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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">10.30895/1991-2919-2018-8-2-</article-id><article-id custom-type="elpub" pub-id-type="custom">vedomostiregmed-159</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>ОБЗОРЫ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS</subject></subj-group></article-categories><title-group><article-title>ЛЕКАРСТВЕННЫЕ СРЕДСТВА, СОДЕРЖАЩИЕ ЗМЕИНЫЙ ЯД:  ИСТОРИЯ РАЗВИТИЯ, НОМЕНКЛАТУРА, ОЦЕНКА ПОДЛИННОСТИ</article-title><trans-title-group xml:lang="en"><trans-title>DRUGS CONTAINING SNAKE VENOM: HISTORY OF DEVELOPMENT, NOMENCLATURE, IDENTIFICATION</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0773-1944</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Григорьева</surname><given-names>В. Э.</given-names></name><name name-style="western" xml:lang="en"><surname>Grigorieva</surname><given-names>V. E</given-names></name></name-alternatives><bio xml:lang="ru"><p>Григорьева Виктория Эдуардовна - эксперт 2-й категории лаборатории микробиологии Испытательного центра экспертизы качества лекарственных средств.</p><p>127051, Москва, Петровский бульвар, д. 8, стр. 2</p></bio><bio xml:lang="en"><p>Viktoria E. Grigorieva - 2nd Professional Category Expert of the Microbiology Laboratory of the Testing Centre for Evaluation of Medicinal Products’ Quality.</p><p>8/2 Petrovsky Boulevard, Moscow 127051</p></bio><email xlink:type="simple">Grigorieva@expmed.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/0000-0001-6474-4795</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гунар</surname><given-names>О. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Gunar</surname><given-names>O. V</given-names></name></name-alternatives><bio xml:lang="ru"><p>Гунар Ольга Викторовна - начальник лаборатории микробиологии Испытательного центра экспертизы качества лекарственных средств, доктор фармакологических наук.</p><p>127051, Москва, Петровский бульвар, д. 8, стр. 2</p></bio><bio xml:lang="en"><p>Olga V. Gunar - Head of the Microbiology Laboratory of the Testing Centre for Evaluation of Medicinal Products’ Quality, Doctor of Pharmaceutical Sciences.</p><p>8/2 Petrovsky Boulevard, Moscow 127051</p></bio><email xlink:type="simple">Gunar@expmed.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/0000-0003-1773-7423</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сахно</surname><given-names>Н. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Sakhno</surname><given-names>N. G</given-names></name></name-alternatives><bio xml:lang="ru"><p>Сахно Надежда Геннадьевна - ведущий эксперт лаборатории микробиологии Испытательного центра экспертизы качества лекарственных средств, кандидат фармакологических наук.</p><p>127051, Москва, Петровский бульвар, д. 8, стр. 2</p></bio><bio xml:lang="en"><p>Nadezhda G. Sakhno - Leading Expert of the Microbiology Laboratory of the Testing Centre for Evaluation of Medicinal Products’ Quality, Candidate of Pharmaceutical Sciences.</p><p>8/2 Petrovsky Boulevard, Moscow 127051</p></bio><email xlink:type="simple">Sakhno@expmed.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/0000-0001-6474-4795</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Булгакова</surname><given-names>Г. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Bulgakova</surname><given-names>G. M</given-names></name></name-alternatives><bio xml:lang="ru"><p>Булгакова Галина Михайловна - ведущий эксперт лаборатории микробиологии Испытательного центра экспертизы качества лекарственных средств.</p><p>127051, Москва, Петровский бульвар, д. 8, стр. 2</p></bio><bio xml:lang="en"><p>Galina M. Bulgakova - Leading Expert of the Microbiology Laboratory of the Testing Centre for Evaluation of Medicinal Products’ Quality.</p><p>8/2 Petrovsky Boulevard, Moscow 127051</p></bio><email xlink:type="simple">Bulgakova@expmed.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/0000-0003-2430-0107</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Молчан</surname><given-names>Н. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Molchan</surname><given-names>N. V</given-names></name></name-alternatives><bio xml:lang="ru"><p>Молчан Нина Валерьевна - научный редактор отдела редакционноиздательской деятельности и защиты интеллектуальной собственности Центра планирования и координации НИР, кандидат фармакологических наук.</p><p>127051, Москва, Петровский бульвар, д. 8, стр. 2</p></bio><bio xml:lang="en"><p>Nina V. Molchan - Scientific Editor of the Department for Editorial and Publishing Activities, and Intellectual Property Protection of the Centre for Planning and Coordination of Scientific Activities. Candidate of Pharmaceutical Sciences.</p><p>8/2 Petrovsky Boulevard, Moscow 127051</p></bio><email xlink:type="simple">molchan@expmed.