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Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of agomelatine in Chinese subjects

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Acta Pharmaceutica Sinica B 2016年第1期6卷 71-78页

作者： Fang Tang rui Zhou Zeneng Cheng Guoping Yang Aiqiao Chen Zhi Liu Hongyi Tan Shuang Yang Sanwang Li Lingli Mu Peng Yu School of Pharmaceutical Sciences Central South University The Third xiangya Hospital Central South University hunan tiger-xiangya r&d company ltd. Medical College Hunan Normal University

The aim of this study was to apply the reference-scaled average bioequivalence (rSABE) approach to evaluate the bioequivalence of 2 formulations of agomelatine, and to investigate the pharmacokinetic properties of agomelatine in Chinese healthy male subjects. This was performed in a single-dose, randomized-sequence, open-label, four-way crossover study with a one-day washout period between doses. Healthy Chinese males were randomly assigned to receive 25 mg of either the test or reference formulation. The formulations were considered bioequivalent if 90% confidence intervals (CIs) for the log-transformed ratios and ratio of geometric means (GMr) of AUC and C m of agomelatine were within the predetermined bioequivalence range based on rSABE method. results showed that both of the 90% CIs for the log-transformed ratios of AUC and C-max of 7-desmethyl-agomelatine and 3-hydroxyagomelatine were within the predetermined bioequivalence range. The 90% CIs for natural log transformed ratios of C-max, AUC(0-t), and AUC(0-infinity) of agomelatine (104.42-139.86, 101.33-123.83 and 97.90-117.94) were within the rSABE acceptance limits, and 3-hydroxy-agomelatine (105.55-123.03, 101.95-109.10 and 101.72-108.70) and 7-desmethyl-agomelatine (104.50-125.23, 102.36-111.50 and 101.62-110.64) were within the FdA bioequivalence definition intervals (0.80-1.25 for AUC and 0.75-1.33 for C-max). The rSABE approach was successful in evaluating the bioequivalence of these two formulations. (C) 2016 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical Sciences. Production and hosting by Elsevier B.V.

关键词： reference-scaled average bioequivalence Agamelatine 3-Hydroxy-agomalatine 7-desmethyl-agomelatine Chinese subjects High variability Generic drug

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determination of 20(S)-protopanaxadiol in human plasma by HPLC–MS/MS:application to a pharmacokinetic study

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Acta Pharmaceutica Sinica B 2013年第6期3卷 385-391页

作者： Feifan Xie Sanwang Li Zeneng Cheng Xingling Liu Hong Zhang Peijiong Li Zhi Liu Xin Guo Peng Yu School of Pharmaceutical Sciences Central South UniversityChangsha 410013China hunan tiger-xiangya r&d company ltd. Changsha 410013China

A rapid,specific and sensitive HPLC-MS/MS method was developed and validated for the determination of 20(S)-protopanaxadiol(PPd)in human *** and the internal standard Pd were extracted from plasma by liquid-liquid extraction with cyclohexane-methylene dichloride(2:1,v/v).The separation was performed on a HyPUrIYTY C18 column using methanol-5 mM ammonium formate(90:10,v/v)as mobile phase at a flow rate of 0.35 mL/*** spectrometric detection was carried out by electrospray ionization(ESI)in the positive ion mode using multiple reaction monitoring(MrM).The monitored transitions were m/z 425.4-217.2 for PPd and at m/z 461.4-425.5 for *** method was linear over the range 0.512-100 ng/mL with a lower limit of quantification(LLOQ)of 0.512 ng/*** mean extraction recovery of PPd was greater than 78.2%and no significant matrix effect was *** intra-and inter-day precisions were less than 10%and the biases below 4%for *** validated method was applied to a three-level single-dose clinical pharmacokinetics study of 12 healthy Chinese volunteers and the main pharmacokinetic parameters of PPd were obtained.

关键词： 20(S)-Protopanaxadiol HPLC–MS/MS Human plasma Pharmacokinetics Liquid–liquid extraction

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research on photodarkening in rare earth doped fibers

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Journal of rare Earths 2012年第11期30卷 1102-1105页

作者：成煜 State Key Laboratory of Optical Fibre and Cable Manufacture Technology R&D CentreYangtze Optical Fibre and Cable Company Ltd.

