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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 pub-id-type="doi">10.33380/2305-2066-2025-14-4-2159</article-id><article-id custom-type="elpub" pub-id-type="custom">pharmjournal-2204</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>ДОКЛИНИЧЕСКИЕ И КЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PRECLINICAL AND CLINICAL STUDIES</subject></subj-group></article-categories><title-group><article-title>Подострая токсичность, местнораздражающее и аллергизирующее действие экстракта копеечника Семенова (Hedysarum semenowii Regel &amp; Herder)</article-title><trans-title-group xml:lang="en"><trans-title>Subacute toxicity, local irritant, and allergenic effects of Hedysarum semenowii extract</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-5502-6142</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Келеке</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Keleke</surname><given-names>A. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>050012, г. Алматы, ул. Толе Би, д. 94</p></bio><bio xml:lang="en"><p>94, Tole Bi str., Almaty, 050012</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-8381-5330</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ибрагимова</surname><given-names>Л. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Ibragimova</surname><given-names>L. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>050012, г. Алматы, ул. Толе Би, д. 94</p></bio><bio xml:lang="en"><p>94, Tole Bi str., Almaty, 050012</p></bio><email xlink:type="simple">ibragimova.l@kaznmu.kz</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4477-4051</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сакипова</surname><given-names>З. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Sakipova</surname><given-names>Z. B.</given-names></name></name-alternatives><bio xml:lang="ru"><p>050012, г. Алматы, ул. Толе Би, д. 94</p></bio><bio xml:lang="en"><p>94, Tole Bi str., Almaty, 050012</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9631-0112</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кулманбетов</surname><given-names>Р. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Kulmanbetov</surname><given-names>R. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>050012, г. Алматы, ул. Толе Би, д. 94</p></bio><bio xml:lang="en"><p>94, Tole Bi str., Almaty, 050012</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-8036-604X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Нургожин</surname><given-names>Т. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Nurgozhin</surname><given-names>T. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>050012, г. Алматы, ул. Толе Би, д. 94</p></bio><bio xml:lang="en"><p>94, Tole Bi str., Almaty, 050012</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0005-6902-6262</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сулейменов</surname><given-names>М. К.</given-names></name><name name-style="western" xml:lang="en"><surname>Suleimenov</surname><given-names>M. K.</given-names></name></name-alternatives><bio xml:lang="ru"><p>050012, г. Алматы, ул. Толе Би, д. 94</p></bio><bio xml:lang="en"><p>94, Tole Bi str., Almaty, 050012</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1268-9867</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ибадуллаева</surname><given-names>Г. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Ibadullayeva</surname><given-names>G. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>050012, г. Алматы, ул. Толе Би, д. 94</p></bio><bio xml:lang="en"><p>94, Tole Bi str., Almaty, 050012</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-5118-3914</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ахелова</surname><given-names>А. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Аkhelova</surname><given-names>A. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>050012, г. Алматы, ул. Толе Би, д. 94</p></bio><bio xml:lang="en"><p>94, Tole Bi str., Almaty, 050012</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2448-513X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гришина</surname><given-names>А. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Grishina</surname><given-names>A. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>197022, г. Санкт-Петербург, ул. Профессора Попова, д. 14, литера А</p></bio><bio xml:lang="en"><p>14A, Professora Popova str., Saint-Petersburg, 197022</p></bio><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Некоммерческое акционерное общество «Казахский национальный медицинский университет имени С. Д. Асфендиярова» (КазНМУ)</institution><country>Казахстан</country></aff><aff xml:lang="en"><institution>Asfendiyarov Kazakh National Medical University</institution><country>Kazakhstan</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное образовательное учреждение высшего образования «Санкт-Петербургский государственный химико-фармацевтический университет» Министерства здравоохранения Российской Федерации (ФГБОУ ВО СПХФУ Минздрава России). Центр экспериментальной фармакологии</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Saint-Petersburg State Chemical and Pharmaceutical University. Center for Experimental Pharmacology</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>03</day><month>12</month><year>2025</year></pub-date><volume>14</volume><issue>4</issue><fpage>208</fpage><lpage>220</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Келеке А.С., Ибрагимова Л.Н., Сакипова З.Б., Кулманбетов Р.И., Нургожин Т.С., Сулейменов М.К., Ибадуллаева Г.С., Ахелова А.Л., Гришина А.Ю., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Келеке А.С., Ибрагимова Л.Н., Сакипова З.Б., Кулманбетов Р.И., Нургожин Т.С., Сулейменов М.К., Ибадуллаева Г.С., Ахелова А.Л., Гришина А.