General pharmacopoeial article 13th edition. State Pharmacopoeia of the Russian Federation XIII edition published in the Federal Electronic Medical Library

XIII edition, M.: FEMB, 2015. - 1292 p.
The main part contains 229 general pharmacopoeial monographs (GPM) and 179 pharmacopoeial monographs (PS) presented in the respective sections.
The section "General pharmacopoeial articles" contains the following subsections: general articles, methods of analysis, reagents, dosage forms and methods for their analysis; medicinal plant materials and methods for assessing its quality; groups of immunobiological drugs and methods for their analysis; medicinal products from blood and blood plasma of humans and animals and methods of analysis used in assessing their quality; radiopharmaceuticals. They set out general methods of 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 drugs and groups of drugs from blood and blood plasma of humans and animals.
A description of dosage forms and methods for their analysis, including the definition of pharmaceutical and technological indicators, is also given.
Pharmacopoeia articles are presented in the sections "Pharmaceutical substances" and "Drugs". The section "Pharmaceutical substances" is represented by pharmacopoeial articles on pharmaceutical substances of synthetic or mineral origin used as active and/or excipients. In addition, pharmacopoeial articles on medicinal plant materials used in pharmaceutical production, including herbal medicinal products, are presented as a separate subsection.
The section "Drugs" consists of two subsections: immunobiological drugs and drugs derived from human blood and blood plasma.
Reference tables are given in the appendices to the RF GF of the XIII edition: a table of atomic masses, alcoholometric tables, a table of isotonic equivalents of medicinal substances by sodium chloride, a table of the number of drops in 1 g and in 1 ml and the mass of 1 drop of liquid drugs at a temperature of 20 ° C according to standard drop meter, drawings of IR spectra of standard samples of pharmaceutical substances, pharmacopoeial articles for which are included in the current edition of the RF SP XIII edition.
For the first time, 99 general pharmacopoeial articles are introduced in the RF State Fund for the XIIIth edition, including 30 GPM for methods of analysis, 5 GPM for dosage forms and 12 GPM for methods for determining pharmaceutical and technological indicators of dosage forms, 2 GPM for medicinal plant raw materials and 3 GPM for methods of its analysis, 7 GPM for groups of immunobiological drugs and 28 GPM for methods of their testing, 3 GPM for groups of drugs from blood and blood plasma of humans and animals, 9 GPM for methods of analysis of drugs obtained from blood and blood plasma of humans and animals.
For the first time, 20 pharmacopoeial monographs are introduced in the SP RF XIII edition, including 4 FS for pharmaceutical substances, 4 FS for medicinal plant materials, 8 FS for immunobiological drugs and 4 FS for drugs from human blood and blood plasma.
A number of OFS previously presented in the USSR State Pharmacopoeia X and XI editions (SPS USSR X edition, SP USSR XI editions) are excluded from the practice of modern pharmacopoeial analysis as unclaimed.
For the first time, the SP RF XIII edition includes a subsection “Biological medicinal products”, containing general pharmacological and pharmacological agents that regulate the requirements for immunobiological medicinal products, medicinal products obtained from human and animal blood and blood plasma and methods for their testing.
Other current OFS and FS of the State Pharmacopoeia of the USSR X edition, the State Pharmacopoeia of the USSR XI edition and the State Fund of the Russian Federation of the XII edition are 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, a trivial name, a name in Latin, and for medicinal plant raw materials - a 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.
Alcoholic tables.
IR spectra of standard samples of pharmaceutical substances.

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

PHARMACOPIES AUTHORIZATION

ginsengpresentrootsFS.2.5.0013.15

Panacis ginseng radices Instead of GFXI, issue. 2, art. 66

Collected in late August - early September and dried roots of a wild-growing and cultivated perennial herb of real ginseng - Panax ginseng C. A. Mey, family Araliaceae - Araliaceae.

AUTHENTICITY

External signs. Whole raw material. 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, rarely spirally wrinkled, brittle, the fracture is even. The "body" of the root is thickened, almost cylindrical, from above with clearly expressed annular thickenings. In the upper part of the root there is a narrowed transversely wrinkled rhizome - the "neck". The rhizome is short with several scars from fallen stems, at the top it forms a “head”, which is an extended stem remnant and an apical bud (sometimes 2-3). One or more adventitious roots sometimes depart from the "neck". "Neck" and "head" may be missing. The color of the roots from 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, burning, then spicy-bitter.

crushed raw materials. When considering the crushed raw materials under a magnifying glass (10×) or a stereomicroscope (16×), pieces of roots of various shapes are visible, passing through a sieve with holes of 7 mm. The color from the surface and at the break is yellowish-white. The smell is specific. The taste of water extract is sweet, burning, then spicy-bitter.

