【摘要】 目的研究2种奥美拉唑肠溶胶囊的生物等效性。方法20名健康男性志愿者随机分成2组,交叉口服受试制剂和参比制剂各40mg,采用高效液相色谱法测定人血清中奥美拉唑浓度,由DAS软件计算药动学参数及相对生物利用度。结果受试制剂与参比制剂的t1/2分别为(1.685±0.866)、(1.653±0.862)h,tmax分别为(2.425±0.693)、(2.200±0.865)h,Cmax分别为(0.894±0.481)、(0.865±0.342)μg·mL-1,AUC0～10分别为(2.041±1.446)、(2.022±1.322)μg·h·mL-1,AUC0～∞分别为(2.163±1.594)、(2.125±1.507)μg·h·mL-1,受试制剂的相对生物利用度为(100.3±17.4)%。结论2种奥美拉唑肠溶胶囊具有生物等效性。更多还原

【Abstract】 OBJECTIVE:To evaluate the bioequivalence of 2 kinds of omeprazole enteric-coated capsules in healthy volunteers.METHODS:A total of 20 healthy male volunteers were divided randomly into two groups,administered with two preparations of omeprazole respectively in an open randomized cross-over test.A single oral dose of the test and reference preparation was 40mg for each alternative.The omeprazole concentrations in the serum were determined by HPLC and the pharmacokinetic parameters and relative bioavailability were obtained by using DAS software.RESULTS:The pharmacokinetic parameters of the test and reference preparation were as follows:t1/2 were(1.685±0.866)h and(1.653±0.862)h;tmax were(2.425±0.693)h and(2.200±0.865)h;Cmax were(0.894±0.481)μg·mL-1 and (0.865±0.342)μg·mL-1;AUC0～10 were(2.041±1.446)μg·h·mL-1 and (2.022±1.322)μg·h·mL-1;AUC0～∞ were(2.163±1.594)μg·h·mL-1 and (2.125±1.507)μg·h·mL-1,respectively.The relative bioavailability of the test preparation was(100.3±17.4)%.CONCLUSION:The two formulations of omeprazole enteric-coated capsules are bioequivalent.更多还原