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Evidence-based expert consensus on clinical management of safety of bruton’s tyrosine kinase inhibitors(2024)

第十一届全国青年药学工作者最新科研成果交流会

作者： Dan Yan a,Yong-shen Ren a,b,Ping Zhang a,c,Jia-bo Wang a,Xiao-xi Du d,Xiao-he Xiao a a Military Institute of chinese Materia Medica,302th Military Hospital of china,beijing 100039,china b college of pharmacy,chengdu university of traditional chinese medicine,chengdu 610075,china c Postgraduate Team,Military Medical Postgraduate School of china,beijing 100853,china d Center for Drug Reevaluation,State Food and Drug Administration,beijing 100045,china

Herbal injection is one of the most powerful preparations of modern traditional chinese medicine;however the quality control of it is fairly difficult for their complicated ***,chromatographic fingerprint（CF） has been recommended as a potential strategy for the quality control of herbal injection,nevertheless there are still various substances absent from the inspection of chromatographic method for no spectrum absorption,which might cause grievous drug-induced *** establish a comprehensive and early prediction security control process,biothermodynamic fingerprint（bF） was adopted as a complement for CF to detection the quality fluctuation of herbal injection from both chemical and bioactive *** this work,Yinzhihuang Injection（YZHI） was selected as a representative of herbal injection,10 batches of normal samples and 6 batches of artificial abnormal samples were collected,high performance liquid chromatography and Thermal Active Monitor were applied to develop their CF and bF *** results showed that the CF and bF of normal samples were similar with good stability and consistence;however the abnormal samples deviated from *** abnormal samples could be correctly distinguished when coupled CF with bF,the recognition ratio was higher than CF and bF respectively,and the key factors of quality fluctuation extent could be ordered as bacterial contamination,high temperature,lighting and sterilizing *** established method could be used for early prediction adverse drug events,which would be potentially helpful to improve the safety level of herbal injection in clinical application.

关键词： herbal injection Yinzhihuang Injection quality fluctuation chromatographic fingerprinting biothermodynamic fingerprinting

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chinese Journal of Cancer Research 2024年第3期36卷 240-256页

作者： Zaiwei Song Dan Jiang Lingling Yu Yixuan Chen Daobin Zhou Yue Li Depei Wu Lingli Zhang Liyan Miao Jun Ma Jun Zhu Hongmei Jing Rongsheng Zhao the Steering Committee,the Consensus Panel and the Evidence Synthesis Group Evidence-based pharmacy Professional Committee of chinese Pharmaceutical Association(CPA) Hospital pharmacy Professional Committee of chinese Pharmaceutical Association(CPA) Division of Therapeutic Drug Monitoring of chinese Pharmacological Society(CPS) Expert Committee on Lymphoma of chinese Society of Clinical Oncology(CSCO) Expert Committee on Leukemia of chinese Society of Clinical Oncology(CSCO) Society of Integrative Cardio-Oncology of china Anti-Cancer Association(CACA) chinese Society of Hematology of chinese Medical Association(CMA) Hospital pharmacy Professional Committee of Cross-Straits medicine Exchange Association(SMEA) Department of pharmacy Peking University Third HospitalBeijing 100191China Institute for Drug Evaluation Peking University Health Science CenterBeijing 100191China Therapeutic Drug Monitoring and Clinical Toxicology Center Peking UniversityBeijing 100191China Department of pharmacy Administration and Clinical pharmacy School of Pharmaceutical SciencesPeking UniversityBeijing 100191China Department of Hematology Peking Union Medical College HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100005China Department of Cardiology the First Affiliated HospitalHarbin Medical UniversityHarbin 150001China Department of Hematology the First Affiliated Hospital of Soochow UniversitySuzhou 215006China Department of pharmacy Evidence-based Pharmacy CenterWest China Second HospitalSichuan UniversityChengdu 610041China Department of pharmacy the First Affiliated Hospital of Soochow UniversitySuzhou 215006China Department of Hematology and Oncology Harbin Institute of Hematology and OncologyHarbin 150010China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/beijing) Department of LymphomaPeking University Cancer Hospital&InstituteBeijing 100142China Department of Hematology Peking University Third HospitalBeijing 100191China 不详

