State Pharmacopoeia 13th edition Ministry of Health. State Pharmacopoeia of the Russian Federation XIII edition published in the Federal Electronic Medical Library

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

PHARMACOPOEIAL ARTICLE

GinsengpresentrootsFS.2.5.0013.15

Panacis ginseng radices In return for the Global FundXI, vol. 2, Art. 66

Collected in late August - early September and dried roots of the wild and cultivated perennial herbaceous plant true ginseng - Panax ginseng C. A. Mey, sem. Araliaceae – Araliaceae.

AUTHENTICITY

External signs. Whole raw materials. Roots up to 25 cm long, 0.7–2.5 cm thick, with 2–5 large branches, less often without them. The roots are taprooted, longitudinally, less often spirally wrinkled, fragile, with an even fracture. The “body” of the root is thickened, almost cylindrical, with clearly defined annular thickenings on top. In the upper part of the root there is a narrowed transversely wrinkled rhizome - a “neck”. The rhizome is short with several scars from fallen stems; at the top it forms a “head”, which is an expanded remainder of the stem and an apical bud (sometimes 2–3). One or more adventitious roots sometimes extend from the “neck”. The “neck” and “head” may be missing. The color of the roots on the surface and on the cut is yellowish-white, on a fresh fracture it is white. The smell is specific. The taste of the water extract is sweet, pungent, then spicy-bitter.

Crushed raw materials. When examining crushed raw materials under a magnifying glass (10×) or a stereo microscope (16×), pieces of roots are visible various shapes passing through a sieve with holes measuring 7 mm. The color on the surface and on the fracture is yellowish-white. The smell is specific. The taste of the water extract is sweet, pungent, then spicy-bitter.

Powder. When examining the powder under a magnifying glass (10×) or a stereo microscope (16×), a mixture of crushed particles of roots of various shapes of a yellowish-white color is visible, passing through a sieve with 2 mm holes. The smell is specific. The taste of the water extract is sweet, pungent, then spicy-bitter.

Microscopic signs. Whole raw materials. A cross section of the main root reveals a narrow layer of light brown plug, wide bark, a clear cambium line and wood.

The main root is covered with periderm, the cells of which are thin-walled and lignified, non-suberized. Phloem and xylem are separated by the cambial zone, which runs approximately through the middle of the root radius and

sometimes it is not visible. To the periphery, large-celled primary radial rays of parenchyma tissue extend from the primary xylem, between which there is secondary xylem, intersected by numerous secondary radial rays of the main parenchyma. Xylem consists of thin-walled parenchyma cells containing starch grains. The vessels of the medullary rays have thickened, lignified walls and are located singly or collected in groups of 3–6. Cells containing yellow pigments are occasionally found in the wood parenchyma. In the center of the root there are vaguely recognizable remains of primary xylem in the form of 2 rays. Phloem consists mainly of small-celled elements; it contains clearly visible schizogenic containers containing droplets of secretion from light yellow to red-brown. Starch grains are small, round, simple. Individual parenchyma cells contain drusen of calcium oxalate. The outer part of the secondary cortex is bordered by a zone of several (4–6) rows of large tangentially elongated parenchyma cells of the phelloderm, round or oval, with a slightly thickened shell.

Picture – Real ginseng roots.

1 – fragment of a cross section of the main root (100×); 2 – cork fragment (400×); 3 – fragment of a cross section of an adventitious root: a – xylem vessels, b – starch grains (400×); 4 – fragment of a cross section of the main root with a secretory canal: a – lining cells of the canal, b – canal cavity (400×); 5 – fragment of the parenchyma of the medullary rays: a – calcium oxalate drusen, b – starch grains (400×); 6 – parenchyma cells of the medullary ray (100×).

On a cross section of an adventitious root, in the center, a ray of vessels of the primary xylem is the remnant of the diarchic vascular bundle in the primary structure. Two sectors of secondary xylem are separated by radial rays of the main parenchyma. Parenchyma cells are round or oval, partially or completely filled with starch grains. The cork consists of 5–7 layers of rectangular, thin-walled cells, weakly lignified.

Crushed raw materials. When examining a pressed specimen, fragments of transverse and longitudinal sections of the main and adventitious roots should be visible.

Fragments of the main root are represented by xylem rays and vessels, filling parenchyma cells of the medullary rays with starch grains, canal cavities and lining cells, parenchyma cells with pigments, and cambium cells.

Fragments of the adventitious root are represented by plug cells, parenchyma with starch grains, receptacles, primary and secondary cortex, vessels, medullary rays.

Powder. When examining a microslide, fragments of the epidermis, cork, wood, parenchyma, as well as drusen of calcium oxalate are visible.

Determination of the main groups of biologically active substances

Thin layer chromatography

On the starting line of an analytical chromatographic plate with a layer of silica gel with a fluorescent indicator measuring 10 × 15 cm on an aluminum substrate, apply 20 μl of the test solution (see section “Quantitative determination”, preparation of solution A of the test solution) and 50 μl of the solution standard sample(CO) panaxoside Rg 1 (see section “Quantitative determination” preparation of solution A CO panaxoside Rg 1). The plate with the applied samples is dried in air, placed in a chamber, pre-saturated for at least 2 hours with a solvent mixture of chloroform - methanol - water (26:14:3), and chromatographed using an ascending method. When the solvent front passes about 80–90% of the length of the plate from the starting line, it is removed from the chamber, dried until traces of solvents are removed, treated with phosphotungstic acid with a 20% alcohol solution and heated in an oven at 100–105 °C for 3 minutes, after which is viewed in daylight.

