基于耐缺氧能力检测心脑宁胶囊质量控制方法研究.docVIP

基于耐缺氧能力检测心脑宁胶囊质量控制方法研究 　　[摘要] 目的 建立可用于心脑宁胶囊质量控制的生物活性测定方法。方法 该次研究地点为贵州医科大学药学院，于2016年9月―2017年4月选择健康昆明KM小鼠随机分为6组，每组10只，即正常组、盐酸异丙肾上腺素模型组、盐酸川芎嗪阳性药组以及心脑宁胶囊高、中、低剂量组。皮下注射盐酸异丙肾上腺素 建立心肌缺氧模型（正常组注射生理盐水）后，小鼠分别给予药物盐酸川芎嗪以及不同剂量的心脑宁胶囊，测定存活时间。并测定12批心脑宁胶囊的生物活性。结果 与模型组比较，心脑宁胶囊以0.68 g/kg、1.35 g/kg剂量给药3 d后，可显著增加缺氧小鼠的存活时间（P0.05） ，分别增加21.42%、25.31%；且12批样品均具有较好的生物活性，使小鼠存活时间增加24.74%以上（P0.05）。?Y论 基于耐缺氧能力的心脑宁胶囊生物活性测定方法准确、可靠，能有效控制心脑宁胶囊的内在质量。 　　[关键词] 心脑宁胶囊；耐缺氧能力；生物活性测定；质量控制 　　[中图分类号] R286 [文献标识码] A [文章编号] 1674-0742（2017）12（b）-0012-04 　　[Abstract] Objective To establish the measurement method of biology activity of quality control of xinnaonign capsules. Methods 10 healthy Kunming KM mice in 6 group in our hospital from September 2016 to April 2017 were selected， including the normal group， isoproterenol hydrochloride mode group， and Ligustrazine Hydrochloride positive drug group and high-dose， moderate-dose and low-dose xinnaoning capsules group， and the mice was respectively given the ligustrazine hydrochloride and different doses of xinnaoning capsules after establishing the myocardial anoxia modes （injection of normal saline in the normal group）， and the survival time was measured， and the biology activities of 12 batches of xinnaoning capsules was measured. Results The administration of xinnaoning capsules of 0.68 g/kg and 1.35 g/kg for three days can obviously increase the survival time of hypoxia mice compared with that in the mode group（P0.05）， and the increase values were respectively 21.42% and 25.31%， and 12 batches of samples had better biology activity， thus increasing the survival time of mice by more than 24.74%（P0.05）. Conclusion The xinnaoning capsule based on the hypoxia-resistance ability test is accurate and reliable， which can effectively control the internal quality of xinnaoning capsules. 　　[Key words] Xinnaoning capsules； Hypoxia tolerance； Biochemical activity measurement； Quality control 　　心脑宁胶囊是治疗心血管疾病的常用中药复方制剂，由银杏叶、小叶黄杨等配伍组成的，主要用于治疗气滞血瘀的胸痹，头痛，眩晕，症见：胸闷刺痛，心悸不宁，头晕目