注射用重组人干扰素β1b的分离纯化及质量研究  

Purification and quality control of recombinat human IFN-β1b for injection

作　　者：张振龙[1] 刘建源 杨云凯 崔春青[1] 邓宛明[1] 汤燕文[1] 赵建英[1] 郭秀梅[1] 郭鹏[1] 

机构地区：[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

出　　处：《中国新药杂志》2005年第7期887-890,共4页Chinese Journal of New Drugs

摘　　要：目的:研制注射用重组人干扰素β1b(rhIFN-β1b)并对其质量进行鉴定。方法: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:纯化的rhIFN-β1b比活性平均为2·59×107IU·mg-1,纯度超过99%,复性纯化后平均活性回收率为51·89%,其他各项技术指标均符合质量控制标准。结论:建立了大规模制备rhIFN-β1b的纯化工艺,研制出了符合规程要求的注射用rhIFN-β1b纯品,为临床研究奠定了基础。Objective：To prepare recombinant human IFN-β1b for injection and investigate the quality. Methods：The E. coli was homogenized and the inclusion bodies were collected. The rhIFN-β1b was purified by organic extraction, acid precipitation, Sephacryl S-200 and Sephadex G-75 chromatography, etc. The final product was identified by various method. Results：The specific activity and purity of rhIFN-β1b purified by the procedure were 2.59 × lO7 IU·mg^-1 and 99%, respectively. The mean recovery rate was 51.89%. All the items of the rhIFN-β1b met the standard for quality control. Conclusion：The large-scale purification procedure was set up for rhlFN-β1b.Purified product of rhlFN-β1b for injection was prepared by the procedure. It laid a foundation ofclinical study on rhlFN-β1b.

关 键 词：重组人干扰素β1b 纯化 质量 材料 

分 类 号：R927.2[医药卫生—药学] R977.6