Bioequivalence Study of Zhengqing Fengtongning Enteric-coated Tablets in Beagle Dogs

OBJECTIVE:To study the bioequivalence of Zhengqing fengtongning enteric-coated tablets in beagle dogs.METH-ODS:12 healthy beagle dogs were administered with single oral dose of trial tablet (Zhengqing fengtongning enteric-coated tablets from Hunan) 100 g and reference tablet (Zhengqing fengtongning enteric-coated tablets from Xi'an) 100 g by crossover design.Plasma concentration of sinomenine was measured by HPLC and pharmacokinetic parameters and bioavailability of Zhengqing fengtongning enteric-coated tablets were calculated by 3p97 software.RESUITS:Plasma concentration-time curves of two enteric-coated tablets conformed with one compartment model.The pharmacokinetic parameters of trial tablets vs.reference tablets were as follows:t1/2(Ke):(84.77±19.33) min vs.(87.63±18.26) min;Cmax:(0.18±0.049) μg·mL-1 vs.(0.13±0.018) μg·mL-1;tmax:(79.27±15.62) min vs.(69.66±16.41) min;AUC0～t:(38.51±13.23) μg·h-1·mL-1 vs.(35.43±9.84) μg·h-1·mL-1.The relative bioavailability of tested tablet was(108.71±8.97)%.CONCLUSION:Results of variance analysis and t-test show that 2 kinds of Zhengqing fengtongning enteric-coated tablets were bioequivalent (P0.05).