中国临床药理学杂志2012，Vol.28Issue(4)：278-280,3.
盐酸二甲双胍片在中国健康人体的生物等效性
Bioequivalence of metformin hydrochloride tablets in Chinese healthy volunteers
邱相君 1孙永健 1刘涛 1刘心霞 2袁世英 2陈汇2
作者信息
- 1. 河南科技大学医学院药理学教研室,河南洛阳 471003
- 2. 华中科技大学同济医学院药理学系,武汉430030
- 折叠
摘要
Abstract
Objective To evaluate the bioequivalence of two domestic metformin hydrochloride tablets in healthy volunteers. Methods A single oral dose (1. 0 g of test and reference formulation) was given to 20 healthy volunteers in a randomized crossover study. The concentrations of metformin hydrochloride in plasma were determined by HPLC. The bio-availability and bioequivalence of two formulations were evaluated by DAS 2. 0 software, then the bioequivalence was judged. Results After a single dose, the pharmacokinetic parameters for tested and reference metformin hydrochloride were as follows: Cmax were (2. 83 ± 0. 53 ), (2.57±0.57) mg , L-1; Twere (1.55 ±0. 39) , (t. 63 ±0. 36) h; t1/2 were ( 3. 70 + 1. 76), (3. 36 ± 0. 72) h; AUC0_24 were (10. 20 ± 1. 95), (9. 71 ± 2. 56) mg · h · L-1, respectively. The 90% confidential interval of AUC0-24, AUC0-∞ and Cmax of test formulation were 99. 1% -114.6% , 99. 1% -113. 8% and 100.6% -110.4% , respectively. The relative bioavailability of test to reference formulation was (108. 3 ± 20. 5 ) % . Conclusion The test and reference metformra hydrochloride were bioequivalence.关键词
盐酸二甲双胍/药代动力学/生物等效性/高效液相色谱法Key words
metformin hydrochloride/ pharmacokinetics/ bioequivalence/ HPLC分类
医药卫生引用本文复制引用
邱相君,孙永健,刘涛,刘心霞,袁世英,陈汇..盐酸二甲双胍片在中国健康人体的生物等效性[J].中国临床药理学杂志,2012,28(4):278-280,3.
