注射液对安瓿内表面化学稳定性的影响与分析

Influence and analysis of injection on chemical stability of ampoule inner surface

目的:评价注射液对安瓿内表面化学稳定性的影响。方法:选取肌苷注射液和骨瓜提取物注射液为代表性品种,从安瓿内表面化学侵蚀的机制入手,分析了影响安瓿内表面耐受性的几种主要因素,采用亚甲蓝染色法和电镜观察法对安瓿内表面侵蚀程度进行了考察,建立了以扫描电镜-X射线能谱分析技术为基础的药液中不溶性物质的显微鉴定方法。结果:肌苷注射液包装用安瓿内表面观察到侵蚀区域,药液中不溶性物质主要为玻璃成分。骨瓜提取物注射液包装用安瓿内表面未观察到侵蚀区域,药液中不溶性物质主要为有机物。结论:建立的方法可对注射液与包装用安瓿之间的相互作用进行分析,以评估注射液包装用安瓿内表面的化学稳定性。

Objective:To evaluate the influence of injection on chemical stability of ampoule inner surface.Methods:The Inosine Injection and Gugua Extract Injection were selected as the representative drug products.Some major influence factors were analyzed from the mechanism of chemical erosion of ampoule inner surface,and the erosion degree of ampoule inner surface was investigated with methylene blue staining and electron microscope observation methods.The microscopic identification method of insoluble substance in drug solution was established based on SEM-EDX technology.Results:Erosion areas on the inner surface of ampoules for Inosine Injection were observed,and the insoluble substances in the injection were mainly glass components.No erosion area on the inner surface of ampoules for Gugua Extract Injection was observed.Conclusion:The established method can be used to analyze the interaction between injection and packaging container of ampoule in order to evaluate the chemical stability of the inner surface of ampoule for injection packaging.