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

microscopic signs. Whole raw material. On the cross section of the main root, a narrow layer of light brown cork, a wide bark, a clear cambium line and wood are visible.

The main root is covered with periderm, the cells of which are thin-walled and lignified, not corky. The phloem and xylem are separated by the cambial zone, which runs approximately through the middle of the root radius and

sometimes not visible. To the periphery from the primary xylem, large-cell primary radial rays of the parenchymal tissue depart, between which there is a secondary xylem, crossed by numerous secondary radial rays of the main parenchyma. Xylem consists of thin-walled parenchymal cells containing starch grains. Vessels of the medullary rays have thickened lignified walls and are located singly or collected in groups of 3-6. In the parenchyma of wood, cells containing yellow pigments are occasionally found. In the center of the root there are indistinctly diagnosed remnants of primary xylem in the form of 2 rays. The phloem consists mainly of small-celled elements, it contains well-marked schizogenic receptacles containing droplets of secretion from light yellow to red-brown. Starch grains are small, round, simple. Some cells of the parenchyma contain druses of calcium oxalate. The outer part of the secondary cortex borders on a zone of several (4–6) rows of large tangentially elongated parenchymal phellodermal cells, round or oval, with a slightly thickened membrane.

Figure - Ginseng present 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 - a fragment of a transverse 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 - cells of the parenchyma of the medullary ray (100×).

On the transverse section of the adventitious root in the center, the ray of vessels of the primary xylem is the remnant of the diarch vascular bundle in the primary structure. The two sectors of the 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, weakly lignified cells.

Crushed raw materials. When examining a crushed preparation, 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 the parenchyma cells of the medullary rays with starch grains, canal cavities and lining cells, parenchyma cells with pigments, and cambial cells.

Adventitious root fragments are represented by cork cells, parenchyma with starch grains, receptacles, primary and secondary cortex, vessels, medullary rays.

Powder. When examining the micropreparation, fragments of the epidermis, cork, wood, parenchyma, as well as druses of calcium oxalate are visible.

Determination of the main groups of biologically active substances

Thin layer chromatography

On the start 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 standard sample solution (RS) of panaxoside Rg 1 (see section "Quantitative determination" preparation of solution A CO of panaxoside Rg 1). The plate with the applied samples is dried in air, placed in a chamber, preliminarily saturated for at least 2 h with a mixture of solvents chloroform - methanol - water (26:14:3), and chromatographed in an ascending manner. When the solvent front passes about 80 - 90% of the length of the plate from the start line, it is removed from the chamber, dried to remove traces of solvents, treated with phosphotungstic acid with an alcohol solution of 20% and heated in an oven at 100 - 105 ° C for 3 minutes, after what 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 level of the zone on 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 powder of ginseng roots, after 1-2 minutes, a brick-red color appears, turning into red-violet, and then into violet (panaxosides).

TESTS

Humidity. whole raw material, shredded raw material, powder - no more than 13%.

Ash is common. whole raw material, shredded raw material, powder - no more than 5%.

Ash insoluble in hydrochloric acid. whole raw material, shredded raw material, powder - no more than 2%.

Fineness of raw materials.Whole Raw Material: particles passing through a sieve with holes of 3 mm - no more than 5%. Shredded raw materials: particles that do not pass through a sieve with holes of 7 mm - no more than 5%; particles passing through a sieve with holes of 0.5 mm - no more than 5%. Powder: particles that do not pass through a sieve with holes of 2 mm in size - no more than 5%; particles passing through a sieve with holes of 0.18 mm in size - no more than 5%.

Foreign matter

Roots darkened from the surface . whole raw material, shredded raw material no more than 3%.

organic impurity. whole raw material, shredded raw material 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 herbal raw materials and medicinal herbal preparations".

Radionuclides. In accordance with the requirements of the General Pharmacopoeia Monograph "Determination of the content of radionuclides in medicinal herbal raw materials and medicinal herbal preparations".

Residual amounts of pesticides. In accordance with the requirements of the General Pharmacopoeia Monograph "Determination of the content of residual pesticides in medicinal herbal raw materials and medicinal herbal preparations".

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

quantitation. whole raw material, shredded raw material, powder: the sum of panaxosides in terms of panaxoside Rg 1  not less than 2%; extractives extracted with 70% alcohol - not less than 20%.

Sum of panaxosides

Preparation of solutions.

