注射用透明质酸钠玻璃包装脱片研究

Study on the Delamination of Pharmaceutical Glass Packaging of Sodium Hyaluronate for Injection

目的:通过对模拟试验和加速试验后的透明质酸钠玻璃包装和浸提溶液进行测试,考察西林瓶的脱片趋势。方法:通过亚甲蓝染色和扫描电镜对玻璃容器内表面进行检查,观察药用玻璃包装的脱片情况。通过酸碱度测试、电感耦合等离子体发射光谱仪测定浸提液中元素迁移量对侵蚀后的浸提溶液进行检测分析,从不同角度评估注射用透明质酸钠玻璃包装的脱片趋势,以预测玻璃内表面腐蚀以及玻璃脱片的倾向。结果:在模拟试验中,西林瓶未发生明显脱片;在加速试验中,西林瓶表现出脱片趋势。结论:经过亚甲蓝染色、扫描电镜、酸碱度、元素迁移等表征测试,西林瓶的脱片情况可以得到准确有效的判断,为注射用透明质酸钠药包材相容性研究提供重要依据。

Objective:By testing sodium hyaluronate glass packaging and extraction solution,including simulated test and accelerated test,the delamination trend of cillin bottle was investigated.Methods:The inner surface of the pharmaceutical glass container was examined by methylene blue staining and scanning electron microscope,to observe the delamination of pharmaceutical glass packaging.The solution was tested for pH and elemental analysis by ICP-OES.The delamination trend of pharmaceutical glass packaging was evaluated from different angles to predict the internal surface corrosion of glass and the tendency of glass stripping.Results:In the simulation experiment,no obvious delamination occurs in the cillin bottle.In the accelerated experiment,there was a tendency of delamination in the cillin bottle.Conclusion:Through methylene blue staining,scanning electron microscopy,pH and element migration characterization tests,the delamination trend of pharmaceutical glass packaging can be accurately and effectively judged.This article provides an important basis for the compatibility study of sodium hyaluronate pharmaceutical glass packaging.