头孢泊肟酯片的人体相对生物利用度研究

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。

Pharmacokinetics and relative bioavailability of domestic vs imported cefpodoxime proxetil tablets in human body

AIM: To compare pharmacokinetics and the relative bioavailability of domestic and imported cefpodoxime proxetil tablets in normal human body. METHODS: A single oral domestic cefpodoxime proxetil tablet or imported tablet 200 mg was given to 24 healthy male volunteers in randomized self-crossover study. Plasma concentration of cefpodoxime was measured by reverse phase high performance liquid chromatography. The pharmacokinetic parameters as well as relative bioavailability were measured by 3P97. RESULTS: The concentration-time curves of domestic cefpodoxime proxetil tablet conformed to one compartment open model. The T maxwere ( 2.5± s0.6) h and ( 2.3 ±0.5) h,C max( 3.5 ±0.6) mg·L -1and( 3.6 ±0.5) mg·L -1,AUC 0-t(18±3) mg·L -1and (18.0 ±2.8) mg·L -1,AUC 0-∞(19±3) mg·L -1and (19±3) mg·L -1,T 12Ke( 2.0 ±0.3) hand ( 2.2± 0.4) h, respectively. The relative bioavailability of domestic cefpodoxime proxetil tablet was (102±15)% compared with imported cefpodoxime proxetil tablet. CONCLUSION: The results of the statistical analysis shows that the two kinds of tablets are bioequivalent.