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

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

1.0 ml of solution A of 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 of 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 of 2 mm. About 1.0 g (accurately weighed) of crushed raw material is placed in a conical flask with a thin section with a capacity of 100 ml, 30 ml of 70% alcohol are added. Stopper the flask and weigh to the nearest  0.01. The flask is connected to a reflux condenser and heated on a water bath (moderate reflux) for 90 minutes. Then the flask is cooled to room temperature, closed with the same stopper, weighed again and, if necessary, adjusted to the original mass with 70% alcohol. The contents of the flask are thoroughly mixed. The extract is filtered through a paper filter ("red band") (solution A of the test solution).

Place 5.0 ml of solution A of the test solution in a porcelain dish and evaporate 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 volumetric flask with a capacity of 10 ml, the volume of the solution is adjusted to the mark with 96% alcohol and mixed (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 of a 70% solution are added and heated on a water bath for 10 minutes (solution C of the test solution). After cooling, measure the optical density of solution B of the test solution on a spectrophotometer at a wavelength of 526 nm in a cuvette with a layer thickness of 10 mm. Alcohol 96% is used as a reference solution.

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

where A

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

a– weight of raw materials, g;

a 0 – weighed SS of panaxoside Rg 1, g;

R is the content of the main substance in the SS of panaxoside Rg 1 , %;

W– raw material moisture content, %.

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

where A is the 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– raw material moisture content, %.

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 - alcohol 70%).

Note. The determination of the amount of panaxosides in terms of panaxoside Rg 1 is carried out for raw materials intended for the production of herbal medicines (packs, filter bags); determination of extractives extracted with alcohol 70%, and the amount of panaxosides in terms of panaxoside Rg 1 - for raw materials intended for the production of tinctures.

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 herbal raw materials and medicinal herbal preparations".

Ministry of Health of the Russian Federation

Federal State Budgetary Educational Institution

Higher education

FIRST MOSCOW STATE MEDICAL

UNIVERSITY named after I.M. SECHENOV

FACULTY OF PHARMACEUTICS

DEPARTMENT OF PHARMACOGNOSY

Practice Guide

According to pharmacognosy

Topic: Mastering the methods of pharmacognostic analysis

Moscow 2016

THEME 1

PHARMACOGNOSTIC ANALYSIS METHODS

In practical classes, the student receives the 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 should use the State Pharmacopoeia of the Russian Federation (http://www.femb.ru/feml), which reflects modern quality requirements for all medicines, including medicinal herbal raw materials and herbal medicinal products, methods for determining quality and norms . Federal Law No. 61 "On the Circulation of Medicines" includes Chapter 3 "State Pharmacopoeia".

The Federal State Educational Standard in the specialty "Pharmacy" includes professional competence:

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

date_______ SESSION 1

WHOLE LEAVES AUTHENTICATION

Independent work(preparation for class)

Exercise 1. Analyze OFS. 1.5.1.0001.15 “Medicinal plant materials. Pharmaceutical substances of plant origin”, OFS.1.5.3.0004.15 “Determination of authenticity, fineness 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 materials» - _________

"Pharmaceutical substance of plant origin" -

« Authenticity» - _____________________________

Medicinal plant materials Leaves» - ____

What document regulates the analysis of medicinal plant raw materials "leaves"? ___

Task 2. Draw the shape of the leaves May lily of the valley, stinging nettle, common bearberry, woolly foxglove.

Task 3. Draw the venation of the leaves plantain large and foxglove large-flowered.

Task 4. Draw the edge of the sheet digitalis purple, peppermint, lily of the valley, coltsfoot.

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

Task 6. Draw the types of simple and capitate hairs, and give examples of MV "leaves" where they occur.

Write down in which tissue the hairs are located: ________________________________

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

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

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

"Entrance control passed" ___________________ "____" _______ 20___ G.

(teacher's signature)

WORK IN THE CLASS

Note:

Ø The authenticity of the MRL "leaves" during the lesson is established in accordance with the sections of the Federal Assembly "External signs" and "Microscopy".

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

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

Ø Regulatory documentation is used only at the final stage of the analysis of raw materials to compare the results obtained and write a conclusion on the conformity of 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 in which sections there is a discrepancy.

Task 1. Conduct an analysis of the proposed sample of raw materials in the sections "External signs" and "Microscopy" of the RD. Prepare an analysis protocol.

PROTOCOL OF ANALYSIS

Whole medicinal herbal raw materials were submitted for analysis (Russian, Latin names)_____

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

Family ( Russian, Latin names)__________

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

The raw material is _______________________

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

Task 2. Perform microscopic analysis of raw materials.

1. Write down the method of preparing a micropreparation of a sheet from the surface: _________

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

3. Fill in the table of distribution of diagnostic features by tissues:

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

Conclusion. The raw materials received for analysis ________ ___ meet (do not meet) 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, large plantain, species of eucalyptus, medicinal sage, peppermint, common lingonberry, common bearberry, nettle nettle.

