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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。
Traditional Chinese medicine is the study of raw materials made of suitable dosage form for clinical application of science, the scope of its research and the traditional chemical drugs there are significant differences. Due to the complex and diverse composition of traditional Chinese medicine, the composition of the nature is not clear, not uniform, the pretreatment process is the Chinese medicine formulations of drugs and drug safety and effectiveness of the key factors. The connotation of traditional Chinese medicine is a huge systematic project, which should not only include the traditional formulation design process, but also the structure optimization process of material base components; the extraction, separation and purification of components; the process of characterization of components of traditional Chinese medicines; Select the appropriate dosage form in order to maximize efficacy and evaluation of the preparation of the drug pharmacology and toxicology and other research processes. Therefore, based on the requirements of modern and innovative Chinese medicine preparations, based on the overall and systemic aspects of traditional Chinese medicine, this article focuses on the characteristics of extension and extensibility of modern Chinese medicine preparations, including the material basis for exploring the role of traditional Chinese medicine based on the theory of compositional structure and the separation of components Purification and purification, structural optimization of components and network pharmacology and regulation, the representative components of the biopharmaceutical properties, and as a basis for the construction of multi-unit drug delivery system and multi-dimensional structure of traditional Chinese medicine dynamic quality control technology system. This article expounds the scientific connotation and systematicness of modern innovative Chinese medicine preparations and provides ideas and methods for the research and development of modern and innovative Chinese medicine preparations.