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Post-marketing safety monitoring of Shenqifuzheng injection: a solution made of Dangshen(Radix Codonopsis)and Huangqi(Radix Astragali Mongolici)

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Journal of Traditional Chinese Medicine 2014年第4期34卷 498-503页

作者： Qinghua Ai Wen Zhang Yanming Xie Wenhua Huang Hong Liang Hui Cao Institute of Basic research in Clinical Medicine China Academy of Chinese Medical Sciences national engineering research center for modernization of tcm Livzon (group) Limin Pharmaceutical Factory national engineering research center for modernization of tcm

OBJECTIVE:Toidentify the potential risk factors associated with Shenqifuzheng injection(SFI), a solution made of Dangshen(Radix Codonopsis) and Huangqi(Radix Astragali Mongolici), for the timely provision of information to regulatory ***: A comprehensive analysis of the production process, quality standards, pharmacology,post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions(ADR), case analyses, and systematic reviews,intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital in-formationsystem(HIS).RESULTS: Sub-acute toxicity tests suggesting that a dose of 15 mL/kg(concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85‰. From March to November 2013,of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI ata dosageanda treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash,chills,feeling cold,palpitation,dyspnea,edemaofa lower extremity, palpebral edema, and superficial vein in flammation,among ***: This study introduces "get full access" to the flow of information on med

关键词： Post-marketing re-evaluation Safety research Shenqifuzheng injection

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Elucidation of the fragmentation pathways of a complex 3,7-O-glycosyl flavonol by CID, HCD, and PQD on an LTQ-Orbitrap Velos Pro hybrid mass spectrometer

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Chinese Journal of Natural Medicines 2015年第11期13卷 867-872页

作者： YANG Wen-Zhi WU Wan-Ying YANG Min GUO De-An Shanghai research center for modernization of Traditional Chinese Medicine National Engineering Laboratory for TCM Standardization Technology Shanghai Institute of Materia Medica Chinese Academy of Sciences

The present study was designed to systematically investigate the ESI-MSn behavior of a complex 3, 7-O-glycosyl flavonol, kaempferol 3-O-α-L-[2,3-di-O-β-D-（6-E-p-coumaroyl）glucopyranosyl]-rhamnopyranosyl-7-O-α-L-rhamnopyranoside （KO） isolated from Epimedium wushanense, and to address the elimination priority among different glycosylation sites and different sugars/substituents. The direct-infusion ESI-MSn experiment of KO was performed on a hybrid LTQ-Orbitrap Velos Pro mass spectrometer in both negative and positive ion modes by three different fragmentation mechanisms （CID, HCD, and PQD）. The CID, HCD, and PQD analyses of KO exhibited remarkable discrimination in respect of the scan range, richness, and distribution of product ions through the entire spectra. KO experienced different fragmentation pathways between two ionization modes： the negative mode CID of KO eliminated the glycosyl portions （priority： 7-sugar 〉 3-substituent and terminal substituents 〉 inner sugar） and produced aglycone product ions at m/z 284.03/285.04; however, abundant sodium-adduct B32 together with subsequent ijX30 cleavages were found characteristic for the positive mode CID-MSn. The fragmentation pathways by CID for KO were proposed by analyzing the high accuracy ESI-MS＂ data. Complementary structural information of KO regarding the aglycone and glycosyl portions was obtained by analyzing the ESI-MSn data in both ionization modes. In conclusion, the LTQ-Orbitrap method facilitates highly reliable qualitative analysis of bioactive flavonoids with three alternative fragmentation modes.

