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Journal of Huazhong University of Science and Technology(Medical Sciences) 2012年第5期32卷 779-784页

作者：刘亚妮黄建耿刘金梅马林吕永宁师少军 clinical Trial organization for pharmaceutical products Union HospitalTongji Medical CollegeHuazhong University of Science and Technology Department of Pharmaceutics School of PharmacyTongji Medical CollegeHuazhong University of Science and Technology

A simple and sensitive liquid chromatographic method was developed for quantification of cefotetan disodium (CTT),a semi-synthetic cephamycin antibiotic,in human *** and the internal standard chloramphenicol were extracted from plasma by a simple one-step protein precipitation with 35% (v/v) perchloric *** was carried out on a reverse-phase C18 column with a mobile phase of acetonitile-water containing 0.5% (v/v) phosphoric acids (20:80,v/v) at a flow rate of 1.0 mL/*** column effluent was monitored by UV detection at 300 *** column temperature was maintained at 40°*** method demonstrated good linearity in the range of 0.525-300.0 μg/mL,with correlation coefficients greater than *** limit of quantification (LOQ) was 0.525 μg/mL in human ***-and inter-day precisions were less than 6.63% in terms of relative standard deviation (RSD).The accuracy,when expressed by the bias,ranged from 0.57% to 4.04%.The mean extraction recovery of CTT was higher than 40.94%.The method was found to be precise,accurate,and specific for CTT quantitative analysis,and was successfully applied for a pharmacokinetic study of CTT after a single intravenous dose of 1.0 g of CTT in healthy Chinese subjects.

关键词： cefotetan disodium liquid chromatography human plasma pharmacokinetics

Transcriptome Analysis of Schwann Cells at Various Stages of Myelination Implicates Chromatin Regulator Sin3A in Control of Myelination Identity

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Neuroscience Bulletin 2022年第7期38卷 720-740页

作者： Bin Zhang Wenfeng Su Junxia Hu Jinghui Xu Parizat Askar Shuangxi Bao Songlin Zhou Gang Chen Yun Gu Jiangsu Key Laboratory of Neuroregeneration Co-innovation Center of NeuroregenerationJiangsu Clinical Medicine Center of Tissue Engineering and Nerve Injury RepairNMPAKey Laboratory for ResearchEvaluation of Tissue Engineering Technology ProductsNantong UniversityNantong 226001China

Enhancing remyelination after injury is of utmost importance for optimizing the recovery of nerve *** the formation of myelin by Schwann cells(SCs)is critical for the function of the peripheral nervous system,the temporal dynamics and regulatory mechanisms that control the progress of the s lineage through myelination require further ***,using in vitro co-culture models,gene expression profiling of laser capture-microdissected SCs at various stages of myelination,and multilevel bioinformatic analysis,we demonstrated that SCs exhibit three distinct transcriptional characteristics duringmyelination:the immature,promyelinating,and myelinating *** showed that suppressor interacting 3a(Sin3A)and 16 other transcription factors and chromatin regulators play important roles in the progress of ***3A knockdown in the sciatic nerve or specifically in SCs reduced or delayed the myelination of regenerating axons in a rat crushed sciatic nerve model,while overexpression of Sin3A greatly promoted the remyelination of ***,in vitro experiments revealed that Sin3A silencing inhibited SC migration and differentiation at the promyelination stage and promoted SC proliferation at the immature *** addition,SC differentiation and maturation may be regulated by the Sin3A/histone deacetylase2(HDAC2)complex functionally cooperating with Sox10,as demonstrated by rescue ***,these results complement the recent genome and proteome analyses of SCs during peripheral nerve myelin *** results also reveal a key role of Sin3A-dependent chromatin organization in promoting myelinogenic programs and SC differentiation to control peripheral myelination and *** findings may inform new treatments for enhancing remyelination and nerveregeneration.

