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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">phkinetica</journal-id><journal-title-group><journal-title xml:lang="ru">Фармакокинетика и Фармакодинамика</journal-title><trans-title-group xml:lang="en"><trans-title>Pharmacokinetics and Pharmacodynamics</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2587-7836</issn><issn pub-type="epub">2686-8830</issn><publisher><publisher-name>ООО «Издательство ОКИ»</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">phkinetica-9</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>ИССЛЕДОВАНИЯ КЛИНИЧЕСКОЙ ФАРМАКОКИНЕТИКИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>CLINICAL PHARMACOKINETIC RESEARCHES</subject></subj-group></article-categories><title-group><article-title>Исследование фармакокинетики мебеверина в форме капсул с пролонгированным высвобождением</article-title><trans-title-group xml:lang="en"><trans-title>Pharmacokinetic study of prolonged release capsules of mebeverine</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>Хохлов</surname><given-names>А. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Khokhlov</surname><given-names>A. L.</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>Джурко</surname><given-names>Ю. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Dzhurko</surname><given-names>Yu. A.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шитов</surname><given-names>Л. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Shitov</surname><given-names>L. N.</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>Яичков</surname><given-names>Илья Игоревич</given-names></name><name name-style="western" xml:lang="en"><surname>Yaichkov</surname><given-names>I. I.</given-names></name></name-alternatives><email xlink:type="simple">Hya_1993_08@mail.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>Шитова</surname><given-names>А. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Shitova</surname><given-names>A. M.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Хозова</surname><given-names>Л. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Khozova</surname><given-names>L. A.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мирошников</surname><given-names>А. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Miroshnikov</surname><given-names>A. E.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ВО «Ярославский государственный медицинский университет» МЗ РФ; ООО «Квинта-Аналитика Ярославль»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>The Yaroslavl State Medical University; Quinta-Analytica Yaroslavl LLC</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ООО «Квинта-Аналитика Ярославль»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Quinta-Analytica Yaroslavl LLC</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ФГБОУ ВО «Ярославский государственный медицинский университет» МЗ РФ</institution><country>Россия</country></aff><aff xml:lang="en"><institution>The Yaroslavl State Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2017</year></pub-date><pub-date pub-type="epub"><day>06</day><month>02</month><year>2017</year></pub-date><volume>0</volume><issue>1</issue><fpage>57</fpage><lpage>62</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Хохлов А.Л., Джурко Ю.А., Шитов Л.Н., Яичков И.И., Шитова А.М., Хозова Л.А., Мирошников А.Е., 2017</copyright-statement><copyright-year>2017</copyright-year><copyright-holder xml:lang="ru">Хохлов А.Л., Джурко Ю.А., Шитов Л.Н., Яичков И.И., Шитова А.М., Хозова Л.А., Мирошников А.Е.</copyright-holder><copyright-holder xml:lang="en">Khokhlov A.L., Dzhurko Y.A., Shitov L.N., Yaichkov I.I., Shitova A.M., Khozova L.A., Miroshnikov A.E.</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.pharmacokinetica.ru/jour/article/view/9">https://www.pharmacokinetica.ru/jour/article/view/9</self-uri><abstract><p>Было проведено исследование фармакокинетики мебеверина в форме капсул с пролонгированным высвобождением на 24 здоровых добровольцах. Известно, что данное лекарственное вещество полностью метаболизируется на пресистемном этапе. Поэтому измерялись фармакокинетические параметры только его основных метаболитов - мебевериновой кислоты и деметилированной мебевериновой кислоты. Для определения концентрации данных метаболитов в плазме крови разработана биоаналитическая методика с использованием высокоэффективной жидкостной хроматографии с масс-спектрометрическим детектированием.</p></abstract><trans-abstract xml:lang="en"><p>Pharmacokinetic study of prolonged release capsules of mebeverine was carried out on 24 volunteers. It is known that the drug substance is completely metabolized due to first-pass effect. Therefore, pharmacokinetic parameters of the main metabolites -mebeverine acid and desmethyl mebeverine acid were measured. Bioanalytical method was developed to measurement of concentrations of these metabolites in blood plasma by using HPLC-MS/MS.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>мебеверин</kwd><kwd>мебевериновая кислота</kwd><kwd>деметилированная мебевериновая кислота</kwd><kwd>фармакокинетика</kwd><kwd>ВЭЖХ-МС/МС</kwd><kwd>mebeverine</kwd><kwd>mebeverine acid</kwd><kwd>desmethyl mebeverine acid</kwd><kwd>pharmacokinetic</kwd><kwd>HPLC-MS/MS</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">Brittain H.G. Analytical Profiles of Drug Substances and Excipients, Vol. 25.California:Academic press, 1998.</mixed-citation><mixed-citation xml:lang="en">Brittain H.G. Analytical Profiles of Drug Substances and Excipients, Vol. 25.California:Academic press, 1998.