吉非罗齐胶囊的相对生物利用度研究

STUDY ON PHARMACOKINETICS AND BIOEQUIVALENT EVALUATION OF GEMFIBROZIL CAPSULE

目的 :对吉非罗齐胶囊的相对生物利用度和药物动力学进行研究。方法 :采用RP HPLC测定 10名志愿受试者单剂量口服 6 0 0mg吉非罗齐胶囊供试品与其标准参比制剂后的血药浓度 ;用 3p87药动学程序处理实验数据 ,并对结果进行双单侧 t检验。结果 :两种制剂AUC为 12 7 70± 2 7 0 2、139.13± 31.2 0mg·ml-1·h-1,达峰时间分别为 2 .15± 0 .5 8h与 2 .15± 0 .5 3h ,峰浓度分别是 37.2 4± 6 .38mg·ml-1与 40 .79± 8.0 9mg·ml-1,与吉非罗齐胶囊标准参比制剂比较 ,供试品的相对生物利用度为 92 .15 %± 7.32 %。结论

OBJECTIVE:The pharmacokinetics and relative bioavailability of Gemfibrozil capsules were studied. METHODS: Gemfibrozil was determined after a single oral dose of two Gemfibrozil preparations were given respectively to 10 volunteers in an open randomized cross over test. Gemfibrozil concentration in plasma was assayed by RP HPLC method. RESULTS:After taking a single oral dose 600 mg two of Gemfibrozil preparations , the AUC 0→∞ of Gemfibrozil test preparations and standard preparations were 127.70 ± 27.02 μg·ml -1 ·h -1 and 139.13 ± 31.20 μg·ml -1 ·h -1 , T max  were 2.15 ± 0.58 h and 2.15 ± 0.53 h; C max  were 37.24 ± 6.38 μg·ml -1 and 40.79 ± 8.09 μg·ml -1 ,respectively. CONCLUSION:The results of statistical analysis showed that there were no significant difference of the AUC 0→∞ ?T max  and C max  of Gemfibrozil between the two formations and the two Gemfibrozil capsules were bioequivalent.