肝素钠鉴别及有关物质检查用国家对照品的研制  

Study on Establishment for National Reference Standard of Heparin Sodium's Identification and Related Substances

作　　者：宋玉娟[1] 任丽萍[1] 王悦[1] 廖海明[1] 郝苏丽[1] 范慧红[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2011年第9期885-886,898,共3页Chinese Pharmaceutical Affairs

摘　　要：目的建立肝素钠鉴别及有关物质检查用国家对照品。方法采用红外光谱、核磁法进行结构确认,SEC-MALLS法测绝对分子质量,毛细管电泳和离子色谱法进行纯度分析。结果本批待标品红外吸收峰与肝素钠的结构特征相吻合,核磁谱图解析结果与文献一致,毛细管电泳和离子色谱法纯度均为100%。结论所建肝素钠鉴别及有关物质检查用对照品可用作国家对照品。Objective To establish a national reference standard for heparin sodium＇s identification and related substances.Methods Structure elucidation by IR and NMR,determination of absolute molecular weight by SEC-MALLS method,purity test by capillary electrophoresis and ion chromatography.Results The IR spectrum met the structural features of heparin and NMR spectrum is in accordance with literature;the purity of capillary electrophoresis and ion chromatography were both 100%.Conclusion The establishment of national reference standard of heparin sodium can be used for identification and related substances.

关 键 词：肝素钠 国家对照品 质量分析 

分 类 号：R95[医药卫生—药学] R927