辐照灭菌后医用口罩溢出异味成分分析和检测

Analysis and detection of odor components of medical masks spilled after irradiation sterilization

目的研究采用辐照灭菌后医用口罩中溢出异味物质的种类,确定其成分并建立气相色谱定量方法。方法采用气相色谱比较了医用口罩不同灭菌方式溢出异味成分的差异,采用气相色谱-质谱联用仪分析辐照灭菌后医用口罩溢出异味成分结构,确定组成成分,并建立其气相色谱定量方法。结果对比医用口罩灭菌前和采用环氧乙烷灭菌,辐照灭菌的医用口罩产生的挥发性成分较多,主要有酮类、酸类、芳香烃类和硅氧烷结构类等物质;建立了丙酮、环氧乙烷和其他挥发性成分的定量方法,结果显示,丙酮在0.8~8μg/g的线性范围内具有良好线性关系(r=0.9950),检出限(s/n=3)为0.2μg/g,在3个加标水平下得到的回收率为82.1%~98.3%,标准偏差为6.8%;环氧乙烷在0.8~12μg/g的线性范围内具有良好线性关系(r=0.9993),检出限(s/n=3)为0.1μg/g,回收率为90.7%~96.8%,标准偏差为2.5%。结论建立的气相色谱定量方法准确度高,重现性好,可用于辐照灭菌后医用口罩中溢出异味成分的分析检测。

Objective To study the types of odor substances spilled from medical masks after irradiation sterilization,and to determine their components and establish a quantitative method by gas chromatography.Methods The gas chromatography was used to compare the differences of odor components in medical masks with different sterilization methods,and the gas chromatography-mass spectrometry was used to analyze the structure of odor components in medical masks after irradiation sterilization.The components were determined,and the quantitative method by gas chromatography was established.Results Compared with those before sterilization and those sterilized by ethylene oxide,medical masks sterilized by irradiation produced more volatile components,mainly including ketones,acids,aromatic hydrocarbons and siloxane structured substances.The quantitative method for acetone,ethylene oxide and other volatile components was established.The results showed that acetone had a good linear relationship in the linear range of 0.8-8μg/g(r=0.9950)with a limit of detection(s/n=3)of 0.2μg/g,a recovery rate obtained at three spiked levels was 82.1%-98.3%and a standard deviation of 6.8%.Meanwhile,according to the results,ethylene oxide had a good linear relationship in the linear range of 0.8-12μg/g(r=0.9993)with a limit of detection(s/n=3)of 0.1μg/g,a recovery rate of 90.7%-96.8%and a standard deviation of 2.5%.Conclusion The established quantitative method by gas chromatography is of high accuracy and good reproducibility,which can be used for the analysis and detection of odor components in medic al masks spilled after irradiation sterilization.