各国药典对β-内酰胺酶抑制剂复方及其单方制剂中有关物质的控制  

Related Substances and Their Control Methods of Compound Antibiotics Including β-lactamase Inhibitor and Their Simple Recipes in Pharmacopoeias

作　　者：高靓[1,2] 李苌清 张玉英[4] 王霆[1,2] 

机构地区：[1]天津市人民医院,天津300121 [2]湘北威尔曼制药股份有限公司,长沙410331 [3]重庆市红十字会医院,重庆400024 [4]广州市药品检验所,广州510160

出　　处：《中国药品标准》2013年第6期415-421,共7页Drug Standards of China

基　　金：国家"十二五""重大新药创制"科技重大专项(2011ZX09201-101-3)

摘　　要：上市的含β-内酰胺酶抑制剂复方抗生素品种很多,但国内外药典中收载的只有四种,且仅《中国药典》对有关物质进行了规定。本文综述了含β-内酰胺酶抑制剂复方及其单方制剂在各国药典中规定的有关物质及其控制方法,并对其进行了比较分析。There were many kinds of compound antibiotics including β-lactamase inhibitor in the market, but only four were recorded in pharmacopoeias, and related substances were regulatedonly in Ch. P2010. In this paper, related substances and their control methods of compound antibiotics including β-lactamase inhibitor and their simple recipes were reviewed and analysised.

关 键 词：复方抗生素 Β-内酰胺酶抑制剂 有关物质 质量控制 药典 

分 类 号：R921.2[医药卫生—药学]