Zhou Gang, He Yan-Ping
Zhongguo Zhong Yao Za Zhi. 2014 Sep;39(17):3389-91.
The new traditional Chinese medicine compound is the main part of the research of new drug of traditional Chinese medicine (TCM), and the new Chinese herbal compound reflects the characteristics of TCM theory. The new traditional Chinese medicine compound quality standard research is one of the main content of pharmaceutical research, and is also the focus of the new medicine pharmaceutical evaluation content. Although in recent years the research level of new traditional Chinese medicine compound has been greatly improved, but the author during the review found still some common problems existing in new traditional Chinese medicine compound quality standard research data, this paper analyzed the current quality standards for new traditional Chinese medicine compound and the problems existing in the research data, respectively from measurement of the content of index selection, determine the scope of the content, and the quality standard design concept, the paper expounds developers need to concern. The quality of new traditional Chinese medicine compound quality standard is not only itself can be solved, but quality standards is to ensure the key and important content of product quality, improving the quality of products cannot do without quality standards. With the development of science and technology, on the basis of quality by design under the guidance of the concept, new traditional Chinese medicine compound quality standard system will be more scientific, systematic and perfect.
中药新复方是中药新药研究的主要内容，中药新复方体现了中医理论特色。中药新复方质量标准研究是药学研究的主要内容之一，也是新药药学评价内容的重点。虽然近年来中药新复方的研究水平有了很大提高，但笔者在审评过程中发现中药新复方质量标准研究资料仍存在一些共性问题，本文分析了中药新复方现行质量标准及研究资料中存在的问题，分别从指标成分含量测定的选择、含量测定范围的确定以及质量标准设计理念等方面，阐述了研发者需要关注的问题。中药新复方质量标准的质量不仅自身有待解决，而且质量标准是保证产品质量的关键和重要内容，提高产品质量离不开质量标准。随着科技的发展，在质量源于设计理念的指导下，中药新复方质量标准体系将更加科学、系统和完善。