The chromatogram of the test solution should show at least 6 adsorption zones from light pink to dark pink; the dominant zone is at the zone level in the chromatogram of the CO solution of panaxoside Rg 1 ; detection of other adsorption zones is allowed.

When a drop of concentrated sulfuric acid is applied to the ginseng root powder after 1–2 minutes, a brick-red color appears, turning into red-violet, and then violet (panaxosides).

TESTS

Humidity. Whole raw materials crushed raw materials, powder – no more than 13%.

Common ash. Whole raw materials crushed raw materials, powder – no more than 5%.

Ash, insoluble in hydrochloric acid. Whole raw materials crushed raw materials, powder – no more than 2%.

Grinding of raw materials.Whole raw materials: particles passing through a sieve with holes measuring 3 mm - no more than 5%. Crushed raw materials: particles that do not pass through a sieve with holes measuring 7 mm - no more than 5%; particles passing through a sieve with holes measuring 0.5 mm - no more than 5%. Powder: particles that do not pass through a sieve with holes measuring 2 mm - no more than 5%; particles passing through a sieve with holes measuring 0.18 mm - no more than 5%.

Foreign matter

Roots darkened from the surface . Whole raw materials crushed raw materials – no more than 3%.

Organic impurity. Whole raw materials crushed raw materials – no more than 0.5%.

Mineral impurity . Whole raw materials, crushed raw materials, powder – no more than 1%.

Heavy metals. In accordance with the requirements of the General Pharmacopoeia Monograph “Determination of the content of heavy metals and arsenic in medicinal plant materials and medicinal herbal preparations.”

Radionuclides. In accordance with the requirements of the General Pharmacopoeia Monograph “Determination of radionuclide content in medicinal plant materials and medicinal herbal preparations.”

Pesticide residues. In accordance with the requirements of the General Pharmacopoeia Monograph “Determination of the content of residual pesticides in medicinal plant materials and medicinal herbal preparations.”

Microbiological purity. In accordance with the requirements of the General Pharmacopoeia Monograph “Microbiological purity”.

quantitation. Whole raw materials crushed raw materials, powder: the amount of panaxosides in terms of panaxoside Rg 1 - not less than 2%; extractive substances extracted with 70% alcohol - at least 20%.

Total panaxosides

Preparation of solutions.

Sulfuric acid solution. To 45 ml of water, carefully add 60 ml of concentrated sulfuric acid while stirring.

Panaxoside R CO solutiong 1 . About 0.03 g (exactly weighed) CO panaxoside Rg 1 is placed in a 25 ml volumetric flask, dissolved in a small amount of 96% alcohol, the volume of the solution is adjusted to the mark with the same solvent and mixed (solution A CO panaxoside Rg 1). The shelf life of the solution is 30 days.

1.0 ml of solution A CO of panaxoside Rg 1 is placed in a flask with a capacity of 25 ml, 5 ml of sulfuric acid solution of 70% is added and heated in a water bath for 10 minutes (solution B CO of panaxoside Rg 1). The shelf life of the solution is 30 days.

An analytical sample of raw materials is crushed to the size of particles passing through a sieve with holes measuring 2 mm. About 1.0 g (exactly weighed) of crushed raw material is placed in a conical flask with a ground section with a capacity of 100 ml, 30 ml of 70% alcohol is added. The flask is stoppered and weighed to the nearest  0.01. The flask is connected to a reflux condenser and heated in a water bath (moderate boiling) for 90 minutes. Then the flask is cooled to room temperature, closed with the same stopper, weighed again and, if necessary, brought to the original mass with 70% alcohol. The contents of the flask are thoroughly mixed. The extract is filtered through a paper filter (“red stripe”) (solution A of the test solution).

5.0 ml of solution A of the test solution is placed in a porcelain cup and evaporated to dryness in a water bath. The dry residue is dissolved in 5–6 ml of water, quantitatively transferred to a glass filter with a layer of polyamide 1–1.5 cm high and eluted with 10–15 ml of water. The aqueous eluate is discarded. Then the polyamide layer is eluted with 96% alcohol, collecting the eluate in a 10 ml volumetric flask, adjust the volume of the solution with 96% alcohol to the mark and mix (solution B of the test solution).

1.0 ml of solution B of the test solution is placed in a flask with a capacity of 25 ml, 5 ml of sulfuric acid solution of 70% is added and heated in a water bath for 10 minutes (solution B of the test solution). After cooling, measure the optical density of solution B of the test solution using a spectrophotometer at a wavelength of 526 nm in a cuvette with a layer thickness of 10 mm. 96% alcohol is used as a reference solution.

In parallel, the optical density of solution B CO panaxoside Rg 1 is determined under the same conditions.

Where A

A 0 – optical density of solution B CO panaxoside Rg 1 ;

a– weight of raw materials, g;

a 0 – weighed portion of CO panaxoside Rg 1, g;

R– content of the main substance in the RM of panaxoside Rg 1,%;

W– moisture content of raw materials, %.

It is allowed to calculate the content of the sum of panaxosides in terms of panaxoside Rg 1 using the specific absorption rate of the hydrolysis products of panaxoside Rg 1 with a solution of sulfuric acid according to the formula:

Where A– optical density of solution B of the test solution;

– specific absorption index of the products of hydrolysis of panaxoside Rg 1 with a solution of sulfuric acid at 526 nm, equal to 25;

a– weight of raw materials, g;

W– moisture content of raw materials, %.

