目的 以注射用丹參多酚酸（SAFI）體外抗血小板聚集活性為基礎(chǔ)，建立該制劑的生物活性測(cè)定方法，并對(duì)30批樣品進(jìn)行測(cè)定，從而探索一種反映其有效性的新質(zhì)控方法。方法 以家兔全血為試驗(yàn)系，一定濃度的SAFI與富血小板血漿混合后，采用光學(xué)比濁法檢測(cè)二磷酸腺苷（ADP）誘導(dǎo)的血小板聚集率，通過(guò)與丹酚酸B對(duì)照品的測(cè)定結(jié)果進(jìn)行比較，運(yùn)用斜率比例法計(jì)算相對(duì)效價(jià)，并進(jìn)行方法學(xué)考察驗(yàn)證。結(jié)果 方法學(xué)驗(yàn)證結(jié)果表明，建立的體外抗血小板聚集生物活性測(cè)定法符合要求；30批次樣品的相對(duì)效價(jià)均值為0.366 1，RSD為9.43%。結(jié)論 SAFI具有較強(qiáng)的抗血小板聚集活性，所建方法適用于SAFI體外抗血小板聚集活性測(cè)定，對(duì)于補(bǔ)充調(diào)整SAFI的全面質(zhì)量控制具有重要意義。

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