预灌封注射器国内外标准的比较  

Comparison of Domestic and International Standards for Prefilled Syringes

作　　者：薄晓文 孙光宇 刘爱娟 沈永 张敏 陈蕾[2] BO Xiaowen;SUN Guangyu;LIU Aijuan;SHEN Yong;ZHANG Min;CHEN Lei(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging,Jinan 250101,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院,国家药品监督管理局药品包装材料质量控制重点实验室,济南250101 [2]国家药典委员会,北京100061

出　　处：《医药导报》2025年第4期527-531,共5页Herald of Medicine

基　　金：2023年度国家药品标准制修订研究课题—预灌封注射器相关通则(2023Y48)。

摘　　要：目的全面解析预灌封注射器的国内外标准体系,以期推动标准的科学化与国际化进程。方法细致梳理2015年版《国家药包材标准》(简称YBB标准)标准体系、国际标准化组织(ISO)11040国际标准体系及美国药典标准体系的架构、适用范围与质量控制要点,运用比较分析法揭示三者的异同,从而挖掘各自的特点。结果YBB标准聚焦于预灌封注射器的质量控制,条款明确、操作性强,为企业提供了精准的生产与检验指导。但该标准在产品覆盖范围方面存在一定的局限性。ISO标准适用的产品范围较为广泛,内容相对更全面,且具备一定的灵活性,特别强调产品的通用性和与其他国际标准的兼容性,便于跨国生产和贸易。美国药典有多个章节涉及预灌封注射器,但缺乏一定的针对性和系统性。结论充分学习和借鉴国内外标准中关于预灌封注射器质量控制的理念、标准架构及控制要点,以期为构建《中华人民共和国药典》预灌封注射器标准体系提供参考。Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system.Methods A thorough review of the framework,scope,and quality control key points of the 2015 national pharmaceutical packaging material standards(abbreviated as YBB standards),the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted.Comparative analysis was employed to reveal the similarities and differences among the three,thereby uncovering the unique characteristics of each.Results The YBB standards emphasize quality control for prefilled syringes,offering clear and operational guidelines that provide companies with precise directives for production and testing.However,the scope of these standards is relatively limited.ISO standards apply to a wide range of products,featuring comprehensive coverage and a degree of flexibility.They emphasize the universality of products and compatibility with other international standards,which facilitates global production and trade.USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach.Conclusion By thoroughly studying and drawing upon the quality control philosophies,standard frameworks,and key control points of prefilled syringes from both domestic and international standards,we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.

关 键 词：预灌封注射器 YBB标准 ISO标准 美国药典 

分 类 号：R95[医药卫生—药学]