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TMR Modern Herbal Medicine 2019年第1期2卷 3-10页

作者： Zhi-Rui Yang Ai-Ting Wang Juan Liu Xin-Yu Yang Xiao-Fang Wang Lei Zhang Na Guo Jia-Chen Zi Cheng Peng Shu-Xun Yan Dan Yan Beijing Shijitan Hospital Capital Medical UniversityBeijingChina Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use BeijingChina International Cooperation&Joint Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use BeijingChina Experimental Research Center China Academy of Chinese Medical SciencesBeijingChina JiNan University GuangzhouChina Chengdu University of Traditional Chinese Medicine ChengduChina The first affiliated hospital Henan University of China MedicineZhengzhouChina

quality marker(Q-marker)of Chinese materia medica(CMM)plays an important role in quality control of CMM ***,its research strategy and technique remain *** on the fact that quality standard of CMM should be associated with clinical efficacy,taking Jinqi Jiangtang tablet treating type 2 diabetes as an example,the Q-marker related to activity via the reverse analysis of drug metabolism in clinic and traceability of botanic biosynthetic pathways is discovered and ***,we proposed a new research strategy of Q-marker of CMM with"Discovery of clinical active constituents as guidance,Reverse analysis of metabolic transformations as link,and Traceability of biosynthesis pathways as key",to improve quality control of CMM products.

关键词： Chinese materia medica quality marker Clinical metabolic analysis Biosynthetic pathway Jinqi Jiangtang Tablet Type 2 diabetes

A New Concept on quality marker for quality Assessment and Process Control of Chinese Medicines

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Chinese Herbal Medicines 2017年第1期9卷 3-13页

作者： Chang-xiao Liu Yi-yu Cheng De-an Guo Tie-jun Zhang Ya-zhuo Li Wen-bin Hou Lu-qi Huang Hai-yu Xu Research Center for New Drug Evaluation Tianjin Institute of Pharmaceutical Research Tianjin 300193 China Institute of Pharmaceutical Information Zhejiang University Hangzhou 310058 China Shanghai Institute of Materia Medica Chinese Academy of Sciences Shanghai 201203 China Research Center for Modern Chinese Medicines Tianjin Institute of Pharmaceutical Research Tianjin 300193 China Institute of Chinese Materia Medica China Academy of Chinese Medical Sciences Beijing 100700 China

Chinese medicine （CM） is the most typical conventional therapy compared with any other traditional or alternative medicine systems. The active components of CMs are either primary or secondary metabolites generated by metabolic and biosynthetic enzymes in plants, protecting the plants from environmental stress. The characteristics of these metabolites are diverse, complicated and unique. In this paper, current approaches for quality assessment were extensively reviewed, a new concept of quality marker （Q-marker） was then proposed for CM quality assessment. Additionally, definition of the Q-marker, as well as the relevant methods, were discussed, on the basis of the biosynthetic pathways of secondary metabolites and source of biological active components. Study design of Q-marker is complex system for quality assessment and production process control of CM products with transitivity and traceability. Therefore, the system with characteristics of transmission and traceability is expected to be established for regulation of quality. Upon the concept which the transitivity and traceability in the quality assessment and production process control covered the entire process, such as raw materials, decoction slices, processing, extraction and production can be further enhanced. The transitivity and traceability will inevitably require close attention to ＂who, what, where, when, and why＂ details at each stage of Q-markers of CM production form raw materials to patent product. The establishing quality standards are enablers of many and various transitivity and traceability solutions, not a solution in them. It means that the transitivity and traceability system is readily link between products and across borders in quality. According to the thinking mode and methods of investigation on quality assessment of CM product, we focus on the entire process, in terms of safety and effectiveness and quality control. The standard preparation of CM or CM decoction is not only the basis

关键词： Chinese medicine formulation medicinal resource quality administration quality marker quality standard quantitative analysis secondary metabolites

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Mass spectrometry imaging for unearthing and validating quality markers in traditional Chinese medicines

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Chinese Herbal Medicines 2025年第1期17卷 31-40页

作者： Zhiyun Wang Huajie Chang Qian Zhao Wenfeng Gou Yiliang Li Zhengwei Tu Wenbin Hou Tianjin Key Laboratory of Radiation Medicine and Molecular Nuclear Medicine Institute of Radiation Medicine Peking Union Medical College & Chinese Academy of Medical Sciences Tianjin Nankai District Wangdingdi Hospital Tianjin Key Laboratory of Acute Abdomen Disease Associated Organ Injury and ITCWM Repair Tianjin Nan Kai Hospital

quality marker(Q-marker) is an innovative concept and model for quality control of Traditional Chinese medicines(TCMs),which will navigate the new direction of quality development of ***,how to characterize the overall quality attributes of TCMs and their biological effects is still *** view of this key scientific issue,this paper proposes a research method based on mass spectrometry imaging(MSI) technology for the discovery and confirmation of TCMs *** is powerful in investigating the spatial distribution of molecules in a variety of samples,and visualizing the information obtained from *** this basis,combine with the five principles of TCMs Q-marker validation,i.e.,specificity,transmission and traceability,testability,prescription compatibility,and validity,were applied to confirm the finalized *** will lead the new direction of quality development of TCMs.

