国产复方利福平片与进口药人体相对生物利用度研究  

Relative bioavailability of domestic and imported compound rifampicin tablets in healthy volunteers

作　　者：殷琦[1] 车宁[1] 赫广威[1] 孙春华[1] 

机构地区：[1]卫生部北京医院临床研究基地,北京100730

出　　处：《中国抗生素杂志》2002年第5期298-300,314,共4页Chinese Journal of Antibiotics

摘　　要：采用随机分组自身前后交叉给药对 18名健康志愿者 ,单剂量口服复方利福平片与进口对照药品 (商品名Rifinah)进行人体相对生物利用度研究。采用HPLC紫外检测法测定给药后受试者血浆中利福平、异烟肼两种有效成分的浓度。结果表明复方利福平片与进口对照药中的利福平平均药动学参数Tmax分别为( 1.2 78± 0 .45 3)和 ( 1.389± 0 .40 4)h ,T1/ 2ke分别为 ( 6 .882± 1.92 0 )和 ( 6 .0 84± 0 .5 6 3)h ,Cmax分别为 ( 19.30 2±5 .830 )和 ( 17.95 1± 5 .6 0 7)mg/L ;两种药中异烟肼的Tmax分别为 ( 0 .6 47± 0 .310 )和 ( 0 .6 89± 0 .5 0 4)h ,T1/ 2ke分别为 ( 3.30 9± 1.46 4)和 ( 3.40 7± 1.2 2 8)h ,Cmax分别为 ( 6 .6 6 7± 2 .45 9)和 ( 6 .876± 2 .5 93)mg/L。两药中利福平的AUC0～ 2 4 分别为 ( 94.5 73± 2 4.478)和 ( 94.36 8± 2 0 .2 46 )h·mg/L。两种药中异烟肼的AUC0～ 12 分别为 ( 15 .2 86±3.85 8)和 ( 16 .738± 4.6 5 9)h·mg/L ,被试制剂中利福平、异烟肼的相对生物利用度分别为 ( 10 0 .3± 12 .3) %、( 92 .4± 10 .5 ) %。对复方利福平片与进口品中两种有效成分利福平和异烟肼分别进行方差分析和双单侧检验 ,无显著性差异 (P <0 .0 5 )。结论 :两者为生物等效制剂。To study the bioavailability of domestic compound rifampicin tablets in 18 healthy male volunteers according to a randomized 2-way cross-over design. The concentration of rifampicin and isoniazid in plasma was determined by the HPLC-UV method. The peak plasma level ( C max ) of rifampicin in the test drug and reference drug were (19.302±5.830) and (17.951±5.607)mg/L respectively, the peak time ( T max ) were (1.278±0.453) and (1.389±0.404)h, T 1/2ke were (6.882±1.920) and (6.084±0.563)h, and AUC 0-24 were (94.573±24.478) and (94.368±20.246)h·mg/L. The peakplasma level ( C max ) of isoniazid in the test drug and reference drug were (6.667±2.459) and (6.876±2.593)mg/L, the peaktime ( T max ) were ( 0.647 ± 0.310) and (0.689±0.504)h, T 1/2ke were ( 3.309 ±1.464) and (3.407±1.228) respectively, and AUC 0～12 were (15.286±3.858) and (16.738±4.659)h·mg/L respectively. The relative bioavailability of rifampxcin and isoniazid in the test drug were (100.3±12.3), (92.4±10.5)%. There was no statistical difference between the two kind of compound rifampicin tablets. The relative bioavailability data obtained in the study suggested that both domestic and imported compound rifampicin tablets are bioequivalent.

关 键 词：利福平 异烟肼 高效液相色谱法 人体生物等效性 

分 类 号：R978.3[医药卫生—药品] R969.1[医药卫生—药学]