Tradition- and science-based quality control of Chinese medicines--introducing the Phyto-True system.

The current QC practice of quantifying presumed active chemicals or arbitrarily selected chemical markers is of doubtful value in assessing multicomponent complex traditional Chinese medicines (CMs) and often leads to an inconsistent or irreproducible research and clinical outcome. Consequently, the first and most important step in the QC of CMs (or other botanical medicines) whose exact active chemical components are unknown is to use analytical techniques that can comprehensively define the totality of the components/attributes making up their identity and quality. One of the most versatile techniques is HPTLC. Using HPTLC, along with other simple techniques such as FTIR spectroscopy and UV-Vis spectroscopy combined with complementary gene expression profiling, we have been able to correctly identify CM materials, detect adulterants, and differentiate closely related materials and botanical species. Our research has resulted in the introduction of the concept and specimens of Phyto-True Reference Material (PTRM), aka Representative Botanical Reference/Research Material (RBRM), now commercially available, and a novel patent-pending technology (Phyto-True system) that can serve as a starting point for the meaningful QC of traditional CMs so far not possible for these complex materials. Examples will be highlighted to demonstrate this new concept.