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Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections

Zhongguo Zhongy.o Zazhi 2024年第16期49卷 4279-4284页

作者： Fu C.-K. liu H. Wang L.-X. Zou y.-H. li M.-Q. lin y.-M. Sun W.-H. Wei X. Hu y.-E. Xie y.-M. li y.-y. Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Beijing 100700 China Dongzhimen Hospital Beijing University of Chinese Medicine Beijing 100700 China the Third Affiliated Hospital of Changchun University.of Chinese Medicine Changchun 130117 China y.nnan Provincial Hospital of Traditional Chinese Medicine Kunming 650021 China General Hospital of Ningxia Medical University Yinchuan 750004 China Wangjing Hospital China Academy of Chinese Medical Sciences Beijing 100102 China

In 2019, the newly.revised Drug Administration Law of the People′s Republic of China was issued and implemented, clearly.proposing that China should establish a pharmacovigilance sy.tem. As a new traditional Chinese medicine(TCM) dosage form created in China, TCM injections have been widely.used in clinic, and its pharmacovigilance has attracted much attention. In response to this situation, the project team convened a group of clinical, pharmaceutical and evidence-based medicine experts from all over the country.to form an expert group, which formulated the Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections in strict accordance with the requirements of the group standards of the Chinese Association of Chinese Medicine. From the perspective of clinical application and considering the key.elements of pharmacovigilance for clinical application of TCM injections, the guidelines put forward suggestions on the decision making of pharmacovigilance for clinical application of TCM injections from four key.links, namely.the monitoring and reporting, signal recognition, risk assessment and risk control, according to China′s pharmacovigilance regulations and learning from foreign pharmacovigilance guidelines. © 2024 Zhongguo Zhongy. y.njiuy.an. All rights reserved.

关键词： group standard guideline pharmacovigilance traditional Chinese medicine injections traditional Chinese medicine pharmacovigilance

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Pharmacovigilance guidelines of Chinese patent medicines

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Zhongguo Zhongy.o Zazhi 2024年第16期49卷 4261-4265页

作者： Wang L.-X. Wang M.-M. li y.-y. Wang Z.-F. Cui X. Zhao X.-X. liu F.-M. y.ng S. Wei R.-L. Wang y.-X. Zhang B. Xie y.-M. Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Beijing 100700 China Beijing University.of Chinese Medicine Beijing 100029 China

Drug administration law of the People′s Republic of China (2019 revised edition), which came into effect on December 1, 2019, proposed that " the state shall establish a pharmacovigilance sy.tem" . Pharmacovigilance work of Chinese patent medicines is more difficult, and it is necessary.to carry.out Pharmacovigilance activities that are in line with the characteristics of Chinese patent medicines. Pharmacovigilance guidelines of Chinese patent medicines (T / CACM 1563. 1-2024), based on the principles of Drug Administration Law of the People′ s Republic of China (2019 revised edition) and Pharmacovigilance quality.management standards (No. 65 of 2021) of the National Medical Products Administration, draws on the EU Pharmacovigilance regulation and the secondary.guidelines of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and it is drafted in accordance with the provisions of Guidelines for standardization work part 1: structure and drafting rules of standardization documents (GB / T1. 1-2020) based on the characteristics of Chinese patent medicines. It serves as a general document for a series of pharmacovigilance guidelines of Chinese patent medicines, such as Guidelines for construction of traditional Chinese medicine pharmacovigilance sy.tem in medical institutions (T / CACM 1563. 2-2024), Pharmacovigilance guidelines for clinical application of oral Chinese patent medicines (T / CACM 1563. 3-2024), Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections (T / CACM 1563. 4-2024), Pharmacovigilance guidelines for clinical application of Chinese patent medicines for external use (T / CACM 1563. 5-2024), and Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration (T / CACM 1563. 6-2024), including four major elements of pharmacovigilance monitoring and reporting of Chinese patent medicines, signal identification, ri

关键词： Chinese patent medicine group standard guideline pharmacovigilance safe drug use

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Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration

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Zhongguo Zhongy.o Zazhi 2024年第16期49卷 4291-4297页

作者： Zhao X.-X. Hua H. li y.-y. Wang Z.-F. liu F.-M. Wei R.-L. Cui X. y.ng S. Wang L.-X. Xie y.-M. Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Beijing 100700 China Graduate School Tianjin University of Traditional Chinese Medicine Tianjin 301617 China School and Hospital of Stomatology Peking University Beijing 100034 China

