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Development of a Ready-to-Use PSMA-11 Kit Formulation and Biological Evaluation of Binding Affinity

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Advances in Molecular Imaging 2024年第2期13卷 7-22页

作者： Maria Renata Valente Brandão Freire Natália Marchesan Bexiga Marco Antonio Stephano João Ezequiel Oliveira Carlos Roberto Jorge soares Ana Cláudia Camargo Miranda Anna Carolina de Alcântara Barbosa Marycel Figols de Barboza Laura Fernanda Garcia Luiz Felipe S. Teixeira Maria Helena Marumo Bellini Natanael Gomes da silva Luiza Mascarenhas Balieiro Joel Mendes Elaine Bortoleti de Araújo Centro de Radiofarmcia Instituto de Pesquisas Energticas e Nucleares (IPEN) Cidade Universitria So Paulo Brasil Departamento de Tecnologia Farmacutica Faculdade de Cincias Farmacuticas (USP) Cidade Universitria So Paulo Brasil Centro de Biotecnologia Instituto de Pesquisas Energticas e Nucleares (IPEN) Cidade Universitria So Paulo Brasil Departamento de Medicina Nuclear do Hospital Israelita Albert Einstein So Paulo/SP Brasil

Introduction: 68Ga-PSMA-11 is considered the gold standard in detection of micro and oligometastases in advanced prostate cancer, being used for therapeutic planning, as well as, potentially, for evaluating response to treatment. The development of ready-to-use lyophilized kit of PSMA-11 adds quality and safety to the routine use of this radiopharmaceutical and represents a pharmacotechnical challenge as it must preserve the integrity and specificity of the ligand. Methods: PSMA-11 kit formulation was proposed, considering radiolabeling parameters and the preservation of the peptide during the lyophilization process, using mannitol as an excipient. Critical temperature characterization studies were carried out using DSC equipment and the freeze-drying process was developed. The direct radiolabeling conditions were evaluated and standardized using 68Ge/68Ga generator eluate from two different manufacturers (ITG and Eckert & Ziegler). The radiochemical purity was evaluated by TLC and HPLC. Biological evaluation was carried out with lyophilized PSMA-11 to demonstrate the integrity of the peptide and preservation of biological activity after the lyophilization process. Results: Based on critical temperature characterization studies, the freeze-drying cycle was designed to reach a freezing temperature of around −40˚C and primary drying at 2˚C. Using 20 mg of mannitol, an intact and elegant lyophilized cake was obtained. PSMA-11 lyophilized kit was directly labeled with 68Ga eluate from 68Ge/68Ga GMP generators (ITG and Eckert & Ziegler) resulting in % RP > 95% at pH 4.0 to 4.5. The results obtained from in vitro and in vivo biological competition studies confirmed the preservation of PSMA-11 affinity for the receptor after lyophilization. Conclusion: A lyophilized formulation (Kit) of PSMA-11 was successfully obtained, which preserved the integrity and biological activity of the peptide and guaranteed radiolabeling efficiency.

关键词： 68Ga-PSMA-11 Prostate-Specific Membrane Antigen (PSMA) Ready-to-Use Kit GMP-Grade Generators Metastatic Prostate Cancer PET Imaging

Bartter's syndrome:clinical findings,genetic causes and therapeutic approach

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World Journal of Pediatrics 2021年第1期17卷 31-39页

作者： Flavia Cristina Carvalho Mrad Sílvia Bouissou Morais soares Luiz Alberto Wanderley de Menezes silva Pedro Versiani dos Anjos Menezes Ana Cristina Simoes-e-silva Interdisciplinary Laboratory of Medical Investigation Faculty of MedicineFederal University of Minas Gerais(UFMG)Av.Alfredo Balena190Room#281Belo HorizonteMG 30130-100Brazil Pediatric Nephrology Unit Faculty of MedicineUFMGBelo HorizonteBrazil

