司帕沙星人体药代动力学与相对生物利用度研究

 目的:研究司帕沙星片在健康人体内的药代动力学与相对生物利用度?方法:采用反相高效液相色谱法测定10名健康志愿者po 200mg国产和进口的司帕沙星片后血药浓度变化情况,计算两者的药代动力学参数及相对生物利用度,并以AUC_0～∞,t_max,c_max为指标,用配对t检验法分析国产片与进口片的生物等效性?结果:国产与进口司帕沙星片的药-时曲线可用二室模型拟合,其AUC_0～∞分别是:(23.73±2.11)μg·h·ml^-1与(23.91±3.18)μg·h·ml^-1;t_max分别是(3.13±0.54)h与(2.84±0.56)h,c_max分别是:(0.70±0.05)μg·ml^-1与(0.73±0.05)μg·ml^-1?配对t检验结果表明:AUC_0～∞,t_max,c_max均无显著性差异(P>0.05)?结论:国产与进口司帕沙星片为生物等效制剂;国产司帕沙星片对进口片的相对生物利用度为(97.81±13.62)%?

Pharmacokinetics and relative bioavailability of sparfloxacin tablet in human

OBJECTIVE: To study the pharmacokinetics and the relative bioavailability of sparfloxacin tablet. METHODS: 200mg single oral dose of domestic and imported sparfloxacin tablets were given to 10 healthy volunteers in an open randomized crossover study. Sparfloxacin concentrations in plasma were determined by RP-HPLC. The pharmacokinetic parameters as well as relative bioavailability were measured. RESULTS: The concentration-time curves of domestic and imported sparfloxacin tablets were conformed to a two compartment open model. The AUC0 was(23.732.11) ghml-1 and (23.913.18)ghml-1,tmax(3.130.54)h and (2.840.56)h ,cmax (0.700.05)gml-1 and (0.730.05) gml-1respectively. There was no significant difference between the two formulations in the AUC0,tmax,cmax. CONCLUSION: The result of the statistical analysis showed that the two formations were bioequivalent. The relative bioavailability of domestic sparfloxacin tablet was (97.8113.62)% compared with the imported tablet.