摘要
目的:聚焦于生物制品领域,探讨常用小规格玻璃注射剂瓶的装量差异对其与药物相容性的影响。方法:选取4种不同类型的2 mL玻璃注射剂瓶,灌装不同体积的模拟溶液,检测溶液中玻璃主要组成元素的迁移量和注射剂瓶被侵蚀情况。结果:随着装量的减少,不同玻璃注射剂瓶的元素迁移量均有不同程度的增加,中硼硅玻璃管制注射剂瓶内表面可见明显侵蚀,且受装量影响显著,而中硼硅玻璃模制注射剂瓶与铝硅玻璃管制注射剂瓶未见明显侵蚀,在不同装量下情况基本一致。结论:低装量的药品更易暴露于中硼硅玻璃管制注射剂瓶的“脆弱”区域,中硼硅玻璃模制注射剂瓶与铝硅玻璃管制注射剂瓶不存在此“脆弱”区域。建议为注射剂选择玻璃瓶包装或改变装量时,应开展全面的相容性研究。
Objective:This study,focusing on the field of biopharmaceuticals,aims to investigate the impact of fill volume variation in commonly used small-volume glass injection vials on drug compatibility.Methods:Four types of 2 mL glass injection vials were selected and filled with simulated solutions at different volumes.The migration levels of primary glass constituent elements into the solutions and the erosion of the vials were analyzed.Results:As the fill volume decreased,the migration of glass elements increased to varying degrees across all vial types.Significant inner surface erosion was observed in tubular borosilicate glass vials,with a notable correlation to reduced fill volume.In contrast,molded middle borosilicate glass vials and aluminosilicate glass tubing vials exhibited no visible erosion,maintaining consistent performance across fill volumes.Conclusion:Low fill volumes in pharmaceutical products increase exposure to the“susceptible regions”of tubular borosilicate glass vials.In contrast,molded borosilicate glass vials and aluminosilicate glass vials lack such vulnerable areas.Therefore,comprehensive compatibility studies should be conducted when selecting glass vial packaging or adjusting fill volumes for injectable formulations.
作者
李晓宇
齐艳菲
袁淑胜
赵霞
LI Xiao-yu;QI Yan-fei;YUAN Shu-sheng;ZHAO Xia(China Pharmaceutical University,Nanjing 211198,China;National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国新药杂志》
北大核心
2026年第5期530-537,共8页
Chinese Journal of New Drugs
基金
国家药品监督管理局药品监管科学体系建设重点资助项目:基于生物制品新型包装系统质量评价研究(RS2024S002)。
关键词
注射剂瓶
装量
相容性
生物制品
injection vials
fill volume
compatibility
biopharmaceuticals