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">StockisA., Guelen P.J.M., de Vos D. Identification of Mebeverine Acid as the Main Circulating Metabolite of Mebeverine in Man. J Pharm Biomed Anal. 2002; 29: 335-340.</mixed-citation><mixed-citation xml:lang="en">StockisA., Guelen P.J.M., de Vos D. Identification of Mebeverine Acid as the Main Circulating Metabolite of Mebeverine in Man. J Pharm Biomed Anal. 2002; 29: 335-340.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Winsemius A., Meuwsen I.M., Boon C., van der Laan A., Brekle A., de Vries M. A pharmacokinetic comparison of the modified release capsule and a plain tablet formulation of mebeverine. Int J Clin Pract. 2002; 9 (56): 659-662.</mixed-citation><mixed-citation xml:lang="en">Winsemius A., Meuwsen I.M., Boon C., van der Laan A., Brekle A., de Vries M. A pharmacokinetic comparison of the modified release capsule and a plain tablet formulation of mebeverine. Int J Clin Pract. 2002; 9 (56): 659-662.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Elliott S., Burgess V. Investigative implications of the Instability and Metabolism of Mebeverine. J Anal Tox. 2006; 30: 91-97.</mixed-citation><mixed-citation xml:lang="en">Elliott S., Burgess V. Investigative implications of the Instability and Metabolism of Mebeverine. J Anal Tox. 2006; 30: 91-97.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Bergeron M., Bergeron A., Amsterdam P., Furtado M., Garofolo F. Use of polarity switching for the simultaneous bioanalysis of analytes with three orders of magnitude difference in concentration by HPLC-MS/MS. Bioanal. 2013; 5 (15): 1911-1918.</mixed-citation><mixed-citation xml:lang="en">Bergeron M., Bergeron A., Amsterdam P., Furtado M., Garofolo F. Use of polarity switching for the simultaneous bioanalysis of analytes with three orders of magnitude difference in concentration by HPLC-MS/MS. Bioanal. 2013; 5 (15): 1911-1918.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Khatri C.A., Phanikumar Ch.V., Jayaveera K., Reddy K.Y. Development and Validation of Bioanalytical Method for Simultaneous Quantification of Veratric Acid, Mebeverine Acid and Desmethyl Mebeverine Acid in Human Edta Plasma by Using LC-MS/MS. J Pharm Chem. 2012; 4 (6): 11 - 18.</mixed-citation><mixed-citation xml:lang="en">Khatri C.A., Phanikumar Ch.V., Jayaveera K., Reddy K.Y. Development and Validation of Bioanalytical Method for Simultaneous Quantification of Veratric Acid, Mebeverine Acid and Desmethyl Mebeverine Acid in Human Edta Plasma by Using LC-MS/MS. J Pharm Chem. 2012; 4 (6): 11 - 18.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Guideline on validation of bioanalytical methods (draft), European Medicines Agency, Committee for medicinal products for human use; 2010.</mixed-citation><mixed-citation xml:lang="en">Guideline on validation of bioanalytical methods (draft), European Medicines Agency, Committee for medicinal products for human use; 2010.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Guidance for Industry: Bioanalytical method validation. U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evolution and Research (CDER), U. S. Government Printing Office, Washington, DC; 2013.</mixed-citation><mixed-citation xml:lang="en">Guidance for Industry: Bioanalytical method validation. U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evolution and Research (CDER), U. S. Government Printing Office, Washington, DC; 2013.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Миронов А.Н., ред. Руководство по экспертизе лекарственных средств. Т. 1. М.: Гриф и К; 2013.</mixed-citation><mixed-citation xml:lang="en">Миронов А.Н., ред. Руководство по экспертизе лекарственных средств. Т. 1. М.: Гриф и К; 2013.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Food and Drugs Administration Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on Biopharmaceutics Classification SystemRockville, MD: U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research; 2015.</mixed-citation><mixed-citation xml:lang="en">Food and Drugs Administration Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on Biopharmaceutics Classification SystemRockville, MD: U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research; 2015.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Guidance on the investigation of bioequivalence,European Medicines Agency, Committee for medicinal products for human use; 2010.</mixed-citation><mixed-citation xml:lang="en">Guidance on the investigation of bioequivalence,European Medicines Agency, Committee for medicinal products for human use; 2010.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Declaration of Helsinki of the AMM-Ethical Principles for Medical Research in humans, World Medical Assembly, 64th General Assembly; 2013.</mixed-citation><mixed-citation xml:lang="en">Declaration of Helsinki of the AMM-Ethical Principles for Medical Research in humans, World Medical Assembly, 64th General Assembly; 2013.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Хохлов А.Л., Лилеева Е.Г., Синицина О.А., Спешилова С.А., Демарша С.М., Шитов Л.Н. Проблемы проведения биоаналитической части исследований биоэквивалентности лекарственных препаратов в России. Фармакокинетика Фармакодинамика. 2014; 1: 37-43.</mixed-citation><mixed-citation xml:lang="en">Хохлов А.Л., Лилеева Е.Г., Синицина О.А., Спешилова С.А., Демарша С.М., Шитов Л.Н. Проблемы проведения биоаналитической части исследований биоэквивалентности лекарственных препаратов в России. Фармакокинетика Фармакодинамика. 2014; 1: 37-43.</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>
