Summary on Quality Control of TCMs in Chinese Pharmacopoeia (2010 version)

The main aim of the Chinese Pharmacopoeia (ChP 2010 version) is to build up a quality controlling module that is in accordance with the characteristics of TCMs and is different from that of chemical medicines. It will change gradually from using single ingredient into using active, multiple ingredients, fingerprint or bio-determination to totally control the quality of TCMs. For the safety control of TCMs, the species of pesticides were determined examining the pesticides residues according to the actual utility of chemical pesticides. This residue determination is required in more and more monographs within the Chinese material medica. The pesticides residue limits have been established in the ChP (2010 version). Other pollutants, such as heavy metals, sulphur dioxide, etc., were determined, controlled, and their acceptable limits established in the ChP (2010 version). The efficacy control of TCMs, TLC-bioautography and bio-activity determination techniques were used to establish the quality of TCMs. These results may reflect the true quality more directly and precisely than using a single ingredient. For well-controlled quality TCMs, DNA molecular marking and fingerprint techniques were adopted by ChP. DNA molecular marking technique was also used in Chinese material medica monographs to define their species which can not be identified by microscopic, chemical or chromatographic methods, especially in multi-origin CMMs. Fingerprinting techniques were used to control the uniformity and stability of TCMs in order to reflect the integrity of the herbs and their complex ingredients.