Retrospective Analysis on the Application of Fingerprint and Characteristic Chromatography Technology in the National Standards of Traditional Chinese Medicine Dispensing Granules

Fingerprint and characteristic chromatography technology plays a very important role in the quality control of traditional Chinese Medicine(TCM). Compared with the national standards of Chinese medicine decoction pieces and proprietary Chinese medicine, the fingerprint or characteristic chromatography of TCM dispensing granules have been established in accordance with the "technical requirements for quality control and standard formulation of TCM dispensing granules". By reviewing and analyzing the application of fingerprint and characteristic chromatography technology in 196 national standards of TCM formula granules, it was found that some national standard of TCM formula granules had problems such as weak material basic research, too long analysis time and too many reference materials of fingerprint and characteristic chromatography technology. Enterprises producing traditional Chinese medicine formula granules should implement the main responsibility of standard maintenance, practice the concept of green standards, continue to conduct research on the material basis of traditional Chinese medicine standard decoction, optimize the chromatographic conditions of fingerprint and characteristic chromatography, and deeply explore the information of fingerprint and characteristic chromatography. By locating the relative retention time or setting relative peak area regulations, to establish national standards of TCM dispensing granules that can distinguish multiple sources, raw and processed products, counterfeit and easily confused products to ensure the safety and effectiveness of clinical use of TCM dispensing granules.