不同溶出介质中头孢地尼胶囊溶出曲线的相似性比较  

Similarity comparison of the dissolution curve of cefdinir capsules in various dissolution media

作　　者：刘小燕[1] 金涌[1] 臧洪梅[1] 

机构地区：[1]安徽医科大学药学院,安徽合肥230032

出　　处：《安徽医药》2013年第5期749-752,共4页Anhui Medical and Pharmaceutical Journal

基　　金：安徽省高等学校自然科学基金研究项目(No KJ2010B376);安徽医科大学校科研基金(No 2010XKJ008);安徽医科大学博士启动基金(No XJ200902)

摘　　要：目的采用不同溶出介质进行头孢地尼胶囊溶出度实验,考察不同溶出条件对头孢地尼胶囊溶出度的影响,同时为难溶性药物制剂质量判断提供参考。方法以盐酸溶液(稀盐酸24→1000)、水、PBS4.0缓冲溶液、PBS7.0缓冲溶液为溶出介质,绘制参比制剂和自制制剂的溶出曲线,以相似因子f2作为指标,对比自制制剂与参比制剂溶出特性。结果在这4种介质中,参比制剂与自制制剂相似高于60。结论自制制剂与参比制剂在4种不同介质中溶出行为基本一致。Objective To compare the dissolution curves of cefdinir capsules in various dissolution media and to provide the reference for insoluble drug quality evaluation. Methods The dissolution curves of the cefdinir capsules were determined in various dissolution media, and the resemblances of dissolution curve were compared by similarity factors （ f2 ）. Results The similarity factors （ f2 ） in various conditions were over 60. Conclusion The dissolution curve of two products in various dissolution media was in good comparability.

关 键 词：头孢地尼 胶囊 溶出 相似因子 

分 类 号：R927.2[医药卫生—药学]