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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">pharmjournal</journal-id><journal-title-group><journal-title xml:lang="ru">Разработка и регистрация лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Drug development &amp; registration</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2305-2066</issn><issn pub-type="epub">2658-5049</issn><publisher><publisher-name>LLC «CPHA»</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">pharmjournal-334</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>ЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ ЛЕКАРСТВЕННЫХ СРЕДСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>DRUG PRODUCTS EFFICACY AND SAFETY</subject></subj-group></article-categories><title-group><article-title>ДОКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ ГЕМОСОВМЕСТИМОСТИ ИМПЛАНТИРУЕМЫХ МЕДИЦИНСКИХ ИЗДЕЛИЙ: ОБЗОР ЛИТЕРАТУРЫ И РЕЗУЛЬТАТЫ СОБСТВЕННЫХ РАЗРАБОТОК</article-title><trans-title-group xml:lang="en"><trans-title>PRECLINICAL HEMOCOMPATIBILITY STUDIES FOR IMPLANTABLE MEDICAL DEVICES: REVIEW AND EXPERIMENTAL RESEARCH RESULTS</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>Боярский</surname><given-names>М. Д.</given-names></name><name name-style="western" xml:lang="en"><surname>Boyarskiy</surname><given-names>M. D.</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>Тарасов</surname><given-names>Ю. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Tarasov</surname><given-names>Y. 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>Филиппов</surname><given-names>Ю. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Philippov</surname><given-names>Y. I.</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>Сачивкина</surname><given-names>Н. П.</given-names></name><name name-style="western" xml:lang="en"><surname>Sachivkina</surname><given-names>N. P.</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>Станишевкий</surname><given-names>Я. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Stanishevkiy</surname><given-names>Ya. M.</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>Федеральное государственное бюджетное учреждение «Эндокринологический научный центр» Министерства здравоохранения Российской Федерации</institution></aff><aff xml:lang="en"><institution>Federal state institution "Endocrinology research centre"</institution></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов»</institution></aff><aff xml:lang="en"><institution>Federal state autonomous educational institution of higher professional education "Russian peoples friendship University"</institution></aff></aff-alternatives><pub-date pub-type="collection"><year>2017</year></pub-date><pub-date pub-type="epub"><day>09</day><month>01</month><year>2019</year></pub-date><volume>0</volume><issue>1</issue><fpage>168</fpage><lpage>176</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Боярский М.Д., Тарасов Ю.В., Филиппов Ю.И., Сачивкина Н.П., Станишевкий Я.М., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Боярский М.Д., Тарасов Ю.В., Филиппов Ю.И., Сачивкина Н.П., Станишевкий Я.М.</copyright-holder><copyright-holder xml:lang="en">Boyarskiy M.D., Tarasov Y.V., Philippov Y.I., Sachivkina N.P., Stanishevkiy Y.M.</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.pharmjournal.ru/jour/article/view/334">https://www.pharmjournal.ru/jour/article/view/334</self-uri><abstract><p>Активное использование медицинских изделий контактирующих с кровеносным руслом создало потребность в четко сформулированных требованиях к тестированию таких изделий, созданию различных способов моделирования и оценки потенциальных осложнений. Одним из важнейших аспектов тестирования таких изделий является оценка их непосредственного влияния на кровь. Для получения объективных результатов исследования любое моделирование должно быть максимально приближено к ситуации клинического применения и воспроизводить характеристики кровотока. Помимо этого необходимо учитывать возможность применения антикоагулянтов и введения в модель дополнительных фармакологических препаратов, если они могут оказывать влияния на биохимические и физические характеристики крови, а их применение неразрывно связано с использованием изделия. Настоящая статья содержит результаты проведенных научно-исследовательских и опытно-конструкторских работ по созданию прибора для имитации условий кровотока с целью доклинического тестирования экспериментальных образцов материалов и устройств, предназначенных для имплантации в тело человека для постоянного или длительного контакта с кровью.