国产舍曲林片的人体药动学及生物等效性研究

 目的评价国产和进口舍曲林片在中国人群中的生物等效性。方法采用液相色谱-质谱联用法测定18名健康受试者po100 mg舍曲林片后血浆中的舍曲林浓度。采用统计软件计算药动学参数,并评价其生物等效性。结果国产舍曲林片和进口片的药动学参数AUC_0-100分别为(836.73±427.15)和(839.55±423.66)μg·h·L^-1,实测ρ_max为(27.71±9.67)和(26.34±8.21)μg·L^-1,实测t_max为(5.78±1.11)和(5.83±1.20)h,MRT为(31.73±3.59)和(32.83±3.89)h,t_1/2为(28.89±6.32)和(31.13±9.63)h。国产舍曲林片和进口片的相对生物利用度为(99.52±8.87)%。结论经统计学分析,国产舍曲林片和进口片具有生物等效性。

Studies on Pharmacokinetics and Bioequivalence of Domestic Sertraline Tablet in Healthy Volunteers

OBJECTIVE To evaluate the bioequivalence of domestic sertraline tablets and imported tablets.METHODS A single oral dose of 100 mg domestic or imported sertraline tablets was given to 18 healthy volunteers in a randomized crossover study.The concentrations of sertraline were determined by HPLC-MS method.RESULTS The main pharmacokinetic parameters of two products were as follows:AUC_0-100(836.73±427.15) and(839.55±423.66) μg·h·L^-1,ρ_max(27.71±9.67) and(26.34±8.21) μg·L^-1,t_max(5.78±1.11) and(5.83±1.20)h,MRT(31.73± 3.59) and(32.83±3.89)h,t_1/2(28.89±6.32) and(31.13±9.63)h,respectively.The relative bioavailability of domestic sertraline tablet to imported tablet was(99.52±8.87)%.There were no significant differences on the pharmacokinetic parameters between the two preparations(P>0.05).CONCLUSION The results of stastical analysis demonstrated that the two preparations were bioequivalent.