| 陈婧,希迪.莫苏拉,杨宗蕊.中性硼硅玻璃与药物相容性研究进展[J].包装工程,2021,42(10):37-43. |
| 中性硼硅玻璃与药物相容性研究进展 |
| Compatibility of Neutral Borosilicate Glass and Drugs |
| 投稿时间：2021-01-22 |
| DOI：10.19554/j.cnki.1001-3563.2021.10.007 |
| 中文关键词: 中性硼硅玻璃 注射剂 相容性 药品质量 |
| 英文关键词: neutral borosilicate glass injection compatibility quality of drugs |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
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