首批甘精胰岛素国家对照品的研制  

Establishment and standardization of the first National Reference Standard of insulin glargine

作　　者：张慧[1] 杨化新[1] 李克坚[1] 李晓东[1] 梁成罡[1] 郝苏丽[1] 王大梅[2,3] 刘月娥[2,3] 李群[2,3] 代红[2,3] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]北京甘礼药业有限公司,北京101102 [3]北京市药品检定所,北京100035

出　　处：《药物分析杂志》2006年第9期1192-1194,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：国家863课题(2003AA223480)

摘　　要：目的:建立甘精胰岛素国家对照品。方法:用质谱测定分子量、HPLC法肽图鉴别及测定纯度。结果:以氮含量、纯度扣除法以及外标法结果综合考虑,最终确定首批甘精胰岛素国家对照品的含量为93.7%。即每1mg含甘精胰岛素0.937mg。Objective： To establish a National Reference Standard fo weight was analyzed by LC -MS ,The peptide map ,the protein content suits：The first National Reference Standard for insulin glargine was e glargin ful for r insulin glargine. Methods：The molecular and purity were determinated by HPLC, Restabilished, the content is 0. 937 mg insulin e per mg drug substances. Conclusion：The National Reference Standard has been established. It can be usethe development of analogous drugs produced domestically and the quality control of import medicines.

关 键 词：甘精胰岛素 对照品 

分 类 号：R917[医药卫生—药物分析学]