摘要
目的比较自制马来酸氟吡汀胶囊与进口马来酸氟吡汀胶囊的溶出度。方法参考进口药品注册标准,分别测定自制马来酸氟吡汀胶囊和进口马来酸氟吡汀胶囊在不同条件下的溶出曲线,采用相似因子(f2)进行溶出曲线相似性比较。结果各条件下的相似因子(f2)均可到达60以上。结论自制马来酸氟吡汀胶囊与进口产品的溶出曲线具有良好的相似性。
Aim To compare the dissolution curve of the flupirtine maleate capsules with imported products.Methods The dissolution curve of the flupirtine maleate capsules and imported products were determined in different conditions,and the resemblance of dissloution curve were compared by similarity factors(f2).Results The similarity factors(f2) under various conditions were over 60.Conclusion The dissolution curve of two products was in good comparability.
出处
《安徽医药》
CAS
2011年第12期1493-1496,共4页
Anhui Medical and Pharmaceutical Journal
关键词
马来酸氟吡汀
胶囊
溶出曲线
相似因子
flupirtine maleate
capsule
dissolution curve
similarity factor