摘要
目的药品包装材料与药物相容性实验是评价药品包装材料安全性能与药品质量的重要研究项目,中性硼硅玻璃具有膨胀系数小、耐极冷极热性强、不易炸裂、化学稳定性好等特点,已成为注射剂包装的首选材质。探索中性硼硅玻璃与药物相容性的研究进展与发展趋势,为中性硼硅玻璃用于药品包装材料提供参考。方法分别从玻璃成分中金属离子向药液中的迁移量、有害物质的浸出量、不同温度与酸碱条件下玻璃的脱片、玻璃对药物的吸附以及药物对玻璃表面的侵蚀程度等方面综述中性硼硅玻璃与药物相容性的研究进展,考察中性硼硅玻璃对于药品质量的影响。结论中性硼硅玻璃与药物的相容性评价方法逐渐完善,为中性硼硅玻璃作为药用包装材料的研究提供参考。
The compatibility test of pharmaceutical packaging materials and drugs is an important research project to evaluate the safety performance of pharmaceutical packaging materials and drug quality.Neutral borosilicate glass has small expansion coefficient,strong resistance to extreme cold and extreme heat,not easy to burst,and good chemical stability which has become the preferred material for injection packaging.The paper aims to explore the research progress and development trend of the compatibility of neutral borosilicate glass and drugs,so as to provide theoretical basis for the use of neutral borosilicate glass as pharmaceutical packaging materials.The research progress of the compatibility between neutral borosilicate glass and drugs was reviewed from the following aspects:the migration of metal ions from glass components to drug solution,the leaching amount of harmful substances,the stripping of glass under different temperature and acid-base conditions,the adsorption of drugs by glass,and the erosion degree of drugs on glass surface.The method for evaluating the compatibility of neutral borosilicate glass and drugs is gradually perfected,which provides a reference for the research of neutral borosilicate glass as pharmaceutical packaging materials.
作者
陈婧
希迪·莫苏拉
杨宗蕊
CHEN Jing;SITI Mastura Md Ishak;YANG Zong-rui(Beijing Pharmaceutical Group University of Stuff and Workers,Beijing,100071,China;Universiti Putra Malaysia,Serdang,43400,Malaysia)
出处
《包装工程》
CAS
北大核心
2021年第10期37-43,共7页
Packaging Engineering
关键词
中性硼硅玻璃
注射剂
相容性
药品质量
neutral borosilicate glass
injection
compatibility
quality of drugs
作者简介
陈婧(1988-),女,黑龙江人,硕士,北京医药集团职工大学讲师,主要研究方向为药物分析。
