对贴敷类医疗器械中非甾体抗炎药非法添加检验方法的探究  

Exploration of the Testing Method for Illegal Addition of Nonsteroidal Anti-Inflammatory Drugs in Adhesive Medical Devices

作　　者：战佳慧 韩昀初 姜晨阳 王妙 鲁刚 ZHAN Jiahui;HAN Yunchu;JIANG Chenyang;WANG Miao;LU Gang(Weihai Institute of Food and Drug Inspection and Testing,Weihai 264200,China)

机构地区：[1]威海市食品药品检验检测研究院,山东威海264200

出　　处：《山东化工》2025年第6期160-162,共3页Shandong Chemical Industry

摘　　要：国家药品监督管理局网站发布国家医疗器械监督抽检结果的通告(2023年第50号),其中,29家医疗器械公司产品抽检不符合标准规定,9家医疗器械公司产品涉及药物添加。目前,不少以物理控温、穴位刺激等原理的贴敷类医疗器械产品中通过加入化学药物来达到预期效果,例如:医用冷敷贴、退热贴等中主要非法添加的非甾体抗炎药物有氨基比林、对乙酰氨基酚、水杨酸甲酯、酮洛芬、萘普生、保泰松、氟比洛芬、布洛芬、吲哚美辛等九种。主要对上述九种化学药物的检测方法进行探究,采用高效液相色谱条件进行优化,探究测定贴敷类医疗器械产品中这九种非甾体抗炎药成分的检测方法,结果表明,色谱柱为Shim-pack GIST C_(18)(4.6 mm×250 mm,5μm)、检测波长为220 nm、柱温30℃、采用梯度洗脱方式,可快速、精确、可靠的实现对非法添加药物的检测,同时,为相关市场监管工作提供对策与参考。The website of the National Medical Products Administration has released a notice(No.50 of 2023)on the results of national medical device supervision and sampling.Among them,29 medical device companies'products did not meet the standard requirements during sampling,and 9 medical device companies'products involved drug additives.At present,many adhesive medical devices based on principles such as physical temperature control and acupoint stimulation achieve the expected effect by adding chemical drugs.For example,the main non steroidal anti-inflammatory drugs illegally added in medical cold compress patches,antipyretic patches,etc.include nine types:aminopyrine,acetaminophen,methyl salicylate,ketoprofen,naproxen,prednisone,flurbiprofen,ibuprofen,indomethacin,etc.The detection methods for the nine chemical drugs mentioned above were mainly explored,and high-performance liquid chromatography conditions were optimized to explore the detection methods for these nine nonsteroidal anti-inflammatory drug components in adhesive medical device products.The results showed that the chromatographic column was Shim pack GIST C_(18)(4.6 mm×250 mm,5μm),the detection wavelength was 220 nm,the column temperature was 30℃,and the gradient elution method was used,which could quickly,accurately,and reliably detect illegally added drugs.At the same time,it provided countermeasures and references for relevant market supervision work.

关 键 词：贴敷类医疗器械 非甾体抗炎药 高效液相色谱法 液质联用法 

分 类 号：TQ460[化学工程—制药化工]