关键词： (Re)myelination Schwann cells Sin3A Transcriptome Peripheral nerve injury

Targeting PI3K/AKT signaling for treatment of idiopathic pulmonary fibrosis

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Acta Pharmaceutica Sinica B 2022年第1期12卷 18-32页

作者： Jincheng Wang Kaili Hu Xuanyan Cai Bo Yang Qiaojun He Jiajia Wang Qinjie Weng Center for Drug Safety Evaluation and research College of Pharmaceutical SciencesZhejiang UniversityHangzhou 310058 Hangzhou Institute of Innovative Medicine College of Pharmaceutical SciencesZhejiang UniversityHangzhou 310058

Idiopathic pulmonary fibrosis(IPF) is a chronic progressive fibrotic interstitial pneumonia with unknown causes. The incidence rate increases year by year and the prognosis is poor without ***, phosphatidylinositol 3-kinase(PI3 K)/protein kinase B(PKB/AKT) signaling pathway can be considered as a master regulator for IPF. The contribution of the PI3 K/AKT in fibrotic processes is increasingly prominent, with PI3 K/AKT inhibitors currently under clinical evaluation in IPF. Therefore,PI3 K/AKT represents a critical signaling node during fibrogenesis with potential implications for the development of novel anti-fibrotic strategies. This review epitomizes the progress that is being made in understanding the complex interpretation of the cause of IPF, and demonstrates that PI3 K/AKT can directly participate to the greatest extent in the formation of IPF or cooperate with other pathways to promote the development of fibrosis. We further summarize promising PI3 K/AKT inhibitors with IPF treatment benefits, including inhibitors in clinical trials and pre-clinical studies and natural products, and discuss how these inhibitors mitigate fibrotic progression to explore possible potential agents, which will help to develop effective treatment strategies for IPF in the near future.

关键词： Idiopathic pulmonary fibrosis PI3K/AKT signaling Pathogenesis Coagulation cascade Immune activation Fibroblast accumulation Therapeutic target Drug therapy

Pharmacokinetics and Tolerability of Oral Dosage Forms of Huperzine A in Healthy Chinese Male Volunteers: a Randomized,Single Dose, Three-period, Six-sequence Crossover Study

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Journal of Huazhong University of Science and Technology(Medical Sciences) 2017年第5期37卷 795-802页

作者：伍三兰甘珺饶静贺思洁朱雯雯赵瑛吕永宁黄建耿刘亚妮 Department of Pharmacy Union Hospital Tongji Medical College Huazhong University of Science and Technology clinical research organization for pharmaceutical products Union Hospital Tongji Medical College Huazhong University of Science and Technology Department of Pharmaceutics School of Pharmacy Tongji Medical College Huangzhong University of Science and Technology

Huperzine A is a potent, reversible, and blood-brain barrier permeable acetylcholinesterase inhibitor. The aim of this study was to compare the pharmacokinetics, tolerability, and bioavailability of two formulations with the established reference formulation of huperzine A in a fasting, healthy Chinese male population. This was a randomized, single-dose, 3-period, 6-sequence crossover study. The plasma concentrations of huperzine A were determined by liquid chromatography tandem mass spectrometry. Tolerability was assessed based on subject interview, vital sign monitoring, physical examination, and routine blood and urine tests. The mean（SD） pharmacokinetic parameters of the reference drug were Cmax, 1.550（0.528） ng/m L; t1/2, 12.092（1.898） h; AUC0-72 h, 17.550（3.794） ng·h/m L. Those of the test formulation A and test formulation B were Cmax, 1.412（0.467）, 1.521（0.608） ng/m L; t1/2, 12.073（2.068）, 12.271（1.678） h; AUC0-72 h, 15.286（3.434） ng·h/mL, 15.673（3.586） ng·h/m L. The 90% confidence intervals for the AUC0-72 h and Cmax were between 0.80 and 1.25. No adverse events were reported by the subjects or found with results of clinical laboratory test. The test and reference products met the regulatory criteria for bioequivalence in these fasting, healthy Chinese male volunteers. All three formulations appeared to be well tolerated.

