摘要
药品包装的安全性是保障药品安全的关键属性之一,可通过对药品包装的生物学评价来实现。对药品包装的生物学评价不能仅依赖生物学试验,而是应该建立科学的评价理念。本文通过对药品包装生物学评价的国内外新进展进行介绍,首次提出了在风险管理过程中进行生物学评价与试验选择的理念,重点阐述基于风险管理原则的药品包装生物学评价基本原则、评价过程、样品制备以及提取溶剂和提取条件的选择原则,旨在为更好地进行药品包装生物学评价服务。
The safety of pharmaceutical packaging is one of the key attributes to ensure the safety of drugs,which can be achieved by biological evaluation.The biological evaluation for pharmaceutical packaging should not only rely on biological tests,but also should establish the scientific evaluation concept.This paper introduced the update of biological evaluation for pharmaceutical packaging at home and abroad,and put forward the concept of over all biological evaluation and test selection in the process of risk management for the first time.It focused on the basic principles of biological evaluation based on risk management principles,evaluation process,sample preparation,and the selection principles of extraction solvent and extraction conditions,aiming to better serve the biological evaluation for pharmaceutical packaging.
作者
刘成虎
施燕平
孙晓霞
乔春霞
孙立魁
孙令骁
刘佳
侯丽
王昕
LIU Cheng-hu;SHI Yan-ping;SUN Xiao-xia;QIAO Chun-xia;SUN Li-kui;SUN Ling-xiao;LIU Jia;HOU Li;WANG Xin(Shandong Institute of Medical Devices and Pharmaceutical Packaging Inspection,NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging,Jinan 250101,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2022年第11期1877-1883,共7页
Chinese Journal of Pharmaceutical Analysis
基金
国家药典委员会2021年度国家药品标准提高补充课题(2021Y27)。
关键词
药品包装
安全性
生物学评价
风险管理
终点
pharmaceutical packaging
safety
biological evaluation
risk management
endpoint
