基于体外抗血小板聚集活性的丹参注射液生物活性测定法

Biological activity assay of Danshen injection based on anti-platelet aggregation activity in vitro

目的研究丹参注射液的体外抗血小板聚集活性,建立丹参注射液的生物活性测定法,从而探索一种反映其有效性的新质控模式。方法通过丹参注射液体外抗血小板聚集作用为试验系,进行量效学关系考察和规定效价,采用量反应平行线法进行实验设计并计算效价,建立基于体外抗血小板聚集活性的丹参注射液生物活性测定法。结果丹参注射液浓度在37.7%~52.2%范围内具备显著量效关系,规定标准品效价为1000 U·L-1,由此测定其他8个批次(170203、20180601、180727B1、1807241、170204、20180701、180725B1、1807251)效价依次为931.2、1584.9、1252.7、1054.1、990.1、2667.9、1312.1、1035.7 U·L-1,方法学考察表明方法可靠,重复性良好。结论利用以抗血小板聚集活性为指标的丹参注射液生物活性测定法可对丹参注射液的药效活性进行区分评价,操作简单易行、方法可靠,对于补充调整中药、中药复方及制剂的全面质量控制具有重大意义。

Aim To establish the biological activity assay of Danshen injection via studying the anti-platelet aggregation activity of Danshen injection in vitro,so as to explore a new quality control method for the effectiveness of Danshen injection.Methods The anti-platelet aggregation effect of Danshen injection was used as the experimental system,then the dose-effect relationship and potency were investigated.The experimental design was carried out by the parallel line method of quantitative reaction.Finally the biological activity assay of Danshen injection based on the anti-platelet aggregation activity in vitro was established.Results The concentration of Danshen injection has a significant dose-effect relationship in the range of 37.7%~52.2%,and the standard product potency was 1000 U·L-1.Thus the potency of the other batches(170203,20180601,180727B1,1807241,170204,20180701,180725B1,1807251)was 931.2,1584.9,1252.7,1054.1,990.1,2667.9,1312.1,1035.7 U·L-1,respectively.The method was reliable and repeatable.Conclusions The bioactivity assay of Danshen injection based on anti-platelet aggregation activity could be used to distinguish and evaluate pharmacodynamic activity of Danshen injection.The method is not only simple and reliable,but also has positive significance for the quality control of traditional Chinese medicine,compound traditional Chinese medicine and other preparations.