ABSTRACT
The construction of the comprehensive evaluation index system of the famous classical formula preparations after the marketing has both theoretical and practical significance. In this study， literature related to the post-marketing comprehensive evaluation of traditional Chinese medicine（TCM） compound preparations was retrieved from China National Knowledge Infrastructure（CNKI）， China Science and Technology Journal Database（VIP）， Wanfang Data Knowledge Service Platform（WanFang） and SinoMed from January 1， 2000 to April 30， 2022. CiteSpace 6.1.R2， a scientometrics software， was used to visualize the keywords involved， and to analyze the dynamic evolution trend and research hotspots in this field. Then， the existing comprehensive post-marketing evaluation index system of TCM compound preparations was screened and extracted， and the research status was systematically analyzed by mathematical statistics. It was found that there were problems such as the generalized boundaries between assessment dimensions and assessment elements， the lack of data sources for individual evaluation indexes， unset weight of some index system and insufficient application degree. In addition， according to the characteristics of famous classical formulas， the authors discuss the importance of evidence evaluation based on combination of disease and syndrome， pharmacovigilance of famous classical formulas preparations， and whole-process quality control of famous classical formulas， and put forward the construction strategy of comprehensive post-marketing evaluation of the famous classical formula preparations， which is oriented by clinical value， centered on evidence evaluation， and guaranteed by the whole-process quality control.
ABSTRACT
The ancient famous classical formulas were developed based on the characteristics of excellent curative effect, small toxic and side effects, and wide clinical application. Its development will promote the development of traditional Chinese medicine (TCM) with huge social and economic benefits. TCM and TCM compounds are multi-component systems, which are multi-component, multi-target and multi-pathway effect on human body, their curative effect is the result of synergistic effect of multi-component. Because of its characteristics, its mechanism of action is still unclear and quality is difficult to control. Therefore, on the basis of biological properties of the multi-components of TCM, it is the key issue to study the preparation process of the medicinal materials-decoction pieces-preparations and the transferability, stability and homogeneity of the quality attributes. Moreover, the supramolecular theory can explain the basic theory of TCM from the macroscopic and microscopic aspects, the study of ancient famous classical formulas can use the supramolecular theory. Both TCM and human body are giant complex supramolecules, and their components are clustered objects reflecting the characteristics of the original imprinting template with genetic polymorphism. The quality attributes, processing, formulation preparation and quality attribute evaluation of TCM are all affected by supramolecular chemistry, which is finally reflected in the preparation of imprinting template and the transfer law of quality properties. Therefore, the application of supramolecular imprinting template theory to study the biogenetic polymorphism of TCM, processing, formulation preparation and quality attribute evaluation of medicinal materials can improve the availability rate of successful research and development of ancient famous classical formulas.