseptic.

Infusions and decoctions- official dosage forms. Their preparation is regulated by the general article of the Global Fund. Infusions and decoctions- liquid dosage forms, which are aqueous extracts from medicinal plant materials (MPS), as well as aqueous solutions dry and liquid standardized extracts (concentrates).

Infusions and decoctions are widely used as individual dosage forms, as well as in complex liquids. medicines. Water extracts can be used both internally (infusions) and externally (rinsing, lotions, washing, etc.). According to their physicochemical nature, aqueous extracts are combined systems with a liquid dispersion medium. In most cases they are a combination of true, IUD and colloidal solutions substances extracted from plant materials, sometimes containing small quantities of emulsified and suspended components that are insoluble in water. The composition of aqueous extracts is very complex and cannot always be fully characterized qualitatively and quantitatively.

Use of aqueous extracts for various diseases began in ancient times. Even Claudius Galen (about 1800 years ago), who rejected Hippocrates’ opinion about the existence of ready-made medicines in nature, argued that plants, along with active substances, also contain ballast substances that can have a harmful effect on the body. Already in those days, they tried to obtain a more convenient form for use through the simplest processing of plant material. Paracelsus especially persistently defended the idea of ​​​​replacing plant material with extracts from them, who contemptuously called whole herbs “soup seasoning.”

Water extracts have not lost their importance to this day. In modern pharmacy formulations, aqueous extracts account for 10-20%.

Featuresdata dosage forms is that:

They are used to treat sluggish, chronic diseases and are not used to provide first aid;

Often this type of dosage form is prepared by patients at home. Advantage This dosage form is based on the natural composition of the active ingredients.

Disadvantages of aqueous extracts from MP:

Instability during storage, since the extractant is water, and the drug contains microorganisms and enzymes;

Rule 1

The shelf life of aqueous extracts from MP is 2 days (order M3 No. 214).

The dosage form is non-standard in any case;

Manufacturing requires grinding;

Dispensing to the patient is delayed due to long production times.

23.1. THEORETICAL BASIS OF THE EXTRACTION PROCESS

Extraction (extraction) - the process of separating a mixture of liquid or solid substances using selective solvents (extractants).

The physical essence of extraction consists in the transition of the extracted (extracted) substance from one phase (liquid or solid) into the phase of the liquid extractant upon their mutual contact.

Extraction includes the following main operations:

1. Bringing into contact (mixing) the initial mixture of substances and the extractant.

2. Mechanical separation of the resulting 2 phases.

3. Removal and regeneration of the extractant from each phase. The extractant used must have the following properties:

Selectivity;

Chemical inertness, possibly less volatility, non-toxicity, availability and low cost.

The advantages of the extraction process are:

Low operating temperatures;

Cost-effectiveness of extracting valuable components;

The relative simplicity of the equipment and its accessibility. Conventionally, the extraction process itself is divided into 3 stages:

1. Wetting of plant material and penetration of the extractant into it (endoosmosis).

2. Formation of “primary juice” - filling cells with extractant, dissolving target substances.

3. Transfer of substances from plant material to a liquid medium (mass transfer).

Extraction is a mass transfer process. The efficiency of mass transfer processes is determined by the Fick-Shchukarev equation:

dS(dt) = -D . F. dc(dx), where dS(dt)- speed of the diffusion process, m/s; D- molecular diffusion coefficient, m/s; F- area of ​​diffuse exchange (total area of ​​crushed plant materials), m;

dc(dx)- concentration gradient (change in the concentration of a substance at a distance dx);

sign (-) means that the diffusion process is directed towards

side of decreasing concentration. Analysis of the Fick-Shchukarev equation shows that the efficiency of extracting active substances from medicinal products is directly proportional to the diffusion coefficient, the difference in the concentration of the substance in the raw material and solution and the mass transfer surface, i.e. grinding of raw materials. The profile of changes in concentrations is presented in Fig. 23.1.

23.2. FACTORS AFFECTING THE EFFICIENCY OF EXTRACTION AND THE QUALITY OF AQUEOUS EXTRACTS

1. Standardity of raw materials (technology for collecting and drying medicinal plant materials).

2. Properties of plant material (plant parts and organs, cellular structure).

3. Properties of the extracted substance (solubility, wettability, desorption, thermal stability).

4. Technological process extraction.

Rice. 23.1.Profile of changes in concentration under conditions of extraction of target substances from medicinal plants:

T - solid phase; LS - laminar layer; F - liquid phase of the extractant; C0 is the concentration of target substances in the feedstock; C1 - concentration at the interface; C2 - concentration at the boundary of the laminar layer; C3 - concentration in the extractant volume

1. Standardity of raw materials

The composition and concentration of aqueous extracts, the strength and nature of their effect on the body depend primarily on the starting raw material and, in particular, on the content of active substances in it. The amount of the latter in plant materials varies depending on the conditions and place of growth of the plant, collection time, drying regime and other reasons.

Standard is the raw material that meets the requirements regulatory documents.

Rule 2

For the preparation of aqueous extracts, only standard or high-grade raw materials should be used. When using raw materials with increased content active ingredients, it should be taken in smaller quantities, taking into account the correction factor.

Raw materials with a lower content of active ingredients than required by the standard for the preparation of extracts are not permitted.

Plant materials arriving at warehouses must be accompanied by an analytical passport, which contains data on the amount of active substances contained in this raw material. This information is indicated either as a percentage (alkaloids) or as the number of biological units (IU) per 1.0 g of raw material.

Example 1

According to the pharmacopoeia, standard adonis herb must contain at least 50 units per 1.0 g of raw material.

A herb containing 70 units per 1.0 g was obtained.

You should take less grass, namely: x = 6.0. 0.5: 0.7 = 4.3 g.

2. Raw material grinding degree

For various types raw materials there is a certain optimal particle size, below which it is undesirable to grind the material. According to the Global Fund, plant materials must be crushed in accordance with the requirements of regulatory documents (see articles on medicinal plant materials).

Rule 3

Optimal grinding:

For leaves, flowers, herbs, particle size reduction is considered to be no more than 5 mm, with the exception of bearberry, eucalyptus, and lingonberry leaves - no more than 1 mm;

Stems, bark, rhizomes and roots are crushed to 3 mm;

Fruits and seeds - no more than 0.5 mm.

The raw materials must be screened out from dust, since ballast substances swell in water, the mass will stick together, be enveloped in air and be poorly wetted.

3. Ratio of raw materials and extractant Rule 4

In accordance with the Global Fund, in the absence of instructions in the recipe about the amount of medicinal plant raw materials, infusions and decoctions are prepared in a ratio of 1:10,

From marshmallow roots - 1:20;

From adonis herb, rhizomes with valerian roots - 1:30;

Flax seed mucilage - 1:30.

Extracts from medicinal plant materials containing potent substances are prepared in a ratio of 1:400.

Rule 5

If the prescription does not specify the concentration, then the standard ratio is used and the doses are not checked. If the recipe specifies a ratio, then the doses for list B drugs must be checked.

Example 2

Rp.: Decocti corticis Quercus 210 ml D.S. Rinse (2 times a day).