关键词： Flavonol 3,7-O-glycoside LTQ-Orbitrap Fragmentation pathway

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Development of specific and quantitative methods for the quality control of the polysaccharides from sea-tangle and sargassum

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Chinese Journal of Natural Medicines 2016年第12期14卷 954-960页

作者： LONG Hua-Li ZHANG Jing-Xian GUO Ji-Ling SUI Guo-Qi HOU Jin-Jun YANG Wen-Zhi HAN Su-Mei WU Wan-Ying GUO De-An national engineering Laboratory for tcm Standardization Technology Shanghai Research Center for Modernization of Traditional Chinese Medicine Shanghai Institute of Materia Medica Chinese Academy of Sciences

Polysaccharides from numerous traditional Chinese medicines have been proven as the bioactive ingredients and are hence used as the quality control markers. However, the assessment criteria always show a poor specificity, due to the lack of matic comparison among the analogous herbs. In the present study, two similar materials, namely sea-tangle and sargassum, were selected as the model herbs to develop more specific methods for quality control. Two well-established methods, determination of the total polysaccharides content and monosaccharides composition analysis, were both employed. Based upon the quantitative results, the evaluation criteria of the polysaccharides contents of not less than 2.0% and 1.7% were proposed for sea-tangle and sargassum, tively. Nine identical monosaccharide derivatives appeared on the HPLC chromatograms of the hydrolysis and derivatized solutions of the two drugs. Principal component analysis and orthogonal partial least squares discriminant analysis using the peak areas of monosaccharides derivatives as the variables were performed, and the results indicated that mannuronic acid and xylose with the opposite concentrations in the two drugs were the differential components. A discriminative criterion using the peak area ratio of these two monosaccharides derivatives was proposed for the qualitative identification. In conclusion, a more specific and quantitative quality control method was developed for sea-tangle and sargassum.

关键词： Sea-tangle Sargassum Polysaccharides Quality control

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Simultaneous determination and assignment of 13 major flavonoids and glycyrrhizic acid in licorices by HPLC-DAD and Orbirap mass spectrometry analyses

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Chinese Journal of Natural Medicines 2015年第3期13卷 232-240页

作者： WEI Shan-Shan YANG Min CHEN Xin WANG Qiu-Rong CUI Ya-Jun School of Chinese Materia Medica Shanghai University of Traditional Chinese Medicine national engineering Laboratory for tcm Standardization Technology Shanghai Research Center for TCM ModernizationShanghai Institute of Materia Medica Chinese Academy of Sciences

To determine 13 flavonoids and glycyrrhizic acid in licorice （Glycyrrhiza spp.）, several samples from different areas were examined by HPLC-DAD analysisThe analysis was performed on a Zorbax Extend-C18 （250 mm× 4.6 mm, 5 μm） column connected with a Zorbax Extend guard column （20 mm × 4.6 mm, 5 μm）. The mobile phase consisted of （A） acetonitrile and （B） 0.026% aqueous H3PO4 （V/V） using a gradient elution of 20%-25% A at 0-20 min, 25%-33% A at 20-30 min, 33%-50% A at 30-55 min, 50%-60% A at 55-65 min, and 60% A between 65 min and 80 min, and peaks were detected at 280 rim. The fourteen compounds were assigned by HPLC-Orbitrap MS methods. The regression coefficient for the linear equations for the 14 compounds ranged between 0.9998 and 1. The limits of detection and quantification lay in the range of 0.032-2.461 and 0.154-8.202 μg·mL^-1, respectively. The relative recovery rates for the 14 compounds were in the range of 93.90%-106.73% with RSDs being less than 5%. Coefficient variations for intra-day and inter-day precisions were in the range of 0.27%-2.38% and 0.31%-3.51%, respectively. In summary, the validated method was applied to the simultaneous determination of the 14 components in 29 different licorice samples and was proven to be suitable for quality evaluation of licorices and their active fractions.

