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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">rmjournal</journal-id><journal-title-group><journal-title xml:lang="ru">Эталоны. Стандартные  образцы</journal-title><trans-title-group xml:lang="en"><trans-title>Measurement Standards. Reference Materials</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2687-0886</issn><publisher><publisher-name>D. I. Mendeleyev Institute for Metrology</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.20915/2077-1177-2023-19-2-19-34</article-id><article-id custom-type="elpub" pub-id-type="custom">rmjournal-385</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>Стандартные образцы</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>Reference materials</subject></subj-group></article-categories><title-group><article-title>Стандартный образец тилозина тартрата</article-title><trans-title-group xml:lang="en"><trans-title>Certified Reference Material of Tylosin Tartrate</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-6493-9701</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гуляева</surname><given-names>А. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Gulyaeva</surname><given-names>A. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Гуляева Анастасия Юрьевна – канд. биол. наук, заместитель заведующего отделом контроля за безопасностью обращения фармакологических лекарственных средств</p><p>123022, г. Москва, Звенигородское шоссе, 5</p></bio><bio xml:lang="en"><p>Anastasia Yu. Gulyaeva – Cand. Sci. (Biol.), Deputy Head of the department for pharmaceutical medicines safety control</p><p>5 Zvenigorodskoye highway, Moscow, 123022</p></bio><email xlink:type="simple">a.gulyaeva@vgnki.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Хрущев</surname><given-names>А. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Khrushchev</surname><given-names>A. Y.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Хрущев Алексей Юрьевич – канд. хим. наук, ведущий научный сотрудник лаборатории контроля качества лекарственных средств</p><p>Researcher ID: AAD-5363–2019</p><p>123022, г. Москва, Звенигородское шоссе, 5</p></bio><bio xml:lang="en"><p>Alexei Y. Khrushchev – Cand. Sci. (Chem.), Leading Researcher of the laboratory for quality control of medicines</p><p>5 Zvenigorodskoye highway, Moscow, 123022</p></bio><email xlink:type="simple">a.hruschev@vgnki.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/0000-0001-5523-171X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Колячкина</surname><given-names>С. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Kolyachkina</surname><given-names>S. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Колячкина Светлана Викторовна – канд. хим. наук, заместитель заведующего отделом контроля за безопасностью обращения фармакологических лекарственных средств</p><p>123022, г. Москва, Звенигородское шоссе, 5</p></bio><bio xml:lang="en"><p>Svetlana V. Kolyachkina – Cand. Sci. (Chem.), Deputy Head of the department for pharmaceutical medicines safety control</p><p>5 Zvenigorodskoye highway, Moscow, 123022</p></bio><email xlink:type="simple">s.kolyachkina@vgnki.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/0000-0002-5395-9579</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Муравьева</surname><given-names>В. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Muravieva</surname><given-names>V. B.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Муравьева Виктория Борисовна – канд. вет. наук, ведущий научный сотрудник лаборатории контроля качества лекарственных средств</p><p>123022, г. Москва, Звенигородское шоссе, 5</p></bio><bio xml:lang="en"><p>Victoria B. Muravieva – Cand. Sci. (Vet.), Leading Researcher of the laboratory for quality control of medicines</p><p>5 Zvenigorodskoye highway, Moscow, 123022</p></bio><email xlink:type="simple">v.muravieva@vgnki.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/0000-0003-0886-4578</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Антонова</surname><given-names>С. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Antonova</surname><given-names>S. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Антонова Светлана Владимировна – канд. хим. наук, ведущий научный сотрудник лаборатории контроля качества лекарственных средств</p><p>123022, г. Москва, Звенигородское шоссе, 5</p></bio><bio xml:lang="en"><p>Svetlana V. Antonova – Cand. Sci. (Chem.), Leading Researcher of the laboratory for quality control of medicines</p><p>5 Zvenigorodskoye highway, Moscow, 123022</p></bio><email xlink:type="simple">s.antonova@vgnki.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">ФГБУ «Всероссийский государственный Центр качества и стандартизации лекарственных средств для животных и кормов»<country>Россия</country></aff><aff xml:lang="en">The Russian State Center for Animal Feed and Drug Standardization and Quality (VGNKI)<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2023</year></pub-date><pub-date pub-type="epub"><day>10</day><month>04</month><year>2023</year></pub-date><volume>19</volume><issue>2</issue><fpage>19</fpage><lpage>34</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Гуляева А.Ю., Хрущев А.Ю., Колячкина С.В., Муравьева В.Б., Антонова С.В., 2023</copyright-statement><copyright-year>2023</copyright-year><copyright-holder xml:lang="ru">Гуляева А.Ю., Хрущев А.Ю., Колячкина С.В., Муравьева В.Б., Антонова С.В.</copyright-holder><copyright-holder xml:lang="en">Gulyaeva A.Y., Khrushchev A.Y., Kolyachkina S.V., Muravieva V.B., Antonova S.V.</copyright-holder><license 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.rmjournal.ru/jour/article/view/385">https://www.rmjournal.ru/jour/article/view/385</self-uri><abstract><p>Достаточно часто в современном мире применяют антибиотики для лечения инфекционных заболеваний в медицине и ветеринарии, а также в качестве стимуляторов роста в животноводстве. Бесконтрольное применение антибиотиков приводит к появлению остатков антибиотиков в пищевых продуктах, которые легко передаются человеку по пищевым цепочкам. Из-за этих нежелательных эффектов и в связи с оборотом недоброкачественных и контрафактных лекарственных препаратов необходимо контролировать качество лекарственных препаратов, а также проводить мониторинг пищевой безопасности продукции животноводства путем определения содержания остатков лекарственных препаратов в ней посредством применения стандартных образцов (СО).