目的 基于红花注射液具有抗血小板聚集作用,建立红花注射液生物活性测定方法,优化红花注射液质量控制模式.方法 通过红花注射液体外抗血小板聚集活性建立试验系,对诱导剂的种类、血小板的数量及不同的剂间比都做了对比,进行量效学关系考察并定义效价,采用量反应平行线(3.3)法进行实验设计及计算效价,建立红花注射液生物活性测定法并验证其可行性.结果 选择二磷酸腺苷作为血小板聚集诱导剂,血小板的数量选用 500×109 个·L-1.通过量效关系考察,发现红花注射液在剂间比为 1∶0.5,在25%~100%与测定值线性良好,并测定了 4 个厂家 8 个批次红花注射液的效价,验证了方法的适用性.结论 本方法结果可靠且重复性和中间精密度良好,通过效价测定量化了红花注射液抑制血小板聚集活性以评价不同批次红花注射液质量,在现行的红花注射液质量控制的模式上进行补充,对全面控制红花注射液的质量具有重大意义.
Objective To determine the biological activity of Safflower injection,via the anti-platelet aggregation effect of Safflower injection,and to optimize the quality control of Safflower injection.Methods In vitro antiplatelet aggregation of Safflower injection was used to establish a test line.The type of inducer,number of platelets and different inter-agent ratios were compared,the quantitative relationship was examined and the potency was defined,and the experiment was designed and potency calculated by the quantitative response parallel(3.3).The bioactivity assay of Safflower injection was established and feasibility verified.Results Adenosine diphosphate was selected as the platelet aggregation inducer,and the platelet count was chosen to be 500×109 platelets·L-1.By examining the quantitative and qualitative relationship,the linearity of Safflower injection was found good at the inter-agent ratio of 1∶0.5,and the linearity was good at 25%~100%.The potency of eight batches of Safflower injection from four manufacturers was determined,and the applicability of the method verified.Conclusion The bioactivity assay is"potent"with good repeatability and intermediate precision.The method quantifis the platelet aggregation inhibiting activity of Safflower injection and evaluates the quality of different batches of Safflower injection through potency determination,which is complementary to the current quality control model essential for the comprehensive quality control of Safflower injection.