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Postmarketing safety evaluation: depside salt injection made from Danshen(Radix Salviae Miltiorrhizae)

Journal of Traditional Chinese Medicine 2014年第6期34卷 749-753页

作者： Yanpeng Chang Wen Zhang Yanming Xie Xiangyang Xu rendi sun Zheng Wang Ruihua Yan Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences Intensive Care Unit of Shenyang Orthopedic Hospital Shanghai Green Valley Pharmaceutical Ltd.

OBJECTIVE: To systematically examine the postmarketing safety of depside salt injection made from Danshen(Radix Salviae Miltiorrhizae),identifythe potential risk factors, and ensure its clinical ***: We examined a comprehensive series of studies on the production process, quality standards, pharmacology, population pharmacokinetics, and safety evaluation of depside salt injection made from Danshen(Radix Salviae Miltiorrhizae). Data from Ⅰ-Ⅳ clinical drug trials, hospital information systems(HIS), and spontaneous reporting systems(SRS) were also ***: The effective components of salvianolic acid salt content reached almost 100%, and the magnesium lithospermate B content reached morethan 80%. The median lethal dose(LD50) calculated by the Bliss method was 1.49 g/kg, with 95%confidence intervals of 1.29-1.72 g/kg. Long-term tests on Beagle dogs indicated that doses of less than 80 mg/kg were safe and doses of 320 mg/kg were toxic. Adverse drug reactions(ADRs) included digestive disorders; drug-induced erythrocyte deformation in lung, liver, spleen, kidney, bone marrow, intestinal mucosa, lymph nodes, and other tissues; megakaryocytes in lung, liver, and spleen resulting from mild hemolysis; and mild hyperplasia in bone marrow hematopoietic tissue. Other studies indicated no irritative effect of the injection on local tissues and blood vessels, and no allergic reactions, erythrocyte coagulation, or hemolysis. SRS data showed that the most common ADRs were headache, head distention, dizziness, facial flushing, skin itching, thrombocytopenia, and the reversibility of elevated Aspartate transaminase. HIS data indicated no damage to renal function from using depside salt injection made from Danshen(Radix Salviae Miltiorrhizae) at a dosage higher than the recommended ***: This study analyzes the clinical characteristics of ADRs from depside salt injection made from Danshen(Radix Salviae Miltiorrhizae),and discusses the factors influencing s

关键词： Product surveillance, postmarketingChinese medicine Safety Danshen (Radix SalviaeMiltiorrhizae) Depside salt injection

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Characteristics of the anti-dementia drug system of Zisu Fang preparations based on pharmacokinetic and pharmacodynamic analysis

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Journal of Traditional Chinese Medical Sciences 2017年第2期4卷 207-215页

作者： Jianye Quan Shujuan Yang Fang Zhang Li Tan Jing Kong Yanyan Jiang rendi sun Renbing Shi School of Chinese Pharmacy Key Unit of Exploring Effective Substances of Classical and Famous Formulas of State Administration of Traditional Chinese MedicineBeijing University of Chinese MedicineBeijing 100102China Quality Control Technology and Engineering Center of Chinese Medicine Beijing Municipal Commission of EducationBeijing 100102China Shanghai Green Valley Pharmaceutical Life Park Shanghai 201707China

