【摘要】 目的:研究托拉塞米试验制剂(胶囊)和参比制剂(片剂)的人体药动学和生物等效性。方法:20名健康受试者随机交叉口服托拉塞米胶囊(试验制剂)和托拉塞米片(参比制剂),剂量均为10mg。血样加入内标(呋塞米)经预处理后采用HPLC法测定。结果:试验胶囊、参比片剂的主要药动学参数Cmax分别为(1160.1±188.0),(1271.2±326.8)μg.L-1;Tmax分别为(1.1±0.4),(1.0±0.4)h;t1/2分别为(4.1±1.0),(4.0±1.0)h;AUC0→t分别为(3662.3±782.2),(3783.2±1390.1)μg.h.L-1。以AUC0→t计算的试验胶囊的相对生物利用度为(100.6±23.9)%。结论:经方差分析及双单侧t检验结果显示,试验制剂和参比制剂具有生物等效性。更多还原

【Abstract】 OBJECTIVE To study the pharmacokinetics and bioequivalence of torasemide test capsules and reference tablets in healthy volunteers.METHODSA single oral dose of 10mg the test or the reference preparation was given to 20 healthy volunteers in a randomized two-period crossover study.HPLC-UV was performed to detect torasemide with furosemide as the internal standard(IS).RESULTSThe main pharmacokinetic parameters of test capsules and reference tablets were as follows:Cmax were(1 160.1±188.0)and(1 271.2±326.8)μg· L-1;Tmax were(1.1±0.4)and(1.0±0.4)h;t1/2 were(4.1±1.0)and(4.0±1.0)h;AUC0→t were(3 662.3±782.2)and(3 783.2±1 390.1)μg·h·L-1,respectively.The relative bioavalability of the test capsules was(100.6±23.9)%.CONCLUSIONThe results show that the test capsules of torasemide and the reference tabtets are bioequivalent.更多还原