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Centre for Expert Evaluation of Medicinal Products</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2018</year></pub-date><pub-date pub-type="epub"><day>22</day><month>05</month><year>2018</year></pub-date><volume>8</volume><issue>2</issue><fpage>77</fpage><lpage>83</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Григорьева В.Э., Гунар О.В., Сахно Н.Г., Булгакова Г.М., Молчан Н.В., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Григорьева В.Э., Гунар О.В., Сахно Н.Г., Булгакова Г.М., Молчан Н.В.</copyright-holder><copyright-holder xml:lang="en">Grigorieva V.E., Gunar O.V., Sakhno N.G., Bulgakova G.M., Molchan N.V.</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/159">https://www.vedomostincesmp.ru/jour/article/view/159</self-uri><abstract><p>Представлены общие данные о химическом составе, свойствах ядов змей и истории их применения в медицинской практике. Рассмотрены отличия, характеризующие яд змей той или иной систематической группы. Отмечено, что яды продолжают оставаться ценным источником новых лекарств. Проведено сравнение существующих методов анализа ядов (иммунологического, хроматографического, электрофоретического, масс-спектрометрического). Особое внимание уделено методическим особенностям определения их подлинности в зависимости от объекта и цели анализа. Выполнено сравнение различных модификаций реакции преципитации между собой. Выявлены преимущества и недостатки существующих методов. Показано, что иммунологические методы ввиду своей доступности и простоты исполнения чаще всего применяются при анализе ядов в биологических средах для диагностики источника отравления. А инструментальные методы благодаря большей информативности незаменимы для детальных исследований состава ядов при их изучении и сравнении. Проведен ретроспективный анализ данных, полученных при испытании подлинности змеиных ядов за период с 2006 по 2017 г. Установлено, что нормативная документация на отдельные лекарственные средства в ряде случаев не содержит указаний на использование конкретного вида реакции преципитации или описание методик. Сделан вывод о целесообразности модификации существующего метода, выбора условий пробоподготовки или разработки альтернативных методов для определения подлинности змеиных ядов, входящих в состав лекарственных средств.</p></abstract><trans-abstract xml:lang="en"><p>The article presents general data on the chemical composition and properties of snake venoms, as well as the history of their use in medical practice. It considers the differences characteristic of the venom of snakes belonging to different systematic groups. It demonstrates that venoms remain a valuable source of new medicines. The article compares existing methods of venom analysis (immunological, chromatographic, electrophoretic, mass spectrometric). Particular attention is paid to specific metho-dological aspects of identification testing depending on the object and purpose of the analysis. The article also compares different modifications of the precipitation reaction. It highlights the advantages and disadvantages of existing methods. The affordability and simplicity of immunological methods accounts for their wide use in the analysis of poisons in biological media which helps to determine the cause of poisoning. While greater informativeness of instrumental methods makes them a perfect toll for detailed examination of poison composition during poisons research and comparison. The authors of the article performed  a retrospective analysis of data obtained in identification testing of snake venoms during the period from 2006 to 2017. It has been established that manufacturer specifications for individual medicinal products in some cases do not contain instructions on the use of a specific type of precipitation reaction or the description of test procedures. It was concluded that some modifications should be made to the existing method, the choice of conditions for sample preparation should be considered, or alternative methods for identification of snake venoms in medicinal products should be developed.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>лекарственные средства</kwd><kwd>змеиный яд</kwd><kwd>экспертиза качества</kwd><kwd>подлинность</kwd><kwd>реакция преципитации</kwd></kwd-group><kwd-group xml:lang="en"><kwd>medicines</kwd><kwd>snake venom</kwd><kwd>quality evaluation</kwd><kwd>identification</kwd><kwd>precipitation reaction</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Перелыгина ОВ, Комаровская ЕИ, Мухачева АВ, Саяпина ЛВ, Обухов ЮИ, Бондарев ВП. Гетерологичные сывороточные препараты в практике современной медицины. Биопрепараты. 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