Evaluation on similarity of dissolution profiles of different cefuroxime axetil tablets by factor2 method / 国际检验医学杂志

ABSTRACT

Objective To evaluate the similarity of dissolution profiles of self-produced and original drug cefuroxime axetil tab-lets.Methods Based on the dissolution detection method in the Chinese Pharmacopoeia,the dissolution behaviors of the self-pro-duced preparation and original drug were investigated in pure water,0.1 mol/L hydrochloric acid,0.05 mol/L hydrochloric acid, pH4.5 and pH6.8 medium and the rotation speed of 50,25,75 r/mim.The stripping curves were evaluated by the f2 factor method. Results In the rotation speed of 50 r/min,the f2 factors in different mediums were 57.65,79.17,73.56,66.83 and 62.33 respec-tively;the medium was 0.1 mol/L hydrochloric acid with the rotation speed of 25,75 r/min,the f2 factors were 65.35 and 78.48 re-spectively.Conclusion The stripping curves of self-produced preparation and original drug are similar under various conditions.