[关键词]
[摘要]
梳理了中药质量标志物(quality marker,Q-Marker)在药材、饮片、制剂质量研究及全过程研究中的应用进展,中药Q-Marker的提出为中药质量研究和全过程控制提供了研究思路,并具有很好的指导意义。提出应加强与有效性和安全性相关联的质量研究,加强整体质量表征和多元化控制,完善源头和全过程质量控制,重视药材、饮片和制剂之间的相关性研究,分阶段开展质量标准研究,不断提高中药质量控制水平。
[Key word]
[Abstract]
The application of quality markers (Q-Marker) of traditional Chinese medicine (TCM) in the whole process of quality control research of medicinal materials, herbal pieces and preparations are reviewed in this paper, and the Q-Marker of TCM provide a good guiding significance and research idea for the quality research and whole process control of TCM. It is proposed that the quality research of TCM should strengthen the association with effectiveness and safety, strengthen the holistic quality representation and diversified quality control methods, improve the quality control of the source and whole process, and pay more attention to the correlation research among the medicinal materials, pieces and preparations. The quality standards of TCM can be carried out in different stages, so as to improve the quality control level of TCM.
[中图分类号]
R283;R284
[基金项目]