[Scalability and extensionality of innovative Chinese medicine preparation under guidance of component structure theory]

Chinese medicine preparation is a science to study how to make raw material into suitable dosage forms to be used in clinical operations. Its study scope is significantly different from traditional chemical drugs. As is known, the ingredients of Chinese medicine are complex and various, as a result, the composition of the ingredients is not clear and the property is not unified. The pre-treatment process is the key factor to affect the druggability, safety and efficacy of the Chinese medicine. The connotation of Chinese medicine is a huge systematic project, not only including the traditional dosage form design process but also including the components structure optimization process on material basis, components extraction, separation and purification process, components characterization process as well as the pharmacological and toxicological study processes which aim to select suitable dosage form to exert the maximum drug efficacy and evaluate the properties of preparations. Therefore, according to the requirement of modern innovative preparations and based on the integrity and systematicness of Chinese medicine, in this paper we will explore the scalability and extensionality of modern Chinese medicine, including the material basis of Chinese medicine based on component structure theory; separation, refining and purification of components; component structure optimization and network pharmacology and regulation, as well as biopharmaceutics properties of representative components, and we will construct the multi-unit drug delivery system and Chinese medicine multi-dimensional dynamic quality control system. This paper elaborates the scientific connotation and systematicness of modern Chinese preparation, and provides ideas and methods for the development of modern innovative Chinese preparations.