阿维A胶囊人体生物等效性研究  

Bioavailability of acitretin capsules in healthy subjects

作　　者：蒙华[1] 王宁[1] 周远大[2] 毛郴[1] 何海霞[2] 

机构地区：[1]重庆医科大学临床学院药剂科 [2]重庆医科大学临床药理研究室,重庆400016

出　　处：《重庆医科大学学报》2004年第2期188-190,共3页Journal of Chongqing Medical University

摘　　要：目的 :对重庆华邦制药有限公司研制的阿维A胶囊 (国产阿维A胶囊 )与瑞士罗氏制药厂生产的阿维A胶囊 (进口阿维A胶囊 )进行人体相对生物利用度评价。方法 :2 0名男性健康志愿者随机交叉单剂量口服国产或进口的阿维A胶囊 ,高效液相色谱法测定血浆中阿维A浓度 ,经 3p97生物利用度和生物等效性计算程序处理拟合。结果 :国产或进口的阿维A胶囊体内药时曲线符合一室模型 ,国产或进口的阿维A胶囊 :Cmax分别为 4 90 .5 1± 136 .5 0 ,4 70 .91± 118.5 9ng/ml;Tmax分别为4 .13± 1.16和 3.75± 1.18h ;AUC(0～ 2 4) ,分别为 2 891.97± 80 9.6 0 ,2 883.0 1± 90 5 .6 0ng·h·ml-1,相对生物利用度为 10 0 .2 3±11.0 3%。结论 :经方差分析和单双侧t检验 ,表明国产或进口的两种胶囊具有生物等效性。Objective:To study the relative bioavailability and pharmacokinetics of domestic acitretin capsules in 22 healthy male volunteers.Methods:A single dose of 50mg of domestic or imported acitretin was administered by randomized crossover way in 22 volunteers and the plasma concentrations of acitrctin were determined by HPLC.The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioequivalency was evaluated.Results:The concentration-time curves of two preparations fitted one-compartment model.The peak plasma levels(C max )of domestic and imported acitretin were 490.51±136.50 and 470.91±118.59ng/ml respectively.The peak time(T max ) were 4.13±1.16 and 3.75±1.18h respectively.And AUC (0～24) were 2891.97±809.60 and 2883.01±905.60ng·h·ml -1 respectively.The relative bioavailability of domestic acitretin capsule was 100.23±11.03%.Conclusion:The result of two one-sided tests suggests that the domestic capsule is bioequivalent to the imported capsule.

关 键 词：阿维A 生物利用度 生物等效性 HPLC 

分 类 号：R969.1[医药卫生—药理学]