Extractives . In accordance with the requirements of the General Pharmacopoeia Monograph “Determination of the content of extractive substances in medicinal plant raw materials” (method 1, extractant – 70% alcohol).

Note. Determination of the amount of panaxosides in terms of panaxoside Rg 1 is carried out for raw materials intended for the production of medicinal herbal preparations (packs, filter bags); determination of extractive substances extracted with 70% alcohol and the amount of panaxosides in terms of panaxoside Rg 1 - for raw materials intended for the production of tincture.

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

Storage. In accordance with the requirements of the General Pharmacopoeia Monograph “Storage of medicinal plant raw materials and medicinal herbal preparations”.

Feature modern stage standardization medicines is the need to harmonize the requirements for the quality of medicines and their testing methods imposed by the Russian Pharmacopoeia and leading foreign pharmacopoeias.
XII edition of the State Pharmacopoeia Russian Federation will include five parts.
The first part describes general provisions, methods of analysis, requirements for pharmaceutical substances, and pharmacopoeial monographs for the substance.

The State Pharmacopoeia (SP) is a collection of basic standards used in pharmacopoeial analysis and production of medicines. The state pharmacopoeia has a legislative nature. The basis of the State Pharmacopoeia is made up of general pharmacopoeial monographs (GPM) and pharmacopoeial monographs (FS). The General Pharmacopoeial Monograph describes the general provisions and methods of analysis adopted in pharmacopoeial analysis, or includes a list of standardized indicators and test methods for a particular dosage form. The FS determines the level of requirements for specific medicines.

CONTENT
I. EDITORIAL BOARD OF ROSZDRAVNADZOR ON THE ORGANIZATION OF WORK ON THE STATE PHARMACOPOEIA 7
II. PREFACE 9
III. ORGANIZATIONS, INSTITUTIONS OF RUSSIA AND SPECIALISTS WHO TOOK PART IN THE PREPARATION OF PART 1 OF THE STATE PHARMACOPOEIA OF THE RUSSIAN FEDERATION XII EDITION 10
IV. INTRODUCTION 13
GENERAL PHARMACOPOEIAL ARTICLES
1. Rules for the use of pharmacopoeial monographs (OFS 42-0031-07) 17
2 pieces international system(SI) used in the pharmacopoeia and their correspondence to other units (OFS 42-0032-07) 22
ANALYSIS METHODS 26
3. Equipment (OFS42-0033-07) 26
PHYSICAL AND PHYSICAL-CHEMICAL METHODS OF ANALYSIS 29
4. Melting point (OFS 42-0034-07) 29
5. Solidification temperature (OFS 42-0035-07) 34
6. Temperature limits of distillation and boiling point (OFS 42-0036-07) 36
7. Density (OFS 42-0037-07) 38
8. Viscosity (OFS 42-0038-07) 41
9. Determination of ethyl alcohol in liquid pharmaceutical preparations (OFS 42-0039-07) 49
10. Refractometry (OFS 42-0040-07) 52
11. Polarimetry (OFS 42-0041 -07) 54
12. Spectroscopic methods 56
12.1. Spectrophotometry in the ultraviolet and visible regions (OFS 42-0042-07) 56
12.2. Spectrometry in the infrared region (OFS 42-0043-07) 62
12.3. Atomic emission and atomic absorption spectrometry (OFS 42-0044-07) 66
12.4. Fluorimetry (OFS 42-0045-07) 70
12.5. Nuclear magnetic resonance spectroscopy (OFS42-0046-07) 73
13. Osmolarity (OFS 42-0047-07) 78
14. Ioiom&trt (OFS 42-0048-07) 85
15. Solubility (OFS 42-0049-07) 92
16. Color degree of liquids (OFS 42-0050-07) 93
17. Transparency and degree of turbidity of liquids (OFS 42-0051-07) 98
CHEMICAL METHODS OF ANALYSIS 101
18. Determination of nitrogen in organic compounds Kjeldahl method (OFS 42-0052-0 7) 101
19. Determination of protein (OFS 42-0053-07) 105
20. Nitritometry SOFS 42-0054-0 7) 114
IMPURITY LIMIT TEST 115
21. Total ash (OFS 42-0055-07) 115
22. Sulfated ash (OFS 42-0056-07) 115
23. Residual organic solvents (OFS 42-0057-07) 115
24. Test for purity and permissible limits of impurities 118
24.1. Iron (OFS 42-0058-07) 119
24.2. Heavy metals (OFS 42-0059-07) 121
BIOLOGICAL CONTROL METHODS 124
25. Abnormal toxicity (OFS 42-0060-07) 124
26. Pyrogenicity (OFS 42-0061-07) 125
27. Bacterial endotoxins (OFS 42-0062-07) 128
28. Histamine test (OFS 42-0063-07) 136
29. Test for depressant substances (OFS 42-0064-07) 140
30. Biological methods for assessing the activity of medicinal plant materials and drugs containing cardiac glycosides (OFS 42-0065-07) 141
31. Sterility (OFS 42-0066-0 7) 150
32. Microbiological purity (OFS 42-0067-07) 160
33. Determination of the antimicrobial activity of antibiotics by diffusion into agar (OPS 42-0068-0 7) 194
34. Determination of the effectiveness of antimicrobial preservatives for drugs (OFS 42-0069-07) 216
REAGENTS 220
35. Reagents. Indicators (OFS 42-0070-07) 220
36. Titrated solutions (OFS 42-0071-07) 425
37. Buffer solutions (OFS 42-0072-07) 443
38. Radiopharmaceuticals (OFS 42-0073-07) 456
39. Pharmaceutical substances (OFS 42-0074-07) 484
40. Shelf life of medicines (OFS 42-0075-07) 488
PHARMACOPOEIAL ARTICLES 493

