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.
关键词
生物活性测定/红花注射液/血小板聚集/质量控制
Key words
determination of biological activity/Safflower injection/platelet aggregation/quality control
维普
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