顶空气相色谱法同时测定一次性医疗器械产品中的环氧乙烷和2-氯乙醇的残留量

目的：建立顶空气相色谱法同时测定一次性无菌医疗器械产品中可能存在的灭菌残留产物，包括环氧乙烷和2-氯乙醇。方法采用气相色谱-氢火焰离子化检测器进行检测，色谱柱为DB-624，载气为氮气，柱温为100℃，检测器和进样口温度分别为250℃和200℃；顶空平衡温度80℃，平衡时间30min，外标法定量。结果环氧乙烷和2-氯乙醇的线性范围分别为1.4μg/mL~21.7μg/mL（r=0.9993）和3.8μg/mL~60.4μg/mL（r=0.9985），加样回收率分别为96.2%和93.7%，样品选用的是有2-氯乙醇残留物的一次性使用动脉止血压迫器，2-氯乙醇残留物含量为21.54μg/g。结论该方法简便、快速、准确，可用于环氧乙烷灭菌工艺的一次性使用无菌医疗器械产品中常见两种灭菌残留物的同时检测。

Determination of EO and ECH residuals in disposable medical device by headspace-gas chromatography

Objective To establish a method for determination of the ethylene oxide sterilization residuals including ethylene oxide （EO） and ethylene chlorohydrin （ECH） in disposable medical device by headspace-gas chromatography. Methods GC analysis＆nbsp;of the residuals was performed by an Agilent 7890A gas chromatography equipped with FID and a DB-624 capillary column and quantified by external standard method. Carrier gas was nitrogen; column temperature was 100℃;injector and detector temperature was 200℃and 250℃respectively. The sample vials were heated at a temperature of 85℃for 30min. Result The linear ranges of EO and ECH were 1.4μg/mL~21.7μg/mL （r=0.9993） and 3.8μg/mL~60.4μg/mL （r=0.9985）. The average recoveries were 96.2%and 93.7%respectively. The results showed that only ECH were found in the sample with the contents of 21.54μg/g. Conclusion The method is simple, rapid and accurate for the content determination of the EO and ECH in disposable medical device.