Promotion of quality standard of Chinese herbal medicine by the integrated and efficacy-oriented quality marker of Effect-constituent Index.
Multiple constituents have been applied currently as markers to control the quality of Chinese herbal medicine (CHM). However, those constituents are isolated from each other, failed to present their contribution differences to the bioeffect of CHM. Besides, a CHM for different clinic uses is often controlled by the same quality marker (Q-marker), which cannot correlate its efficacies differentially. The study aims to promote the quality standard of CHM by the integrated and efficacy-oriented Q-marker of Effect-constituent Index (ECI). With Coptidis Rhizoma (C. Rhizoma) as a case study, the Q-marker of ECI based on the integration of bioeffect and active constituents was developed. According to the efficacies of C. Rhizoma, we investigated its antibacterial and antineoplastic effects by microcalorimetry and MTT assay, respectively. High performance liquid chromatography was performed to determine the active constituents of C. Rhizoma extract simultaneously. ECIS of inhibition on Shigella dysenteriae (S. dysenteriae) and ECIH of inhibition on HepG2 cells were established by multi-indicator synthetic evaluation method. The organoleptic evaluation scores of C. Rhizoma samples were given by Delphi method. The correlation analysis showed that ECIS and ECIH were significantly correlated with the inhibiting effects of C. Rhizoma extract on the growth of S. dysenteriae (P < 0.01) and proliferation of HepG2 cells (P < 0.01), respectively. Moreover, ECI showed a good ability to distinguish and predict the bioeffect-based quality grade, whereas the organoleptic evaluation and chemical analysis failed to achieve it. Plus, some samples with lower ECIS showed higher ECIH and vice versa. The Q-marker of ECI is useful to associate different pharmacologic effects of C. Rhizoma containing multiple active constituents, which is beneficial for the improvement of quality standard of the CHM in an integrated, convenient, and differentiated way.