Study on the Relative Bioavailability of Yifuxian'an Capsules in Human Body / 中国药房

ABSTRACT

OBJECTIVE:To study the relative bioavailability of yifuxian'an capsules.METHODS:Concentrations of ri-fampicin,isoniazid and pyrazinamide in plasma were determined on12volunteers respectively after a single oral dose of yifux-ian'an capsules(tested preparations)and rifater(reference preparation)by RP-HPLC method;the pharmacokinetics parame-ters were processed by3p97process.RESULTS:The AUC 0～t of the tested preparation and reference substance of rifampicin were(70.69?36.32)and(70.77?32.26)(?g?h)/ml respectively,t max of which were(1.82?0.28)and(1.79?0.25)h re-spectively,C max of which were(12.83?4.98)?g/ml and(12.84?3.95)?g/ml respectively;The AUC 0～t of which were(14.30?8.25)and(13.76?6.16)(?g?h)/ml respectively,t max of which were(1.54?0.36)and(1.58?0.38)h respectively,C max of which were(5.42?2.52)and(5.46?2.46)?g/ml respectively;The AUC 0～t of which of pyrazinamide were(243.56?128.98)and(238.07?117.63)(?g?h)/ml respectively,t max of which were(1.58?0.64)and(1.69?0.55)h respectively,C max of which were(29.45?12.45)and(27.46?11.02)?g/ml respectively.The relative bioequivalence of rifampicin,isoniazid and pyrazi-namide of the tested preparation were(99.88?12.92)%,(103.84?24.10)%and(102.57?12.31)%respectively.CONCLU-SIONBioavailability of the2preparations are bioequivalent.