中国现代中药2023,Vol.25Issue(10):2055-2060,6.DOI:10.13313/j.issn.1673-4890.20230901002
2022年国家药品抽检中成药质量状况分析
Quality Analysis of Chinese Patent Medicines Based on 2022 National Drug Sampling and Inspection
摘要
Abstract
National drug sampling and inspection adopt a problem-oriented and risk prevention approach,with standard testing combined with exploratory research as an evaluation model,providing crucial technical support for post-market drug regulation in China and constituting an important measure for ensuring drug quality and safety.In 2022,national drug sampling and inspection covered 47 varieties of Chinese patent medicines.Based on quality analysis reports for each variety,an overall assessment of Chinese patent medicine quality was conducted.The main quality problems identified were analyzed and summarized,along with relevant improvement recommendations.This study is expected to serve as a reference for further enhancing the quality of Chinese patent medicine and implementing scientifically sound regulation.关键词
国家药品抽检/中成药/质量/标准/探索性研究Key words
national drug sampling and inspection/Chinese patent medicine/quality/standard/exploratory research分类
医药卫生引用本文复制引用
刘静,朱炯,王翀,金红宇,戴忠,魏锋,马双成..2022年国家药品抽检中成药质量状况分析[J].中国现代中药,2023,25(10):2055-2060,6.基金项目
国家"重大新药创制"科技重大专项(2018ZX09735-006) (2018ZX09735-006)