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Remodeling “cold” tumor immune microenvironment via epigenetic-based therapy using targeted liposomes with in situ formed albumin corona

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Acta Pharmaceutica Sinica B 2022年第4期12卷 2057-2073页

作者： Yang He Yuefei Fang Meng Zhang Yuge Zhao Bin Tu Mingjie Shi Bahtiyor Muhitdinov Akmal Asrorov Qin Xu Yongzhuo Huang state Key Laboratory of drug Research Shanghai Institute of Materia MedicaChinese Academy of SciencesShanghai 201203China University of Chinese Academy of Sciences Beijing 100049China Zhongshan Institute for drug Discovery Chinese Academy of SciencesZhongshan 528437China Department of Pharmacy the First Affiliated Hospital of Zhengzhou UniversityZhengzhou 450052China Artemisinin Research center Guangzhou University of Chinese MedicineGuangzhou 510450China Women’s Hospital School of MedicineZhejiang UniversityHangzhou 310006China Institute of Bioorganic Chemistry Uzbekistan Academy of SciencesTashkent 100125Uzbekistan National Medical Products administration Key Laboratory for Quality Research and Evaluation of Pharmaceutical ExcipientsShanghai 201203China

There is a close connection between epigenetic regulation,cancer metabolism,and *** combination of epigenetic therapy and immunotherapy provides a promising avenue for cancer *** an epigenetic regulator of histone acetylation,panobinostat can induce histone acetylation and inhibit tumor cell proliferation,as well as regulate aerobic glycolysis and reprogram intratumoral immune ***1 is a BRD4 inhibitor that can suppress PD-L1 ***,we proposed a chemo-free,epigenetic-based combination therapy of panobinostat/JQ1 for metastatic colorectal cancer.A novel targeted binary-drug liposome was developed based on lactoferrin-mediated binding with the LRP-1 *** was found that the tumor-targeted delivery was further enhanced by in situ formation of albumin *** lactoferrin modification and endogenous albumin adsorption contribute a dual-targeting effect on the receptors of both LRP-1 and SPARC that were overexpressed in tumor cells and immune cells(e.g.,tumor-associated macrophages).The targeted liposomal therapy was effective to suppress the crosstalk between tumor metabolism and immune evasion via glycolysis inhibition and immune ***,lactic acid production was reduced and angiogenesis inhibited;TAM switched to an anti-tumor phenotype,and the anti-tumor function of the effector CD8+T cells was *** strategy provides a potential method for remodeling the tumor immune microenvironment(TIME).

关键词： Tumor immune microenvironment Tumor-associated macrophage Epigenetic therapy Immune checkpoint Angiogenesis Panobinostat JQ1 Liposome

Chelerythrine chloride from Macleaya cordata induces growth inhibition and apoptosis in human gastric cancer BGC-823 cells

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Acta Pharmaceutica Sinica B 2012年第5期2卷 464-471页

作者： Zhengfu Zhang Ying Guo Lingwei Zhang Jianbin Zhang Xionghui Wei Department of Applied Chemistry College of Chemistry&Molecular EngineeringPeking UniversityBeijing 100871China center for drug Certification State Food and Drug AdministrationBeijing 100061China Department of Chemical Biology School of Pharmaceutical SciencesPeking UniversityBeijing 100083China

This study aimed to investigate the ability of chelerythrine chloride(CHE),the main active ingredient of Macleaya cordata,to induce apoptosis in human gastric cancer BGC-823 *** results demonstrate that CHE inhibits cell proliferation in a time-and dose-dependent manner with accompanying S phase *** also induces apoptosis by a mechanism involving a reduction in the mitochondrial mem brane potential,the release of cytochrome c,activation of caspase 3 and cleavage of poly-ADP-ribose *** addition,CHE-induced apoptosis is accompanied by down-regulation of Bcl-x1 and Bcl-2 proteins with no change in the levels of Bax *** together,the results support the development of CHE as a potentially useful anticancer drug for the treatment of gastric cancer.

关键词： Macleaya cordata Chelerythrine chloride BGC-823 cells Apoptosis

Requirements for evaluation on drug-medical Device

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Chinese Journal of Biomedical Engineering(English Edition) 2009年第4期18卷 178-184页

作者： DENG Jie TIAN Jia-xin GU Han-qing center for Medical Device evaluation State Food and Drug Administration Beifing 100044 China Tianjin Medical University Tianjin 300070 China

The administration of combination products in *** and drug administration(FDA)are analyzed and summarized in this ***,the technical evaluation on drug-medical device in the state food and drug administration of China(SFDA)is also ***,this paper discusses how to promote the development of drug-medical device in the administration and technical evaluation.