Backgound Bartter's syndrome(BS)is a rare group of salt losing tubulopathies due to the impairment of transport mecha-nisms at the thick ascending limb of the Henle's *** sources Literature reviews and original research articles were collected from database,including PubMed and *** According to the time of onset and symptoms,BS can be classified into antenatal and classic *** studies have identified different subtypes of *** types Ⅰ,Ⅱ and Ⅲ are caused by mutations on genes encoding the luminal Na^(+)-K^(+)-2Cl^(-) co-transporter,the luminal K+ channel ROMK,and the basolateral chloride channel ClC-Kb(CLCNKB),***-of-function mutations of Barttin CLCNK type accessory beta subunit cause BS type Ⅳ*** mutations of CLCNKB and CLCNKA cause BS type Ⅳ*** type Ⅴ consists in a novel transient form characterized by antenatal presentation due to mutations in the MAGE family member *** gain-of-function mutations of the extracellular calcium sensing receptor gene can result in an autosomal dominant condition of *** clinical and biochemical alterations in BS include polyuria,dehydration,hypokalemia,hypochloremic metabolic alka-losis,hyperreninemia,high levels of prostaglandins,normal or low blood pressure,hypercalciuria and failure to *** focuses mainly at correcting dehydration and electrolyte disturbances and in measures to reduce polyuria,including the use of nonsteroidal anti-inflammatory medications to control excessive renal prostaglandin E2 *** Early diagnosis and treatment of BS may prevent long-term consequences such as growth failure,nephrocal-cinosis and end-stage renal disease.

关键词： Bartter's syndrome Hypercalciuria Hypokalemia Metabolic alkalosis Nephrocalcinosis

Effectiveness and safety of opicapone in Parkinson’s disease patients with motor fluctuations: the OPTIPARK open-label study

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Translational Neurodegeneration 2020年第1期9卷 96-104页

作者： Heinz Reichmann Andrew Lees José-Francisco Rocha Diogo Magalhaes Patrício soares-da-silva the OPTIPARK investigators Department of Neurology University of DresdenDresdenGermany University College London Reta Lila Weston InstituteLondonUK Global Parkinson’s Disease Department BIAL–Portela&CA S.ACoronadoPortugal Research and Development Department BIAL–Portela&CA S.Ada Siderurgia Nacional4745-457 S Mamede do CoronadoPortugal Department of Pharmacology and Therapeutics Faculty of MedicineUniversity PortoPortoPortugal MedInUP Center for Drug Discovery and Innovative MedicinesUniversity PortoPortoPortugal 不详

Background:The efficacy and safety of opicapone,a once-daily catechol-O-methyltransferase inhibitor,have been established in two large randomized,placebo-controlled,multinational pivotal ***,clinical evidence from routine practice is needed to complement the data from the pivotal ***:OPTIPARK(NCT02847442)was a prospective,open-label,single-arm trial conducted in Germany and the UK under clinical practice *** with Parkinson’s disease and motor fluctuations were treated with opicapone 50 mg for 3(Germany)or 6(UK)months in addition to their current levodopa and other antiparkinsonian *** primary endpoint was the Clinician’s Global Impression of Change(CGI-C)after 3 *** assessments included Patient Global Impressions of Change(PGI-C),the Unified Parkinson’s Disease Rating Scale(UPDRS),Parkinson’s Disease Questionnaire(PDQ-8),and the Non-Motor Symptoms Scale(NMSS).Safety assessments included evaluation of treatment-emergent adverse events(TEAEs)and serious adverse events(SAEs).Results:Of the 506 patients enrolled,495(97.8%)took at least one dose of *** these,393(79.4%)patients completed 3 months of ***,71.3 and 76.9%of patients experienced any improvement on CGI-C and PGI-C after 3 months,respectively(full analysis set).At 6 months,for UK subgroup only(n=95),85.3%of patients were judged by investigators as improved since commencing *** scores at 3 months showed statistically significant improvements in activities of daily living during OFF(mean±SD change from baseline:?3.0±4.6,p<0.0001)and motor scores during ON(?4.6±8.1,p<0.0001).The mean±SD improvements of?3.4±12.8 points for PDQ-8 and-6.8±19.7 points for NMSS were statistically significant versus baseline(both p<0.0001).Most of TEAEs(94.8%of events)were of mild or moderate *** considered to be at least possibly related to opicapone were reported for 45.1%of patients,with dyskinesia(11.5%)and dry mouth(6.5%)being

