2种奥沙普秦肠溶片的人体相对生物利用度研究

目的:比较2种国产奥沙普秦肠溶片的相对生物利用度。方法:20名健康志愿者分别单剂量交叉口服受试制剂和对照制剂各400mg,采用高效液相色谱法测定人血浆中奥沙普秦浓度;采用3p97软件计算二者药动学参数,并计算生物利用度。结果:受试制剂和对照制剂的t1/2β分别为(73.468±24.354)、(73.556±24.406)h,tmax分别为(13.275±8.012)、(13.200±15.154)h,Cmax分别为(44.283±7.535)、(45.429±15.107)μg/ml,AUC0～Tn分别为(4471.792±1387.724)、(4234.328±1741.380)(μg.h)/ml,AUC0～inf分别为(5040.407±2092.744)、(4858.292±2423.656)(μg.h)/ml,均无统计学差异;受试制剂的相对生物利用度为(112.8±38.5)%。结论:2种国产奥沙普秦肠溶片具有生物等效性。

Relative Bioavailability of 2 Kinds of Oxaprozin Enteric Tablets

OBJECTIVE:To compare the relative bioavailability of 2 kinds of domestic oxaprozin enteric tablets.METHODS:20 healthy volunteers were administered with single oral dose of trial tablet 400g and reference tablet 400g by crossover design,whose plasma oxaprozin level was determined by HPLC.The pharmacokinetic parameters and bioavailability of oxaprozin enterosoluble tablets were calculated by 3p97 software.RESULTS:The pharmacokinetic parameters of tested enteric tablets vs.reference tablets were as follows,t 1/2β(73.468±24.354),(73.556±24.406)h,t max(13.275±8.012),(13.200±15.154)h,C max(44.283±7.535)、(45.429±15.107)μg/ml,AUC 0～Tn(4471.792±1387.724),(4234.328±1741.380)(μg·h)/ml,AUC 0～inf(5040.407±2092.744),(4858.292±2423.656)(μg·h)/ml;No significant differences were noted between 2 tablets.The relative bioavailability of tested tablet was(112.8±38.5)%.CONCLUSION:2 kinds of oxaprozin enterosoluble tablets were bioequivalent.