鲁尔接头预灌封注射器相关功能性评价方法要点解析  

Key Points Analysis of Functionality Evaluation Methods for Prefilled Syringe with Luer Conical Fitting

作　　者：于晓慧 李文丽 赵艺伟 张博 陈蕾[2] YU Xiaohui;LI Wenli;ZHAO Yiwei;ZHANG Bo;CHEN Lei(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,NMPA Key Laboratory of Quality Control for 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542-546,共5页Herald of Medicine

基　　金：国家药典委员会国家药品标准制修订研究课题(2023Y49)。

摘　　要：目的助力药品和药包材生产企业理解并使用鲁尔接头预灌封注射器相关功能性评价方法,进而科学规范产品质量。方法通过对比国内外标准现状,结合鲁尔接头预灌封注射器产品结构特点和生产使用情况,分析需重点关注的相关功能性评价方法内容及测试要点。结果鲁尔接头预灌封注射器相关功能性评价方法是对预灌封注射器国内标准的改进和补充,应注意依据产品形式选择适宜的方法进行测试。结论建立鲁尔接头预灌封注射器相关功能性评价方法,在指导药品和药包材生产企业进行标准化质量控制的同时,能够更好地满足市场监管的需要,这也是推动行业整体发展的有效途径之一。Objective To assist drug and pharmaceutical packaging material manufacturers in understanding and utilizing the functionality evaluation methods for prefilled syringe with Luer conical fittings,thereby scientifically specifying product quality.Methods By comparing the standards status both domestically and internationally,and in conjunction with the product characteristics,production,and actual usage situation of prefilled syringe with Luer conical fittings,the test contents and key points of related functionality evaluation methods were analyzed.Results The functionality evaluation methods for prefilled syringe with Luer conical fittings represent improvements and supplements to domestic standard,appropriate methods should be selected based on the product type.Conclusion Developing functionality evaluation methods for prefilled syringe with Luer conical fittings will provide guidance to standardized quality control for drug and pharmaceutical packaging material manufacturers.It will also better meet the requirements for market regulation,and is an effective way to promote the overall development of the industry.

关 键 词：预灌封注射器 鲁尔圆锥接头 功能性 评价方法 

分 类 号：R95[医药卫生—药学] TH77[机械工程—仪器科学与技术]