药物中痕量磺酸酯类物质的检测技术研究进展.pdfVIP

- 304 - Drug Evaluation Research 第 35 卷 第 4 期 2012 年 8 月 药物中痕量磺酸酯类物质的检测技术研究进展 1 2 3 1 2* 张园园 ，李银峰 ，王杰晶 ，李 佩 ，靳朝东 1. 天津中医药大学，天津 300193 2. 天津药物研究院 分析测试中心，天津 300193 3. 河南大学，河南 开封 475001 摘 要：烷基磺酸酯和芳基磺酸酯类化合物作为潜在性基因毒性杂质，严重威胁人类健康，因此需要控制食品及药品中磺酸 酯的限度。主要介绍了磺酸酯类物质的痕量分析检测技术手段，如 GC-MS、HPLC-MS 、NMR 等，同时阐述了各种检测技 术的优缺点。另外，还论述了这些杂质产生的条件，从而提出了避免生成该类杂质的具体措施。因此，主要从避免杂质的产 生和痕量检测两方面进行了综述，讨论了有效控制药品中基因毒杂质限度的方法，以保证用药安全。 关键词：基因毒性杂质；磺酸酯；痕量分析；GC-MS ；HPLC-MS ；限度 中图分类号：R991 文献标志码：A 文章编号：1674 - 6376 (2012) 04 - 0304 - 04 Advances in studies on analytical techniques for trace amount of sulfonate esters in pharmaceuticals 1 2 3 1 2 ZHANG Yuan-yuan , LI Yin-feng , WANG Jie-jing , LI Pei , JIN Chao-dong 1. Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China 2. Center of Forecasting and Analysis, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China 3. Henan University, Kaifeng 475001, China Abstract: Alkyl sulfonate esters and aryl sulfonate esters as potential genotoxic impurities badly threatened people’s health. Therefore, it was necessary to control the limit of sulfonate esters in foods and pharmaceuticals. Now the analytical techniques for trace amount of sulfonate esters, for instance, GC-MS, HPLC-MS, and NMR etc, were introduced, and their characteristics were discussed in this paper. It also demonstrated the generation of impurities under various situations and the detailed measures to avoid their formations. In a word, the study mainly summarized the obviation of impurities and determination of them by trace analysis, aiming at discussing the methods used for controling the limit of those sulfonate esters effectively, and then ensuring the safety of medication. Key words: genotoxic impurities; sulfonate esters; trace analysis; GC-MS; HPLC-MS; limit