中国中药杂志

2015, v.40(23) 4597-4602

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基于抑制血小板聚集活性检测的血栓通胶囊质量控制研究
Anti-platelet aggregation bioassay based quality control for XST capsules

韩冰;毛鑫;韩淑娴;陈影;项彦华;葛一蒙;廖福龙;游云;
HAN Bing;MAO Xin;HAN Shu-xian;CHEN Ying;XIANG Yan-hua;GE Yi-meng;LIAO Fu-long;YOU Yun;Harbin Zhenbao Pharmaceutical Co.,Ltd.;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences;School of Pharmacy,Beijing University of Chinese Medicine;Key Laboratory of Chinese Internal Medicine under Ministry of Education,Beijing University of Chinese Medicine;

摘要(Abstract):

通过建立血栓通胶囊(XST)体外抑制血小板聚集的生物活性测定法用于补充其质量控制方法。以体外抑制大鼠血小板聚集作用来考察血栓通胶囊的生物活性。以三七总皂苷、注射用血塞通冻干粉作为标准对照物质进行效价测定。研究结果发现血栓通胶囊对凝血酶诱导的血小板聚集具有显著抑制作用,并且呈现出剂量依赖关系。注射用血塞通冻干粉比三七总皂苷对照品体外抗血小板活性更稳定,适宜作为标准对照物质。采用"量反应平行线"法作为血栓通胶囊体外抗凝血酶诱导血小板聚集的生物效价检测方法,重复性较好(RSD 2.9%),样品检测结果均能通过可靠检验(偏离直线P>0.05,偏离平行P>0.05)。该研究建立的生物效价检测方法可以作为血栓通胶囊生物评价的质控方法之一。
A in vitro platelet aggregation bioassay was developed for the quality control of XST capsules. The in vitro anti-platelet aggregation effect in rats was observed to detect the bioactivity of XST capsules. Panax notoginseng saponins and Xuesaitong lyophilized powder for injection were taken as standard control substances to determine the potency. According to the results,XST capsules showed a significant inhibitory effect on thrombin-induced platelet aggregation in a dose-dependent manner. The in vitro anti-platelet activity of lyophilized powder for injection was stabler than that of Panax notoginseng saponins,and so suitable to serve as a standard control substance. The biological potency of XST capsules compared with standard control substance was detected by using parallel line assay. According to the results,the established bioassay method had a good repeatability( RSD 2. 92%). The sample test results could pass the reliability test( linear deviation P > 0. 05,parallel deviation P > 0. 05). This bioassay method could be used as one of the complementary quality control methods for XST capsules.

关键词(KeyWords): 血栓通胶囊;血小板聚集;生物活性测定法;质量控制
XST capsules;platelet aggregation;bioassay;quality control

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金项目(81274006);; 国家“重大新药创制”科技重大专项(2014ZX09201022-009)

作者(Author): 韩冰;毛鑫;韩淑娴;陈影;项彦华;葛一蒙;廖福龙;游云;
HAN Bing;MAO Xin;HAN Shu-xian;CHEN Ying;XIANG Yan-hua;GE Yi-meng;LIAO Fu-long;YOU Yun;Harbin Zhenbao Pharmaceutical Co.,Ltd.;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences;School of Pharmacy,Beijing University of Chinese Medicine;Key Laboratory of Chinese Internal Medicine under Ministry of Education,Beijing University of Chinese Medicine;

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