Since the ratio is not specified, and oak bark is not a potent drug, a ratio of 1/10 is taken, i.e. 21 g of oak bark should be taken.

Rule 6

The recipe prescribes the amount of finished extract, not the water required to obtain it.

The volume of purified water is calculated using the formula: volume of extraction + weighed portion of the drug. water absorption coefficient. Water absorption coefficient (WAC) is the amount of extraction retained by 1 g of plant material after squeezing it in a perforated glass of infundirka.

The CVP of medicinal products for the most commonly used types of raw materials are presented in Table. 23.1.

Table 23.1.Water absorption coefficients of herbal medicinal products

End of table. 23.1

name of raw materials	Coefficient, ml/g
Roots of origin
Licorice roots
Serpentine rhizomes
Rhizomes with valerian roots
Rhizomes with burnet roots
Potentilla rhizomes
Lingonberry leaves
nettle leaves
Coltsfoot leaves
Mint leaves
Plantain leaves
Senna leaves
Bearberry leaves
Sage leaves
Rowan fruits
Dog-rose fruit
Adonis grass
St. John's wort herb
Lily of the valley grass
Artemisia grass
Motherwort grass
Cushion herb
Horsetail grass
Grass succession
Linden flowers
Chamomile flowers
Hop cones

Note.If there is no KVP for raw materials, it is recommended to use the following values:

For roots and rhizomes - 1.5 ml/g;

For bark, grass and flowers - 2.0 ml/g;

For seeds - 3.0 ml/g;

For briquettes - 2.3 ml/g.

Example 3

Rp.: 1nlusi foliorum Menthae ex 20.0 - 200 ml

D.S. Rinse 3 times a day.

200 + (20.0 . 2.4) = 248 ml (2.4 - KVP of mint leaves).

Rule 7

GF requires, after pressing the raw material, to measure the volume of extraction and add water to the prescribed volume of extraction after filtering through the same layer of filter material.

Rule 8

When preparing aqueous extracts from plant materials, you cannot use concentrates of salts and medicinal substances from a burette unit.

23.3. TECHNOLOGICAL SCHEME FOR OBTAINING WATER EXTRACTS OF medicinal products

In pharmacy, 2 types of extracts from medicinal plants are accepted (Scheme 23.1).

23.4. PRIVATE TECHNOLOGY FOR OBTAINING WATER EXTRACTIONS

A. Raw materials containing alkaloids

When making infusions from raw materials containing alkaloids, hydrochloric acid is added to water in an amount equivalent to the mass of alkaloids. Hydrochloric acid is taken in terms of pure hydrogen chloride. The introduction of acid leads to the formation of highly soluble salts from sparingly soluble alkaloid bases. Extraction mode and technology - according to accepted rules.

The exception is ergot horns, which are infused in a water bath for 30 minutes and artificially cooled, given their thermolability.

Example 4

Rp.: Infusi herbae Thermopsidis 200 ml Natrii hydrocarbonatis 2.0,

Scheme 23.1.Technology of aqueous extracts from MP

Liquoris Ammonii anisati 4 ml

Thermopsis herb belongs to the group of potent medicinal plant materials, therefore, in accordance with the instructions of the Global Fund, the infusion is prepared in a concentration of l: 400, i.e. take 0.5 g of thermopsis grass. Thermopsis grass must contain at least 1.5% alkaloids. When using raw materials with a large amount of active ingredients (in our example - 1.7% alkaloids), the weight of non-standard raw materials is: x = 0.5. 1.5: 1.7 = 0.44 g.

Acid is calculated as follows:

1.7 - 100.0; x - 0.44; hence x = 0.0075 g.

0.44 g of thermopsis herb contains 0.0075 g of alkaloids, therefore hydrochloric acid 0.83% should take 0.0075 g, or:

0.83 - 100 ml; 0.0075 - x, i.e.

x = 0.0075. 100: 0.83 = 0.9 ml (18 drops).

Take 200 ml of water for infusion (KVP is not taken into account, since the herbs are less than 1.0 g).

Place 0.44 g of thermopsis grass, crushed to 5 mm, into an infundibulum glass, add 200 ml of purified water and 18 drops of a solution of hydrochloric acid (1:10). Leave in the infusion apparatus for 15 minutes and cool for 45 minutes with occasional stirring. 4.0 g of sodium bicarbonate is dissolved in the cooled and strained infusion. The resulting solution is filtered again and brought to the required volume with water. Add ammonia-anise drops to the center of the bottle and shake carefully. Design the bottle.

B. Raw materials containing tannins

This group of raw materials includes: oak bark (Cortex Quercus), cinquefoil rhizomes (Rhizoma Tormerttillis), coil (Bistortae), bearberry leaves (Folia Uvae Ursi) and etc.

Aqueous extracts from raw materials containing tannins are filtered after infusion without cooling. Bearberry leaves contain at least 6% arbutin, which, when hydrolyzed, forms hydroquinone, which has antiseptic and diuretic properties. Glycosides are always accompanied by tannins, which adsorb compounds of this class on their surface. When cooled for 10 minutes, arbutin is precipitated along with tannins, which is filtered out along with the leaves. Therefore, the extracts are squeezed out and filtered without cooling. In addition, raw materials cannot be infused using metal objects.

B. Raw materials containing saponins

This group includes: licorice root, senega root, istoda, etc. Features:

- a decoction is always prepared;

- the extractant must have an alkaline reaction, therefore, if NaHCO 3 is prescribed in the recipe, then it is added to the base mixture with the raw materials and extractant, and infusion is carried out with it. If NaHCO 3 is not prescribed in the recipe, then it is added at the rate of 1.0 per 10.0 raw materials.

D. Raw materials containing anthraglycosides

This group of raw materials includes rhubarb roots (Radix Rhei) buckthorn bark (Cortex Frangulae), senna leaf (Folium Sennae), Joster fruits, etc. From these raw materials decoctions are always prepared. Only in the form of a decoction can anthraglycosides be extracted.

Decoctions of rhubarb root should be filtered immediately after removal from the water bath, otherwise the amount of hydroxymethylanthraquinones will decrease. Rhubarb root contains pharmacological antagonists: anthraglycosides (which determine the laxative effect), tannoglycosides, which determine the fixing effect.

An exception is a decoction of senna leaves. It is completely cooled since resinous substances that cause side effect(cutting).

D. Medicinal plant materials containing mucous substances

This is marshmallow root, flax seeds.

Marshmallow root(Radix Althaeae)contains up to 10% mucus and 38% starch. It is necessary to obtain an extract with a maximum mucus content and a minimum amount of starch, which in this case is a ballast substance.

In order to prevent the mechanical transition of starch grains, marshmallow roots are infused for 30 minutes at room temperature; After infusion, the broth is poured through a layer of gauze without squeezing.

Therefore, unlike other radars, to calculate the amount of marshmallow roots and water, instead of the CVP, the consumption coefficient (Cr.) is used. Kraskh. shows how many times the amount of root and water should be increased to obtain the required amount of extraction. If the recipe does not indicate the amount of marshmallow roots, a 5% infusion is prepared based on GF, i.e. take 5 parts of marshmallow root

and 100 parts purified water. Kraskh. other concentrations are indicated in the order of the Ministry of Health? 308.