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2. Pharmacopoeial monographs
2.1. Pharmaceutical substances of synthetic origin
2.1.1. Aminocaproic acid (FS.2.1.0001.15)
2.1.2. Amlodipine besilate (FS.2.1.0002.15)
2.1.3. Metamizole sodium (FS.2.1.0003.15)
2.1.4. Umifenovir hydrochloride (FS.2.1.0004.15)
2.1.5. Articaine hydrochloride (FS.2.1.0005.15)
2.1.6. Acetylsalicylic acid (FS.2.1.0006.15)
2.1.7. Benzylnicotinate (FS.2.1.0007.15)
2.1.8. Diamond green (FS.2.1.0008.15)
2.1.9. Bromhexine hydrochloride (FS.2.1.0009.15)
2.1.10. Butyl parahydroxybenzoate (FS.2.1.0010.15)
2.1.11. Validol (FS.2.1.0011.15)
2.1.12. Gliclazide (FS.2.1.0012.15)
2.1.13. Bismuth subgallate (FS.2.1.0013.15)
2.1.14. Mebhydrolin napadisylate (FS.2.1.0014.15)
2.1.15. Dioxidin (FS.2.1.0015.15)
2.1.16. Droperidol (FS.2.1.0016.15)
2.1.17. Indapamide (FS.2.1.0017.15)
2.1.18. Potassium permanganate (FS.2.1.0018.15)
2.1.19. Calcium gluconate (FS.2.1.0019.15)
2.1.20. Carbamazepine (FS.2.1.0020.15)
2.1.21. Ketamine hydrochloride (FS.2.1.0021.15)
2.1.22. Ketorolac trometamol (FS.2.1.0022.15)
2.1.23. Levomenthol (FS.2.1.0023.15)
2.1.24. Lemon acid(FS.2.1.0024.15)
2.1.25. Meloxicam (FS.2.1.0025.15)
2.1.26. Racementol (FS.2.1.0026.15)
2.1.27. Sodium salt of N-nicotinoyl gamma-aminobutyric acid (FS.2.1.0027.15)
2.1.28. Sodium propyl parahydroxybenzoate (FS.2.1.0028.15)
2.1.29. Nifedipine (FS.2.1.0029.15)
2.1.30. Pyrazinamide (FS.2.1.0030.15)
2.1.31. Ribavirin (FS.2.1.0031.15)
2.1.32. Rifampicin (FS.2.1.0032.15)
2.1.33. Salicylic acid (FS.2.1.0033.15)
2.1.34. Sucrose (FS.2.1.0034.15)
2.1.35. Sorbic acid (FS.2.1.0035.15)
2.1.36. Ethyl alcohol 95%, 96% (FS.2.1.0036.15)
2.1.37. Streptomycin sulfate (FS.2.1.0037.15)
2.1.38. Sulfanilamide (FS.2.1.0038.15)
2.1.39. Taurine (FS.2.1.0039.15)
2.1.40. Timol (FS.2.1.0040.15)
2.1.41. Phenobarbital (FS.2.1.0041.15)
2.1.42. Phenol (FS.2.1.0042.15)
2.1.43. Formaldehyde (FS.2.1.0043.15)
2.1.44. Basic fuchsin (FS.2.1.0044.15)
2.1.45. Enalapril maleate (FS.2.1.0045.15)
2.1.46. Ethylmethylhydroxypyridine succinate (FS.2.1.0046.15)
2.1.47. Alpha-bromoisovaleric acid ethyl ester (FS.2.1.0047.15)
2.1.48. Ethyl parahydroxybenzoate (FS.2.1.0048.15)
2.2. Pharmaceutical substances of mineral origin
2.2.1. Barium sulfate (FS.2.2.0001.15)
2.2.2. Boric acid (FS.2.2.0002.15)
2.2.3. Vaseline (FS.2.2.0003.15)
2.2.4. Vaseline oil (FS.2.2.0004.15)
2.2.5. Hydrogen peroxide (FS.2.2.0005.15)
2.2.6. Glycerin (FS.2.2.0006.15)
2.2.7. Iodine (FS.2.2.0007.15)
2.2.8. Potassium iodide (FS.2.2.0008.15)
2.2.9. Potassium chloride (FS.2.2.0009.15)
2.2.10. Magnesium sulfate (FS.2.2.0010.15)
2.2.11. Sodium bicarbonate (FS.2.2.0011.15)
2.2.12. Sodium tetraborate (FS.2.2.0012.15)
2.2.13. Sodium fluoride (FS.2.2.0013.15)
2.2.14. Sodium chloride (FS.2.2.0014.15)
2.2.15. Solid paraffin (FS.2.2.0015.15)
