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A novel alternative for pyrogen detection based on a transgenic cell line

Signal Transduction and Targeted Therapy 2024年第3期9卷 1221-1229页

作者： Qing He Chuan-Fei Yu Gang Wu Kai-Qin Wang Yong-Bo Ni Xiao Guo Zhi-Hao Fu Lan Wang De-Jiang Tan Hua Gao Can Wang Gang Chen Xu-Hong Chen Bo Chen Jun-Zhi Wang National Institutes for food and drug control BeijingChina School of Life Science and Biopharmaceutics Shenyang Pharmaceutical UniversityShenyangChina Shanghai Institute for food and drug control ShanghaiChina KeyMed Biosciences Inc. ChengduChina

Pyrogen,often as a contaminant,is a key indicator affecting the safety of almost all parenteral drugs(including biologicals,chemicals,traditional Chinese medicines and medical devices).It has become a goal to completely replace the in vivo rabbit pyrogen test by using the in vitro pyrogen test based on the promoted‘reduction,replacement and refinement’principle,which has been highly considered by regulatory agencies from different *** used NF-κB,a central signalling molecule mediating inflammatory responses,as a pyrogenic marker and the monocyte line THP-1 transfected with a luciferase reporter gene regulated by NF-κB as an in vitro model to detect pyrogens by measuring the intensity of a fluorescence ***,we show that this test can quantitatively and sensitively detect endotoxin(lipopolysaccharide from different strains)and nonendotoxin(lipoteichoic acid,zymosan,peptidoglycan,lectin and glucan),has good stability in terms of NF-κB activity and cell phenotypes at 39 cell passages and can be applied to detect pyrogens in biologicals(group A&C meningococcal polysaccharide vaccine;basiliximab;rabies vaccine(Vero cells)for human use,freeze-dried;Japanese encephalitis vaccine(Vero cells),inactivated;insulin aspart injection;human albumin;recombinant human erythropoietin injection(CHO Cell)).The within-laboratory reproducibility of the test in three independent laboratories was 85%,80%and 80%and the interlaboratory reproducibility among laboratories was 83.3%,95.6%and 86.7%.The sensitivity(true positive rate)and specificity(true negative rate)of the test were 89.9%and 90.9%,*** summary,the test provides a novel alternative for pyrogen detection.

关键词： pyrogen rabbit replace

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Overexpression of wild-type HRAS drives non-alcoholic steatohepatitis to hepatocellular carcinoma in mice

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Zoological Research 2024年第3期45卷 551-566页

作者： Chen Ling Su-Su Liu Yu-Ya Wang Gui-Tao Huo Yan-Wei Yang Nan Xu Hong Wang Yong Wu Yu-Fa Miao Rui Fu Yu-Wei Zhao Chang-Fa Fan College of Life Sciences Northwest UniversityProvincial Key Laboratory of Biotechnology of Shaanxi ProvinceXi’anShaanxi 710069China Division of Animal Model Research Institute for Laboratory Animal ResourcesNational Institutes for Food and Drug Control(NIFDC)Beijing 102629China National center for Safety Evaluation of drugs National Institutes for Food and Drug Control(NIFDC)Beijing 100176China Division of HIV/AIDS and Sexually Transmitted Virus Vaccines Institute for Biological Products ControlNational Institutes for Food and Drug Control(NIFDC)Beijing 102629China Division of Laboratory Animal Monitoring Institute for Laboratory Animal ResourcesNational Institutes for Food and Drug Control(NIFDC)Beijing 102629China

Hepatocellular carcinoma(HCC),a prevalent solid carcinoma of significant concern,is an aggressive and often fatal disease with increasing global incidence rates and poor therapeutic *** etiology and pathological progression of non-alcoholic steatohepatitis(NASH)-related HCC is multifactorial and ***,no single animal model can accurately mimic the full NASH-related HCC pathological progression,posing considerable challenges to transition and mechanistic ***,a novel conditional inducible wild-type human HRAS overexpressed mouse model(HRAS-HCC)was established,demonstrating 100%morbidity and mortality within approximately one month under normal dietary and lifestyle *** symptoms of HCC such as ascites,thrombus,internal hemorrhage,jaundice,and lung metastasis were successfully replicated in ***-depth pathological features of NASH-related HCC were demonstrated by pathological staining,biochemical analyses,and typical marker gene *** murine anti-PD-1 and sorafenib treatment effectively prolonged mouse survival,further confirming the accuracy and reliability of the *** on protein-protein interaction(PPI)network and RNA sequencing analyses,we speculated that overexpression of HRAS may initiate the THBS1-COL4A3 axis to induce NASH with severe fibrosis,with subsequent progression to ***,our study successfully duplicated natural sequential progression in a single murine model over a very short period,providing an accurate and reliable preclinical tool for therapeutic evaluations targeting the NASH to HCC continuum.