关键词： Levodopa Motor fluctuations Open-label Opicapone Parkinson’s disease

Liquefaction of Kraft Lignin at Atmospheric Pressure

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Journal of Renewable Materials 2019年第6期7卷 527-534页

作者： Silvia Helena Fuentes da silva Patricia soares Bilhalva dos Santos Darci Alberto Gatto Maria Angeles Andres Itziar Egüés Chemical and Environmental Engineering Department University of Basque CountryPlaza Europa 120018Donostia-San SebastiánSpain Faculty of Forestry Engineering Federal University of ParáC.JoséPorfirio2515AltamiraBrazil College of Material Engineering(PPGCEM) Federal University of PelotasBrazil

Kraft lignin was liquefied using polyethylene glycol#400(PEG)and glycerol(G)in a weight ratio of 80/20(w/w)and sulphuric acid(SA)as catalyst under atmospheric pressure at 160º*** three independent variables:reaction time(60,80 and 100 min),percentage of lignin(15,20 and 25%,w/w),and catalyst concentration(0,3 and 6%,w/w),were varied resulting in 27 experimental *** effect of these reaction conditions on the properties of the polyols was *** statistical analysis showed that only“the percentage of lignin”did not influence the properties of the liquefied products,however,reaction time and catalyst load were important *** resulting liquefied products were characterized by FTIR analysis.

关键词： Biopolyols Kraft lignin liquefaction renewable resource thermochemical conversion

Entropy model to assess sediment resuspension probability and trap efficiency of small dams

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International Journal of Sediment Research 2022年第5期37卷 675-686页

作者： Francisco Jairo soares Pereira Antonio Viana da silva Filho José Wellington Batista Lopes José Carlos de Araújo Department of Agricultural Engineering Federal University of Ceará Campus Do Pici Rural Federal University of Pernambuco Federal University of Piauí

In the Brazilian drylands, there are tens of thousands of small dams. Despite their paramount importance to the rural population, they are rarely monitored. Water demand increases with time while, simultaneously, siltation reduces reservoir water capacity and availability. Reservoir siltation models are, therefore, mandatory to manage the numerous ungauged small dams in these *** objective of the current study is to improve sediment trap efficiency(TE) modeling by including resuspension as a key probabilistic process. The Shannon entropy was used to estimate the sediment resuspension probability, which was merged with the Camp model and generated the RETSED entropy model. To validate the RETSED model, an experimental check dam(ECD, 300 m3), located in the Gilbu es desertification site, Brazil, was monitored hourly during one hydrological year(July 2018-July 2019). Measurements show that the annual volumetric decline of the check dam was 12%; and that the average trap efficiency equaled 86%. Only 9.5% of the hourly sediment concentration outflow exceeded the average plus one standard deviation, showing that the reservoir is well mixed; a fact which highlights the relevance of the resuspension process. Three empirical models failed to mimic the experimental results: Churchill(TE = 99%), Brune(TE = 75%), and Maryland(TE = 94%). According to the RETSED entropy model, the resuspension probability during the experiment was 10%and TE = 81%, a value only 6% below the measured one. The Camp model simulated TE = 89%, only 3%higher than the measured value, but confirmed the Camp model’s tendency to overestimate TE due to a disregard of resuspension. The deterministic model showed low sensitivity concerning the hydrodynamic effects, whereas the entropy formulation proved to be more consistent with physical behavior: the resuspension probability clearly increased and trap efficiency decreased with rising reservoir discharge.

