Bioequivalence study on Yifuxianan tablets (II) in healthy volunteers

Objective To study the bioequivalence of Yifuxianan tablets(II)(compound preparation of rifampicin,isoniazid and pyrazinamide) after a single oral dose of the tested and referred preparations to 20 healthy volunteers.Methods Concentrations of rifampicin,isoniazid and pyrazinamide in plasma were determined by RP-HPLC,pharmacokinetic parameters and relative bioavailability were calculated by using DAS software.Results The linear ranges of rifampicin,isoniazid and pyrazinamide were 0.40-25.0 mg · L-1,0.10-10.0 mg · L-1 and 0.30-60.0 mg · L-1,with good linearity(r0.99),intra-and inter-day precisions were below 15%,average recoveries of three drugs were above 70%,the relative bioavailability of rifampicin,isoniazid and pyrazinamide were(97.5±25.5)%,(108.7±24.0)% and(109.0±17.4)%,respectively.Conclusions The tested preparation is bioequivalent with the referred preparation.