单剂量口服曲昔匹特胶囊的相对生物利用度及生物等效性  

Relative bioavailability and bioequivalance of troxipide capsule in healthy volunteers after a single oral administration

作　　者：赵亚男[1] 裘福荣[1] 王伟佳[1] 孙华[1] 戴敏[1] 杨青青[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,安徽芜湖241001

出　　处：《中国临床药理学杂志》2003年第6期434-436,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 研究曲昔匹特胶囊的药代动力学特征及生物等效性。方法 18名健康男性志愿者随机双交叉给药,分别单剂量口服100mg的曲昔匹特胶囊试验药和片剂对照药,用血浆碱化、液相萃取提取和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 口服曲昔匹特胶囊100mg试验药及片剂对照药的主要药代动力学参数t_(1/2ke)分别为6.52±1.62和7.03±2.27h;t_(max)分别为2.89±0.93和2.97±1.25h,C_(max)分别为0.98±0.27和1.06±0.31mg·L^(-1),AUC_(0-24)分别为15.18±4.11和15.96±3.97mg·h·L^(-1),AUC_(0-∞)分别为15.83±4.12和16.82±4.47 mg·h·L^(-1)相对生物利用度为(95.72±14.92)％。结论 试验药曲昔匹特胶囊和对照药曲昔匹特片剂具有生物等效性。Objective To study the pharmacokinetics and relative bioavailability of troxipide capsule. Methods A single oral dose of 100 mg troxipide capsule (test group) and tablet (control group) were given to 18 healthy volunteers in an open randomized crossover design. The concentrations in plasma were determined by reverse phase HPLC method. Results The main pharmacokinetic parameters were as follow: t1/2ke were 6.52 ± 1.62 and 7.03 ± 2.27 h, tmax were 2.89 ± 0.93 and 2.97 ± 1.25 h, Cmax were 0.98 ± 0.27 and 1.06 ±0.31 mg.L-1, AUC0-24 were 15.18 ± 4.11 and 15.96± 3.97 mg.h.L-1, AUC0- were 15.83 ± 4.12 and 16.82 ± 4.47 mg .h .L-1 for test and control, respectively. Conclusion The results of statistics analysis demonstrated that two formulations were bioequivalent.

关 键 词：单剂量 口服 曲昔匹特胶囊 相对生物利用度 生物等效性 测定 血药浓度 

分 类 号：R975.6[医药卫生—药品] R969.1[医药卫生—药学]