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Simultaneously quantification of ginsenoside Rb1,Rb2,Rc,Rd,Re,Rf,Rg1 in dog plasma by liquid chromatography-tandem mass spectrometry and its application in six-month toxicokinetic study of Shenmai injection

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中国药理学与毒理学杂志 2013年第3期 560-561页

作者： YU Jian GU Li-qiang XIN Yan-fei GAO Hai-yan XU Pan-sheng MA Zhu-feng YOU Zhen-qiang ZHANG Sheng WANG Zhi XUAN Yao-xian Center of Safety Evaluation Zhejiang Academy of Medical Sciences chiatai qingchunbao pharmaceutical co. Ltd.

OBJECTIVE Shenmai injection(SMI) is a kind of herbal injection widely used in China derived from SHENMAI *** is the alcohol extraction part of Panax ginseng and Ophiopogon ***’s generally accepted that ginsenosides are the major components in SMI according to their abundance and *** In order to monitor the kinetic profile of major components in SMI during long-term treatment and to further analyze its connection to toxic effect,a 6-month toxicokinetic experiment was performed in 24 beagle *** were equally and randomly divided into four groups: control group(0.9% NaCl solution per day;n = 6),low-dosage Group(2 g·kg-1 per day;n = 6),medium-dosage Group(6 g·kg-1 per day;n = 6) and High-dosage Group(20 g·kg-1 per day;n = 6).Vehicle and SMI were *** injected everyday for 180 continuous days(6 months).Blood sample were collected at 0,90,180 d after the beginning of the administration of *** concentration of ginsenoside Rb1,Rb2,Rc,Rd,Re,Rf and Rg1 in plasma were determined simultaneously for the first time by liquid chromatography-tandem mass spectrometry(LC-MS /MS) and liquid-liquid extraction ***-compartmental parameters were further simultaneously calculated and ***,the level of bodyweight,AST,ALT and CK were also monitored to evaluate the toxic effect caused by *** According to the results,significant differences existed between 20(S)-protopanaxadiol type(PPD type) and 20(S)-protopanaxatriol type(PPT type) *** accumulation of ginsenoside PPD type ginsenosides can be observed with the proceeding of the *** long-term administration of 6 g /mL and 20 ***-1 SMI caused a slowing down in the growth of bodyweights,no toxic effect could be reviewed from the level of ALT,AST and *** Although no significant toxic effect could be observed during the toxicokinetic study,the kinetic profile of PPD type ginsenoside was severely *** SMI is wild used in the co-

关键词： Shenmai injection toxicokinetics ESI-LC-MS /MS ginsenosides

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Postmarketing studies on safety of Dengfeng~ shenmai injection

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Journal of Traditional Chinese Medicine 2013年第6期33卷 827-831页

作者： Lianxin Wang Wen Zhang Yanming Xie Yang Bai Mulan Wang Qinghua Ai Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Marketing Department Research Department of Chiatai Qingchunbao Pharmaceutical Company Ltd.

OBJECTIVE: To systematically research the postmarketing safety of Dengfeng shenmai injection, identify potential risk factors, and ensure its clinical safety. METHODS: We investigated a comprehensive series of studies on the production process, quality standards, pharmacology, postmarketing clinical studies, and safety evaluation of Shenmai injection, including literature analysis of adverse drug reaction(ADR) case analysis and systematic review. Data from the hospital information system(HIS) and spontaneous reporting system(SRS) were also analyzed. RESULTS: The approximate dosage leading to death in dogs is 45.0-67.5 g raw drug/kg and the toxic reactions are restlessness, skin irritation, salivation, and vomiting. The results of chronic toxicity tests in mice and dogs, and the other tests such as 6-month toxicity, drug safety, genetic toxicity, and reproductive toxicity of rats and dogs, were positive or qualified. Patient ADR history and ADR family history were closely associated with itching based on the data analysis from SRS. There was no damage to renal function from Shenmai injection use at a dosage and a treatment course outside the recommended dosage and treatment course as specified based on data analysis from HIS. The most common ADR from Shenmai injection are difficulty breathing, facial flushing, nausea, vomiting, chest tightness, skin itching, rash, and back pain. coNCLUSION: This study includes complete information on Shenmai injection ADR incidence rate. We found that Shenmai injection is safe and this study can provide clinical, research, and production institutions with an objective, reliable, and scientific basis for use of Shenmai injection.