Example 5

Rp.: Decoctum Radix Althaeae 100 ml.

Since the recipe does not indicate the concentration, a 5% extraction is prepared. 6.5 g of chopped marshmallow roots (Col. = 1.3) pour into 130 ml cold water(Col. = 1.3), leave at room temperature for 30 minutes. After which the liquid is drained without squeezing out the remainder, and filtered through gauze into a dispensing bottle. Thus, to obtain a 5% infusion of raw marshmallow root, you need to take 130 ml of water (100 × 1.3).

Flax seed mucilage. Flax seeds contain 6% mucilage and 35% fatty oil. The mucilage is found in the epidermis of the seed coat and is extracted very quickly.

Fatty oils are a ballast substance; they can go rancid and become medicinal bad taste and smell. To prevent this from happening, you should not use crushed seeds so that the fatty oils are not extracted.

The mucus is prepared at 1:30 unless a different ratio is indicated.

When calculating water, Kr, KVP are not used, since the raw material does not absorb water.

The mucilage is obtained by shaking the seeds with hot water (not less than 95? C). In this case, the bottle must be of a significantly larger volume than the volume of the dosage form being manufactured, and it must be properly sealed. To keep the water from cooling for a long time, wrap the bottle in a towel. Shake for 15 minutes. After shaking, the mucus is filtered through 2 layers of gauze into a bottle for release.

E. Raw materials containing cardiac glycosides

These are leaves of foxglove, lily of the valley, adonis herb, etc. When infused:

Standard raw materials are used or recalculation is done. The activity of the raw material is indicated in the written control passport;

- extraction regime must be followed. If you increase the time or temperature during extraction, the cardiac glycosides will be destroyed, since they contain an ether group. Extraction is carried out in a closed infundibulum.

G. Raw materials containing essential oils

These are rhizomes with valerian roots, mint leaves, sage, chamomile flowers, etc.

Peculiarities:

Only infusions are prepared from these raw materials;

- cooked in a tightly closed saucepan(so that essential oils do not evaporate);

- the raw materials are not stirred during infusion;

The infusion is filtered after complete cooling to prevent loss of active ingredients.

23.5. EXTRACT TECHNOLOGY USING EXTRACT-CONCENTRATES

Aqueous extracts from concentrate extracts are prepared much faster. They always turn out the same, since the concentrate extracts are standardized. When preparing aqueous extracts from concentrated extracts, you can use concentrated solutions of medicinal substances. If the doctor prescribed an aqueous extract from the raw material, and the pharmacy has an extract-concentrate of this raw material, then it is easier and faster to use the extract-concentrate. But in this case, on the back of the recipe you need to indicate that the dosage form is prepared from a concentrated extract (in Latin the name of the concentrated extract and its quantity is written). This is done in order not to mislead the patient, since the aqueous extract from the drug and from the extract-concentrate are different in color.

The pharmacy uses 2 types of extract-concentrates:

1. Dry extracts-concentrates - Extracta sissa standartisata. They are prepared in the factory and used in a 1:1 ratio in relation to the pharmaceutical products. For example: thermopsis extract, spring adonis herb, marshmallow roots.

2. Liquid extracts-concentrates - Extracta fluida standartisata. They are also prepared in factory conditions (extraction with a weak ethanol solution of 20-40%). Prepare in a ratio of 1:2, i.e. You need to take 2 times more concentrate extract than the prescription drug.

A. Features of the preparation of aqueous extracts from dry extract concentrates

1. Take the same amount of extract-concentrate as MP.

2. When calculating the concentration (%) of dry water-soluble substances, the dry extract concentrate is also taken into account, since it is soluble in water.

3. Dry extract concentrates are dissolved in water first, regardless of the list of other substances, since dissolution requires a swelling stage (5-15 minutes). They form solutions of unlimitedly swelling high-molecular substances. The exception is the extract-concentrates of the thermopsis herb - without the swelling stage, it can be easily dissolved in a sodium bicarbonate solution if it is prescribed in the recipe.

B. Features of the preparation of aqueous extracts from liquid extract-concentrates (1:2)

1. They take 2 times more than the drug prescribed.

2. When calculating water, it is necessary to subtract the volume of liquid extract concentrate.

3. Is the liquid extract concentrate added as ordered? 308 as a finished liquid medicinal product, given that it contains 20-40% alcohol.

Preparation of aqueous extracts from standardized extract concentrates

Pharmacies widely use liquid extracts of valerian, motherwort and adonis (1:2) and dry extracts of marshmallow, thermopsis and adonis (1:1). The use of extracts greatly speeds up the preparation of infusions. In addition, when adding other components to infusions, you can use a burette system.

Liquid extract concentrates are alcohol-water extracts (20-30% ethanol) from plant raw materials, containing the sum of active substances, maximally purified from ballast substances and standardized by chemical or biological methods to a ratio of 1:2 by weight of the drug. Accordingly, 2 times more concentrate is used.

Example 6

Rp.: Codeini phosphatis 0.2

Dec. rhizomatis cum radicibus Valerianae 180 ml

Sodium bromide 6.0

The number of rhizomes with valerian roots in the absence of instructions in the recipe in accordance with the article of the State Fund X “Infusions and decoctions” is taken in a ratio of 1:30, i.e. 6.0 g, therefore, liquid valerian extract - 1:2 = 12 ml. Calculations for the remaining components of the prescription are carried out according to the “Instructions for the preparation of liquid medicines by the mass-volume method”.

Passport

Codeine phosphate solution 1:10 - 2 ml Sodium bromide solution 1:5 - 30 ml Liquid valerian extract 1:2 - 12 ml Purified water 136 ml Total volume 180 ml

136 ml of purified water, 2 ml of codeine phosphate solution (1:10), 30 ml of sodium bromide solution (1:5) and 12 ml of liquid valerian extract (1:2) are measured into a 200 ml orange glass bottle.

Shake it up. The mixture is prepared for vacation.

23.6. EQUIPMENT FOR THE PRODUCTION OF WATER EXTRACTS

In pharmacy, an infundir apparatus is used. The infusion apparatus AI-3 (Fig. 23.2) is intended for the preparation of infusions and decoctions from medicinal plant materials. It consists of a water or steam bath with porcelain or metal closed vessels (infundir glasses) and a mechanism for squeezing raw materials.

Rice. 23.2.Infoundation apparatus AI-3. Infoundation glass:

1 - cover; 2 - glass made of stainless mesh; 3 - piston for pressing;

4 - handle

23.7. TECHNOLOGY FOR THE MANUFACTURE OF COMPLEX MEDICINES CONTAINING AQUEOUS EXTRACTS

Rule 9

Medicinal substances should be introduced into ready-made strained and cooled extracts. The resulting solutions must be filtered again.

In the case of direct mixing of concentrated salt solutions with infusion concentrates, precipitation or turbidity may form.

Rule 10

The production of multicomponent aqueous extracts from raw materials containing the same group of biological active substances, regardless of the histological structure, is prepared simultaneously in accordance with the order of the Ministry of Health? 308.

