[關(guān)鍵詞]
[摘要]
中藥質(zhì)量標(biāo)志物是中藥質(zhì)量控制的新概念,反映了中藥質(zhì)量本質(zhì)的科學(xué)內(nèi)涵。 該新概念提出以來,我國中藥行業(yè)開展了廣泛的研究,形成豐碩的研究成果,但是,迄今尚未提出中藥質(zhì)量標(biāo)志物發(fā)現(xiàn)和確定的技術(shù)規(guī)范。 中華中醫(yī)藥學(xué)會(huì)立項(xiàng)制訂《中藥質(zhì)量標(biāo)志物研究技術(shù)指南》, 意在明確質(zhì)量標(biāo)志物發(fā)現(xiàn)和確定的原則、研究路徑、技術(shù)方法。 本指南制定集合了起草單位各團(tuán)隊(duì)中藥質(zhì)量標(biāo)志物研究工作,并結(jié)合公開發(fā)表的中藥質(zhì)量標(biāo)志物文獻(xiàn)調(diào)研結(jié)果,經(jīng)過多個(gè)學(xué)科專家充分討論后形成共識,同時(shí)廣泛征求來自大專院校、科研院所、檢驗(yàn)檢測機(jī)構(gòu)及中藥生產(chǎn)企業(yè)的多學(xué)科專家意見,保證了指南的實(shí)用性、規(guī)范性、科學(xué)性及可行性。
[Key word]
[Abstract]
Quality markers (Q-Markers) of traditional Chinese medicine (TCM) represent a novel concept in TCM quality control, reflecting the scientific essence of TCM quality. Since its introduction, extensive research has been conducted in China's TCM industry, yielding substantial outcomes. However, standardized technical specifications for the discovery and determination of Q-Markers have yet to be established. The Technical Guide for Research on Quality Markers of Traditional Chinese Medicine, initiated by the China Association of Chinese Medicine (CACM), aims to define principles, research pathways, and technical methods for identifying and validating Q-Markers. This guideline consolidates research efforts from drafting teams, integrates literature reviews on Q-Markers, and incorporates multidisciplinary expert consensus through extensive discussions and consultations with academia, research institutions, testing agencies, and TCM manufacturers, ensuring its practicality, standardization, scientificity, and feasibility.
[中圖分類號]
R28
[基金項(xiàng)目]
國家自然科學(xué)基金區(qū)域聯(lián)合基金項(xiàng)目(U21A20406);安徽省科技重大專項(xiàng)資助(202303a07020007)