亚硫酸盐在药品监督管理中的安全性控制OA北大核心CSTPCD

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.