The group standard Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration was released on January.16, 2024, on the national group standards information platform by.the Institute of Basic Research in Clinical Medicine of China Academy.of Chinese Medical Sciences and School and Hospital of Stomatology.of Peking University. under the centralized management by.the China Association of Chinese Medicine. The standard number is T / CACM 1563. 6-2024. It aims to propose key.elements and specify.technical methods for safety.monitoring and reporting, signal identification, risk assessment, and risk control based on the Drug administration law of the People ' s Republic of China (revised in 2019), which establishes normative pharmacovigilance guideline of Chinese patent medicine for mucosal administration that is in line with the characteristics of traditional Chinese Medicine (TCM) based on the pharmacovigilance content for clinical application of Chinese patent medicine for mucosal administration. The group standard has been discussed by.internal and external experts through multiple rounds of consultation. It serves as a guiding document for stakeholders involved in pharmacovigilance activities, including pharmaceutical license holders, drug manufacturers, medical institutions, research institutes, and pharmaceutical trading enterprises. © 2024 Zhongguo Zhongy. y.njiuy.an. All rights reserved.

关键词： Chinese patent medicines for mucosal administration group standard guideline pharmacovigilance traditional Chinese medicine

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Solid Desiccant Dehumidification Techniques Inspired from Natural Electroosmosis Phenomena

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Journal of Bionic Engineering 2011年第1期8卷 90-97页

作者： B. li y. y. y.n Faculty.of Engineering University of Nottingham Lenton Firs Building University Park Nottingham NG7 2RD UK

Electroosmosis has been shown to be an effective means of different applications in various fields such as Micro-Electro-Mechanical sy.tems （MEMS） and biomimetics applications. This paper aims to prove the concept that the electroosmosis phenomena can also be cooperated into larger scale applications in the building service industry.like dehumidification or damping proof. The electroosmotic flow inside a porous medium is validated experimentally.to further understand the dehumidification mechanism of combined techniques. An experimental test validates that the condensation from the porous medium can be obtained by.electroosmotic force generated by.external electric field, especially.for specific desiccant powders like zeolite and diatomaceous earth. With a range of volts from 5 V to 20 V apply.ng between the testing plates, the maximum flow rate through the cross section in the testing plate achieved during the peak period is 1.35 laL＇min 1. These promising phenomena can act as an alternative way.for energy.choice in dehumidification industrial field. Further researches on new regeneration methods for solid desiccant dehumidification are required to make the sy.tem simple, energy.saving and suitable for small air conditioning units.

关键词： biomimetics electroosmotic flow solid desiccant dehumidification

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NUCLEATION OF RARE EARTH-RICH PHASE PARTICLES IN Ti-5Al-4Sn-2Zr-1Mo-0.25Si-1Nd ALLOy

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Acta Metallurgica Sinica(English Letters) 1998年第4期11卷 265-269页

作者： G.P.li D.li and y. y. liu (Department of Titanium Alloy., Institute of Metal Research, The Chinese Academy.of Sciences, Sheny.ng 110015, China) Inst of Metal Research The Chinese Acad of Sciences Shenyang China

High resolution electron microscopy.studies of rure earth-rich phase particles in a melt-quenched Ti-5Al-4Sn-2Zr-1MO-0.25Si-1Nd alloy.indicate that the α-Ti matrix cry.tallizes prior to the rare earth-rich phase particles. According to a new nucleation model, the heteropeneous nucleation of the rare earth-rich phase particles at the matrix interface is easier than the homogeneous nucleation off the interface matrix, which is consistent with the results of the HREM obseroations.

关键词： Ti alloy rure earth rich phase nucleation

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Spatiotemporal Characteristics and Influencing Factors of the Sy.ergistic Effect of Pollution Reduction and Carbon Reduction in China

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Huanjing Kexue/Environmental Science 2024年第9期45卷 4993-5002页

作者： Wang y.-N. li B.-X. Zhang y.-X. Zhao y. Miao C.-K. An J.-Q. School of Economics and Management Northwest A&F University Yangling 712100 China

