盐酸氨溴索注射液玻璃安瓿包装中20种元素迁移量的测定与风险评估  

Migration determination and risk assessment of 20 elements in ambroxol hydrochloride injection in glass ampoule packaging

作　　者：齐艳菲 贾菲菲 王颖[1] 赵霞[1] 杨会英[1] QI Yan-fei;JIA Fei-fei;WANG Ying;ZHAO Xia;YANG Hui-ying(National Institutes for Food and Drug Control,Beijing 100050)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中南药学》2024年第1期194-199,共6页Central South Pharmacy

基　　金：中国食品药品检定研究院中青年发展基金(No.2019C8)。

摘　　要：目的 测定盐酸氨溴索注射液玻璃安瓿包装中20种元素的迁移量,并进行风险评估。方法 采用电感耦合等离子体质谱法(ICP-MS)测定B、Al、Li、Ba、Mg、Fe、Zn、Mn、Cd、Ti、Co、Cd、Pb、As、Sb、Ce、Zr 17种元素,采用电感耦合等离子体发射光谱法(ICPOES)测定Si、K、Ca 3种元素。结果 20种元素回收率为90.6%~107.7%。ICP-MS法测定17种元素检测限为0.004~2.8 ng·mL^(-1),ICP-OES法测定Si、K、Ca 3种元素检测限分别为7.4、10.1、7.9 ng·mL^(-1)。各元素按每日最大摄入量计,均在安全范围内,玻璃安瓿中主要迁出Si、B、Al、Fe、Ti、Ba、Li元素。结论 ICP-MS法与ICP-OES法经方法学验证可用于盐酸氨溴索注射液玻璃安瓿包装中20种元素迁移量的测定,迁移量及迁移趋势可为其风险监控及玻璃包装发生脱片风险的预判提供参数。Objective To determine the migration amount of 20 elements in ambroxol hydrochloride injection from glass ampoule packaging and to determine and evaluate the risk of migration amount in sample.Methods Inductively coupled plasma mass spectrometry(ICP-MS) was used to determine the migration amounts of 17 elements,including B,Al,Li,Ba,Mg,Fe,Zn,Mn,Cd,Ti,Co,Cd,Pb,As,Sb,Ce and Zr.Inductively coupled plasma emission spectrometry(ICP-OES) was used to determine the migration amounts of Si,K and Ca.Results The recovery of 20 elements was 90.6% ~ 107.7%.The detection limit of 17 elements by ICP-MS was 0.004 ~ 2.8 ng·mL^(-1),and the detection limit of Si,K and Ca by ICP-OES were 7.4,10.1,7.9 ng·mL^(-1),respectively.According to the maximum daily intake,all the elements were within the safe range.Si,B,Al,Fe,Ti,Ba and Li were mainly removed from the glass ampoule.Conclusion ICP-MS and ICP-OES analysis is effective for the determination of 20 elements in ambroxol hydrochloride injection migrating from glass ampoule.Migration amount and migration trend can provide parameters for risk monitoring and prediction of glass delamination.

关 键 词：盐酸氨溴索注射液 玻璃安瓿 电感耦合等离子体质谱法 电感耦合等离子体发射光谱法 

分 类 号：R917[医药卫生—药物分析学]