中国药业2025，Vol.34Issue(11)：61-66,6.DOI:10.3969/j.issn.1006-4931.2025.11.013
中硼硅玻璃注射剂瓶与灭菌注射用水的相互作用研究
Interaction Between Injection Vials Made of Middle Borosilicate Glass and Sterile Water for Injection
摘要
Abstract
Objective To investigate the interaction between injection vials made of middle borosilicate glass and sterile water for injection.Methods Inductively coupled plasma-optical emission spectroscopy(ICP-OES)was used to determine the migration of elements in glass components in injection vials made of moulded middle borosilicate glass and injection vials made of middle borosilicate glass tubing.The RF power was 1 200 W,the flow rates of plasma gas,auxiliary gas and carrier gas were 10,0.6,and 0.7 L/min,respectively,the pump speed was 20 r/min,the detection wavelengths of boron(B),silicon(Si),aluminum(Al),and sodium(Na)elements were 249.773,251.611,396.153,589.592 nm,respectively,and the exposure time was 30 s.The observation mode was quantitative axial.The scanning electron microscopy(SEM)was conducted to investigate the erosion of the inner surface of injection bottles.Results Both types of injection vials made of middle borosilicate glass showed migration of the main components into the sterile water for injection.The migration amount was Si,Na,B,and Al elements in descending order,and the migration of these elements gradually increased with time.The migration trends of Si/Na and Si/B ratios were different for the two types of injection vials.SEM observation results showed no erosion in the injection vials made of moulded middle borosilicate glass,while significant erosion was observed in injection vials made of middle borosilicate glass tubing.Conclusion Both types of injection vials made of middle borosilicate glass interacted with sterile water for injection,but the interaction results are different.关键词
中硼硅玻璃注射剂瓶/灭菌注射用水/电感耦合等离体发射光谱法/扫描电镜Key words
injection vials made of middle borosilicate glass/sterile water for injection/ICP-OES/scanning electron microscopy分类
医药卫生引用本文复制引用
齐艳菲,袁淑胜,王颖,李晓宇,赵霞..中硼硅玻璃注射剂瓶与灭菌注射用水的相互作用研究[J].中国药业,2025,34(11):61-66,6.基金项目
国家药典委员会国家药品标准修订研究课题[2023Y58-3]. （）
