目的 建立玻璃与药物相容性研究的实验方法,以考察玻璃输液瓶与碳酸氢钠注射液的相容性。方法 通过视检、电感耦合等离子体发射质谱仪(ICP-MS)、电感耦合等离子体原子发射光谱仪(ICP-OES)、扫描电镜、亚甲蓝染色等方法考察侵蚀液或药液中可见异物变化、离子浓度变化、玻璃表面变化情况,以判断玻璃侵蚀趋势及药物与包装材料间相互作用情况。结果 随玻璃受到侵蚀时间的延长,玻璃输液瓶中的侵蚀液可见脱片,侵蚀液中玻璃主要成分离子浓度也随侵蚀时间延长而升高,玻璃表面可见染色及侵蚀。结论 本实验建立的综合性研究方法可有效的判断药物与玻璃包装材料相容性是否良好,为药物选择适宜的包装材料提供了数据支持,可更好的保证药品安全有效。
Abstract
OBJECTIVE To develop a method to investigate the compatibility between glass infusion bottles and sodium bicarbonate injection. METHODS The delamination tendency and the compatibility between glass infusion bottles and sodium bicarbonate injection were investigated via inspection for glass lamellae or inner surface and testing ion concentration by using ICP-MS, ICP-OES, SEM, methylene blue stain method and so on. RESULTS With the extension of the corrosion time, erosion on the inner surface of glass infusion bottles was observed with increasing visible glass lamellae,increasing ion concentration and surface discoloration. CONCLUSION The established method can be used to evaluate the compatibility between glass infusion bottles and pharmaceutical products. The results can provide data and evidence for selecting suitable packaging materials for injections, thus ensure their safety and therapeutic effect.
关键词
玻璃输液瓶 /
药物 /
相容性 /
碳酸氢钠
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Key words
glass infusion bottles /
medicine /
compatibility /
sodium bicarbonate
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中图分类号：
R917
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脚注
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基金
中国食品药品检定研究院中青年课题(2016C2)
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