【摘要】 目的:建立重组人p43蛋白原液中宿主DNA残留量的检测方法。方法:以重组人p43工程菌基因组DNA为模板,制备地高辛标记的探针,并以此探针与阳性对照品及供试品进行杂交及显色反应。结果:3批次重组人p43蛋白原液中每人份剂量的宿主DNA残留量均小于10 ng。结论:该方法灵敏度高,特异性强,重复性好,操作安全简便,可用于重组人p43制备过程中的原液检定及质量监控。更多还原

【Abstract】 Objective:To establish a method for testing the residual DNA in recombinant human p43 using digoxin labeled probe.Methods:Genomic DNA of bacteria engineered to contain recombinant human p43 was labeled by digoxin and used as probe for hybridization assay of residual DNA in bulk products of recombinant human p43 protein.Results:The residual DNA in three batches of bulk products is less than 10 ng per dosage for per person.Conclusion:This method is sensitive,specific and convenient,and can be well repeated,which could be used for the quality control of recombinant human p43 protein and standardization of bulk products.更多还原