Study on Pharmacokinetics and Bioequivalen of Multi-Absorption Enhancer and Puerarin Tablet

Objective:To establish an analytical method for the determination of puerarin in dog plasma with HPLC-FLD,and to evaluate the pharmacokinetics and relative-bioavailability of puerarin of tested multi-absorption enhancer and puerarin tablet after a single oral dose in healthy dogs. Method:Six healthy dogs took muti-absorption enhancer and puerarin tablets with a single oral dose in a randomized cross-over design in the case. The serum concentration of puerarin was determined by HPLC-FLD method. Result:The puerarin in test and reference formulations were Cmax(0. 326 ± 0. 121) and(0. 272 ± 0. 083) ng·mL-1,tmax(2. 750 ± 0. 957) and(4. 500 ± 1. 732) h,t1/2α(1. 157 ± 0. 748) and(1. 223 ± 0. 311) h,t1/2β(6. 679 ± 2. 552) and(1. 987 ± 0. 386) h,AUC(0-t) (2. 513 ± 1. 046) and(1. 951 ± 0. 442) mg·h·L-1,AUC(0-∞) (5. 035 ± 2. 190) and(3. 001 ± 1. 382) mg·h· L-1,respectively. The relative bioavailability of puerarin was(128. 8 ± 31. 2) % . Cmax,AUC(0-t) and AUC(0-∞) were not bioequivalent through the bioequivalent tests. Conclusion:The method is proved to be accurate,sensitiveand rapid. Puerarin in the test formulation is not bioequivalent to the reference formulation. The relative-bioavailability of puerarin of tested multi-absorption enhancer and puerarin tablet is enhanced by 28. 8 percents.