一次性使用无菌阴道扩张器中环氧乙烷残留量测定的影响因素考察

Study on Factors Influencing the Determination of Residual Ethylene Oxide in Disposable Aseptic Vaginal Dilators

目的考察扩张器中环氧乙烷残留量测定的影响因素。方法采用顶空气相色谱法测定扩张器中环氧乙烷残留量,从材质、碎片面积、拆开单包装放置时间和碎片水浸泡时间四个方面来考察对结果的影响。结果扩张器采用聚苯乙烯材质,更易吸附环氧乙烷;样品前处理时,碎片面积越小,环氧乙烷越容易析出,含量越高;将扩张器拆开单包装放置,在短时间内对环氧乙烷的析出影响不大,无变化规律;样品前处理时,室温下碎片在顶空瓶中水浸泡时间越长,环氧乙烷析出量越多,且影响较大。结论通过考察影响因素,可以在测定扩张器环氧乙烷残留量的过程中,尽量排除这些因素的干扰,达到准确测量的目的。

Objective To study the factors influencing the determination of residual ethylene oxide in vaginal dilators.Methods Ethylene oxide residues in dilators were determinated by headspace gas chromatography.The influence on the results was investigated from four aspects:material,area of debris,placement time after removing package and soaking time of debris in water.Results The dilators made of polystyrene adsorbed ethylene oxide easily.The smaller the debris area,the easier it was to precipitate ethylene oxide and the higher ethylene oxide content during sample pretreatment.Short placement time after removing package had little effect on the precipitation of ethylene oxide.At room temperature,the longer the debris was soaked in the water of the top bottle,the more ethylene oxide was precipitated with great effect.Conclusion By studying the influencing factors,we can eliminate the interference of these factors and achieve the purpose of accurate measurement in the process of determining ethylene oxide residues from dilators.