Abstract:
OBJECTIVE To establish an HPLC method to determinate sodium ferulate in Beagle dogs and compare the pharmacokinetic pararmeters between sodium ferulate gastric floating sustained-release tablets and sodium ferulate tablets by single dose in Beagle dogs. And to demonstrate the controlled release effect of sodium ferulate gastric floating sustained-release tablets. METHODS Use a standard two period cross-over design, the plasma concentration of sodium ferulate was determined by HPLC after a single oral dosage(equal to 100 mg sodium ferulate). Methanol-10% TCA (1∶1) was used as a protein precipitant agent with a ratio of plasma-protein precipitant agent(3∶2). After centrifugation, the supernatant was analyzed and the pharmacokinetic parameters were obtained by 3P97 statistical analysis software. RESULTS Sodium ferulate gastric floating sustained-release tablets indicated a good controlled release profiles with prolonged
tmax, lower
Cmax and no burst effect. CONCLUSION The HPLC method meets the requirement of sensitivity, specific and recovery and is capable to determine sodium ferulate in Beagle dogs. Sodium ferulate gastric floating sustained-release tablets indicates a marked sustained release profiles.