bruton’s tyrosine kinase inhibitors(bTKis)have revolutionized the treatment of b-cell ***,safety issues related to the use of bTKis may hinder treatment continuity and further affect clinical efficacy.A comprehensive and systematic expert consensus from a pharmacological perspective is lacking for safety issues associated with bTKi treatment.A multidisciplinary consensus working group was established,comprising 35 members from the fields of hematology,cardiovascular disease,cardio-oncology,clinical pharmacy,and evidencebased *** evidence-based expert consensus was formulated using an evidence-based approach and the Delphi *** Joanna briggs Institute Critical Appraisal(JbI)tool and Grading of Recommendations Assessment,Development,and Evaluation(GRADE)approach were used to rate the quality of evidence and grade the strength of recommendations,*** consensus provides practical recommendations for bTKis medication based on nine aspects within three domains,including the management of common adverse drug events such as bleeding,cardiovascular events,and hematological toxicity,as well as the management of drug-drug interactions and guidance for special *** multidisciplinary expert consensus could contribute to promoting a multi-dimensional,comprehensive and standardized management of bTKis.

关键词： Consensus bTK inhibitors safety adverse drug events drug-drug interactions

Investigation of the effect of berberines alkaloids in Coptis chinensis Franch on bacillus shigae growthby microcalorimetry

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Science china Chemistry 2007年第5期50卷 638-642页

作者： YAN Dan1,2,3, JIN Cheng1, XIAO XiaoHe1 & DONG XiaoPing2 1 Institute of chinese medicine, 302 Hospital of People’s Liberation Army, beijing 100039, china 2 chengdu university of traditional chinese medicine, chengdu 610075, china 3 Chongqing Institute of Technology, Chongqing 400050, china Institute of chinese medicine 302 Hospital of People's LiberationArmyBeijing 100039China chengdu university of traditional chinese medicine Chengdu610075China Chongqing Institute of Technology Chongqing 400050China

The inhibitory effects of five berberines alkaloids (bAs) from rhizoma ofCoptis chinensis Franch,a traditional chinese medicinal (TCM) herb,on bacillus shigae(***)growth were investigated by *** power-time curves of *** with and without bAswere acquired;meanwhile,the extent and duration of inhibitory effects on the metabolism wereevaluated by growth rate constants (k1,k2),half inhibitory ratio (IC50),maximum heat output(P_(max)),and peak time (t_p).The values of k1 and k2 of a shigae in the presence of the five bAsdecreased with the increasing concentrations of ***,P_(max) was reduced,and the value oft_p increased with increasing concentrations of the five *** inhibitory activity varied withdifferent ***50 of the five bAs was respectively 75 mu g/mL for berberine,90 ng/mL forcoptisine,115 mu g/mL for palmatine,220 mu g/mL for epiberberine,and 400 mu g/mL *** sequence of antimicrobial activity of the five bAs:berberine > coptisine >palmatine > epiberberine > *** functional groups methylenedioxy at C2 and C3 on phenylring improve antimicrobial activity more strongly than methoxyl at C2 and C3 on ***,the effect of bacteriostasis is not significant with methylenedioxy or methoxyl at C9and C10 on phenyl ring.

关键词： berberines alkaloids, microcalorimetry, bacillus shigae, inhibitory effect

Synthesis of molecularly imprinted polymers for the application of selective clean-up vinblastine from Catharanthus roseus extract

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中国科学：化学英文版 2010年第12期53卷 2587-2592页

作者： ZHU QuanHong,HUANG DanDan,LI Li & YIN YongGuan college of traditional chinese medicine,Southern Medical university,Guangzhou 510515,china 1. college of traditional chinese medicine Southern Medical University Guangzhou 510515 China

