摘要
药物制剂组成复杂,在各种生产过程均可能引入元素杂质,这些元素杂质不仅可能影响药效,还是影响药品质量安全的重要因素。根据国际人用药物注册技术协调会议(International Conference of Harmonization,ICH)发布的Q3D元素杂质指南,分析元素杂质在药物制剂中的引入途径及限度要求,发现元素杂质在元素周期表中呈较规律分布,而元素杂质存在的形态与其毒性有较大关系,旨在为药品质量监控提供参考。
The composition of pharmaceutical preparations is complex,and elemental impurities may be introduced into pharmaceutical preparations in various drug production processes.These elemental impurities may not only affect the efficacy,but also affect the quality and safety of drugs.According to the guidelines of Q3D issued by the International Conference of Harmonization(ICH),the introduction ways and limit requirements of elemental impurities in pharmaceutical preparations were analyzed.It was found that elemental impurities were regularly distributed in the periodic table of elements and their morphology was related to their toxicity.The aim is to provide reference for drug quality monitoring.
作者
贺彦
徐娟娟
王有娣
HE Yan;XU Juan-juan;WANG You-di(School of Pharmacy,Xinhua College of Sun Yat-sen University,Guangdong Guangzhou 510520,China)
出处
《广州化工》
CAS
2020年第19期7-9,14,共4页
GuangZhou Chemical Industry
基金
广东省本科高校教学质量与教学改革工程建设项目(2018JP001)。
关键词
元素杂质
药物制剂
药品质量
elemental impurities
pharmaceutical preparations
drug quality
