vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/1991-2919-2022-12-2-142-148vedomostiregmed-390Research ArticleГЛАВНАЯ ТЕМА: СОВРЕМЕННЫЕ ПОДХОДЫ К ЭКСПЕРТИЗЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ РАСТИТЕЛЬНОГО ПРОИСХОЖДЕНИЯMAIN TOPIC: CURRENT APPROACHES TO EVALUATION OF HERBAL MEDICINESГармонизация фармакопейных требований при определении близкородственных видов в лекарственных средствах растительного происхожденияHarmonisation of Pharmacopoeial Requirements for Identification of Closely Related Species in Herbal Medicinal Productshttps://orcid.org/0000-0003-2191-1033ЕвдокимоваО. В.EvdokimovaO. V.

Евдокимова Ольга Владимировна, д-р фарм. наук, доцент

Петровский б-р, д. 8, стр. 2, Москва, 127051

Olga V. Evdokimova, Dr. Sci. (Pharm.), Associate Professor

8/2 Petrovsky Blvd, Moscow 127051

evdokimovaov@expmed.ruhttps://orcid.org/0000-0002-8220-1054ЛякинаМ. Н.LyakinaM. N.

Лякина Марина Николаевна, д-р фарм. наук, старшийнаучный сотрудник

Петровский б-р, д. 8, стр. 2, Москва, 127051

Marina N. Lyakina, Dr. Sci. (Pharm.), Senior Research Associate

8/2 Petrovsky Blvd, Moscow 127051

Ljakina@expmed.ruhttps://orcid.org/0000-0001-6975-516XБекетоваА. В.BeketovaA. V.

Бекетова Анастасия Викторовна, канд. фарм. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051

Anastasia V. Beketova, Сand. Sci. (Pharm.)

8/2 Petrovsky Blvd, Moscow 127051

beketova@expmed.ruhttps://orcid.org/0000-0003-4551-8252ЛадыгинаЛ. А.LadyginaL. A.

Ладыгина Лиана Александровна

Петровский б-р, д. 8, стр. 2, Москва, 127051

Liana A. Ladygina

8/2 Petrovsky Blvd, Moscow 127051

Ladygina@expmed.ruhttps://orcid.org/0000-0002-2658-6279ЩетининаА. П.ShchetininaA. P.

Щетинина Анастасия Павловна

Петровский б-р, д. 8, стр. 2, Москва, 127051

Anastasia P. Shchetinina

8/2 Petrovsky Blvd, Moscow 127051

ishchap@gmail.comФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation202217052022122142148Copyright © Евдокимова О.В., Лякина М.Н., Бекетова А.В., Ладыгина Л.А., Щетинина А.П., 20222022Евдокимова О.В., Лякина М.Н., Бекетова А.В., Ладыгина Л.А., Щетинина А.П.Evdokimova O.V., Lyakina M.N., Beketova A.V., Ladygina L.A., Shchetinina A.P.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/390

Во всем мире растет интерес к лекарственным средствам растительного происхождения (ЛСРП), что вызывает увеличение спроса на лекарственное растительное сырье. Оборотной стороной роста объемов продаж лекарственного растительного сырья являются риски увеличения масштабов распространения фальсифицированных и недоброкачественных ЛСРП. Применение подобных средств может повлечь за собой развитие серьезных осложнений и даже летальный исход. Таким образом, увеличивается актуальность исследований с целью идентификации и контроля качества лекарственного растительного сырья. Актуальность проводимых исследований обусловлена также необходимостью гармонизации методов идентификации близкородственных видов как допустимых примесей в лекарственных средствах растительного происхождения. Цель работы  — выявить наиболее часто используемые методы идентификации близкородственных видов растений и оценить возможность гармонизации национальных стандартов качества с требованиями монографий зарубежных фармакопей. В результате проведенного анализа показателей подлинности установлено, что основным методом идентификации примесей близкородственных видов является метод хроматографии в тонком слое сорбента. При оценке подлинности также используются морфолого-анатомические характеристики растений. Методические подходы идентификации близкородственных видов в лекарственных средствах растительного происхождения, используемые в  Европейской фармакопее, нашли применение при актуализации фармакопейных стандартов Государственной фармакопеи Российской Федерации. Они гармонизированы с требованиями монографий ведущих зарубежных фармакопей и предусматривают обнаружение недопустимых примесей в лекарственных средствах растительного происхождения по морфолого-анатомическим и хроматографическим характеристикам.

Global interest in herbal medicinal products is growing, thus increasing the demand for medicinal plant raw materials. However, the growth in sales of raw materials entails the risk of a wider spread of counterfeit and substandard medicinal products. The use of such products can lead to serious complications and even death. This brings to the forefront the studies aiming at identification and quality control of herbal drugs. In addition, the relevance of these studies stems from the need for harmonisation of test methods for identification of related plant species as acceptable foreign elements in herbal medicinal products. The aim of the study was to determine the most widely used methods for identification of closely related plant species and to analyse the possibility of aligning the requirements of Russian standards and foreign pharmacopoeial monographs. According to the analysis of identification requirements, the main test method for identification of related plant species is thin-layer chromatography; morphological and anatomical characteristics of plants are also used. Methodological approaches of the European Pharmacopoeia to identification of closely related species in herbal medicinal products have found application in updating compendial standards of the Russian Pharmacopoeia. Russian standards are harmonised with the requirements described in monographs of leading pharmacopoeias and provide for the detection of unacceptable impurities in herbal medicinal products by morphological, anatomical and chromatographic characteristics.

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The authors declare that there are no conflicts of interest present.