国产替米沙坦胶囊在健康人体内的药动学

Pharmacokinetics of domestic telmisartan capsules in Chinese healthy volunteers

目的:研究国产替米沙坦胶囊在健康人体内的药动学。方法:10名健康志愿者单剂量口服120mg替米沙坦胶囊,采用高效液相色谱法测定血浆中替米沙坦浓度,并用3P97软件统计处理。结果:替米沙坦胶囊药-时曲线符合二室模型,其Cmax,tmax,t1/2,AUC0-84,AUC0-∞分别为(821.6±271.0)μg.L-1,(0.68±0.17)h,(24.6±2.5)h,(2 132±1 171)μg.L-1.h,(2 208±1 183)μg.L-1.h。结论:替米沙坦胶囊在人体内药动学过程符合二室开放模型,本试验可为临床用药提供药动学参数。

OBJECTIVE To study the pharmacokinetics of telmisartan capsules in Chinese bealthy volunteers. METHODS 10 healthy subjects received a single oral dose of 120 mg telmisartan capsules. The plasma concentrations of telmisartan were determined by an improved HPLC method. Data of plasma level-time were disposed with 3P97 software. RESULTS The main pharmacokinetics parameters of telmisartan were as follows： Cmax （821.6 ± 271.0）μg·L^-1, tmax was （0. 68 ± 0. 17） h, t, 2 was （24.6±2.5）h,AUC0-132 was （2 132±1 171）μg·L^-1,h,AUC0-∞ was （2 208±1 183）μg·L^-1. CONCLUSION The pharmacokinetics of telm-isartan capsules in human body accorded with two-compartment open model. The study will offer the parameters of the pharmaeokinetics for the clinical application of telmisartan.