目的：确认注射用泮托拉唑钠与低硼硅玻璃管包装容器的相容性和适用性，避免因药物与药用包装容器的相容性问题可能导致的安全性风险。方法：对经强降解试验14d、加速试验6个月和长期试验12月前后的注射用泮托拉唑钠与玻璃瓶，分别采用HPLC法、微粒计数法、金相显微法和ICP-MS法等分析检测方法对可见异物、不溶性微粒、迁移离子、pH和有关物质等主要指标进行检测。结果：表明注射用泮托拉唑钠用低硼硅玻璃管制注射剂瓶包装容器存放，经强降解试验、加速试验和长期试验后，发现注射用泮托拉唑钠中硅、钙是有上升趋势，铝、硼也有一定程度的上升，镁、镉、铅、砷、锑迁移数值略有波动，但均明显低于PDE值要求；玻璃容器及其迁移离子对药物的质量影响较小，未发生明显的变化；药物对玻璃容器稳定性的略有影响，但玻璃瓶内表面未发现有明显的脱片、麻点、裂痕和侵蚀痕迹等现象。结论：公司目前采用的低硼硅玻璃管制注射剂瓶基本满足药品包装要求，现有的包装材料包装的药品质量仍是安全、稳定、可靠的。
Objective: To confirm the suitability and compatibility between pantoprazole sodium for injection and low borosilicate glass ampoule, and prevent the safety risk potentially caused by the compatibility between drug and container.Methods: During 14-days stress test, 6-months accelerated test and 12-months long-term test, pantoprazole sodium for injection and glass ampoules were tested respectively by HPLC, particle counting, metallurgical microscopy and ICP-MS method, to monitor visible particles, sub-visible particles, ion migration, pH and related substances.Results: The testing results indicated that after stress, accelerated and long-term test, Si and Ca contented in pantoprazole sodiμm for injection increased obviously, Al and B contents increased slightly, Mg, Cd, Pb, As and Sb contented fluctuated slightly but obviously less than PDE value; the glass container and its migration ions had little influence on drug quality.The drug had a little influence to glass container stability, but no evidence of shedding, pits, crack and erosion being observed on the inner surface of glass container.Conclusion: The currently-used low borosilicate glass ampoules almost meet the packaging requirement for drug.The drug packed by this container is safe, stable and reliable.