</p></abstract><trans-abstract xml:lang="en"><p>Active use of medical devices in contact with the blood stream has created the need to articulate the testing requirements of such products [<xref ref-type="bibr" rid="cit1">1</xref>], various methods of modelling and assessment of potential complications. One of the most important aspects of testing such products is to evaluate their direct impact on blood. To obtain objective results of the study any modeling should be as close as possible to the situation of clinical use and reproduce the characteristics of blood flow. And also take into account the possibility of the use of anticoagulants and introducing in the model additional pharmacological preparations if they can influence the biochemical and physical characteristics of blood and their use is inextricably linked to the use of the product. The present article contains the results of the conducted scientific-research and experimental-design works on creation of the device to simulate the conditions of the blood flow to the preclinical testing of experimental samples of materials and devices intended for implantation in the human body for permanent or prolonged contact with blood</p></trans-abstract><kwd-group xml:lang="ru"><kwd>доклинические исследования</kwd><kwd>кровь</kwd><kwd>имплантация</kwd><kwd>ex vivo</kwd><kwd>симуляция</kwd><kwd>биосовместимость</kwd></kwd-group><kwd-group xml:lang="en"><kwd>preclinical study</kwd><kwd>ex vivo</kwd><kwd>blood</kwd><kwd>biocomparability</kwd><kwd>simulation</kwd><kwd>implantation</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">ГОСТ ISO 10993-4-2011. Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 4. Исследования изделий, взаимодействующих с кровью.</mixed-citation><mixed-citation xml:lang="en">ГОСТ ISO 10993-4-2011. Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 4. Исследования изделий, взаимодействующих с кровью.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">M. Jordan, M. Mueller, R. Kortlepel, B. Glasmacher. Modified Chandler Loop system for dynamic hemocompatibility testing of vascular implants // 48th DGBMT Annual Conference Biomedizinische Technik; 2014. Р. 28-30.</mixed-citation><mixed-citation xml:lang="en">M. Jordan, M. Mueller, R. Kortlepel, B. Glasmacher. Modified Chandler Loop system for dynamic hemocompatibility testing of vascular implants // 48th DGBMT Annual Conference Biomedizinische Technik; 2014. Р. 28-30.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">V. Oeveren, I. Tielliu, J. de Hart. Comparison of Modified Chandler, Roller Pump, and Ball Valve Circulation Models for In Vitro Testing in High Blood Flow Conditions: Application in Thrombogenicity Testing of Different Materials for Vascular Applications //International Journal of Biomaterials. 2012. № 1. Р. 1-7.</mixed-citation><mixed-citation xml:lang="en">V. Oeveren, I. Tielliu, J. de Hart. Comparison of Modified Chandler, Roller Pump, and Ball Valve Circulation Models for In Vitro Testing in High Blood Flow Conditions: Application in Thrombogenicity Testing of Different Materials for Vascular Applications //International Journal of Biomaterials. 2012. № 1. Р. 1-7.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">J. Slee, I. Alferiev, R. Levy, S. Stachelek. The Use of the Ex Vivo Chandler Loop Apparatus to Assess the Biocompatibility of Modified Polymeric Blood Conduits // Journal of Visualized Experiments. 2014. V. 90.</mixed-citation><mixed-citation xml:lang="en">J. Slee, I. Alferiev, R. Levy, S. Stachelek. The Use of the Ex Vivo Chandler Loop Apparatus to Assess the Biocompatibility of Modified Polymeric Blood Conduits // Journal of Visualized Experiments. 2014. V. 90.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">S. Boodram, E. Evans. Use of Leukocyte-Depleting Filters During Cardiac Surgery With Cardiopulmonary Bypass: A Review // The Journal of Extra-corporeal Technology. 2008. V. 40(1). Р. 27-42.</mixed-citation><mixed-citation xml:lang="en">S. Boodram, E. Evans. Use of Leukocyte-Depleting Filters During Cardiac Surgery With Cardiopulmonary Bypass: A Review // The Journal of Extra-corporeal Technology. 2008. V. 40(1). Р. 27-42.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">A. Erlenkötter, P. Endres, B. Nederlof et al. Score Model for the Evaluation of Dialysis Membrane Hemocompatibility // Artif Organs. 2008. № 32(12). Р. 962-969.</mixed-citation><mixed-citation xml:lang="en">A. Erlenkötter, P. Endres, B. Nederlof et al. Score Model for the Evaluation of Dialysis Membrane Hemocompatibility // Artif Organs. 2008. № 32(12). Р. 962-969.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">S. Ritz-Timme, N. Eckelt, E. Schmidtke, H. Thomsen. Genesis and diagnostic value of leukocyte and platelet accumulations around «air bubbles» in blood after venous air embolism // Int J Legal Med. 1998. V. 111(1). Р. 22-26.</mixed-citation><mixed-citation xml:lang="en">S. Ritz-Timme, N. Eckelt, E. Schmidtke, H. Thomsen. Genesis and diagnostic value of leukocyte and platelet accumulations around «air bubbles» in blood after venous air embolism // Int J Legal Med. 1998. V. 111(1). Р. 22-26.</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>
