[Bio-characteristic profiling related to clinic:thought and practice on quality evaluation of Chinese materia medica].

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.