组分结构理论指导下创新中药制剂的拓展与外延

中药制剂学是研究原料制成适宜剂型以供临床应用的科学,其研究范围与传统的化学制剂药物存在显著差别。中药由于成分复杂多样,成分性质不明确、不统一,其制剂前处理过程是影响中药制剂成药性及药物安全有效性的关键因素。中药制剂的内涵是一个巨大的系统工程,不仅应包括传统上的剂型设计过程,还包含物质基础组分结构优化过程;组分提取、分离、精制纯化过程;中药组分性质表征过程;以及为了选择适宜剂型以在最大程度上发挥药效和对制剂进行评价所进行的药物药理毒理等研究过程。因此,该文根据现代创新中药制剂的要求,基于中药的整体和系统性,重点阐述现代中药制剂的拓展性和外延性特点,包括基于组分结构理论探究中药作用的物质基础、组分的分离精制纯化、组分结构优化与网络药理与调控、代表性组分生物药剂学性质,并以此为依据构建多单元释药系统以及中药多维结构过程动态质量控制技术体系。该文科学阐述现代创新中药制剂的科学内涵和系统性,为研发现代创新中药制剂提供思路和方法。

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.