药物相互作用研究在新药研发和审评决策中的应用

药物相互作用改变了剂量效应关系，可能会降低疗效或增加毒性，是临床应用中合并用药治疗时重要的考虑因素。预测具有临床意义的药物相互作用是药物研发过程中获益风险评估的重要环节。本文概述了药物研发过程中药物相互作用研究的目的和意义，体内和体外研究的主要内容；梳理分析了2020年国家药品监督管理局（National Medical Products Administration, NMPA）和美国食品药品监督管理局（Food and Drug Administration, FDA）批准上市的新药药物相互作用研究情况，旨在为我国药物研发过程中药物相互作用研究及其监管审评提供参考。     

Comparative evaluation of extraction of tetra- and hexa-valent neptunium ions by CMPO in a room temperature ionic liquid

ABSTRACT

Solvent extraction studies were performed to understand the extraction behavior of Np⁴⁺ and NpO₂ ²⁺ from acidic feeds with CMPO (octyl (phenyl)-N,N-diisobutyl carbamoyl methyl phosphine oxide) dissolved in 1-butyl-3-methylimidazolium bis(trifluoromethane sulfonyl)imide, a water immiscible ionic liquid. Slope analyses on the distribution data revealed the extraction of ML₂ type species, where M = Np⁴⁺ or NpO₂ ²⁺, and L = CMPO. Studies were also carried out with Pu⁴⁺ and UO₂ ²⁺ under identical conditions. The nature of the extracted species was found to vary with the nature of the ionic species.     

国家级核应急医学救援分队能力评估指标体系的建立与应用

为进一步摸清国家核应急医学救援分队能力建设现状,国家核应急响应技术支持中心建立了评估指标体系、评分标准,对依托苏州大学附属第二医院(核工业总医院)设立的国家核应急医学救援分队开展能力评估。评估重点包括政策法规、组织机构、预案方案、指挥控制、应急设施与装备、应急响应行动和培训演练等7项一级指标。通过评估,摸清了现状,查找了问题,同时对救援方案、物资装备配备及管理、培训演练等国家核应急医学救援分队能力建设以及核应急能力评估等工作提出改进建议。     

青年医学工作者科普能力培养新模式

为了培养青年医师运用医学科普语言传播医学知识的能力，向社会提供更优质、可及的健康知识，改善医患关系，促进社会和谐；同时出于向社区、媒体推送一批优秀青年医学科普人才的考虑，本文在总结北京协和医院培养青年医务人员医学科普能力经验的基础上，尝试构建一套适合大型公立医院（尤其是教学医院）培养青年医务人员医学科普能力的新模式——“科普训练营”。本文旨在系统介绍该模式的产生背景、实践经验及初期效果，阐释实施后的重要意义，及实施过程中的挑战与应对策略。     

Computational modelling of water flow inside laboratory Knelson concentrator bowl

Enhanced gravity concentrators such as Knelson concentrator (KC) are extensively used in the mineral processing industry. The complexities of KC bowl geometry and variation of feed characteristics have forced process engineers to design empirically new units using laboratory and pilot-scale Knelson concentrators. However, numerical modelling methods such as computational fluid dynamics (CFD) and discrete element method (DEM) provide a better insight of flow behaviour of fluid and particulate solid phases inside these processing units. This article reports findings of CFD simulations for single-phase water flow inside the laboratory KC. An available standard 7.5-cm laboratory KC bowl was numerically simulated using realisable k-ε turbulence model to resolve the turbulence dispersion of existing transitional flow regime. The effects of relative centrifugal force (RCF) intensity and bed fluidisation water flow rate on the water velocity and pressure distributions were studied. Simulations confirmed the swirling flow pattern governing inside the bowl. The results revealed that the impact of RCF intensity on the water field values is greater than that of bed fluidisation water flow rate. Both velocity and pressure variations inside the bowl rings followed a linear trend.     

Precipitating spinel into precursor glass and its assistance in crystallization

The crystallization phenomena of spinel in CaO-MgO-Al₂O₃-SiO₂-Fe₂O₃ glass have received much attention due to the particular role in preparation of glass-ceramic materials, which represent an effective option to manage hazardous waste. In this study, both preliminary spinel and secondary spinel were precipitated in the precursor glass. The formation of these spinel was meticulously assessed by a combination of X-ray diffractometry and scanning electron microscopy. The structure of the microenvironment in the precursor glass was characterized by Raman spectrums. These advanced techniques highlight the potential for one-step crystallization of the glass. The investigation, which focused on one-step crystallization, demonstrated the growth of pyroxene on spinel accompanying a migration of chromium. The results also show the microstructure of the obtained glass-ceramic was very dependent on the heat-treat temperature. This study not only unambiguously reveals the precipitation mechanisms of spinel but also provides more documentation for one-step crystallization in the glass-ceramics field.     

Strength and dilatancy behaviors of deep sands in Shanghai with a focus on grain size and shape effect

With rapid development of infrastructures like tunnels and open excavations in Shanghai, investigations on deeper soils have become critically important. Most of the existing laboratory works were focused on the clayey strata up to Layer 6 in Shanghai, i.e. at depth of up to 40 m. In this paper, Layers 7, 9, and 11, which were mostly formed of sandy soils at depth of up to 150 m, were experimentally investigated with respect to physico-mechanical behaviors. The stress–strain behaviors were analyzed by the consolidated drained/undrained (CD/CU) triaxial tests under monotonic loading. One-dimensional (1D) oedometer tests were performed to investigate the consolidation properties of the sandy soils. Specimens were prepared at three different relative densities for each layer. Also, the micro-images and particle size analyzers were used to analyze the shape and size of the sand grains. The influences of grain size, density, and angularity on the stress–strain behaviors and compressibility were also studied. Compared to the other layers, Layer 11 had the smallest mean grain size (D₅₀), highest compressibility, and lowest shear strength. In contrast, Layer 9 had the largest mean grain size, lowest compressibility, and highest shear strength. Layer 7 was of intermediate mean grain size, exhibiting more compressibility and less shear strength than that of Layer 9. Also, the critical state parameters and maximum dilatancy rate of different layers were discussed.     

Tuning effect of silicon substitution on magnetic and high frequency electromagnetic properties of R2Fe17 and their composites

In this work, we report the tuning effect of the Si substitution on the magnetic and high frequency electromagnetic properties of R₂Fe₁₇ compounds and their paraffin composites. It is found that the introduction of Si can remarkably improve the magnetic and electromagnetic properties of the R₂Fe₁₇ compounds, making the R₂Fe_17–xSi_x-paraffin composites excellent microwave absorption materials (MAMs). By introducing the Si element, their saturation magnetizations decrease slightly, while much higher Curie temperatures are obtained. Furthermore, better impedance match is reached due to the decrease of the high-frequency permittivity ε′ by about 40%–50%, which finally enhances the performance of the microwave absorption. The peak frequency (f_RL) of the reflection loss (RL) curve moves toward high frequency domain and the qualified bandwidth (QB, RL ≤ ?10 dB) increases remarkably. The maximum QB of 3.3 GHz (12.0–15.3 GHz) is obtained for the Sm_1.5Y_0.5Fe₁₅Si₂-paraffin composite (d = 1.0 mm) and the maximum RL of ?53.6 dB is achieved for Nd₂Fe₁₅Si₂-paraffin composite (d = 2.2 mm), both surpassing most of the reported MAMs. Additionally, a distinguished dielectric microwave absorption peak is observed, which further increases the QB in these composites.     

交叉试验

发生了质量事故,是设备、操作等硬件的缘故,抑或药液的缘故?通过交叉试验的故事,把真相找了出来。