泮托拉唑肠溶片药动学及相对生物利用度

 目的：比较国产和进口泮托拉唑肠溶片的相对生物利用度。方法：8名健康男性受试者交叉 po 单剂量国产和进口泮托拉唑肠溶片40 mg，采用HPLC测定血浆中泮托拉唑浓度。结果：国产及进口制剂的体内药动学主要参数分别为：c_max为(2932.3±665.8)和(3251.9±731.4)μg·L^-1；t_max为(2.9±0.7)和(2.9±0.6) h；AUC_o～∞为(9920.7±5250.9)和(10890.1±6015.6) μg·h·L^-1；t_1/2为(1.8±0.4)和(2.1±0.4) h；MRT为(4.8±1.0)和(4.7±0.7) h。国产制剂的平均相对生物利用度为(92.8±10.1)%。结论：经统计学分析，两种制剂为生物等效制剂。

Pharmacokinetics and relative bioavailability of pantoprazole

OBJECTIVE:To compare the relative bioavailability of domestic and imported pantoprazole tablet. METHODS:In randomized crossover design,single dose of pantoprazole domestic tablet or imported tablet 40 mg was given to 8 healthy male volunteers.Plasma concentration was determined with HPLC method. RESULTS:The pharmacokinetic parameters of domestic and imported products were c_max:(2932.3±665.8),(3251.9±731.4) μg·L^-1；t_max(2.9±0.7),(2.9±0.6) h；AUC_0～∞(9920.7±5250.9),(10890.1±6015.6) μg·h·L^-1；t_1/2:(1.8±0.4),(2.1±0.4) h；MRT:(4.8±1.0),(4.7±0.7) h,respectively. CONCLUSION:The results demonstrated that there were no statistically significant difference between the two products in AUC obtained from the studies.