头孢泊肟酯片的处方工艺及质量研究  

Study on Preparation Technology and Quality of Cefpodoxime Proxetil Tablets

作　　者：杨宏硕 李敏 马亚松 贾玉捷 孙燕 YANG Hong-shuo;LI Min;MA Ya-song;JIA Yu-jie;SUN Yan(NCPC Hebei Huamin Pharmaceutical Co.,Ltd.,Shijiazhuang 050000,China)

机构地区：[1]华北制药河北华民药业有限责任公司

出　　处：《化工管理》2020年第4期191-192,共2页Chemical Engineering Management

摘　　要：文章研究头孢泊肟酯片的处方工艺,并对其质量进行考察。根据头孢泊肟酯片参比制剂的处方剖析结果,选择合适辅料进行处方筛选,将制得的样品进行湿、热、光照影响因素试验和溶出度考察;按照优选处方制备的头孢泊肟酯片经加速实验考察,有关物质含量均合格,在水中30min的累积溶出度≥85%;研究制备的头孢泊肟酯片质量稳定,适合进一步研究开发。Objective:To study thepreparation technology of Cefpodoxime Proxetil tablets and its quality.Methods:according to the results of prescription analysis of Cefpodoxime Proxetil Tablets reference preparation,select the best preparation prescription.The quality and stability of the newly designed tablets were investigated by the influential factor test and accelerated test.Results:Cefpodoxime Proxetil tablet prepared by the optimal technology displayed good stablility in accelerated test,with the content of related substances were qualified and in water the accumulative dissolution in 30 min more than 85%.Conclusion:Cefpodoxime Proxetil tablet were stable and suitable for further development.

关 键 词：头孢泊肟酯 处方工艺 影响因素 质量控制 

分 类 号：TQ460.6[化学工程—制药化工]