目的:研究复方异烟肼胶囊中主要成分利福平在犬体内的相对生物利用度。方法:采用单剂量随机自身交叉对照试验。口服给予犬复方异烟肼胶囊与普通制剂,用高效液相色谱法测定血浆中利福平的浓度,计算相对生物利用度。结果:受试制剂和参比制剂中利福平的主要药动学参数:tmax分别为(3.8±1.7),(3.3±0.8)h;Cmax分别为(38.8±10.9),(37.8±9.1)mg·L^-1;AUC0→∞。分别为(583.2±188.5).(583.7±200.9)mg·L^-1;AUC0→∞分别为(605.1±197.2),(596.4±202.1)mg·h·L^-1;t1/2分别为(9.5±1.5),(9.1±1.4)h;F为(102.8±17.3)%。结论:经统计学分析,两种制剂中的利福平具有生物等效性。
OBJECTIVE To study the relative bioavailability of rifampicin of compound isoniazid capsules in dogs. METHODS Six dogs were enrolled in a randomized crossover study with a single oral dose of the two formulations respectively. The rifampicin in plasma was measured by HPLC. RESULTS The pharmacokinetic parameters of test and reference preparation for rifampicin were: tmax(3.8 ±1.7) and (3.3 ±0.8) h, Cmax(38.8 ±10.9) and (37.8 ±9.1) mg·L^-1, AUC0→∞ (583.2 ±188.5) and (583.7 ± 200.9) mg·-h·L^-1 , AUC0→∞ (605.1 ±197.2) and (596.4 ±202.1) mg·h·L^-1 , t1/2(9.5 ±1.5) and (9.1 ±1.4)h, F (102.8 ± 17.3) %. CONCLUSION The results of the statistical analysis show that the two rifampicin preparations are bioequivalent.