注射用泮托拉唑钠与玻璃容器的相容性研究

Compatibility study of pantoprazole sodium for injection and glass container

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、p H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, A1 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.