复方丹参片体外抑制血小板聚集的生物活性测定法  

Bioassay method for Compound Danshen Tablets based on a platelet aggregation inhibition test

作　　者：郭玉东[1] 胡宇驰[1] 曹春然[1] 王志斌[2] 左泽平[1] 高阳[1] 娄天宇 马贝贝 GUO Yu-dong;HU Yu-chi;CAO Cun-ran;WANG Zhi-bin;ZUO Ze-ping;GAO Yang;LOU Tan-yu;MA Bei-bei(Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing Institute for Drug Control,Beijing 102206,China;Beijing University of Chinese Medicine,Beijing 100102,China)

机构地区：[1]北京市药品检验所,中药成分分析与生物评价北京市重点实验室,北京102206 [2]北京中医药大学,北京100102

出　　处：《药学学报》2019年第12期2184-2188,共5页Acta Pharmaceutica Sinica

摘　　要：本文建立复方丹参片体外抑制血小板聚集的生物活性测定法,量化复方丹参片的药理作用,补充其质量控制方法。以复方丹参片体外抑制家兔血浆血小板聚集作用为实验体系,通过量效关系考察和效价定义,利用量反应平行线法计算效价,建立复方丹参片体外抑制血小板聚集的生物活性测定方法,并进行方法学验证,考察方法的可行性。通过量效关系考察,发现在浓度0.128~0.205 g·mL^-1范围内线性良好,并根据效价定义得出复方丹参片标准品效价为7659 U·g^-1,方法学考察表明方法可靠,重现性和适用性良好。复方丹参片抑制血小板聚集的生物活性测定法为体外方法,操作简单、方便,测定结果可靠,并能通过效价测定量化了复方丹参片抑制血小板聚集的活性,评价不同批次质量,可以尝试将该方法推广到其质量控制中,为中药质量控制开辟新的途径。A bioassay method for inhibiting platelet aggregation in vitro was established to quantify the pharmacological effects of Compound Danshen Tablets and support its quality control.The inhibition of platelet aggregation in rabbit plasma in vitro by Compound Danshen Tablets was used as the experimental system.The titer was calculated by using the method of dose-response parallel lines.As a result,a bioassay for the inhibition of platelet aggregation in vitro by Compound Danshen Tablets was established.Linearity was good in the concentration range of 0.128 g·mL^-1 to 0.205 g·mL^-1,and the titer of standard Compound Danshen tablets was 7659 U·g^-1 according to the titer definition.This in vitro assay was simple,reliable,reproducible and convenient.The activity of Compound Danshen Tablets in inhibiting platelet aggregation was quantified by potency assay and the quality of different batches was evaluated.The method can be applied for the quality control of Compound Danshen Tablets.

关 键 词：复方丹参片 血小板聚集 生物活性测定法 质量控制 

分 类 号：R917[医药卫生—药物分析学]