"Protocol of the lesson is credited" ___________________ "____" _______ 20___ G.

(teacher's signature)

Reference materials

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

OFS.1.5.1.0001.15 Medicinal plant materials. Pharmaceutical substances

plant origin

The requirements of this General Pharmacopoeia Article apply to medicinal plant 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 by pharmacy organizations, veterinary pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities.

Pharmaceutical substance of plant origin - a standardized medicinal plant material, as well as a substance / substances of plant origin and / or combinations thereof, products of primary and secondary synthesis of plants, including those obtained from plant cell culture, the amount 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.

Medicinal herbal product - a medicinal product produced or manufactured from one type of medicinal plant raw materials or several types of such raw materials and sold in packaged form in secondary (consumer) packaging.

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

By grinding, medicinal plant materials can be:

Whole;

crushed;

Powder.

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

By appointment, medicinal plant raw materials are divided into raw materials:

Used for the production of medicinal herbs

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

Used to make 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 herbal raw materials and pharmaceutical substances of plant origin, it is necessary to follow the relevant rules for cultivation, harvesting, drying, grinding and storage conditions. In medicinal plant materials and pharmaceutical substances

of plant origin, the content of foreign impurities, both organic (parts of other non-toxic plants) and mineral (earth, sand, pebbles) origin, is allowed in accordance with the requirements of the General Pharmacopoeia Monograph "Determination of the authenticity, fineness and content of impurities in medicinal plant materials and herbal medicinal preparations".

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

To conduct an analysis in order to determine the compliance of the quality of medicinal plant raw materials and pharmaceutical substances of plant origin and herbal medicinal products derived from them with the requirements of a pharmacopoeial article or regulatory documentation, uniform requirements for sampling are established (in accordance with the requirements of the General Pharmacopoeia Monograph "Sampling of medicinal plant materials and medicinal plant medications").

In the manufacture of infusions and decoctions from medicinal plant 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 materials”.

QUALITY INDICATORS AND METHODS OF TESTING MEDICINAL PLANT RAW MATERIALS

Authenticity. Medicinal plant materials are identified by macroscopic (external) and microscopic (anatomical) features (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 materials and medicinal herbal preparations"), and also determine the presence in the analyzed medicinal vegetable raw materials of the main groups of biologically active substances, confirming its authenticity (in accordance with the requirements of the General Pharmacopoeia Monograph "Determining the authenticity, fineness and content of impurities in medicinal plant raw materials and herbal preparations"). For this, methods of physicochemical, chemical, histochemical and microchemical analysis are used.

Crushing. The determination is carried out in accordance with the General Pharmacopoeia Monograph "Determination of the authenticity, fineness and content of impurities in medicinal plant raw materials and herbal medicinal preparations".

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

Ash is common. The determination is carried out in accordance with the requirements of the General Pharmacopoeia Monograph "Total 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 impurities. The determination is carried out in accordance with the General Pharmacopoeia Monograph "Determination of the authenticity, fineness and content of impurities in medicinal plant raw materials and herbal medicinal preparations". Does not apply to plant cell culture.

Pest infestation stocks. The determination is carried out in accordance with the General Pharmacopoeia Monograph "Determining the degree of contamination of medicinal plant materials and medicinal plant preparations with stock pests". This indicator is assessed during the storage of medicinal plant 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 the content of radionuclides in medicinal plant materials and herbal medicinal preparations".

Residual quantities of pesticides. 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" at the stage of the technological process.

Microbiological purity. The determination is carried out in accordance with the OFS "Microbiological purity".

Quantitation. The content of biologically active substances that determine the pharmacological action of medicinal plant 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 should be validated.

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

In medicinal plant raw materials, a 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 herbal medicinal preparations";

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

Fatty oils - in accordance with the requirements of the General Pharmacopoeia Monograph "Fatty vegetable oils";

Tannins - in accordance with the requirements of the General Pharmacopoeia Monograph "Determination of the content of 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 the designation of two limits "not less" and "not more". In the case of an overestimated content of these groups of biologically active substances in medicinal plant materials, its further use for the production of medicinal products is allowed, which is calculated by the formula:

where m is the amount of medicinal plant material required for the production of herbal medicinal products, g;

A - the prescribed amount of medicinal plant 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%.

Packing, marking and transportation. It is carried out in accordance with the requirements of the General Pharmacopoeia Monograph "Packaging, labeling and transportation of medicinal plant materials and herbal medicinal products".

Storage. It is carried out in accordance with the requirements of the General Pharmacopoeia Monograph “Storage of medicinal herbal raw materials and medicinal herbal preparations”. In the case of using disinfectants, disinfectants and other agents during storage of medicinal plant 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.