Samarium doped aluminosilicate fiber was fabricated by modified chemical vapor deposition （MCVd） process. The optical properties of this fiber were characterized by white light source and OSA. The photodarkening property of the fiber was measured by an Ar^＋ laser. The experiment results proved that the samarium doped aluminosilicate fiber had better photodarkening resistance than that of the samarium doped germanosilicate fiber. A brief explanation showed that the photodarkening loss could be reduced by changing the fiber core＇s material from germanosilicate to aluminosilicate. Samarium doped aluminosilicate fiber was very promising for the red fiber laser application.

关键词： fiber fabrication MCVd samarium photodarkening rare earths

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Numerical Analysis of Aerodynamic Characteristics of the HALE diamond Joined-Wing Configuration UAV

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Journal of Harbin Institute of Technology(New Series) 2019年第6期26卷 31-45页

作者： Junlei Sun Heping Wang Zhou Zhou Shan Lei School of Aeronautic Northwestern Polytechnical UniversityXi'an 710072China r&d Center AVIC Xi'an Aircraft Industry(Group)Company Ltd.(China)Xi'an 710089China

The investigation on the aerodynamic characteristics of the high-attitude long-endurance (HALE) diamond Joined-Wing configuration unmanned aerial vehicle ( UAV) was carried out by the theoretical analysis method and numerical simulation. research indicates that as the wing of the UAV is composed of the front wing and the after wing, the after wing has the ability to transmit the front wing's boundary layer to the after wing root which can inhibit the front wing's flow separation. Although the front wing was affected by the retardation of the after wing, the aerodynamic performance of the front wing was better than that of alone front wing in most cases. The after wing was also affected by the wake and downwash of the front wing, and its aerodynamic performance was greatly decreased. The characteristic curve of the pitching moment of the UAV had nonlinear characteristics. The flow field structure of the after wing changed by the front wing wake direct sweep and flow separation at the after wing root were the main reasons that non-linear ′rise′phenomenon occurred in two segments ( α = 0° and α = 8° ) of the characteristic curve of pitching moment. Moreover, coupling of the flow separation characteristic of the front wing and the after wing resulted in the pitching moment ′pitchup′ phenomenon. The lateral-directional static stability of the flat layout was weak. The HALE diamond Joined-Wing configuration UAV ' s aerodynamic performance can be improved and the problems in engineering applications can be effectively alleviated by adjusting the overall layout parameters.

关键词： diamond Joined-Wing configuration HALE numerical simulation aerodynamic characteristic layout parameters

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The research of dimensional design "2MM Project" System and the Key role in the Self-owned Vehicle Platform

The Research of Dimensional Design "2MM Project" System and ...

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2014中国汽车工程学会年会

作者： Zhou Zhihan Tan Peng Liang Changming Wang Xiangfei Changan Auto Global r＆d Center Changan Automobile Co.Ltd.

ISBN: (纸本)9783662450420

The related concepts of dimension "2MM" engineering of the automotive products are *** dimension design "2MM" engineering is the foundation of vehicle dimension manufacturing "2MM" project This paper introduces the route and method of vehicle dimension manufacturing "2MM" project in the auto product design process under the current development model of Chang An company and the functional attributes of vehicle dimension,it also emphasizes the key role that played by vehicle dimension design "2MM" engineering in the own brand car company for building the car platform,finally through a series of problems,cause the related thinking,for example,system construction,personnel training,in the field of vehicle dimension development in the own brand car company.

关键词： 2MM vehicle car dimension dimension engineering platform

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Failure evaluation mechanism of cement sheath sealing integrity under casing eccentricity during multistage fracturing

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Petroleum Science 2024年第5期21卷 3428-3445页

作者： Yan Xi Yu Yao Xue-Li Guo Jun Li Yu-dong Tian Gong-Hui Liu Beijing University of Technology Beijing100124China CNPC Engineering Technology r&d company ltd. Beijing102200China China University of Petroleum-Beijing at Karamay Karamay834000XinjiangChina China University of Petroleum-Beijing Beijing102249China CNPC daqing drilling Engineering Corporation Daqing163311HeilongjiangChina