Ю.</copyright-holder><copyright-holder xml:lang="en">Keleke A.S., Ibragimova L.N., Sakipova Z.B., Kulmanbetov R.I., Nurgozhin T.S., Suleimenov M.K., Ibadullayeva G.S., Аkhelova A.L., Grishina A.Y.</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/2204">https://www.pharmjournal.ru/jour/article/view/2204</self-uri><abstract><sec><title>Введение</title><p>Введение. Лекарственные растения, такие как копеечник Семенова (Hedysarum semenowii Regel &amp; Herder) рода Hedysarum L., обладают богатым фитохимическим профилем и могут стать перспективной основой для разработки новых фармацевтических препаратов. Несмотря на известную фармакологическую активность многих видов Hedysarum L., профиль безопасности этих растений изучен недостаточно, что требует дополнительной оценки их токсичности и потенциальных побочных эффектов. В этой связи проведены исследования по определению подострой токсичности, местнораздражающего действия и аллергенности экстракта Hedysarum semenowii для оценки его безопасности и терапевтического потенциала.</p></sec><sec><title>Цель</title><p>Цель. Определение подострой токсичности, местнораздражающего действия и аллергенности экстракта копеечника Семенова (Hedysarum semenowii Regel &amp; Herder).</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. Исследование подострой токсичности экстракта Hedysarum semenowii проводилось на беспородных крысах, где животным вводили экстракт надземной части растения перорально в дозах 500, 2000 и 5000 мг/кг в течение 28 дней, наблюдая за их состоянием. По окончании исследований подострой токсичности исследовали патологические изменения в печени и почках экспериментальных животных. Местнораздражающее и аллергенное действие оценивали на крысах и морских свинках соответственно с использованием визуальных методов и шкалы Дрейза.</p></sec><sec><title>Результаты и обсуждение</title><p>Результаты и обсуждение. В ходе 28-дневного исследования подострой токсичности у животных не выявлено значимой токсичности, смертности или изменений в поведении. Масса тела, потребление корма и воды оставались стабильными. По результатам макроскопического и микроскопического исследования в печени и почках отмечены незначительные физиологические изменения, выраженность которых коррелировала с дозой введенного экстракта. Кроме того, экстракт не вызывал раздражения кожи или аллергенных реакций в тестах с участием крыс и морских свинок.</p></sec><sec><title>Заключение</title><p>Заключение. В результате исследований экстракт Hedysarum semenowii продемонстрировал низкую токсичность, отсутствие раздражающего и аллергизирующего действий, что подтверждает его безопасность и перспективность для дальнейшего изучения в качестве потенциального терапевтического средства.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. Hedysarum semenowii Regel &amp; Herder of the genus Hedysarum L., possess a rich phyto-chemical profile and hold promise as a foundation for developing novel pharmaceuticals. Despite the recognized pharmacological activities of various Hedysarum L. species, their safety profiles have not been sufficiently studied, necessitating further investigation to evaluate their toxicity and potential adverse effects. To address this gap, a study was conducted to assess the subacute toxicity, local irritant effects, and allergenicity of Hedysarum semenowii extract, with the aim of determining its safety and therapeutic potential.</p></sec><sec><title>Aim</title><p>Aim. Determination of subacute toxicity, local irritant effect and allergenicity of the Hedysarum semenowii Regel &amp; Herder extract.</p></sec><sec><title>Materials and methods</title><p>Materials and methods. The subacute toxicity study was performed using outbred rats, with the extract from aerial part of the plant administered orally at doses of 500, 2000, and 5000 mg/kg over a 28-day period. The condition of the animals was monitored throughout the study. At the conclusion of the subacute toxicity evaluation, pathological changes in the liver and kidneys of the experimental animals were examined. Local irritant and allergenic effects were assessed in rats and guinea pigs, respectively, employing visual inspection and the Draize scoring system.</p></sec><sec><title>Results and discussion</title><p>Results and discussion. The 28-day subacute toxicity study revealed no significant toxicity, mortality, or behavioral changes in the animals. Body weight, food consumption, and water intake remained stable across all groups. According to the results of macroscopic and microscopic examination, minor physiological changes were noted in the liver and kidneys, the severity of which correlated with the administered doses of the extract. Furthermore, the extract did not induce skin irritation or allergenic reactions in tests involving rats and guinea pigs.</p></sec><sec><title>Conclusion</title><p>Conclusion. Hedysarum semenowii extract exhibited low toxicity and an absence of irritant and allergenic effects, affirming its safety and potential for further exploration as a therapeutic agent.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>Hedysarum semenowii</kwd><kwd>подострая токсичность</kwd><kwd>местнораздражающее действие</kwd><kwd>аллергизирующее действие</kwd><kwd>доклинические исследования</kwd></kwd-group><kwd-group xml:lang="en"><kwd>Hedysarum semenowii</kwd><kwd>subacute toxicity</kwd><kwd>local irritant effect</kwd><kwd>allergenic effect</kwd><kwd>preclinical studies</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">Builders P. F., editor. Herbal Medicine. London: IntechOpen; 2019. 314 р. DOI: 10.5772/intechopen.69412.</mixed-citation><mixed-citation xml:lang="en">Builders P. F., editor. Herbal Medicine. London: IntechOpen; 2019. 314 р. 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