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生物合成人胰岛素的研究、开发、生产及安全性。

Research, development, production, and safety of biosynthetic human insulin.

作者信息

Chance R E, Frank B H

机构信息

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.

出版信息

Diabetes Care. 1993 Dec;16 Suppl 3:133-42. doi: 10.2337/diacare.16.3.133.

DOI:10.2337/diacare.16.3.133
PMID:8299470
Abstract

This paper provides some historical aspects on the research and development of Humulin (rDNA origin), the first human health-care product derived from rDNA technology more than a decade ago. Also referred to as biosynthetic human insulin, Humulin is currently produced via the human proinsulin route, using an Escherichia coli fermentation process. The authenticity, high purity, and safety of BHI has been investigated and verified by a complex battery of analytical and physicochemical methods. The daily treatment of more than two million diabetic patients worldwide with this rDNA human insulin not only demonstrates the value of rDNA technology in providing an important medical product, it is assurance that diabetic patients will have unlimited supplies of this vital hormone as well as potential analogue refinements.

摘要

本文介绍了十多年前首个源自重组DNA技术的人类保健产品优泌林(重组DNA来源)研发的一些历史情况。优泌林也被称为生物合成人胰岛素,目前通过人胰岛素原途径,利用大肠杆菌发酵工艺生产。已通过一系列复杂的分析和物理化学方法对优泌林的真实性、高纯度和安全性进行了研究和验证。全球超过两百万糖尿病患者每天使用这种重组DNA人胰岛素,这不仅证明了重组DNA技术在提供重要医疗产品方面的价值,也确保糖尿病患者将能获得这种重要激素的无限供应以及潜在的类似物改进产品。

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1
Research, development, production, and safety of biosynthetic human insulin.生物合成人胰岛素的研究、开发、生产及安全性。
Diabetes Care. 1993 Dec;16 Suppl 3:133-42. doi: 10.2337/diacare.16.3.133.
2
Cytoplasmic inclusion bodies in Escherichia coli producing biosynthetic human insulin proteins.产生生物合成人胰岛素蛋白的大肠杆菌中的细胞质包涵体。
Science. 1982 Feb 5;215(4533):687-9. doi: 10.1126/science.7036343.
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Preliminary studies on the immunogenicity and amount of Escherichia coli polypeptides in biosynthetic human insulin produced by recombinant DNA technology.重组DNA技术生产的生物合成人胰岛素中大肠杆菌多肽的免疫原性及含量的初步研究。
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Production scale purification of biosynthetic human insulin by reversed-phase high-performance liquid chromatography.通过反相高效液相色谱法对生物合成人胰岛素进行生产规模的纯化。
J Chromatogr. 1989 Jan 6;461:45-61. doi: 10.1016/s0021-9673(00)94274-2.
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Human insulin prepared by recombinant DNA techniques and native human insulin interact identically with insulin receptors.通过重组DNA技术制备的人胰岛素与天然人胰岛素和胰岛素受体的相互作用完全相同。
Proc Natl Acad Sci U S A. 1981 Mar;78(3):1391-5. doi: 10.1073/pnas.78.3.1391.
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Increased production of low molecular weight recombinant proteins in Escherichia coli.大肠杆菌中低分子量重组蛋白产量的增加。
Protein Sci. 1997 Sep;6(9):1953-62. doi: 10.1002/pro.5560060916.
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[Preparation of recombinant human insulin--study of downstream process].[重组人胰岛素的制备——下游工艺研究]
Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2004 Oct;21(5):805-8.
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The synthesis of insulin in bacteria: a model for the production of medically useful proteins in prokaryotic cells.细菌中胰岛素的合成:在原核细胞中生产医学上有用蛋白质的模型。
Birth Defects Orig Artic Ser. 1980;16(1):53-68.
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Proc Natl Acad Sci U S A. 1981 Sep;78(9):5401-5. doi: 10.1073/pnas.78.9.5401.

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