质粒DNA作为生物药剂(尤其作为基因治疗和基因疫苗的载体)的意义和需求越来越大。质粒DNA作为一种新的非病毒转基因载体,优点是安全可靠、稳定、对外源基因的容纳量大、不会引起免疫系统反应及易于生产等。随着基因治疗和DNA疫苗从实验室进入临床研究和批准上市,必须开发出一个经济、简单以及高重复性的质粒分离纯化生产工艺,使其质量达到临床应用的标准。近年来,国外针对生物药剂质粒DNA的分离纯化,开发了机械破碎、碱法裂解等工艺破碎细胞释放质粒,离心或过滤分离细胞碎片、变性蛋白和核酸,醋酸盐和聚乙二醇等澄清和浓缩质粒DNA提取液,反相色谱、离子交换色谱、分子筛色谱,三链DNA-亲和色谱纯化超螺旋质粒DNA等...With ongoing identification of functional genes modern medical treatments like genetic vaccination or gene therapy are beginning to evolve because with these novel therapies illness can be cured at the genetic level (genotype) and not by treating the symptoms (phenoptype). Production of nucleic acids as an active pharmaceutical ingredient (API) in gene therapy and genetic vaccination is gaining mo...学位:工学硕士院系专业:化学化工学院化学工程与生物工程系_化学工程学号:20033300