</p><p>Целью настоящего исследования стала разработка СО утвержденного типа состава тилозина тартрата.</p><p>В ходе выполнения исследования апробирована и успешно реализована методика подготовки исходного материала СО, проведен критический анализ методов измерений содержания тилозина тартрата, обоснован выбор метода ВЭЖХ в качестве основного метода количественного определения аттестованного значения измеряемой величины (массовой доли тилозина). Показаны недостатки микробиологического метода и метода титриметрии, рассмотренных в качестве альтернативных методов. В соответствии с РМГ 93–2015 и ГОСТ ISO Guide 35–2015 оценена стандартная неопределенность аттестованного значения СО от метода характеризации, от неоднородности и от нестабильности материала. Рассчитана расширенная неопределенность аттестованного значения. Результатом выполненных работ явилось утверждение нового типа СО состава тилозина тартрата ГСО 11632–2020.</p><p>Нормированные метрологические характеристики: массовая доля тилозина 800–1100 мкг/мг, относительная расширенная неопределенность при k = 2, Р= 0,95 равна 6%. СО хранится в запаянных ампулах, отдельно от продуктов питания и кормов, в сухом, защищенном от света месте при температуре от +4 °С до -18 °С, срок годности СО 4 года.</p><p>Практическая значимость полученных результатов позволяет расширить возможность аттестации методик измерений и контроля точности результатов измерений массовой доли тилозина в лекарственных средствах ветеринарного применения, в продуктах питания и продовольственном сырье, кормах для животных, объектах окружающей среды. СО может также использоваться для определения подлинности тилозина в лекарственных средствах и определения чувствительности патогенных микроорганизмов к тилозину.</p></abstract><trans-abstract xml:lang="en"><p>To date, antibiotics are often used in the treatment of infectious diseases in medicine and veterinary medicine, as well as growth promoters in animal husbandry. The uncontrolled use of antibiotics leads to antibiotic residues in food products that are easily transmitted to humans through food chains. Due to these undesirable effects, as well as in connection with the circulation of substandard and counterfeit medicinal products, it is necessary to control the quality of medicinal products, as well as monitor the food safety of animal products by determining the content of drug residues using reference materials (RMs).</p><p>The aim of this research was to develop a CRM for the composition of tylosin tartrate.</p><p>In the course of the research, a method for preparing the initial RM was tested and successfully implemented, a critical analysis of methods for measuring the content of tylosin tartrate was carried out, and the choice of the HPLC method as the main method for quantitative determination of the certified value of the measured quantity (mass fraction of tylosin) was justified. The disadvantages of the microbiological method and the titrimetry method as alternative methods were shown. In accordance with RMG 93–2015 and GOST ISO Guide 35–2015, the standard uncertainty of the RM certified value from the characterization method, heterogeneity and instability of the material was estimated. The expanded uncertainty of the certified value was calculated. The result of the work performed was the approval of a new type of the CRM for the composition of tylosin tartrate GSO 11632 2020.</p><p>Normalized metrological characteristics: the mass fraction of tylosin is 800–1100 µg/mg, the relative expanded uncertainty at k = 2, P= 0.95 is 6%. The CRM is stored in sealed ampoules separately from food and feed in a dry and dark place at a temperature from plus 4 °C to minus 18 °C, the shelf life of the CRM is 4 years.</p><p>The practical significance of the results obtained makes it possible to expand the possibility of certification of measurement methods and control of the accuracy of the measurement results of the mass fraction of tylosin in veterinary medicinal products, food and food raw materials, animal feed, and environmental objects. The CRM can also be used to identify tylosin in medicinal products and to determine the susceptibility of pathogens to tylosin.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>тилозин</kwd><kwd>стандартный образец</kwd><kwd>лекарственный препарат</kwd><kwd>ветеринария</kwd><kwd>безопасность пищевой продукции</kwd><kwd>Таможенный союз</kwd></kwd-group><kwd-group xml:lang="en"><kwd>tylosin</kwd><kwd>reference material</kwd><kwd>medicinal product</kwd><kwd>veterinary medicine</kwd><kwd>food safety</kwd><kwd>Customs Union</kwd></kwd-group><funding-group xml:lang="ru"><funding-statement>Исследования выполнены в ФГБУ  «ВГНКИ» в рамках научно-исследовательской работы  по теме «Разработка государственных стандартных образцов (ГСО) тилозина и доксициклина» (2019–2020 гг.)  (государственная работа «Проведение прикладных научных исследований»). Все измерения проводились с использованием оборудования ФГБУ «ВГНКИ».</funding-statement></funding-group><funding-group xml:lang="en"><funding-statement>The research was carried out  at the Russian State Center for Animal Feed and Drug  Standardization and Quality (VGNKI) as part of the research work on the project «Development of certified reference materials (GSO) of tylosin and doxycycline» (2019–2020) as part of the State work «Applied scientific research».  All measurements were carried out using the equipment  of the Russian State Center for Animal Feed and Drug  Standardization and Quality.</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">Третьякова О. С., Заднипряный И. В. 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