Objectives:To investigate the pharmacokinetics (PK) and pharmacodynamics (PD)of index components of Zisu Fang preparations and additionally analysis the anti-dementia drug system ***:A PK-PD-drug interaction (DI) method was applied to determine the characteristics of index components of Zisu Fong preparations in ***:In the PK study,maximum plasma concentration,area under the plasma concentration-time curve,and mean residence time of index components of Zisu Fang preparations were higher in the memory-deficit model group than in the control *** suggested that the index components of Zisu Fang preparations had an affinity for the state of dementia in this *** the PD study,at the peak time points of anti-dementia efficacy (0.17 h and 1 h),the plasma concentrations of index components of Zisu Fang preparations reached the first or second largest plasma concentration peak or were close to the plasma concentration peak,and showed positive correlation between these two peaks,indicating that the index components of Zisu Fang synergistically exerted an anti-dementia *** to the association analysis of PK-PD-DI,baicalin,rosmarinic acid,salvianolic acid B,matrine,and tanshinone ⅡA were the main active ingredients of the anti-dementia drug system of Zisu Fang preparations in vivo,but were only efficacious against dementia when all five components were present at a specific concentration and ***:Based on the PK and PD correlation analysis,baicalin,rosmarinic acid,salvianolic acid B,matrine,and tanshinone ⅡA are the main active ingredients of Zisu Fang preparations with regard to its anti-dementia effects,and represent the basic characteristics of drug system:natures,synergy,and affinity.

关键词： Index components Pharmacokinetics Pharmacodynamics Characteristics of anti-dementia drug system

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顶空毛细管气相色谱法测定丹参多酚酸盐原料中乙醇残留量

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中国药师 2013年第8期16卷 1127-1128页

作者：孙仁弟杨瑞花上海绿谷制药有限公司上海201203

目的:建立丹参多酚酸盐原料中乙醇残留量的测定方法,并测定其残留量。方法:采用顶空毛细管气相色谱法,以水为溶剂,色谱柱为HP-5(5%苯基～95%甲基聚硅氧烷固定液)石英毛细管柱(30 m×0.32 mm,0.5μm),载气为氮气。进样口温度为220℃,FID... 详细信息

目的:建立丹参多酚酸盐原料中乙醇残留量的测定方法,并测定其残留量。方法:采用顶空毛细管气相色谱法,以水为溶剂,色谱柱为HP-5(5%苯基～95%甲基聚硅氧烷固定液)石英毛细管柱(30 m×0.32 mm,0.5μm),载气为氮气。进样口温度为220℃,FID检测器温度为260℃,柱温为50℃;顶空进样,平衡温度为80℃,平衡时间为30 min,分流比2:1。结果:被测物能得到很好的分离,峰面积与浓度呈良好的线性关系,精密度和回收率良好。结论:该法可用于丹参多酚酸盐原料中乙醇残留量的检测。

关键词：丹参多酚酸盐乙醇残留量毛细管气相色谱

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响应面法优化紫苏子中迷迭香酸超声提取工艺的研究

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上海医药 2017年第7期38卷 75-78页

作者：张玥莉孙仁弟上海绿谷制药有限公司上海复方中药(绿谷)工程技术研究中心上海201707

目的 :优选紫苏子中迷迭香酸的超声提取工艺。方法 :在单因素试验基础上,以超声功率、乙醇浓度、提取时间为考察因素,以迷迭香酸提取率为考察指标,利用Design-Expert 7.0进行三因素三水平响应面分析优选工艺条件。结果 :最佳提取工艺为... 详细信息

目的 :优选紫苏子中迷迭香酸的超声提取工艺。方法 :在单因素试验基础上,以超声功率、乙醇浓度、提取时间为考察因素,以迷迭香酸提取率为考察指标,利用Design-Expert 7.0进行三因素三水平响应面分析优选工艺条件。结果 :最佳提取工艺为:超声功率380 W、乙醇浓度60%、提取时间85 min,模型相关系数R^2=0.960 2,该条件下迷迭香酸平均提取率为0.59%。结论 :该提取工艺可为进一步开发紫苏子药用价值提供依据。

关键词：紫苏子迷迭香酸响应面超声提取

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基于灰色关联度和偏最小二乘回归分析的芩苏胶囊抑菌谱效关系研究

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药物评价研究 2022年第6期45卷 1060-1069页

作者：黄广伟陈淮臣刘渝孙仁弟杨素德上海绿谷生命园医药有限公司上海201707 上海复方中药(绿谷)工程技术研究中心上海201707

目的基于灰色关联度法和偏最小二乘法研究芩苏胶囊抑菌作用的谱效关系。方法使用高效液相色谱(HPLC)法建立10批芩苏胶囊的指纹图谱,采用管碟法测定芩苏胶囊(0.3 g·mL^(−1))对5种常见致病菌(金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌... 详细信息

