基于中药四性的中药新药研究策略

Research Strategy of New Chinese Medicine Based on Four Properties of Traditional Chinese Medicine

中药四性理论是指导中药临床用药的重要依据。然而,中药现代化研究中发现大量药性未明的中药有效物质,亟待构筑以中药四性理论为指导的中药新药研发体系。本文从"中药药性必有其物质基础"的认识出发,在已知的中药四性认识的基础上,提出基于"标准平性中药模型"的中药偏性组分的克隆与新药研究策略:选择一定数量具有代表性的平性中药进行系统分离,以各分离组分的含量与比例关系为参照,建立"标准平性中药模型";以此为准,凡是中药分离组分的含量与比例关系偏离"标准模型"者,即为该中药偏寒或偏热的偏性组分;并从克隆寒热药之偏性组分出发,研究中药偏性组分的质量标准,探讨其纠偏作用与机制,期望形成以中药四性理论指导的以药效组分为主要组成的中药新药。

The four properties theory of traditional Chinese medicine（TCM） is an important basis for the guidance of TCM clinical medication. However, TCM modernization has produced a large number of active substances with unknown medicine properties. Therefore, it is urgent to build a new drug development system guided with TCM four properties theory. From the view of that four properties of TCM must have their material basis, and based on the known knowledge on TCM four properties, this paper proposed strategies of new drug research by cloning TCM partial components based on the ＂TCM model of standard level property.＂ A certain number of representative standard level property TCM drugs were selected to conduct system separation for the establishment of a ＂TCM model of standard level property with the proportion and content of each separated component as a reference.＂ The standard model was used as a boundary. Contents and proportions of the experimental TCM separation components deviated from this ＂standard model＂ were classified as hot or cold properties. From cloning of the partial components of TCM with hot or cold property medicine, the quality standards of partial components of experimental TCM were also studied, in order to investigate their corrective actions and mechanisms. The TCM partial components were expected to form a new TCM drug with the four properties theory of TCM as guidance.