Molecularly imprinted polymers (MIPs) are synthetic tailor-made polymers with high selectivity towards a particular substance (template).An MIP using vinblastine (VLb) as the template molecule was synthesized and *** presence of monomer-template complexes in a non-covalent way was confirmed by UV-vis spectrometry *** polymerization was performed using methacrylic acid (MAA) as the functional monomer,ethylene glycol dimethacrylate (EGDMA) as the cross-linking agent,and toluene as the porogenic solvent by a thermo-polymerization *** characterization of the obtained MIP was evaluated by scanning electron microscopy (SEM) and brunauer-Emmett-Teller (bET) *** was observed that the morphology of the MIP was more porous and rough,and the surface area had a significant increase compared with that of the non-imprinted polymer (NIP).This MIP was used as the sorbents of solid-phase extraction (SPE) to assess the selectivity of the MIP after optimization of the SPE *** was specifically adsorbed on the MIP cartridge,while to vincristine (VCR),the chemical analog of VLb,almost no selective binding *** the basis of the results,Catharanthus roseus extract was applied to the MIP cartridge for investigating its capability to extract VLb from the plant extract,and the capacity of the MIP cartridge was also *** was shown that the MIP could effectively enrich VLb from *** extract and the recovery amounted to 93.8%.The solvents dissolving the samples had significant influence on the capacity of the MIP cartridge;it was 750 μg/g in toluene,625 μg/g in chloroform,and 250 μg/g in methanol.

关键词： molecular imprinting polymer vinblastine selective extraction Catharanthus roseus extract

Distribution and Elimination of Lead Species in Soils Related to GAP of chinese Medicinal Materials of Ligusticum Chuanxiong Hort

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地球科学进展 2004年第S1期19卷 419-423页

作者： DENG Tian-long~(1,2),JIA Min-ru~2,LIAO Meng-xia~1 (1. college of Materials and bioengineering, chengdu university of Technology, chengdu 610059, china 2. college of Pharmacology, chengdu university of traditional chinese medicine, chengdu 610059 ,china)

In this paper, the sequential extraction procedure was used for the selection of fractions of lead in seven stages corresponding to lead exchangeable, lead bounded to carbonates, to manganese oxides, to organic matters, to amorphous iron, and lead associated to crystallized iron, and to residuals. The vertical distributions of lead species were carried out in the soils related to good agriculture progress (GAP) of chinese medical materials of Ligusticum chuanxiong Hort in Dujiangyan city and Wenchuan Co...

关键词： chinese medical Materials Phytoremediation Soils Lead speciation

Theoretical study on the hydrolysis mechanism of N,N-dimethyl-N′-(2′,3′-dideoxy-3′-thiacytidine)formamidine

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Science china Chemistry 2008年第10期51卷 911-917页

作者： ZHANG Chang1 & XUE Ying2? 1 college of Chemistry and Environment Protection Engineering, Southwest university for Nationalities, chengdu 610041, china 2 college of Chemistry, Sichuan university, chengdu 610064, china 1. college of Chemistry and Environment Protection Engineering Southwest University for Nationalities Chengdu 610041 China 2. college of Chemistry Sichuan University Chengdu 610064 China

The hydrolysis mechanisms of N,N-dimethyl-N′-(2′,3′-dideoxy-3′-thiacytidine)formamidine (FA-3TC) in the gas phase and in aqueous solution were studied by use of the density functional theory b3LYP/6-31+G(d, p) method. Two possible reaction pathways in the title reaction were considered. In one pathway water attacks the C=N double bond first (path A) while in the other water attacks the C—N single bond first (path b). The calculated results indicate that the first step in both pathways is the rate-limiting process and path A is more favorable than path b in the gas phase. The effect of solvent water on the title reaction was assessed at the b3LYP/6-31+G(d, p) level of theory based on the po-larizable continuum model (CPCM). In water the first mechanism (path A) is also favored.

关键词： N N-dimethyl-N′-(2′ 3′-dideoxy-3′-thiacytidine)formamidine hydrolysis solvent effect b3LYP polarizable continuum model

EFFECTS OF ELECTROACUPUNCTURE ON EPILEPTIFORM HIPPOCAMPAL UNIT ACTIVITY INDUCED bY INTRACERE-bROVENTRICUILAR INJECTION OF CORIARIA LACTONE

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针刺研究 1989年第Z1期 49-50页

作者： Gao Chong Liao Weihong Yang Jizeng Department of Physiology, chengdu traditional chinese medicine college, chengdu Department of Physiology, The Third Military Medical university, Chongqing

In our present study we build up a new experimental model in the rat forepilepsy and examine the effects of electroacupuncture on epileptiform hippo-campal unit activity. Experiments were carried out on conscious immobilized male rats, CoriariaLactone at a concentration of 30μg/10μl in saline was injected intracerebrove-ntricularly. Electrocorticography (ECoG) and hippocampal unit activity wererecorded simultaneously on the side of brain which received the drug *** some cases, the hippocampal EEG was also recorded. Acupuncture of Da-zhui, Shenzhu, Taichong and Kunlun were stumulated respectively.