2.2.16. Precipitated sulfur (FS.2.2.0016.15)
2.2.17. Talc (FS.2.2.0017.15)
2.2.18. Zinc oxide (FS.2.2.0018.15)
2.2.19. Water for injection (FS.2.2.0019.15)
2.2.20. Purified water (FS.2.2.0020.15)
2.5. Medicinal plant raw materials
2.5.1. Althea roots (FS.2.5.0001.15)
2.5.2. Chokeberry fresh fruits (FS.2.5.0002.15)
2.5.3. Chokeberry dry fruits (FS.2.5.0003.15)
2.5.4. Bergenia thick-leaved rhizome (FS.2.5.0004.15)
2.5.5. Birch leaves (FS.2.5.0005.15)
2.5.6. Birch buds (FS.2.5.0006.15)
2.5.7. Sandy immortelle flowers (FS.2.5.0007.15)
2.5.8. Black elderberry flowers (FS.2.5.0008.15)
2.5.9. Valerian medicinal rhizomes with roots (FS.2.5.0009.15)
2.5.10. Ginkgo biloba leaves (FS.2.5.0010.15)
2.5.11. Sweet clover grass (FS.2.5.0011.15)
2.5.12. Oregano common grass(FS.2.5.0012.15)
2.5.13. Real ginseng roots (FS.2.5.0013.15)
2.5.14. Zhostera laxative fruits (FS.2.5.0014.15)
2.5.15. St. John's wort herb (FS.2.5.0015.15)
2.5.16. Wild strawberry leaves (FS.2.5.0016.15)
2.5.17. Viburnum common bark (FS.2.5.0017.15)
2.5.18. Coriander sativum fruits (FS.2.5.0018.15)
2.5.19. Stinging nettle leaves (FS.2.5.0019.15)
2.5.20. Belladonna grass (FS.2.5.0020.15)
2.5.21. Buckthorn alder bark (FS.2.5.0021.15)
2.5.22. Lily of the valley grass, lily of the valley leaves, lily of the valley flowers (FS.2.5.0022.15)
2.5.23. Potentilla erecta rhizome (FS.2.5.0023.15)
2.5.24. Linden flowers (FS.2.5.0024.15)
2.5.25. Burdock roots (FS.2.5.0025.15)
2.5.26. Flax seeds (FS.2.5.0026.15)
2.5.27. Coltsfoot leaves (FS.2.5.0027.15)
2.5.28. Common juniper fruits (FS.2.5.0028.15)
2.5.29. Peppermint leaves (FS.2.5.0029.15)
2.5.30. Medicinal marigold flowers (FS.2.5.0030.15)
2.5.31. Tansy flowers (FS.2.5.0031.15)
2.5.32. Large plantain leaves (FS.2.5.0032.15)
2.5.33. Wormwood herb (FS.2.5.0033.15)
2.5.34. Motherwort grass (FS.2.5.0034.15)
2.5.35. Milk thistle fruits (FS.2.5.0035.15)
2.5.36. Rhodiola rosea rhizomes and roots (FS.2.5.0036.15)
2.5.37. Chamomile flowers (FS.2.5.0037.15)
2.5.38. Senna leaves (FS.2.5.0038.15)
2.5.39. Blue cyanosis rhizomes with roots (FS.2.5.0039.15)
2.5.40. Licorice roots (FS.2.5.0040.15)
2.5.41. Scots pine bud (FS.2.5.0041.15)
2.5.42. Poplar buds (FS.2.5.0042.15)
2.5.43. Dill fruits (FS.2.5.0043.15)
2.5.44. Violet grass (FS.2.5.0044.15)
2.5.45. Horsetail grass (FS.2.5.0045.15)
2.5.46. Common hops (FS.2.5.0046.15)
2.5.47. Thyme herb (FS.2.5.0047.15)
2.5.48. Sequences of tripartite grass (FS.2.5.0048.15)
2.5.49. Bird cherry fruits (FS.2.5.0049.15)
2.5.50. Common blueberry fruit (FS.2.5.0050.15)
2.5.51. Salvia officinalis leaves (FS.2.5.0051.15)
2.5.52. Horse sorrel roots (FS.2.5.0052.15)
2.5.53. Eleutherococcus senticosus rhizomes and roots (FS.2.5.0053.15)
2.5.54. Erva woolly grass (FS.2.5.0054.15)
2.5.55. Echinacea purpurea herb (FS.2.5.0055.15)

