Development of Formula Design Method Based on SYSTCM (SYSTCM-FD) and Its Application to an Immunoenhancing Herbal...

Formula design is a common aim for the research and development of traditional Chinese medicine (TCM) and health-functional foods. TCM emphasizes pharmacological effects and efficacies, while health-functional foods are developed based on improvement of biomarkers and health functions. As demand rises for TCM-derived health foods, a new formula design method integrating both framework is urgently needed. We developed SYSTCM-FD, a formula design method for TCM-based health products targeting health functions by integrating pharmacological research and TCM clinical experience. We integrated data of health functions, biomarkers, pharmacological effects, efficacies, and TCMs using SYSTCM database and literature mining. An exponential distribution was used to calculate TCM scores, and top-ranking TCMs were combined into formulae. SYSTCM-FD covered 24 health functions, 173 biomarkers, 40 pharmacological effects, 18 efficacies, and 167 TCMs. Using immune enhancement as a validation case, nine candidate TCMs and 126 candidate formulae were generated. A lead formula containing Siraitia grosvenorii, Ligustrum lucidum, Panax ginseng leaves, and Rosa rugosa was selected and characterized by UPLC-MS/MS, identifying 64 components. In an immunosuppressed mouse model, this formula significantly improved spleen indices, increased peripheral immune cell counts, and alleviated spleen damage. SYSTCM-FD provides a theoretical and practical strategy for developing of TCM-based functional health foods.