Study on the Bioavailability and Pharmacokinetics of Compound Rifampicin Tablets in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of compound rifampicin tablets MET_HODSPlasma levels of rifampicin(RFP),isoniazid(INH)and pyrazinamid(PZA) at different time were determined by HPLC methods,then we drew the time-concentration curves and got the pharmacokinetic parameters and relative bioavailability of test-tablets based on the curves RESULTS:The main pharmacokinetic parameters of RFP,INH and PZA in test-tablets wereTmax,(1 69?0 60)h,(0 94?0 57)h and(2 36?1 10)h;Cmax,(9 86?2 09)?g/ml,(5 36?1 77)?g/ml and (16 20?4 85)?g/ml;T1/2,(3 43?0 72)h,(2 98?0 75)h and(9 26?1 58)h;AUC0～t,(59 34?13 17)?g/(ml?h),(21 87?14 29)?g/(ml?h) and(212 97?71 52)?g/(ml?h) respectively The main pharmacokinetic parameters of RFP,INH and PZA in control tablets were Tmax,(1 83?0 66)h,(0 86?0 38)h and (2 08?0 97)h;Cmax,(9 98?1 63)?g/ml,(5 60?2 01)?g/ml and (17 79?4 57)?g/ml;T1/2,(3 97?1 58)h,(3 15?0 88)h and (9 36?1 85)h;AUC0～t,(62 46?14 02)?g?h/ml,(21 39?14 53)?g/(ml?h) and (227 09?70 91)?g/(ml?h) respectively The relative bioavailability of test-tablets were (98 47?15 00)%,(103 76?15 80)% and (94 38?12 07)% CONCLUSION:The results of two one-sided tests and rank sum test showed that two formulae were statistically bioequivalent