异福片的人体相对生物利用度研究  

Study on Bioequivalent Evaluation of LIFU Tablet in Healthy Volunteers

作　　者：付翔[1] 邓立东[1] 陈钧[2] 贾运涛[2] 卢来春[2] 程强[3] 

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 [3]四川省抗菌素工业研究所,四川成都610051

出　　处：《华夏医学》2003年第6期787-791,共5页Acta Medicinae Sinica

摘　　要：目的 :研究异福片与参比片卫非宁的药物动力学 ,评价两者的生物等效性。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片供试品与卫非宁片标准参比制剂后 ,利福平和异烟肼血药浓度变化情况 ,用 3p97药动学程序和 SAS统计学软件包进行数据处理。结果 :异福片与参比片卫非宁两种制剂利福平药时曲线下面积AU Cn→ t分别是 (6 0 .79± 1 8.82 ) μg· ml- 1· h与 (5 9.5 3± 1 8.75 ) μg· ml- 1· h,达峰时间分别为 :(1 .94± 0 .2 7) h与(2 .0 2± 0 .35 ) h,峰浓度分别是 :(1 3.1 1± 3.4 8) μg/ m l与 (1 3.2 3± 3.5 5 ) μg/ ml。两种制剂异烟肼药时曲线下面积AU Cn→ t分别是 :(1 2 .1 3± 3.6 9) μg· ml- 1· h与 (1 6 .5 6± 5 .34) μg· ml- 1· h,达峰时间分别为 :(1 .73± 0 .2 5 ) h与(1 .85± 0 .35 ) h,峰浓度分别是 :(4 .36± 1 .4 3) μg/ m l与 (5 .36± 1 .5 5 ) μg/ ml。经剂量校正 ,两种制剂中两种组份的AU Cn→∞ 、AUCn→ t、Cmax及 Tmax经方差分析均无显著性差异 (P>0 .0 5 )。经双单侧 t检验进行生物等效性评价 ,表明异福片分别与参比片卫非宁为生物等效制剂 (P<0 .0 5 )。结论 :异福片供试品中利福平和异烟肼的相对生物利用度分别为 :(1 0 2 .5 8± 9.Objective:To study pharmacokinetics and relative bioavaiability of LIFU.Methods:Isoniazid and Rifampicin were determined after a single oral dose of testing preparation LIFU and standard preparation Rifinah were given respectively to 24 volunteers in an open randomized cross over test.Isoniazid and Rifampicin concentration in plasma were assayed by RP HPLE method.Results:The AUC 0→∞ of Rifampicin of the two formations were 60.79±18.82μg·ml -1 ·h and 59.53±18.75μg·ml -1 ·h;T max were 1.94±0.27 h and 2.02±0.35h;C max were 13.11±3.48μg·ml -1 and 13.23±3.55μg·ml -1 ,respectively.The AUC 0→∞ of Isoniazid of the two formations were 12.13±3.69μg·ml -1 ·h and 15.85±4.97μg·ml -1 ·h;T max wre 1.73±0.25 h and 1.85±0.35h;C max were 4.36±1.43μg·h·ml -1 and 5.36±1.55μg·ml -1 respectively.The result of statistical analysis showed that there were no significant difference of the AUC 0→∞ 、T max and C max of Isoniazid and Rifampicin between the two formations( P >0.05).LIFU and Rifinah tablets were bioequivalent using Isoniazid and Rifampicin as evaluated factors.Conclusion:The bioequivalence fo Rifampicin and Isoniazid of LIFU are 102.58±9.33% and 103.39±12.05% using Rifinah tablet as standard preparation.

关 键 词：异福片 利福平 异烟肼 生物等效性 

分 类 号：R978.3[医药卫生—药品]