论文部分内容阅读
目的 :研究左旋氧氟沙星胶囊的生物利用度及其药物动力学。方法 :HPLC法测定 10名健康受试者口服单剂量乳酸左旋氧氟沙星的药 时数值 ,以PKBP N1程序拟合其药动学参数 ,采用梯形面积法计算其相对生物利用度 ,用方差分析和双单侧t检验法检验其等效性。结果 :乳酸左旋氧氟沙星的片剂和胶囊的药动学参数分别为 :Tmax为 (1.0 8± 0 .31)h和 (0 .78± 0 .14)h ,Cmax为 (2 .0 7± 0 .30 ) μg·ml-1和 (2 .16± 0 .18) μg·ml-1,T1/ 2 为 (7.8± 0 .7)h和 (7.6± 0 .4)h ,AUC0 ∞ 为 (13.4± 2 .1) μg·h·ml-1和 (13.5± 2 .9) μg·h·ml-1。用方差分析和双单侧t检验法检验其Tmax,Cmax,T1/ 2 和AUC ,除Tmax(P <0 .0 5 )外 ,其它药动学参数差异均无显著性。结论 :两种制剂相对生物利用度为 (10 0 .8± 13.1) % ,经方差分析和双单侧t检验法检验 ,结果为等效制剂
Objective: To study the bioavailability and pharmacokinetics of levofloxacin capsules. Methods: The pharmacokinetic parameters of single oral dose of levofloxacin lactate in 10 healthy volunteers were determined by HPLC. The pharmacokinetic parameters were determined by PKBP N1 program. The relative bioavailability was calculated by the trapezoidal area method. The variance Analysis and double unilateral t test to test its equivalence. Results: The pharmacokinetic parameters of levofloxacin tablets and capsules were as follows: Tmax was (1.08 ± 0.31) h and (0.78 ± 0.14) h, Cmax was (2.0 7 ± 0.30) μg · ml-1 and (2.16 ± 0.18) μg · ml-1, respectively, with T1 / 2 of 7.8 ± 0.7 h and 7.6 ± 0.4 h, AUC0 ∞ was (13.4 ± 2.1) μg · h · ml-1 and (13.5 ± 2.9) μg · h · ml-1, respectively. Tmax, Cmax, T1 / 2 and AUC were tested by analysis of variance and double unilateral t-test. There was no significant difference in other pharmacokinetic parameters except Tmax (P <0.05). Conclusion: The relative bioavailability of the two preparations was (100.8 ± 13.1)%, which was tested by analysis of variance and double unilateral t test