摘要
采用顶空气相色谱法,对纸塑包装聚乙醇酸、聚乙醇酸三亚甲基碳酸酯和聚碳酸酯医疗器械环氧乙烷残留量进行检测,并对灭菌后的器械进行自然通风及室温下真空和80℃下真空强制解吸,确保产品环氧乙烷残留量在安全使用范围.研究发现,经环氧乙烷灭菌后,三种材质器械的环氧乙烷残留量均超过安全使用限度,聚碳酸酯器械最高,聚乙醇酸三亚甲基碳酸酯次之,聚乙醇酸最低.80℃下真空强制解吸48 h后,环氧乙烷残留量均满足安全使用限度要求.建立了可降解聚酯器械中环氧乙烷检测方法,探寻了较好的解吸方法,为产品的安全使用提供保障.
The ethylene oxide residual in medical devices of degradable polyester such as polyglycolic acid,polyglycolic acid trimethylene carbonate and polycarbonate with paper and plastic packaging was determined by headspace gas chromatography(GC).The devices sterilized by ethylene oxide were desorbed under natural ventilation or force analyzed by vacuum at room temperature or by vacuum at 80℃to make sure that the devices were safe to be used.It was found that the ethylene oxide residual in the three kinds of devices exceeded the safety limitation,and the polycarbonate device was the highest,followed by the polyglycolic acid trimethylene carbonate device,and the polyglycolic acid device was the lowest.After 48 h of forced desorption at 80℃in vacuum,the ethylene oxide residual in three kinds of devices can meet the requirement of safety limitation.The determination method of ethylene oxide residual was established.It was found that the amount of adsorbed ethylene oxide was different in the devices of polyglycolic acid,and polyglycolic acid trimethylene carbonate and polycarbonate,The better desorbed method was explored to ensure the safe use of the device.
作者
马丽霞
王宪朋
朱爱臣
吴倩倩
董浩
王传栋
王勤
刘阳
MA Lixia;WANG Xianpeng;ZHU Aichen;WU Qianqian;DONG Hao;WANG Chuandong;WANG Qin;LIU Yang(Shandong Provincial Key Laboratory of Biomedical Polymers,Shandong Academy of Pharmaceutical Sciences,Jinan 250101,Shandong,China)
出处
《化学研究》
CAS
2020年第3期241-245,共5页
Chemical Research
基金
山东省重点研发计划资助项目(2017GSF18168,2018GSF118132).
