药品包装用玻璃容器耐热性和耐冷冻性及热稳定性评价调研分析

Investigation and Analysis on the Evaluation of Heat Resistance,Freezing Resistance,and Thermal Stability of Glass Containers for Pharmaceutical Packaging

目的建立更加科学合理的药品包装用玻璃容器耐热性、耐冷冻性以及热稳定性的评价方式,以适应新形势下药品的监管需求。方法以问卷形式向国内注射剂的生产企业进行调研,调研内容包括注射剂生产过程中药品包装用玻璃容器清洗、终端灭菌的工艺参数,以及冻干制剂的冻干工艺流程等工艺过程。结果注射剂在实际生产中用到的干热灭菌、冷冻干燥和湿热灭菌工艺参数变化范围很广,通过实验室模拟单一条件进行评价,缺少科学性和实用性。结论为落实《中华人民共和国药典》2025年版中药品包装用玻璃容器新标准体系的搭建,通过本次调研,了解药品实际生产工艺参数,提出在药品包装用玻璃容器新标准体系中不再对耐热性、耐冷冻性和热稳定性的具体实验条件进行限定,企业可根据各自实际的工艺过程设定适合的实验条件对性能进行评价。

Objective To establish a more scientific and reasonable evaluation method for the heat resistance,freezing resistance,and thermal stability of glass containers for pharmaceutical packaging to meet the regulatory needs of drugs in the new situation.Methods A survey was conducted on domestic injection production enterprises in the form of a questionnaire,including the process parameters of cleaning for glass containers for pharmaceutical packaging,terminal sterilization during injection production,and the freeze-drying process flow of freeze-dried formulations.Results The parameters of dry heat sterilization,freeze-drying,and moist heat sterilization used in actual production of injections vary widely,and evaluation through laboratory simulation under single conditions lacks scientific and practical applicability.Conclusions In order to implement the construction of the new standard system for glass packaging materials in 2025 edition of the Chinese Pharmacopoeia,through this investigation,the actual production process parameters of drugs were shown,and it is proposed that specific experimental conditions for heat resistance,freezing resistance,and thermal stability will no longer be limited in the new standard system for use.Suitable experimental conditions can be set by enterprises based on their actual process to evaluate performance.