影响输液不溶性微粒的相关因素  

Related factors affecting insoluble particles in infusions

作　　者：彭姝 李慧芬 任重远[2] 张伟[2] PENG Shu;LI Huifen;REN Zhongyuan;ZHANG Wei(China Pharmaceutical University, Nanjing 211198 , China;Chinese Pharmacopoeia Commission, Beijing 100061 , China)

机构地区：[1]中国药科大学,南京211198 [2]国家药典委员会,北京100061

出　　处：《中国药品标准》2019年第2期101-109,共9页Drug Standards of China

基　　金：国家药典委员会.基础输液中不溶性微粒及相关因素研究课题(编号:2017012)

摘　　要：本文根据国家药典委员会开展的基础输液中不溶性微粒及相关因素研究课题的有关研究成果,归纳整理了输液产品全生命周期中各个环节影响不溶性微粒的相关因素,并结合生产实践,介绍了生产实践中不溶性微粒控制的有关措施和做法。结果与结论:输液产品中的不溶性微粒水平受输液产品整个生命周期的影响,包括生产过程、储存和运输过程以及临床使用过程的各个环节的诸多因素。通过对不溶性微粒相关因素的分析认为,不溶性微粒是评估输液产品生产管理和质量的一项重要指标。According to the research findings of the project on insoluble particles and related factors in the basic infusions which arecarried out by Chinese Pharmacopoeia Commission,the article concludes the relevant factors affecting the insoluble particulates in every aspect of infusions’ whole life cycle,and introduces the methods of controllinginsoluble particles according to the production practice. Result and conclusion: The insoluble particles are effected by infusions’ whole life cycle including every factorin the process of production,storage,transportation and clinical use. Based on the analysis of the related factors affecting insoluble particles,it is considered that insoluble particles are an important indicator to evaluate the manufacturing management and quality of infusions.

关 键 词：不溶性微粒 可见异物 输液 成因 生产管理 质量评估 质量指标 

分 类 号：R921.2[医药卫生—药学]