关键词： Product surveillance, postmarketing Medicine, Chinese traditional Safety Shenmai in-jection

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Profiling the mid-adult cecal microbiota associated with host healthy by using herbal formula Kang Shuai Lao Pian treated mid-adult mice

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Chinese Journal of Natural Medicines 2020年第2期18卷 90-102页

作者： GONG Shu-Qing YE Ting-Ting WANG Mei-Xia HONG Zhu-Ping LIU Li CHEN Huan QIAN Jing pharmaceutical Informatics Institute College of Pharmaceutical SciencesZhejiang UniversityHangzhou 310058China Key laboratory of Microbial Technology and Bioinformatics of Zhejiang Province NMPA Key laboratory for Testing and Risk Warning of Pharmaceutical MicrobiologyZhejiang Institute of MicrobiologyHangzhou 310012China Technical Center Chiatai Qingchunbao Pharmaceutical Co.Ltd.Hangzhou 310023China

With the occurrence of aging process,decreased neuron dopamine,disrupted brown adipose tissue(BAT)remodeling and decreased butyrate level all reflect a weak host healthy in certain ***,the signs of mid-adult gut microbiota,and its association with host healthy are not well *** current study,we deemed to illustrate the associations of age,neuron dopamine,BAT remodeling,butyrate and gut microbiota with the aid of traditional herbal formula Kang Shuai Lao Pian(KSLP),which is known for its anti-aging ***,ELISA was performed to detect the production of brain dopamine,the mass of inguinal white adipose tissue versus interscapular brown adipose tissue(iWAT/iBAT)was calculated and considered as a sign of BAT remodeling,16 S rRNA gene sequencing was used to the detection of gut microbiota profiling and gas chromatography was used to measure the butyrate level in mice *** results indicated mid-adult mice already present distinctive gut microbiota profiling compared with young mice,concomitant with which are the lower brain dopamine level and disrupted brown adipose *** treatment improved the host healthy and regulated gut microbiota with enriched Firmicutes at the expense of Bacteroidetes,particularly increased the relative abundance of bacteria functionally related to dopamine and butyrate productions,which suggest KSLP treatment constructs a healthier gut *** conclusion,modulation of gut microbiota and butyrate may connectively regulate dopamine production and BAT remodeling through gut-brain axis and gut-metabolism axis.

关键词： Mid-adult Gut microbiota Host health Gut-brain axis Gut-metabolism axis

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Identification of bioactive anti-angiogenic components targeting tumor endothelial cells in Shenmai injection using multidimensional pharmacokinetics

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Acta Pharmaceutica Sinica B 2020年第9期10卷 1694-1708页

作者： Chongjin Zhong Chao Jiang Suiying Ni Qizhi Wang Lingge Cheng Huan Wang Qixiang Zhang Wenyue Liu Jingwei Zhang Jiali Liu Mulan Wang Min Jin Peiqiang Shen Xuequan Yao Guangji Wang Fang Zhou Key Laboratory of Drug Metabolism and Pharmacokinetics State Key Laboratory of Natural MedicinesChina Pharmaceutical UniversityNanjing 210009China Department of Digestive Tumor Surgery Affiliated Hospital of Nanjing University of Chinese MedicineNanjing 210029China chiatai qingchunbao pharmaceutical co. Ltd.Hangzhou 310023China

Shenmai injection(SMI)is a well-defined herbal preparation that is widely and clinically used as an adjuvant therapy for ***,we found that SMI synergistically enhanced the activity of chemotherapy on colorectal cancer by promoting the distribution of drugs in xenograft ***,the underlying mechanisms and bioactive constituents remained *** the present work,the regulatory effects of SMI on tumor vasculature were determined,and the potential anti-angiogenic components targeting tumor endothelial cells(TECs)were *** pharmacokinetic profiles of ginsenosides in plasma,subcutaneous tumors,and TECs were *** results showed that the concentrations of protopanaxadiol-type(PPD)ginsenosides(Rb1,Rb2/Rb3,Rc,and Rd)in both plasma and tumors,were higher than those of protopanaxatriol-type(Rg1 and Re)and oleanane-type(Ro)*** PPD-type ginsenosides,Rd exhibited the greatest concentrations in tumors and TECs after repeated *** vivo bioactivity results showed that Rd suppressed neovascularization in tumors,normalized the structure of tumor vessels,and improved the anti-tumor effect of 5-fluorouracil(5 FU)in xenograft ***,Rd inhibited the migration and tube formation capacity of endothelial cells in *** conclusion,Rd may be an important active form to exert the anti-angiogenic effect on tumor after SMI treatment.

