头孢氨苄胶囊制剂人体生物等效性研究

目的:研究新仿制的头孢羟氨苄胶囊制剂与市场在售的同类制剂在健康人体内的生物等效性。方法:采用随机交叉试验设计,20名健康男性志愿者分别口服受试制剂与参比制剂500 mg,HPLC法测定血浆中头孢氨苄的浓度,用DAS 2.0软件计算药动学参数并进行生物等效性评价。结果:受试制剂和参比制剂两药的主要药代动力学参数,Cmax分别为(18.12±3.17)μg/ml和(21.28±3.77)μg/ml,Tmax分别为(1.09±0.37)h和(1.04±0.33)h,t1/2分别为(1.15±0.22)h和(1.14±0.20)h,AUC0-t分别为(35.43±5.39)μg h/ml和(37.27±4.76)μg h/ml,AUC0-∞分别为(36.68±6.06)μg h/ml和(38.62±5.48)μg h/ml,受试制剂的平均相对生物利用度为(96.50±7.2)%。结论:受试制剂和参比制剂具有良好的生物等效性。

Study on Bioequiavailability of a Newly Prepared-Cefalexin Capsule

Objective: To compare a newly prepared Cefalexin capsule with a commercial one in bioavailability.Methods: In a randomized crossover study,20 healthy male volunteers were given a single oral dose of 500 mg test and reference formulations.The plasma concentration of Cefadroxil was determined by using an HPLC method.The pharmacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS 2.0 software.Results: The main pharmacokinetic parameters in the test and the reference preparation of Cefalexin were as follows: Cmax were(18.12±3.17) μg/ml and(21.28±3.77) μg/ml,Tmax were(1.09± 0.37)h and(1.04±0.33)h,t1/2 were(1.15±0.22)h and(1.14±0.20)h,AUC0-t were(35.43±5.39) μg h/ml and(37.27±4.76)μg h/ml,AUC0-∞were(36.68±6.06)μg h/ml and(38.62±5.48) μg h/ml.The relative bioavailability o f the test tablets was(96.50±7.2)%.Concluion: The newly prepared and the reference Cefalexin capsule are of equal bioavailability.