苯扎贝特在中国汉族和藏族健康人体内的药动学初探

Pharmacokinetics of bezafibrate in Chinese Han and Tibetan healthy volunteers

目的研究汉族和藏族健康志愿者单剂量口服苯扎贝特片的药物动力学。方法健康志愿者20名(其中汉族和藏族各10名,男女各半),单剂量口服苯扎贝特片400mg,采用HPLC法测定血浆中苯扎贝特的含量。用DAS软件程序进行数据处理,用SPSS软件对不同性别药动学参数进行统计分析。结果受试者单剂量口服400mg苯扎贝特片后,汉族健康志愿者的主要药动学参数:Cmax为(11.33±3.02)μg·mL-1,tmax为(1.96±0.21)h,t1/2为(2.05±0.37)h,AUC0～12为(40.54±11.25)μg·h·mL-1;AUC0～∞为(46.63±12.42)μg·h·mL-1。藏族健康志愿者的主要药动学参数:Cmax为(11.17±3.26)μg·mL-1,tmax为(2.05±0.32)h,t1/2为(2.04±0.31)h,AUC0～12为(38.25±9.74)μg·h·mL-1;AUC0～∞为(44.52±10.35)μg·h·mL-1。结论健康志愿者单剂量口服苯扎贝特片的体内药动学过程符合二室开放模型。由于样本数太少,以上结果仅是初探,要得出有无种属差异的结论,尚需扩大样本数,作进一步研究才行。

Objective To determine the pharmacokinetics of bezafibrate tablets after a single oral dose in Han and Tibetan healthy volunteers.Methods Ten healthy Han volunteers and 10 healthy Tibetan volunteers enrolled in the study.Each subject received a single dose of 400 mg bezafibrate tablets.The plasma concentration was determined by HPLC.The pharmacokinetic parameters were calculated by DAS and statistically analyzed by SPSS.Results The main pharmacokinetic parameters of Chinese Han were as follows： Cmax（11.33±3.02）μg·mL-1,t max（1.96±0.21）h,t1/2（2.05±0.37）h,AUC0～12（40.54±11.25）μg·h·mL-1,and AUC0～∞（46.63±12.42）μg·h·mL-1.The main pharmacokinetic parameters of Tibetan were as follows： Cmax（11.17±3.26）μg·mL-1,t max（2.05±0.32）h,t1/2（2.04±0.31）h,AUC0～12（38.25±9.74）μg·h·mL-1,and AUC0～∞（44.52±10.35）μg·h·mL-1.Conclusion The plasma concentration-time curve of bezafibrate fits a two-compartment open model.Due to the small number of volunteers in the trial,further research is needed.