研究治疗骨质疏松症的新药 "AOS "的急性毒性。

A. A. Mironov, N. S. Mamina, S. Y. Voronin, A. A. Bayramov
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摘要

背景。骨质疏松症是最常见的疾病之一,它与心肌梗塞、中风、癌症和猝死一样,在人口发病率和死亡率结构中占据首要地位。绝经后妇女最易患病,患病几率大约是男性的 4 倍(占所有患者的 80%),与骨质疏松症相关的骨折导致发病率、残疾率和死亡率显著上升,尤其是在老年人中。研究新药 "抗骨质疏松症药物"(2015 年 2 月 26 日专利号:02-04-16643/15-0)对成熟的雌雄近交大鼠一次胃内给药的急性毒性。根据 OECD 420 和 GOST 32296-2013 协议,对雌雄外种鼠进行了研究。根据行为测试、临床检查、体重变化、器官组织的病理形态学检查结果以及血液和尿液的生化指标,对毒性作用的产生进行了断定。根据研究结果,按照《全球统一制度》的分类,试验药物的活性物质被归为第 5 类(2000本文章由计算机程序翻译,如有差异,请以英文原文为准。
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Study of acute toxicity of a new drug “AOS” for the treatment of osteoporosis.
Background. Osteoporosis is one of the most common diseases, which, along with myocardial infarction, stroke, cancer, and sudden death, occupies a leading place in the structure of morbidity and mortality of the population. Postmenopausal women are most vulnerable and are approximately 4 times more likely to be affected than men (80 % of all patients), and osteoporosis-related fractures are responsible for a significant increase in morbidity, disability, and mortality, especially in the elderly.Objective. To study the acute toxicity of the new drug “Antiosteoporosis drug” (patent No. 02-04-16643/15-0 dated February 26, 2015) with a single intragastric administration to mature outbred rats of both sexes.Design and methods. The study was conducted on outbred rats of both sexes according to protocol OECD 420, GOST 32296-2013. The development of a toxic effect was concluded based on behavioral tests, clinical examinations, changes in body weight, the results of pathomorphological examination of organ tissue and biochemical parameters of blood and urine.Results. According to the results of the study, the tested drug was classified according to the active substance into category 5 according to the GHS classification (2000
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