XIII edition, M.: FEMB, 2015. - 1292 pp. State Pharmacopoeia Russian Federation XIII edition (SF RF XIII edition) consists of an introductory part, the main part and appendices.
The main part contains 229 general pharmacopoeial monographs (GPM) and 179 pharmacopoeial monographs (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; immunobiological groups medicines 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 outline general methods of analysis, methods of physical, physicochemical, 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 Fund of the Russian Federation, for the first time, 20 pharmacopoeial monographs are introduced, 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 Pharmacopeia XI edition) are excluded from the practice of modern pharmacopoeial analysis as unclaimed.
For the first time, the XIII edition of the State Fund of the Russian Federation includes a subsection “Biological medicinal products”, containing the General Pharmacopoeia Monograph and the FS, regulating the requirements for immunobiological medicinal products, medicinal products obtained from the blood and blood plasma of humans and animals and their testing methods.
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.
The following sequence of names is adopted in the headings of pharmacopoeial monographs for pharmaceutical substances: INN in Russian, trivial name, name in Latin, and for medicinal plant raw materials - the 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.
Medicines.
Biological drugs.
Applications.
Names, symbols and relatives atomic masses 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 drugs, 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 medicines 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

Thoughts about creating a unified list of drugs indicating dosages and standardizing the nomenclature appeared among 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 the starting point for the 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 normative document, which 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 has a legal status that is different from other similar documents, which was given to it by the Cabinet of Ministers. 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 have issued national pharmacopoeias for internal regulation of issues related to medicines. At the 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 reissue 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 Health Insurance Fund with the involvement 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 that Russian specialists were involved in 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 weight and 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.

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.

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 a 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 rays and xylem 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 a standard sample solution (SS) of 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”.

Quantification. 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 materials 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”.

Ministry of Health of the Russian Federation

Federal state budget educational institution

Higher education

FIRST MOSCOW STATE MEDICAL

I.M. SECHENOV UNIVERSITY

FACULTY OF PHARMACEUTICS

DEPARTMENT OF PHARMACOGNOSY

Guide to practical exercises

By pharmacognosy

Topic: Mastering methods of pharmacognostic analysis

Moscow 2016

TOPIC 1

PHARMACOGNOSTIC ANALYSIS METHODS

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

To implement quality control competencies, students must 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 medicinal herbal preparations, methods for determining quality and standards . Federal law No. 61 “On the Circulation of Medicines” includes Chapter 3 “State Pharmacopoeia”.

The Federal State Educational Standard for the specialty “Pharmacy” includes the following professional competence:

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

date_______ LESSON 1

DETERMINING THE AUTHENTICITY OF WHOLE LEAVES

Independent work (preparation for class)

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

« Medicinal plant» -___________________

« Medicinal plant raw materials» - _________

"Pharmaceutical substance of plant origin" -

« Authenticity» - _____________________________

Medicinal plant raw materials « Leaves» - ____

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

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

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

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

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

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

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

Write down in which tissue the hairs are located:________________________________

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

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

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

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

(teacher signature)

WORK IN CLASS

Please note:

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

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

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

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

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

ANALYSIS PROTOCOL

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

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

Family ( Russian, Latin names)__________

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

Raw materials are _______________________

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

Task 2. Conduct microscopic analysis of raw materials.

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

2. Prepare a microscopic specimen of the _________________ leaf from the surface, study it, sketch the anatomical structure and provide symbols.

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

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

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

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

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

(teacher signature)

Reference materials

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

GPM.1.5.1.0001.15 Medicinal plant raw materials. Pharmaceutical substances

plant origin

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

Basic terms and definitions

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

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

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

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

According to grinding, medicinal plant raw materials can be:

Whole;

Shredded;

Powder.

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

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

Used for the production of medicinal herbs

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

Used for making medicinal herbs

drugs (for example, infusions, decoctions).

PRODUCTION

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

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

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

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

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

QUALITY INDICATORS AND TESTING METHODS OF MEDICINAL PLANT RAW MATERIALS

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Tannins - in accordance with the requirements of the General Pharmacopoeia Monograph “Determination of 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 two limits “no less” and “no more”. In case of excessive content of these groups of biologically active substances in medicinal plant raw materials, it is allowed further use for the production of medicines, which is calculated by the formula:

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

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

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

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

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

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

OFS. 1.5.1.0003.15 Leaves. Folia.

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

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

Small and leathery leaves are examined dry;

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

Fresh leaves are examined without pre-treatment.

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

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

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

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

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

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

6. The presence of a petiole, its size.

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

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

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

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

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

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

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

The smell is determined by rubbing.

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

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

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

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

Pay attention to the following anatomical and diagnostic signs:

1. The nature of the cuticle of the upper and lower epidermis (smooth; wrinkled, including longitudinally wrinkled, transversely wrinkled, radiantly wrinkled; streaked; comb-like, etc.).

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

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

4. Type of stomatal apparatus:

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

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

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

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

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

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

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

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

5. Presence of water stomata (differ large size and are usually located at the top of the leaf or tooth, above the hydathode).

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

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

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

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

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

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

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

13. Leaf structure (dorsoventral, isolateral).

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

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

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

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

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

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

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

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

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

Qualitative microchemical and histochemical reactions

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

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

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

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

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

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

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

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

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

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

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

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