基于中医方证代谢组学的关黄柏质量标志物发现

中药质量是关系到中医生死存亡的关键问题。质量标准是衡量和控制中药质量的依据，质量标志物是其核心要素，它是否具有特异、可测、有效、可溯源及反映方剂配伍等属性是质量标准能否控制中药材、饮片、提取物及制剂内在质量的关键。中医方证代谢组学是在方证对应并显效的前提下，发现与临床疗效相关，体现方剂配伍，来源于组成药物药效物质基础的方法，是发现质量标记物的有效途径；关黄柏是常用清热燥湿、滋阴除蒸药物，其质量标准中指标成分一直与黄连无异，既无特异性和可溯源性，更没有体现关黄柏在经典方剂中表达的特有疗效。本课题以方证代谢组学为核心技术，以反映关黄柏清热燥湿功能的栀子柏皮汤及反映关黄柏滋阴除蒸功能的知柏地黄丸为研究对象，在配伍环境下发现关黄柏与功效及配伍相关的化学成分群，实现其药材质量标志物与功效关联具有特异性，其制剂质量标志物与疗效关联具有特征性且可溯源，助力解决现行国家标准存在的难以逾越障碍。

The quality of Chinese herbal medicines is a key issue that concerns the survival of Chinese medicine. The quality standard is the basis for measuring and controlling the quality of Chinese herbal medicines. The quality-markers are the core factor. Its specificity, measurability, validity, traceability and compatibility with other ingredients are the key to the inherent quality standard of the preparation. Under the effective condition of syndromes corresponding prescription, chinmedomics is used to found the substance basis that is related to clinical efficacy, embody prescription compatibility, and derived from the prescription composition, and is the effective way to find the quality markers. Phellodendron amurense Rupr. is commonly used to heating dampness, nourishing yin in addition to steamed drugs, its quality standards indicators have been consistent with Coptis chinensis Franch., but non-specific and traceability, and did not reflect the unique effect in the classical prescription. In this study, chinmedomics as the core technology, Zhizibaipi Tang that to reflect the function of heat-clearing and damp-drying and Zhibaidihaung Wan that to reflect the function of nourishing yin and removing steam as the research objects, is used to discover the chemical compositions of Phellodendron amurense Rupr. related to the efficacy and compatibility, to achieve its specificity and traceability of quality markers associated with efficacy, help solve the insurmountable obstacles of national standards.