不同级别聚山梨酯80中残留溶剂的测定及风险分析  

Determination and risk analysis of residual solvents in different grades of polysorbate 80

作　　者：张悦 李昌亮 赵勇 刘雁鸣 谢莹莹 ZHANG Yue;LI Changliang;ZHAO Yong;LIU Yanming;XIE Yingying(Institute of Research on Medicines Inspection and Detection in Hunan Province,Key Laboratory of National Medical Products Administration’s Pharmaceutical Accessories Engineering Technology Research,Hunan,Changsha 410001,China;Center of Medicines Audit and Inspection in Hunan Province,Hunan,Changsha 410001,China)

机构地区：[1]湖南省药品检验检测研究院国家药品监督管理局药用辅料工程技术研究重点实验室,湖南长沙410001 [2]湖南省药品审核查验中心,湖南长沙410001

出　　处：《中国医药科学》2025年第7期60-63,共4页China Medicine And Pharmacy

基　　金：湖南省自然科学基金科药联合基金项目(2023JJ60106,2024JJ8238)。

摘　　要：目的测定不同级别聚山梨酯80(PS80)中溶剂残留,分析产品风险。方法建立顶空气相色谱法,对6批试剂级PS80、22批药用辅料级PS80、28批PS80(Ⅱ)样品中残留溶剂进行测定。结果试剂级、药用辅料级PS80样品均未检出甲醇、丙酮,部分PS80(Ⅱ)样品中检出甲醇、丙酮。结论PS80(Ⅱ)中甲醇、丙酮残留可能与生产工艺有关,企业应不断提升工艺水平,提高产品质量。Objective To determine the residual solvents in different grades of polysorbate 80(PS80),and to analyze the product risks.Methods Headspace gas chromatography was established to determine the residual solvents in 6 batches of reagent grade PS80,22 batches of pharmaceutical excipients grade PS80 and 28 batches of PS80(Ⅱ)samples.Results Neither methanol and acetone were detected in reagent grade an d pharmaceutical excipients grade PS80 samples,while they were detected in some PS80(Ⅱ)samples.Conclusion The residue of methanol and acetone in PS80(Ⅱ)may be related to the production process.Enterprises should constantly improve the process level and increase product quality.

关 键 词：聚山梨酯80 风险分析 残留溶剂 气相色谱法 

分 类 号：R927.2[医药卫生—药学]