吗替麦考酚酯分散片在中国健康男性志愿者体内的药动学和生物等效性研究(1)
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[摘要] 目的：研究吗替麦考酚酯分散片在中国健康男性志愿者体内的药动学和生物等效性。方法：采用双周期交叉试验设计，20名健康男性受试者随机交叉单剂量口服吗替麦考酚酯分散片(试验制剂)和吗替麦考酚酯胶囊(参比制剂)1 g，以高效液相色谱法测定给药后不同时间麦考酚酸的血药浓度，用DAS Ver 2.0软件计算药动学参数，评价两种制剂的生物等效性。结果：吗替麦考酚酯试验制剂和参比制剂的主要药动学参数Cmax分别为(19.88±3.55) μg/ml和(20.16±3.47) μg/ml；tmax分别为(0.74±0.19) h和(0.80±0.17) h；t1/2分别为(8.86±2.73) h和(8.77±3.00) h；AUC0-t分别为(48.63±16.53) μg/(h·ml)和(49.96±18.01) μg/(h·ml)，AUC0-∞分别为(54.34±16.63) μg/(h·ml)和(55.38±18.68) μg/(h·ml)；试验制剂的AUC0-t、AUC0-∞、Cmax的90%置信区间分别为参比制剂相应参数的91.03%～104.53%、92.91%～105.26%和94.92%～102.17%。以AUC0-t计算试验制剂中吗替麦考酚酯对参比制剂的相对生物利用度F为(99.25±17.02)%。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。
[关键词] 吗替麦考酚酯分散片；麦考酚酸；高效液相色谱法；药动学；生物等效性
[中图分类号] R969.1[文献标识码]A [文章编号]1673-7210(2009)05(a)-024-04
Pharmacokinetics and bioequivalence of Mycophenolate Mofetil Dispersible Tablets in Chinese healthy male volunteers
HUANG Haiwei1, LI Jianhe2, PENG Liubao2, CAO Junhua2, LUO Xia2, WAN Xiaomin2
(1.Department of Pharmacy, the Third Hospital of Changsha City, Hunan Province, Changsha 410015, China; 2.Department of Pharmacy, the Second Xiangya Hospital of Central South University, Changsha 410011, China)
[Abstract] Objective: To study the pharmacokinetics and bioequivalence of Mycophenolate Mofetil Dispersible Tablets in Chinese healthy male volunteers. Methods: 20 healthy male volunteers were orally administered with single dose of 1 g Mycophenolate Mofetil Dispersible Tablets (test preparation) and Mycophenolate Mofetil Capsules (reference preparation) by randomized crossover way, then the plasma concentrations of mycophenolic acid were determined by HPLC methods. The pharmacokinetic parameters and the relative bioequivalence of the two preparations of Mycophenolate Mofetil was calculated by DAS Ver 2.0 software. Results: The main pharmacokinetic parameters of test and reference preparations were as follows: Cmax were (19.88±3.55) μg/ml and (20.16±3.47) μg/ml respectively; tmax were (0.74±0.19) h and (0.80±0.17) h respectively; t1/2 were (8 ......
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