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采用HPLC荧光检测法进行两种氧氟沙星片剂的人体药代动力学及生物等效性研究。8位男性健康受试者按交叉试验方案单次口服两种氧氟沙星片,经拟合优度比较其血药浓度-时间曲线符合一级吸收的一室模型,其主要药代动力学参数t1/2β、Cmax、AUC、Vd、CL、Tpeak北京片分别为6.16±0.67h,4780±825ng/ml,44651±3867ng·h/ml,60.35±977L,677±0.63L/h,0.97±0.26h;天津片分别为5.92±1.17h,4878±914ng/ml,44235±2641ng·h/ml,57.63±9.56L,6.80±0.41L/h,1.05±0.32h。北京片的相对生物利用度为10.2±9.7/,两种片剂的主要药动学参数之间的差异无显著意义。北京片与天津片生物利用度相当,两种片剂生物等效。
Pharmacokinetics and bioequivalence study of two ofloxacin tablets by HPLC fluorescence detection method. Eight healthy male subjects were given two oral inloxacin tablets orally in a crossover trial. Their blood concentration-time curves were fitted to a one-compartment model of one-compartment absorption by goodness-of-fit. The pharmacokinetics The parameters t1 / 2β, Cmax, AUC, Vd, CL and Tpeak were 6.16 ± 0.67h, 4780 ± 825ng / ml, 44651 ± 3867ng · h / ml, 60.35 ± 977L and 677 ± 0 respectively. 63L / h, 0.97 ± 0.26h respectively; Tianjin tablets were 5.92 ± 1.17h, 4878 ± 914ng / ml, 44235 ± 2641ng · h / ml, 57.63 ± 9.56L, 6.80 ± 0.41 L / h, 1.05 ± 0.32 h. The relative bioavailability of Beijing tablets was 10.2 ± 9.7 /, with no significant difference between the major pharmacokinetic parameters of the two tablets. Beijing tablets and Tianjin tablet bioavailability quite, two tablets bioequivalence.