顶空气相色谱法测定一次性使用雾化器中的环氧乙烷残留量  

Determination of Residual Ethylene Oxide in Disposable Nebulizer by Headspace Gas Chromatography

作　　者：罗育浩 刘向辉 张哲 刘东 孙小莉 王兴媛 LUO Yuhao;LIU Xianghui;ZHANG Zhe;LIU Dong;SUN Xiaoli;WANG Xingyuan(Henan Province Medical Instrument Testing Institute,Zhengzhou 450000,China)

机构地区：[1]河南省医疗器械检验所,河南郑州450000

出　　处：《河南科技》2022年第12期95-98,共4页Henan Science and Technology

摘　　要：本研究阐述了使用顶空气相色谱法测定一次性使用雾化器中的环氧乙烷残留量的方法和步骤。选用CP-Wax 52CB色谱柱(30 m×0.53 mm×1.0μm)分离,采用水为萃取剂,用氢火焰离子化检测器(FID)检测。柱温在45℃保持5 min,然后以50℃/min升高至160℃,保持4 min。试验结果显示,环氧乙烷质量浓度在0.25~10.00μg/mL范围内与峰面积呈良好的线性关系,回归方程为y=6.648 9 x+0.270 4,R=0.999 9,回收率为98.4%~104.0%,最低检出限为0.05μg/mL,线性范围宽,检出限低,回收率高,是一种简单、快速、准确测定一次性使用雾化器中环氧乙烷残留量的检测方法。This study describes the method and procedure of determination of residual ethylene oxide in disposable nebulizer by headspace gas chromatography.CP-Wax 52CB capillary column(30 m×0.53 mm×1.0 μm) was used for separation, water was used as the extractant, and hydrogen flame ionization detector(FID) was used for detection. The column temperature was first kept at 45 ℃ for 5 min, and then raised to160 ℃ at 50 ℃/min, and maintained for 4 min. The concentration of ethylene oxide in the range of 0.25~10.00 μg/mL showed a good linear relationship with the peak area.The regression equation is y=6.648 9x+0.270 4, R = 0.999 9, the recovery rate is 98.4 %~104.0 %, the minimum detection limit is 0.05 μg/mL,the linear range is wide, the detection limit is low and the recovery rate is high. It is a simple, rapid and accurate detection method for the determination of the residual amount of ethylene oxide in disposable nebulizer.

关 键 词：顶空气相色谱法 环氧乙烷 一次性使用雾化器 残留量 

分 类 号：R927.1[医药卫生—药学]