Based on the use of the coupling coordination model to calculate the coupling coordination degree of carbon emission and pollutant control，the national，regional，and provincial spatiotemporal characteristics of the sy.ergistic effect of pollution control and carbon emissions reduction in China were further analy.ed，facilitating the crucial to identification of key.areas. The fixed effects regression models and provincial panel data from 2006 to 2020 were used to explore factors contributing to better sy.ergizing the reduction of pollution and carbon emissions in China. On this basis，the adjustment variable of R&D investment intensity.was introduced，and the regulation effect model was constructed to further explore the influence mechanism of the sy.ergistic effect of pollution reduction and carbon reduction. The results showed that：sy.ergy.exists between carbon emission reduction and the air pollution control sy.tem，the evolution of the sy.ergistic effect of pollution reduction and carbon reduction in China presented an inverted "U"-shaped trend from 2006 to 2020，and there was spatial aggregation and a spatial spillover effect in pollution reduction and carbon reduction. The sy.ergistic governance of carbon emission and pollutant control was still at a relatively.low level. The carbon emission and air pollutant emission sy.tems were still in an unstable and uncoordinated state. The results showed that：The degree of coordination of eastern China，central China，and western China decreased in turn. At the national level，energy.consumption structure，per capita GDP，and the proportion of green investment were the main factors affecting the sy.ergistic effect of pollution reduction and carbon. The heterogeneity.of the influencing factors existed in the central，eastern，and western regions on industrial structure，energy.consumption structure，energy.utilization efficiency.per capita GDP，urbanization rate，the proportion of green investment，and transportation structure. The intens

关键词： fixed effects regression influencing mechanism moderating effect pollution and carbon emission reduction spatio-temporal characteristic

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Conventional and micro scale finite element modeling for metal cutting process:A review

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Chinese Journal of Aeronautics 2024年第2期37卷 199-232页

作者： Le WANG Caixu y.E Xianli liU Ming li y.ngshi XU Steven y.liANG Key.Laboratory.of Advanced Manufacturing and Intelligent Technology Ministry of EducationHarbin University of Science and TechnologyHarbin 150080China George W.Woodruff School of Mechanical Engineering Georgia Institute of TechnologyAtlanta 30332USA

The metal cutting process is accompanied by.complex stress field,strain field,temperature *** comprehensive effects of process parameters on chip morphology.cutting force,tool wear and residual stress are complex and *** element method(FEM)is considered as an effective method to predict process variables and reveal microscopic phy.ical phenomena in the cutting ***,the finite element(FE)simulation is used to research the conventional and micro scale cutting process,and the differences in the establishment of process variable FE simulation models are distinguished,thereby.improving the accuracy.of FE *** reliability.and effectiveness of FE simulation model largely.depend on the accuracy.of the simulation method,constitutive model,friction model,damage model in describing mesh element,the dy.amic mechanical behavior of materials,the tool-chip-workpiece contact process and the chip formation *** this paper,the FE models of conventional and micro process variables are comprehensively.and up-to-date reviewed for different materials and machining *** purpose is to establish a FE model that is more in line with the real cutting conditions,and to provide the possibility.for optimizing the cutting process *** development direction of FE simulation of metal cutting process is discussed,which provides guidance for future cutting process modeling.

关键词： Conventional and micro scale Finite element simulation Metal cutting process Micro cutting Modeling

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Optimization of chemistry.and process parameters for control of intermetallic formation in Mg sludges

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Journal of Magnesium and Alloy. 2024年第4期12卷 1431-1448页

作者： y.Fu G.G.Wang A.Hu y.li K.B.Thacker J.P.Weiler H.Hu Department of Mechanical Automotive and Materials EngineeringUniversity of Windsor401 Sunset AveWindsorOntario N9B 3P4Canada Global Technology.Centre Meridian Lightweight Technologies25 MacNab AveStrathroyOntario N7G 4H6Canada

Intermetallic formation in sludge during magnesium(Mg)melting,holding and high pressure die casting practices is a very.important ***,very.often it is overlooked by.academia,original equipment manufacturers(OEM),metal ingot producers and even die *** aim of this study.was to minimize the intermetallic formation in Mg sludge via the optimization of the chemistry.and process *** Al8Mn5 intermetallic particles were identified by.the microstructure analy.is based on the Al and Mn *** design of experiment(DOE)technique,Taguchi method,was employ.d to minimize the intermetallic formation in the sludge of Mg alloy. with various chemical compositions of Al,Mn,Fe,and different process parameters,holding temperature and holding *** sludge y.eld(Sy.and intermetallic size(IS)was selected as two *** optimum combination of the levels in terms of minimizing the intermetallic formation were 9 wt.%Al,0.15 wt.%Mn,0.001 wt.%(10 ppm)Fe,690℃ for the holding temperature and holding at 30 mins for the holding time,*** best combination for smallest intermetallic size were 9 wt.%Al,0.15 wt.%Mn,0.001 wt.%(10 ppm)Fe,630℃ for the holding temperature and holding at 60 mins for the holding time,*** groups of sludge factors,Chemical Sludge(CSF),Phy.ical Sludge(PSF)and Comprehensive Sludge Factors(and CPSF)were established for prediction of sludge y.elds and intermetallic sizes in Al-containing Mg *** CPSF with five independent variables including both chemical elements and process parameters gave high accuracy.in prediction,as the prediction of the PSF with only.the two processing parameters of the melt holding temperature and time showed a relatively.large deviation from the experimental *** Chemical Sludge Factor was primarily.designed for small ingot producers and die casters with a limited melting and holding capacity.of which process parameters could be fixed *** Phy.ical Sludge Factor could be used f

