外用药膏中非法化合物快速检测技术研究

IF 1.8 4区 医学 Q4 BIOCHEMICAL RESEARCH METHODS
Xiaoan Li, Yaning Cui, Li Liu, Longjiang Guo, Yudong Liu, Xuegao Song, Na Song, Jianzhong Jia, Zhuanping Zhang
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引用次数: 0

摘要

可以缓解各种颈椎和腰椎疼痛的局部膏药和应用医疗器械可能含有非法药物添加剂或类似物,具有额外的健康风险,但客户可能不知道他们使用的是什么。国家药品监督管理局于2022年1月审定批准了山东省医疗器械药品包装检验研究所起草的《贴附医疗器械中17种化学物质鉴定及含量测定补充试验方法》,但该试验方法样品处理简单,难以提取膏体中的化学成分,可能造成大多数非法添加化学药品漏检现象。本工作对样品处理和提取方法进行了改进和优化,采用HPLC-MS/MS法对47批贴装医疗器械中非法添加化学物质的含量进行了检测,共检出37批,非甾体类抗炎药尼美舒利和阿司匹林检出最多。它表明,在医疗器械中添加了非法化学药物,许多人可能每天服用几种不同的补充剂,并且接触到相当高水平的有毒化合物。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Study on Rapid Detection Technology of Illegal Chemical Compounds Added to External Poultices

Topical poultices and applied medical devices that can relieve a variety of cervical vertebrae and lumbar vertebrae pain may have illegal additives of pharmaceutical drugs or analogues have additional health risks, but customers may not be aware of what they are using. National Medical Products Administration reviewed and approved “Supplementary test method for identification and content determination of 17 chemicals in affixed medical devices” drafted by Shandong Provincial Institute of Medical Devices and Drug Packaging Inspection in January 2022, but the test method is simple in sample processing and difficult to extract the chemical components in the paste that may cause the phenomenon of missing detection of most illegal added chemical drugs. In this work, the sample handling and extraction methods have been improved and optimized, the content of illegal added chemicals in 47 batches of affixed medical devices was determined by HPLC-MS/MS method and was detected in 37 batches, and the non-steroidal anti-inflammatory drug nimesulide and aspirin were detected in most samples. It shows that there are illegal chemical drugs added in the medical devices and many people may take several different supplements daily and encounter quite high levels of combined exposure to toxic compounds.

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来源期刊
Biomedical Chromatography
Biomedical Chromatography 生物-分析化学
CiteScore
3.60
自引率
5.60%
发文量
268
审稿时长
2.3 months
期刊介绍: Biomedical Chromatography is devoted to the publication of original papers on the applications of chromatography and allied techniques in the biological and medical sciences. Research papers and review articles cover the methods and techniques relevant to the separation, identification and determination of substances in biochemistry, biotechnology, molecular biology, cell biology, clinical chemistry, pharmacology and related disciplines. These include the analysis of body fluids, cells and tissues, purification of biologically important compounds, pharmaco-kinetics and sequencing methods using HPLC, GC, HPLC-MS, TLC, paper chromatography, affinity chromatography, gel filtration, electrophoresis and related techniques.
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