药品包装用金属容器元素杂质浸提条件探究  

Exploration and Determination of Leaching Conditions for Elemental Impurities in Metal Containers for Pharmaceutical Packaging

作　　者：李颖 袁淑胜 赵霞[1] LI Ying;YUAN Shusheng;ZHAO Xia(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药学杂志》2024年第20期1962-1966,共5页Chinese Pharmaceutical Journal

摘　　要：目的 对药品包装用金属容器的元素杂质浸提条件进行研究。方法 设定不同浸提条件,对收集到的6类药品包装用金属容器进行浸提,采用电感耦合等离子体质谱法测定浸提出的元素含量。结果 两种浸提介质水和体积分数4%乙酸相比,后者作为浸提介质时,各类容器溶出的元素杂质量均较多。以水为浸提介质分别在(121±2)℃、保温30 min或(70±2)℃、保温24 h条件下浸提时,各种容器溶出的As、Cd、Pb、V、Co、Ni、Cr、Cu元素的量基本一致。对于Mg、Al、Mn、Fe、Zn元素,有机内涂层容器在两种浸提条件下所得浸提量基本一致;阳极氧化和等离子喷涂内壁的容器、裸金属容器,在(121±2)℃、保温30 min条件下,除Mg外,其他元素均浸出更多量。结论 药品包装用金属容器元素杂质测定浸提时,可选用体积分数4%乙酸作为加严控制的浸提介质;以水浸提,(70±2)℃、保温24 h,可满足ICH-Q3D中1类、2A类和3类元素的测定需求。OBJECTIVE To explore the extraction conditions for elemental impurities in metal containers used for drug packaging.METHODS Different extraction conditions were set,and the metal containers used for packaging 6 types of drugs were extracted separately.The content of the extracted elements was determined using inductively coupled plasma mass spectrometry.RESULTS When 4%acetic acid is used as the extraction medium,more impurities of elements are released from various containers.When using water as the extraction medium,the amount of As,Cd,Pb,V,Co,Ni,Cr,and Cu elements dissolved from various containers is basically the same when extracted at(121±2)℃,held for 30 min or(70±2)℃,and held for 24 h.For Mg,Al,Mn,Fe,and Zn elements,the extraction amount obtained by organic inner coating containers under two extraction conditions is basically the same.Containers with anodized and plasma sprayed inner walls,as well as bare metal containers,can leach more elements except for Mg at(121±2)℃for 30 min of insulation.CONCLUSION When determining elemental impurities in metal containers for drug packaging,4%acetic acid can be selected as the extraction medium with stricter control.By water extraction at(70±2)℃and insulation for 24 h,it can meet the determination requirements of Class 1,Class 2A,and Class 3 elements in ICH-Q3D.

关 键 词：药品包装 金属容器 元素杂质 浸提介质 浸提条件 药品包装材料 

分 类 号：R917[医药卫生—药物分析学]