高效液相色谱-串联质谱法快速测定敷贴类医疗器械中非法添加的23种化学成分

Rapid Determination of 23 Illegal Chemical Components in Adhesive Medical Devices by High-Performance Liquid Chromatography-Tandem Mass Spectrometry

目的:建立敷贴类医疗器械中非法添加的23种化学成分的快速测定方法。方法:采用高效液相色谱-串联质谱法,以临床应用较为广泛的23种拟肾上腺素和抗组胺药物为研究对象,建立了一种同时测定敷贴类医疗器械中23种非法添加化学成分的检测方法。使用Hypersil Gold 100mm×2.1mm,1.9μm为分析色谱柱,流动相采用0.01mol/L乙酸铵(含0.1%甲酸)水溶液-乙腈进行梯度洗脱;体积流量0.2mL/min;柱温40℃;电喷雾离子源正负离子扫描模式;多反应检测模式检测,对敷贴类医疗器械中23种非法添加成分进行测定。结果:建立了快速分离检测敷贴类医疗器械中23种非法添加化学成分的测定方法,有1批样品检出马来酸氯苯那敏,1批样品检出盐酸萘甲唑林。结论:该方法简便、快速、准确、灵敏度高,可作为医疗器械中非法添加化学药物的检测方法,为敷贴类医疗器械的监管提供了有力的技术支撑。

Objective:To establish a rapid method for the determination of 23 kinds of chemical components illegally added in applied medical devices.Methods:Using high-performance liquid chromatography-tandem mass spectrometry,a detection method was established to simultaneously determine the illegal additives of 23 sympathomimetic and antihistamine drugs commonly used in clinical practice in adhesive medical devices.High-performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS)was used with Hypersil Gold 100mm×2.1mm,1.9μm column.The mobile phase was eluted with 0.01mol/L ammonium acetate(containing 0.1%formic acid)aqueous solution and acetonitrile;Volume flow rate 0.2mL/min;Column temperature 40℃;Electrospray ion source positive and negative ion scanning mode;Multiple response detection mode detection was used to determine 23 illegal additives in applied medical devices.Results:A rapid separation and detection method for 23 kinds of illegal chemical components in applied medical devices was establishedChlorpheniramine maleate was detected in 1 batch of samples,and naphthozoline hydrochloride was detected in 1 batch of samples.Conclusion:The method is simple,rapid,accurate and sensitive,and can be used as a detection method for illegal addition of chemical drugs in medical devices,which provides a strong technical support for the supervision of applied medical devices.