关键词: 吉非罗齐;相对生物学效应;药代动力学;色谱法，高压液相

    摘 要:目的 考察吉非罗齐在正常人体内的药代动力学过程，评价两种胶囊制剂的人体相对生物等效性. 方法 采用标准二阶段交叉设计自身对照试验方法，10例健康受试者单剂量口服两种吉非罗齐胶囊后，以HPLC法测定吉非罗齐的血浆浓度. 结果 吉非罗齐的体内过程符合血管外一室开放模型.吉非罗齐胶囊A与B的主要药动学参数Tmax ，Cmax ，AUC(0～12h)分别为:(1.5±0.3)和(1.6±0.4)h;(33.2±5.5)和(34.6±5.3)mg·L-1 ;(134.5±11.2)和(131.7±17.0)mg·h·L

    -1 ，经统计学处理，两者间无显著性差异. 结论 吉非罗齐胶囊A相对胶囊B的平均生物利用度为(103.5±15.3)%，两种制剂具有生物等效性.

    Relative bioeffects of gemfibrozil capsule in healthy volunteers

    ZHAO Lei，WEN Ai-Dong，JIANG Yong-Pei，ZHANG San-Qi，FAN Ya-Xuan

    Department of Pharmacy，Xijing Hospital，Fourth Military Medical University，Xi'an710033，China

    Keywards:gemfibrozil;relative biological effect;pharma-cokinetics;chromatography，high pressure liquid

    Abstract:AIM To compare the pharmacokinetics and the relative bioeffects between two kinds of gemfibrozil capsules.METHODS Gemfibrozil concentrations in plasma were de-termined by HPLC method after two kinds of gemfibrozil cap-sules in a single dose were given orally to10healthy volun-teers in a two-period crossover design way.RESULTS Pharmacokinetics of gemfibrozil could be described by one-compartment open model.The T ......