注射用丹参(冻干)抗人血小板聚集标准研究

目的以确定注射用丹参(冻干)对血小板聚集抑制率的限度标准为目的 ,确定血小板聚集率指标符合生产和临床实际。方法采集人血进行初步处理,将测定样品制成适宜浓度的溶液,将适宜用量的样品溶液和人血混合后测定血小板聚集率,计算其血小板聚集抑制率。进行重复性试验和重现性试验,确定血小板聚集抑制率限度标准。结果本实验的注射用丹参(冻干)对血小板聚集抑制率限度标准的下限为25.1±9.2。结论该试验提供的方法可行,可以确定小板聚集抑制率的限度标准。

Study on standard of platelet aggregation inhibition rate of Salvia for Injection (lyophilized)

OBJECTIVE To determine Salvia for Injection（lyophilized）on platelet aggregation inhibition rate limits of the standard for the purpose,determining platelet aggregation rate target consistent with the production and clinical practice.METHODS To collect blood and do preliminary processing,suitable concentration of solution was made by working sample,mixed appropriate amount of the sample solution and people＇s blood to determine platelet aggregation rate and calculated platelet aggregation inhibition rate.Test for repeatability and reproducibility test.Determining platelet aggregation inhibition limits of the standard rate.RESULTS Identification of platelet aggregation inhibition of platelet aggregation limits of the standard rate is 25.1±9.2.CONCLUSION This test method was feasible for identify the limits standard of platelet aggregation inhibition rate.