丹参配方颗粒与标准煎剂体内抗家兔血小板聚集药理等效性研究

目的：观察丹参配方颗粒与丹参标准煎剂体内抗血小板聚集效应的药理等效性。方法：对比观察8个剂量丹参标准煎剂（1／4—32倍临床等效剂量）、丹参配方颗粒（1／4—32倍临床等效剂量）和复方丹参滴丸（1／8～16倍）一次口服给药后对家兔血小板1，3，5min和最大聚集抑制率（MAIR）的影响，并以MAIR为效应指标，根据所拟合量效曲线，在可比区间内计算三药等效应剂量（DEE）和等剂量效应（EED）。结果：丹参标准煎剂、丹参配方颗粒和复方丹参滴丸各8个剂量组灌胃给药后，均可显著抑制ADP所诱导家兔血小板的聚集（P〈0．01）；丹参配方颗粒和复方丹参滴丸抗血小板聚集效应均显著高于同等临床等效剂量的丹参标准煎剂（P〈0．01）；MAIR47．15％-63．99％，DEE＊拳＆i《粗（mg·kg^-1）=-62．432＋0．115×DEE丹参标准煎剂（mg·kg^-1），1／4—2倍临床等效剂量（175～1400mg·kg^-1），EED丹参配方颗粒（％）=30．558＋0．775XEED丹参标准煎剂（％）。结论：一定剂量范围内，丹参颗粒抗血小板聚集的效应劣于丹参滴丸，而优于丹参煎剂。

Experimental Study on Pharmacological Equivalence of Salvia Granules and Standard Decoction on the Anti-platelet Aggregation of Rabbits in vivo

Objective： To study the pharmacological equivalence of Salvia granules and standard decoction on the anti-platelet ag- gregation of rabbits in vivo. Method： The rabbits were randomly divided into three groups and respectively given single oral dose of Sal- via standard decoction （ 1/4-32 times of the clinical equivalent dose）, Salvia granules （ 1/4-32 times of the clinical equivalent dose） and compound Salvia dropping pills （ 1/8-16 times of the chnical equivalent dose）. The platelet aggregation inhibition rate at 1,3 and 5 min and the maximum platelet aggregation inhibition rate （MAIR） of the three groups were observed and compared. The dose equivalent effect （DEE） and equivalent effect dose （EED） of the three Salvia preparations were calculated in the comparable range by the dose- effect curves with MAIR as the effect indicator. Result： The three Salvia preparations all could significantly inhibit the ADP-induced platelet aggregation （P 〈 0. 01 ）, and the effect of Salvia granules and compound Salvia dropping pills was both better than that of Salvia standard decoction （ P 〈 0. 01 ）. Within the MAIR limit of 47. 15%-63.99%, DEESalvia Granules （ mg· kg^-1 ） = -62. 432 ＋ 0. 115 x DEESalvia standard decoction（mg·kg^-1）, and in the range of 1/4-2 times the clinical equivalent dose （175-1 400 mg· kg^-1）, EEDSalvia granules （ % ） = 30. 558 ＋ 0. 775 x EEDSalivia standard decoction （ % ）- Conclusion： Within the certain range of doses, the effect of Salvia grmmles on an- ti-platelet aggregation is lower than that of compound Salvia dropping pills, while better than that of Salvia standard decoction at the same dose.