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  

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

作　　者：周文[1] 李朝武[1] 薛玉英[1] 靖百谦[1] 王雪瓶[1] 韩文修 

机构地区：[1]山东医科大学附属医院药剂科,济南市250012

出　　处：《中国药房》2000年第4期173-174,共2页China Pharmacy

摘　　要：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OBJECTIVE:The pharmacokinetics and relative bioavailability of domestic levofoxacin distributive tablet in healthy volunteers were studied METHODS: A single oral 200mg dose of domestic levofoxacin distributive tablet or imported levofoxacin tablet was given to 12 healthy male volunteers in a randomized cross-over clinical study The serum concentrations of levofoxacin were determined by HPLC The pharmacokinetics parameters were analyzed by 3p97 computer software RESULTS:The serum concentration-time curve fitted to two compartment model,and the main pharmacokinetic parameters of domestic distributive tablet and imported tablet 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 and imported tablet CONCLUSION:The domestic distributive tablet and imported tablet are bioequivalent

关 键 词：盐酸左旋氧氟沙星 高效液相色谱 生物利用度 生物等效性 药代动力学 

分 类 号：R978.1[医药卫生—药品]