【摘要】 目的:评价布洛芬软胶囊与布洛芬胶囊的人体生物等效性。方法:20名健康志愿者随机交叉口服单剂量(400 mg)布洛芬软胶囊与参比制剂布洛芬胶囊,采用高效液相色谱法测定血浆中布洛芬的血药浓度。结果:受试制剂与参比制剂的Tmax分别为(2．78±0．57)和(2．83±0．47)h,Cmax分别为(34．94±6．58)和(32．77±5．50)μg·mL-1,t1/2分别为(2．49±0．65)和(2．39±0．58)h,AUC0～1分别为(148．49±26．44)和(147．57±36．18)μg·h·mL-1,AUC0-∞分别为(157．28±27．96)和(157．43±42．47)μg·h·mL-1,以AUC0-∞计算,布洛芬软胶囊的相对生物利用度平均为(103．5±18．1)％。结论:布洛芬软胶囊与参比制剂布洛芬胶囊生物等效。更多还原

【Abstract】 Objective:To evaluate the relative bioavailability of ibuprofen soft capsules (test) versus hard capsules (reference). Methods:The blood ibuprofen concentrations from 20 healthy male volunteers,who received a single crossover dose of test and reference ibuprofen 400 mg,were measured by HPLC.Results:The pharmacokinetic profiles of test and reference ibuprofen were Cmax(34.94±6.58)vs. (32.77±5.50)μg·mL-1,Tmax(2.78±0.57) vs. (2.83±0.47)h, AUC0～1(148. 49±26.44)vs. (147.57±36.18)μg·h·mL-1,AUC0～∞(157.28±27.96)vs. (157.43±42.47)μg·h·mL-1 and t1/2(2. 49±0.65) vs. (2.39±0.58)h, respectively. The relative bioavailability of the test ibuprofen was(103.5±18.1)%.Conclusion:The test ibuprofen was bioequivalent to the reference ibuprofen.更多还原