Example 7

Quatera potion

Rp.: Infusi rhizomatis cum radicibus Valerianae ex 10.0

Infusi foliorum Menthae ex 4.0

Coffeini-natrii benzoatis 200 ml

Sodium bromidi 0.4

Magnesii sulfatis 0.8 - 3.0

M.D.S. 1 tablespoon 3 times a day.

Extracts from rhizomes and roots of valerian (KVP = 2.9) and mint leaves (KVP = 2.4) are prepared simultaneously, since the same extraction regime is required. In this case, water is taken: 200 + (10.0...2.9) + (4.0...2.4) = 238.6 ml.

After bringing the infusion to the specified volume (200 ml), the prescribed ingredients are dissolved and the infusion is filtered into a bottle.

23.8. DESIGN AND PACKAGING

Extracts are packaged similarly to liquid dosage forms in containers that ensure the preservation of the quality of the drug during the shelf life. The most convenient way is to pack it in orange glass bottles of appropriate capacity.

Labeling of extracts. When labeling, they additionally indicate: “Store in a cool, dark place, avoid freezing”, “Shake before use”, “Shelf life - 2 days”

(order of the Ministry of Health? 214).

23.9. QUALITY CONTROL

Is quality control of water extracts carried out in accordance with the requirements of the orders of the Ministry of Health? 305 and 214.

23.10. EXAMPLES OF FREQUENTLY REPEATED CREDITS (ORDER OF THE USSR Ministry of Health? 223 of 08/12/1991)

1. Infusion of rhizomes with valerian roots

Rp.: Infusi rhizomatis cum radicibus Valerianae 10.0-200 ml M.D.S. 1 tablespoon 3 times a day.

Action and indications: has a sedative effect, enhances the effect of sleeping pills, and has antispasmodic properties. Used for nervous excitement, insomnia, cardiac neuroses vascular system, spasms of the gastrointestinal tract, etc.

2. Infusion of adonis herb 3; 4; 5%

Rp.: Infusi herbae Adonidis vernalis 6.0 (8.0; 10.0) 200 ml M.D.S. 1 tablespoon 3-4 times a day.

Action and indications: as a cardiotonic. Has a calming effect on the central nervous system and reduces the excitability of motor centers. Used for chronic failure blood circulation, heart neuroses, neurasthenia.

3. Infusion of rhizomes with valerian roots with sodium bromide Rp.: Infusi rhizomatis cum radicibus Valerianae 10.0-200 ml Natrii bromidi 4.0

M.D.S. 1 tablespoon 3 times a day.

Action and indications: has a sedative effect, enhances the effect of sleeping pills, and has an antispasmodic effect. Used for nervous excitement, insomnia, neuroses of the cardiovascular system, spasms of the gastrointestinal tract, etc.

4. Infusion of motherwort herb with sodium bromide Rp.: Inf.herbae Leonuri 10.0-200.0 (12.0-200) ml 12.0-200 ml Natrii bromidi 4.0 (3.0)

M.D.S. 1 tablespoon 3 times a day. Take 3-4 weeks; for children - the dosage is 2 times less.

Action and indications: as a sedative for increased nervous excitability and cardiovascular neuroses.

5. Marshmallow root infusion

Rp.:Inf. rad. Althaeae 6.0 - 200 ml

M.D.S. 1 tablespoon 3-4 times a day after meals. Action and indications:

6. Thermopsis herb infusion

M.D.S. 1 tablespoon 3-4 times a day.

Action and indications: used as an expectorant for respiratory diseases.

7. Infusion of thermopsis herb with sodium bicarbonate, sodium benzoate and ammonia-anise drops

Rp.:Inf. Thermopsidis 0.6 - 200 ml

Sodium hydrocarbonatis

sodium benzoatis

Liq. Ammonii anisati 4.0 ml

Sirupi Glycyrrhizae 10.0 ml

M.D.S. 1 tablespoon 3 times a day.

Action and indications: has an expectorant and anti-inflammatory effect. Used for respiratory diseases.

8. O creature of lingonberry leaves 10; 20%

Rp.: Dec.fo1.Vitis idaei 10% (20%) - 200.0 ml M.D.S. 1 teaspoon 3 times a day. Action and indications: diuretic.

9. Decoction of bearberry leaves 10; 20%.

Rp.: Dec.fo1 Uvae ursi 10% (20%) - 200.0 ml M.D.S. 1 teaspoon 3 times a day. Action and indications: diuretic.

10. Bekhterev's medicine Rp.: Codeini 0.12

Inf. herb. Adonisidis 6.0 - 200 ml; Sodium bromidi 6.0.

Action and indications: has a sedative and hypnotic effect.

11. Medicine with marshmallow root extract, aminophylline, sugar syrup and alcohol

Rp.: Extr.rad. Althaeae 4.0 Euphyllini 5.0 Sirupi simplicis 30.0

Spiritus aethylici 95% - 50.0 Aq. ad 400 ml

M.D.S. One tablespoon 3 times a day.

Action and indications: has an expectorant, anti-inflammatory and antispasmodic effect. Used for respiratory diseases.

12. Peters potion Rp.: Natrii salicylatis 3.0 Natrii hydrocarbonatis 6.0 Aq. Menthae 30 ml

Aq. pur. ad 100 ml

M.D.S. 1 tablespoon 3 times a day.

Action and indications: anti-inflammatory, analgesic, sedative.

13. Dryagin's potion

Rp.:Inf. rhiz. turn rad. Valerianae 6.0 - 200 ml

Codeini 0.12

Natrii bromidi 6.0 Chlorali hydrati 4.0 Tinct. Valerianae 4 ml

M.D.S. 1 tablespoon 3 times a day. Action and indications: sedative.

Control questions

1. What are the main requirements for aqueous extracts?

2. In what ways is the concentration of medicinal products indicated?

3. How is GF infusions and decoctions characterized?

4. What techniques speed up the extraction of medicinal substances?

5. What equipment is used?

6. How to prepare a solution from aqueous extracts?

7. What is the water absorption coefficient, and how is it used in the preparation of aqueous extracts?

Tests

1. Infusions and decoctions - dosage form:

1. Official.

2. Unofficial.

2. The peculiarity of these dosage forms is that they are used to treat:

1. Acute emergency diseases.

2. Sluggish, chronic diseases.

3. Shelf life of aqueous extracts from MP:

1. 2 days.

2. 3 days.

3. 10 days.

4. To prepare aqueous extracts the following should be used:

1. Standard raw materials or high quality raw materials.

2. Raw materials with a reduced content of active ingredients.

5. Rp.: Infusi herbae Adonidis vernalis ex 6.0 - 200 ml D.S. A tablespoon 3 times a day.

According to the pharmacopoeia, standard adonis herb must contain at least 50 units per 1.0 g of raw material. A herb was obtained containing 70 units per 1.0 g. Herbs should be taken:

1. 4.3 g.

2. 6.0 g.

3. 7.4 g.

6. Optimal grinding for leaves, flowers, herbs - no more than:

1.3 mm.

2.5 mm.

3. 1 mm.

7. The optimal grinding of stems, bark, and rhizomes is considered to be:

1. 1 mm.

2.3 mm.

3.5 mm.

8. Extracts from medicinal plant materials containing potent substances are prepared in the following ratio:

1. 1:400.

2. 1:200.

