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化学进展 2010, Vol. 22 Issue (0203): 482-488 前一篇   后一篇

• 综述与评论 •

离子交换色谱在药用质粒分析中的应用*

张敏莲**;胡丁;刘孟儒;孔宪   

  1. （清华大学化学工程系 北京 100084）
  • 收稿日期:2009-03-13 修回日期:2009-05-12 出版日期:2010-03-24 发布日期:2010-03-18
  • 通讯作者: 张敏莲 E-mail:zhangminlian@mail.tsinghua.edu.cn
  • 基金资助:

    国家自然科学基金项目;国家自然科学基金

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Application of Ion Exchange Chromatography for Pharmaceutical Plasmid Analysis

Zhang Minlian**; Hu Ding; Liu Mengru; Kong Xian   

  1. （Department of Chemical Engineering, Tsinghua University, Beijing 100084, China）
  • Received:2009-03-13 Revised:2009-05-12 Online:2010-03-24 Published:2010-03-18
  • Contact: Zhang Minlian E-mail:zhangminlian@mail.tsinghua.edu.cn
  • Supported by:

    National Natural Science Foundation of China;National Natural Science Foundation of China

基因治疗和DNA疫苗在重大疾病的诊断和治疗方面具有广阔的前景，而分离过程的实时监测以及产品质量和规格的评定对于质粒制备过程开发、认证、产品批准至关重要。本文对阴离子交换色谱在药用质粒分析方面的应用与研究进展进行综述。目前应用于药用质粒制备过程流分析的离子交换色谱介质包括多孔、灌注、薄壳和非多孔等四种类型。文中概述了4类色谱介质在质粒和杂质以及质粒拓扑异构体分析中的应用现状并进行了对比，对于离子交换色谱分析方法在药用质粒分析过程中存在问题以及发展趋势进行了评述。

关键词： 基因治疗, DNA疫苗, 质粒, 离子交换色谱

Gene therapy and DNA vaccines have shown a great potential for the cure and diagnosis of important diseases. The monitoring of the downstream procedure, as well as the assessment of final product purity and specifications, is a key issue in process validation and final product approval. In this review, the application of anion exchange chromatography to pharmaceutical plasmid analysis was reviewed. There are four types of chromatography media for plasmid analysis, including poros, perfusion, pellicular and non poros media. The separation and analysis properties of the four types of chromatography media on plasmid with impurities and plasmid with other isoformers are summarized and compared with each other. The main problems and future prospects are discussed from the viewpoint of practical application.

Contents
1 Introduction
2 Manufacture process of pharmaceutical plasmid and the analysis of the streamline
3 Application of ion exchange chromatography to plasmid analysis
3.1 Principle of ion exchange chromatography for plasmid analysis and the type of the separation media
3.2 Poros ion exchange chromatography media
3.3 Perfusion ion exchange chromatography media
3.4 Pellicular ion exchange chromatography media
3.5 Non poros ion exchange chromatography media
4 Comparison of ion exchange chromatography media for plasmid analysis
4.1 Separation of plasmid with impurities
4.2 Analysis of plasmid isoformers
4.3 Quantitation of plasmid
5 Conclusions and prospects

Key words: gene therapy, DNA vaccine, plasmid, ion exchange chromatography

中图分类号: 

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