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<article article-type="review-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">pharmjournal</journal-id><journal-title-group><journal-title xml:lang="ru">Разработка и регистрация лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Drug development &amp; registration</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2305-2066</issn><issn pub-type="epub">2658-5049</issn><publisher><publisher-name>LLC «CPHA»</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.33380/2305-2066-2026-15-3-2373</article-id><article-id custom-type="elpub" pub-id-type="custom">pharmjournal-2433</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ПОИСК И РАЗРАБОТКА НОВЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>RESEARCH AND DEVELOPMENT OF NEW DRUG PRODUCTS</subject></subj-group></article-categories><title-group><article-title>Лекарственные грибы и их место в фармакопейных монографиях разных стран (обзор)</article-title><trans-title-group xml:lang="en"><trans-title>Medicinal mushrooms and their place in pharmacopoeial monographs from different countries (review)</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0001-0543-3791</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Денисов</surname><given-names>С. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Denisov</surname><given-names>S. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>197022, г. Санкт-Петербург, вн. тер. г. муниципальный округ Аптекарский остров, ул. Профессора Попова, д. 14, лит. А</p></bio><bio xml:lang="en"><p>14A, Professora Popova str., Aptekarsky Ostrov Municipal Okrug, Saint Petersburg, 197022</p></bio><email xlink:type="simple">denisov.sergej@spcpu.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7938-5721</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ханды</surname><given-names>М. Т.</given-names></name><name name-style="western" xml:lang="en"><surname>Khandy</surname><given-names>M. T.</given-names></name></name-alternatives><bio xml:lang="ru"><p>690022, г. Владивосток, пр-т 100-летия Владивостока, д. 159</p></bio><bio xml:lang="en"><p>159, prospekt 100-letiya Vladivostoka, Vladivostok, 690022</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7768-9059</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Повыдыш</surname><given-names>М. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Povydysh</surname><given-names>M. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>197022, г. Санкт-Петербург, вн. тер. г. муниципальный округ Аптекарский остров, ул. Профессора Попова, д. 14, лит. А</p></bio><bio xml:lang="en"><p>14A, Professora Popova str., Aptekarsky Ostrov Municipal Okrug, Saint Petersburg, 197022</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное образовательное учреждение высшего образования «Санкт-Петербургский государственный химико-фармацевтический университет» Министерства здравоохранения Российской Федерации (ФГБОУ ВО СПХФУ Минздрава России)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Saint Petersburg State Chemical and Pharmaceutical University (SPCPU)</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение науки «Федеральный научный центр биоразнообразия наземной биоты Восточной Азии» Дальневосточного отделения Российской академии наук (ФНЦ Биоразнообразия ДВО РАН)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Federal Scientific Center of the East Asia Terrestrial Biodiversity of Far Eastern Branch of the Russian Academy of Sciences</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2026</year></pub-date><pub-date pub-type="epub"><day>09</day><month>09</month><year>2026</year></pub-date><volume>15</volume><issue>3</issue><fpage>38</fpage><lpage>50</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Денисов С.В., Ханды М.Т., Повыдыш М.Н., 2026</copyright-statement><copyright-year>2026</copyright-year><copyright-holder xml:lang="ru">Денисов С.В., Ханды М.Т., Повыдыш М.Н.</copyright-holder><copyright-holder xml:lang="en">Denisov S.V., Khandy M.T., Povydysh M.N.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.pharmjournal.ru/jour/article/view/2433">https://www.pharmjournal.ru/jour/article/view/2433</self-uri><abstract><sec><title>Введение</title><p>Введение. Грибы (Fungi) – эволюционно обособленная группа гетеротрофных организмов, занимающая уникальное положение в системе живой природы. В настоящее время они рассматриваются медициной как перспективные источники новых биологически активных веществ. Несмотря на тысячелетнюю историю применения в традиционной медицине и рост числа исследований биологической активности различных групп веществ грибов, внедрение этого сырья в фармацевтическую практику ограничено. Ключевая проблема – сложность стандартизации из-за отсутствия нормативной документации. В отличие от растений, число фармакопейных монографий на грибное сырье (плодовые тела, мицелий, экстракты) исчисляется единицами, отсутствуют унифицированные подходы к оценке качества. Таким образом, разработка и гармонизация стандартов на сырье грибного происхождения позволит реализовать его терапевтический потенциал.