Pharmacokinetics and Bioequivalence of Zhengqing Fengtongning Enteric Tablets in Beagle Dogs

OBJECTIVE:To investigate the pharmacokinetics and bioequivalence of Zhengqing fengtongning enteric tablets in Beagle dogs.METHODS:In randomized crossover design,10 Beagle dogs were administered with 10 mg·kg -1 of reference tablet or test tablet.Plasma concentration of Zhengqing fengtongning enteric tablets were determined by HPLC.The pharmacokinetic parameters and bioequivalence were calculated using 3p97 software.RESULTS:The concentration-tine curves of reference tablet and test tablet fitted to one-compartment model in Beagle dogs.The main pharmacokinetic parameters of reference tablet vs.test tablet were as follows:T max :(86.25±10.61)min vs.(75.00±16.04)min;C max :(0.18±0.038)μg·mL -1 vs.(0.18±0.042)μg·mL -1 ;t 1/2 Ke:(78.34±15.21)min vs.(88.77±30.90)min;AUC 0～T :(30.31±7.82)μg·min·mL -1 vs.(32.09±8.61)μg·min·mL -1.The relative bioavailability of test tablet was(94.45±5.49)%.CONCLUSION:Results of variance analysis,t-test and non-parameter test shows the two formulations were bioequivalent.