摘要
目的 研究格列齐特片的健康人体药物动力学及相对生物利用度。方法 8例健康受试者单剂量交叉口服格列齐特片标准参比制剂和被试制剂 80mg后 ,用高效液色谱法测定血浆中格列齐特片浓度。结果 两药体内过程均符合一房室开放模型 ,Tmax分别为 (5 5 0± 0 5 3)h和 (5 0 0± 0 5 3)h ,Cmax为 (2 95± 0 4 1)mg·L-1和 (3 0 2± 0 31)mg·L-1,AUC为 (45 79± 5 99)mg·h·L-1和 (42 99± 6 93)mg·h·L-1,被试制剂的相对生物利用度为 (10 2 9± 8 2 ) %。两种制剂的药动学参数无显著性差异。结论 两种制剂具有生物等效性。
Objective To study the relative bioavailability of gliclazide in healthy volunteers.Methods The plasma concentrations of gliclazide were determined by HPLC in 8 healthy male volunteers after an oral dose of 80 mg standard or tested formulations in crossways.Results The concentration time curves of the two formulations were all fitted to the one compartment open model.The T max values were(5.0±0.53)h and (5.50±0.53)h,the C max values were (3.02±0.31)mg·L -1 and (2.95±0.41)mg·L -1 ,the AUC were (42.99±6.93)mg·h·L -1 and (45.79±5.99)mg·h·L -1 ,respectively.The relative bioavailability of the tested formulation was (102.9±8.2)%.Conclusion The two formulations were bioequivalent.
出处
《河南职工医学院学报》
2002年第1期8-10,共3页
Journal of Henan Medical College For Staff and Workers
