2种阿奇霉素片的人体生物等效性研究  

Bioequivalence of 2 Kinds of Azihromycin Tablets in Healthy Volunteers

作　　者：张亚玲 何海霞[2] 

机构地区：[1]重庆市长寿区人民医院,重庆401220 [2]重庆医科大学附属第一医院药学部,重庆400016

出　　处：《中国药房》2012年第46期4358-4360,共3页China Pharmacy

摘　　要：目的:比较2种阿奇霉素片的人体生物等效性。方法:18名健康男性志愿受试者采用双周期双制剂交叉试验设计,单剂量口服2种阿奇霉素片,用微生物杯碟法测定血药浓度,以3p97计算药动学参数,并进行生物等效性评价。结果:2种阿奇霉素片主要药动学参数分别为:cma(x1.21±0.56)、(1.25±0.62)μg·mL-1,tma(x1.94±0.64)、(2.44±1.15)h,AUC0～144(h11.33±7.49)、(11.61±7.15)μg·h·mL-1,受试制剂的相对生物利用度为(97.59±12.72)%。结论:经方差分析和双单侧t检验,2种阿奇霉素片具有生物等效性。OBJECTIVE： To compare the bioequivalence of 2 kinds of Azihromycin tablets in healthy volunteers. METHODS： 2 kinds of Azihromycin tablets were administered by randomized crossover way in 18 male volunteers for 2 periods, and the blood concentrations of azihromycin were determined by microbiological assay. The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioequivalence was evaluated. RESULTS： Main pharmacokinetic parameters were as follows： cmax（1.21±0.56）μg·mL-1 and （1.25±0.62）μg·mL-1; tmax（1.94±0.64）h and （2.44±1.15）h; AUC0～144 h（11.33±7.49）μg·h·mL-1 and （11.61±7.15）μg·h·mL-1. The relative bioavailability of test tablets was （97.59±12.72）%. CONCLUSION： Results of variance analysis and t-tests suggest that 2 kinds of Azihromycin tablets are bioequivalent.

关 键 词：阿奇霉素片 药动学 生物等效性 

分 类 号：R969.1[医药卫生—药理学] R978.15[医药卫生—药学]