Leaves in pharmaceutical practice are called medicinal plant materials, which are dried or fresh leaves or individual leaves of a complex leaf. The leaves are usually harvested 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 crumpled) are softened in a humid chamber or by immersion for several minutes in hot water;

Fresh leaves are examined without pretreatment.

The leaves prepared for analysis are laid out on a glass plate, carefully spreading, 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 features:

1. Structure (simple, complex - unpaired-pinnate, paired-pinnate, double-paired-pinnate, double-unpaired-pinnate, palmately compound, trichately compound, etc.) and the dimensions of the leaf blade.

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

3. Depth of cutting of the leaf blade (palchatolobe, pinnate-lobed, ternate-lobed, digitipartite, pinnate, ternate, digitidissected, pinnate-dissected, ternate-dissected).

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

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

6. The presence of a petiole, its dimensions.

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

8. The presence of the vagina, stipules (free, fused), characteristics, dimensions.

9. Pubescence of the leaf and petiole (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 leaf surface or the presence of receptacles 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 a dry material in daylight.

The smell is determined by grinding.

Taste is determined by tasting a dry raw material or an aqueous extract of the leaves (only in non-poisonous objects).

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

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

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

Pay attention to the following anatomical and diagnostic features:

1. The nature of the cuticle of the upper and lower epidermis (smooth; wrinkled, including longitudinally wrinkled, transversely 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.); sinuosity of the walls of the cells of the upper and lower epidermis (straight, sinuous, wavy, zigzag, jagged, etc.), the degree of sinuosity; thickening of the cell walls of the upper and lower epidermis (uniform, beaded).

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 cells of the epidermis;

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

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

Anisocytic type (non-isocellular) - stomata are surrounded by three parotid cells, of which one is much smaller than the other two;

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

Hexacytic type - the stomata is surrounded by 6 parotid 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 guard cells;

Actinocytic type - characterized by several side cells, radially diverging from the trailing cells.

5. The presence of water stomata (they differ in large size and are usually located on 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, unicellular and multicellular, uni-, bi- and multi-row, bundle, branched and unbranched), their size, features of their attachment points (the presence of a rosette), thickening of the walls (thick, thin walls), the nature of the cuticle (smooth, warty, shrikhovy).

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

9. Presence of secretory canals, lactifers, receptacles (in the parenchyma under the epidermis).

10. The presence and structure of crystalline inclusions (single crystals of various shapes, drusen, rafids, styloids, cystolites, 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. Structure of the mesophyll (cell shape, homogeneity, location, presence of aerenchyma).

13. Leaf structure (dorsoventral, isolateral).

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

15. The presence of mechanical tissue (collenchyma, sclerenchymal fibers, stony cells, bast fibers, etc.).

16. The structure of the petiole: on the transverse section of the petiole of the leaf indicate its shape in the middle, basal and apical parts (rounded, triangular, grooved, crescent-shaped, slightly pterygoid, 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 the powder, fragments of leaves with the main and secondary veins, fragments of leaves with the edge of the leaf blade, fragments of the top of the leaf, fragments in cross section, fragments of the petiole are considered. In the studied powder particles, all manifesting anatomical and diagnostic features 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 the particles of the sheet; many fragments of tissues and individual elements are observed in the powder: hairs and their fragments, glands, individual crystals of calcium oxalate and fragments of the crystal-bearing lining, mechanical cells - fibers, sclereids, fragments of secretory channels, receptacles, lactifers, 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 the destruction of cells, individual crystals, druses, etc. can occur.

It is even more difficult to isolate anatomical and diagnostic features in the powder of 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 leaf mesophyll - individual hairs, glands, their fragments, crystals, etc.

The description of the main diagnostic features should be accompanied by illustrative material.

Luminescence microscopy. Consider a dry powder, less often a transverse section of a sheet, prepared from whole or crushed raw materials after preliminary softening in a humid chamber. There is own (primary) fluorescence of the raw material in ultraviolet light. 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, have the brightest glow. 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 transverse 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 receptacles 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 materials and medicinal herbal preparations".

Qualitative reactions are carried out with extraction from the leaves according to the methods given in pharmacopoeial articles or regulatory documents.

Chromatography. Extracts are analyzed by various chromatographic techniques using standard samples. Most often, components of essential oils, flavonoids, etc. are determined chromatographically in leaf extracts.

Spectrum (UV spectrum). The analysis is carried out in the extract from the leaves in the presence of appropriate instructions in the monograph or regulatory documentation. A reference to the "Quantification" section is allowed. A description is given of the conditions for recording the spectrum, indicating the wavelengths at which maximum(s) and minimum(s) of absorption should be observed.

