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

亚硫酸盐类抗氧化剂具较强的还原性,多年来作为常用辅料广泛应用于食品、化妆品及药品中,某些注射剂中甚至非法添加此类抗氧化剂以保证药品质量。抗氧剂的使用解决了部分药物在高温灭菌和储存过程中易被氧化的难题,但由此引发的毒副反应不容忽视。中国药品监督管理部门对亚硫酸盐在药品中使用以及药品标签规范等方面的管理十分重视。该文全面汇总和分析了国内外药典及其他质量标准中亚硫酸盐类及其他原辅料、制剂中亚硫酸盐(包括二氧化硫)的检测方法收载情况,为进一步开展药品中亚硫酸盐检测方法研究、限度制定及相关政策制定提供参考。

Sulfite-type antioxidants have strong reducing properties and have been widely used for many years as common 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 detection 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.