摘要

This paper studied the main pharmacokinetic parameters of pridinol mesylate orally disintegrating tablets and conventional tablets and assessed their release characteristics and absorption characteristics in Beagle dogs. According to a paired and cross-over design, six Beagle dogs were randomly divided into two groups, to which pridinol mesylate orally disintegrating tablets and conventional tablets were given separately by oral administration at a single dose of 12 mg. At certain time points after drug administration, the venous blood was collected from dogs in both groups for plasma separation, and the concentrations of pridinol mesylate in the plasma were measured according to HPLC method. The pharmacokinetic parameters, C-max, AUC(0-12), T-max and T-1/2 and relative bioavailabilities were calculated using DAS 3.2.1 software. The pharmacokinetic parameters of pridinol mesylate orally disintegrating tablets and conventional tablets were respectively as follows: C-max 43.78 +/- 3.66 and 36.48 +/- 4.92 ng/mL; AUC(0-12) 84.59 +/- 37.24 and 77.58 +/- 29.22 ng.h/mL; T-max 0.52 +/- 0.12 and 0.97 +/- 0.16 h; T-1/2 1.43 +/- 0.42 and 1.52 +/- 0.67 h. F0-12 was 109.03% and F0-infinity was 108.03%. Compared to conventional tablets, pridinol mesylate orally disintegrating tablets had more advantages in the velocities of release and absorption and had higher bioavailability.