3. 1:10.

9. Choose the wrong answer.

1. If the concentration is not specified in the recipe, then the standard ratio is used and the doses are not checked.

2. If a ratio is indicated in the recipe, then the doses for list B drugs must be checked.

3. Doses of drug lists A and B are always checked.

10. Rp.: Decocti corticis Quercus 150 ml. To make the recipe you need crushed oak bark:

1. 10.0 g.

2. 15.0 g.

3. 0.5 g.

11. Water absorption coefficient - the amount of extraction retained by 1 g of plant material after:

1. His push-ups in a perforated glass of infundirka.

2. Squeeze it and strain it into a graduated cylinder.

12. If there is no water absorption coefficient for raw materials, it is recommended to use the following value for roots and rhizomes:

1. 1.0 ml/g.

2. 1.5 ml/g.

3. 2.0 ml/g.

4. 3.0 ml/g.

13. If there is no water absorption coefficient for raw materials, it is recommended to use the following value for bark, grass and flowers:

1. 1.0 ml/g.

2. 1.5 ml/g.

3. 2.0 ml/g.

4. 2.3 ml/g.

5. 3.0 m l/g.

14. If there is no water absorption coefficient for raw materials, it is recommended to use the following value for seeds:

1. 1.0 ml/g.

2. 1.5 ml/g.

3. 2.0 ml/g.

4. 2.3 ml/g.

5. 3.0 m l/g.

15. Rp.: Infusi foliorum Menthae ex 20.0 - 200 ml. D.S. Rinse 3 times a day.

Purified water for infusion should be taken:

1. 200 ml.

2. 248 ml.

3. 260 ml.

4. 243 ml.

16. GF requires, after pressing the raw material, to measure the extraction volume and add water to the prescribed extraction volume:

1. After filtering.

2. After filtering, through the same layer of filtered material.

3. Before filtering.

17. When preparing aqueous extracts from plant materials, you cannot use concentrates of salts and medicinal substances:

1. Freshly prepared.

2. Hot.

3. From a burette setup.

4. Unfiltered.

18. Infusions are obtained from the leaves:

1. Lingonberries.

2. Bearberry.

3. Nettles.

4. Eucalyptus.

19. Leaves, flowers, herbs are crushed to particle size:

1. Not less than 5 mm.

2. No more than 5 mm.

3. Not less than 1 mm.

4. No more than 1 mm.

20. When making infusions from raw materials containing alkaloids, acid is added to water:

1. Sulfur.

2. Phosphorus.

3. Hydrochloric acid.

4. Vinegar.

21. Aqueous extracts from raw materials containing tannins, after infusion:

1. Don't strain.

2. Strain without refrigeration.

3. Strain after cooling.

22. For raw materials containing saponins, the extractor must have the reaction:

1. Alkaline.

2. Sour.

3. Neutral.

23. Rp.: Decoctum Radix Althaeae 100 ml. To prepare the water recipe you need to take:

1. 123 ml.

2. 100 ml.

3. 130 ml.

24. Rp.: Decoctum Radix Althaeae 100 ml. To prepare the marshmallow recipe you need to take:

1. 6.5 g.

2. 6.0 g.

3. 5.0 g.

25. Infusions from raw materials containing essential oils:

1. Cook with constant stirring.

2. Prepare in a tightly closed container.

3. Cook without closing the container.

4. Strain without cooling.

5. Add hydrochloric acid.

Ministry of Health of the Russian Federation

Federal state budget educational institution

Higher education

FIRST MOSCOW STATE MEDICAL

I.M. SECHENOV UNIVERSITY

FACULTY OF PHARMACEUTICS

DEPARTMENT OF PHARMACOGNOSY

Guide to practical exercises

By pharmacognosy

Topic: Mastering methods of pharmacognostic analysis

Moscow 2016

TOPIC 1

PHARMACOGNOSTIC ANALYSIS METHODS

On practical exercises the student receives skills and practical skills to solve professional problems in the analysis of whole medicinal plant materials in accordance with state quality standards.

To implement quality control competencies, students must use the State Pharmacopoeia of the Russian Federation (http://www.femb.ru/feml), which reflects modern requirements to the quality of all medicinal products, including medicinal plant materials and medicinal herbal preparations, methods for determining quality and standards. the federal law No. 61 “On the Circulation of Medicines” includes Chapter 3 “State Pharmacopoeia”.

To the Federal State educational standard The specialty “Pharmacy” includes the following professional competencies:

Ø ability and willingness to analyze and evaluate the quality of medicinal plant raw materials (plant organs used, histological structure, chemical composition of active and other groups of biologically active substances);

date_______ LESSON 1

DETERMINING THE AUTHENTICITY OF WHOLE LEAVES

Independent work(preparation for class)

Exercise 1. Analyze the OFS. 1.5.1.0001.15 “Medicinal plant raw materials. Pharmaceutical substances of plant origin", OFS.1.5.3.0004.15 "Determination of authenticity, grinding and impurity content in medicinal plant raw materials and medicinal herbal preparations", OFS. 1.5.1.0003.15 “Leaves. Folia" Write down the definitions of the concepts:

« Medicinal plant » -___________________

« Medicinal plant raw materials» - _________

"Pharmaceutical substance of plant origin" -

« Authenticity» - _____________________________

Medicinal plant raw materials " Leaves» - ____

Which document regulates the analysis of medicinal plant raw materials “leaves”? ___

Task 2. Sketch the shape of the leaves lily of the valley, stinging nettle, bearberry, foxglove.

Task 3. Sketch the leaf veins plantain and foxglove grandiflora.

Task 4. Sketch the edge of the sheet foxglove purple, peppermint, lily of the valley, coltsfoot.

Task 5. Sketch the types of leaf stomatal complexes lingonberry, peppermint, three-leaf watch, belladonna, lily of the valley and give their names.

Task 6. Sketch the types of simple and capitate hairs and give examples of LRS “leaves” where they are found.

Simple hairs	Capitate hairs
Structure	Drawing	LRS	Structure	Drawing	LRS
unicellular, smooth			single-celled head on a single-celled stalk
Unicellular "retort-shaped"			two-cell head on a one-cell stalk
2–4-celled, with a warty surface			single-celled head on a multicellular stalk
3–4 cell, top cell long, strongly curved			multicellular head on a unicellular stalk
			multicellular head on a multicellular stalk

Write down in which tissue the hairs are located:________________________________

Task 7. Sketch the types of calcium oxalate inclusions in leaves. stinging nettle, lily of the valley, cassia (senna) holly, belladonna.

Write down in which tissue calcium oxalate inclusions are located: ____________

Task 8. Sketch the secretory structures found in leaves peppermint, wormwood, eucalyptus and indicate their location.

“Input control passed” ___________________ “____”________ 20___ G.

(teacher signature)

WORK IN CLASS

Note:

Ø The authenticity of the “leaves” plant during the lesson is established in accordance with the sections of the FS “External signs” and “Microscopy”.

Ø When studying the external characteristics of leaves, the size and shape (except for leathery leaves) are determined visually on soaked raw materials, other characteristics - on dry raw materials. The smell is established by grinding the raw materials. Taste is determined only in non-poisonous plants in aqueous extract or by chewing the raw material (without swallowing).

