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’)10.30895/1991-2919-2023-13-3-426-432vedomostiregmed-524Research ArticleЛЕКАРСТВЕННЫЕ СРЕДСТВА РАСТИТЕЛЬНОГО ПРОИСХОЖДЕНИЯHERBAL MEDICINAL PRODUCTSСравнительный анализ требований к качеству лекарственных средств на основе конского каштана обыкновенного семянComparative Analysis of Quality Requirements for Medicines Based on Horse-Chestnut Seedshttps://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/0000-0003-0379-6158БагироваВ. Л.BagirovaV. L.

Багирова Валерия Леонидовна, д-р фарм. наук, профессор

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

Valeria L. Bagirova, Dr. Sci. (Pharm.), Professor

8/2 Petrovsky Blvd, Moscow 127051

bagirova@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/0000-0002-8220-1054ЛякинаМ. Н.LyakinaM. N.

Лякина Марина Николаевна, д-р фарм. наук, старший научный 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.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation202327092023133426432Copyright © Евдокимова О.В., Багирова В.Л., Бекетова А.В., Лякина М.Н., 20232023Евдокимова О.В., Багирова В.Л., Бекетова А.В., Лякина М.Н.Evdokimova O.V., Bagirova V.L., Beketova A.V., Lyakina M.N.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/524

Актуальность. В рамках работы по унификации условий качественного и количественного анализа биологически активных веществ лекарственных средств растительного происхождения  было установлено отсутствие отечественных стандартов качества на лекарственные средства на основе конского каштана обыкновенного.Цель. На основе изучения зарубежных стандартов качества выявить наиболее перспективные методы анализа основных групп биологически активных веществ конского каштана обыкновенного семян и использовать данные методы при разработке проектов фармакопейных статей на соответствующие лекарственные препараты растительного происхождения.Обсуждение. Проведен сравнительный анализ требований зарубежных фармакопей к качеству лекарственного растительного сырья и фармацевтических субстанций растительного происхождения конского каштана обыкновенного семян по показателям «Идентификация» и «Количественное определение».Выводы. Основным методом установления подлинности лекарственных средств на основе конского каштана обыкновенного семян является метод тонкослойной хроматографии, а количественного определения — спектрофотометрический метод с использованием эсцина в качестве фармакопейного стандартного образца. Подготовлен проект фармакопейной статьи «Конского каштана обыкновенного семян экстракт сухой + тиамина гидрохлорид, раствор для приема внутрь», который предусматривает оценку качества лекарственного препарата с использованием методов тонкослойной хроматографии и спектрофотометрии в видимой области спектра.

Scientific relevance. When harmonising conditions for qualitative and quantitative analysis of bioactive compounds in herbal medicines, the Institute of Pharmacopoeia and Medicinal Product Standardisation has discovered that horse-chestnut products lack national quality standards.Aim. This study aimed to review international quality standards in order to identify the most promising testing methods for the main groups of bioactive compounds in horse-chestnut seeds and draw upon these methods when drafting national pharmacopoeial monographs for horse-chestnut seed products.Discussion. The authors compared the requirements established by leading world pharmacopoeias for the identification and assay of herbal drugs and herbal drug preparations derived from horse-chestnut seeds.Conclusions. The study results show that, predominantly, identification tests are based on thin-layer chromatography, assays rely on spectrophotometry, and aescin is used as a pharmacopoeial reference standard. The authors drafted a pharmacopoeial monograph for the medicinal product Horse-Chestnut Seed Dry Extract + Thiamine Hydrochloride, Oral Solution, which requires using thin-layer chromatography and spectrophotometry for qualitative and quantitative testing.

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