【摘要】 目的:建立重组人血清白蛋白-干扰素α2a融合蛋白(rHSA-IFNα2a)的质控方法和质量标准。方法:分别使用抗HSA抗体和抗IFNα2a抗体、采用免疫印迹法对成品进行鉴别试验,采用WISH细胞病变抑制法测定成品和原液的生物学活性,原液以胰蛋白酶酶切后,用HPLC分析肽图,其余项目按2010年版中国药典(三部)的规定进行检测。结果:样品与抗HSA抗体和抗IFNα2a抗体均呈阳性反应,比活性>1.5×105 IU.mg-1,其肽图与参考品的一致,其余项目均符合2010年版中国药典(三部)的规定,根据检测结果建立了rHSA-IFNα2a的质量标准。结论:建立的质控方法和质量标准可以保证rHSA-IFNα2a的安全、有效和质量可控,可以用于rHSA-IFNα2a的常规检定。更多还原

【Abstract】 Objective:To establish methods and requirements for quality control of recombinant human serum albumin-interferon α2a fusion protein(rHSA-IFNα2a).Methods:Western blotting was carried out using anti-HSA antibody and anti-IFNα2a antibody.Biological activity was assayed by WISH-VSV system.The peptide map was obtained by trypsin digestion and HPLC assay.Other routine tests were all fulfilled according to the ChP(2010).Results:Western blotting was positive.Biological activities were more than 1.5×105 IU·mg-1.HPLC peptide maps paralleled that of reference.Results of other routine tests all complied with the standard requirements.The quality control methods and standards for rHSA-IFNα2a were established accordingly.Conclusion:The established quality control methods and standards for rHSA-IFNα2a are safe and effective,which can be used for routine quality control of rHSA-IFNα2a.更多还原