[關(guān)鍵詞]
[摘要]
烷基磺酸酯和芳基磺酸酯類化合物作為潛在性基因毒性雜質(zhì),嚴重威脅人類健康,因此需要控制食品及藥品中磺酸酯的限度。主要介紹了磺酸酯類物質(zhì)的痕量分析檢測技術(shù)手段,如GC-MS、HPLC-MS、NMR等,同時闡述了各種檢測技術(shù)的優(yōu)缺點。另外,還論述了這些雜質(zhì)產(chǎn)生的條件,從而提出了避免生成該類雜質(zhì)的具體措施。因此,主要從避免雜質(zhì)的產(chǎn)生和痕量檢測兩方面進行了綜述,討論了有效控制藥品中基因毒雜質(zhì)限度的方法,以保證用藥安全。
[Key word]
[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.
[中圖分類號]
[基金項目]