复方利福平微丸胶囊中利福平在犬体内的生物利用度研究

In vivo bioavailability study of rifampicin in the rifampicin compound micropill in dogs

目的比较复方利福平微丸胶囊与普通四联制剂中主要成份利福平在犬体内的相对生物利用度。方法采用双周期随机交叉试验,单剂量给予犬复方利福平微丸胶囊与普通四联制剂,用HPLC法测定血浆中利福平的浓度,计算相对生物利用度。结果利福平微丸胶囊和普通四联制剂中利福平的Tmax为(4.67±0.52)和(3.33±0.82)h;Cmax为(42.76±8.65)和(37.80±9.10)mg/L;AUC0→24为(669.15±195.79)和(596.44±218.35)mg·h/L;F为(115.53±11.46)%。利福平微丸胶囊中的利福平Tmax大于普通四联制剂,经t检验P<0.01,表明利福平微丸胶囊中的利福平比普通四联制剂达峰慢。结论两种制剂中的利福平生物等效。

Objective To study the relative bioavailability of rifampicin in the rifampicin compound ~micropill in dogs. Methods An oral single dose of rifampicin compound miropill and ordinary four agent preparations were given to 6 dogs in a randomized cross-over study. The plasma concentration of rifampicin was determined with HPLC. Results The pharmacokinetic parameters of test and reference preparation for ~rifampicin were: T_~max (4.67±0.52) and (3.33±0.82)h, C_~max (42.76±8.65) and (37.80±9.10)mg/L, AUC_~0→24 (669.15±195.79) and (596.44±218.35)mg·h/L, and F(115.53±11.46)% respectively. Conclusion The two preparations were bioequivalent.