直接实时分析质谱超速分析在药品监管中的应用  

Ultra Speed Direct Analysis in Real Time Mass Spectrometry (DART-MS) for Drug Administration

作　　者：王铁松[1] 张喆[1] 赵明[1] 车宝泉[1] 高青[1] 王威[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国药学杂志》2011年第9期699-703,共5页Chinese Pharmaceutical Journal

摘　　要：目的建立直接实时分析质谱(DART-MS)超速分析方法应用于药品监管检验工作。方法 DART-MS将实时直接分析离子源(DART)与离子阱质谱联用,离子源放电电压为4 kV,载气为氦气,流速为6 L.min-1,温度为400℃。在不进行样品色谱分离的前提下,直接分析被测物质或其溶液。结果 DART-MS与液质联用相比检定效率提高近50倍,对西地那非、米诺地尔等已知物质可在20 s内检测出,对未知衍生物可在4 min内完成其多级质谱研究,对传统液相色谱法难以分析的辅料如混合脂肪酸甘油酯等也能准确分析。结论 DART-MS样品处理简单,方法准确速度快,能广泛应用于非法添加、药物污染、制剂辅料成分的快速检定,开创了药品监管的新方法,能有效提高对突发安全事件的反应能力。OBJECTIVE To establish an ultra speed direct analysis in real time（DART）-ion trap mass spectrometry method for screening of shampoo and herbal remedies for the presence of illegal additives.METHODS The DART temperature was 400 ℃,the helium flow rate was 6 L·min-1 and the mass cone voltage was 4 kV.The solution was directly screened using a 12-DIP sampler.RESULTS The speed of DART-MS was 50 times faster than that of LC-MS for identifying the additives including minoxidil,sildenafil,and mixed glycerides.CONCLUSION Each additive studied was rapidly identified within 20 seconds by DART-MS/MS,suggesting this technique can be used for drug administration.However,its sensitivity and quantitation still requires further study and improvement.

关 键 词：直接实时分析质谱 米诺地尔 西地那非 辅料 快速检测 

分 类 号：R917[医药卫生—药物分析学]