关键词： drug-medical device combination products evaluation

Incidence of Hospitalized Rhabdomyolysis in Patients Treated With Lipid-Lowering drugs

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Incidence of Hospitalized Rhabdomyolysis in Patients Treated...

Development of Botanical New drugs:*** Update 2007

中成药上市后药物流行病学评价培训会议

作者： David J.Graham Judy A.Staffa Deborah Shatin Susan E.Andrade Stephanie D.Schech Lois La Grenade Jerry H.Gurwitz K.Arnold Chan Michael J.Goodman Richard Platt Office of drug Safety Center for Drug Evaluation and ResearchFood and Drug AdministrationRockvilleMd MDMPH Office of drug Safety Center for Drug Evaluation and ResearchFood and Drug AdministrationRockvilleMd PhD center for Health Care Policy and evaluation Eden PrairieMinn PhD Meyers Primary Care Institute Fallon Foundation and the University of Massachusetts Medical SchoolWorcester ScD center for Health Care Policy and evaluation Eden PrairieMinn MPH Meyers Primary Care Institute Fallon Foundation and the University of Massachusetts Medical SchoolWorcester MD School of Public Health Channing Laboratory Brigham and Women's Hospital and Harvard Medical School Department of EpidemiologyHarvard MDScD Boston Mass Channing Laboratory Brigham and Women's Hospital and Harvard Medical School Department of Ambulatory Care and Prevention Harvard Pilgrim Health Care and Harvard Medical School MDMSc

Context Lipid-lowering agents are widely prescribed in the United *** estimates of rhabdomyolysis risk with various lipid-lowering agents are not available. Objective To estimate the incidence of rhabdomyolysis in patients treated with different statins and fibrates,alone and in combination,in the ambulatory setting. Design,Setting,and Patients drug-specific inception cohorts of statin and fibrate users were established using claims data from 11 managed care health plans across the United *** with at least 180 days of prior health plan enrollment were entered into the cohorts between January 1,1998,and June 30,***-time was classified as monotherapy or combined statin-fibrate therapy. Main Outcome Measure Incidence rates of rhabdomyolysis per 10000 person-years of treatment,number needed to treat,and relative risk of rhabdomyolysis. Results In 252460 patients treated with lipid-lowering agents,24 cases of hospitalized rhabdomyolysis occurred during *** incidence per 10000 person-years for monotherapy with atorvastatin,pravastatin,or simvastatin was 0.44(95% confidence interval[CI],0.20-0.84);for cerivastatin,5.34(95%CI,1.46-13.68);and for fibrate,2.82(95%CI,0.58-8.24).By comparison,the incidence during unexposed person-time was 0(95%CI,0-0.48;P=.056).The incidence increased to 5.98 (95%CI,0.72-216.0) for combined therapy of atorvastatin,pravastatin,or simvastatin with a fibrate,and to 1035(95%CI,389-2117) for combined cerivastatin-fibrate *** year of therapy,the number needed to treat to observe 1 case of rhabdomyolysis was 22727 for statin monotherapy,484 for older patients with diabetes mellitus who were treated with both a statin and fibrate,and ranged from 9.7 to 12.7 for patients who were treated with cerivastatin plus fibrate. Conclusions Rhabdomyolysis risk was similar and low for monotherapy with atorvastatin, pravastatin,and simvastatin;combined statin-fibrate use increased risk,especially in older patients w

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Chinese Journal of Integrative Medicine 2008年第1期 67-67页

作者： Shaw T.Chen food and drug administration Office of drug evaluation I center for drug evaluation and Research USA

This presentation will assess the current status of botanical new drug development,from the regulatory prospective of *** environment for botanical drugs in the *** be reviewed first with

关键词： Development of Botanical New drugs CDER

New phenolic constituents obtained from Polygonum multiflorum

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Chinese Herbal Medicines 2020年第3期12卷 342-346页

作者： Jian-bo Yang Hua Sun Jie Ma Yun-fei Song Yue Liu Qi Wang Shuang-cheng Ma Xian-long Cheng Feng Wei Research and Inspection center of Traditional Chinese Medicine and Ethnomedicine National Institutes for Food and Drug ControlState Food and Drug AdministrationBeijing 100050China state Key Laboratory of Bioactive Substance and Function of Natural Medicines Institute of Materia MedicaChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100050China

Objective:To isolate the phenolic compounds obtained from the dried roots ofPolygonum multiflorum and investigate their pharmacological ***:The chemical constituents were isolated and purified by combining them with a macroporous resin(DM-8),MCI gel,and Sephadex LH-20 and by performing ODS column *** structures were elucidated by 1D and 2D NMR analyses,as well as mass *** isolated compounds were evaluated to determine their hepatoprotective andα-glucosidase inhibitory activities in ***:Two phenolic compounds,namely,polygonimitin E(1)and polygonimitin F(2),were isolated from the dried roots of *** 2(10μmol/L)only showed moderate hepatoprotective activity against N-acetyl-p-aminophenol(APAP)-induced HepG2 cell ***,these two compounds exhibited noα-glucosidase inhibitory ***:Compounds 1 and 2 were new *** 2 could be one of the potential hepatoprotective constituents of ***.