关键词： Shenmai injection Ginsenoside Rd Multidimensional pharmacokinetics Anti-angiogenic Tumor endothelial cell

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Simultaneously quantification of ginsenoside Rb1,Rb2,Re,Rd,Re Rf,Rg1 in dog plasma by liquid chromatography-tandem mass spectrometry and its application in six-month toxicokinetic study of Shenmai injection

Simultaneously quantification of ginsenoside Rb1,Rb2,Re,Rd,R...

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作者： YU Jian GU Li-qiang XlNYan-fei GAO Hai-yan XU Pan-sheng MA Zhu-feng YOU Zhen-qiang ZHANG Sheng WANG Zhi XUAN Yao-xian chiatai qingchunbao pharmaceutical co. Ltd. Center of Safety Evaluation Zhejiang Academy of Medical Sciences

OBJECTIVE Shenmai injection(SMI) is a kind of herbal injection widely used in China derived from SHENMAI *** is the alcohol extraction part of Panax ginseng and Ophiopogon ***''''s generally accepted that ginsenosides are the major components in SMI according to their abundance and *** In order to monitor the kinetic profile of major components in SMI during long-term treatment and to further analyze its connection to toxic effect,a 6-month toxicokinetic experiment was performed in 24 beagle *** were equally and randomly divided into four groups:control group(0.9%NaCI solution per day;n=6),low-dosage Group(2 g·kg~(-1) per day;n=6),mediumdosage Group(6 g·kg~(-1) per day;n=6) and High-dosage Group(20g·kg~(-1) per day;n=6).Vehicle and SMI were i.v. drip injected everyday for 180 continuous days(6 months).Blood sample were collected at 0,90,180 d after the beginning of the administration of *** concentration of ginsenoside Rb1,Rb2,Re,Rd,Re,Rf and Rg1 in plasma were determined simultaneously for the first time by liquid chromatography-tandem mass spectrometry(LC-MS/MS) and liquidliquid extraction ***-compartmental parameters were further simultaneously calculated and ***, the level of bodyweight,AST,ALT and CK were also monitored to evaluate the toxic effect caused by *** According to the results,significant differences existed between 20(S)-protopanaxadiol type(PPD type) and 20 (S) -protopanaxatriol type(PPT type) *** accumulation of ginsenoside PPD type ginsenosides can be observed with the proceeding of the *** long-term administration of 6 g/mL and 20 g·ml~(-1) SMI caused a slowing down in the growth of bodyweights,no toxic effect could be reviewed from the level of ALT,AST and *** Although no significant toxic effect could be observed during the toxicokinetic study,the kinetic profile of PPD type ginsenoside was severely *** SMI is wild used in the

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Simultaneously quantification of ginsenoside Rb1,Rb2,Rc,Rd,Re,Rf,Rgl in dog plasma by liquid chromatography-tandem mass spectrometry and its application in six-month toxicokinetic study of Shenmai injection

Simultaneously quantification of ginsenoside Rb1,Rb2,Rc,Rd,R...

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2013年（第三届）中国药物毒理学年会暨药物非临床安全性评价研究论坛

OBJECTIVE Shenmai injection(SMI) is a kind of herbal injection widely used in China derived from SHENMAI *** is the alcohol extraction part of Panax ginseng and Ophiopogon ***’s generally accepted that ginsenosides are the major components in SMI according to their abundance and *** In order to monitor the kinetic profile of major components in SMI during long-term treatment and to further analyze its connection to toxic effect,a 6-month toxicokinetic experiment was performed in 24 beagle *** were equally and randomly divided into four groups:control group(0.9%NaCl solution per day;n=6),low-dosage Group(2 g·kg per day;n=6),mediumdosage Group(6 g·kg per day;n=6) and High-dosage Group(20 g-kg"1 per day;n=6).Vehicle and SMI were i.v. drip injected everyday for 180 continuous days(6 months).Blood sample were collected at 0,90,180 d after the beginning of the administration of *** concentration of ginsenoside Rb1,Rb2,Re,Rd,Re,Rf and Rg1 in plasma were determined simultaneously for the first time by liquid chromatography-tandem mass spectrometry(LC-MS/MS) and liquid-liquid extraction ***-compartmental parameters were further simultaneously calculated and ***, the level of bodyweight,AST,ALT and CK were also monitored to evaluate the toxic effect caused by *** According to the results,significant differences existed between 20(S)-protopanaxadiol type(PPD type) and 20 (S) -protopanaxatriol type(PPT type) *** accumulation of ginsenoside PPD type ginsenosides can be observed with the proceeding of the *** long-term administration of 6 g/mL and 20 g·ml SMI caused a slowing down in the growth of bodyweights,no toxic effect could be reviewed from the level of ALT,AST and *** Although no significant toxic effect could be observed during the toxicokinetic study,the kinetic profile of PPD type ginsenoside was severely *** SMI is wild used in the co-administration

