注射用重组人干扰素βser17的分离纯化及鉴定

Purification and identification of recombinant human IFN-β ser17 for injection

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。

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.