棕色中硼硅玻璃安瓿包装盐酸氨溴索注射液的元素迁移量及内表面脱片的研究  

Investigation on elemental migration and internal surface delamination of ambroxol hydrochloride injection in brown middle borosilicate glass ampoules

作　　者：杨启乐 李总盛 李雷 张海翔 李从英 YANG Qile;LI Zongsheng;LI Lei;ZHANG Haixiang;LI Congying(Shandong Linuo Technical Glass Co.,Ltd.,Jinan 251600,China)

机构地区：[1]山东力诺特种玻璃股份有限公司,济南251600

出　　处：《中国药品标准》2024年第3期313-320,共8页Drug Standards of China

摘　　要：目的:考察棕色中硼硅玻璃安瓿对盐酸氨溴索注射液药品安全性的影响。方法:通过模拟盐酸氨溴索注射液的存放条件,利用电感耦合等离子体发射光谱仪(ICP-OES)和扫描电镜(SEM)设计实验研究元素迁移量及内表面脱片情况。结果:随着时间的推移,注射液中Si元素含量增加,经过0~48月各阶段试验后的玻璃样品内表面未出现脱片现象;Cd、Pb、As等各类元素向注射液中发生了迁移,但含量未超出相关规定限值。结论:棕色中硼硅玻璃安瓿包装盐酸氨溴索注射液在48月内安全稳定,棕色中硼硅玻璃安瓿可作为盐酸氨溴索注射液的良好盛装容器。Objective:To examine the effect of brown midle borosilicate glass ampoules on the drug safety of ambroxol hydrochloride injection.Methods:By simulating the storage conditions of ambroxol hydrochloride injection,experimental studies were designed using inductively coupled plasma emission spectroscopy(ICP-OES)and scanning electron microscopy(SEM)to investigate element migration and internal surface detachment.Results:The Si content in the injections increased over time,and after 0 to 48 months of various stages of testing,the inner surface of the glass was intact,with no detachment or erosion;the migration of various target elements,such as Cd,Pb,As,Hg,etc.,into the injections took place,but the contents were in accordance with the limits set by the relevant regulations.Conclusion:Brown middle borosilicate glass ampoule packaging for ambroxol hydrochloride injection is safe and stable for 48 months.Brown middle borosilicate glass ampoule can be used as a good container for ambroxol hydrochloride injection.

关 键 词：盐酸氨溴索注射液 棕色中硼硅玻璃安瓿 元素迁移量 内表面脱片 电感耦合等离子体发射光谱仪 扫描电镜 

分 类 号：R921.2[医药卫生—药学]