Opportunities and challenges in development of compound preparations of traditional Chinese medicine: problems and countermeasures in research of ancient classical prescriptions

Abstract

As an outstanding representative of traditional Chinese medicine( TCM),ancient classical prescriptions carry the profound accumulation of the splendid civilization of Chinese medicine for thousands of years. It is the best part of the great treasure-house of Chinese medicine after thousands of years' training of TCM theory. It condenses the wisdom of all generations of doctors,and as the summary of clinical experience,it is the most brilliant pearl in the treasure house of TCM. The in-depth research and development of ancient classic prescriptions is a golden key to excavate the treasure house of TCM,which not only conforms to the development trend of TCM industry,but also brings unprecedented opportunities and challenges for the inheritance and innovation of contemporary Chinese herbal compound preparations. However,as a " new member" in the national drug research and development system,classic prescriptions have no specific implementation rules although the guidance is given by macro policies,and there is no successful case of research and development according to the registration requirements. Therefore,unified consensus and standards have not yet been formed for some key issues in the process of the development of the classic prescriptions,and much work is still in the exploration stage,so it is necessary to conduct in-depth research and discussion on these issues. In this paper,the problems in the research process of classical prescriptions were summarized,such as the resources of medicinal materials,the processing of decoction pieces,the prescription dosage,the molding technology and the quality evaluation,and the research strategy was put forward after analysis,hoping to provide a reference for the research and development of classical prescriptions.