关键词： Licorice Flavonoids Glycyrrhizic acid Simultaneous determination HPLC-DAD Orbitrap mass spectrometry

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Chemical profiling of Huashi Baidu prescription, an effective anti-COVID-19 tcm formula, by UPLC-Q-TOF/MS

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Chinese Journal of Natural Medicines 2021年第6期19卷 473-480页

作者： WEI Wen-Long WU Shi-Fei LI Hao-Jv LI Zhen-Wei QU Hua YAO Chang-Liang ZHANG Jian-Qing LI Jia-Yuan WU Wan-Ying GUO De-An Shanghai research center for modernization of Traditional Chinese Medicine National Engineering Laboratory for TCM Standardization TechnologyShanghai Institute of Materia MedicaChinese Academy of SciencesShanghai 201203China

Huashi Baidu prescription(HSBDF),recommended in the Guideline for the Diagnosis and Treatment of Novel Coronavirus(2019-nCoV)Pneumonia(On Trials,the Seventh Edition),was clinically used to treat severe corona virus disease 2019(COVID-19)with cough,blood-stained sputum,inhibited defecation,red tongue *** study was aimed to elucidate and profile the knowledge on its chemical constituents and the potential anti-inflammatory effect in *** the study,the chemical constituents in extract of HSBDF were characterized by UPLC-Q-TOF/MS in both negative and positive modes,and the pro-inﬂammatory cytokines were measured by enzyme-linked immunosorbent assays(ELISA)to determine the effects of HSBDF in lipopolysaccharide(LPS)-stimulated RAW264.7 *** results showed that a total of 217 chemical constituents were tentativedly characterized in ***,HSBDF could alleviate the expression levels of IL-6 and TNF-αin the cell models,indicating that the antiviral effects of HSBDF might be associated with regulation of the inflammatory cytokines production in RAW264.7 *** hope that the results could be served as the basic data for further study of HSBDF on anti-COVID-19 effect.

关键词： Huashi Baidu prescription Corona virus disease 2019 Characterization of chemical constituents ELISA

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tcm-based new drug discovery and development in China

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Chinese Journal of Natural Medicines 2014年第4期12卷 241-250页

作者： WU Wan-Ying HOU Jin-Jun LONG Hua-Li YANG Wen-Zhi LIANG Jian GUO De-An Shanghai research center for modernization of Traditional Chinese Medicine and national engineering Laboratory for tcm Standardization Technology Shanghai Institute of Materia Medica Chinese Academy of Sciences

Over the past 30 years, China has significantly improved the drug development environment by establishing a series of policies for the regulation of new drug approval. The regulatory system for new drug evaluation and registration in China was gradually developed in accordance with international standards. The approval and registration of tcm in China became as strict as those of chemical drugs and biological products. In this review, tcm-based new drug discovery and development are introduced according to the tcm classification of nine categories.

关键词： China China Food and Drug Administration(CFDA) Traditional Chinese Medicine Regulatory classification Drug discovery Drug development

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Anti-proliferation activity of terpenoids isolated from Euphorbia kansui in human cancer cells and their structure-activity relationship

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Chinese Journal of Natural Medicines 2017年第10期15卷 766-774页

作者： HOU Jin-Jun SHEN Yao YANG Zhou FANG Lin CAI Lu-Ying YAO Shuai LONG Hua-Li WU Wan-Ying GUO De-An Shanghai research center for modernization of Traditional Chinese Medicine National Engineering Laboratory for TCM Standardization Technology Shanghai Institute of Materia Medica Chinese Academy of Sciences Haike Road 501 Shanghai 201203 China

Euphorbia kansui is a commonly used traditional Chinese medicine for the treatment of edema,pleural effusion,and asthma,*** to the previous researches,terpenoids in *** possess various biological activities,e.g.,anti-virus,anti-allergy,antitumor *** this work,twenty five terpenoids were isolated from ***,including thirteen ingenane-and eight jatrophane-type diterpenoids(with two new compounds,kansuinin P and Q)and four *** of them were analyzed by MTS assay for in vitro anticancer activity in five human cancer cell ***-activity relationship for 12 ingenane-type diterpenoids in colorectal cancer Colo205 cells were preliminary *** anti-proliferation activities were observed in human melanoma cells breast cancer MDA-MB-435 cells and Colo205 *** than half of the isolated ingenane-type diterpenoids showed inhibitory activities in MDA-MB-435 *** ingenane-and one jatrophane-type diterpenoids possessed much lower IC_(50) values in MDA-MB-435 cells than positive control *** structure-activity relationship analysis showed that substituent on position 20 was important for the activity of ingenane-type diterpenoids in Colo205 cells and substituent on position 3 contributed more significant biological activity of the compounds than that on position 5 in both MDA-MB-435 and Colo205 cells.