Ø During microscopic analysis of the sample, it is necessary to establish the localization of diagnostic signs by tissue (epidermis, mesophyll).

Ø Regulatory documentation is used only at the final stage of raw material analysis to compare the results obtained and write a conclusion on the authenticity of the proposed sample. If a sample of raw materials does not comply with the requirements of the FS, it is necessary to indicate for which sections there is a discrepancy.

Task 1. Carry out an analysis of the proposed sample of raw materials in the sections “External signs” and “Microscopy” of the ND. Prepare an analysis protocol.

ANALYSIS PROTOCOL

Whole medicinal plant raw materials were received for analysis (Russian, Latin names )_____

Producing plant(s) ( Russian, Latin names)________________________

Family ( Russian, Latin names)__________

The quality of the analyzed drug is regulated ( name, number)_____________________

Raw materials are _______________________

Exercise 1. Conduct a macroscopic analysis of the raw material and describe its external characteristics in the form of a table:

Task 2. Swipe microscopic analysis raw materials.

1. Write down the method for preparing a microscopic specimen of a leaf from the surface: _________

2. Prepare a microscopic specimen of the _________________ leaf from the surface, study it, sketch it anatomical structure and give the designations of the signs.

3. Fill out the table of distribution of diagnostic characteristics by tissue:

4. Make a conclusion about the compliance of medicinal plant raw materials with the sections “External signs” and “Microscopy” of the FS.

Conclusion. The raw materials received for analysis ________ ___conform (do not comply) with the requirements of Article_____ GF XIII, sections “External signs” and “Microscopy”.

Task 2. Familiarize yourself with samples of the herbarium of medicinal plant materials of coltsfoot, plantain, eucalyptus species, sage, peppermint, lingonberry, bearberry, and stinging nettle.

“The minutes of the lesson have been passed” ___________________ “____”________ 20___ G.

(teacher signature)

Reference materials

State Pharmacopoeia of the Russian Federation XIII edition, vol. 2

GPM.1.5.1.0001.15 Medicinal plant raw materials. Pharmaceutical substances

plant origin

The requirements of this general pharmacopoeial article apply to medicinal plant raw materials and pharmaceutical substances of plant origin.

Basic terms and definitions

Medicinal plant raw materials - fresh or dried plants, or parts thereof, used for the production of medicines by drug manufacturing organizations or for the manufacture of medicines pharmacy organizations, veterinary pharmacy organizations, individual entrepreneurs with a license for pharmaceutical activities.

Pharmaceutical substance of plant origin - standardized medicinal plant raw materials, as well as substance/substances of plant origin and/or combinations thereof, products of primary and secondary synthesis of plants, including those obtained from plant cell culture, sums of biologically active substances of plants, products obtained by extraction, distillation, fermentation or other processing of medicinal plant materials, and used for the prevention and treatment of diseases.

Herbal medicinal product is a medicinal product produced or prepared from one type of medicinal plant raw material or several types of such raw materials and sold prepackaged in secondary (consumer) packaging.

Medicinal plant raw materials can be represented by various morphological groups: grass, leaves, flowers, fruits, seeds, bark, buds, roots, rhizomes, bulbs, tubers, corms and others.

According to grinding, medicinal plant raw materials can be:

Whole;

Shredded;

Powder.

Medicinal plant raw materials are distinguished by the presence of main groups of biologically active substances used to standardize medicinal plant raw materials, for example, raw materials containing flavonoids, cardiac glycosides, alkaloids, anthracene derivatives, tannins, etc.

According to their intended purpose, medicinal plant materials are divided into raw materials:

Used for the production of medicinal herbs

preparations (for example, flowers crushed in packs, powder in filter bags);

Used for making medicinal herbs

drugs (for example, infusions, decoctions).

PRODUCTION

Medicinal plant materials and pharmaceutical substances of plant origin are obtained from cultivated or wild plants. To ensure the quality of medicinal plant raw materials and pharmaceutical substances of plant origin, it is necessary to comply with the appropriate rules for cultivation, procurement, drying, grinding and storage conditions. In medicinal plant materials and pharmaceutical substances

of plant origin, the content of foreign impurities is allowed, both organic (parts of other non-poisonous plants) and mineral (soil, sand, pebbles) origin in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of the authenticity, grinding and content of impurities in medicinal plant raw materials and medicinal herbal preparations.”

Medicinal plant raw materials and pharmaceutical substances of plant origin used for the production and manufacture of medicines must comply with the requirements of the relevant pharmacopoeial articles or regulatory documentation.

To carry out analysis in order to determine the compliance of the quality of medicinal plant raw materials and pharmaceutical substances of plant origin and medicinal herbal preparations obtained from them with the requirements of the pharmacopoeial monograph or regulatory documentation, uniform sampling requirements are established (in accordance with the requirements of the General Pharmacopoeia Monograph "Sampling of medicinal plant raw materials and medicinal herbal drugs").

When producing infusions and decoctions from medicinal plant raw materials and pharmaceutical substances of plant origin, the water absorption coefficient and consumption coefficient are determined in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of the water absorption coefficient and consumption coefficient of medicinal plant raw materials.”

QUALITY INDICATORS AND TESTING METHODS OF MEDICINAL PLANT RAW MATERIALS

Authenticity. Medicinal plant raw materials are identified by macroscopic (external) and microscopic (anatomical) characteristics (in accordance with the requirements of the General Pharmacopoeia Monograph for the morphological group of raw materials and the General Pharmacopoeia Monograph “Technique for microscopic and microchemical examination of medicinal plant raw materials and medicinal herbal preparations”), and also determine the presence of medicinal substances in the analyzed drug plant raw materials of the main groups of biologically active substances, confirming their authenticity (in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of authenticity, grinding and impurity content in medicinal plant raw materials and herbal preparations”). For this purpose, methods of physicochemical, chemical, histochemical and microchemical analysis are used.

Grinding. The determination is carried out in accordance with the General Pharmacopoeia Monograph “Determination of authenticity, grinding and impurity content in medicinal plant raw materials and medicinal herbal preparations.”

Humidity. The determination is carried out in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of moisture content of medicinal plant materials and medicinal herbal preparations”.

Common ash. The determination is carried out in accordance with the requirements of the General Pharmacopoeia Monograph “General Ash”. Does not apply to plant cell culture.

Ash, insoluble in hydrochloric acid. The determination is carried out in accordance with the requirements of the General Pharmacopoeia Monograph “Ash, insoluble in hydrochloric acid.” Does not apply to plant cell culture.

Organic and mineral impurity. The determination is carried out in accordance with the General Pharmacopoeia Monograph “Determination of authenticity, grinding and impurity content in medicinal plant raw materials and medicinal herbal preparations.” Does not apply to plant cell culture.

Pest infestation of stocks. The determination is carried out in accordance with the General Pharmacopoeia Monograph “Determination of the degree of contamination of medicinal plant raw materials and medicinal herbal preparations by stock pests.” This indicator is assessed during the storage of medicinal plant raw materials and when they enter processing.

Heavy metals. The determination is carried out in accordance with the General Pharmacopoeia Monograph “Determination of the content of heavy metals and arsenic in medicinal plant materials and medicinal herbal preparations.”

