《中华人民共和国药典》(2025年版)药品包装用橡胶密封件指导原则解读  

Interpretation of Guideline for Rubber Closures for Pharmaceutical Packaging in the Chinese Pharmacopoeia(2025 Edition)

作　　者：徐俊 杨美成 陈蕾[2] XU Jun;YANG Meicheng;CHEN Lei(Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]上海市食品药品包装材料测试所,上海201203 [2]国家药典委员会,北京100061

出　　处：《医药导报》2024年第11期1754-1758,共5页Herald of Medicine

摘　　要：目的解析《中华人民共和国药典》(2025年版)药品包装用橡胶密封件指导原则,促进相关方更好理解和合理使用该指导原则。方法结合橡胶密封件质量控制需求,对指导原则制定的必要性及质量控制相关内容进行说明,并给出合理使用建议。结果相关方应基于指导原则的通用要求,结合产品性质及实际应用情况,制定橡胶密封件产品的企业标准或质量协议。结论基于全过程风险管理理念,经相关方积极参与制定的药品包装用橡胶密封件指导原则,明确了橡胶密封件的质量控制要求及关键质量属性,有助于促进橡胶密封件的质量控制。Objective To interpret the guideline for rubber closures for pharmaceutical packaging in the Chinese Pharmacopoeia(2025 Edition)for relative parties to facilitate their better understanding and reasonable application of the guideline.Methods Based on the considerations of lifecycle risk management and combined with the developing requirements for the quality management of rubber closures,the necessity of establishing the guideline was explained and the relevant contents of quality control were interpreted,and suggestions of the reasonable utilization of rubber closures were given.Results According to the rubber closures’properties and their actual application,relative parties should establish the enterprise standards or the quality agreements of the rubber closures,in line with the general baseline requirements settled by the guideline.Conclusion Based on the risk management concept in the whole process,the established guideline defining the quality control requirements of rubber closures and their critical quality attributes would be helpful to promote the quality control of rubber closures.

关 键 词：药品包装 橡胶密封件 中华人民共和国药典 指导原则 解析 

分 类 号：R95[医药卫生—药学] R921