PVC/LDPE复合包装中13种化学物的迁移及安全评估  

Migration of 13 ChemicalsinPVC/LDPE Composite Packaging and Their Safety Assessment

作　　者：罗任杰 汪钰文 黎永乐[3] 林勤保[1] LUO Ren-jie;WANG Yu-wen;LI Yong-le;LIN Qin-bao(Packaging Engineering Institute,Jinan University,Zhuhai 519070,China;School of Mechanical Engineering,Wuhan Polytechnic University,Wuhan 430023,China;Shenzhen Academy of Metrology&Quality Inspection,Shenzhen 518116,China)

机构地区：[1]暨南大学包装工程研究所,广东珠海519070 [2]武汉轻工大学机械工程学院,武汉430023 [3]深圳市计量质量检测研究院,广东深圳518116

出　　处：《包装工程》2021年第17期29-38,共10页Packaging Engineering

基　　金：国家重点研发计划(2018YFC1603204);广东省动植物与食品进出口技术措施研究重点实验室开放课题(IQTC201804)。

摘　　要：目的利用超高效液相色谱-串联质谱法(UPLC-MS/MS),对PVC/LDPE复合硬片包装中13种化学物向葡萄糖酸钙锌口服溶液及其模拟液的迁移进行研究,并进行安全性评估。方法配制体积分数为0.6%,1.25%,2.5%的乳酸溶液作为食品模拟液,按照GB 31604.1—2015的要求进行迁移实验。将口服液原液、模拟液浸泡液经过滤后进样,分别以H-ESI+和H-ESI−模式进行定量分析,并对结果采用毒理学关注阈值分析法(TTC)进行安全风险评估。结果口服液及其食品模拟物中的13种化学物在其对应浓度范围线性良好,R2均大于0.99,各个物质在3个浓度水平的加标回收率范围为82.7%~120%,相对标准偏差为1.1%~11%;各物质的迁移量均低于GB 9685—2016、TTC的规定限量及计算得到的理论允许迁移量。结论文中研究的检测方法可以灵敏、准确地测定葡萄糖酸钙锌口服溶液及其模拟液中13种目标化学物的迁移量。13种化学物来源可分为有意添加的塑料添加剂、非有意添加物以及溶剂残留,对其分别单独进行安全评估,结果显示,最大迁移量均低于限量要求,且暴露量均低于TTC法计算出的最大日摄入量。The purpose of thispaperis to study the migration of 13 chemicals from PVC/LDPE composite hard tablet into calcium zinc gluconate oral solution and its simulants by ultra-high performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS),andto assess their safety.Prepare lactic acid solution with volume fraction of 0.6%,1.25%and 2.5%as food simulation solution,and conduct migration test according to the requirements of GB 31604.1—2015.The original oral solution and its simulants after immersion are filtered and injected.Quantitative analysis is carried out in H-ESI+and H-ESI−modes respectively.The results areassessed by means of threshold of toxicological concern(TTC).The 13 chemicalsin oral solution and its food simulant have good linearity in their corresponding concentration range,R2 is greater than 0.99,the spike-and-recoveryrange of each substance at three concentration levels are 82.7%-120%,and the relative standard deviation is 1.1%-11%.The migration amount of each substance is lower than the specified limit in GB 9685-2016 and TTC and the calculated theoretical allowable migration amount.The detection me-thod studied in this paper can sensitively and accurately determine the migration of 13 target chemicalsin calcium zinc gluconate oral solution and its simulants.The sources of 13 chemicalscan be divided into intentionally added plastic addi-tives,non-intentionally added substances and solvent residues.Their safety assessment is conducted separately.The re-sults show that the maximum migration amount is lower than the limit requirements,and the exposure amount is lower than the maximum daily intake calculated by TTC method.Therefore,it is preliminarily considered that the safety risk is low.

关 键 词：口服液 PVC/LDPE复合包装 超高效液相色谱-三重四级杆质谱法 迁移 毒理学关注阈值 食品药品安全 

分 类 号：R927.2[医药卫生—药学] TS202.3[轻工技术与工程—食品科学]