吡咯地尔片的人体相对生物利用度研究  

RELATIVE BIOAVAILABILITY OF BEPRIDIL TABLET IN HEALTHY VOLUNTEERS

作　　者：李连利[1] 张静华[1] 钟明康[1] 张莉莉[1] 王大猷[1] 

机构地区：[1]上海医科大学华山医院临床药学研究室,上海200040

出　　处：《中国临床药学杂志》1996年第4期161-163,共3页Chinese Journal of Clinical Pharmacy

摘　　要：8名健康男性志愿者,按交叉设计单剂量po 200mg国产吡咯地尔片剂和进口Vascor片剂.高效液相色谱法测定血浆药物浓度,进行相对生物利用度研究.结果表明:国产和进口片剂的T_(max)分别为2.50±0.55h和2.54±0.48h,C_(max)分别为480.97±96.98ng/ml和494.38±64.10ng/ml,AUC分别为3.58±0.83μg·h·ml^(-1)和3.41±0.82μg·h·ml^(-1).药-时曲线符合一级吸收二室模型.经统计学检验.两种药品的各项药物动力学参数均无显著性差异(P>0.05);吡咯地尔片和Vascor片具有生物等效性,吡咯地尔片的平均相对生物利用度为105.3%.8 healthy male volunteers were administered a single oral dose of 200mg domestic bepridil tablet or imported Vascor tablet in two-period crossover design. HPLC was used to determine the level in plasma. It was shown that two-compartment model and first-order absorption were suitable for plasma concentration-time curve. Tmax of domestic and imported tablets was 2. 50±0. 55h and 2. 54±0. 48h,Cmax was 480. 97±96. 98ng/ml and 494. 38 ±64.10ng/ml,AUC was 3. 58±0. 83μg ·h ·ml^(-1) and 3. 41±0. 82μg ·h ·ml^(-1)respectivly. There was no significant difference (P>0. 05) in each of the parameters between two preparations. Bepridil tablet was bioequivalent with Vascor tablet,and it's relative bioavilability was 105.3%.

关 键 词：吡咯地尔片 Vascor 相对生物利用度 高效液相色谱法 

分 类 号：R96[医药卫生—药理学]