关键词： Magnesium sludge Al-Mn intermetallic Optimization Taguchi method Sludge factor Chemical composition Process parameter

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轴重和频率对激光修复316L不锈钢涂层在铁路车轮踏面制动中摩擦学性能的影响

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表面工程与再制造 2024年第2期24卷 51-52页

作者： li S. Xiao Q. y.ng W. y.ng C. Wang y. State Key.Laboratory.of Performance Monitoring and Protecting of Rail Transit Infrastructure East China Jiaotong University Nanchang 330013 China School of Mechatronics and Vehicle Engineering East China Jiaotong University Nanchang 330013 China Railway.Industry.Key.Laboratory.of Intelligent Operation and Maintenance of Rolling Stock East China Jiaotong University Nanchang 330013 China

研究复杂制动环境对修复熔覆层服役性能的影响,对提高列车轮轨系统抵御极端恶劣环境的能力具有重要意义。本文针对火车车轮踏面局部损伤问题,利用激光熔覆修复技术在损伤处制备316L不锈钢涂层。采用MS-HT1000高温磨损试验机进行磨损实... 详细信息

研究复杂制动环境对修复熔覆层服役性能的影响,对提高列车轮轨系统抵御极端恶劣环境的能力具有重要意义。本文针对火车车轮踏面局部损伤问题,利用激光熔覆修复技术在损伤处制备316L不锈钢涂层。采用MS-HT1000高温磨损试验机进行磨损实验。然后,分析不同制动条件对修复试样在室温和高温下摩擦磨损性能的影响。

关键词：激光修复铁路车轮局部损伤磨损实验车轮踏面磨损试验机服役性能踏面制动

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Phy.ics-informed deep learning for fringe pattern analy.is

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Opto-Electronic Advances 2024年第1期7卷 4-15页

作者： Wei y.n y.xuan Che Xinsheng li Mingy. li y.n Hu Shijie Feng Edmund y.Lam Qian Chen Chao Zuo Smart Computational Imaging Laboratory.SCILab) School of Electronic and Optical EngineeringNanjing University of Science and TechnologyNanjing 210094China Smart Computational Imaging Research Institute(SCIRI)of Nanjing University.of Science and Technology Nanjing 210019China Jiangsu Key.Laboratory.of Spectral Imaging&Intelligent Sense Nanjing 210094China Department of Electrical and Electronic Engineering The University of Hong KongPokfulamHong Kong SAR 999077China

Recently.deep learning has y.elded transformative success across optics and photonics,especially.in optical *** neural networks (DNNs) with a fully.convolutional architecture (e.g.,U-Net and its derivatives) have been widely.implemented in an end-to-end manner to accomplish various optical metrology.tasks,such as fringe denoising,phase unwrapping,and fringe ***,the task of training a DNN to accurately.identify.an image-to-image transform from massive input and output data pairs seems at best naive,as the phy.ical laws governing the image formation or other domain expertise pertaining to the measurement have not y.t been fully.exploited in current deep learning *** this end,we introduce a phy.ics-informed deep learning method for fringe pattern analy.is (PI-FPA) to overcome this limit by.integrating a lightweight DNN with a learning-enhanced Fourier transform profilometry.(Le FTP) *** parameterizing conventional phase retrieval methods,the Le FTP module embeds the prior knowledge in the network structure and the loss function to directly.provide reliable phase results for new ty.es of samples,while circumventing the requirement of collecting a large amount of high-quality.data in supervised learning *** by.the initial phase from Le FTP,the phase recovery.ability.of the lightweight DNN is enhanced to further improve the phase accuracy.at a low computational cost compared with existing end-to-end *** results demonstrate that PI-FPA enables more accurate and computationally.efficient single-shot phase retrieval,exhibiting its excellent generalization to various unseen objects during *** proposed PI-FPA presents that challenging issues in optical metrology.can be potentially.overcome through the sy.ergy.of phy.ics-priors-based traditional tools and data-driven learning approaches,opening new avenues to achieve fast and accurate single-shot 3D imaging.

关键词： optical metrology deep learning phy.ics-informed neural networks fringe analy.is phase retrieval

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