基于Q-Marker理论的化学标识物研究及应用  

Research and Application of Chemical Marker Based on Q-marker Theory

作　　者：林永强 林林 焦阳 穆向荣 郭东晓 汪冰 王淑华 LIN Yong-qiang;LIN Lin;JIAO Yang;MU Xiang-rong;GUO Dong-xiao;WANG Bing;WANG Shu-hua(NMPA Key Laboratory for Quality Evaluation of Gelatin Products,Shandong Provincial Insititute for Food and Drug Control,Jinan 250101,China;NMPA Center for Drug Evaluation,Beijing 100022,China)

机构地区：[1]山东省食品药品检验研究院,国家药品监督管理局胶类产品质量评价重点实验室,济南250101 [2]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国药学杂志》2020年第2期161-166,共6页Chinese Pharmaceutical Journal

基　　金：山东省自然科学基金项目资助(ZR2013HM074)。

摘　　要：目的探寻一种新的中药质量控制研究模式,为中药质量控制和研究提供新的思路和视角,提升中药产品质量,促进中药产业健康发展。方法在刘昌孝院士提出的中药质量标志物(Q-Marker)理论体系下,提出化学标识物概念,寻找来源某药材(饮片)特有的而不是来源于其他药材的化学物质作为化学标识物,用于中药的真伪鉴别以及质量控制。结果与讨论分别以白薇、阿胶、皂矾作为植物药、动物药、矿物药的代表,进行了正伪品的化学标识物研究,并将其应用于女金丸、乙肝解毒胶囊等制剂中,在国家药品评价性抽验中发挥了重大的作用。OBJECTIVE To explore a new research mode of TCM quality control,provide new ideas and perspectives for TCM quality control and research,improve the quality of TCM products,and promote the healthy development of TCM industry.METHODS Under the theoretical system of Q-marker proposed by academician LIU Chang-xiao,we put forward the concept of chemical markers,looking for sources of some medicinal herbs(slices) unique and not from other medicinal chemistry as a chemical Marker used for the identification and quality control of Chinese traditional medicine.RESULTS AND CONCLUSION Cynanchi Atrati Radix Et Rhizoma,Asini Corii Colla and Melanteritum were used as the representatives of plant medicine,animal medicine and mineral medicine respectively to study the chemical markers of genuine and fake products,and to apply them in the preparations such as Nvjin pill and Yigan jiedu capsule,which played an important role in the national drug evaluation sampling test.

关 键 词：中药 质量控制 质量标志物 化学标识物 

分 类 号：R917[医药卫生—药物分析学]