In whole, crushed raw materials and powder determine:

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 materials and herbal medicinal preparations";

Humidity in accordance with the requirements of the General Pharmacopoeia Monograph "Determination of the moisture content of medicinal herbal raw materials and medicinal herbal preparations";

hydrochloric acid, in accordance with the requirements of the General Pharmacopoeia Monograph "General ash" and the General Pharmacopoeia Monograph "Ash insoluble in hydrochloric acid";

Fineness and content of impurities in accordance with the requirements of the General Pharmacopoeia Monograph "Determination of authenticity, fineness and

The mass of the contents of the package must comply with the requirements of the General Pharmacopoeia Monograph "Sampling of medicinal herbal raw materials and medicinal herbal preparations".

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

"Determination of the degree of contamination of medicinal plant materials and medicinal plant preparations with stock pests".

What is a pharmacopoeia? If you start from afar, then it must have occurred to every person at least once how doctors manage to memorize so many drugs, know their dosages, chemical composition and mechanism of action. In this they are helped by numerous reference books and compendiums containing the necessary information. And their authors, in turn, draw inspiration from the pharmacopoeia. So what is it?

Definition

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

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

The State Pharmacopoeia is a pharmacopoeia that has legal force and is under state supervision. The requirements and recommendations set forth in it are binding on all organizations in the country involved in the manufacture, storage, sale and use of medicines. For violation of the rules fixed in the document, a legal entity or individual faces criminal liability.

History of the International Pharmacopoeia

Thoughts on creating a single list of drugs indicating dosages and standardizing the nomenclature appeared in the scientific medical community at the end of the nineteenth century, in 1874. The first conference on this subject was held in Brussels in 1092. On it, experts came to an agreement on common names for drugs and the form of their discharge in prescriptions. Within four years, this agreement was ratified in twenty countries. This success became the starting point for the further development of the pharmacopoeia and its publication. Twenty years later, the second conference took place in Brussels, which was attended by representatives of forty-one countries of the world.

From that moment on, the care of publishing and revising the pharmacopoeia passed to the League of Nations. At the time of the agreement, the principles of preparation and dosage of 77 medicinal substances were included in the compendium. 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 to an international document.

The 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 meetings of the WHO, it was decided to create a program of international non-proprietary names for the unification of the nomenclature of medicines.

First edition

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

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

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

The headings of the articles were in Latin, as this was a common designation for all medical workers. To collect the necessary information, experts in biological standardization were involved, as well as narrow 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, the 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 health care and at the same time have a relatively low cost. This edition contained five volumes and was released in 1975. New revisions to the document were made only in 2008. They concerned the standardization of medicines, methods of their manufacture and distribution.

A pharmacopeia is a book that combines not only the nomenclature of medicinal substances, but also instructions for their manufacture, storage and purpose. This book contains a description of the chemical, physical and biological methods of drug analysis. In addition, it contains information about reagents and indicators, medicinal substances and preparations.

The WHO Committee compiled lists of poisonous (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 on a par with the International Pharmacopoeia, complements it and focuses on the peculiarities of medicine in this region. This book has been developed by the European Directorate for the Quality of Medicines, which is part of the Council of Europe. The Pharmacopoeia has a different legal status from other similar documents, which was given to it by the Cabinet of Ministers. The official language of the European Pharmacopoeia is French. The last, sixth, reissue was in 2005.

National pharmacopoeias

Since the International Pharmacopoeia has no legal force and is rather advisory in nature, individual countries have issued national pharmacopoeias for domestic regulation of drug-related issues. At the moment, most countries in the world have individual books. In Russia, the first pharmacopeia was published in 1778 in Latin. Only twenty years later a Russian-language version came out, becoming the first book of this type in the national language.

In 1866, half a century later, the first official Russian-language pharmacopeia was published. The 11th edition, the last during the existence of the USSR, appeared in the early nineties of the last century. The preparation, addition and reissue of the document used to be entrusted to the Pharmacopoeial Committee, but now this is done by the Ministry of Health, Roszdravnadzor and the General Medical Insurance Fund with the involvement of the country's leading scientists.

State Pharmacopoeia of the Russian Federation 12 and 13 editions

During the period when the state pharmacopoeia was subject to adjustment, the quality of medicines was regulated through the pharmacopoeial articles of the enterprise (FSP) and the general pharmacopoeial articles (GPM). The twelfth edition of the State Pharmacopoeia of the Russian Federation was significantly influenced by the fact that Russian specialists were involved in the work of the pharmacopoeia. The twelfth edition consists of five parts, each of which includes basic standards and regulations for the manufacture, prescription or sale of medicines. This book was published in 2009.

