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注射用重组人干扰素βser17的分离纯化及鉴定
引用本文:张振龙,刘建源,杨云凯,崔春青,邓宛明,汤燕文,赵建英,郭秀梅,郭鹏.注射用重组人干扰素βser17的分离纯化及鉴定[J].微生物学免疫学进展,2005,33(1):32-35.
作者姓名:张振龙  刘建源  杨云凯  崔春青  邓宛明  汤燕文  赵建英  郭秀梅  郭鹏
作者单位:1. 北京生物制品研究所,北京,100024
2. 北京天坛生物制品股份有限公司,北京,100024
摘    要:重组人干扰素βser17(rhIFN βser17)工程菌经发酵培养后,采用高压匀浆破菌、离心分离包涵体、有机抽提、酸沉淀、SephacrylS -200、SephadexG -75等进行分离纯化,通过各种方法对终产品进行鉴定。结果显示,纯化的rhIFN- βser17比活性超过 2×107IU/mg,纯度超过 99%,其它各项质量指标均符合质量标准。通过研究建立了大规模制备rhIFN- βser17的纯化工艺,研制出了符合规程要求的注射用rhIFN -βser17纯品,为临床研究奠定了基础。

关 键 词:重组人干扰素βser17  纯化  鉴定
文章编号:1005-5673(2005)01-0032-04
修稿时间:2004年9月21日

Purification and identification of recombinant human IFN-β ser17 for injection
ZHANG Zhen-long ,LIU Jian-yuan ,YANG Yun-kai ,et al..Purification and identification of recombinant human IFN-β ser17 for injection[J].Progress In Microbiology and Immunology,2005,33(1):32-35.
Authors:ZHANG Zhen-long  LIU Jian-yuan  YANG Yun-kai  
Institution:ZHANG Zhen-long~ 1,LIU Jian-yuan~ 1,YANG Yun-kai~ 2,et al.
Abstract:The rhIFN-β ser17 was purified by means of disruption of bacteria by homogenizer, separation of inclusion body by centrifugation, organic extraction, acid precipitation,Sephacryl S-200 and Sephadex G-75 chromatography etc. The final product was identified and the results showed that the specific activity and purity of purified rhIFN-β ser17 reached above 2×10~ 7IU/mg and 99% respectiviely. All specifications of the rhIFN-β ser17 met the standards for quality control. The large-scale purification procedure was set up in this study,by which the purified product of rhIFN-β ser17 for injection was prepared. It laid a foundation of clinical study on rhIFN-β ser17.
Keywords:Recombinant human IFN-β ser17  Purification  Identification
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