摘要
目的:研究两种替米沙坦片的人体生物等效性.方法:20名健康男性受试者按照两制剂两周期的随机交叉试验设计,分别单剂量口服受试制剂和参比制剂80mg,用HPLC-荧光法测定血浆中替米沙坦的浓度,用DAS1.0软件对所得药动学参数进行统计分析.结果:受试制剂和参比制剂在受试者体内的药动学参数如下:cmax分别为(0.92±0.62)和(1.04±0.61)μg/ml;tmax分别为(0.97±0.61)和(1.03±0.65)h;AUG0-96h分别为(4.32±2.86)和(4.41±2.51)μg·h·ml-1;AUG0-∞分别为(4.60±3.08)和(4.59±2.64)μg·h·ml-1;t1/2分别为(24.38±10.50)和(21.31±6.81)h.tmax、cmax、AUC0-96h、AUG0-∞在两制剂间均元显著性差异,双单侧t检验结果表明受试制剂cmax的90%置信区间落在参比制剂70%～143%之间,受试制剂AUG的90%置信区间落在参比制剂80%～125%之间;受试制剂的相对生物利用度为(109.2±31.9)%.结论:两制剂具有生物等效性.
Objective：To study the bioequivalence of two kinds of telmisartan tablet in healthy human subjects. Methods： In a randomized crossover study,20 healthy male volunteers were given a single oral dose of 80 mg test telmisartan tablet and reference telmisartan tablet. The concentrations of telmisartan in plasma were determined by a HPLC method with fluorescence detection. The pharmacokinetic parameters were processed by DAS 1.0 program for statistic analysis. Results：The pharmacokinetic parameters of the test and reference tablets were as follows：era.,were （0.92±0.62） and （1.04 ±0.61）μg/ml;tmax were （0.97±0.61） and （1.03±0.65）h;AUC0-96h were （4.32±2.86） and （4.41±2.51）μg. h. ml^-1;AUC0-∞ were （4.60±3.08） and （4.59±2.64）μg. h. ml^-1;t1/2 were（24.38±10.50） and （21.31± 6.81 ） h, respectively. The relative bioavailability of the test tablet was （ 109. 2 ± 31.9 ） %. There was no significant difference in t cmax, AUC0-96h and AUC0-∞. between the two preparations. The 90% confidential interval of cmax and AUC were between 70% - 143% and 80% - 125% of those of reference tablet. Conclusions：The two preparations were bioequivalent.
出处
《华北国防医药》
2005年第6期395-397,共3页
Medical Journal of Beijing Military Region
关键词
替米沙坦
片剂
人体
生物等效
Telmisartan
Tablet
Human body
Bioequivalence
