盐析-顶空气相色谱法测定三层共挤输液袋中油墨残留溶剂在复方电解质葡萄糖注射液中的迁移量  

Determination of Migration of the Ink Residual Solvents from Three-layer Co-extrusion Infusion Bag in Compound Electrolyte Glucose Injection by Salting Out-headspace Gas Chromatography

作　　者：田绍琼 陈苑 梅蕾[1] 林黄静 张毅兰 TIAN Shaoqiong;CHEN Yuan;MEI Lei;LIN Huangjing;ZHANG Yilan(NMPA Key Lab.for Compatibility Studies of Pharmaceutical Products and Packaging Materials,Shanghai Institute of Pharmaceutical Industry Research and Inspection Center of Pharmaceutical Packaging Center,Niational Advanced Medical Engineering Research Center,Shanghai 201203)

机构地区：[1]医药先进制造国家工程研究中心,上海医药工业研究院药品包装材料科研检验中心,国家药品监督管理局药包材与药物相容性研究重点实验室,上海201203

出　　处：《中国医药工业杂志》2022年第9期1328-1332,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了盐析-顶空气相色谱法测定三层共挤输液袋中油墨残留溶剂丁酮(2)、甲基异丁基酮(3)和正丁醇(4)在复方电解质葡萄糖注射液(1)中的迁移量。采用HP-INNOWAX色谱柱(60 m×0.32 mm×0.50μm),氢火焰离子化检测器,柱流速为1.2 ml/min,进样口温度为200℃,顶空瓶中加入盐析试剂无水硫酸钠2.5 g。结果显示,2、3和4分别在相应浓度范围内线性关系良好,检测限分别为0.006、0.0026、0.012μg/ml,平均回收率(n=3)分别为100.9%、104.4%、96.1%,RSD分别为4.1%、6.2%、6.2%。建立的方法专属性好、灵敏度高、操作简便,可用于测定2、3和4在1中的迁移量。A salting out-headspace gas chromatography method was established for the determination of migration of the ink residual solvents,namely butanone(2),methyl isobutyl ketone(3)and n-butyl alcohol(4),from in three-layer co-extrusion infusion bag in compound electrolyte glucose injection(1).The HP-INNOWAX column(60 m×0.32 mm×0.50μm)and hydrogen flame ionization detector were used,the column flow rate was 1.2 ml/min,and the injection port temperature was 200℃.Anhydrous sodium sulfate(2.5 g)as the salting-out agent was added to the headspace vial.The results showed it was linear for 2,3 and 4 in the corresponding concentration ranges,the detection limits were 0.006,0.0026,0.012μg/ml,and the average recoveries(n=3)were 100.9%,104.4%,96.1%,with the RSDs of 4.1%,6.2%,and 6.2%,respectively.The established method has good specificity,high sensitivity and simple operation,which can be used to determine the migration of 2,3 and 4 in 1.

关 键 词：盐析 顶空气相色谱法 三层共挤输液袋 油墨残留溶剂 

分 类 号：R917[医药卫生—药物分析学]