头孢克洛胶囊人体药代动力学与相对生物利用度研究  

Relative bioavailability and bioequivalence study of cefaclor capsule in Chinese healthy volunteers

作　　者：丁青山[1] 陈铁锋[1] 周志凌[1] 麦丽萍[1] 陈秀云[1] 杨敏[1] 余细勇[1] 

机构地区：[1]广东省医学科学院广东省人民医院科教处,广东广州510080

出　　处：《海南医学》2013年第5期633-635,共3页Hainan Medical Journal

摘　　要：目的研究头孢克洛胶囊的相对生物利用度，评价该试验制剂的生物等效性。方法对20名男性健康受试者采用随机交叉双周期给药方式，分别口服单剂量参比制剂和头孢克洛试验制剂500mg，通过反相高效液相色谱法测定血药浓度，计算两者的相对生物利用度和药代动力学参数，评价该制剂的生物等效性。结果按InAUC0-t计算，与参比制剂相比，单剂量口服受试药的相对生物利用度为（97．54-10．0）％。试验制剂头孢克洛胶囊和参比制剂头孢克洛胶囊之间InAUC0-T、InAUC0-∞经双向单侧t检验，AUC0-T、AUC0-∞的[1-2α]置信区间在参比制剂相应参数的80％～125％范围内，表明两种制剂在吸收程度具有生物等效性山c一经方差分析和双向单侧￡检验，Cmax的[1-2α]置信区间在参比制剂相应参数的75％～133％范围内，表明两种制剂在吸收的峰值浓度上具有生物等效性；Tmax经非参检验，两制剂间差异无统计学意义，表明两制剂在达峰时间上具有生物等效性。结论头孢克洛的两种胶囊制剂具有相似的人体药代动力学特点，生物利用度也相同。Objective To study the relative bioavailability ofcefaclor capsule in Chinese healthy volunteers and evaluate the bioequivalence. Methods A single oral dose 500 mg of test and reference formulations was given to 20 healthy volunteers in a randomized cross-over study. The concentrations of cefaclor in plasma were determined by HPLC. Results The relative bioavailability of lnAUC0-T was （97.5±10.0）%. Two formulations were bioequiva-lent. The 90% confidence interval of AUC0-T and AUC0-∞ were in the range of 80-125%; Cmax was in the range of 75-133%, so the two tablets were bioequivalent. Conclusion There were similar human pharmacokinetic characteristics and same bioavailability in human subjects between two capsules of cefaclor.

关 键 词：头孢克洛 生物利用度 高效液相色谱法 

分 类 号：R978.1[医药卫生—药品]