中国临床药理学杂志2011，Vol.27Issue(9)：689-692,4.
头孢丙烯胶囊在健康人体的生物等效性
Bioequivalence of cefprozil capsules in Chinese healthy volunteers
郭京艳 1宋浩静 2王本杰 3魏春敏 3衷桂妍 3刘晓燕 3郭瑞臣3
作者信息
- 1. 山东大学药学院,济南,250012
- 2. 山东省医学科学院,附属医院,济南,250031
- 3. 山东大学齐鲁医院,临床药理研究所,济南,250012
- 折叠
摘要
Abstract
Objective To determinate the plasma concentrations of cis - or trans - cefprozil and to evaluate the bioequivalence of two domestic cefprozil capsules in Chinese healthy volunteers. Methods Twenty subjects were randomly divided into two groups and the plasma concentrations of cis - and trans - eefprozil were determined by HPLC method after single oral dose of 500 mg cefprozil capsules. The main pharmacokinetic parameters of cis - and trans - cefprozil were calculated and the bioequivalence were evaluated by DAS 2. 0. Results The main pharmacokinetic parameters of cis - and trans - cefprozil of test and reference were as follows;tmax were (1. 82 ±0. 52) h, (1.65 ±0.40) h and (1. 75 ±0.30) h, (1.56 ±0.40) h; Cmax were (7. 20 ±1.24) μg ? mL1, (6. 69 ±1.06) μg ? mL1 and (0.74 ±0.24) jtg ? mL1, (0.68 ± 0.17) μg- mL-1; t1/2 were (1.39 ±0.38) h, (1.42 ±0.44) h and (1. 12 ±0.38) h, (1.02 ±0.25) h; AUC0_12 were (22.07 ±4.54) μg-mL-1 -h, (20.33 ±3.04) μg ? mL1 ? H and (1.87 ±0.38) μg-mL-'-h, (1.73 ±0.40) |xg ? mL"1 ? H; AUC0_00. Were (22. 19 ±4. 57) μg-mL-1 -h , (20.44 ±3.04) μg . mL1 ? H and(1.96 ±0. 45) ng ? mL-1 ? H, (1. 80 ±0. 41) μg ? mL-1 ? H, respectively. The relative bioavailabilities of cefprozil test, calculated by cis - and trans - isomers, were (108.3 ±11.7)% and (107.7 ±15.0)% , respectively. Conclusion The reference and test of cefprozil capsules, evaluated by its cis - and trans - isomers, are bioequivalent关键词
顺、反式头孢丙烯/高效液相色谱法/生物等效性Key words
cis and trans cefprozil capsule/ HPLC/ bioequivalence分类
医药卫生引用本文复制引用
郭京艳,宋浩静,王本杰,魏春敏,衷桂妍,刘晓燕,郭瑞臣..头孢丙烯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(9):689-692,4.
