国产盐酸左旋氧氟沙星分散片药代动力学及生物利用度研究

目的 :对国产盐酸左旋氧氟沙星分散片药代动力学及生物利用度进行研究。方法 :12名健康志愿者交叉口服单剂量盐酸左旋氧氟沙星分散片和左旋氧氟沙星片剂200mg ,应用HPLC法测定其经时血药浓度。结果 :实验数据经3p97程序处理 ,两制剂口服吸收符合二室模型。盐酸左旋氧氟沙星分散片和盐酸左旋氧氟沙星片各相关药代动力学参数 :Cmax 分别为 (1 14±0 29)mg/L和(1 18±0 31)mg/L ,Tmax 分别为 (1 05±0 87)h和 (1 04±0 83)h ,AUC分别为 (6 92±2 19)mg/(L·h)和 (6 92±2 04)mg/(L·h)。根据盐酸左旋氧氟沙星分散片和盐酸左旋氧氟沙星片血药浓度 -时间曲线下面积 ,AUC计算盐酸左旋氧氟沙星分散片相对生物利用度为 (100 8±17 69) %。经方差分析及双单侧t检验和 (1α～2α)置信区间分析 ,显示两制剂AUC值在制剂间、周期间和个体间均无显著性差异。结论 :盐酸左旋氧氟沙星分散片与盐酸左旋氧氟沙星片具有生物等效性

Pharmacokinetics and Relative Bioavailability of Domestic Levofoxacin Distributive Tablet in Healthy Volunteers

OBJECTIVEThepharmacokinetics and relative bioavailability of domestic levofoxacin distributive tabletin healthy volunteers were studied.METHODSA single oral 200mg dose of domesticlevofoxacin distributive tablet or imported levofoxacin tablet was given to 12 healthymale volunteers in a randomized cross-over clinical study.The serum concentrations oflevofoxacin were determined by HPLC.The pharmacokinetics parameters were analyzed by 3p97computer software.RESULTSThe serum concentration-time curve fitted to two compartmentmodel,and the main pharmacokinetic parameters of domestic distributive tablet and importedtablet were as follows respectively.Cmax=(1.14± 0.29)mg/L and (1.18±0.31)mg/L,Tmax=(1.05± 0.87)h and (1.04± 0.83)h,AUC=(6.92± 2.19)mg/(L· h)and(6.92± 2.04)mg/(L· h).The relative bioavailability of domestic was (100.8±17.69)%.There were no significant difference between the domestic distributive tablet andimported tablet.CONCLUSIONThe domestic distributive tablet and imported tablet arebioequivalent.