关键词： huperzine A pharrnacokinetics bioequivalence tolerability liquid chromatography tandem mass spectrometry

Real-world studies: bridging the gap between trial-assessed efficacy and routine care

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The Journal of Biomedical research 2022年第3期36卷 147-154页

作者： Daohong Chen research Institute Changshan Biochemical PharmaceuticalShijiazhuangHebei 050800China

Even though randomized controlled clinical trials(RCTs)have been accepted as the gold standard for official assessment of novel interventions,there is a substantial gap between the efficacy observed in RCTs and the impact on clinical practice and in terms of patient *** real-world studies(RWS)are emerging to confer valuable complementing evidence in this regard and beyond,the evolving role of RWS is yet to be *** article delineates an updated profile of RWS covering effectiveness verification,rare adverse effects discovery,indication repurposing,to name a *** tends not only to improve the efficiency of clinical investigations for regulatory approval,but also optimizes the whole-life cycle evaluation of biomedical/pharmaceutical products.

关键词： real-world evidence therapeutic effectiveness pharmacovigilance

Anti-infective, cytotoxic and antioxidant activity of Ziziphus oxyphylla and Cedrela serrata

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Asian Pacific Journal of Tropical Biomedicine 2016年第8期6卷 671-676页

作者： Rizwan Ahmad Niyaz Ahmad Atta Abbas Naqvi Paul Cos Louis Maes Sandra Apers Nina Hermans Luc Pieters Natural products and Alternative Medicine College of Clinical Pharmacy University of Dammam Department of Pharmaceutics College of Clinical Pharmacy University of Dammam Department of Pharmacy Practice College of Clinical Pharmacy University of Dammam Faculty of pharmaceutical Biomedical and Veterinary Sciences Laboratory of Microbiology Parasitology and Hygiene (LMPH) University of Antwerp Faculty of pharmaceutical Biomedical and Veterinary Sciences Natural Products & Food–Research and Analysis (NatuRA)University of Antwerp

Objective: To search for the most active antimicrobial and antioxidant sub-fractions related to traditional use of Ziziphus oxyphylla(Z. oxyphylla) and Cedrela serrata(C. serrata) in Pakistan against infectious and liver ***: Factions of different polarity were tested in vitro for their antiprotozoal,antimalarial, antibacterial and antifungal activity against different pathogens. Cytotoxicity on MRC-5 cell lines(human lung fibroblasts) as well as, in vitro radical scavenging activity was evaluated using the 1, 1-diphenyl-2-picrylhydrazyl radical ***: The highest antiprotozoal activity was observed for the CHCl3 fractions of Z. oxyphylla roots and leaves, and C. serrata bark. The CHCl3 and Et OAc fractions of Z. oxyphylla roots, the CHCl3 fraction of Z. oxyphylla leaves, the Et OAc and the residual Me OH: H2 O fraction of C. serrata bark showed antibacterial activity against Staphylococcus aureus. The same residual Me OH: H2 O fraction of C. serrata bark was active against Candida albicans. The highest antioxidant activity was observed for the more hydrophilic Et OAc fractions of Z. oxyphylla leaves, C. serrata bark and leaves, and the residual Me OH: H2 O fraction of C. serrata ***: This study supports at least in part the traditional uses of these plants for antimicrobial purposes and against liver diseases.

关键词： Antifungal Antibacterial Antiprotozoal Cytotoxicity Antioxidant Ziziphus oxyphylla Cedrela serrata Rhamnaceae Meliaceae Pakistan

Effect of counter-ion agents on metronidazole loaded chitosan microparticles prepared by w/o emulsification method

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Asian Journal of pharmaceutical Sciences 2016年第1期11卷 96-97页

作者： Wiwat Pichayakorn Medical products Innovations from Polymers in clinical Use research Unit and Faculty of pharmaceutical Sciences Prince of Songkla University

Chitosan microparticles for controlling drug delivery have been prepared by water in oil(w/o)emulsification *** is normally used as cross-linking agent for hardening chitosan polymer into the rigid particles[1].From the cationic charge of ammonium groups in chitosan structure,moreover,it is also possible to cross-link the polymeric chain by the anionic counter-ion *** hydroxide(NaOH)and tripolyphosphate(TPP)are the rich negatively charged molecules that are normally used in pharmaceutical *** might be more appropriate to be chosen for the co-crosslinking process due to its safety[2].Therefore,this study aimed to investigate the effect of counter-ion NaOH and TPP agents on the properties of chitosan microparticles crosslinked by *** was used as model drug loaded in these systems.

