复方丹参滴丸中丹参素的药物动力学研究

Pharmacokinetic Study of Danshensu in Compound Danshen Dropping Pill

采用高效液相色谱法 (HPLC)测定了血清中丹参素的浓度。紫外检测波长为 2 79nm。丹参素的血药浓度在 0 .5～ 1 6mg/L浓度范围内线性关系良好 (r2 =0 .9988) ,方法回收率为 93 .1 %～ 1 0 1 .7%。并用高效液相色谱法测定了大鼠灌服复方丹参滴丸后 ,丹参素在药后不同时间的血药浓度 ,从药 -时配对资料获得有关动力学参数。丹参素在大鼠体内的动力学过程可用具吸收过程的二室开放模型来描述。Kα 为 4 .956h- 1,α为3 .4 87h- 1,β为 0 .2 1 1h- 1,T1/2 (α) 为 0 .1 99h ,T1/2 ( β) 为 3 .2 8h ,T1/2 (Ab) 为 0 .1 4 0h ,Tmax为 0 .5h。实验结果可为复方丹参滴丸在临床用药的安全和有效提供依据。

HPLC method for the assay of serum Danshensu in compound Danshen Dropping Pill was developed.Serum samples was extracted with ethyl acetate.The analysis of samples was on C 18 reversed_phase column with the internal standard of phydroxybenzoic acid at λ=279nm.The linera range of calibration curve is 0.5 ～16μg/mL(r 2= 0.9988 ),the detection limit of this method was 0.3 μg/mL. The recovery is 93.1% ～ 101.7%. Serum Danshangsu level in rats was determined in various time after oral administration of compound Danshen Dropping Pill.The serm Danshensu concentration_time curve of rats was fitted to a two_compartment model with t 1/2 (Ab)= 0.140 h,t 1/2α = 0.199 h,t 1/2 β= 3.28 h,T max = 0.50 h.The results can provide an evidence for the safety and efficiency of compound Danshen Dropping Pill in clinical application.