A microannulus(MA) is the primary reason for sustained casing pressure in multi-stage fractured-shale gas wells. However, the effect of the casing eccentricity on the long horizontal section has not been considered. In this study, a full-scale integrity tester for cement sheaths is adopted to measure the cumulative plastic deformation. Numerical models are applied to evaluate the development of the cumulative plastic deformation and quantify the MA width considering casing centralization and eccentricity in the context of multiple loading and unloading cycles. Subsequently, the influences of the eccentricity distance and angle, cement-sheath mechanical variables, and different well depths on the cumulative sheath plastic deformation and sheath MA development are explored. The research results demonstrate that casing eccentricity significantly increases the cumulative sheath plastic deformation compared with that of the casing-centered condition. Consequently, the risk of sealing integrity failure increases. The accumulated plastic deformation increases when the eccentricity distance increases. In contrast, the initial plastic deformation increases as the eccentricity angle increases. However, the cumulative plastic deformation decreases after a specific loading and unloading cycle count. Affected by the coupled influence of the internal casing pressure and fracturing stages, the width of the MA in the horizontal section increased from the toe to the heel, and the casing eccentricity significantly increased the MA width at each stage, thus increasing the risk of gas channeling. Finally, an engineering case is considered to study the influence of casing eccentricity. The results show that cement slurries that form low and high elastic moduli can be applied to form a cement sheath when the fracturing stage is lower or higher than a specific value, respectively. The results of this study offer theoretical references and engineering support for the integrity control of c

关键词： Cement sheath Microannulus Casing eccentricity Numerical simulation

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One-pot Baeyer-Villiger oxidation of cyclohexanone with in situ generated hydrogen peroxide over Sn-Beta zeolites

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Green Chemical Engineering 2021年第3期2卷 294-300页

作者： Jianwei Luo Haoran Yuan Hui Liu Jingbo Li Yu Wang Yong Wang Jia Yao Haoran Li department of Chemistry ZJU-NHU United R&D CenterZhejiang UniversityHangzhou310027China State Key Laboratory of Chemical Engineering College of Chemical and Biological EngineeringZhejiang UniversityHangzhou310027China Zhejiang NHU company ltd. Xinchang312500China

ε-Caprolactone is traditionally produced through Baeyer-Villiger oxidation of cyclohexanone oxidized by peracids in industry,which inevitably results in large discard acid and environmental *** this end,a green route toε-caprolactone was developed by coupling the direct generation of hydrogen peroxide from aerobic oxidation of benzhydrol catalyzed by NHPI and Baeyer-Villiger oxidation of cyclohexanone with the in situ hydrogen peroxide over Sn-Beta zeolites in one *** oxygen was employed as the terminal oxidant,and the effects of several reaction factors were *** with one-step process,the one-pot two-step method noticeably improved the selectivity ofε-*** the amount of in situ hydrogen peroxide was 0.72 equivalent,the selectivity ofε-caprolactone was obtained 94.8%with 39.2%conversion of cyclohexanone,and the efficiency of H_(2)O_(2) was up to 51.5%.As compared to the commercial 30 wt%aqueous H_(2)O_(2) added directly,in situ H_(2)O_(2) dramatically improved the selectivity ofε-caprolactone and had higher ***,the catalyst could be easily separated from the reaction solution and reused several times without the remarkable loss of activity.

关键词： Baeyer-Villiger oxidation ε-Caprolactone Sn-Beta Hydrogen peroxide Molecular oxygen

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Improved algorithms and coupled neutron-photon transport for auto-importance sampling method

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Chinese Physics C 2017年第1期41卷 100-109页

作者：王鑫李君利武祯邱睿李春艳梁漫春张辉刚直徐红 department of Engineering Physics Tsinghua University Beijing 100084 China Key Laboratory of Particle ＆ radiation Imaging Ministry of Education Beijing 100084 China Nuctech company Limited Beijing 100084 China State Nuclear Hua Qing (Beijing) Nuclear Power Technology r＆d Center Co. ltd. Beijing 102209 China

