ABSTRACT
OBJECTIVE:To study the bioequiavailability of both the domestic and the imported azithromycin tablets in healthy human body.METHODS:The serum concentrations in 12 healthy volunteers was determined by HPLC-UV after administration of a single oral dose of 500mg azithromycin tablets by a cross-over design.The compartment model was discriminated by F-test and AIC method and the pharmacokinetic parameters were calculated by DAS program.RESULTS:The optimal compartment model fitted to two-compartment model.The main pharmacokinetics parameters of the domestic azithromycin tablets vs.the imported ones were the following:Cmax was(437.4 670? 51.5 670),(442.9 670? 61.5 030)? g/L;t1/2? was(44.7 450? 13.1 750),(49.2 670? 15.1 740)h;tmax was(2.5 830? 0.5 150),(2.5 830? 0.5 150)h;AUC0～ 144 was(13.2 799? 2.9 827),(12.1 953? 2.9 140)(mg? h)/L.The relative bioavailability of the domestic azithromycin tablets was(101.7? 0.1)%.CONCLUSION:The domestic azithromycin tablets and the imported ones were bioequivalent.
ABSTRACT
OBJECTIVE:To determine whether bacterial endotoxins test(BET) can replace the pyrogen test for the sodium bicarbonate injection.METHODS:The comparative experiment of tachypleus amebocyte lysate(TAL) and rabbits were studied to determine the sensitivity.RESULTS:The sensitivity of TAL test was 0.125 EU.ml－1, 12 times higher than that of using rabbits.CONCLUSIONS:BET may replace pyrogen test.