地高辛探针检测重组肝靶向干扰素宿主DNA残留量的研究  

Testing for Residual DNA in Recombinant Liver- targeting Interferon Using Digoxin Labeled Probe

作　　者：汪洁[1,2] 卢雪梅[1,2] 黄演婷[1,2] 金小宝[1,2] 朱家勇[1,2] 

机构地区：[1]广东药学院药用生物活性物质研究所,广东广州510006 [2]广东省生物活性药物研究重点实验室,广东广州510006

出　　处：《生物技术》2014年第5期80-83,共4页Biotechnology

基　　金：国家科技部新药创制重大专项资助项目("CSP I-plus修饰的肝靶向IFN抗HBV的成药性研究";No.2013ZX09103003-003)

摘　　要：目的:建立检测重组肝靶向干扰素宿主DNA残留量的方法,根据此法检测3批重组肝靶向干扰素每人份剂量宿主DNA残留量。方法:以重组肝靶向干扰素工程菌基因组DNA为模板,并制备探针,用此标记探针对3批重组产品进行DNA残留量检测。结果:3批次重组肝靶向干扰素原液每人份剂量宿主DNA残留量均小于10 ng。结论:地高辛标记探针斑点杂交检测DNA残留量具有特异性强,灵敏度高,重现性好,操作简单,能快速高效检定重组肝靶向干扰素原液并对其制备过程进行质量监控。Objective： To establish a detection method analyzing the residual DNA in recombinant liver- targeting interferon by using digoxigenin- labeled probe,using this method to detect the residual DNA in three batches of bulk products for per person. Method： Genomic DNA of engineering bacteria of recombinant liver- targeting interferon was labeled by digoxin and used as probe for hybridization assay of residual DNA in three batches samples. Result： The residual DNA in three batches of bulk products is less than 10 ng per dosage for per person. Conclusion： This method is specific,sensitive and convenient,which could be used for the process quality control and efficient testing of recombinant liver- targeting interferon and standardization of bulk products.

关 键 词：地高辛 重组肝靶向干扰素 斑点杂交 DNA残留量 

分 类 号：R917[医药卫生—药物分析学]