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本试验对 12名男性志愿受试者签署知情同意书 ,按随机双交叉设计口服国产复方利福平片 (华北制药康欣有限公司研制 ,含利福平 12 0 mg,异烟肼 80 mg,吡嗪酰胺 2 5 0 mg)与相同处方的美国进口 rifater片各 4片后 ,定时抽取血样并分别对利福平、异烟肼和吡嗪酰胺的血药浓度和药代动力学参数进行比较。血药浓度用 HPL C法检测 ,用 3P87和 NDST程序 ,按非室模型进行药代动力学分析。结果表明 ,口服国产复方利福平片 (又称异福酰胺片 )和进口 rifater片各 4片后 ,利福平的 AUC分别为 (73.90±2 3.41)与 (72 .84± 2 5 .5 8) mg· h/ L ,Cmax为 (16 .7± 3.6 )与 (16 .6± 3.6 ) mg/ L ,Tmax为 (1.8± 0 .3)与 (1.8± 0 .2 ) h;异烟肼的 AUC分别 (4 0 .74± 16 .11)与 (4 3.2 6± 17.99) mg· h/ L ,Cmax为 (9.9± 3.4)与 (10 .0± 2 .8) mg/ L ,Tmax为 (1.7± 0 .4)与 (1.7± 0 .4) h;吡嗪酰胺的 AUC分别为 (4 99.35± 194.35 )与 (5 15 .6 9± 198.931) mg· h/ L,Cmax为 (4 0 .4± 13.2 )与 (4 0 .6± 12 .4) mg/ L,Tmax为 (1.6± 0 .4)与 (1.6± 0 .4) h。以进口的 rifater片为 10 0 % ,华北制药康欣有限公司提供的利福平三联片口服后三成分的相对生物利用度 :利福平为 10 1.45 % ,异烟肼为 94.17%和吡嗪?
In this study, 12 male volunteers signed informed consent, randomized double-crossover design oral domestic rifampicin tablets (North China Pharmaceutical Kangxin Co., Ltd., containing rifampin 120 mg, isoniazid 80 mg, Pyrazinamide 250 mg) and 4 imported rifater tablets of the same prescription, blood samples were taken periodically and the plasma concentration and pharmacokinetic parameters of rifampicin, isoniazid and pyrazinamide were compared respectively . Plasma concentrations were detected by HPL C assay using 3P87 and NDST programs and pharmacokinetic analysis was performed on a non-compartmental model. The results showed that the AUC of rifampicin were (73.90 ± 2 3.41) and (72.84 ± 2.55, respectively) after orally taking domestic compound rifampicin (also known as isoformate tablets) and imported rifater tablets 8) mg · h / L, Cmax was (16.7 ± 3.6) and (16.6 ± 3.6) mg / L and Tmax was (1.8 ± 0.3 and 1.8 ± 0.2 h) The AUC of hydrazine were (40.7 ± 16.11) and (42.2 ± 17.99) mg · h / L, respectively, with Cmax of (9.9 ± 3.4) and (10 ± ± 2.8) mg / L, respectively (1.7 ± 0.4) and (1.7 ± 0.4) h, respectively. The AUC of pyrazinamide were (4 99.35 ± 194.35) and (515.69 ± 198.931) mg · h / 4 0 .4 ± 13.2) and (40 ± 6 ± 12. 4) mg / L respectively. The Tmax was (1.6 ± 0.4) and (1.6 ± 0.4) h. The relative bioavailability of the three components after oral administration of the rifampin triplex tablets provided by North China Pharmaceuticals Kangxin Co., Ltd. was 10 1.45%, isoniazid 94.17% and pyrazine ?