一次性输液器组成材料的可提取物研究

Study on extractables in disposable syringe materials

针对5个不同厂家的一次性输液器进行提取试验,采用顶空GC-MS对其中易挥发性物质进行分析,采用GC-MS对其中挥发和半挥发性物质进行分析,电离方式EI,质量扫描范围m/z 30~650。采用香兰素作为内标物监控整个处理过程,并分别比较液-液萃取法和固相萃取法两种提取方法的差异。提取试验分别选择HCl,NaOH,吐温80,乙醇-水溶液作为提取溶剂,比较一次性输液器组成材料中可提取物的种类差异。结果表明,所建立的分析测试方法可靠,能够准确、灵敏地检测出输液器中所含的挥发性成分,获得材料中可提取物的信息,从而达到对一次性输液器安全性考察的目的。

Extraction experiment of volatile compounds in disposable syringes from five manufacturers was undertaken by GC-MS with high-space injection and semi-volatile compounds were tested by GC-MS.MS detection ranged from 30 to 650 with electron ionization（EI）source.Vanillin was used as internal standard to monitor the sample pretreatment process.Liquid-liquid extraction（LLE）and solid-phase extraction（SPE）were compared to acquire a simple processing method with more extractables in syringe materials.HCl,NaOH,Tween 80 and ethanol-aqueous solution were used as extraction solvents.The method was successfully developed to determine the unknown volatile extractables and the results were used to investigate the safety of disposable syringes comprehensively.