The Concept, Method And Application Of Equivalent Coefficient Of Chromatographic Figureprints

Chromatographic fingerprint of Traditional Chinese Medicine (TCM) has played an important role in TCM quality control, in which choosing an appropriate evaluation measurement and setting up equivalent coefficient is a key to evaluate stability of TCM. It is essential to establish an equivalent value for the pharmacy administrators to monitor quality consistency of different batches in the development of TCM industry. Currently, there are a variety of similarity evaluation methods for chromatographic fingerprints; however, the research on the system of methods mating their evaluating indicators has not been reported. The dissertation proposed a new concept, established a new model of equivalent coefficient for chromatographic fingerprints, and introduced its application in TCM, then built a reasonable evaluation system and evaluating indicator and applied them in quality control on different batches of TCM, generic and original drugs. The main achievements as followed:Firstly, an improved approach for feasible application was proposed by finding out the commonness and individuality of the methods and their limitations in practical application, and deeply investigation had been done on the existing similarity methods.Secondly, a new model of equivalent coefficient was set up. The experimental and simulated data were used to verify the characteristics and superiority of the model. The results proved that there are many strong points in the model, and its highlight depends on the sensibility towards practical fluctuation scope of the batches. Thus, the new model improved the practical utilization for TCM quality control.Thirdly, two basic theories and methods were raised on the establishment of weight and equivalent coefficient of chromatographic fingerprints. Based on the above, a reasonable system was formed for pharmacy administers to evaluate the equivalency on original and generic, and different batches of TCM.