关键词： α-glucosidase inhibition hepatoprotective activity phenolic compounds polygonimitin E polygonimitin F Polygonum multiflorum Thunb

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卫生保健中的射频识别技术获益与潜在危险

美国医学会杂志（中文版） 2008年第3期27卷 175-177页

作者： Binita S. Ashar, MD, MBA Ann Ferriter, BS 赵秀丽(译) Office of Device evaluation Center for Devices and Radiological HealthUS Food and Drug AdministrationRockvilleMaryland

目前，卫生保健系统正面临一个扩大无线电技术应用范围、改善患者保健护理的机会。从医生办公室到手术室，无线电技术的开展使诸如实时心脏波形传输、医疗器械报警通知、外科仪器或医院器材跟踪以及电子处方书写等服务具有巨大的潜力。... 详细信息

目前，卫生保健系统正面临一个扩大无线电技术应用范围、改善患者保健护理的机会。从医生办公室到手术室，无线电技术的开展使诸如实时心脏波形传输、医疗器械报警通知、外科仪器或医院器材跟踪以及电子处方书写等服务具有巨大的潜力。射频识别（radiofrequency identification，RFID）是一种为改善患者保健、提高医院效率而出现于卫生保健领域的无线电技术。由于各种短程无线电技术在医院内近距离同时使用，

关键词：卫生保健系统射频识别技术潜在危险无线电保健护理医疗器械处方书写医院器材

Bufalin-induced cardiotoxicity: new findings into mechanisms

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Chinese Journal of Natural Medicines 2020年第7期18卷 550-560页

作者： LI Min WANG Xi-Jie ZHAO Qi WANG Jia-Xian XING Hong-Yan ZHANG Yi-Zhe ZHANG Xue-Xia ZHI Yang-Yang LI Hua MA Jing China state Institutes of Pharmaceutical Industry National Shanghai center for New drug Safety evaluation and Research Shanghai 201203China Shanghai InnoStar Bio-Tech Co. Ltd.Shanghai 201203China Department of Cardiology the First Affiliated Hospital of Nanjing Medical UniversityNanjing Medical UniversityNanjing 211100China Department of Research and Development HELP Stem Cell TherapeuticsNanjing 211100China

Bufalin is one of the main pharmacological and toxicological components of Venenum Bufonis and many traditional Chinese medicine *** cardiotoxicity clearly limits its application to patients living in ***,an investigation of its toxicological mechanism is helpful for new drug development and treatment of the related clinical adverse *** investigate the cardiotoxicity of bufalin using human induced pluripotent stem cells-derived cardiomyocytes(hiPSC-CMs)(0.003–0.1μmol·L–1),human induced pluripotent stem cells-derived cardiomyocytes(hiPSC-CMs)(0.03–0.3μmol·L–1)and eight human cardiac ion channel currents(0.01–100μmol·L–1)combined with an impedance-based bioanalytical and patch clamp *** effect of bufalin on the contractility in hiPSC-CMs,which has been shown to strengthen myocardial contractility,accelerate conduction,and increase beating rate at the earlier stage of administration,whereas weakened myocardial contractility,abolished conduction,and ceased beating rate at the later stage of *** decreased the action potential duration(Action potential duration at 30%,50%and 90%repolarization),cardiac action potential amplitude,and maximal depolarization rate and depolarized the resting membrane potential of *** beating rates of hiPSC-CMs were markedly increased at 0.03μmol·L–1,while were weakened at 0.3μmol·L–1 after *** blocks INav1.5 in a concentration-dependent manner with half maximal inhibitory concentration of 74.5μmol·L–*** respectively increased the late sodium current and Na+-Ca2+exchange current with a concentration for 50%of maximal effect of 2.48 and 66.06μmol·L–1 in ***,bufalin showed no significant effects on other cardiac ion channel *** enhancement of the late sodium current is one of the main mechanism for cardiotoxicity of bufalin.

关键词： Bufalin Cardiomyocytes Cardiotoxicity Ion channels Stem cell

4-Methyloxazole-5-carbonitrile,90-day oral toxicity study in rats after gavage administration

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4-Methyloxazole-5-carbonitrile,90-day oral toxicity study in...