Discussions on the Quality Controls of Chinese Herbal Decoction Pieces Based on Requirements for Drug Technical Evaluation

The prescription of Chinese herbal decoction pieces is the material basis for the treatment and prevention of diseases. It is used not only in the clinical formulation of traditional Chinese medicine(TCM), but also in the production of TCM. Its quality directly relates to the safety and effectiveness of the medicine used by the people. Combining the quality problems of Chinese herbal decoction pieces in the past five years, this article analyzes the problems related to the standard of Chinese herbal decoction pieces in the process of drug evaluation, and sorts out the basic requirements of Chinese herbal decoction pieces for new TCM, new TCM drug on classic famous prescription, modified new TCM, TCM with same name and prescription, and marketed TCM. It is convenient to strengthen the quality control of Chinese herbal decoction pieces, and provide a useful reference for the quality control of Chinese herbal decoction pieces and related research.