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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 custom-type="elpub" pub-id-type="custom">vedomostiregmed-86</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>СТАНДАРТИЗАЦИЯ И КОНТРОЛЬ КАЧЕСТВА ЛЕКАРСТВЕННЫХ СРЕДСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>STANDARDIZATION AND QUALITY CONTROL OF MEDICINES</subject></subj-group></article-categories><title-group><article-title>Современные требования к стандартизации гомеопатического сырья и субстанций</article-title><trans-title-group xml:lang="en"><trans-title>Current requirements for standardization of homeopathic raw materials and substances</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><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>Teryoshina</surname><given-names>N. S.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.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>Самылина</surname><given-names>И. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Samylina</surname><given-names>I. A.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.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>Цуканов</surname><given-names>Ю. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Tsukanov</surname><given-names>Yu. V.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.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>Патудин</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Patudin</surname><given-names>A. V.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Первый Московский государственный медицинский университет им. И. М. Сеченова</institution><country>Россия</country></aff><aff xml:lang="en"><institution>I. M. Sechenov First Moscow State Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Российское гомеопатическое общество</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Russian Homeopathic Society</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2016</year></pub-date><pub-date pub-type="epub"><day>13</day><month>02</month><year>2018</year></pub-date><volume>0</volume><issue>3</issue><fpage>16</fpage><lpage>20</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Терёшина Н.С., Самылина И.А., Цуканов Ю.В., Патудин А.В., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Терёшина Н.С., Самылина И.А., Цуканов Ю.В., Патудин А.В.</copyright-holder><copyright-holder xml:lang="en">Teryoshina N.S., Samylina I.A., Tsukanov Y.V., Patudin A.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/86">https://www.vedomostincesmp.ru/jour/article/view/86</self-uri><abstract><p>Рассмотрены современные требования к стандартизации гомеопатического сырья и субстанций. Приведен анализ номенклатуры сырья растительного, животного, минерального и химического происхождения, которое используется для получения гомеопатических субстанций. Показаны основные методы обработки сырья для получения гомеопатических субстанций и основные принципы контроля качества сырья в разных странах. Показано наличие разночтений в составе субстанций, использующихся под одинаковыми названиями, а также в методах приготовления гомеопатических субстанций. Сформулированы основные подходы к стандартизации гомеопатического сырья, использованные при подготовке проектов фармакопейных статей на гомеопатические лекарственные средства для Государственной фармакопеи Российской Федерации.</p></abstract><trans-abstract xml:lang="en"><p>The article considers modern requirements for standardization of homoeopathic raw material and substances. The study included the analysis of a range of raw materials of plant, animal, mineral and chemical origin, which are used for the production of homeopathic substances. The article describes basic ways of processing raw material for producing homeopathic substances and basic principles of the quality control of raw materials in different countries. It was revealed that there was a difference in the composition of substances used under the same name, as well as in methods of preparation of homeopathic substances. The authors formulated the main approaches to standardization of homoeopathic raw material that were used in the elaboration of monographs on homeopathic products for the State Pharmacopoeia of the Russian Federation.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>сырье растительного</kwd><kwd>животного</kwd><kwd>минерального и химического происхождения</kwd><kwd>стандартизация</kwd><kwd>гомеопатическая субстанция</kwd><kwd>raw material of plant</kwd><kwd>animal</kwd><kwd>mineral and chemical origin</kwd><kwd>standardization</kwd><kwd>homeopathic substances</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">Патудин АВ, Терешина НС, Мищенко ВС, Губанов ИА. Мировые ресурсы гомеопатического лекарственного сырья. М.; 2006.</mixed-citation><mixed-citation xml:lang="en">Patudin AV, Teryoshina NS, Mishchenko VS, Gubanov IA. World resources homeopathic  medicinal raw materials. Moscow; 2006 (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">British Homoeopathic pharmacopoeia (B. Hom. P.). 1993.</mixed-citation><mixed-citation xml:lang="en">British Homoeopathic pharmacopoeia (B. Hom. P.). 1993.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Homöopathisches Arzneibuch. 2014.</mixed-citation><mixed-citation xml:lang="en">Homöopathisches Arzneibuch. 2014.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Homoeopathic pharmacopoeia of India (H. P. I.). Vol. 1, 1971; vol. 2, 1974; vol. 3, 1978; vol. 4, 1984; vol. 5, 1987; vol. 6, 1990.</mixed-citation><mixed-citation xml:lang="en">Homoeopathic pharmacopoeia of India (H. P. I.). Vol. 1, 1971; vol. 2, 1974; vol. 3, 1978; vol. 4, 1984; vol. 5, 1987; vol. 6, 1990.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Pharmacopée française. 11ème édition. Preparations homeopathiques.</mixed-citation><mixed-citation xml:lang="en">Pharmacopée française. 11ème édition. Preparations homeopathiques.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">The Homњopathic Pharmacopњia of the United States. 1989, 1990.</mixed-citation><mixed-citation xml:lang="en">The Homoeopathic Pharmacopoeia of the United States. 1989, 1990.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">European Pharmacopoeia, 6th edition.</mixed-citation><mixed-citation xml:lang="en">European Pharmacopoeia, 6th edition.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Аврач АС, Сергунова ЕВ, Самылина ИА. Перспективы использования замороженного лекарственного растительного сырья в аллопатической медицине и гомеопатии. В кн.: Инновационные процессы в лекарствоведении: сборник научных трудов. Ярославль; 2012. С. 27-30.</mixed-citation><mixed-citation xml:lang="en">Avrach AS, Sergunova EV, Samylina IA. Prospects for the use of frozen medicinal  plants in allopathic medicine and homeopathy. In: Innovation in pharmacology: Proceedings. Yaroslavl; 2012. P. 27–30 (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Терёшина НС. Методы консервации свежего лекарственного растительного сырья. В кн.: Проблемы экологии, здоровья, фармации и паразитологии. Научные труды. М: МГМУ им. И. М. Сеченова; 2012. С. 35-40.</mixed-citation><mixed-citation xml:lang="en">Teryoshina NS. Preservation methods of fresh medicinal vegetative raw materials.  In: Problems of ecology, health, pharmacies and parasitology. Research papers. Moscow;  MGMU im. I. M. Sechenova; 2012. P. 35–40 (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Агеева ТК. Гомеопатические лекарственные средства животного происхождения. М.: Гомеопатическая медицина; 2001.</mixed-citation><mixed-citation xml:lang="en">Ageeva TK. Homeopathic medicines of animal origin. Moscow: Gomeopaticheskaya meditsina; 2001 (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Safety issues in the preparation of homeopathic medicines. World Health Organization. Available from: http://www.who.int/medicines/areas/traditional/Homeopathy.pdf.</mixed-citation><mixed-citation xml:lang="en">Safety issues in the preparation of homeopathic medicines. World Health  Organization. Available from: http://www.who.int/medicines/areas/traditional/Homeopathy.pdf.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Терёшина НС, Цуканов ЮВ, Самылина ИА. Создание отечественных субстанций растительного происхождения для гомеопатических лекарственных препаратов. Правовые, экономические, технические аспекты импортозамещения в современных условиях. Сборник статей. М.: ЭкООнис; 2015.</mixed-citation><mixed-citation xml:lang="en">Teryoshina NS, Samylina IA, Tsukanov YuV. The creation of the domestic substances of plant origin for homeopathic medicines. Legal, economic, technical aspects of  import substitution in modern conditions. A collection of articles. M.: EcOOnis; 2015.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