The Auto-Importance Sampling（AIS） method is a Monte Carlo variance reduction technique proposed for deep penetration problems, which can significantly improve computational efficiency without pre-calculations for importance distribution. However, the AIS method is only validated with several simple examples, and cannot be used for coupled neutron-photon transport. This paper presents improved algorithms for the AIS method, including particle transport, fictitious particle creation and adjustment, fictitious surface geometry, random number allocation and calculation of the estimated relative error. These improvements allow the AIS method to be applied to complicated deep penetration problems with complex geometry and multiple materials. A Completely coupled Neutron-Photon Auto-Importance Sampling（CNP-AIS） method is proposed to solve the deep penetration problems of coupled neutron-photon transport using the improved algorithms. The NUrEG/Cr-6115 PWr benchmark was calculated by using the methods of CNP-AIS, geometry splitting with russian roulette and analog Monte Carlo, respectively. The calculation results of CNP-AIS are in good agreement with those of geometry splitting with russian roulette and the benchmark solutions. The computational efficiency of CNP-AIS for both neutron and photon is much better than that of geometry splitting with russian roulette in most cases, and increased by several orders of magnitude compared with that of the analog Monte Carlo.

关键词： Monte Carlo deep penetration auto-importance sampling coupled neutron-photon transport

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Fracture geometry and breakdown pressure of radial borehole fracturing in multiple layers

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Petroleum Science 2024年第1期21卷 430-444页

作者： Yu-Ning Yong Zhao-Quan Guo Shou-Ceng Tian Lu-Yao Ma Tian-Yu Wang Mao Sheng National Key Laboratory of Petroleum resources and Engineering China University of Petroleum(Beijing)Beijing102249China Beijing Petroleum Machinery company Limited CNPC Engineering Technology R&D Company LimitedBeijing102206China Smart Energy Co. LtdChina Xiongan GroupXiong’an New Area071000HebeiChina

radial borehole fracturing that combines radial boreholes with hydraulic fracturing is anticipated to improve the output of tight oil and gas *** paper aims to investigate fracture propagation and pressure characteristics of radial borehole fracturing in multiple layers.A series of laboratory experiments with artificial rock samples(395 mm×395 mm×395 mm)was conducted using a true triaxial fracturing *** crucial factors corresponding to the vertical distance of adjacent radial borehole layers(vertical distance),the azimuth and diameter of the radial borehole are *** results show that radial borehole fracturing in multiple layers generates diverse fracture *** types of fractures are identified based on the connectivity between hydraulic fractures and radial *** vertical distance significantly influences fracture propagation perpendicular to the radial borehole *** increase in the vertical distance impedes fracture connection across multiple radial borehole layers and reduces the fracture propagation distance along the radial borehole *** azimuth also influences fracture propagation along the radial borehole *** the azimuth reduces the guiding ability of radial boreholes,which makes the fracture quickly curve to the maximum horizontal stress *** breakdown pressure correlates with diverse fracture geometries *** the fractures connect multi-layer radial boreholes,increasing the vertical distance decreases the breakdown *** the azimuth and increasing the diameter also decrease the breakdown *** extrusion force exists between the adjacent fractures generated in radial boreholes in multiple rows,which plays a crucial role in enhancing the guiding ability of radial boreholes and results in higher breakdown *** research provides valuable theoretical insights for the field application of radial borehole fracturing technology in tight oil and g

关键词： Multi-layer radial boreholes Hydraulic fracturing Fracture propagation Pressure characteristic

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Prospect of new pumped-storage power station

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Global Energy Interconnection 2019年第3期2卷 235-243页

作者： Jingyan Li Chuanbao Yi Sujie Gao State Grid Xinyuan company ltd.

In this paper, a new type of pumped-storage power station with faster response speed, wider regulation range, and better stability is proposed. The operational flexible of the traditional pumped-storage power station can be improved with variable-speed pumped-storage tech no logy. Combined with chemical en ergy storage, the failure to achieve sec on d-order response speed and the insufficient safety and reliability of pumped-storage power units could be solved. With the better solar en ergy and site resources, the in teg rated performance can be improved by an optical storage system in stalled in future pumped-storage stations. Through the characteristics analysis of the new type of pumped-storage power station, three types of optimal station locations are proposed, namely, the load concentration area, new energy concentration area, and ultrahigh- voltage direct current receiver area. Taking the new pumped-storage power station as an example, the advantages of multi-energy cooperation and joint operation are analyzed. It can be predicted that the frequency and load regulation of the power grid will be more flexible, and the service capacity to the main power grid will be much stronger in the future.

关键词： Pumped-storage power station Variable-speed pumped-storage technology Chemical energy storage Solarenergy storage system

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