Zou Mei-jua
2007
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Quality indicators
Journal
Chinese Journal of Pharmaceutics
Abstract
Objective To study the pharmacokinetics of benproperine phosphate sustained-release pellets in dogs. Methods A single oral dose of 52.6 mg of benproperine phosphate sustained-release pellets and tablets were given to 6 dogs in a randomized crossover design. The plasma concentrations of drug were determined by HPLC. Results The main pharmacokinetics parameters of test and reference formulations were as follows: tmax was(4.3±1.4) h and(3.3±1.5) h; ρmax was(1.0±0.3) mg·L-1and(1.0±0.3) mg·L-1;AUC0-t was(12.15±3.95) μg·h·L-1and(11.58±2.53) μg·h·L-1, respectively. Conclusion The relative bioavailability of the test formulation is( 103.4±7.2)%. The result shows that the two formulations are bioequivalent.