奥美拉唑肠溶胶囊人体生物等效性研究

目的:比较2种奥美拉唑肠溶胶囊的人体生物等效性。方法:18名健康受试者随机自身交叉单剂量口服奥美拉唑肠溶胶囊受试制剂与参比制剂,用高效液相色谱法测定血药浓度,3p97计算机软件计算药动学参数和生物利用度。结果:2种奥美拉唑肠溶胶囊体内药-时曲线符合一室模型,受试制剂与参比制剂的药动学参数分别为:Cma(x1.69±1.00)、(1.71±1.02)μg.mL-1,tmax(3.22±1.11)、(3.06±1.00)h,AUC0～2(48.42±4.38)、(8.87±5.32)μg.h.mL-1,AUC0～∞(10.35±5.01)、(10.81±5.86)μg.h.mL-1。受试制剂相对于参比制剂的生物利用度为(94.93±14.54)%。结论:2种奥美拉唑肠溶胶囊具有生物等效性。

Bioequivalence of Omeprazole Enteric-coated Capsules in Healthy Volunteers

OBJECTIVE：To compare the bioequivalence of 2 kinds of Omeprazole enteric-coated capsules. METHODS： A single dose of Omeprazole enteric-coated capsules was given to 18 healthy volunteers by randomized crossover method, and the plasma concentrations of omeprazole were determined by HPLC. The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioequivalence was evaluated. RESULTS： The plasma concentration-time curve of two preparations fitted to one-compartment model. The pharmacokinetic parameters of test preparation vs. reference preparation were as follows： Cmax（1.69±1.00） μg·mL-1 vs. （1.71±1.02） μg·mL-1; tmax（3.22±1.11）h vs. （3.06±1.00）h; AUC0～24（8.42±4.38） μg·h·mL-1 vs. （8.87±5.32） μg·h·mL-1; AUC0～∞（10.35±5.01） μg·h·mL-1 vs. （10.81±5.86） μg·h·mL-1. The relative bioavailability of Omeprazole enteric-coated capsules was（94.93±14.54）%.CONCLUSION：2 kinds of Omeprazole enteric-coated capsules are bioequivalent.