关键词： Chitosan Microparticles Counter-ion Sodium hydroxide Tripolyphosphate

Analysis of the Current Situation of Drug clinical Trial Institutions in Shaanxi Province

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Journal of clinical and Nursing research 2024年第1期8卷 78-87页

作者： Yurong Zhang Qi Zhang Li Wang Rui Xu Lili Zhao Enze Li Xin Wang Department of clinical Trial Institution the First Affiliated Hospital of Xi’an Medical CollegeXi’an 710077Shaanxi ProvinceChina Department of Drug and Vaccine Inspection Shaanxi Medical Products AdministrationXi’an 710065Shaanxi ProvinceChina Department of clinical Coordination Xi’an Evidence-Based Medicine Co.LtdXi’an 710000Shaanxi ProvinceChina

To understand the current situation of institutional registration in Shaanxi Province after the implementation ofregistration system management in drug clinical trial *** information was collected on the“Announcement on the Accreditation of Drug clinical Trial Institutions”issued by the National Medical products Administration from 2005 to August 2022,the record management information system of drug and medical device clinical trial institutions,and the drug clinical trial registration and information publicity platform.A retrospective analysis was carried out in terms of institutional development,regional distribution,registered majors,principal investigators,and the number of drug clinical *** the implementation of institution registration,the number of drug clinical trial institutions in Shaanxi Province increased by 47.4%,884 principal investigators were registered,the number of registered majors expanded from 58 qualified to 117,and the professional scope increased by 50.4%.The policy of institution registration is conducive to promoting the rational use of medical resources and the development of drug clinical trial institutions and improving the healthy development of the pharmaceutical industry in Shaanxi Province.

关键词： Drug clinical trial Institution registration Registered majors Current situation analysis Professional group Shaanxi Province

Aged diabetic amputee with COVID-19:A medication therapy

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Chronic Diseases and Translational Medicine 2022年第3期8卷 242-243页

作者： Sunil Kumar Salkapuram Karthikeyan Elumai Department of Post Graduate research in clinical Medicine Santhiram College of PharmacyNandyalIndia Department of pharmaceutical Chemistry Faculty of PharmacyBharath Institute of Higher Education and ResearchSelaiyurChennaiIndia

To the editor:Both innate and acquired immunity can be presented in the human *** defends us against disease of foreign organisms like bacteria,viruses,and other microbes.'Corona virus disease 2019(COVID-19)has been declared a global pandemic by the World Health organization,as the novel coronavirus continues to spread swiftly over the world.

关键词： immunity medication editor

Problems and Countermeasures to Improve clinical Trial Participants’Compensation Rights in China

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Asian Journal of Social Pharmacy 2024年第1期19卷 58-63页

作者： Yang Xiuqiao Wen Ping Lin Hong Chen Wenhuan Chen Yuwen Department of clinical Trail Management Shenzhen Maternity&Child Healthcare HospitalShenzhen 518028China School of Business Administration Shenyang Pharmaceutical UniversityShenyang 110016China Jincheng Tongda&Neal Shenzhen 518000China

Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their *** The literature related to the participants’right to compensation at home and abroad was searched to study the inadequacy of the compensation right for clinical trial participants in China from four aspects:insurance system,principle of attribution,legal relationship and compensation ***,some suggestions to improve the participants’right to compensation were *** and Conclusion China lacks clear legal norms for participants’right to *** are problems such as unclear insurance rules and compensation rules,unclear contractual relationships between parties to clinical trials,and no laws and regulations to rely on for attribution and *** should issue regulatory guidelines related to the right to compensation of participants in clinical trials,so that all parties in clinical trials can have rules to follow if there is the occurrence of injury,which can better protect the rights and interests of the participants.

关键词： clinical trial participant compensation right