ICP-MS测定三层共挤输液用袋中镁、铝元素的含量及迁移量  

Determination of Extraction Contents and Migration of Mg and Al in 3-Layer Co-extrusion Infusion Bags by ICP-MS

作　　者：徐燕慧 林芳 戴林泉 李翔 林强 罗燕华 XU Yan-hui;LIN Fang;DAI Lin-quan;LI Xiang;LIN Qiang;LUO Yan-hua(Fujian Provincial Institute forMedical Devices and Pharmaceutical Packaging Materials,Fuzhou 350001,China)

机构地区：[1]福建省医疗器械与药品包装材料检验所,福建福州350001

出　　处：《海峡药学》2020年第3期93-98,共6页Strait Pharmaceutical Journal

摘　　要：目的建立三层共挤输液用袋中镁、铝元素的含量及迁移量的ICP-MS测定方法。方法采用炽灼残渣的方法对样品进行前处理,ICP-MS检测镁、铝元素的含量。取三层共挤输液用袋包装的葡萄糖、氯化钠两种临床常用的注射液做加速试验,通过ICP-MS检测镁、铝元素的迁移量。结果镁、铝元素在0.01~0.20μg·mL^-1范围内线性关系良好,r值均为0.9999。镁、铝元素在三层共挤输液用袋含量试验中的平均回收率分别为99.6%(RSD=3.2%,n=9)、101.0%(RSD=4.0%,n=9);在0.9%氯化钠注射液中镁、铝迁移量平均回收率分别为95.1%(RSD=2.0%,n=9)和93.2%(RSD=1.2%,n=9);三层共挤输液用袋装5%葡萄糖注射液中镁、铝迁移量平均回收率分别为102.7%(RSD=1.6%,n=9)和100.3%(RSD=1.3%,n=9)。结论本方法准确、灵敏,操作简便,可用于测定三层共挤输液用袋中镁、铝元素的含量及迁移量,同时为其安全性提供数据参考。OBJECTIVE To establish an ICP-MS method to determine the extraction contents and migration of Mg and Al in 3-layer co-extrusion infusion bags.METHODS The method of residue on ignition was used to pretreat the sample of 3-layer co-extrusion infusion bags,with ICP-MS determination the contents of Mg and Al.Two injections commonly used in clinics were put into 3-layer co-extrusion infusionbags to carry out accelerated experiment,and the migration of Mg and Al were determined by ICP-MS.RESULTS Both Mg and Al had a good linear range between 0.01-0.2μg·mL^-1,with r values of 0.9999.The recovery rates of Mg and Al in 3-layer co-extrusion infusion bags for extraction contents test were 99.6%(RSD=3.2%,n=9)and 101.0%(RSD=4.0%,n=9),respectively.The recovery rates of Mg and Al were 95.1%(RSD=2.0%,n=9)and 93.2%(RSD=1.2%,n=9)in 0.9%sodium chloride injections migration test,which were 102.7%(RSD=1.6%,n=9)and 100.3%(RSD=1.3%,n=9)in 5%glucose injections migration test.COCLUSION The proposed method is accurate,sensitive,and simple,and can be used for determination of Mg and Al extraction contents and migration in 3-layer co-extrusion infusion bags,which can also provide reference for the safety data.

关 键 词：电感耦合等离子体质谱法(ICP-MS) 三层共挤输液用袋 镁 铝 注射液 迁移量 

分 类 号：R927[医药卫生—药学]