吸入溶液用低密度聚乙烯瓶及其粒料中可提取邻苯二甲酸酯的检测  

Determination of Extractable Phthalate Esters in Low Density Polyethylene Bottles and Granules for Inhalation Solution

作　　者：罗琳 余成 陈岚 姜骏 蔡荣 LUO Lin;YU Cheng;CHEN Lan;JIANG Jun;CAI Rong(School of Science,University of Shanghai for Science and Technology,Shanghai 200093;Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203)

机构地区：[1]上海理工大学理学院,上海200093 [2]上海市食品药品包装材料测试所,上海201203

出　　处：《中国医药工业杂志》2020年第8期1043-1047,共5页Chinese Journal of Pharmaceuticals

摘　　要：采用气相色谱-质谱(GC-MS)法对吸入溶液用低密度聚乙烯瓶及其粒料中18种邻苯二甲酸酯类化合物进行检测。样品采用正己烷提取,选择离子扫描模式测定,采用3种内标以提高测定结果的准确性。结果显示,18种邻苯二甲酸酯均具有良好的线性关系,方法检出限为2.0~50.5 ng/g,平均回收率为82.1%~108.2%,相对标准偏差为0.1%~8.5%。低密度聚乙烯粒料样品和低密度聚乙烯瓶样品中可检出邻苯二甲酸二乙酯、邻苯二甲酸二异丁酯、邻苯二甲酸二丁酯和邻苯二甲酸二(2-乙基己基)酯。该方法快速、准确,可用于药包材中可提取邻苯二甲酸酯类化合物的检测。A gas chromatography-mass spectrometry(GC-MS)method was established for the determination of 18 phthalate esters in low density polyethylene bottles and granules for inhalation solution.The samples were extracted with n-hexane and determined by GC-MS with selected ion monitoring mode.Three kinds of internal standards were applied to ensure the accuracy of results.The results showed that 18 phthalate esters all had good linear relationships.The detection limits of target compounds ranged from 2.0-50.5 ng/g.The recovery rates were in the range of 82.1%-108.2%,and the relative standard deviation was 0.1%-8.5%.Diethyl phthalate,diisobutyl phthalate,dibutyl phthalate and di(2-ethylhexyl)phthalate could be detected in low density polyethylene granules and bottle samples.This method was rapid and accurate,which was suitable for the screening and evaluation of extractable phthalate esters in packaging materials for pharmaceutical use.

关 键 词：气相色谱-质谱法 低密度聚乙烯 邻苯二甲酸酯 可提取物 

分 类 号：R917[医药卫生—药物分析学] O657.7[医药卫生—药学]