关键词： five principles quality marker quality control traditional Chinese medicines

Research Progress on Rodgersia and Predictive Analysis on its quality markers

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World Journal of Traditional Chinese Medicine 2023年第3期9卷 243-257页

作者： Ling-Ling Chu Bin Li Jia Wu Ling Jiang Xu-Dong Zhou Wen-Bing Sheng Cai-Yun Peng Salman Zafar Ping-An Liu Wei Wang TCM and Ethnomedicine Innovation and Development International Laboratory School of PharmacyHunan University of Chinese MedicineChangshaHunanChina Institute of Chemical Sciences University of PeshawarPeshawarPakistan Hunan Academy of Chinese Medicine ChangshaHunanChina

Rodgersia is a traditional Chinese medicine that contains a variety of chemical constituents,including flavonoids,terpenoids,phenylpropanoids,gallic acid derivatives,steroids,volatile oils,and tannins,with anti-inflammatory,antioxidant,antitumor,antibacterial,antivirus,hepatoprotective,and other *** this paper,the main chemical constituents and pharmacological effects of Rodgersia are *** this basis,the quality markers of this genus were predicted based on chemical composition,traditional medicinal properties,traditional efficacy,and measurable *** review provides the basis for in-depth research,utilization,and quality control of Rodgersia.

关键词： Bergenin chemical constituents pharmacological activity quality marker Rodgersia

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Research progress and quality markers prediction analysis of Dysosma versipellis

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Traditional Medicine Research 2023年第3期8卷 36-50页

作者： Yuan-Hui Guo Peng Lu Jia-Xing He Bao-Nan Ma Ebuka-Olisaemeka Nwafor Wen-Xin Wang Chuan-Xin Liu Endocrine and Metabolic Disease Center First Affiliated Hospitaland College of Clinical Medicine of Henan University of Science and TechnologyMedical Key Laboratory of Hereditary Rare Diseases of HenanLuoyang Sub-center of National Clinical Research Center for Metabolic DiseasesLuoyang 471000China Department of Pharmacy Suzhou TCM Hospital Affiliated to Nanjing University of Chinese MedicineSuzhou 215009China College of Traditional Chinese Medicine Beijing University of Traditional Chinese MedicineBeijing 100029China School of Health&Biomedical Sciences RMIT University–Bundoora CampusMelbourne 3083Australia School of Biological and Medical Engineering Beihang UnivesityBeijing 100083China

Dysosma versipellis is the rhizome of Bajiaolian in *** is a unique medicinal plant in China and it was the first to be recorded in Shennong’s Classic of Materia Medica(unknown author,25–220 C.E.).It has complex chemical components as well as complex,pharmacological and toxicological effects are *** on the recent research progress,the chemical constituents,pharmacological activities and toxicological effects of Dysosma versipellis were *** with the core concept of quality markers of traditional Chinese medicine,the prediction and analysis were carried out from the aspects of phytogenetics and the source pathway of specific chemical constituents,traditional medicinal properties,traditional efficacy,chemical composition measurability,blood components,and pharmacokinetics,in order to provide reference for further study of Dysosma versipellis.

关键词： Dysosma versipellis lignans flavonoids chemical composition pharmacological activity toxicological effect quality marker podophyllotoxin kaempferol quercetin

Study on quality markers and Action Mechanisms of Inulae Flos on Anti-Hepatitis Through Network Pharmacology and High-Performance Liquid Chromatography Fingerprints

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World Journal of Traditional Chinese Medicine 2022年第3期8卷 426-435页

作者： Li Lin Lian-Lin Su Huan-Huan Li Chun-Qin Mao De Ji Hui Xie Tu-Lin Lu Chinese Materia Medica Processing Laboratory College of PharmacyNanjing University of Chinese MedicineNanjing 210023China

Objective:The objective of the study is to combine network pharmacology with high-performance liquid chromatography(HPLC)to screen for quality markers(Q-markers)of Inulae Flos and predict mechanism on *** and Methods:Active ingredient library of Inulae Flos is structured using databases and the literature.“Compound-target-pathway”network on anti-hepatitis and protein–protein interaction(PPI)network are constructed using network ***,chromatographic fingerprints of Inulae Flos in 7 origins are obtained through HPLC,and chemometric analysis is implemented to identify chemical markers,which is combined with network pharmacology to identify Q-markers and detect ***:1,6-O,O-Diacetylbritannilactone,Ivangustin,and Inulanolide A are key ingredients of Inulae Flos to interact with 82 potential targets related to ***,signal transducer and activator of transcription 3,tumor necrosis factor,interleukin-6,and transcription factor AP-1 are the core targets in the PPI *** fingerprints of the Inulae Flos define 20 common peaks and identify 8 peaks using reference *** partial least square discriminant analysis,7compounds including caffeic acid,chlorogenic acid,and 1,6-O,O-Diacetylbritannilactone were main chemical markers for variability.1,6-O,O-Diacetylbritannilactone is both a key ingredient and exclusive chemical ***,1,6-O,O-diacetylbritannilactone is a Q-marker of Inulae Flos,and the average content is 1.82 mg/***:1,6-O,O-diacetylbritannilactone is determined to be a Q-marker of Inulae Flos.

