目的 挖掘现有改善睡眠类保健食品的组方规律，构建“数据挖掘统计-药食同源/经典名方筛选-中医药理论说明”新方体系，并探讨其潜在作用机制。方法 从国家市场监督管理总局收集公开的改善睡眠类保健食品备案信息，分析原料中药及配伍规律；基于挖掘结果构建改善睡眠药食同源新方，并利用网络药理学预测其潜在作用靶点及信号通路，并通过分子对接验证活性成分与核心靶点的结合能力。结果 共纳入符合标准的改善睡眠类保健食品541种，涉及中药154味，其中酸枣仁、五味子、茯苓等为高频使用中药；性味以甘、平为主，归经多集中于心、肝经；关联规则分析发现“五味子-酸枣仁”“茯苓-酸枣仁”等核心药对；剂型以胶囊剂、片剂、颗粒剂为主；用法用量以每日1～2次为主，99.8%的产品未标注服用疗程；保健功能除改善睡眠外，常兼具增强免疫力、缓解体力疲劳等复合功能；适宜人群以睡眠状况不佳者为主，不适宜人群以少年儿童、孕期及哺乳期妇女为主；由百合、鲜地黄、酸枣仁、天麻、葛根组成的新方经网络药理学预测，筛选出有效成分42个，作用靶点760个，失眠潜在靶点189个；增强免疫力潜在靶点196个；调节肠道菌群潜在靶点63个。主要富集于神经活性配体-受体相互作用、磷脂酰肌醇-3-羟激酶（phosphatidylinositol-3-hydroxykinase，PI3K）-蛋白激酶B（protein kinase B，Akt）信号通路、内分泌抵抗等与改善睡眠、增强免疫力、调节肠道菌群调控密切相关的通路；分子对接显示新方的活性成分与核心靶点结合良好。结论 筛选出改善睡眠保健食品新方“百合-鲜地黄-酸枣仁-天麻-葛根”，其改善睡眠主要与增强免疫力、调节肠道菌群调控等密切相关，为改善睡眠后续保健品开发提供了科学的理论支持。

Objective To explore the formulation rules of existing sleep-improving health foods, construct “data mining statistics-medicine and edible homology/classical formula screening-traditional Chinese medicine theoretical interpretation” new formula system and investigate its potential mechanisms of action. Methods The publicly available record information of sleep-improving health foods was collected from the State Administration for Market Regulation, and the raw materials and compatibility rules were analyzed. Based on the data mining results, a novel sleep-improving formula of medicine and edible homology was constructed. Network pharmacology was used to predict the potential action targets and signaling pathways, and molecular docking was performed to verify the binding affinity between active components and core targets. Results A total of 541 sleep-improving health foods meeting the inclusion criteria were included, involving 154 Chinese medicinal materials. The high-frequency materials included Suanzaoren (Ziziphi Spinosae Semen), Wuweizi (Schisandrae Chinensis Fructus), and Fuling (Poria). Their nature and taste are mainly sweet and neutral, and its meridians mainly focus on the heart and liver meridians. Association rule analysis revealed core drug pairs such as “Schisandrae Chinensis Fructus-Ziziphi Spinosae Semen” and “Poria-Ziziphi Spinosae Semen”. Capsules, tablets, and granules were the main dosage forms. The usage and dosage were mainly 1–2 times daily, and 99.8% of the products did not specify a course of administration. Besides the core function of sleep improvement, these products often also claimed enhancing immunity and relieving physical fatigue as combined functions. The suitable population was primarily individuals with poor sleep status, while the unsuitable population mainly included children, pregnant and lactating women. A novel formula consisting of Baihe (Lilii Bulbus), Dihuang (Rehmanniae Radix), Ziziphi Spinosae Semen, Tianma (Gastrodiae Rhizoma), Gegen (Puerariae Lobatae Radix) was constructed. Network pharmacology predicted 42 active components, 760 action targets, among which 189 were associated with sleep, 196 with immune enhancement, and 63 with gut microbiota regulation. The enrichment analysis indicated that the main pathways involved neuroactive ligand-receptor interaction, phosphatidylinositol-3-hydroxykinase (PI3K)-protein kinase B (Akt) signaling pathway, and endocrine resistance, which are closely related to sleep improvement, immune enhancement, and gut microbiota regulation. Molecular docking showed that the active components of the novel formula bound well with the core targets. Conclusion A new formula of health food for improving sleep, “Lilii Bulbus-Rehmanniae Radix-Ziziphi Spinosae Semen-Gastrodiae Rhizoma-Puerariae Lobatae Radix”, is screened out. Its sleep-improving effect is mainly closely related to enhancing immunity and regulating intestinal microbiota, which provides scientific theoretical support for the subsequent development of health products for sleep improvement..

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国家自然科学基金资助项目（82560842）；云南省科技厅-云南省中医药基础研究联合专项项目（202501AZ070001-024，202001AZ070001-008）；云南省重点研发计划项目（202303AC100025）；2024年度云南省专业学位研究生教学案例库项目（《生物药剂学与药物动力学》研究生教学案例库）；云南省科技厅创新引导与科技型企业培育计划项目（202404BU090035）