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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">10.30895/1991-2919-2018-8-3-145-150</article-id><article-id custom-type="elpub" pub-id-type="custom">vedomostiregmed-158</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>СОВРЕМЕННЫЕ АСПЕКТЫ СТАНДАРТИЗАЦИИ ГОМЕОПАТИЧЕСКИХ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ</article-title><trans-title-group xml:lang="en"><trans-title>MODERN ASPECTS OF HOMEOPATHIC MEDICINES STANDARDISATION</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8536-4804</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Саканян</surname><given-names>Е. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Sakanyan</surname><given-names>E. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Саканян Елена Ивановна - доктор фармацевтических наук, профессор, директор Центра фармакопеи  и  международного  сотрудничества ФГБУ «НЦЭСМП» Минздрава России.</p><p>Петровский бульвар, д. 8, стр. 2, Москва,  127051.</p></bio><bio xml:lang="en"><p>Elena I. Sakanyan - Dr. Sci. (Pharm.), Professor,  Director of the Centre of Pharmacopoeia and International Collaboration of the FSBI «SCEEMP» of the Ministry of Health of Russia.</p><p>8/2 Petrovsky Blvd, Moscow 127051.</p></bio><email xlink:type="simple">Sakanjan@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/0000-0001-8421-197X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Терёшина</surname><given-names>Н. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Tereshina</surname><given-names>N. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Терешина  Наталья  Сергеевна - доктор фармацевтических наук, главный аналитик отдела  государственной фармакопеи  и  фармакопейного  анализа Центра фармакопеи и международного сотрудничества ФГБУ «НЦЭСМП»  Минздрава  России.</p><p>Петровский бульвар, д. 8, стр. 2, Москва,  127051.</p></bio><bio xml:lang="en"><p>Natalia S. Tereshina - Dr. Sci. (Pharm.), Chief Analyst of the Department of State Pharmacopoeia  and Pharmacopoeial Analysis of the Centre of Pharmacopoeia  and International Collaboration of the FSBI «SCEEMP» of the Ministry of Health of Russia.</p><p>8/2 Petrovsky Blvd, Moscow 127051.</p></bio><email xlink:type="simple">tereshina@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/0000-0002-8220-1054</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Лякина</surname><given-names>М. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Lyakina</surname><given-names>M. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Лякина Марина Николаевна - доктор фармацевтических наук, заместитель директора Центра фармакопеи и международного сотрудничества ФГБУ «НЦЭСМП»  Минздрава  России.</p><p>Петровский бульвар, д. 8, стр. 2, Москва,  127051.</p></bio><bio xml:lang="en"><p>Marina N. Lyakina - Dr. Sci. (Pharm.), Deputy Director of the Centre of Pharmacopoeia  and International Collaboration of the FSBI «SCEEMP» of the Ministry of Health of Russia.</p><p>8/2 Petrovsky Blvd, Moscow 127051.</p></bio><email xlink:type="simple">Ljakina@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>20</day><month>08</month><year>2018</year></pub-date><volume>8</volume><issue>3</issue><fpage>145</fpage><lpage>150</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Саканян Е.И., Терёшина Н.С., Лякина М.Н., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Саканян Е.И., Терёшина Н.С., Лякина М.Н.</copyright-holder><copyright-holder xml:lang="en">Sakanyan E.I., Tereshina N.S., Lyakina 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.vedomostincesmp.ru/jour/article/view/158">https://www.vedomostincesmp.ru/jour/article/view/158</self-uri><abstract><p>Охарактеризовано состояние стандартизации гомеопатических лекарственных средств в ведущих зарубежных фармакопеях. Рассмотрены основные  требования  к сырью растительного, животного и минерального происхождения, используемого для получения  гомеопатических лекарственных средств. Разработаны требования  к гомеопатическим фармацевтическим субстанциям, в том числе технологии  получения  настоек  гомеопатических матричных,  гомеопатических  разведений, тритураций  и др., моно-  и многокомпонентных гомеопатических препаратов, а также методы контроля   качества  гомеопатических субстанций   и  гомеопатических лекарственных препаратов.  Приведен   анализ номенклатуры гомеопатического сырья  и гомеопатических фармацевтических субстанций  по ведущим  зарубежным фармакопеям. Выработаны  требования, предъявляемые к гомеопатическим лекарственным формам: «Гранулы гомеопатические», «Капли глазные гомеопатические», «Мази гомеопатические», «Настои и отвары гомеопатические», «Настойки гомеопатические матричные», «Растворы для инъекций гомеопатические», «Растворы и жидкие разведения  гомеопатические», «Сиропы гомеопатические», «Смеси гомеопатические», «Суппозитории гомеопатические», «Таблетки гомеопатические», «Тритурации гомеопатические». Показана перспективность использования методов вибрационной и рамановской спектроскопии для выявления отличительных особенностей гомеопатических препаратов  при сверхвысоком  разведении. Разработана методология  построения фармакопейных стандартов  на сырье  для производства фармацевтических субстанций, фармацевтические субстанции, используемые для получения  гомеопатических лекарственных  препаратов, и лекарственные формы,  включающие  особенности технологии  и стандартизации гомеопатических лекарственных средств, реализованные при подготовке  проектов  фармакопейных статей для Государственной фармакопеи Российской Федерации.</p></abstract><trans-abstract xml:lang="en"><p>The article describes the status of homeopathic medicines standardisation in the leading world pharmacopoeias. It reviews main requirements for raw materials of plant, animal, and mineral origin, which are used in the production of homeopathic medicines. It also considers requirements for homeopathic pharmaceutical substances, including technologies of obtaining homeopathic mother tinctures, homeopathic dilutions, triturations, etc., mono- and multi-component homeopathic medicines, as well as quality control of homeopathic substances and homeopathic medicines. The article analyses the nomenclature of homeopathic raw materials and homeopathic substances used by the leading world pharmacopoeias. It dwells upon the results of work devoted to the development of requirements for the following homeopathic dosage forms: homeopathic granules, homeopathic eye drops, homeopathic ointments, homeopathic infusions and decoctions,  homeopathic mother tinctures,  homeopathic solutions for injection,  homeopathic solutions and liquid dilutions,  homeopathic syrups, homeopathic mixtures,  homeopathic suppositories, homeopathic tablets, homeopathic triturations.  The article illustrates significant potential of using vibrational spectroscopy and Raman spectroscopy for the detection of distinctive features of homeopathic medicines at ultra-high dilutions. The article presents methodology for structuring pharmacopoeial standards for raw materials used in the production of pharmaceutical substances, for pharmaceutical substances that are used in homeopathic medicines, and for dosage forms, including specific aspects of production and standardisation of homeopathic medicines, which was implemented during preparation of draft monographs for the State Pharmacopoeia of the Russian Federation.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>стандартизация</kwd><kwd>гомеопатические фармацевтические субстанции</kwd><kwd>гомеопатические лекарственные препараты</kwd><kwd>фармакопейные статьи</kwd><kwd>общие фармакопейные статьи</kwd><kwd>контроль качества</kwd></kwd-group><kwd-group xml:lang="en"><kwd>standardisation</kwd><kwd>homeopathic substances</kwd><kwd>homeopathic medicines</kwd><kwd>monographs</kwd><kwd>general chapters</kwd><kwd>quality control</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">ФГБУ «НЦЭСМП» Минздрава России</funding-statement><funding-statement xml:lang="en">FSBI “SCEEMP” of the Ministry of Health of Russia</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">Гомеопатия в странах мира. 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