头孢克洛胶囊溶出度质量评价  

Quality Evaluation of Dissolution for Cefaclor Capsules

作　　者：顾珉[1] 扈春萍 

机构地区：[1]苏州市药品检验所,江苏苏州215002

出　　处：《中国医药指南》2012年第17期20-21,共2页Guide of China Medicine

摘　　要：目的通过对国内不同药品生产企业头孢克洛胶囊在四介质中的溶出度进行考察,为药物质量评价和标准提高提供参考。方法采用转篮法进行体外溶出度实验,分别以水、pH1.2缓冲液、pH4.0缓冲液、pH6.8缓冲液作为溶出介质,转速为100r/min。采用f2因子法,考察国内11家公司的头孢克洛胶囊与参比公司的头孢克洛胶囊溶出度的差异。结果只有1个公司的头孢克洛胶囊在四介质中的f2值均>50,溶出度与参比公司制剂相似。其他10个公司的头孢克洛胶囊至少在一个介质中的f2值小于50,溶出度与参比公司制剂存在明显差异。结论考察的国内公司的头孢克洛胶囊溶出度有显著差异,仿制药品的质量有待提高。Objective To evaluate the quality of cefaclor capsules by determining the dissolution of cefaclor capsules from different domestic pharmaceutical manufacturers in four mediums.Provide the reference for drug quality evaluation and the improvement of drug standard.Methods The dissolution tests were proceeded using rotating basket method at the speed of 100r/min,using water,pH1.2 buffer solution,pH4.0 buffer solution and pH6.8 buffer solution as the dissolution medium respectively.The difference of dissolution rate between cefaclor capsules of 11 domestic companies with cefaclor capsules of reference preparation was evaluated by f2 factor method.Results The f2 factors of cefaclor capsules produced by only one company in four mediums were more than 50,and its dissolution behavior is similar to reference preparation.The f2 factors of the other ten companies were below 50 in at least one medium.The drug release behavior has significant difference to that of the reference preparation.Conclusion There are significantly different among the quality of the cefaclor capsules from different manufacturers.The quality of genetic drugs need improve furthermore.

关 键 词：头孢克洛 体外溶出 质量评价 F2因子 

分 类 号：R917[医药卫生—药物分析学]