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。 Recombinant human interferon βser17 (rhIFN βser17) engineered bacteria after fermentation, using high-pressure homogenate broken bacteria, centrifugation inclusion bodies, organic extraction, acid precipitation, Sephacryl S -200, SephadexG -75, etc. were isolated and purified by various Methods The final product was identified. The results showed that the purified rhIFN-βser17 specific activity of more than 2 × 107IU / mg, more than 99% purity, and other quality indicators are in line with the quality standards. The purification process of rhIFN-βser17 was established on the basis of the research and the pure rhIFN-βser17 for injection was developed, which lays the foundation for clinical research.