中性硼硅玻璃安瓿中铝、硅、硼元素的迁移量与其内表面脱片趋势关系的研究

目的：考察中性硼硅玻璃安瓿中铝（Al）、硅（Si）、硼（B）元素的迁移量与内表面脱片趋势的关系。方法：采用亚甲基蓝染色及扫描电子显微镜（scanning electron microscope，SEM）法观察中性硼硅玻璃安瓿被侵蚀液侵蚀后的脱片情况，并通过电感耦合等离子体发射光谱（inductively coupled plasma optical emission spectrometer，ICP-OES）法测定不同侵蚀时间的中性硼硅玻璃安瓿中Al、Si、B元素的迁移量，根据迁移量的变化及脱片的趋势确定二者之间的关系。结果：电感耦合等离子体发射光谱法测定的3种元素质量浓度在0.2~10.0 mg·L^-1范围内线性关系良好，相关系数为0.999 4~0.999 9；回收率为88.2%~100.5%；3种元素检测下限分别为0.001 5 μg·mL^-1（Al）、0.002 9 μg·mL^-1（Si）、0.020 5 μg·mL^-1（B）。随着时间增加，Al、Si、B的迁移量不断增大，对应时间点的脱片情况也不断加剧，二者呈同向变化关系。结论：可通过ICP-OES检测药物溶液中Al、Si、B的含量来推断包装液体药物的中性硼硅玻璃安瓿内表面的脱片情况。

Objective: To investigate the relationship between the migration of aluminum (Al),silicon (Si) and boron (B) in the neutral borosilicate glass ampoule and the tendency of the inner surface stripping. Methods: Methylene blue staining and scanning electron microscopy (SEM) were used to observe the epitaxial condition of neutral borosilicate glass ampoules eroded by erosive liquid,and inductively coupled plasma optical emission spectrometer (ICP-OES) was used to determine migration of Al,Si and B in neutral borosilicate glass ampoules with different erosion times. The relationship between the epitaxial condition and the leaching amount is determined by the change in migration and the trend of stripping. Results: The linear concentration of each element in the range of 0.2-10.0 mg·L^-1 was good,the correlation coefficient was 0.999 4-0.999 9;The recovery rate was 88.2%-100.5%;The detection limits of the three elements were 0.001 5 μg·mL^-1 (Al),0.002 9 μg·mL^-1 (Si),0.020 5 μg·mL^-1 (B). As time goes on,the migration of Al,Si and B is increasing,and the stripping situation at corresponding time points is also intensified. The migration of three elements was positively correlated with the inner surface stripping. Conclusion: The content of Al,Si,and B in the drug solution can be detected by ICP-OES to infer the release of the neutral borosilicate glass ampoule of the packaged liquid drug.

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