镍钛形状记忆合金骨植入物中环氧乙烷残留量测定方法  

Method for Determination of Residual Ethylene Oxide in Nickel-Titanium Shape Memory Alloy Bone Implants

作　　者：杨艳丽 李晨 YANG Yanli;LI Chen(Gansu Medical Device Inspection and Testing Institute,Lanzhou 730070,China)

机构地区：[1]甘肃省医疗器械检验检测所,甘肃兰州730070

出　　处：《生物化工》2024年第2期138-140,150,共4页Biological Chemical Engineering

基　　金：甘肃省药品监督管理局项目(2023GSMPA014)。

摘　　要：目的:建立适合医疗器械产品镍钛形状记忆合金弹力聚合器环氧乙烷残留量测定的顶空气相色谱法。方法:采用气相色谱法-氢火焰离子化检测器进行检测,色谱柱为HP-INNOWax,柱温80℃保持15 min,进样口温度200℃,检测器温度250℃,氢气流量35 mL/min,空气流量350 mL/min,平衡时间40 min。结果:环氧乙烷在1~10μg/mL线性良好,方法检出限0.01 mg/L,精密度RSD=0.01%,回收率在86.6%~96.6%。为保证结果的准确性,样品应立刻测定,剪样面积应尽可能小。结论:该方法操作简单,检出限低,可以用于镍钛形状记忆合金骨植入物中环氧乙烷残留量的快速测定。Objective:To establish a headspace gas chromatography method for determination of ethylene oxide residue in Ni-Ti shape memory alloy elastic polymerizer for medical devices.Methods:Gas chromatography with hydrogen flame ionization detector is performed on HP-INNOWax column.The column temperature is 80℃for 15 min,the inlet temperature is 200℃,the detector temperature is 250℃,the hydrogen flow rate is 35 mL/min,the air flow rate is 350 mL/min,and the balance time is 40 min.Results:The linearity of ethylene oxide is good in 1μg/mL to 10μg/mL.The detection limit is 0.01 mg/L,the precision RSD is 0.01%,and the recovery is 86.6%to 96.6%.In order to ensure the accuracy of the results,the sample should be measured immediately and the cutting area should be as small as possible.Conclusion:The method is simple and has low detection limit,and can be used for rapid determination of ethylene oxide residue in Ni-Ti shape memory alloy bone implants.

关 键 词：环氧乙烷 顶空气相色谱法 镍钛形状记忆合金弹力聚合器 

分 类 号：O657.71[理学—分析化学]