中国临床药理学杂志2011，Vol.27Issue(11)：851-855,5.
厄贝沙坦氢氯噻嗪胶囊在健康人体的生物等效性
Bioequivalence of irbesartan and hydrochlorothiazide capsules in Chinese healthy volunteers
邱相君 1刘涛 1袁世英 2刘心霞 2陈汇2
作者信息
- 1. 河南科技大学医学院,河南 洛阳471003
- 2. 华中科技大学同济医学院,武汉430030
- 折叠
摘要
Abstract
Objective To study the bioequivalence of irbesartan and hydrochlorothiazide capsules in healthy volunteers. Methods A single o-ral dose of test and reference formulations were given to 22 healthy volunteers in a randomised crossover study. The concentrations of irbesartan and hydrochlorothiazide in plasma were determined by HPLC, respectively. The pharmacokinetic parameters were calculated and the bioavailability and bioequivalence of irbesartan and hydrochlorothiazide were evaluated by DAS program, respectively. Results After a single dose, the pharmacokinetic parameters of irbesartan for test and reference formulations were as follows; Cmax were (2.61 ±0. 62) and (2. 57 ±0.46) mg · L-1; AUC0-36 were (15. 14±3.43) and (15.39 ±3.91) mg · H · L-1; AUC0_∞ were (16. 37 ±3.42) and (16. 80 ±4. 28) mg · H · L-1, respectively. The relative bioavailability of irbesartan was (100.75 ± 19.42)%. The pharmacokinetic parameters of hydrochlorothiazide for test and reference formulations were as follows: Cmax were (162.51 ±27.55) and (168.18 ±25.71) μg · L-1; AUC0-36 were (1115.41 ±147.34) and (1144.15 ±171.62)μg · H · L-1; AUC0-∞ were (1212.68 ± 160.77) and (1252.75 ±211.27) μg · H · L-1, respectively. The relative bioavailability of hydrochlorothiazide was(98. 53 ± 13. 35)%. Conclusion The results of the statistic analysis showed that the two formulations were bioequiv-alence.关键词
厄贝沙坦/氢氯噻嗪/生物等效性/高效液相色谱法Key words
irbesartan/ hydrochlorothiazide/ bioequivalence/ HPLC分类
医药卫生引用本文复制引用
邱相君,刘涛,袁世英,刘心霞,陈汇..厄贝沙坦氢氯噻嗪胶囊在健康人体的生物等效性[J].中国临床药理学杂志,2011,27(11):851-855,5.
