介绍了一种成本低、步骤少、简单易行的质粒纯化制检工艺。该工艺选择优势产生超螺旋质粒的大肠杆菌菌株以无蛋白质培养基进行发酵罐培养,采用碱裂解法,对质粒制备过程中所用的层析吸附材料、核酸结合溶液、去除内毒素等杂质的方法和浓缩等步骤进行了实用性改进,并建立了相应的检定方法,所得质粒的纯度达到临床级要求。 Introduced a low cost, less steps, simple and easy plasmid purification of the inspection process. The process selects the supercoiled plasmids producing Escherichia coli strains in a fermentor-free culture medium, using alkaline lysis method, the plasmid preparation process used in the chromatographic adsorbent, the nucleic acid binding solution, the method of removing endotoxin and other impurities And enrichment steps such as practical improvements, and the establishment of a corresponding test method, the purity of the resulting plasmid to meet clinical requirements.