3. Medicines
3.3. Biological drugs
3.3.1. Immunobiological drugs
3.3.1.1. Recombinant tuberculosis allergen in standard dilution (FS.3.3.1.0001.15)
3.3.1.2. Adsorbed diphtheria-tetanus toxoid (ADS - toxoid) (FS.3.3.1.0002.15)
3.3.1.3. Diphtheria-tetanus toxoid adsorbed with reduced antigen content (ADS-M-anatoxin) (FS.3.3.1.0003.15)
3.3.1.4. Diphtheria toxoid adsorbed with reduced antigen content (AD-M-anatoxin) (FS.3.3.1.0004.15)
3.3.1.5. Staphylococcal toxoid, purified, adsorbed, suspension for subcutaneous administration (FS.3.3.1.0005.15)
3.3.1.6. Purified staphylococcal toxoid, for subcutaneous administration (FS.3.3.1.0006.15)
3.3.1.7. Adsorbed tetanus toxoid (AS-anatoxin) (FS.3.3.1.0007.15)
3.3.1.8. Adsorbed trianatoxin (FS.3.3.1.0008.15)
3.3.1.9. Tetraanatoxin adsorbed (FS.3.3.1.0009.15)
3.3.1.10. Adsorbed pertussis-diphtheria-tetanus vaccine (DTP vaccine) (FS.3.3.1.0010.15)
3.3.1.11. Live brucellosis vaccine (FS.3.3.1.0011.15)
3.3.1.12. Typhoid vaccine V - polysaccharide (FS.3.3.1.0012.15)
3.3.1.13.
3.3.1.14. Leptospirosis vaccine concentrated inactivated liquid (FS.3.3.1.0014.15)
3.3.1.15. Meningococcal serogroup A vaccine, dry polysaccharide (FS.3.3.1.0015.15)
3.3.1.16. Live anthrax vaccine (FS.3.3.1.0016.15)
3.3.1.17. Anthrax vaccine combined (FS.3.3.1.0017.15)
3.3.1.18. Live tuberculosis vaccine BCG (FS.3.3.1.0018.15)
3.3.1.19. Live tularemia vaccine (FS.3.3.1.0019.15)
3.3.1.20. Cholera vaccine, bivalent chemical, enteric-coated (FS.3.3.1.0020.15)
3.3.1.21. Live plague vaccine, for resorption (FS.3.3.1.0021.15)
3.3.1.22. Live plague vaccine (FS.3.3.1.0022.15)
3.3.1.23. Purified tuberculin (PPD) (purified tuberculosis allergen) (FS.3.3.1.0023.15)
3.3.1.24. Cultured live rubella vaccine (FS.3.3.1.0024.15)
3.3.1.25. Rabies vaccine culture concentrated purified inactivated (FS.3.3.1.0025.15)
3.3.1.26. Hepatitis B vaccine, recombinant (FS.3.3.1.0026.15)
3.3.1.27. Live influenza vaccine (FS.3.3.1.0027.15)
3.3.1.28. Inactivated influenza vaccine (FS.3.3.1.0028.15)
3.3.1.29. Vaccine for the prevention of hepatitis A, culture purified, concentrated, adsorbed, inactivated liquid (FS.3.3.1.0029.15)
3.3.1.30. Yellow fever vaccine live, dry, lyophilisate for the preparation of solution for subcutaneous administration (FS.3.3.1.0030.15)
3.3.1.31. Tick-borne encephalitis vaccine, culture purified, concentrated, inactivated, liquid, sorbed or dry, complete with aluminum hydroxide solvent (FS.3.3.1.0031.15)
3.3.1.32. Cultured live measles vaccine (FS.3.3.1.0032.15)
3.3.1.33. Live smallpox vaccine (FS.3.3.1.0033.15)
3.3.1.34. Inactivated smallpox vaccine (FS.3.3.1.0034.15)
3.3.1.35. Live embryonal smallpox vaccine (FS.3.3.1.0035.15)
3.3.1.36. Live cultural mumps vaccine (FS.3.3.1.0036.15)
3.3.1.37. Oral polio vaccine types 1, 2, 3, for oral administration (FS.3.3.1.0037.15)
3.3.1.38. Rabies immunoglobulin from horse blood serum (FS.3.3.1.0038.15)
3.3.1.39. Human smallpox immunoglobulin (FS.3.3.1.0039.15)
3.3.1.40. Human leukocyte interferon (FS.3.3.1.0040.15)
3.3.1.41. Anti-gangrenous polyvalent equine serum (FS.3.3.1.0041.15)
3.3.1.42. Antibotulinum serums of types A, B, E for horses (FS.3.3.1.0042.15)
3.3.1.43. Horse anti-diphtheria serum (FS.3.3.1.0043.15)
3.3.1.44. Horse anti-tetanus serum (FS.3.3.1.0044.15)
3.3.1.45. Serum against the venom of the common horse viper (FS.3.3.1.0045.15)
3.3.1.46. Horse serum diluted 1: 100 (FS.3.3.1.0046.15)
3.3.1.47. Pyrogenal, for intramuscular administration (FS.3.3.1.0047.15)
3.3.1.48. Pyrogenal, rectal suppositories (FS.3.3.1.0048.15)
3.3.2. Medicines derived from human blood and plasma
3.3.2.1. Human plasma for fractionation (FS.3.3.2.0001.15)
3.3.2.2. Human blood coagulation factor VII (FS.3.3.2.0002.15)
3.3.2.3. Clotting factor blood VIII human (FS.3.3.2.0003.15)
3.3.2.4. Human blood coagulation factor IX (FS.3.3.2.0004.15)
3.3.2.5. Von Willebrand factor (FS.3.3.2.0005.15)
3.3.2.6. Human albumin (FS.3.3.2.0006.15)
3.3.2.7. Normal human immunoglobulin (FS.3.3.2.0007.15)
3.3.2.8. Normal human immunoglobulin for intravenous administration (FS.3.3.2.0008.15)

