医药导报2024，Vol.43Issue(5)：727-734,8.DOI:10.3870/j.issn.1004-0781.2024.05.010
亚硫酸盐在药品监督管理中的安全性控制
Safety Control of Sulfites in Drug Supervision
摘要
Abstract
Sulfite-type antioxidants have strong reducing properties and have been widely used for many years as com-mon excipients in foods,cosmetics,and pharmaceuticals.In some injections,such antioxidants are even illegally added to ensure the quality of the drug.The use of antioxidants has solved the problem of some drugs being easily oxidized during high-temperature sterilization and storage,but the toxic side effects caused by this cannot be ignored.The NMPA is gradually paying more attention to the use of sulfites in drugs and the standardisation of drug labelling.In this paper,we collected and analyzed the records and de-tection methods for sulfites(including sulfur dioxide)and other raw materials in pharmacopoeias and other quality standards in domestic and aboard,to provide references for further research,limit value restrict,and policy development on sulfite in drugs.关键词
亚硫酸盐/辅料/安全性/药品监督管理Key words
Sulfite/Auxiliary materials/Safety/Drug supervision分类
医药卫生引用本文复制引用
李恒,李克,吴健鸿,晏菊姣..亚硫酸盐在药品监督管理中的安全性控制[J].医药导报,2024,43(5):727-734,8.基金项目
湖北省食品药品监督管理局科研项目(201801012). （201801012）