Six years later, the twelfth edition was revised. At the end of 2015, the State Pharmacopoeia, 13th edition, appeared on the official website of the Ministry of Health of the Russian Federation. It was an electronic version, since the release was carried out at the expense of funds from the sale. Therefore, at the legislative level, it was decided that each pharmacy and wholesaler should have a state pharmacopoeia (13th edition). This enabled the book to pay for itself.

What is a pharmacopoeial monograph?

There are two types of substance and finished dosage form. Each article "on the substance" has a title in two languages: Russian and Latin, international non-proprietary and chemical name. It contains empirical and structural formulas, molecular weight and amount of the main active substance. In addition, there is a detailed description of the appearance of the medicinal substance, quality control criteria, solubility in liquids, and other physical and chemical properties. The terms of packaging, manufacturing, storage and transportation are stipulated. 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, permissible deviations in mass, volume and particle size of the medicinal substance, as well as the maximum single and daily dosages for children and adults.

State Pharmacopoeia of the Russian Federation, edition XIII (13) in MS Word format, volume 3 (Moscow, 2015)

2. Pharmacopoeia articles
2.1. Pharmaceutical substances of synthetic origin
2.1.1. Aminocaproic acid (FS.2.1.0001.15)
2.1.2. Amlodipine besylate (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. Benzyl nicotinate (FS.2.1.0007.15)
2.1.8. Brilliant 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. Mebhydroline napadisylate (FS.2.1.0014.15)
2.1.15. Dioxidine (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. Citric 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% (ФС.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. Thymol (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. Fuchsin basic (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. Ethyl ester of alpha-bromoisovaleric acid (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 (ФС.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 (ФС.2.2.0015.15)
2.2.16. Sulfur, precipitated (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 (ФС.2.2.0020.15)
2.5. Medicinal plant materials
2.5.1. Marshmallow roots (FS.2.5.0001.15)
2.5.2. Aronia chokeberry fresh fruits (FS.2.5.0002.15)
2.5.3. Aronia chokeberry dry fruits (ФС.2.5.0003.15)
2.5.4. Badana 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. Immortelle sandy flowers (FS.2.5.0007.15)
2.5.8. Black elderberry flowers (FS.2.5.0008.15)
2.5.9. Valerian officinalis 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 grass (ФС.2.5.0012.15)
2.5.13. Ginseng real roots (FS.2.5.0013.15)
2.5.14. Joster laxative fruit (FS.2.5.0014.15)
2.5.15. St. John's wort (FS.2.5.0015.15)
2.5.16. Wild strawberry leaves (ФС.2.5.0016.15)
2.5.17. Viburnum bark (FS.2.5.0017.15)
2.5.18. Coriander fruit (FS.2.5.0018.15)
2.5.19. Stinging nettle leaves (FS.2.5.0019.15)
2.5.20. Demoiselle 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 erect 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 (ФС.2.5.0026.15)
2.5.27. Common coltsfoot leaves (FS.2.5.0027.15)
2.5.28. Common juniper fruit (FS.2.5.0028.15)
2.5.29. Peppermint leaves (FS.2.5.0029.15)
2.5.30. Marigold medicinal flowers (FS.2.5.0030.15)
2.5.31. Common tansy flowers (FS.2.5.0031.15)
2.5.32. Plantain leaves (ФС.2.5.0032.15)
2.5.33. Wormwood herb (FS.2.5.0033.15)
2.5.34. Motherwort herb (FS.2.5.0034.15)
2.5.35. Milk thistle fruit (FS.2.5.0035.15)
2.5.36. Rhodiola rosea rhizomes and roots (FS.2.5.0036.15)
2.5.37. Chamomile flowers (ФС.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. Pine buds (FS.2.5.0041.15)
2.5.42. Poplar buds (FS.2.5.0042.15)
2.5.43. Dill fragrant fruits (ФС.2.5.0043.15)
2.5.44. Violets grass (FS.2.5.0044.15)
2.5.45. Horsetail grass (ФС.2.5.0045.15)
2.5.46. Common seed hop (FS.2.5.0046.15)
2.5.47. Thyme herb (FS.2.5.0047.15)
2.5.48. Intersections of tripartite grass (ФС.2.5.0048.15)
2.5.49. Bird cherry fruits (FS.2.5.0049.15)
2.5.50. Bilberry 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 prickly rhizome and roots (FS.2.5.0053.15)
2.5.54. Ervy woolly grass (FS.2.5.0054.15)
2.5.55. Echinacea purpurea herb (FS.2.5.0055.15)

