目的 以注射用丹参多酚酸（SAFI）体外抗血小板聚集活性为基础，建立该制剂的生物活性测定方法，并对30批样品进行测定，从而探索一种反映其有效性的新质控方法。方法 以家兔全血为试验系，一定浓度的SAFI与富血小板血浆混合后，采用光学比浊法检测二磷酸腺苷（ADP）诱导的血小板聚集率，通过与丹酚酸B对照品的测定结果进行比较，运用斜率比例法计算相对效价，并进行方法学考察验证。结果 方法学验证结果表明，建立的体外抗血小板聚集生物活性测定法符合要求；30批次样品的相对效价均值为0.366 1，RSD为9.43%。结论 SAFI具有较强的抗血小板聚集活性，所建方法适用于SAFI体外抗血小板聚集活性测定，对于补充调整SAFI的全面质量控制具有重要意义。

Objective To establish a bioassay method for Salvianolic Acid for Injection (SAFI) based on the in vitro anti-platelet aggregation activity and assay 30 batches of SAFI, so as to explore a novel quality control method reflecting its effectiveness. Methods Using rabbit whole blood as test system, a certain concentration of SAFI was mixed with platelet-rich plasma, and the ADP-induced platelet aggregation rate was measured by optical turbidimetric method. Comparing the results with those of salvianolic acid B, relative potency was calculated by the slope ratio method. In addition, the method was investigated by methodological validation. Results The methodological validation results showed that the established in vitro anti-platelet aggregation bioassay method met the requirements; the mean relative potency value of the 30 batches of samples was 0.366 1 with an RSD of 9.43%. Conclusion SAFI has strong anti-platelet aggregation activity, and the proposed method is applicable to the in vitro anti-platelet aggregation activity assay, which is important for complementary adjustment of the overall quality control of SAFI.

R285.6;R286.2