辅助改善睡眠中药类保健食品组方规律及思考

Formulation regularity and thinking of adjuvant sleep-improving Chinese medicinal health products

为了总结和分析使用有助于改善睡眠的保健食品的中药的现状,该研究检索了国家市场监督管理总局(SMAR)特殊食品安全监督管理司发布的有关改善睡眠的保健食品的信息,使用Microsoft Excel和中医传承辅助平台对它们进行统计分析,总结出配方特点,并进行数据分析与总结。共收集到435种辅助改善睡眠的保健食品,其中有344种含有中药类成分;保健食品不适用于青少年的有413种,不适用于孕产妇的有194种,其中,使用频次≥40的中药原料有10味,累计使用1095次(73.1%)。对上述保健食品原料进行无监督的熵层次聚类(设支持度为45,置信度为0.7),得到12个新组方。新组方在药物组成上与中医基本理论改善睡眠的治则基本一致,即补益心脾、养血安神,滋阴降火、交通心肾,益气镇惊、安神定志,清热化痰、和中安神,疏肝泻热、镇心安神。最后得出以下结论:根据中医药基本理论对现存改善睡眠保健食品辨证分型,根据其组方规律进行数据挖掘和分析,可以为研发新的中药保健产品提供新思路,其中,应关注特殊人群的使用需求,为其后续适用于各类人群的研究提供依据,可以达到充分发挥中医药优势的目的,为中药类保健食品更好服务大众提供基础。

To summarize and analyze the current adjuvant sleep-improving Chinese medicinal health products,this study retrieved the information on health products with the sleep-improving effect published by the Department of Special Food Safety Supervision and Management,State Administration for Market Regulation(SMAR),which was statistically analyzed with Microsoft Excel and TCMISS for the characteristics of formulations.A total of 435 sleep-improving health products were collected,including 344 ones containing Chinese herbal medicines.Among them,413 health products were not suitable for adolescents,neither 194 for pregnant women.Ten Chinese herbal medicines showed a frequency of use≥40,with 1095 times(73.1%)in use.Through unsupervised hierarchical entropy-based clustering of the above Chinese herbal medicines of health products(degree of support of 45 and confidence coefficient of 0.7),12 new formulas were obtained.The composition of Chinese herbal medicines was consistent with the principles of improving sleep in traditional Chinese medicine(TCM)theories,i.e.,replenishing the heart and spleen,nourishing blood,calming the nerves,nourishing Yin,reducing internal heat,communicating the heart and kidney,replenishing Qi,relieving convulsions,clearing heat,resolving phlegm,regulating the middle warmer,soothing the liver,relieving heat,and calming the heart.According to TCM theories,syndrome differentiation was performed based on the existing sleep-improving health products,followed by data mining and analysis according to the formulation regularity,aiming to provide new ideas for the development of new Chinese medicinal health products.In particular,attention should be attached to the requirements of special populations to provide a basis for follow-up studies,exert the advantages of TCM,and lay a foundation for Chinese medicinal health products to service the public.