目的基于灰色关联度法和偏最小二乘法研究芩苏胶囊抑菌作用的谱效关系。方法使用高效液相色谱(HPLC)法建立10批芩苏胶囊的指纹图谱,采用管碟法测定芩苏胶囊(0.3 g·mL^(−1))对5种常见致病菌(金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌、肺炎克雷伯菌、肺炎链球菌)的抑菌活性,使用灰色关联度分析法结合偏最小二乘法构建谱效关系。结果10批样品指纹图谱中有37个共有峰,芩苏胶囊对5种致病菌均具有一定的抑菌作用,对金黄色葡萄球菌有较好的抑菌作用。6、10(迷迭香酸)、14、17(丹酚酸B)号峰为芩苏胶囊抑制金黄色葡萄球菌的主要成分;10(迷迭香酸)、17(丹酚酸B)、35(苦参碱)、37(氧化苦参碱)号峰为抑制大肠埃希菌的主要成分;6、7、8、9、10(迷迭香酸)、14、17(丹酚酸B)、27、31(丹参酮Ⅰ)、37(氧化苦参碱)号峰为抑制铜绿假单胞菌的主要成分;8、9、10(迷迭香酸)、14、17(丹酚酸B)、37(氧化苦参碱)为抑制肺炎克雷伯菌的主要成分;5、23(汉黄芩素)、27、30、31(丹参酮Ⅰ)、32、33(丹参酮ⅡA)、34(槐果碱)、36(氧化槐定碱)、37(氧化苦参碱)号峰为抑制肺炎链球菌的主要成分。结论通过谱效关系研究明确了芩苏胶囊抑菌药效作用是多种成分共同作用的结果,可为芩苏胶囊的药效物质基础研究与质量控制提供参考。

关键词：芩苏胶囊抑菌活性指纹图谱谱效关系迷迭香酸丹酚酸B 苦参碱氧化苦参碱汉黄芩素

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不同产地丹参药材对丹参多酚酸盐质量的影响

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上海医药 2014年第9期35卷 53-56页

作者：赵琼孙仁弟杨瑞花薛仁峰上海绿谷制药有限公司上海201203

目的 :考察不同产地丹参药材对丹参多酚酸盐质量的影响。方法 :根据丹参多酚酸盐的生产工艺,将丹参药材70%乙醇提取浓缩后以大孔树脂进行分离,收集20%乙醇洗脱液,制备丹参多酚酸盐,通过高效液相色谱法(HPLC)评价不同产地的丹参药材生产... 详细信息

目的 :考察不同产地丹参药材对丹参多酚酸盐质量的影响。方法 :根据丹参多酚酸盐的生产工艺,将丹参药材70%乙醇提取浓缩后以大孔树脂进行分离,收集20%乙醇洗脱液,制备丹参多酚酸盐,通过高效液相色谱法(HPLC)评价不同产地的丹参药材生产的丹参多酚酸盐的质量。结果与结论 :不同产地丹参生产的丹参多酚酸盐含量虽有差别,但均能符合质量要求。

关键词：丹参药材丹参多酚酸盐含量测定

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Impact of ocean data assimilation on the seasonal forecast of the 2014/15 marine heatwave in the Northeast Pacific Ocean

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Atmospheric and Oceanic Science Letters 2025年第1期18卷 24-31页

作者： Tiantian Tang Jiaying He Huihang sun Jingjia Luo Institute for Climate and Application Research(ICAR)/Key Laboratory of Meteorological Disaster Nanjing University of Information Science and TechnologyNanjingChina