Applications
Names, symbols and relative atomic masses of elements

Table. The number of drops in 1 g and 1 ml and the mass of 1 drop of liquid medications at a temperature of 20 ° C according to a standard drop meter

Table. Isotonic equivalents of medicinal substances in sodium chloride

Alcoholometer tables
Table 1. The relationship between the density of a water-alcohol solution and the content of anhydrous alcohol in the solution

Table 2. Mass quantities (in grams at a temperature of 20 ° C) of water and alcohol of various strengths that must be mixed to obtain 1 kg of alcohol with a strength from 30 to 92%

Table 3. Volumetric amounts of water added to 1 liter of alcohol of known concentration to obtain a given alcohol strength from 30 to 90% (v/v)

Table 4. Volume quantities of alcohol with a strength of 35 to 95% (in ml at a temperature of 20 ° C) that must be mixed to obtain 1 liter of alcohol with a strength of 30 to 90%

Table 5. Volume quantities of alcohol with a strength of 95.1 to 96.5% (in ml at a temperature of 20 ° C) and water that must be mixed to obtain 1 liter of alcohol with a strength of 30 to 90 percent by volume

IR spectra of standard samples of pharmaceutical substances

XIII edition, M.: FEMB, 2015. - 1292 pp. State Pharmacopoeia of the Russian Federation XIII edition (SF RF XIII edition) consists of an introductory part, a main part and applications.
The main part contains 229 general pharmacopoeial articles (GPM) and 179 pharmacopoeial articles (PS), presented in the corresponding sections.
The section “General pharmacopoeial monographs” contains the following subsections: general articles, methods of analysis, reagents, dosage forms and methods of their analysis; medicinal plant raw materials and methods for assessing their quality; groups of immunobiological drugs and methods of their analysis; medicinal products from human and animal blood and blood plasma and analytical methods used in assessing their quality; radiopharmaceuticals. They set out general methods analysis, methods of physical, physico-chemical, chemical and biological analysis, reagents and indicators, titrated and buffer solutions, morphological groups of medicinal plant materials, herbal medicines, groups of immunobiological medicines and groups of medicines from blood and blood plasma of humans and animals .
A description of dosage forms and methods of their analysis is also provided, including the determination of pharmaceutical and technological indicators.
Pharmacopoeial monographs are presented in the sections “Pharmaceutical substances” and “Drugs”. The “Pharmaceutical substances” section is presented by pharmacopoeial articles on pharmaceutical substances of synthetic or mineral origin, used as active and/or excipients. In addition, pharmacopoeial monographs for medicinal plant raw materials used in pharmaceutical production, including medicinal herbal preparations, are presented as a separate subsection.
The “Medicines” section consists of two subsections: immunobiological drugs and drugs obtained from human blood and plasma.
The appendices to the State Fund of the Russian Federation, XIII edition, contain reference tables: a table of atomic masses, alcoholometric tables, a table of isotonic equivalents of medicinal substances for sodium chloride, a table of the number of drops in 1 g and 1 ml and the mass of 1 drop of liquid drugs at a temperature of 20°C standard droplet meter, drawings of IR spectra of standard samples of pharmaceutical substances, pharmacopoeial monographs for which are included in the current edition of the State Pharmacopoeia of the Russian Federation, XIII edition.
For the first time, 99 general pharmacopoeial articles are introduced in the State Pharmacopeia of the Russian Federation in the XIII edition, including 30 General Pharmacopoeial Monographs for methods of analysis, 5 General Pharmacopoeia Monographs for dosage forms and 12 General Pharmacopoeial Monographs for methods for determining pharmaceutical and technological parameters of dosage forms, 2 General Pharmacopoeial Monographs for medicinal plant raw materials and 3 General Pharmacopoeia Monographs for its methods analysis, 7 OFS for groups of immunobiological medicinal products and 28 OFS for methods of their testing, 3 OFS for groups of medicinal products from the blood and blood plasma of humans and animals, 9 OFS for methods of analysis of medicinal products obtained from the blood and blood plasma of humans and animals.
In the XIII edition of the State Pharmacopeia of the Russian Federation, 20 pharmacopoeial monographs are introduced for the first time, including 4 FS for pharmaceutical substances, 4 FS for medicinal plant raw materials, 8 FS for immunobiological medicinal products and 4 FS for medicinal products from human blood and blood plasma.
A number of general pharmaceutical substances previously presented in the USSR State Pharmacopoeia X and XI editions (USSR State Pharmacopoeia X edition, USSR State Pharmacopoeia XI edition) are excluded from the practice of modern pharmacopoeial analysis as unclaimed.
For the first time, the 13th edition of the State Pharmacopoeia of the Russian Federation includes a subsection “Biological medicinal products”, containing the General Pharmacopoeia Monograph and the FS, regulating the requirements for immunobiological medicines, drugs obtained from blood and blood plasma of humans and animals and methods of their testing.
Other current General Pharmacopoeia Monographs and FS State Pharmacopoeia of the USSR X edition, State Fund of the USSR XI edition and State Fund of the Russian Federation XII edition have been revised and supplemented with materials taking into account modern requirements, scientific and practical achievements in the field of pharmacopoeial analysis.
In the headings of pharmacopoeial articles for pharmaceutical substances, the following sequence of names is adopted: INN in Russian, trivial name, name in Latin, and for medicinal plant raw materials - name in Russian and Latin. Volume 3.
Pharmacopoeial articles.
Pharmaceutical substances of synthetic origin.
Pharmaceutical substances of mineral origin.
Medicinal plant raw materials, pharmaceutical substances of plant origin.
Medications.
Biological drugs.
Applications.
Names, symbols and relative atomic masses of elements.
Alcoholometer tables.
IR spectra of standard samples of pharmaceutical substances.

What is a pharmacopoeia? If we start from afar, then probably every person has at least once wondered how doctors manage to remember so many medications, know their dosages, chemical composition and mechanism of action. Numerous reference books and compendiums containing the necessary information help them in this. And their authors, in turn, draw inspiration from the pharmacopoeia. So what is it?

Definition

Pharmacopoeia is a collection of official documents that indicate quality standards for medicinal raw materials, excipients, finished drugs and other drugs used in medicine.

To establish a “gold standard,” specialists in the field of chemistry and pharmaceutical analysis are involved, and randomized international double-blind controlled studies are conducted to find out everything possible about medicinal raw materials and preparations made from them. Compliance with all standards ensures the quality of pharmaceutical products.

The state pharmacopoeia is a pharmacopoeia that has legal force and is under government supervision. The requirements and recommendations set out in it are mandatory for all organizations in the country involved in the manufacture, storage, sale and use of medicines. For violation of the rules recorded in a document, legal or to an individual faces criminal liability.

