异福酰胺片药动学与相对生物利用度  

Study on pharmacokinetics and bioequivalent evaluation of Yifuxianan tablets

作　　者：邓立东[1] 蒋学华[2] 陈钧[2] 程强[2] 

机构地区：[1]桂林医学院附属医院,广西桂林541001 [2]华西医科大学药学院,四川成都610041

出　　处：《中国医院药学杂志》2003年第8期475-478,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的 :研究两种异福酰胺片的药动学 ,评价二者的生物等效性。方法 :采用反相高效液相色谱法测定 2 4名志愿受试者单剂量口服异福酰胺片供试品与卫非特片标准参比制剂后 ,利福平、异烟肼和吡嗪酰胺血药浓度变化情况 ,用 3P97药动学程序处理。结果 :两制剂中 3组分的lnAUC0 -t、lnCmax及Tmax经方差分析 ,差异均无显著性 (P >0 .0 5) ,经双单侧t检验为生物等效 (P <0 .0 5)。以卫非特片作为标准参比制剂计算异福酰胺片供试品中利福平、异烟肼和吡嗪酰胺的相对生物利用度分别为 :(99.6± 13 .0 ) % ,(10 4.1± 2 3 .2 ) %和 (10 2 .2± 11.3 ) %。结论 :统计结果分析显示 ,异福酰胺片与卫非特片为生物等效制剂。OBJECTIVE To study the pharmacokinetics and relative bioavailability of two different kind of Yifuxianan tablets.METHODS Rifampicin and isoniazid and pyrazinamide were determined after a single oral do se of testing preparation Yifuxianan tablets and reference preparation Rifat er given respectively to 24 volunteers in an open randomized cross(over test. Ri fampicin and isoniazid and pyrazinamide concentration in plasma were assayed by RP-HPLC. RESULTS The results of statistical analysis showed that there were no significant differ ence of the AUC 0→t 、T max and C max of rifampicin and i soniazid and pyrazinamide between the two formations(P> 0.05 ).CONCLUSIONS Yifuxianan tablets and Rafiter tablets were bioequivalent, the bioequivalenc e data of rifampicin, isoniazid and pyrazinamide of Yifuxianan tablets were ( 99.6 ± 13.0)% and( 104.1 ± 23.2)% and ( 102.2 ± 11.3)% using Rafiter tablets as reference preparation.

关 键 词：异福酰胺 利福平 异烟肼 吡嗪酰胺 药动学 生物等效性 

分 类 号：R969.1[医药卫生—药理学] R978.3[医药卫生—药学]