关键词： HRAS THBS1 HCC driver factor NASH Fibrosis Cirrhosis HCC Treatment evaluation

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Community Incidence Estimates of Five Pathogens Based on foodborne Diseases Active Surveillance—China,2023

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China CDC weekly 2024年第24期6卷 574-579,I0002页

作者： Penghui Fan Haihong Han Jikai Liu Xiaochen Ma Ronghua Zhang Hong Liu Yijing Zhou Zunhua Chu Jian Wen Li Lin Weiwei Li Yunchang Guo NHC Key Laboratory of food Safety Risk Assessment China National Center for Food Safety Risk AssessmentBeijingChina Beijing center for Disease Prevention and control BeijingChina Zhejiang Provincial center for Disease control and Prevention Hangzhou CityZhejiang ProvinceChina Shanghai center for Disease control and Prevention ShanghaiChina Jiangsu Provincial center for Disease control and Prevention Nanjing CityJiangsu ProvinceChina Shandong Province center for Disease control and Prevention Jinan CityShandong ProvinceChina Guangdong Province center for Disease control and Prevention Guangzhou CityGuangdong ProvinceChina Sichuan Province center for Disease control and Prevention Chengdu CitySichuan ProvinceChina

Summary What is already known about this topic?foodborne diseases,representing significant food safety and public health challenges globally,are not welldocumented in terms of incidence,particularly for cases characterized by acute gastroenteritis(AGI)in *** is added by this report?This study developed a pyramid model to estimate the incidence of five pathogens,stratified by gender and age.

关键词： acute diseases stratified

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Establishment of the benchmarking tool for evaluating the operation of biorepositories for pathogenic resource using a modified Delphi method

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生物安全与健康(英文) 2024年第04期06卷 199-205页

作者： Hong Geng Liu Dongxin Zhao Yuanyuan Zhai Yalin Zhao Fengzekuan Wang Yanhai Jiang Mengnan Wei Qiang National Pathogen Resource center Chinese Center for Disease Control and Prevention Beijing China China center for food and drug International Exchange Beijing China Henan Puruixin Data Technology Co. Ltd Henan China Tonglu center for Disease control and Prevention Zhejiang China National Institute for Viral Disease control and Prevention Chinese Center for Disease Control and Prevention Beijing China

In recent years, as the infectious diseases caused by pathogens such as novel coronavirus and mpox (formerly called monkeypox) spread globally, the significance of identification, preservation, and sharing of pathogenic resources become prominent. Along with the rapid development of biorepositories, it is imperative to evaluate their operation in a scientific manner. By using the literature review and modified Delphi method, this study develops a benchmarking tool for the comprehensive evaluation of the operation of biorepositories for pathogenic resources. The effective response rates of both rounds of expert surveys were 100 %. The authority coefficients (Cr) were 0.82 and 0.85, respectively, manifesting the reliability of consultation results. In the second-round survey, the Kendall’s coefficient of concordance (Kendall’s W) of all indicators ranged from 0.09 to 0.31 (P < 0.001), the comprehensive score ranged from 4.02 to 4.94, the standard deviation ranged from 0.21 to 0.77, and the coefficient of variation (CV) ranged from 0.04 to 0.22, indicating that the expert opinions reached consensus. The final benchmarking tool was composed of 4 primary indicators, 12 secondary indicators, and 65 tertiary indicators. The weights of the four primary indicators allocated through the ranksum ratio method, namely organizational structure, management requirements, biobanking capacity, and sharing capacity, were 30.50 %, 30.08 %, 25.45 %, and 13.97 %, respectively. The benchmarking tool established in this study provides references for the comprehensive evaluation of the operation and puts forward advice for the sustainable development of biorepositories for pathogenic resources.

关键词： Biorepository Pathogenic resource Evaluation Benchmarking tool Modified Delphi method

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Enhanced identification and localization of metabolites in Scutellariae Radix using ion mobility enabled MALDI-Q-TOF/MS imaging

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Journal of Pharmaceutical Analysis 2024年第2期14卷 284-286页

作者： Lixing Nie Lieyan Huang Xiaofei Jia Shuai Kang Lingwen Yao Yanpei Wu Hao Yuan Yongli Liu Feng Wei Hongyu Jin Xiang Li Shuangcheng Ma National Institutes for food and drug control Beijing102629China Chinese Academy of Medical Science and Peking Union Medical College Beijing100006China Waters Corporation Beijing102600China Hebei Institute for drug and Medical Device control Shijiazhuang050227China Department of Pharmacy Medical Supplies Center of the PLA General HospitalBeijing100853China

Unraveling the distribution of metabolites in traditional Chinese medicine(TCM)provides direct indications for understanding their regulatory and functional basis,which is of paramount significance for better utilization and quality control of medicinal plants[1].Recently,imaging techniques such as near-infrared spectroscopy,Raman spectroscopy,and mass spectrometry(MS)were explored to reveal the spatial context of component accumulation and localization[2,3].

