苯扎贝特在不同性别健康人体内的药动学研究

Study on Pharmacokinetics of Bezafibrate in Healthy Volunteers of Different Genders

目的:研究健康男、女志愿者单剂量口服苯扎贝特片的药动学。方法:健康志愿者20名(其中男、女各半),单剂量口服苯扎贝特片400mg,采用高效液相色谱法测定血浆中苯扎贝特的浓度。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:男、女受试者单剂量口服苯扎贝特片400mg的主要药动学参数分别为:cmax(11.41±3.24)、(11.06±3.06)μg/ml,tmax(1.93±0.29)、(2.07±0.38)h,t1/2(2.06±0.33)、(2.03±0.27)h,AUC0-12h(35.46±9.26)、(39.36±9.63)μg.h/ml,AUC0-∞(40.34±10.35)、(39.57±9.28)μg.h/ml。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。经统计学分析,本品在健康志愿者体内药动学过程不存在性别差异。

OBJECTIVE： To study the pharmacokinetics of Bezafibrate tablets after a single oral dose in healthy male or famale volunteers. METHODS： 10 healthy male volunteers and 10 healthy female volunteers were involved in the study. Each subject re- ceived a single dose of Bezafibrate tablets 400 mg. The plasma concentration of bezafibrate was determined by HPLC. The pharma- cokinetic parameters were calculated by DAS software and were statistically analyzed by SPSS software. RESULTS： The main phar- macokinetic parameters of a single dose of Bezafibrate tablets 400 mg in male volunteer vs. female volnteers were as follows： Cmax （11.41 ± 3.24）μg/ml Vs.（11.06 ± 3.06）lxg/ml; tmax（1.93±0.29）h vs.（2.07 ＋ 0.38）h; t1/2（2.06± 0.33） h vs.（2.03± 0.27）h; AUC0-1z h （35.46 ±9.26）μg·h/ml vs. （39.36± 9.63）μ·h/ml;AUC0-∞（40.34± 10.35）μg·h/ml vs.（39.57 ± 9.28） μg·h/ml. CONCLUSION： The results show that the plasma concentration-time curves of bezafibrate are fitted to a two-compartment open model and the main phar- macokinetic parameters of bezafibrate have no significant differences between male and female volunteers.