粉末直接压片制备格列美脲片  

Preparation of glimepiride tablets by direct powder compression

作　　者：温东妹[1] 杨姗姗[1] 

机构地区：[1]扬子江药业集团广州海瑞药业有限公司,广东广州510663

出　　处：《中国医药科学》2013年第22期46-48,共3页China Medicine And Pharmacy

摘　　要：目的建立格列美脲片粉末直接压片工艺。方法根据粉末直接压片工艺流程,对辅料种类、辅料规格、处方比例、混合方式等进行试验分析,选择合适的处方工艺。结果采用粉末直接压片辅料和主药与辅料以等量递增的预混方法生产格列美脲片质量符合标准要求。结论采用粉末直接压片工艺制备格列美脲片,与湿法制粒压片工艺产品比较,质量更稳定。Objective To establish the process of preparing Glimepiride tablets by direct powder compression. Methods The types and specifications of excipients, proportion of prescription,and mixing method were tested and analyzedaecording to the technological process of direct powder compression.The suitable formulation and technology were selected. Results Directed powder compression of excipient and API,as well as the equivalent increase of excipient in pre-mixing method was employed.The Glimepiride tablets produced by this method were complied with the requirements of quality standard. Conclusion Compared with the products made by wet-type granulation tableting,the quality of Glimepiride tablets prepared by direct powder compression are more stable.

关 键 词：粉末直接压片 格列美脲片 

分 类 号：TQ463.2[化学工程—制药化工]