关键词： medicine(TCM) Radix Scutellaria

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Oral peptide therapeutics for diabetes treatment: State-of-the-art and future perspectives

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Acta Pharmaceutica Sinica B 2024年第5期14卷 2006-2025页

作者： Bingwen Ding Zhu Zhu Cong Guo Jiaxin Li Yong Gan Miaorong Yu State Key Laboratory of drug Research and center of Pharmaceutics Shanghai Institute of Materia MedicaChinese Academy of SciencesShanghai 201203China University of Chinese Academy of Sciences Beijing 100049China School of Pharmacy Henan UniversityKaifeng 475004China NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients National Institutes for Food and Drug ControlBeijing 100050China

Diabetes,characterized by hyperglycemia,is a major cause of death and disability ***,such as insulin and glucagon-like peptide-1(GLP-1)analogs,have shown promise as treatments for diabetes due to their ability to mimic or enhance insulin's actions in the *** to subcutaneous injection,oral administration of anti-diabetic peptides is a preferred ***,biological barriers significantly reduce the efficacy of oral peptide *** advancements in drug delivery systems and formulation techniques have greatly improved the oral delivery of peptide therapeutics and their efficacy in treating *** review will highlight(1)the benefits of oral anti-diabetic peptide therapeutics;(2)the biological barriers for oral peptide delivery,including pH and enzyme degradation,intestinal mucosa barrier,and biodistribution barrier;(3)the delivery platforms to overcome these biological ***,the review will discuss the prospects in this *** information provided in this review will serve as a valuable guide for future developments in oral anti-diabetic peptide therapeutics.

关键词： Oral peptides Diabetes Delivery platforms Insulin Glucagon-like peptide-1 Biodistribution Biological barriers Targeted delivery

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Cyclocarysaponins A–J, dammarane-type triterpenoid glycosides from the leaves of Cyclocarya paliurus

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Chinese Journal of Natural Medicines 2024年第10期 955-964页

作者： XI Huiting YUAN Mingming XIE Jianhua WANG Yuanxing State Key Laboratory of food Science and Resources Nanchang University Jiangxi Institute for drug control NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine Jiangxi Provincial Engineering Research Center of Drug and Medical Device Quality

Ten previously undescribed dammarane-type triterpenoid glycosides, cyclocarysaponins A–J(1–10), were isolated from the leaves of Cyclocarya paliurus(Batal.) Iljinskaja. The structures of these compounds were characterized through detailed spectroscopic analysis, including 1D and 2D nuclear magnetic resonance(NMR) and high-resolution electrospray ionization mass spectrometry(HR-ESI-MS). The cytotoxic activities of all isolates were assessed against five human cancer cell lines(Bel-7402, Caski, BGC-823, A2780, and HCT-116). Of the tested compounds, compounds 1, 7, and 9 exhibited selective cytotoxicity against one or more human cancer cell lines.

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Anti-inflammatory mechanism of the non-volatile ingredients performance liquid chromatography-heated electron spray ionization-high resolution mass spectroscope and cell metabolomics

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Journal of Traditional Chinese Medicine 2024年第2期44卷 260-267页

作者： JING Wenguang LIN Xiaoyu LI Chu ZHAO Xiaoliang CHENG Xianlong WANG Penglong WEI Feng MA Shuangcheng Institute of control of Chinese Traditional Medicine and Ethnic Medicine National Institutes for Food and Drug ControlBeijing 102629China School of Traditional Chinese Medicine Beijing University of Chinese MedicineBeijing 102488China Beijing Key Laboratory of Traditional Chinese Medicine Basic Research on Prevention and Treatment of Major Diseases Experimental Research CenterChina Academy of Chinese Medical SciencesBeijing 100700China

