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<article article-type="research-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">vedomostiregmed</journal-id><journal-title-group><journal-title xml:lang="ru">Регуляторные исследования и экспертиза лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Regulatory Research and Medicine Evaluation</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">3034-3062</issn><issn pub-type="epub">3034-3453</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.30895/1991-2919-2026-16-3-341-350</article-id><article-id custom-type="elpub" pub-id-type="custom">vedomostiregmed-890</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>КОНТРОЛЬ КАЧЕСТВА ЛЕКАРСТВЕННЫХ СРЕДСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>QUALITY CONTROL OF MEDICINES</subject></subj-group></article-categories><title-group><article-title>Фомитоидные трутовики: обоснование нормативных требований к качеству сырья</article-title><trans-title-group xml:lang="en"><trans-title>Fomitoid Polypores: Justification of Regulatory Requirements for Raw Material Quality</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0009-9150-5728</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Горбацевич</surname><given-names>Г. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Harbatsevich</surname><given-names>H. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Горбацевич Глеб Иванович, канд. хим. наук, доцент </p><p>пр. Дзержинского, д. 83, Минск, 220116 </p></bio><bio xml:lang="en"><p>Hleb I. Harbatsevich, Cand. Sci. (Chem.), Associate Professor </p><p>83 Dzerzhinsky Ave., Minsk 220116 </p></bio><email xlink:type="simple">hleb.harbatsevich@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0002-0226-8636</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гурина</surname><given-names>Н. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Gurina</surname><given-names>N. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Гурина Наталия Сергеевна, д-р биол. наук, профессор </p><p>пр. Дзержинского, д. 83, Минск, 220116 </p></bio><bio xml:lang="en"><p>Natalia S. Gurina, Dr. Sci. (Biol.), Professor </p><p>83 Dzerzhinsky Ave., Minsk 220116 </p></bio><email xlink:type="simple">nsgur@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Учреждение образования «Белорусский государственный медицинский университет»</institution><country>Беларусь</country></aff><aff xml:lang="en"><institution>Belarusian State Medical University</institution><country>Belarus</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Учреждение образования «Белорусский государственный медицинский&#13;
университет»</institution><country>Беларусь</country></aff><aff xml:lang="en"><institution>Belarusian State Medical University</institution><country>Belarus</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2026</year></pub-date><pub-date pub-type="epub"><day>04</day><month>07</month><year>2026</year></pub-date><volume>16</volume><issue>3</issue><fpage>341</fpage><lpage>350</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Горбацевич Г.И., Гурина Н.С., 2026</copyright-statement><copyright-year>2026</copyright-year><copyright-holder xml:lang="ru">Горбацевич Г.И., Гурина Н.С.</copyright-holder><copyright-holder xml:lang="en">Harbatsevich H.I., Gurina N.S.</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.vedomostincesmp.ru/jour/article/view/890">https://www.vedomostincesmp.ru/jour/article/view/890</self-uri><abstract><sec><title>ВВЕДЕНИЕ</title><p>ВВЕДЕНИЕ. Актуальность настоящего исследования обусловлена возрастающим интересом к трутовым грибам как доступному и возобновляемому источнику биологически активных веществ с доказанной фармакологической активностью (прежде всего фенольных и тритерпеновых соединений). Несмотря на широкую распространенность фомитоидных трутовиков, их сырье практически не стандартизовано и не представлено в фармакопеях большинства стран, что ограничивает его внедрение в медицинскую практику. Отсутствие унифицированных подходов к оценке качества и выбору аналитических маркеров, с учетом высокой вариабельности химического состава, затрудняет стандартизацию сырья. В связи с этим обоснование критериев качества и методов стандартизации сырья фомитоидных трутовиков является важной задачей.</p></sec><sec><title>ЦЕЛЬ</title><p>ЦЕЛЬ. Обоснование критериев качества сырья фомитоидных трутовиков для последующей разработки нормативного документа.</p></sec><sec><title>МАТЕРИАЛЫ И МЕТОДЫ</title><p>МАТЕРИАЛЫ И МЕТОДЫ. Исследовано не менее 20 партий плодовых тел фомитоидных трутовиков видов Fomes fomentarius (L.) Fr., Fomitopsis pinicola (Sw.) P. Karst., Ganoderma applanatum (Pers.) Pat., Piptoporus betulinus (Bull.) P. Karst., Phellinus igniarius (L.) Quél., заготовленных в различных регионах Республики Беларусь и Российской Федерации. Определены потеря в массе при высушивании, общая зола, не растворимая в хлороводородной кислоте зола, сумма экстрактивных веществ, сумма фенольных соединений и сумма стероидных и тритерпеновых соединений спектрофотометрическим и гравиметрическим методами.