History of the International Pharmacopoeia

Ideas about creating a unified list of drugs indicating dosages and standardizing nomenclature appeared among the scientific medical community at the end of the nineteenth century, in 1874. The first conference on this issue was held in Brussels in 1092. At the meeting, experts came to an agreement on common names for drugs and the form of their prescription. Four years later, this agreement was ratified in twenty countries. This success became Starting point for further development of the pharmacopoeia and its publication. Twenty years later, a second conference took place in Brussels, which was attended by representatives of forty-one countries of the world.

From that moment on, the responsibility for publishing and revising the pharmacopoeia passed to the League of Nations. At the time of the agreement, the compendium included the principles of preparation and dosage of 77 medicinal substances. Twelve years later, in 1937, a commission of experts from Belgium, Denmark, France, Switzerland, the USA, the Netherlands and Great Britain was established, who familiarized themselves with all the provisions of the pharmacopoeia and decided to expand it into an international document.

Second World War interrupted the work of the commission, but already in 1947 the experts returned to their work. By 1959, the commission was called the Committee of Experts on the Specification of Pharmaceutical Preparations. At one of the WHO meetings, it was decided to create an International Nonproprietary Names program to unify the nomenclature of medicines.

First edition

The Pharmacopoeia is an international document that has already had four reissues, and after each of them it acquired something new.

The first edition was approved at the Third World Assembly of WHO. A permanent secretariat for the International Pharmacopoeia was established. The book was published in 1951, and four years later the second volume was published with additions in three languages ​​common in Europe: English, French and Spanish. After a short period of time, publications appeared in German and Japanese. The first pharmacopoeia is a collection of regulatory documents on all drugs known at that time. Namely:

• 344 articles on medicinal substances;
• 183 articles on dosage forms (tablets, capsules, tinctures, solutions in ampoules);
• 84 laboratory diagnostic methods.

The headings of the articles were in Latin, since it was the same for everyone medical workers way of designation. To collect the necessary information, experts in biological standardization were brought in, as well as specialists in the most endemic and dangerous diseases.

Subsequent editions of the International Pharmacopoeia

The second edition appeared in 1967. It was dedicated to quality control of pharmaceutical products. In addition, errors of the first edition were taken into account and 162 drugs were added.

The third edition of the pharmacopoeia was aimed at developing countries. It presented a list of substances that are widely used in healthcare and at the same time have a relatively low cost. This edition contained five volumes and was released in 1975. New amendments to the document were made only in 2008. They concerned the standardization of medicines, methods of their manufacture and distribution.

Pharmacopoeia is a book that contains not only the nomenclature of medicinal substances, but also instructions for their production, storage and purpose. This book contains descriptions of chemical, physical and biological methods for analyzing drugs. In addition, it contains information about reagents and indicators, medicinal substances and drugs.

The WHO Committee compiled lists of toxic (list A) and potent substances (list B), as well as tables of maximum single and daily doses of drugs.

European Pharmacopoeia

The European Pharmacopoeia is a regulatory document that is used in most European countries in the production of pharmaceutical products along with the International Pharmacopoeia, complements it and focuses on the peculiarities of medicine in this region. This book was developed by the European Directorate for the Quality of Medicines, which is part of the Council of Europe. The Pharmacopoeia is different from other similar documents legal status, which was given to her by the cabinet. Official language European Pharmacopoeia - French. The last, sixth, reissue was in 2005.

National pharmacopoeias

Since the International Pharmacopoeia does not have legal force and is rather advisory in nature, individual countries issued national pharmacopoeias for internal regulation of issues related to medicines. On this moment most countries in the world have individual books. In Russia, the first pharmacopoeia was published in 1778 in Latin. Only twenty years later a Russian-language version was published, becoming the first book of this type in the national language.

In 1866, half a century later, the first official Russian-language pharmacopoeia was published. The 11th edition, the last during the existence of the USSR, appeared in the early nineties of the last century. The compilation, addition and re-issue of the document used to be the responsibility of the pharmacopoeial committee, but now this is done by the Ministry of Health, Roszdravnadzor and the General Fund. health insurance with the participation of the country's leading scientists.

State Pharmacopoeia of the Russian Federation 12th and 13th editions

During the period of time when the state pharmacopoeia was subject to adjustment, the quality of medical products was regulated through enterprise pharmacopoeial monographs (FSP) and general pharmacopoeial monographs (GPM). The twelfth edition of the State Pharmacopoeia of the Russian Federation was significantly influenced by the fact of attracting Russian specialists into the work of the pharmacopoeia. The twelfth edition consists of five parts, each of which includes essential standards and regulations for the manufacture, prescription or sale of medicinal products. This book was published in 2009.

Six years later the twelfth edition was edited. At the end of 2015, the state pharmacopoeia, 13th edition, appeared on the official website of the Ministry of Health of the Russian Federation. This was an electronic version, since the issue was carried out at the expense of funds from sales. Therefore, at the legislative level it was adopted that every pharmacy and wholesale trade enterprise should have a state pharmacopoeia (13th edition). This enabled the book to become self-sustaining.

What is a pharmacopoeial monograph?

There are two types: the substance and the finished dosage form. Each article “on a substance” has a name in two languages: Russian and Latin, an international non-proprietary name and a chemical name. It provides empirical and structural formula, molecular mass and the amount of the main active ingredient. In addition, there is detailed description appearance drug substance, quality control criteria, solubility in liquids and other physical and Chemical properties. The conditions for packaging, manufacturing, storage and transportation are specified. And also the expiration date.

The article for the finished dosage form, in addition to all of the above, contains the results of clinical and laboratory tests, acceptable standards deviations in mass, volume and particle size of the medicinal substance, as well as maximum single and daily dosages for children and adults.