Yan Dan
Beijing Key Laboratory and International Cooperation & Joint Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing Shijitan Hospital, Capital Medical University Beijing 100038, China.
Zhongguo Zhong Yao Za Zhi. 2019 Feb;44(3):409-414. doi: 10.19540/j.cnki.cjcmm.20190102.004.
The quality evaluation of Chinese materia medica(CMM) is an important and difficult topic research in traditional Chinese medicine, due to its inherent complexity, and incompatibility of evaluation patterns and their key techniques. To solve the issue, it is necessary to break the limit of conventional evaluation, and establish the evaluation pattern and its key techniques about CMM quality related to clinic. Hence, with the strategy- "originating from clinic, validating by experiments and returning to clinic", a novel academic concept is proposed which is termed as "bio-characteristic profiling related to clinic of CMM". A series of key techniques should be established including living-cell dynamic monitoring, enzyme bioactivity dynamic monitoring, electric chemistry dynamic monitoring and isothermal titration dynamic monitoring, etc. Besides, the quality fluctuation of CMM(products) which is hard to control and assess could be evaluated when associated with clinical efficacy and safety(exemplified by Chinese herbal injection, animal medicine and joint use of drugs in clinic). It is expected to form the novel evaluation system for CMM quality based on bio-characteristic profiling related to clinic and its key techniques, which provides novel ideas and techniques for improving quality and clinical efficacy, and promotes the modernization and internationalization of CMM.
中药质量评价是中医药领域的一个重要且困难的课题研究，因其内在复杂性以及评价模式与关键技术的不相容性。为解决该问题，有必要突破传统评价的局限，建立与临床相关的中药质量评价模式及其关键技术。因此，以“源于临床，实验验证，回归临床”为策略，提出了一个新的学术概念，即“中药临床相关生物特征图谱”。应建立一系列关键技术，包括活细胞动态监测、酶生物活性动态监测、电化学动态监测和等温滴定量热动态监测等。此外，当与临床疗效和安全性相关联时（以中药注射剂、兽用药及临床联合用药为例），难以控制和评估的中药（产品）质量波动可以得到评价。期望基于中药临床相关生物特征图谱及其关键技术形成新的中药质量评价体系，为提高质量和临床疗效提供新思路和技术，推动中药现代化和国际化。
