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一次性输液器组成材料的可提取物研究

Study on extractables in disposable syringe materials

  • 摘要: 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。

     

    Abstract: 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.

     

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