Studies on pharmacokinetics and bioequivalance of catalase Studies on pharmacokinetics and bioequivalance of catalase

Abstract:

Objective：To study the pharmacokinetic and bioequivalence of catalase liposome（CALP） in SD rats. Methods：The CALP was prepared by reverse-phase evaporation method and the entrapment efficiency，size and zeta potential of CALP were detected. Twelve male SD rats were randomly divided into two groups. The activity of catalase was assayed after respectively intravenous inject－ing CALP and free catalase（CAT） in two groups. The pharmacokinetic parameters were calculated by software DAS 2.1.1，then the bioequivalenee was judged. Results：The entrapment efficiency of CALP was （53.72±1.67）%. The average particle size was （405.40 ± 21.89） nm，and zeta potential was （-15.7±3.22） mV. AUC0-t of CALP and CAT were （203.22±11.75） U（ml·h） and （50.92± 3.51） U（ml·h），Cmax of CALP and CAT were （70.79±1.33） U/ml and （51.48 ± 2.78） U/ml. Tmax of CALP and CAT were （0.58± 0.14） h and （0.17±0.00） h. The 90% confidential intervals of AUC0-t，AUC0-∞ and Cmax of tested formulation were 133.8%-140.1%，132.3%-146.7%，104.7%-107.5%，respectively. Based on analysis of variance and two-sided t-test，lnAUC and lnCmax differed statisti－cally（P<0.05），while Tmax did not differ statistically（P >0.05） between CALP and CAT. The relative bioavailability of CALP was （399.1±23.1）%. Conclusion：CALP improves the bioavailability of catalase. CALP and CAT are not bioequivalent.