关键词： Shenmai injection toxicokinetics ESI-LC-MS/MS ginsenosides

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Identification of bioactive anti-angiogenic constitutes targeting tumor endothelial cells in Shenmai Injection using multidimensional pharmacokinetics

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中国药理学与毒理学杂志 2019年第9期33卷 681-682页

作者： ZHONG Chong-jin JIANG Chao NI Sui-ying WANG Qi-zhi CHENG Ling-ge WANG Huan ZHANG Qi-xiang LIU Wen-yue ZHANG Jing-wei LIU Jia-li WANG Mu-lan JIN Min SHEN Pei-qiang YAO Xue-quan WANG Guang-ji ZHOU Fang Key Laboratory of Drug Metabolism and Pharmacokinetics State Key Laboratory of Natural MedicinesChina Pharmaceutical UniversityNanjing 210009China Department of Digestive Tumor Surgery Affiliated Hospital of Nanjing University of Chinese MedicineNanjing 210029China chiatai qingchunbao pharmaceutical co.Ltd. Hangzhou 310023China

OBJECTIVE To identify the bioactive anti-angiogenic constitutes targeting tumor endothelial cells(TECs)in Shenmai Injection(SMI).METHEODS For pharmacokinetic(PK)studies,Balb/c mice harboring human colorectal cancer(LoVo)xenografts were treated with SMI 10 mL·kg^-1 daily for 1 or 8 *** PK profiles of ginsenosides in plasma,subcutaneous tumors,and TECs were *** PD studies,the tumor-bearing mice Intravital multi-photon imaging and CD31 immunofluorescence staining were used to evaluate the number of microves⁃sels and *** staining of CD31 and α-SMA was performed to evaluate pericytes coverage ratios around *** was performed to determine the concentrations of VEGF and FGF in tumor *** synergistic anti-tumor study,the tumor-bearing mice were treated with SMI 10 mL·kg^-1 daily,Rd 5 mg·kg^-1 daily with or without 5-FU 15 mg·kg^-1 every 3 d for 20 ***-MS/MS was used to determine the concentrations of 5-FU in plasma and tumor *** SMI decreased the number of microvessels(Pcoverage(Pconcentrations of protopanaxadiol-type(PPD)ginsenosides(Rb1,Rb2/Rb3,Rc,and Rd)in both,plasma and tumors,were higher than those of protopanaxatriol-type(Rg1 and Re)and oleanane-type(Ro)*** PPD ginsenosides,Rd exhibited the greatest concentrations in tumors and TECs after repeated *** fact,the proportion of Rd in the detectable components of SMI gradually increased in the following order:SMI formula(2.8%),plasma(16.0%),tumor tissues(34.3%),and TECs(40.3%).In vivo bioactivity results showed that Rd 5 mg·kg^-1 daily significantly decreased the number of microvessels(Pcoverage(P<0.05)while Rd 0.5 mg·kg^-1 daily,Rb1 and Rg1 had no significant effect on *** 5 mg·kg^-1 suppressed the expression of VEGF and FGF *** 5 mg·kg^-1 enhanced the antit

关键词： Shenmai Injection multidimensional pharmacokinetics ginsenoside Rd anti-angiogenic tumor endo⁃thelial cell

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Establishment and Application of Allergenic Cell Model Using Mouse Basophil Activation Test

Establishment and Application of Allergenic Cell Model Using...

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中国药理学会药检药理专业委员会第十六届（2019年）学术年会

作者： Sang Jing Duan Mingyang Wang Mulan Wang Jiawei Jiang Nan Kuang Rong Zhejiang Institute for Food and Drug control Zhejiang University of Technology Yangtze River Delta Region Green Pharmaceutical Collaborative Innovation Center chiatai qingchunbao pharmaceutical co Ltd.

