Key issues and essential points in non-clinical pharmacology of traditional Chinese medicine formulas: enhancing the scientization and standardization

As the primary form and means of clinical treatment, traditional Chinese medicine formulas (TCM formulas) embody the core of TCM’s syndrome differentiation and treatment approach and serve as a bridge between TCM theory and clinical practice. Exploring the relationship between the chemical constituents of TCM formulas and the body’s vital activities, along with their complex interactive mechanisms, represents one of the key scientific challenges in modern TCM research. However, due to the complexity of TCM chemical constituents and the inherent vast systemic nature of the human body, coupled with the fragmented, experiential, and semi-quantitative nature of TCM formulas pharmacology research, bottlenecks such as complex composition, unclear mechanisms, and insufficient standardization and refinement constrain its in-depth development. Technical guidelines for non-clinical pharmacology research of traditional Chinese medicine formulas systematically review and summarize the research content and relevant advances in non-clinical pharmacology of TCM formulas, integrate multidisciplinary technical approaches, and establish research standards, providing practical standards for systematically elucidating the integrated mechanisms of action between multi-component drugs and the body. This article interprets the core content of the technical guidelines, thereby initiating the following discussion on TCM formulas pharmacology: analyzing critical points, elucidating the complete evidence chain, and describing research content and application scenarios, which aims to enhance the scientization and reliability of TCM formulas pharmacology and to facilitate the research and development of new TCM drugs.