A remarkable marine heatwave,known as the“Blob”,occurred in the Northeast Pacific Ocean from late 2013 to early 2016,which displayed strong warm anomalies extending from the surface to a depth of 300 *** study employed two assimilation schemes based on the global Climate Forecast System of Nanjing University of Information Science(NUIST-CFS 1.0)to investigate the impact of ocean data assimilation on the seasonal prediction of this extreme marine *** sea surface temperature(SST)nudging scheme assimilates SST only,while the deterministic ensemble Kalman filter(EnKF)scheme assimilates observations from the surface to the deep *** latter notably improves the forecasting skill for subsurface temperature anomalies,especially at the depth of 100-300 m(the lower layer),outperforming the SST nudging *** excels in predicting both horizontal and vertical heat transport in the lower layer,contributing to improved forecasts of the lower-layer warming during the *** improvements stem from the assimilation of subsurface observational data,which are important in predicting the upper-ocean *** results suggest that assimilating ocean data with the EnKF scheme significantly enhances the accuracy in predicting subsurface temperature anomalies during the Blob and offers better understanding of its underlying mechanisms.

关键词： Seasonal forecast Ocean data assimilation Marine heatwave Subsurface temperature

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In situ polymerization of poly(3,4-ethylenedioxythiophene)protective layer towards stable zinc anode

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Nano Research 2025年第1期18卷 382-394页

作者： Debin Luo Peng Zhou Xiaowei Lv Panpan sun Xiaohua sun Hewei Zhao College of Materials and Chemical Engineering Key Laboratory of Inorganic Nonmetallic Crystalline and Energy Conversion MaterialsChina Three Gorges UniversityYichang 443002China Hubei Three Gorges Laboratory Yichang 443007China School of Chemistry Beihang UniversityBeijing 100191China

Aqueous zinc-ion devices are considered promising candidates for energy storage due to their high safety,low cost and relatively high energy ***,the dendrite growth,hydrogen evolution reaction(HER)and corrosion of the zinc anode significantly limit the development of Zn-ion ***,an inexpensive poly(3,4-ethylenedioxythiophene)(PEDOT)protective layer was constructed in situ on the Zn surface using electropolymerization to suppress dendrite growth and side reactions,thereby enhancing the reversibility of *** and theoretical calculations revealed that this hydrophilic protective layer promotes the desolvation process of hydrated Zn^(2+)and facilitates the transport of zinc ions,thus improving the thermodynamic and kinetic properties of Zn^(2+)deposition and inhibiting interfacial side ***,the optimized PEDOT@Zn symmetric battery exhibited a cycling stability exceeding 1250 h at 0.5 mA·cm^(-2)and 0.25 mAh·cm^(-2),with a significantly reduced overpotential(from 91.8 to 35 mV).With the assistance of the PEDOT protective layer,the PEDOT@Zn//Cu battery maintained approximately 99.5%Coulombic efficiency after 450 ***-situ scanning electron microscopy(SEM)and in situ optical microscopy characterizations further confirmed that the PEDOT protective layer can effectively suppress the growth of zinc ***,the Zn-ion capacitors assembled by the PEDOT@Zn and activated carbon also demonstrated outstanding cycling stability.

关键词： zinc-ion devices zinc anode poly(3 4-ethylenedioxythiophene)(PEDOT) dendrite desolvation process

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基于网络药理学和分子对接技术芩苏胶囊干预新型冠状病毒肺炎(COVID-19)的潜在药效物质预测分析

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上海中医药杂志 2020年第10期54卷 1-11页

作者：黄广伟陈风晨刘渝杨素德孙仁弟上海绿谷生命园医药有限公司上海201707 上海复方中药(绿谷)工程技术研究中心上海201707

目的运用网络药理学和分子对接技术探究芩苏胶囊防治新型冠状病毒肺炎(COVID-19)的潜在药效物质。方法采用中药系统药理学分析平台(TCMSP)检索出芩苏胶囊中4味药材(黄芩、紫苏子、苦参和丹参)所含有效成分与作用靶点;通过UniProt、GeneC... 详细信息

