首批DNA重组人胰岛素国家标准品的建立  

Calibration of the First National Standard for Recombinant DNA-derived Human Insulin(rhInsulin)

作　　者：李湛君[1] 杨昭鹏[1] 孙磊[1] 李赣忠[1] 齐卫红[1] 徐康森[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国生化药物杂志》1998年第3期113-115,共3页Chinese Journal of Biochemical Pharmaceutics

摘　　要：我国现行的第8次胰岛素国家标准品是猪胰岛素，而国内DNA重组人胰岛素（rh－Insulin）已获新药证书，其质量标准已被我国部颁标准收载，拟上2000版中国药典。因此迫切需要建立与临床供试品同质的国家标准品，为此制备、标定了第一次rh-Insulin国家标准品。经生物测定和HPLC测定，活性效价定为26IU／mg。The 8th National Standard (NS) for insulin established in 1987 consist of impure porcine insulin and is not suitable as standard for the assay of highly purified single-species recombinant human insulin presently used in the treatment of diabetes. The preparation of rh-lnsulin has now been studied and calibrated. It was assayed agains the 1st IS for human insulin and USP referent standard for human insulin by using bioassay and physico-chemical assay (HPLC). The preparation coded 06299801 and was established as the 1st NS for rh-Insulin in terms of International Units, with defined 26.0 IU/mg.

关 键 词：重组 胰岛素 国家标准品 rh-Insulin 

分 类 号：R977.15[医药卫生—药品] TQ467.32[医药卫生—药学]