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目的 :比较国产与进口头孢泊肟酯片在正常人体内的药动学与相对生物利用度。方法 :2 4名男性健康志愿者随机交叉单次口服国产或进口头孢泊肟酯片 2 0 0mg后 ,采用反相高效液相色谱法测定血药浓度 ,用 3P97软件包计算两者的药动学参数与相对生物利用度。结果 :国产片和进口片口服吸收的药 时曲线符合一室模型。Tmax分别为 (2 .5±s0 .6 )h和 (2 .3± 0 .5 )h ,Cmax为 (3.5± 0 .6 )mg·L- 1和 (3.6± 0 .5 )mg·L- 1,AUC0 t分别为 (18± 3)mg·L- 1和 (18.0± 2 .8)mg·L- 1,AUC0 ∞ 分别为(19± 3)mg·L- 1和 (19± 3)mg·L- 1,T12 Ke分别为(2 .0± 0 .3)h和 (2 .2± 0 .4 )h。国产片相对于进口片的相对生物利用度为 (10 2± 15 ) %。经方差分析及双单侧t检验 ,各药动学参数无显著差异 (P >0 .0 5 )。结论 :国产片与进口片生物等效。
Objective: To compare the pharmacokinetics and relative bioavailability of domestic and imported cefpodoxime proxetil tablets in normal human. Methods: Twenty-four male healthy volunteers were randomized to receive oral administration of 200 mg domestic or imported cefpodoxime proxetil, and the plasma concentration was determined by RP-HPLC. The pharmacokinetics of the two drugs were calculated by 3P97 software package Learning parameters and relative bioavailability. Results: The oral absorption curve of domestic tablets and imported tablets fit the one-compartment model. Tmax were (2.5 ± s0.6) h and (2.3 ± 0.5) h respectively, and Cmax was (3.5 ± 0.6) mg · L-1 and (3.6 ± 0.5) mg · L - 1, AUC0 t was (18 ± 3) mg · L-1 and (18.0 ± 2 .8) mg · L-1, respectively; AUC0 ∞ was (19 ± 3) mg · L- ) mg · L -1 and T12 Ke were (2.0 ± 0.3) h and (2.2 ± 0.4) h, respectively. The relative bioavailability of domestic tablets relative to imported tablets was (10 2 ± 15)%. By means of ANOVA and double unilateral t-test, there was no significant difference in each pharmacokinetic parameters (P> 0.05). Conclusion: Domestic and imported tablets bioequivalence.