无菌制剂包装系统密封性检测中阳性对照样品的研究进展  

Research progress in positive control samples in container closure integrity test of aseptic preparations

作　　者：朱佳绮 贾菲菲 赵霞[1] ZHU Jia-qi;JIA Fei-fei;ZHAO Xia(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》2024年第22期2346-2351,共6页Chinese Journal of New Drugs

基　　金：中国食品药品检定研究院中青年发展研究基金资助项目(2023C7)。

摘　　要：包装系统密封性是指包装系统防止内容物损失、微生物侵入以及气体(氧气、空气、水蒸气等)或其他物质进入,保证药品持续符合安全与质量要求的能力。近年来,包装系统密封性检测受到越来越多的关注,本文讨论了国内外包装系统密封完整性检测技术的研究现状,介绍了密封性检测中使用的阳性对照样品的制备、标定方法及面临的问题,归纳了国内密封完整性检测中阳性对照样品的研究要点,对其发展进行了展望,以期为国内药品密封性检测中阳性对照样品研究工作提供参考。The closure integrity of packaging systems refers to the ability of the packaging systems to prevent the loss of contents,invasion of microorganisms,and entry of gases(oxygen,air,water vapor,etc.)or other substances to ensure that the drug continues to meet the safety and quality requirements.In recent years,the closure integrity testing of packaging systems has received more and more attention.This article discussed the current research status of closure integrity testing technology of packaging systems at home and abroad and introduced the preparation method,calibration method and problems faced by positive control samples which are used in packaging system closure integrity testing.Besides,this article also summarized the main points of domestic research on positive control samples in packaging system closure integrity testing,and prospected its development,in order to provide reference for the research on positive control samples in domestic drug packaging system closure integrity testing.

关 键 词：无菌制剂 容器密封完整性 泄漏 泄漏检测技术 阳性对照样品 

分 类 号：R943[医药卫生—药剂学]