关键词： Terpenoids Anti-proliferation activity Human cancer cells Structure-activity relationship

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Traditional Chinese medicine for the treatment of immune-related nephropathy:A review

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Acta Pharmaceutica Sinica B 2024年第1期14卷 38-66页

作者： Pu Jiang Changliang Yao De-an Guo School of Pharmacy Nanjing University of Chinese MedicineNanjing 210023China Shanghai research center for modernization of Traditional Chinese Medicine National Engineering Research Center of TCM Standardization TechnologyShanghai Institute of Materia MedicaChinese Academy of SciencesShanghai 201203China

Immune-related nephropathy(IRN)refers to immune-response-mediated glomerulonephritis and is the main cause of end-stage renal *** pathogenesis of IRN is not fully understood;therefore,treatment is *** Chinese medicines(tcms)have potent clinical effects in the treatment of the IRN conditions immunoglobulin A nephropathy,lupus nephropathy,and diabetic *** underlying mechanisms mainly include its inhibition of inflammation;improvements to renal interstitial fibrosis,oxidative stress,autophagy,apoptosis;and regulation of *** this review,we summarize the clinical symptoms of the three IRN subtypes and the use of tcm prescriptions,herbs,and bioactive compounds in treating IRN,as well as the potential mechanisms,intending to provide a reference for the future study of tcm as IRN treatments.

关键词： IgA nephropathy Diabetic nephropathy Lupus nephritis Traditional Chinese medicine Immunity Pathogenesis Mechanism Pathophysiology

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Medcheck:A novel software for automated de-formulation of traditional Chinese medicine(tcm)prescriptions by liquid chromatography-mass spectrometry

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Journal of Pharmaceutical Analysis 2024年第6期14卷 930-932页

作者： Xiao-lan Li Jian-qing Zhang Yun Li Xuan-jing Shen Huan-ya Yang Lin Yang Meng Xu Qi-rui Bi Chang-liang Yao De-an Guo Shanghai research center for modernization of Traditional Chinese Medicine National Engineering Research Center of TCM Standardization TechnologyShanghai Institute of Materia MedicaChinese Academy of SciencesShanghai201203China b University of Chinese Academy of Sciences Beijing100049China

Prescriptions are the main clinical application of traditional Chinese medicines(tcms).Common forms include Chinese patent medicines,Kampo formulas,and hospital decoctions.A new pre-scription called“famous classical formulas”is recently developed and expected to boom in the *** constituent me-dicinal plants in prescriptions is critical for new drug development and quality control[1],which could avoid safety issues from adulteration or substandard ingredients,as seen in the notorious Longdan Xiegan Pill event.

关键词： medicines formulation prescription

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DART-MS:A New research Tool for Herbal Medicine Analysis

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World Journal of Traditional Chinese Medicine 2016年第1期2卷 2-9页

作者： Yao Shen Wan-Ying Wu De-An Guo Shanghai research center for modernization of Traditional Chinese Medicine National Engineering Laboratory for TCM Standardization TechnologyShanghai Institute of Materia Medica Chinese Academy of Sciences

Direct analysis in real time(DART) possesses the merits of analyzing sample in its native status with minimal or even no sample *** this review, we summarized the recent applications of DART in the field of herbal medicine analysis such as compound detection, species identification, metabolites profiling and initial quantification. DART with the characters of hyper-rapid, easy-hyphenated offers a new research tool for herbal medicines to complete the experimental process in a very simple but still reliable way. It is anticipated that more wide and deep applications of DART in herbal medicine analysis, as rapid quantification, high-throughput active compounds screening, rapid species identification, and fast illegal additives screening will be promising and foreseeable in the near future.

关键词： Ambient mass spectrometry Direct analysis in real time(DART) Herbal medicines Species identification

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