</p></sec><sec><title>Текст</title><p>Текст. В статье рассматриваются вопросы стандартизации сырья грибного происхождения. Описаны основные сферы применения макромицетов. Названы основные виды высших грибов, используемые в медицине, и озвучены перспективы использования других потенциальных кандидатов. Описаны виды подтвержденной биологической активности для определенных видов грибов, включая противоопухолевую, иммуномодулирующую и антиоксидантную активность. Показан рост числа исследований высших грибов как источников биологически активных веществ. Проведен анализ фармакопей России, Китая, Японии, Индии, США, Бразилии и других стран на наличие в них монографий на грибы. Материалами данного обзора послужили различные фармакопейные издания, находящиеся в открытом доступе, на английском и русском языках. Установлены виды фармакопейных грибов, сходства и различия в подходах к стандартизации. Приведены показатели качества сырья, по которым проводят стандартизацию в различных фармакопеях. Приведены примеры лекарственных препаратов (ЛП) и биологически активных добавок (БАД) к пище на основе грибов, зарегистрированных в России. Обозначены проблемы разработки нормативной документации, стандартов качества и методик анализа на сырье грибного происхождения.</p></sec><sec><title>Заключение</title><p>Заключение. Выявлено, что нормативная база, регламентирующая качество сырья грибного происхождения, крайне ограниченна. Необходимо расширение списков фармакопейных видов грибов, используемых для производства лекарственных препаратов и биологически активных добавок к пище.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. Fungi represent an evolutionarily distinct group of heterotrophic organisms that occupy a unique position in the system of wildlife. Currently, they are considered by modern medicine as promising sources of new biologically active compounds. Despite a millennia-long history of use in traditional medicine and an increasing number of studies on the biological activity of various groups of fungal substances, the incorporation of this raw material into pharmaceutical practice remains limited. The key problem lies in the difficulty of standardization due to the absence of regulatory documentation. Unlike plants, the number of pharmacopoeial monographs on fungal raw materials (fruit bodies, mycelium, extracts) is very low, and unified approaches to quality assessment are lacking. Thus, the development and harmonization of standards for fungal raw materials will enable the realization of their therapeutic potential.</p></sec><sec><title>Text</title><p>Text. This article addresses the issues of standardization of fungal raw materials. The main areas of application of macromycetes are described. The principal species of higher fungi used in medicine are named, and the prospects for using other potential candidates are discussed. The types of confirmed biological activity for specific fungal species, including antitumor, immunomodulatory, and antioxidant activities, are described. The increasing number of studies on higher fungi as sources of biologically active compounds is demonstrated. The pharmacopoeias of Russia, China, Japan, India, the USA, Brazil, and other countries were analyzed for the presence of monographs on mushrooms. The materials for this review include various pharmacopoeial editions available in open access in English and Russian. The species of pharmacopoeial fungi are identified, along with similarities and differences in standardization approaches. Quality parameters used for standardization in different pharmacopoeias are presented. Examples of medicinal products and biologically active food additives based on mushrooms registered in Russia are given. The problems of developing regulatory documentation, quality standards, and analytical methods for fungal raw materials are outlined.</p></sec><sec><title>Conclusion</title><p>Conclusion. It has been determined that the regulatory framework governing the quality of fungal raw materials is extremely limited. The expansion of the lists of pharmacopoeial fungal species used for the production of medicines and dietary supplements is necessary.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>лекарственные грибы</kwd><kwd>фармакопейные грибы</kwd><kwd>сырье грибного происхождения</kwd><kwd>биологическая активность</kwd><kwd>биологически активные добавки к пище</kwd></kwd-group><kwd-group xml:lang="en"><kwd>medicinal mushrooms</kwd><kwd>pharmacopoeial mushrooms</kwd><kwd>raw materials of mushroom origin</kwd><kwd>biological activity</kwd><kwd>biologically active food additives</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена в рамках государственного задания Министерства науки и высшего образования Российской Федерации (тема № 124012200181-4).</funding-statement><funding-statement xml:lang="en">This work was carried out within the framework of the state assignment of the Ministry of Science and Higher Education of the Russian Federation (Project No. 124012200181-4).</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Костромина Е. 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