《中华人民共和国药典》预灌封注射器标准体系的构建思路解析  

Analysis of the Construction Approach of the Prefilled Syringe Standard System in Chinese Pharmacopoeia

作　　者：沈永 薄晓文 于晓慧 俞辉 陈蕾[3] SHEN Yong;BO Xiaowen;YU Xiaohui;YU Hui;CHEN Lei(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging,Jinan 250101,China;Zhejiang Institute for Food and Drug Control,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province,Hangzhou 310052,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]浙江省食品药品检验研究院,浙江省药品接触材料质量控制研究重点实验室,杭州310052 [3]国家药典委员会,北京100061

出　　处：《医药导报》2025年第4期523-527,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：目的通过关键条款分析,全面解析拟构建的预灌封注射器标准体系的整体架构及关键质量属性。方法在充分了解市场产品情况、国内外标准现状的基础上,识别预灌封注射器容器系统的关键质量属性。结果构建满足我国监管及行业发展需求的新的预灌封注射器标准体系。结论拟构建的预灌封注射器标准体系兼具刚性和延展性,满足监管需要,有利于推动行业发展。Objective This study aims to comprehensively analyze the overall framework and key quality attributes of the proposed standard system for prefilled syringes through key clause analysis.Methods Based on a thorough understanding of market product conditions and the current status of domestic and international standards;the critical quality attributes of pre-filled syringe container systems were identified.Results A new standard system for prefilled syringes was constructed to meet the regulatory and industry development needs of China.Conclusions The proposed standard system for prefilled syringes is designed with both rigidity and flexibility,meeting regulatory needs and facilitating industry development.

关 键 词：预灌封注射器 半组装预灌封注射器 标准体系 质量属性 

分 类 号：R955[医药卫生—药学]