【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。更多还原

【Abstract】 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 2.59×107 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 rhIFN-β1b.Purified product of rhIFN-β1b for injection was prepared by the procedure.It laid a foundation of clinical study on rhIFN-β1b.更多还原