安吡昔康胶囊在健康志愿者体内的生物等效性

目的：测定人血浆中安吡昔康代谢物吡罗昔康的浓度,评价安吡昔康胶囊在健康志愿者体内的生物等效性。方法：20例健康志愿者,随机分成两组,分别单次口服27mg受试制剂安吡昔康胶囊和参比制剂安吡昔康片。采用HPLC-UV法测定给药后不同时间点血浆中的安吡昔康代谢物吡罗昔康血浓度,用DAS2.1软件计算其药代动力学参数,并作方差分析和双单侧t检验。结果：口服受试制剂和参比制剂后的T1/2为（49.19±11.50）和（47.85±9.86）h,Cmax为（1.885±0.361）和（1.90±0.40）mg.L-1,Tmax为（7.21±3.34）和（6.95±3.33）h,AUC0-216为（155.02±36.60）和（150.23±31.371）mg/L.h,AUC（0-∞）为（164.52±41.20）和（159.00±33.77）mg/L.h。结论：受试制剂安吡昔康胶囊的相对生物利用度为（103.9±17.0）%,两种制剂具有生物等效性。

Bioequivalence of ampiroxicam capsules in healthy volunteers

Objective: To determine the concentration of piroxicam,the metabolin of ampiroxicam,for assessment of bioequivalence of ampiroxicam capsules in Chinese healthy volunteers.Methods:20 healthy volunteers were divided into 2 groups and administrated a single dose of test ampiroxicam capsules or reference ampiroxicam tablets(27mg),respectively.The concentration of piroxicam in human plasma was determined by HPLC-UV collected on various times after administration.The pharmacokinetic parameters were calculated by DAS 2.1 software as well as variation analyses and two one-side t-test.Results:The main pharmacokinetic parameters of test and reference formulation were as follows:t1/2 were(49.19±11.50)and(47.85±9.86)h,Cmax were1(1.885±0.361)and(1.90±0.40)mg/L,Tmax were(7.21±3.34)and(6.95±3.33)h,AUC0-216 were(155.02±36.60) and(150.23±31.371)mg/L·h,AUC0-∞ were(164.52±41.20)and(159.00±33.77)mg/L·h.Conclusion:The relative bioavailability of ampiroxicam capsules was(103.9±17.0)%.The ampiroxicam capsules and tablets are bioequivalent.