pharmjournalРазработка и регистрация лекарственных средствDrug development & registration2305-20662658-5049LLC «CPHA»10.33380/2305-2066-2024-13-1-1624pharmjournal-1700Research ArticleМЕТОДЫ АНАЛИЗА ЛЕКАРСТВЕННЫХ СРЕДСТВANALYTICAL METHODSМетоды определения афлатоксинов и охратоксина А в лекарственном растительном сырье (обзор)Methods for the Determination of Aflatoxins and Ochratoxin A in Medicinal Plant Raw Materials (Review)https://orcid.org/0000-0002-8962-9133ИвановаУ. В.IvanovaU. V.

197022, г. Санкт-Петербург, ул. Профессора Попова, 14, лит. А

14A, Prof. Popova str., Saint-Petersburg, 197022

ivanova.uliana@spcpu.ruhttps://orcid.org/0000-0002-3735-2291ГравельИ. В.GravelI. V.

197022, г. Санкт-Петербург, ул. Профессора Попова, 14, лит. А; 

119991, г. Москва, ул. Трубецкая, д. 8, стр. 2

14A, Prof. Popova str., Saint-Petersburg, 197022;

8/2, Trubetskaya str., Mosсow, 119991

Федеральное государственное бюджетное образовательное учреждение высшего образования «Санкт-Петербургский государственный химико-фармацевтический университет» Министерства здравоохранения Российской Федерации (ФГБОУ ВО СПХФУ Минздрава России)Saint-Petersburg State Chemical and Pharmaceutical UniversityФедеральное государственное бюджетное образовательное учреждение высшего образования «Санкт-Петербургский государственный химико-фармацевтический университет» Министерства здравоохранения Российской Федерации (ФГБОУ ВО СПХФУ Минздрава России); Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И. М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)Saint-Petersburg State Chemical and Pharmaceutical University; I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University)20242612202313195109Copyright © Иванова У.В., Гравель И.В., 20242024Иванова У.В., Гравель И.В.Ivanova U.V., Gravel I.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmjournal.ru/jour/article/view/1700Введение

Введение. Афлатоксины и охратоксин А представляют собой вторичные метаболиты микроскопических плесневых грибов и несут серьезную угрозу здоровью человека и животных. Данные токсины являются канцерогенными, тератогенными, гепатотоксичными, нефротоксичными веществами, также классифицированы Международным агентством по изучению рака (IARC) как канцерогены IA и IIB класса. В настоящее время предельно допустимые концентрации афлатоксинов и охратоксина А в Российской Федерации регулируются только в продуктах питания на основании технического регламента Таможенного союза 021 «О безопасности пищевой продукции», лекарственное растительное сырье не регламентируется. Неблагоприятные экологические и биологические условия (температура, влажность, качество воздуха, насекомые и т. д.) на этапах послеуборочной обработки и хранения могут способствовать заражению плесневыми грибами, что может привести к контаминации лекарственного сырья афлатоксинами и охратоксином А. В связи с этим важным этапом контроля качества сырья является изучение методов анализа, которые используются в современной аналитической практике, и выбор чувствительного метода для обнаружения данных токсинов.

Текст

Текст. В данном обзоре были рассмотрены существующие методы очистки проб, использующиеся на этапе пробоподготовки: твердофазная экстракция, иммуноаффинная колонка, QuEChERS. Были изучены все современные методы анализа для идентификации афлатоксинов и охратоксина А в лекарственном растительном сырье: тонкослойная хроматография, жидкостная хроматография, газовая хроматография и скрининговые методы.

Заключение

Заключение. В качестве наиболее востребованного метода при подготовке проб к анализу был выделен метод QuEChERS, основанный на технологии экстракции твердых фаз. Этот метод сочетает в себе вариабельность подходов к очистке пробы и позволяет исследовать более широкий спектр токсинов. Метод высокоэффективной жидкостной хроматографии, обладающий высокой селективностью, многокомпонентностью анализа и низкими пределами обнаружения, был выделен как самый востребованный метод для проведения качественного и количественного анализа.

Introduction

Introduction. Aflatoxins and ochratoxin A are secondary metabolites of microscopic mold fungi. They seriously threaten human and animal health. These toxins are carcinogenic, teratogenic, hepatotoxic, nephrotoxic substances. International Agency for Research on Cancer (IARC) has classified them as class IA and IIB carcinogens. The maximum permissible concentrations of aflatoxins and ochratoxin A in the Russian Federation are currently regulated only in food products according to the Technical Regulation of the Customs Union 021 "On Food Safety". The content of aflatoxins and ochratoxin A in medicinal plant raw materials is not regulated in any way. Harmful environmental and biological conditions such as temperature, humidity, air quality, insects and others during post-harvest handling can lead to contamination of medicinal raw materials with aflatoxins and ochratoxin A. Therefore, the detection of these toxins is one of the problems of raw materials quality control.

Text

Text. The present review summarizes the following methods of sample purification, used at the sample preparation stage: solid-phase extraction, immunoaffin column and QuEChERS. This review also summarizes the following modern analysis methods for the identification of aflatoxin and ochratoxin A in medicinal plant raw materials: thin-layer chromatography, liquid chromatography, gas chromatography and screening methods.

Conclusion

Conclusion. The QuEChERS method has been identified as the most popular method for preparing samples for analysis. It is based on solid phase extraction technology. This method combines the variability of approaches to sample purification and allows people to study a wider range of toxins. The high-performance liquid chromatography method has been identified as the most popular method for qualitative and quantitative analysis. It has high selectivity, multicomponent analysis and low detection limits.

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