【摘要】 目的 :研究格列吡嗪片在健康人体的药物动力学及相对生物利用度。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 :2种制剂的体内过程均符合一房室开放模型 ,Tmax分别为 (3 .67± 0 .50 )h和 (3 .33± 0 .50 )h。Cmax分别为 (391± 37) μg·L- 1和 (40 0± 35) μg·L- 1 ,AUC分别为 (2 .46± 0 .39) μg·h·L- 1 和 (2 .2 3± 0 .88) μg·h·L- 1 ,被试制剂的相对生物利用度为 (1 0 2 .9± 1 5 .7) %。结论 :用NDST软件对两种制剂的AUC、Cmax、Tmax进行双单侧t检验 ,证明两种制剂具有生物等效性。更多还原

【Abstract】 Aim: To study the pharmacokinetics and relative bioavailability of glipizide in healthy volunteers. Methods: The plasma concentrations of glipizide were determined by HPLC in 9 healthy male volunteers after an oral dose of 5 mg standard or tested formulation in crossways. Results: The concentration time curves of the 2 formulations were all fit to the one compartment open model.The T max values were (3.67±0.50)h and (3.33±0.50)h, the C max values were (391±37) μg·L -1 and (400±35) μg·L -1 , the AUC were (2.46±0.39)μg·h·L -1 and (2.23± 0.88) μg·h·L -1 for standard and tested formulations, respectively.The relative bioavailability of the tested formulation was (102.9±15.7)%. Conclusion: The 2 formulations were bioequivalent.更多还原