摘要
为促进中医药产业健康发展,完善质量标准体系,健全以《中国药典》为核心的国家药品标准体系,提升中药及产品质量标准,在研究现有质量评价与控制方法及存在问题的基础上,提出中药质量标志物的新概念。在此基础上从影响中药质量的因素和次生代谢物的因素、中药产品的质量和质量标准与监管存在的问题、中药质量的物质基础的确定、中药质量标志物的定义、研究方法及其在质量评价中的应用等方面与同行们共同讨论,并愿此概念引起同行共鸣。
To promote the healthy development of pharmaceutical industry,improve the quality standard system,core of national pharmacopoeia standards,and product quality standards of Chinese materia medica(CMM),we analyzed the existing quality assessment methods and problems on the proposed new concept on Chinese medicine quality markers.On this basis,the factors affecting the quality of CMM and secondary metabolites,herbal product quality and quality standards and regulatory problems in the quality of the material basis of CMM to determine the definition of quality markers of CMM,and research methods in terms of quality evaluation of applications to discuss with colleagues.For a common goal,we would like to respond to this concept can lead counterparts.
出处
《中草药》
CAS
CSCD
北大核心
2016年第9期1443-1457,共15页
Chinese Traditional and Herbal Drugs
关键词
中药
制剂
药用资源
药典
质量管理
质量标志物
质量标准
一测多评
次生代谢物
Chinese materia medica
formulation
medicinal resource
pharmacopoeia
quality administration
quality marker
quality standard
quantitative analysis of multi-components by single marker
secondary metabolites