关键词： In EFFECTS OF ELECTROACUPUNCTURE ON EPILEPTIFORM HIPPOCAMPAL UNIT ACTIVITY INDUCED bY INTRACERE-bROVENTRICUILAR INJECTION OF CORIARIA LACTONE

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乌头类生物碱对bcl-2基因表达的影响

毒理学杂志 2010年第2期24卷 94-96页

作者：饶朝龙彭成成都中医药大学药学院药理学教研室四川成都610075

目的研究乌头类生物碱对大鼠视网膜神经细胞细胞增殖周期和bcl-2基因表达的影响,探讨乌头类中药神经毒性的作用机制。方法体外培养大鼠视网膜神经细胞,分别以0.5%的乌头碱、新乌头碱和次乌头碱作用细胞5min后,流式细胞仪检测。结果与阴... 详细信息

目的研究乌头类生物碱对大鼠视网膜神经细胞细胞增殖周期和bcl-2基因表达的影响,探讨乌头类中药神经毒性的作用机制。方法体外培养大鼠视网膜神经细胞,分别以0.5%的乌头碱、新乌头碱和次乌头碱作用细胞5min后,流式细胞仪检测。结果与阴性对照组比较,乌头碱作用组G2/M期细胞比例从2.3%增加到19.5%,细胞增殖活动被抑制;而bcl-2基因表达量显著增加,表达荧光均值从0.78增加到1.45。新乌头碱和次乌头碱作用组结果与乌头碱类似。结论在本试验条件下,bcl-2基因可能在乌头类生物碱的神经毒性作用机制中具有重要意义。

关键词：乌头类生物碱视网膜神经细胞 bcl-2基因神经毒性

A taxonomic re-assessment in the chinese bupleurum(Apiaceae):Insights from morphology,nuclear ribosomal internal transcribed spacer,and chloroplast(trnH-psbA,matK) sequences

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Journal of Systematics and Evolution 2011年第6期49卷 558-589页

作者： Chang-bao WANG Xiang-Guang MA Xing-Jin HE(college of Life Science,Sichuan university,chengdu 610064,china) (college of Life Science Sichuan University Chengdu 610064 China) *Correspondence: Xing-Jin HE *Correspondence: E-mail: xjhe@*** Tel.: 86-28-85415006 Fax: 86-28-85415006.

As one of the big genera in Apiaceae,bupleurum *** received considerable attention from plant ***,there are still many gaps in our knowledge of this genus,especially of those species endemic to china that have often been excluded from previous *** spite of a few recent studies on the phylogeny and classification of the chinese bupleurum,the most essential problem of species delimitation still remains *** re-evaluate the taxonomy of the chinese bupleurum using morphological and molecular *** observations of living plants growing the field and herbarium specimens were made to understand the morphological variation and to ensure species identification for the molecular *** analyses were carried out on sequence data of nuclear ribosomal internal transcribed spacer(nrITS),trnH-psbA,and matK,using parsimony and bayesian approaches to evaluate species *** of both nrITS and combined datasets of the three regions revealed the following results:(i)the chinese bupleurum species were divided into two major lineages;and(ii)most species were well defined,but some traditional inter-and infraspecific relationships were not *** results,along with the results of previous works support that the chinese bupleurum species were derived from two different lineages and should be placed in Neves and Watson’s subgenus *** detailed taxonomic re-assessment of several chinese species resulted in new taxonomic recombinations with rank changes for three species:bupleurum tenerum,***,and ***;new combination for one variety,*** ***;and the description of one variety and one species,*** *** and ***.

关键词： chinese bupleurum chloroplast sequences(trnH-psbA matK) morphology nrITS phylogenetic analyses taxonomy and new species.