3. Medications
3.3. Biological drugs
3.3.1. Immunobiological medicinal products
3.3.1.1. Tuberculosis allergen recombinant in standard dilution (ФС.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 a reduced content of antigens (ADS-M-anatoxin) (FS.3.3.1.0003.15)
3.3.1.4. Diphtheria anatoxin adsorbed with reduced antigen content (AD-M-anatoxin) (FS.3.3.1.0004.15)
3.3.1.5. Purified adsorbed staphylococcal anatoxin, suspension for subcutaneous administration (FS.3.3.1.0005.15)
3.3.1.6. Purified staphylococcal anatoxin, for subcutaneous administration (ФС.3.3.1.0006.15)
3.3.1.7. Adsorbed tetanus anatoxin (AS-anatoxin) (ФС.3.3.1.0007.15)
3.3.1.8. Adsorbed trianatoxin (FS.3.3.1.0008.15)
3.3.1.9. Adsorbed tetraanatoxin (FS.3.3.1.0009.15)
3.3.1.10. Adsorbed pertussis-diphtheria-tetanus vaccine (DPT-vaccine) (FS.3.3.1.0010.15)
3.3.1.11. Brucellosis live vaccine (ФС.3.3.1.0011.15)
3.3.1.12. Typhoid vaccine Vi - polysaccharide (FS.3.3.1.0012.15)
3.3.1.13.
3.3.1.14. Vaccine leptospirosis concentrated inactivated liquid (ФС.3.3.1.0014.15)
3.3.1.15. Vaccine meningococcal serogroup A polysaccharide dry (FS.3.3.1.0015.15)
3.3.1.16. Live anthrax vaccine (ФС.3.3.1.0016.15)
3.3.1.17. Combined anthrax vaccine (ФС.3.3.1.0017.15)
3.3.1.18. Tuberculosis vaccine BCG live (ФС.3.3.1.0018.15)
3.3.1.19. Live tularemia vaccine (FS.3.3.1.0019.15)
3.3.1.20. Bivalent chemical cholera vaccine, enteric-coated (FS.3.3.1.0020.15)
3.3.1.21. Live plague vaccine, for resorption (ФС.3.3.1.0021.15)
3.3.1.22. Live plague vaccine (ФС.3.3.1.0022.15)
3.3.1.23. Tuberculin purified (PPD) (tuberculosis allergen purified) (FS.3.3.1.0023.15)
3.3.1.24. Live cultural rubella vaccine (ФС.3.3.1.0024.15)
3.3.1.25. Anti-rabies culture concentrated purified inactivated vaccine (ФС.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 (ФС.3.3.1.0027.15)
3.3.1.28. Influenza vaccine inactivated (ФС.3.3.1.0028.15)
3.3.1.29. Hepatitis A prevention vaccine culture purified concentrated adsorbed inactivated liquid (ФС.3.3.1.0029.15)
3.3.1.30. Yellow fever vaccine, live, dry, lyophilizate for solution for subcutaneous administration (FS.3.3.1.0030.15)
3.3.1.31. Tick-borne encephalitis vaccine culture purified concentrated inactivated liquid adsorbed or dry complete with aluminum hydroxide solvent (ФС.3.3.1.0031.15)
3.3.1.32. Live measles vaccine (ФС.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 fetal smallpox vaccine (FS.3.3.1.0035.15)
3.3.1.36. Live mumps vaccine (ФС.3.3.1.0036.15)
3.3.1.37. Oral polio vaccine 1, 2, 3 types, 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. Smallpox human immunoglobulin (FS.3.3.1.0039.15)
3.3.1.40. Human leukocyte interferon (FS.3.3.1.0040.15)
3.3.1.41. Serum antigangrenous polyvalent horse (ФС.3.3.1.0041.15)
3.3.1.42. Antibotulinum sera types A, B, E horse (ФС.3.3.1.0042.15)
3.3.1.43. Horse diphtheria serum (ФС.3.3.1.0043.15)
3.3.1.44. Antitetanic horse serum (ФС.3.3.1.0044.15)
3.3.1.45. Serum against the venom of the horse viper snake (ФС.3.3.1.0045.15)
3.3.1.46. Horse serum diluted 1: 100 (ФС.3.3.1.0046.15)
3.3.1.47. Pyrogenal, for intramuscular injection (FS.3.3.1.0047.15)
3.3.1.48. Pyrogenal, rectal suppositories (FS.3.3.1.0048.15)
3.3.2. Medicinal products 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. Human blood coagulation factor VIII (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. 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 in 1 ml and the mass of 1 drop of liquid drugs at a temperature of 20 ° C according to a standard drop meter

Table. Isotonic equivalents of drugs for sodium chloride

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

Table 2. Mass quantities (in grams at a temperature of 20 ° C) of water and alcohol of various strengths, which must be mixed to obtain 1 kg of alcohol with a strength of 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), which 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 volume percent

IR spectra of reference samples of pharmaceutical substances