异福片的药物动力学与相对生物利用度  

The pharmacokinetics and bioequivalent evaluation of Compound Isoniazid tablet

作　　者：赵语[1] 陈钧[2] 蒋学华[2] 周静[2] 杨俊毅[2] 

机构地区：[1]重庆医科大学附属第一医院,重庆400016 [2]四川大学华西药学院,四川成都610041

出　　处：《华西药学杂志》2004年第3期167-170,共4页West China Journal of Pharmaceutical Sciences

摘　　要：目的　研究两种异福片的药物动力学 ,并评价两者的生物等效性。方法　采用RP -HPLC测定 2 4名志愿受试者单剂量po异福片供试品与参比品后利福平和异烟肼血药浓度的变化 ,用 3p97药动学程序拟合药动学参数。结果　两种制剂中利福平AUC0→t分别是 16 3 6 6± 11.33μg·h·ml-1与 172 5 9± 76 .31μg·h ml-1,Tmax分别为 1.92± 0 .19h与 1.96± 0 .4 5h ,Cmax分别是 2 6 .4 2± 11.97μg·ml-1与 2 6 .18± 11.5 7μg·ml-1。两种制剂中异烟肼AUC0→t分别是 4 4 .2 6± 18.84 μg·h·ml-1与 4 6 .18± 16 .6 0μg·h·ml-1,Tmax分别为 1.83± 0 .33h和 1.88± 0 .31h ,Cmax分别是 7.73± 3.2 2 μg·ml-1与 7.76± 3.0 0 μg·ml-1。经剂量校正 ,两种制剂中两组份的lnAUC0→∞ 、lnAUC0→t、Cmax经方差分析均无显著性差异 (P >0 .0 5 ) ;Tmax用双单侧t检验进行生物等效性评价 ,无显著性差异 (P >0 .0 5 )。结论　两种制剂为生物等效制剂 ,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95 .86 %± 11.86 %和 95 .5 4 %± 12 .5 3%。OBJECTIVE To study the pharmacokinetics and relative bioavailability of two Compound Isoniazid tablets(Isoniazid plus Rifampicin).METHODS A single oral dose of the tested or the reference preparation was given to 24 volunteers in an open randomized cross over-test.The concentrations of Rifampicin and Isoniazid in plasma were assayed by RP-HPLC method.RESULTS The AUC 0→t of Rifampicin of the two preparations were 163.66±11.33 μg·h.ml -1 and 172.59±76.31 μg·h·ml -1,T max were 1.92±0.19 h and 1.96± 0.45 h,c max were 26.18±11.57 μg·ml -1 and 13.20±2.77 μg·ml -1,respectively.The AUC 0→t of Isoniazid were 44.26±5.84 μg·hml -1 and 46.68±16.60 μg·h·ml -1;T max were 1.83±0.33 h and 1.88±0.31 h;C max were 7.73±3.22 μg·ml -1 and 7.76±3.00 μg·ml -1,respectively.The result of statistical analysis showed that there were no significant difference of the lnAUC 0→t、T max and lnC max of Rifampicin and Isoniazid between the two preparations(P>0.05).CONCLUSION The two preparations are bioequivalent using lnAUC 0→t、T max and lnC max of Rifampicin and Isoniazid as evaluated factors.The relative bioavailabilities of Rifampicin and Isoniazid of tested tablet are 95.86 %± 11.86% and 95.54%±12.53%,respectively.

关 键 词：异福片 药物动力学 相对生物利用度 利福平 

分 类 号：R978.7[医药卫生—药品] R969.1[医药卫生—药学]