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12名男性健康受试者采用随机分组交叉自身对照给药方案。单剂量口服(内含利福平(RFP)480mg,吡嗪酰胺(PZA)1000mg,异烟肼(INH)320mg)参比药进口异福酰胺和国产试验药各4片 ,对国产复方利福平片与进口异福酰胺作人体生物利用度比较。用HPLC法分别测定利福平,吡嗪酰胺和异烟肼血药浓度。用3P97计算机程序求药代动力学参数。试验药中利福平 ,吡嗪酰胺和异烟肼的主要药代动力学参数:T1/2 3.89±1.16h,11.02±1.62h和2.39±1.03h;Tmax 1.08±0.36h,0.52±0.25h和0.42±0.22h;Cmax 7.49±1.27mg·L-1 ,28.71±6.57mg·L-1 和10.18±2.04mg·L-1;AUC为46.48±10.35mg·h·L -1,347.06±28.78mg·h·L -1和26.55±13.21mg·h·L -1。相对于参比药的生物利用度为103.84 %±0.68 %,97.55 %±10.84 %和105.93 %±5.67 %。AUC和Cmax 经双单侧t检验结果显示两种制剂为生物等效制剂。
Twelve male, healthy subjects were randomized to crossover self-administered dosing regimens. A single oral dose (containing 480mg of rifampicin (RFP), 1000mg of pyrazinamide (PZA) and 320mg of INH) Comparison of bioavailability between plain and imported isoforms of amide. The concentrations of rifampicin, pyrazinamide and isoniazid were determined by HPLC respectively. Pharmacokinetic parameters were calculated using a 3P97 computer program. The main pharmacokinetic parameters of rifampicin, pyrazinamide and isoniazid were: T1 / 2 3.89 ± 1.16h, 11.02 ± 1.62h and 2.39 ± 1.03h; Tmax 1.08 ± 0.36h, 0.52 ± 0.25h And 0.42 ± 0.22h; Cmax 7.49 ± 1.27mg · L-1, 28.71 ± 6.57mg · L-1 and 10.18 ± 2.04mg · L -1; AUC was 46.48 ± 10.35mg · h · L -1,347.06 ± 28.78mg · h · L -1 and 26.55 ± 13.21 mg · h · L -1. The bioavailability relative to the reference drug was 103.84% ± 0.68%, 97.55% ± 10.84% and 105.93% ± 5.67%. AUC and Cmax by double unilateral t-test results show that the two preparations for the bioequivalent formulations.