顶空气相色谱法测定一次性使用无菌注射器中环氧乙烷残留量  

Determination of ethylene oxide in disposable sterile syringes by headspace gas chromatography

作　　者：黄学慧 吴春红[2] 

机构地区：[1]雅安市雨城区人民医院,四川雅安625000 [2]成都大学校医院,四川成都610106

出　　处：《现代医药卫生》2013年第4期513-513,515,共2页Journal of Modern Medicine & Health

摘　　要：目的建立测定一次性使用无菌注射器中环氧乙烷残留量的顶空气相色谱方法。方法采用Alltech AT-624毛细管柱（30m×0．53mm，3．0μm）色谱柱，FID检测器，进样口温度200℃，柱温45℃，检测器温度200℃，顶空平衡温度80℃，保温30min。结果环氧乙烷在1．0～10．0wg／mL范围内呈良好的线性关系（r=O．9991），检出限为0．04μg/mL，平均加样回收率为98．85％（n=9），重复性试验相对标准偏差（RSD）为2．84％（n=6）。结论该方法灵敏、准确、重复性好，可用于一次性使用无菌注射器的临床安全性评价。Abtract To establish a method for the determination of ethylene oxide in disposable sterile syringes by headspace gas chromatography. Methods The Alltech AT-624 capillary column （30 m×0.53 mm,3.0 μm） and the FID detector were adopted, the inlet temperature was 200 ℃, the oven temperature was 45 ℃ and the detector temperature was 200 ℃,the headspace equivilent temperature was 80 ℃ keeping for 30 min. Results The linear range of ethylene oxide was 1.0-10.0 μg/mL （r=0.999 1 ）,the detection limit was 0.04 μg/mL,the average recovery rate was 98.85% （n=9）,RSD in the repetition test was 2.84% （n=6）. Conclusion This method is sensitive and accurate with good reproducibility,which can be used for the clinical safety evaluation of disposable sterile syringes.

关 键 词：一次性设备 注射器 环氧乙烷 分析 色谱法 气相 

分 类 号：R951[医药卫生—药学]