Radionuclides. The determination is carried out in accordance with the General Pharmacopoeia Monograph “Determination of radionuclide content in medicinal plant raw materials and medicinal herbal preparations.”

Residues of pesticides. The determination is carried out in accordance with the General Pharmacopoeia Monograph “Determination of the content of residual pesticides in medicinal plant raw materials and medicinal herbal preparations” at the stage of the technological process.

Microbiological purity. The determination is carried out in accordance with the General Pharmacopoeia Monograph “Microbiological Purity”.

Quantitation. The content of biologically active substances that determine the pharmacological effect of medicinal plant raw materials is determined by the method specified in the pharmacopoeial monograph or regulatory documentation. Methods used for the quantitative determination of the main groups of biologically active substances must be validated.

Depending on the purpose of medicinal plant raw materials, the content standards for one, two or more groups of biologically active substances can be given for the same type of medicinal plant raw material.

In medicinal plant raw materials, quantitative determination is carried out:

Extractive substances - in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of the content of extractive substances in medicinal plant materials and medicinal herbal preparations”;

Essential oil - in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of essential oil content in medicinal plant raw materials and medicinal herbal preparations”;

Fatty oil - in accordance with the requirements of the General Pharmacopoeia Monograph “Vegetable Fatty Oils”;

Tannins - in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of content tannins in medicinal plant raw materials and medicinal herbal preparations.”

Other groups of biologically active substances in accordance with the requirements of pharmacopoeial articles or regulatory documentation.

The content of biologically active substances related to toxic and potent substances (cardiac glycosides, alkaloids, etc.) is indicated with two limits “no less” and “no more”. If the content of these groups of biologically active substances in medicinal plant raw materials is too high, its further use for the production of medicinal products is allowed, which is calculated using the formula:

where t is the amount of medicinal plant raw materials required for the production of medicinal herbal preparations, g;

A - prescribed amount of medicinal plant raw materials, g:

B - the actual number of units of action in the raw material or the content of biologically active active substances in 1 g of raw material in%;

B is the standard content of action units in raw materials or the content of biologically active active substances in 1 g of raw materials in %.

Packaging, labeling and transportation. Carried out in accordance with the requirements of the General Pharmacopoeia Monograph “Packaging, labeling and transportation of medicinal plant raw materials and medicinal herbal preparations.”

Storage. Carried out in accordance with the requirements of the General Pharmacopoeia Monograph “Storage of medicinal plant raw materials and medicinal herbal preparations”. In the case of using disinfectants, disinfestants and other agents when storing medicinal plant raw materials, it is necessary to confirm that they do not affect the raw materials and are almost completely removed after processing.

OFS. 1.5.1.0003.15 Leaves. Folia.

In pharmaceutical practice, leaves are called medicinal plant materials, which are dried or fresh leaves or individual leaves of a complex leaf. Leaves are usually collected when they are fully developed, with or without a petiole.

External signs. Whole and crushed raw materials. Preparing objects for analysis:

Small and leathery leaves are examined dry;

Large, thin leaves (usually crushed) are softened in a damp chamber or by immersing them in hot water for a few minutes;

Fresh leaves examined without pre-treatment.

The leaves prepared for analysis are laid out on a glass plate, carefully straightened, examined with the naked eye, using a magnifying glass (10x) or a stereomicroscope (8*, 16*, 24*, etc.). Pay attention to the following anatomical and diagnostic signs:

1. Structure (simple, complex - odd-pinnate, pair-pinnate, doubly-pinnate, doubly-unpinnate, palmate, trifolate, etc.) and dimensions of the leaf blade.

2. Leaf blade shape(round, elliptical, broadly elliptical, narrowly elliptical, oblong, ovoid, broadly ovoid, narrowly ovate, obovate, rounded obovate, broadly obovate, lanceolate, heart-shaped, arrow-shaped, spear-shaped, sickle-shaped, needle-shaped, etc.).

3. Depth of dissection of the leaf blade (palmate, pinnate, trifolate, palmate, pinnate, tripartite, palmate, pinnately dissected, trifolate).

4. The nature of the base (round, wide-round, narrow-round, wedge-shaped, narrow wedge-shaped, broadly wedge-shaped, truncated, notched, heart-shaped, etc.) and apex (sharp, rounded, obtuse, notched, elongated, etc.) of the leaf blade.

5. The nature of the leaf edge (solid, serrated, doubly serrated, serrated, crenate, notched).

6. The presence of a petiole, its size.

7. The nature of the surface of the petiole (smooth, ribbed, grooved, etc.).

8. Presence of vagina, stipules (free, fused), characteristics, sizes.

9. Leaf and petiole pubescence (abundance and arrangement of hairs).

10. Leaf venation (in monocots - parallel, arcuate; in dicots - pinnate, palmate; in ferns and primitive seed plants (gingko) - dichotomous).

11. The presence of essential oil glands and other formations on the surface of the leaf or the presence of containers in the mesophyll.

Dimensions are determined using a measuring ruler or graph paper. Measure the length and width of the leaf blade, the length and diameter of the petiole.

The color is determined on both sides of the sheet on dry material in daylight.

The smell is determined by rubbing.

Taste is determined by tasting dry raw materials or aqueous extract of leaves (only for non-poisonous objects).

For crushed leaves, the fineness is determined - the size of the sieve holes through which the mixture of particles passes.

Powder. Examine with the naked eye, using a magnifying glass (10x) or stereomicroscope (8 *, 16*, 24*, etc.). The color of the mixture of particles (the total mass and individual inclusions), the shape of the particles, the origin of the particles and their nature (if determined) are noted. When examined under a magnifying glass or stereomicroscope, attention is paid to the pubescence of the fragments and the nature of the surface (smooth, rough, covered with glands, etc.). Determine smell and taste (similar to whole and crushed leaves). The fineness (the size of the sieve holes through which the mixture of particles passes) is determined.

Microscopy. Whole and crushed leaves. Microslides are prepared in accordance with the General Pharmacopoeia Monograph “Technique for microscopic and microchemical examination of medicinal plant raw materials and medicinal herbal preparations” from whole leaves or pieces of a leaf blade with an edge and vein, pieces of a leaf from the base and apex, pieces of a petiole (if the leaf has a petiole), examining them from the surface. When analyzing thick and leathery leaves (eucalyptus, bearberry, lingonberry), cross sections and “squashed” micropreparations are prepared. If necessary, transverse sections of the petioles are also prepared.

Pay attention to the following anatomical and diagnostic signs:

1. The nature of the cuticle of the upper and lower epidermis (smooth; wrinkled, including longitudinal-wrinkled, transverse-wrinkled, radiant-wrinkled; streaked; comb-shaped, etc.).

2. The shape of the cells of the upper and lower epidermis (isodiametric - round, square, polygonal; polygonal - rectangular, oval, diamond-shaped, spindle-shaped, combined, etc.); tortuosity of the cell walls of the upper and lower epidermis (straight, tortuous, wavy, zigzag, jagged, etc.), degree of tortuosity; thickening of the cell walls of the upper and lower epidermis (uniform, clear-shaped).

