GC-MS法测定三层共挤输液用袋中苯乙烯单体在氧氟沙星氯化钠注射液中的迁移量  

Determination of Styrene Monomer Migration Amount in Ofloxacin and Sodium Chloride Injection from Three Layer Coextrusion Infusion Bags by GC-MS

作　　者：刘兴兰 王晓兰 黄萍 

机构地区：[1]四川省食品药品检验检测院,成都611731

出　　处：《中国药师》2018年第1期171-173,共3页China Pharmacist

摘　　要：目的:建立GC-MS法测定三层共挤输液用袋中苯乙烯单体在氧氟沙星氯化钠注射液中迁移量的方法。方法:采用GC-MS法测定氧氟沙星氯化钠注射液中苯乙烯单体含量,从而考察氧氟沙星氯化钠注射液的包装袋(三层共挤输液用袋)中苯乙烯在药液中的迁移量,色谱柱为DB-624 123^(-1)334毛细管柱(30 m×0.32 mm,1.8μm),柱温采用程序升温,顶空自动进样,由电子轰击源(EI)选择离子监测(SIM)模式进行检测。结果:苯乙烯在46.96~543.60 ng·ml^(-1)(r=0.999 9)浓度范围内具有良好线性关系;平均回收率为101.2%,RSD为3.1%(n=9)。结论:本方法简便、准确、重复性好,可用于该药品与包装的相容性评价。Objective： To establish a method for determining styrene monomer migration amount in ofloxacin and sodium chloride injection from three layer coextrusion infusion bags by GC-MS. Methods： The styrene monomer content in ofloxaein and sodium chlo- ride injection was detected by GC-MS in order to study the migration amount of styrene from the packaging bag （ three layer eoextrusion infusion） of ofloxacin and sodium chloride injection. A DB-624 123-1334 capilary column （30 m ×0.32mm,1.8μm） was used, and the detection was carried out with programmed temperature and headspace sampling by the electron bombardment source （EI） in a selective ion monitoring （SIM） mode. Results： The linear concentration range of styrene was 46.96-543.60 ng ml -1 （r = 0.999 9 ）, and the average recovery was 101.2% （RSD =3.1%, n =9）. Conclusion： The method is simple, accurate and reproducible. It can be used for the compatibility testing between medicine and its package.

关 键 词：氧氟沙星氯化钠注射 苯乙烯 三层共挤输液用袋 气相色谱-质谱联用法 

分 类 号：R927.11[医药卫生—药学]