OBJECTIVE:To explore the anti-inflammatory components and mechanism of the non-volatile ingredients of ***:High performance liquid chromatographyheated electron spray ionization-high resolution mass spectroscope(HPLC-HESI-HRMS)was used to analyze the chemical constituents of the non-volatile ingredients of *** anti-inflammatory activity of ingredients was evaluated using lipopolysaccharide(LPS)induced RAW264.7 cell inflammation model,and the antiinflammatory mechanism was investigated using multivariate statistical analysis of cell ***:The non-volatile ingredients of patchouli were characterized by HPLC-HESI-HRMS,and 36 flavonoids and 18 other components were *** ingredients of patchouli not only had a good protective effect on the LPS-induced inflammation model of RAW264.7 cells,but also regulated the expression levels of arginine,L-leucine,cholesterol,fructose and sorbitol by down-regulating arginine metabolism,aminoacyl-tRNA biosynthesis,polyol/sorbitol pathway,so as to reduce inflammation and reduce cell ***:The non-volatile ingredients of patchouli had good anti-inflammatory effect and exerted its curative effect by regulating endogenous metabolic pathway to reduce inflammatory response.

关键词： Pogostemon non-volatile ingredients anti-inflammatory cell metabolomics

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Effect of microstructure on lipolysis behavior of milk fat globules during gastrointestinal digestion

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food Science and Human Wellness 2024年

作者： Xinyun Zhou Ting Guo Chen Chen Hadiatullah Hadiatullah Yunping Yao Changmo Li Xingguo Wang State Key Laboratory of food Nutrition and Safety， Key Laboratory of food Nutrition and Safety， Ministry of Education， College of food Science and Engineering， Tianjin University of Science & Technology Tianjin Key Laboratory for Modern drug Delivery & High-Efficiency， Collaborative Innovation center of Chemical Science and Engineering， School of Pharmaceutical Science and Technology， Tianjin University Collaborative Innovation center of food Safety and Quality control in Jiangsu Province， National Engineering Research center for Functional food， School of food Science and Technology， Jiangnan University

Milk fat globules (MFG) are the primary source of energy and functional factor in dairy-based products. To evaluate the suitability of commercial MFG substitutes for infant and adult consumers， the lipolysis properties and regulatory factors in digesting bovine， caprine， and human MFG were compared. The lipolysis kinetic models of bovine and caprine MFG are comparable， with bovine MFG displaying the highest degree of lipolysis (50.21%) during gastric digestion in infants， resulting in the production short-chain saturated fatty acids. Caprine MFG has a high rate of lipolysis due to its weak phospholipid-glycoprotein layer， which is prominent in both infants’ and adults’ digestion. The effects of consuming bovine and caprine MFG for adults are comparable in terms of lipolysis properties and nutritional value of fatty acid. After gastrointestinal digestion， human MFG has the highest digestibility (93.98%). The advantages of human MFG include its phospholipid structure， exogenous lipase， and lipolysis-regulating proteins. This study provides recommendation for the selection of milk fat substitutes and improvements in commercial dairy.

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pH- and near-infrared light-responsive,biomimetic hydrogels from aqueous dispersions of carbon nanotubes

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Nano Research 2024年第4期17卷 3120-3129页

作者： Lulin Hu Xinxin Yu Jingcheng Hao Lu Xu Shandong Laboratory of Yantai Advanced Materials and Green Manufacturing Yantai 264000China State Key Laboratory of Solid Lubrication Lanzhou Institute of Chemical PhysicsChinese Academy of SciencesLanzhou 730000China Yantai center for food and drug control Yantai 264000China Key Laboratory of Colloid and Interface Chemistry&Key Laboratory of Special Aggregated Materials Shandong UniversityJinan 250100China

Owing to their low flexibility,poor processability and a lack of responsiveness,inorganic materials are usually non-ideal for constructing a living ***,to date,lifelike materials with structural hierarchies and adaptive properties usually rely on light and soft organic molecules,although few exceptions have been acquired using two-dimensional(2D)inorganic ***,with a systematic study on the gelation behavior of carbon-based 0D quantum dots,1D nanotubes,and 3D fullerenes,we find that acidified 1D carbon nanotubes(CNTs)can serve as an alternative building block for fabricating purely inorganic biomimetic soft *** as-prepared CNT gels exhibit not only a pH-or photothermal-triggered mechanical and tribological adaptivity,which allows them to simulate the behavior of sea cucumbers,peacock mantis shrimps,and mammalian muscles or cortical bones,but also a unique damping property that is similar to spider’s cuticular *** high elasticity,effective lubrication,excellent biocompatibility,and controllable friction and wear also allow them to function as a new type of smart lubricants,whose tribological properties can be regulated either by its internal pH changes or spatiotemporally by near-infrared(NIR)light irradiations,free of any toxic and flammable base oils or additives.

关键词： biomimetic hydrogels carbon nanotubes(CNTs) mechanical and tribological adaptivity pH-and near-infrared(NIR)light responsiveness switchable lubrication

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