OBJECTIVE:To establish a allergenic cell model of mouse basophil activation and investigate the potential sensitization of two Chinese herbal ***:Normal mouse peripheral blood basophils were used as target cells and fMLP as sensitizer to stimulate target *** of CD203,CD123,CD63 and CD200 R on bas ophils surface were *** allergenic cell model was established,and the potential sensitization of Danshen injection and Shenmai injection was investigated by the ***:The percentage of CD63 and CD200 R positive cells in peripheral blood of mice increased significantly after 20 pM positive substance of fMLP treatment for 30 min. coNCLUSION:fMLP-induced basophil model can be used as an allergic cell *** changes of percentage of CD63 and CD200 R positive cells could be used evaluate the potential sensitization of *** Injection and Shenmai Injection were evaluated using the *** was no potential hypersensitivity detected from the two kinds of traditional Chinese medicine injections.

关键词： mouse basophil allergenic cell model traditional Chinese medicine injection

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Effect and Safety of Guanxinning Tablet(冠心宁片) for Stable Angina Pectoris Patients with Xin(Heart)-Blood Stagnation Syndrome:A Randomized,Multicenter,Placebo-controlled Trial

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Chinese Journal of Integrative Medicine 2019年第9期25卷 684-690页

作者： SUN Ming-yue MIAO Yang JIN Min DONG Yao-rong LIU Shu-rong WANG Mu-lan GAO Rui Good Clinical Practice Center Xiyuan Hospital China Academy of Chinese Medical Sciences Beijing 100091 China Department of Cardiology Xiyuan Hospital China Academy of Chinese Medical Sciences Beijing 100091 China chiatai qingchunbao pharmaceutical co. Ltd. Hangzhou 310023 China Department of Cardiology Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai 200071 China Department of Cardiology the First Clinical Hospital of Jilin Academy of Chinese Medical Sciences Changchun 130021 China

Objective: To investigate the effect and safety of Guanxinning Tablet(冠心宁片, GXN) for the treatment of stable angina pectoris patients with Xin(Heart)-blood stagnation syndrome(XBSS). Methods: One hundred and sixty stable angina pectoris patients with XBSS were randomly assigned to receive GXN(80 cases) or placebo(80 cases, Guanxinning simulation tablets, mainly composed of lactose), 4 tablets(0.38 g/tablet), thrice daily for 12 weeks. After treatment, an exercise stress test(treadmill protocol), Chinese medicine(CM) syndrome score, electrocardiogram(ECG), and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile, adverse events(AEs) were evaluated during the whole clinical trial. Results: compared with the control group, the time extension of exercise duration in the GXN group increased 29.28±17.67 s after treatment(P>0.05);moreover, the change of exercise duration in the GXN group increased 63.10±96.96 s in subgroup analysis(Pcontrol group(40.58%, 75.36%, 26.92%, 28.21%, respectively, Pconclusion: GXN was a safe and effective treatment for stable angina pectoris patients with XBSS at a dose of 4 tablets, thrice daily.

关键词： Guanxinning Tablet coronary heart disease stable angina pectoris Xin(Heart)-blood stagnation syndrome Chinese medicine

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Screening and Identification of A Probiotic from the Intestinal Tract of Mystus macropterus

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Animal Husbandry and Feed Science 2014年第6期6卷 331-333,344页

作者： Dan Yan Xiong Wei Chen Yuankun Wu Pihong Zhu Jie Zhao Bo Chongqing Fishery Sciences Research Institute Rural Development Department of Pujiang county Chongqing Shuangqiao chiatai co. Ltd.

A total of 25 strains were isolated from the intestinal tract of Mystus macropterus. The inhibitory effects of extracellular enzyme activity to common aquat- ic pathogenic bacteria were screened. A probiotic DQHY -7 strain was isolated, and its safety was detected. DQHY -7 strain was preliminarily identified by mor- phological observation, and physiological and biochemical test. Research results showed that DQHY -7 strain had relatively strong production capacities of amylase, cellulase and protease, and could restrict the growth of Escherichia coli, Aeromonas hydrophila and Pseudomonas fluorescens. Results of acute toxicity test showed that 1. 0 × 108 CFU/mL DQHY -7 bacterial suspension showed no pathogenicity to M. macropterus. According to the colony growth pattern and physiological-bio- chemical characteristics of DQHY -7, the strain was identified to be Bacillus subtilis. Research results showed that DQHY -7 strain could be used as a new candi- date strain for feeding microecologicalagent.

关键词： Mystus macropterus Bacillus sp Probiotic Screening Candidate strain

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