Physical Fingerprint of Traditional Chinese Medicine Powders:A Review

KeyWord:traditional Chinese medicine powders  physical fingerprint  physical characterization  quality consistency evaluation  quality by design

Abstract:

      Traditional Chinese medicine(TCM) powders are important intermediates or products of oral solid preparations of traditional Chinese medicines.The physical properties of the powders not only affect the formation techniques,but also impact the quality of the products directly or indirectly.There are many types of traditional Chinese medicine powders with different scales.Physical fingerprints,as a complementary method for the content determination of traditional Chinese medicine powders or HPLC fingerprint evaluation,are used to evaluate the quality of traditional Chinese medicine powders from the physical properties,which provide a new way for the overall quality control of traditional Chinese medicine powders.A standardized establishment method of the physical fingerprints for traditional Chinese medicine powders is systematically described in this paper,including design of the index system,test or calculation of the secondary indexes,and standardized processing and map display of the secondary indexes.Application of physical fingerprints in the whole process quality evaluation of Chinese medicine wall broken powders,Chinese medicine extract powders,Chinese medicine granules,pharmaceutical excipients,dosage forming process and formulation design is summarized.Carrying out physical fingerprints and physical property analysis method verification to ensure the reliability of the data of the physical fingerprints,combining pattern recognition with artificial intelligence methods to expand the application scenarios of physical fingerprints,supporting the quality consistency evaluation and the design and continuous improvement of the prescription and process of Chinese medicine preparations are the main directions of the future research.