关键词： Hepatitis high-performance liquid chromatography fingerprint Inulae Flos network pharmacology quality marker

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Novel assays for quality evaluation of XueBiJing:quality variability of a Chinese herbal injection for sepsis management

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Journal of Pharmaceutical Analysis 2022年第4期12卷 664-682页

作者： Xuan Yu Wei Niu Ya-Ya Wang Olajide E.Olaleye Jia-Nan Wang Meng-Yuan Duan Jun-Ling Yang Rong-Rong He Zi-Xuan Chu Kai Dong Gui-Ping Zhang Chang-Xiao Liu Chen Cheng Chuan Li State Key Laboratory of Drug Research Shanghai Institute of Materia MedicaChinese Academy of SciencesShanghai201203China School of Pharmacy University of Chinese Academy of SciencesBeijing100049China Graduate School Tianjin University of Traditional Chinese MedicineTianjin300193China Research Institute Tianjin Chasesun Pharmaceutical Co.Ltd.Tianjin301700China State Key Laboratory of Drug Delivery Technology and Pharmacokinetics and Tianjin Key Laboratory of quality-marker of Traditional Chinese Medicines Tianjin Institute of Pharmaceutical ResearchTianjin300193China

XueBiJing is an intravenous five-herb injection used to treat sepsis in *** study aimed to develop a liquid chromatography-tandem mass spectrometry(LC-MS/MS)-or liquid chromatography-ultraviolet(LC-UV)-based assay for quality evaluation of *** development involved identifying marker constituents to make the assay therapeutically relevant and building a reliable one-point calibrator for monitoring the various analytes in *** marker constituents from the five herbs were selected based on XueBiJing's chemical composition,pharmacokinetics,and pharmacodynamics.A selectivity test(for“similarity of response”)was developed to identify and minimize interference by nontarget ***,an intercept test was developed to fulfill“linearity through zero”for each analyte(absolute ratio of intercept to C response,marker constituents(4.1%-14.8%),except for senkyunolide I(26.5%).

关键词： XueBiJing Chinese herbal medicine quality variability quality marker One-point calibration

ETCM v2.0:An update with comprehensive resource and rich annotations for traditional Chinese medicine

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Acta Pharmaceutica Sinica B 2023年第6期13卷 2559-2571页

作者： Yanqiong Zhang Xin Li Yulong Shi Tong Chen Zhijian Xu Ping Wang Meng Yu Wenjia Chen Bing Li Zhiwei Jing Hong Jiang Lu Fu Wenjing Gao Yanhua Jiang Xia Du Zipeng Gong Weiliang Zhu Hongjun Yang Haiyu Xu Institute of Chinese Materia Medica China Academy of Chinese Medical SciencesBeijing 100700China State Key Laboratory of Drug Research Drug Discovery and Design CenterShanghai Institute of Materia MedicaChinese Academy of SciencesShanghai 201203China National Resource Center for Chinese Materia Medica Chinese Academy of Chinese Medical SciencesBeijing 100700China Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical SciencesBeijing 100700China Shaanxi Academy of Traditional Chinese Medicine Xi'an 710003China State Key Laboratory of Functions and Applications of Medicinal Plants Guizhou Provincial Key Laboratory of PharmaceuticsGuizhou Medical UniversityGuiyang 550004China China Academy of Chinese Medical Sciences Beijing 100700China

Existing traditional Chinese medicine(TCM)-related databases are still insufficient in data standardization,integrity and precision,and need to be updated ***,an Encyclopedia of Traditional Chinese Medicine version 2.0(ETCM v2.0,http://***/ETCM2/front/#/)was constructed as the latest curated database hosting 48,442 TCM formulas recorded by ancient Chinese medical books,9872 Chinese patent drugs,2079 Chinese medicinal materials and 38,298 *** facilitate the mechanistic research and new drug discovery,we improved the target identification method based on a two-dimensional ligand similarity search module,which provides the confirmed and/or potential targets of each ingredient,as well as their binding ***,five TCM formulas/Chinese patent drugs/herbs/ingredients with the highest Jaccard similarity scores to the submitted drugs are offered in ETCM v2.0,which may be of significance to identify prescriptions/herbs/ingredients with similar clinical efficacy,to summarize the rules of prescription use,and to find alternative drugs for endangered Chinese medicinal ***,ETCM v2.0 provides an enhanced Java Script-based network visualization tool for creating,modifying and exploring multi-scale biological *** v2.0 may be a major data warehouse for the quality marker identification of TCMs,the TCM-derived drug discovery and repurposing,and the pharmacological mechanism investigation of TCMs against various human diseases.

关键词： Traditional Chinese medicine Database Target identification Network visualization New drug research and development Molecular mechanism quality marker Drug repurposing