f_2因子法评价头孢呋辛酯片溶出曲线相似性

Evaluation on similarity of dissolution profiles of different cefuroxime axetil tablets by factor f_2 method

目的评价自制制剂与原研药的溶出行为相似性。方法基于药典中的溶出度测定方法,分别考察自制制剂与原研药品在纯水,0.1、0.05mol/L盐酸,pH4.5、pH6.8的介质,以及在25、50、75r/min转速时的溶出行为,并用f2因子法比较溶出曲线。结果当转速为50r/min在5种介质中,f2因子分别为57.65,79.17,73.56,66.83和62.33;介质为0.1mol/L的盐酸,转速为25r/min和75r/min时,f2值分别为65.35、78.48。结论自制制剂与原研药各条件下的溶出曲线相似。

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.