基于多组件医疗器械产品的环氧乙烷残留量检测方法研究  

Ethylene oxide residue detection method based on multi-component medical devices

作　　者：刘若锦 王子梦 李挥 邵文亮 刘宝煜 冯毅 LIU Ruo-jin;WANG Zi-meng;LI Hui;SHAO Wen-liang;LIU Bao-yu;FENG Yi(Hebei Province Testing Institute for Drug and Medical Devices,Shijiazhuang 050227,China)

机构地区：[1]河北省药品医疗器械检验研究院,石家庄050227

出　　处：《医疗卫生装备》2024年第1期56-61,共6页Chinese Medical Equipment Journal

基　　金：2022年河北省药品监督管理局科技计划项目(2022ZC1027)。

摘　　要：目的:提出稳定、可靠的环氧乙烷残留量检测方法,并重点分析多组件医疗器械产品中不同材质组件的环氧乙烷残留量情况,以为多组件医疗器械产品包内的样品选取及环氧乙烷残留量检测提供参考。方法:采用顶空-气相色谱法及DB-WAX色谱柱,在80℃平衡20 min的顶空浸提条件下建立针对多组件医疗器械产品环氧乙烷残留量的检测方法,并确定该方法的称样质量、线性关系、检出限、定量限、精密度及回收率。使用该检测方法对经环氧乙烷灭菌的一次性使用会阴护理包、一次性使用妇科检查包、一次性使用缝合换药包、一次性使用清创护理包和一次性使用透析护理包中与人体接触的各组件进行环氧乙烷残留量的测定,并分析不同组件材质吸收、保持和释放环氧乙烷的能力。结果:该检测方法在环氧乙烷质量浓度为0.4~16.0μg/mL范围内线性关系良好(r=0.9998),其称样质量为1.00 g,检出限为0.11μg/mL,定量限为0.37μg/mL,精密度的相对标准偏差为0.35%~1.52%。不同加标量环氧乙烷在3种空白基质中的平均回收率为92.68%~101.42%,相对标准偏差为2.46%~7.59%,均满足检测要求。多组件医疗器械包内橡胶和丙烯腈-丁二烯-苯乙烯共聚物(acrylonitrile-butadiene-styrene copolymer,ABS)材质的组件环氧乙烷残留量最多,木质、脱脂棉、聚丙烯和聚苯乙烯材质的组件环氧乙烷残留量相对较少。结论:该检测方法具有操作简单、专属性优良、定量准确和重现性好的优势,可满足实际经环氧乙烷灭菌的多组件医疗器械包内环氧乙烷残留量的检测需求,且为多组件医疗器械产品的样品选取提供了参考。Objective To establish a stable and reliable method for the determination of ethylene oxide residue,and to analyze ethylene oxide residue in multi components made of different materials involved in some medical devices,so as to provide references for sample selection and ethylene oxide residue detection of multi-component medical device kits.Methods A method for the determination of ethylene oxide residue of multi-component medical devices was developed using headspace-gas chromatography and DB-WAX column under the conditions of headspace extraction with equilibration at 80℃for 20 min,and the weighing mass,linearity,limit of detection,limit of quantification,precision and recovery of the method were determined.Trials of the method were carried out on the items undergoing ethylene oxide sterilization,including disposable perineal care kit,disposable gynecological examination kit,disposable suture dressing kit,disposable debridement kit and the components contacting human body in the disposable dialysis kit,and the abilities of different materials of the components were analyzed in absorbing,retaining and releasing ethylene oxide.Results The method showed high linearity(r=0.9998)in the range of ethylene oxide mass concentration from 0.4 to 16.0μg/mL with a weighing mass of 1.00 g,which had the limit of detection being 0.11μg/mL,the limit of quantification being 0.37μg/mL and the relative standard deviations(RSDs)for the precision from 0.35% to 1.52%.The average recoveries of different spiked amounts of ethylene oxide in the three blank matrices ranged from 92.68% to 101.42% with the relative standard deviations(RSDs)from 2.46% to 7.59%,which all satisfied the detection requirements.The components made of rubber and acrylonitrile-butadiene-styrene copolymer(ABS)in multi-component medical device kits had the highest ethylene oxide residues,followed by the components made of wood,degreased cotton,polypropylene and polystyrene.Conclusion The method proposed gains advantages in easy operation and high specificity,q

关 键 词：多组件医疗器械 顶空条件 环氧乙烷 残留量 气相色谱法 

分 类 号：R318[医药卫生—生物医学工程] R197.39[医药卫生—基础医学]