摘要
国家药品抽检工作在标准检验的基础上,以问题为导向进一步深入开展与药品安全性、真实性、有效性和一致性相关的探索性研究,旨在全面评价药品质量状况,在药品质量评价、监管及质量控制水平提高与完善等方面发挥了重要作用。通过综合分析2020年国家药品抽检中成药品种质量报告,对整体质量状况及发现的主要问题进行梳理,并提出合理化建议,以期更好地保障用药安全性与有效性。
National drug sampling inspection quality analysis is based on standard tests.Further problem-oriented exploratory research on drug safety,authenticity,effectiveness and uniformity is carried out.The purpose is to evaluate the overall quality comprehensively.And it plays an important role in many aspects including drug quality evaluation,supervision,and improvement of quality control.This paper analyzes the quality reports of Chinese patent medicines in 2020 national drug sampling inspection.The overall status and main problems affecting the quality and safety are sorted out.And some corresponding reasonable suggestions are recommended in order to better safeguard the drug safety and effectiveness.
作者
刘静
朱嘉亮
冯磊
戴忠
马双成
LIU Jing;ZHU Jia-liang;FENG Lei;DAI Zhong;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国现代中药》
CAS
2021年第5期755-759,共5页
Modern Chinese Medicine
基金
国家“重大新药创制”科技重大专项(2018ZX09735-006)。
关键词
国家药品抽检
中成药
质量
national drug sampling
Chinese patent medicines
quality
作者简介
通信作者:戴忠,研究员,研究方向:中药质量控制与中药标准物质,Tel:(010)67095268,E-mail:daizhong@nifdc.org.cn;通信作者:马双成,研究员,研究方向:中药质量与安全,Tel:(010)53852076,E-mail:masc@nifdc.org.cn;并列第一作者:朱嘉亮。
