单剂量口服奥美拉唑胶囊的人体药代动力学和相对生物利用度  

Pharmacokinetics and Relative Bioavailability of Omeprazole Capsule in HealthyVolunteers after a Single Oral Administration

作　　者：孙华[1] 裘福荣[1] 陈波[1] 戴敏[1] 杨菁菁[1] 钟秋[1] 冒国光[1] 

机构地区：[1]皖南医学院弋矶山医院国家药品临床研究基地,芜湖241001

出　　处：《中国临床药理学杂志》2002年第2期112-115,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的:研究奥美拉唑胶囊在18名健康志愿者体内的药动学特征及相对生物利用度。方法:18名健康男性志愿者采用随机交叉给药方案,分别单剂量口服60mg的奥美拉唑试验胶囊和参比胶囊,采用固相提取反相高效液相色谱法测定血药浓度,计算两者的药代动力学参数及相对生物利用度。结果:口服奥美拉唑60mg实验药及参比药的主要药代动学参数t(1/2)ke分别为1.36±0.42和1.26±0.45h;tmax分别为3.00±0.67和2.83±0.57h,Cmax分别为1457.9±643.0和1566.2±674.7μg·L-1,AUCO-10分别为4740.2±2661.1和4963.9±2826.6μg·L-1,试验品的相对生物利用度为96.73%±9.92%。结论:利用NDST处理数据对待测胶囊剂及参比奥美拉唑胶囊剂的生物等效性进行评价。结果表明两种制剂具有生物等效性。OBJECTIVE: To study the pharmacokinetics and relative bioavailabilityof omeprazole capsule in l8 healthy volunteers. METHODS: A single oral dose60mg omeprazole of reference or test drugs was given to each volunteer accordingto an open randomized crossover study. The concentrations in plasma weredetermined by RP-HPLC method. RESULT:The main pharmacokinetic parameters ofomeprazole were as follows:t(1/2)ke were (l.36±0.42)h and (l.26±0.45)h,tmax were(3.00±0.67)h and (2.83±0.57)h,Cmax were (l457.9±643.0)μg.L-1 and (l566.2±674.7)μg.L-1,AUC0-10 were(4740.2±266l.l)μg.h.L-1and (4963.9±2826.6)μg.h.L-1fortest and reference capsule respectively. The relative Bioavailability of AUC0-10 was96.73%±9.92%. CONCLUSION: The results of statistical analysis showed thattwo formulations were bioequivalent.

关 键 词：奥美拉唑 药代动力学 高效液相色谱法 生物利用度 

分 类 号：R975.6[医药卫生—药品]