药物中邻苯二甲酸酯类的检测研究进展及其风险评估  

Research progress in the detection and risk assessment of phthalic acid esters in drugs

作　　者：许学丽 魏伟 王洪明 陈敏敏 郝成杰 王辉 王小兵 Xu Xueli;Wei Wei;Wang Hongming;Chen Minmin;Hao Chengjie;Wang Hui;Wang Xiaobing(Binzhou Inspection and Testing Center,Binzhou 256600,Shandong,China;Shandong Phoenix Pharmaceutical Co.,Ltd.,Dongying 257400,Shandong,China;Shandong Institute for Food and Drug Control,Jinan 250000,Shandong,China)

机构地区：[1]滨州市检验检测中心,滨州256600 [2]山东凤凰制药股份有限公司,东营257400 [3]山东省食品药品检验研究院,济南250000

出　　处：《分析仪器》2025年第2期1-8,共8页Analytical Instrumentation

基　　金：滨州市农社领域科技创新政策引导计划项目(2022SHFZ047)。

摘　　要：综述了药物中邻苯二甲酸酯类(phthalate acid esters,PAEs)的前处理方法、检测方法进展,并对文献中报道的检出邻苯二甲酸酯类成分进行了风险评估。随着提取方式的发展,分散液液微萃取、QuEChERS、磁性固相萃取等新兴提取方式,具备提取效率高,环保无害等优点,应用将越来越广泛。气相色谱-质谱联用法、液相色谱-质谱联用法仍是目前邻苯二甲酸酯类的常用检测方法,酶免疫分析法、拉曼光谱法、电化学法等新方法也有越来越多的应用。药物中邻苯二甲酸酯类成分的风险评估提示,薄膜衣片及聚乙烯薄膜包装的药物中检出的比例更高,五味子油萃取装置的部件含有DBP、DEHP,导致五味子油中检出较多DBP、DEHP,其中DEHP致癌风险达到中等。本文为药物中PAEs的检测、风险评估及药物的工艺改进提供参考。The progress of pre-treatment and detection methods for phthalate acid esters(PAEs)in drugs is reviewed,and a risk assessment is carried out on the detected PAEs reported in the literatures.With the development of extraction methods,emerging extraction methods such as liquid-liquid microextraction,QuEChERS,and magnetic solid-phase extraction have the advantages of high extraction efficiency and environmental friendliness,and their applications will become increasingly widespread.Gas chromatography-mass spectrometry and liquid chromatography-mass spectrometry are still commonly used detection methods for PAEs,and new methods such as enzyme immunoassay,Raman spectroscopy,and electrochemical methods are also increasingly being applied.The risk assessment of PAEs in drugs suggests that the proportion of the detected PAES is higher in film coated tablets and drugs packaged with polyethylene films.The components of the Schisandra oil extraction device contain DBP and DEHP,which leads to the detection of more DBP and DEHP in Schisandra oil.Among them,the carcinogenic risk of DEHP is moderate.This article provides reference for the detection,risk assessment,and process improvement of PAEs in drugs.

关 键 词：邻苯二甲酸酯类 前处理方法 检测方法 风险评估 

分 类 号：R917[医药卫生—药物分析学]