3. The presence of stomata, their shape (round, oval), size, frequency of occurrence on the upper and lower epidermis.

4. Type of stomatal apparatus:

Anomocytic type (randomly cellular) - anomocytic (or ranunculoid) - stomata are surrounded by an indefinite number of cells that do not differ in shape and size from the rest of the epidermal cells;

Diacytic type (two-celled) - stomata are surrounded by two parastomatal cells, the adjacent walls of which are perpendicular to the stomatal fissure;

Paracytic type (parallel cell) - on each side of the stomata, one or more parastomatal cells are located along its longitudinal axis;

Anisocytic type (unequal cell) - stomata are surrounded by three parastomatal cells, one of which is significantly smaller than the other two;

Tetracytic type - the stomata is surrounded by 4 symmetrically located parastomatal cells: two cells are parallel to the stomatal fissure, and the other two are adjacent to the poles of the guard cells;

Hexacite type - the stomata is surrounded by 6 parastomatal cells: two pairs are located symmetrically along the guard cells, and two cells occupy polar positions;

Encyclocytic type - side cells form a narrow ring around the guard cells;

Actinocyte type - characterized by several subsidiary cells radiating radially from the guard cells.

5. The presence of water stomata (they are large in size and are usually located at the top of the leaf or clove, above the hydathode).

6. Immersion of stomata in the epidermis (protruding above the epidermis, immersed in the epidermis).

7. The presence and structure of hairs on the upper and lower epidermis (simple and capitate, single- and multicellular, single-, double- and multirowed, fasciculated, branched and unbranched), their sizes, features of the places of their attachment (presence of a rosette), wall thickness (thick, thin walls), the nature of the cuticle (smooth, warty, gritty).

8. The presence of glands on the upper and lower epidermis, their structure, size.

9. The presence of secretory canals, lacticifers, receptacles (in the parenchyma under the epidermis).

10. The presence and structure of crystalline inclusions (single crystals of various shapes, drusen, raphids, styloids, cystoliths, crystalline sand, etc.), their localization (in the parenchyma under the epidermis, in the parenchyma in the form of a crystal-bearing lining around conductive bundles and groups of fibers, rarely in epidermal cells),

11. The presence of inclusions of reserve nutrients: mucus, inulin, etc. (in the parenchyma under the epidermis, less often in the cells of the epidermis).

12. Mesophyll structure (cell shape, uniformity, location, presence of aerenchyma).

13. Leaf structure (dorsoventral, isolateral).

14. The structure of the conducting system of the leaf (shape of the main vein; number, shape, location of vascular bundles in the vein; structure of vascular bundles - location of phloem and xylem, presence of mechanical tissues).

15. The presence of mechanical tissue (collenchyma, sclerenchyma fibers, stone cells, bast fibers, etc.).

16. Petiole structure: on a transverse section of the leaf petiole, indicate its shape in the middle, basal and apical parts (round, triangular, grooved, crescent-shaped, slightly wing-shaped, broad-winged), the number and location of vascular rays, the presence of mechanical tissue (collenchyma, sclerenchyma).

Powder. Micropreparations of leaf powder are prepared in accordance with the General Pharmacopoeia Monograph “Technique for microscopic and microchemical examination of medicinal plant raw materials and medicinal herbal preparations.” In micropreparations of powder, fragments of leaves with the main and secondary veins, fragments of leaves with the edge of the leaf blade, fragments of the leaf apex, fragments in cross section, fragments of the petiole are examined. In the studied powder particles, all the manifesting anatomical and diagnostic signs listed for whole and crushed leaves are noted. Pay attention to the fact that a number of elements (hairs, glands, crystals, druses, etc.) can be separated from leaf particles; in the powder there are many tissue fragments and individual elements: hairs and their fragments, glands, individual crystals of calcium oxalate and fragments of the crystalline lining, mechanical cells - fibers, sclereids, fragments of secretory canals, receptacles, lacticifers, etc.

In a powder with a particle size of more than 0.5 mm, in the fragments under consideration, almost all the features characteristic of whole and crushed raw materials can be distinguished. Some elements of the epidermis may be in the form of fragments of hairs, glands, etc.; due to cell destruction, individual crystals, drusen, etc. may occur.

It is even more difficult to identify anatomical and diagnostic features in powdered medicinal plant raw materials with a particle size of less than 0.5 mm. There may also be fragments of various parts of the leaf epidermis, however, if possible, more attention should be paid to single elements: individual hairs, glands, crystals, cell features, etc.

In the powder of medicinal plant raw materials with a particle size of less than 0.5 mm, attention is paid to the structural features of the cells and the presence of single elements of the epidermis and mesophyll of the leaf - individual hairs, glands, their fragments, crystals, etc.

A description of the main diagnostic signs should be accompanied by illustrative material.

Luminescence microscopy. Consider dry powder, less often a cross-section of a sheet, prepared from whole or crushed raw materials after preliminary softening in a humid chamber. The raw material's own (primary) fluorescence is observed in ultraviolet light. The brightest glow is found in the cuticle, cell membranes of mechanical tissues, xylem elements, hairs, the contents of individual cells or mesophyll tissues, and leaf epidermis, depending on their chemical composition. The leaves of some plants are characterized by a bright and specific glow of the contents of the glands, secretory channels and receptacles, depending on the chemical composition of the contents.

Qualitative microchemical and histochemical reactions

carried out in micropreparations of leaves (on cross sections, preparations from the surface, in powder), most often in order to detect thick cuticle, essential oil (can be presented in the form of drops or enclosed in containers and/or tubules), as well as mucus in accordance with requirements of the General Pharmacopoeia Monograph “Technique for microscopic and microchemical examination of medicinal plant raw materials and medicinal herbal preparations.”

Qualitative reactions are carried out using extracts from leaves according to the methods given in pharmacopoeial monographs or regulatory documentation.

Chromatography. The extracts are analyzed using various chromatographic techniques using standard samples. Most often, components of essential oils, flavonoids, etc. are determined chromatographically in extracts from leaves.

Spectrum (UV spectrum). The analysis is carried out in extracts from leaves if there are appropriate instructions in the pharmacopoeial monograph or regulatory documentation. A reference to the “Quantitative Determination” section is permitted. A description of the conditions for recording the spectrum is given, indicating the wavelengths at which the absorption maximum(s) and minimum(s) should be observed.

In whole, crushed raw materials and powder the following is determined:

It is possible to determine extractive substances in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of the content of extractive substances in medicinal plant raw materials and medicinal herbal preparations”;

Humidity in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of humidity of medicinal plant raw materials and medicinal herbal preparations”;

hydrochloric acid, in accordance with the requirements of the General Pharmacopoeia Monograph “Total Ash” and the General Pharmacopoeia Monograph “Ash insoluble in hydrochloric acid”;

Grinding and impurity content in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of authenticity, grinding and

The weight of the package contents must comply with the requirements of the General Pharmacopoeia Monograph “Sampling of medicinal plant materials and medicinal herbal preparations.”

Pest infestation of stocks. The determination is carried out in accordance with the General Pharmacopoeia Monograph

“Determination of the degree of contamination of medicinal plant raw materials and medicinal herbal preparations by stock pests.”