异福片中利福平的生物等效性评价  

Evaluation of Bioequivalence of Rifampicin in YIFU Tablets

作　　者：邓立东[1] 蒋学华[2] 陈钧[2] 周静[2] 杨俊毅[2] 程强[3] 

机构地区：[1]桂林医学院附属医院,桂林市541001 [2]四川大学华西药学院,成都市610041 [3]四川省抗菌素工业研究所,成都市610051

出　　处：《中国药房》2003年第7期416-418,共3页China Pharmacy

摘　　要：目的 :通过利福平的体内动力学评价异福片中利福平的质量。方法 :采用反相高效液相色谱法测定24名志愿受试者单剂量口服异福片、胶囊后 ,利福平血药浓度的变化。结果 :异福片、胶囊中利福平的AUCn→24 分别为 (60 79±18 82) μg/(ml·h)、(62 28±18 22) μg/(ml·h) ,Tmax 分别为 (1 94±0 27)h、(2.02±0 38)h ,Cmax 分别为 (13 11±3 48) μg/ml、(13 20±2 77) μg/ml。结果表明 ,二者AUC、Tmax、Cmax 均无显著性差异 ,异福片中利福平相对生物利用度为 (102 58±9 33) %。结论 :只要控制好生产条件 。OBJECTIVE:To evaluate the quality of rifampicin in YIFU tablets in term of the pharmacokinetic process in vivo METHODS:The blood concentrations of rifampicin were determined after giving a single oral dose of testing preparation YIFU tablets or capsules in 24 volunteers in an open randomized cross-over design Rifampicin concentrations in plasma were assayed by RP-HPLC method RESULTS:The AUCn→24 of rifampicin of the two formulae were (60 79±18 82)μg/(ml·h) and (62 28±18 22)μg/(ml·h);Tmax were (1 94±0 27)h and (2 02±0 38)h;Cmax were (13 11±3 48)μg/ml and (13 20±2 77)μg/ml respectively The results showed that the two drugs were not significantly different in the pharmacokinetic parameters(T1/2,Cmax,AUC),the bioequivalence of rifampicin in YIFU tablets was (102 58±9 33)% CONCLUSION:The inherent quality of tablets can be guaranteed if the condition of production is good

关 键 词：异福片 利福平 生物等效性 药代动力学 血药浓度 结核病 异烟肼 

分 类 号：R978.3[医药卫生—药品]