The research and development of new traditional Chinese medicine (TCM) drugs have progressively established a novel system founded on the integration of TCM theory, human experience, and clinical trials (termed the "Three Combinations"). However, considering TCM's distinctive features of "syndrome differentiation and treatment" and "multicomponent formulations and complex mechanisms", current TCM drug development faces challenges such as insufficient understanding of the material basis and the overall mechanism of action and an incomplete evidence chain system. Moreover, significant obstacles persist in gathering human experience data, evaluating clinical efficacy, and controlling the quality of active ingredients, which impede the innovation process in TCM drug development. Network pharmacology, centered on the "network targets" theory, transcends the limitations of the conventional "single target" reductionist research model. It emphasizes the comprehensive effects of disease or syndrome biological networks as targets to elucidate the overall regulatory mechanism of TCM prescriptions. This approach aligns with the holistic perspective of TCM, offering a novel method consistent with TCM's holistic view for investigating the complex mechanisms of TCM and developing new TCM drugs. It is internationally recognized as a "next-generation drug research model". To advance the research of new tools, methods, and standards for TCM evaluation and to overcome fundamental, critical, and cutting-edge technical challenges in TCM regulation, this consensus aims to explore the characteristics, progress, challenges, applicable pathways, and specific applications of network pharmacology as a new theory, method, and tool in TCM drug development. The goal is to enhance the quality of TCM drug research and development and accelerate the efficiency of developing new TCM products.
Humans ; Consensus ; Drug Development/standards* ; Drugs, Chinese Herbal/chemistry* ; Medicine, Chinese Traditional ; Network Pharmacology/standards* ; Guidelines as Topic

This study aims to establish a quality grading standard that combines the conventional quality evaluation based on morphological characteristics of traditional Chinese medicine with the modern quality evaluation. Based on the existing standards and market circulation of Isatidis Radix, the diameter and color of Isatidis Radix decoction pieces were selected as the appearance traits for preliminary grading. The effects of internal quality indexes such as moisture, total ash, acid-insoluble ash, ethanol-soluble extractives, and 9 water-soluble components on different grades of decoction pieces were comprehensively compared, and the key grading indexes were determined by t-test. The relevance between appearance traits and the internal quality indexes was investigated by multi-dimensional statistical analyses such as correlation analysis, principal component analysis(PCA), orthogonal partial least squares-discriminant analysis(OPLS-DA), and hierarchical cluster analysis(HCA). Furthermore, the fluorescent substrate was employed to investigate the inhibitory effects of different grades of Isatidis Radix decoction pieces on the neuraminidase of influenza virus. The rationality of the selected grading index components was verified by network pharmacology. The results showed that the diameter of decoction pieces had significantly positive correlations with other index components except moisture. Considering the existing commodity specifications, grading standards, and actual market circulation of Isatidis Radix, the quality grading standard of Isatidis Radix decoction pieces was developed with diameter as the appearance trait and(R,S)-goitrin as the limit index component of being qualified. On this basis, the content of ethanol-soluble extractives, total sinigrin, and total nucleoside were selected for quality grading. The in vitro enzyme activity evaluation showed that the first grade of Isatidis Radix decoction pieces had stronger inhibitory effect on the neuraminidase of influenza virus, and the network pharmacology results showed that the selected index components for quality grading had significant correlations with influenza. This study established a quality grading standard combining appearance traits and internal quality indexes, which provides a scientific basis for improving the existing grading standards and the price and quality of Isatidis Radix decoction pieces.
Isatis/chemistry* ; Plant Roots/chemistry* ; Drugs, Chinese Herbal/standards* ; Network Pharmacology ; Neuraminidase/antagonists & inhibitors* ; Quality Improvement/standards* ; Viral Proteins