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| 首批DNA重组人胰岛素国家标准品的建立 | |
| 引用本文： | 李湛君 杨昭鹏. 首批DNA重组人胰岛素国家标准品的建立[J]. 中国生化药物杂志, 1998, 19(3): 113-115 |
| 作者姓名： | 李湛君 杨昭鹏 |
| 作者单位： | 中国药品生物制品检定所!北京，100050，中国药品生物制品检定所!北京，100050，中国药品生物制品检定所!北京，100050，中国药品生物制品检定所!北京，100050，中国药品生物制品检定所!北京，100050，中国药品生物制品检定所!北京，100050 |
| 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。 |
| 关 键 词： | DNA重组人胰岛素 国家标准品 |
Calibration of the First National Standard for Recombinant DNA-derived Human Insulin(rhInsulin) |
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| Li Zhanjun, Yang Zhaopeng, Sun Lei, Li Ganzhong, Qi Weihong, Xu Kangsen. Calibration of the First National Standard for Recombinant DNA-derived Human Insulin(rhInsulin)[J]. Chinese Journal of Biochemical Pharmaceutics, 1998, 19(3): 113-115 | |
| Authors: | Li Zhanjun Yang Zhaopeng Sun Lei Li Ganzhong Qi Weihong Xu Kangsen |
| Affiliation: | Li Zhanjun; Yang Zhaopeng; Sun Lei; Li Ganzhong; Qi Weihong; Xu Kangsen (National Institute for Control Pharmaceutical and Biological Product (Beijing 100050 |
| Abstract: | 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. |
| Keywords: | rh-Insulin National standard |
| 本文献已被 CNKI 维普 等数据库收录！ | |