中国临床药理学杂志Issue(6)：528-530,3.DOI:10.13699/j.cnki.1001-6821.2014.06.018
格列吡嗪在健康人体的生物等效性
Bioequivalence of glipizide tablets in heathy volunteers
李海燕 1郝光涛 1曲恒燕 1高洪志 1刘泽源 1梁宇光1
作者信息
- 1. 军事医学科学院 附属医院 临床药理学研究室，北京 100071
- 折叠
摘要
Abstract
Objective To evaluate the bioequivalent between the two kinds of glipizide tablets.Methods With two-cycle crossover trial was design, 24 healthy male subjects were given a single oral dose 5 mg of glipizide test preparation and reference preparation.Serum samples were collected at different time points before administration and after adminis-tration.The plasma concentrations were measured by HPLC -MS/MS method.The pharmacokinetic parameters and relative bioavailability were calculated by WinNonlin 6.1 software.Results The main pharmacoki-netic parameters of the test and reference glipizide tablets were as fol-lows: tmax were ( 3.40 ±1.54 ) and ( 3.71 ±1.30 ) h, Cmax were (471.88 ±108.10 ) and ( 480.58 ±132.63 ) μg · L-1 , t1/2 were (5.15 ±1.31) and(5.32 ±1.27)h, AUC0-t were (2805.71 ±592.61 ) and (2873.40 ±697.57 )μg· h-1 · L, respectively.F0-t and F0-∞ of test preparation were ( 105.77 ±27.84 )% and ( 105.28 ±27.63 )% re-spectively.Conclusion The glipizide tablets test and reference are bio-equivalent.关键词
高效液相色谱-质谱/格列吡嗪/生物等效性Key words
HPLC-MS/MS/glipizide/bioequivalence分类
医药卫生引用本文复制引用
李海燕,郝光涛,曲恒燕,高洪志,刘泽源,梁宇光..格列吡嗪在健康人体的生物等效性[J].中国临床药理学杂志,2014,(6):528-530,3.