</p></sec><sec><title>РЕЗУЛЬТАТЫ</title><p>РЕЗУЛЬТАТЫ. Показана межвидовая и внутривидовая вариабельность показателей качества. Установлено, что в зависимости от вида сырья допустимые пределы содержания суммы фенольных соединений составляют 0,10–0,25%, суммы стероидных и тритерпеновых соединений — 0,05–0,30%, экстрактивных веществ — 0,5–14,0%. Показатели общей золы, не растворимой в хлороводородной кислоте золы и потери в массе при высушивании находятся в пределах 1,0–5,0, 1,0–3,0 и 10,0–12,0% соответственно.</p></sec><sec><title>ВЫВОДЫ</title><p>ВЫВОДЫ. Разработаны показатели качества сырья фомитоидных трутовиков, которые могут быть использованы для создания нормативного документа по качеству на сырье грибного происхождения.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>INTRODUCTION</title><p>INTRODUCTION. The relevance of this study is driven by the growing interest in polypore fungi as an accessible and renewable source of biologically active compounds with proven pharmacological activity, particularly phenolic and triterpene compounds. Despite the widespread occurrence of fomitoid polypores, their raw materials remain largely unstandardized and are not represented in the pharmacopoeias of most countries, which limits their introduction into medical practice. The lack of unified approaches to quality assessment and the selection of analytical markers, combined with the high variability of their chemical composition, complicates the standardization of the raw material. Therefore, substantiating quality criteria and standardization methods for raw materials derived from fomitoid polypores is an important task.</p></sec><sec><title>AIM</title><p>AIM. To substantiate quality criteria for raw materials of fomitoid polypores that can be used for the development of regulatory documentation on the quality of fungal raw materials.</p></sec><sec><title>MATERIALS AND METHODS</title><p>MATERIALS AND METHODS. At least 20 batches of fruiting bodies of Fomes fomentarius (L.) Fr., Fomitopsis pinicola (Sw.) P. Karst., Ganoderma applanatum (Pers.) Pat., Piptoporus betulinus (Bull.) P. Karst., Phellinus igniarius (L.) Quél., collected in various regions of the Republic of Belarus and the Russian Federation, were studied. The following parameters were determined using spectrophotometric and gravimetric methods: loss on drying, total ash, acid-insoluble ash, total extractives, total phenolic compounds, and total steroid and triterpene compounds.</p></sec><sec><title>RESULTS</title><p>RESULTS. Inter- and intraspecific variability of quality indicators was demonstrated. It was established that, depending on the species, the specification limits for total phenolic compounds range from 0.10% to 0.25%, for total steroid and triterpene compounds from 0.05% to 0.30%, and for extractives from 0.5% to 14.0%. The values of total ash, acid-insoluble ash, and loss on drying fall within the ranges of 1.0–5.0%, 1.0–3.0%, and 10.0–12.0%, respectively.</p></sec><sec><title>CONCLUSIONS</title><p>CONCLUSIONS. Quality indicators for raw materials of fomitoid polypores have been developed and may be used for the preparation of regulatory documentation on the quality of raw materials of fungal origin.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>Fomes fomentarius</kwd><kwd>Fomitopsis pinicola</kwd><kwd>Ganoderma applanatum</kwd><kwd>Piptoporus betulinus</kwd><kwd>Phellinus igniarius</kwd><kwd>фенольные соединения</kwd><kwd>тритерпеноиды</kwd><kwd>стероидные соединения</kwd><kwd>показатели качества</kwd></kwd-group><kwd-group xml:lang="en"><kwd>Fomes fomentarius</kwd><kwd>Fomitopsis pinicola</kwd><kwd>Ganoderma applanatum</kwd><kwd>Piptoporus betulinus</kwd><kwd>Phellinus igniarius</kwd><kwd>phenolic compounds</kwd><kwd>triterpenoids</kwd><kwd>steroid compounds</kwd><kwd>quality indicators</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена в рамках государственного задания 2.2.2 «Установить химический состав и биологическую активность экстрактов плодовых тел трутовых грибов, распространенных на территории Республики Беларусь».</funding-statement><funding-statement xml:lang="en">The work was carried out within the framework of the state assignment 2.2.2 “To establish the chemical composition and biological activity of extracts of fruiting bodies of tinder fungi common in the Republic of Belarus”.</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">Badalyan SM, Barkhudaryan A, Rapior S. 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