乳酸左旋氧氟沙星胶囊人体生物利用度及其药物动力学  

Study on bioavailability and pharmacokinetics of levofloxacin lactate capsule in ten volunteers

作　　者：谈恒山[1] 韩一波[2] 蔡明虹[1] 刘新 

机构地区：[1]南京军区南京总医院,江苏南京210002 [2]北海市人民医院,广西北海536000 [3]江苏省武警总医院,江苏南京210002

出　　处：《中国医院药学杂志》2000年第4期202-204,共3页Chinese Journal of Hospital Pharmacy

摘　　要：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 。OBJECTIVE:To study the bioavailability of levofloxacin lactate tablet and capsule.METHODS:Ten healthy subjects took oral levofloxacin lactate tablet and capsule in this study.The plasma concentration was quantitated by HPLC,the pharmacokinetic parameters were evaluated by PKBP N1 program,and T max , C max , T 1/2 and AUC were tested by square deviation analysis and two one sides t tests.RESULTS:The results of tablets and capsule: T max were ( 1.08 ± 0.31 )h and ( 0.78 ± 0.14 )h,respectively; C max were ( 2.07 ± 0.30 )μg·ml -1 and ( 2.16 ± 0.18 )μg·ml -1 ,respectively; T 1/2 were ( 7.8 ± 0.7 )h and ( 7.6 ± 0.4 )h,respectively; AUC 0 ∞ were ( 13.4 ± 2.1 )μg·h·ml -1 and ( 13.5 ± 2.9 )μg·h·ml -1 ,respectively.There was no significant difference of these parameters except for T max .CONCLUSIONS:Relative bioavailability was ( 100.8 ± 13.1 )%.Levofloxacin lactate tablet and capsule are bioequivalent.

关 键 词：乳酸 左旋氧氟沙星 相对生物利用度 

分 类 号：R978.19[医药卫生—药品] R969.1[医药卫生—药学]