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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po200mg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AUC0~∞,tmax,cmax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AUC0~∞分别是:(23.73±2.11)μg·h·ml-1与(23.91±3.18)μg·h·ml-1;tmax分别是(3.13±0.54)h与(2.84±0.56)h,cmax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:AUC0~∞,tmax,cmax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)%。
Objective: To study the pharmacokinetics and relative bioavailability of sparfloxacin tablets in healthy volunteers. Methods: The change of plasma concentration of sparfloxacin, which was imported and produced by po200mg in 10 healthy volunteers, was determined by RP-HPLC. The pharmacokinetic parameters and relative bioavailability AUC0 ~ ∞, tmax, cmax as indicators, paired t test analysis of domestic and imported tablets bioequivalence. Results: The drug-time curve of domestic and imported sparfloxacin tablets can be fitted by two-compartment model with AUC0 ~ ∞ of (23.73 ± 2.11) μg · h · ml-1 and (23.91 ± 3.18) μg · h · ml-1; tmax was (3.13 ± 0.54) h and (2.84 ± 0.56) h, respectively, and the values of cmax were (0.70 ± 0.05 ) Μg · ml-1 and (0.73 ± 0.05) μg · ml-1. Paired t test results showed that: AUC0 ~ ∞, tmax, cmax no significant difference (P> 0.05). Conclusion: The domestic and imported sparfloxacin tablets are bioequivalent. The relative bioavailability of domestic sparfloxacin tablets to imported tablets is (97.81 ± 13.62)%.