【摘要】 目的　研究格列吡嗪片在健康人体内的生物等效性。方法　 9名健康受试者单剂量随机交叉口服格列吡嗪片参比制剂和被试制剂 5mg,采用HPLC法测定用药后不同时间的血药浓度。结果　二制剂健康人体的体内过程均符合一房室开放模型 ,Tmax分别为 (3 0± 0 )h和 (3 0± 0 )h ,Cmax分别为 (30 5± 2 2 ) μg·L-1和 (2 99± 13) μg·L-1;T1/2 分别 (3 2 4± 0 37)h和 (3 2 2± 0 4 0 )h ;AUC分别为 (14 90± 70 ) μg·h·L-1和 (14 90± 70 ) μg·h·L-1。被试制剂的相对生物利用度为 (10 0 4± 7 8) %。结论　方差分析和单双侧t检验证明 ,两种制剂具有生物等效性更多还原

【Abstract】 Objective To evaluate the bioequivalence of glipizide tablets in healthy volunteers.Methods The plasma concentration of glipizide was determined by HPLC in 9 healthy male volunteers after an oral dose of 5 mg standard or tested formulation in alternateway.Results The concentrating-time curves of two formulations were all fit to a one-compartment open model. The main pharmacokinetic parameters of two formulations, standard and tested formulations were as the following: T max were (3.0±0)h and (3.0±0)h; C max were (305±22) μg·L -1 and (299±13)μg·L -1 , T 1/2ke were (3.24±0.37)h and (3.22±0.40)h; AUC were (1490±70)μg·h·L -1 and (1490±70)μg·h·L -1. The relative bioavailability of the tested formulation was (100.4±7.8)%.Conclusion The results of ANOVA and the two one-sided t-test statistical analyses show that two formulations are bioequivalent.更多还原