首批还原型谷胱甘肽杂质国家对照品的研制  

Standardization of the National Reference Standard of the Impurity of Glutathione

作　　者：王悦[1] 郝苏丽[1] 杨化新[1] 范慧红[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药事》2010年第3期248-249,297,共3页Chinese Pharmaceutical Affairs

摘　　要：目的建立首批还原型谷胱甘肽中氧化型谷胱甘肽杂质对照品。方法以茚三酮试验进行鉴别,应用液质联用仪、红外光谱仪对氧化型谷胱甘肽进行结构确证,反相高效液相色谱法使用2种流动相体系进行纯度测定比较,用质量平衡法计算含量。结果确证了氧化型谷胱甘肽原料的结构,并确定首批氧化型谷胱甘肽对照品含量为93.6%。结论首批氧化型谷胱甘肽国家对照品(批号:140746-200801)的建立方便了还原型谷胱甘肽中氧化型谷胱甘肽杂质的定性和定量控制。Objective To establish the national reference standard for oxidized glutathione（GSSG）.Methods LC-MS and IR Spectrometer were used to confirm the structure of the material.Two mobile phases were used to determine the purity of oxidized glutathione by HPLC,and the content of the product was calculated by mass balance method.Results The structure of the material has been confirmed,and the content of oxidized glutathione was 93.6%.Conclusion The establishment of national reference standard of oxidized glutathione can efficiently control the quality and quantity of oxidized glutathione in glutathione.

关 键 词：谷胱甘肽 氧化型谷胱甘肽 对照品 HPLC 

分 类 号：R915[医药卫生—微生物与生化药学]