目的运用网络药理学和分子对接技术探究芩苏胶囊防治新型冠状病毒肺炎(COVID-19)的潜在药效物质。方法采用中药系统药理学分析平台(TCMSP)检索出芩苏胶囊中4味药材(黄芩、紫苏子、苦参和丹参)所含有效成分与作用靶点;通过UniProt、GeneCards和OMIM数据库,筛选出COVID-19相关靶点,得到与芩苏胶囊有效成分作用的共同靶点,采用String数据库构建PPI网络;借助Cytoscape3.7.2构建"中药-化合物-靶点"网络;运用DAVID数据库对相关靶点进行GO功能和KEGG通路的富集分析;通过分子对接技术评价"中药-成分-靶点"网络中核心成分与COVID-19的3CL水解酶及血管紧张素转化酶Ⅱ(ACE2)的结合作用。结果芩苏胶囊"中药-成分-靶点"网络121个化合物和274个相关靶点,包含14个核心化合物和33个核心靶点。GO功能富集分析得到527个条目,主要涉及药物应答、炎症反应、RNA聚合酶Ⅱ启动子转录的正调控等。KEGG路富集共得到111条信号通路,筛选得到20条信号通路,涉及乙型肝炎、甲型流感、肺结核等与病毒感染相关的通路。分子对接表明,芩苏胶囊中14个核心成分与COVID-19的3CL水解酶和ACE2的亲和作用较好。质谱指认出芩苏胶囊中5个成分可能是防治COVID-19的核心成分。黄芩素、汉黄芩素、隐丹参酮、丹参酮ⅡA和木犀草素是芩苏胶囊治疗COVID-19的核心药效物质。结论芩苏胶囊可能通过多成分结合SARS-CoV-23CL水解酶及ACE2作用于IL-6、TNF和TP53等关键靶点调节多条信号通路,从而对COVID-19起到治疗作用。

关键词：新型冠状病毒肺炎芩苏胶囊网络药理学分子对接技术 SARS-CoV-23CL水解酶血管紧张素转换酶Ⅱ

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Boosting bidirectional sulfur conversion enabled by introducing boron-doped atoms and phosphorus vacancies in Ni2P for lithium-sulfur batteries

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Journal of Energy Chemistry 2025年第1期100卷 760-769页

作者： Lin Peng Yu Bai Hang Li Meixiu Qu Zhenhua Wang Kening sun Advanced Research Institute of Multidisciplinary Science Beijing Institute of Technology Beijing Key Laboratory of Chemical Power Source and Green Catalysis School of Chemistry and Chemical Engineering Beijing Institute of Technology

Lithium-sulfur （Li-S） batteries have gained great attention due to the high theoretical energy density and low cost,yet their further commercialization has been obstructed by the notorious shuttle effect and sluggish redox ***,we supply a strategy to optimize the electron structure of Ni2P by concurrently introducing B-doped atoms and P vacancies in Ni2P （Vp-B-Ni2P）,thereby enhancing the bidirectional sulfur *** study indicates that the simultaneous introduction of B-doped atoms and P vacancies in Ni2P causes the redistribution of electron around Ni atoms,bringing about the upward shift of d-band center of Ni atoms and effective d-p orbital hybridization between Ni atoms and sulfur species,thus strengthening the chemical anchoring for lithium polysulfides （LiPSs） as well as expediting the bidirectional conversion kinetics of sulfur ***,theoretical calculations reveal that the incorporation of B-doped atoms and P vacancies in Ni2P selectively promotes Li2S dissolution and nucleation ***,the Li-S batteries with Vp-B-Ni2P-separators present outstanding rate ability of 777 m A h g-1at 5 C and high areal capacity of 8.03 mA h cm-2under E/S of 5μL mg-1and sulfur loading of 7.20 mg *** work elucidates that introducing heteroatom and vacancy in metal phosphide collaboratively regulates the electron structure to accelerate bidirectional sulfur conversion.

关键词： Lithium sulfur batteries

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