关键词： Erosion Check dam Sedimentation Ungauged basins Camp model

Radiographic and tomographic description of marlin sucker Remora osteochir, Pisces: Echeneidae—preliminary data of one specimen

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Marine Life Science & Technology 2020年第3期2卷 246-251页

作者： AndréLuiz Veiga Conrado Renata Stecca lunes Carlos Eduardo Malavasi Bruno aline Tiemi Shiraishi Rocha JoséRoberto Machado Cunha da silva Laboratory of Evolutive Histophysiology Department of Cell and Developmental BiologyInstitute of Biomedical SciencesUniversity of Sao PauloAvenida ProfLineu Prestes1524Cidade UniversitariaSao Paulo 05508-000Brazil Laboratory of Immunological Techniques Applied to Morphophysiology School of Veterinary Medicine and Animal ScienceDepartment of SurgeryUniversity of Sao PauloAvenida Prof.Di.Orlando Marques de Paiva87.Cidade UniversitariaSao Paulo 05508-270Brazil

Remoras are commensal fish of various marine species,such as sharks,swordfishes,turtles,dolphins,manta rays and *** specimen of marlin sucker Remora osteochir was evaluated using computed tomography for skeletal digital reconstruction,digital radiology for general evaluation and bone counting,and the double contrast technique to distinguish coelomic *** radiographic images,it was possible to observe otoliths in the center of the neurocranium,to count 27 vertebrae,nine pairs of ribs,and to detect the presence of the hipural and epural bones near of the caudal *** double contrast images,it was possible to visualize the swim bladder,gills,heart,liver,stomach and *** the tomographic images and reconstructions,it was possible to identify the intercalar bones of the cephalic disc;the spine with vertebral bodies composed of neural arches and ventral ribs;and the pectoral girdle formed by posttemporal,cleithrum and scapulocoracoid *** was concluded that digital radiology and computed tomography were able to describe anatomical structures of marlin sucker *** without the need for dissection.

关键词： Teleost fish Double contrast Computed tomography Digital radiology Skeleton

Chemical profile and antimicrobial activity of Secondatia floribunda A. DC(Apocynaceae)

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Asian Pacific Journal of Tropical Biomedicine 2017年第8期7卷 739-749页

作者： Daiany Alves Ribeiro Sarah soares Damasceno aline Augusti Boligon Irwin Rose Alencar de Menezes Marta Maria de Almeida Souza JoséGalberto Martins da Costa Programa de Pós-Graduacao em Etnobiologia e Conservacao da Natureza Universidade Regional do Cariri Departamento de Química Biológica Laboratório de Pesquisas de Produtos NaturaisUniversidade Regional do Cariri Laboratório de Fitoquímica Universidade Federal de Santa Maria Departamento de Química Biológica Laboratório de Farmacologia e Química MolecularUniversidade Regional do Cariri Departamento de Ciências Biológicas Laboratório de Ecologia VegetalUniversidade Regional do Cariri

To establish the chemical profile, and to evaluate the antibacterial and modulatory activity of the ethanolic extracts of the stalk’s inner bark and heartwood of Secondatia *** of total phenols and flavonoids was determined by the Folin-Ciocalteu method and aluminum chloride, respectively. Phenolic compounds were identified and quantified by HPLC-DAD (High Performance Liquid Chromatography-Diodearray Detector) and the Infrared Spectroscopy was performed using the measure by Attenuated Total Reflectance with Fourier Transform (ATR-FTIR). Antibacterial assays for determination of the Minimum Inhibitory Concentration (MIC) and modification of aminoglycosides were performed by *** spectra showed similar characteristics, having among its main absorption bands hydroxyl group (OH). The antibacterial activity showed clinically significant results for the strains of Staphylococcus aureus and Escherichia coli. In modulation assay, synergic and antagonistic effect for both extracts was observed. Heartwood extract in combination with antibiotics showed a significant MIC reduction at 19.8% (P < 0.000 1)-79.3% (P < 0.01).ConclusionsThis study is the first report of chemical and biological information of Secondatia floribunda suggesting that it is clinically relevant source of a new antibacterial therapy, especially due to the presence of significant levels of phenolic compounds.

关键词： Chemical composition HPLC Cinchonain Natural product Modification resistance

Peroxisome proliferator-activated receptors as targets to treat metabolic diseases:Focus on the adipose tissue,liver,and pancreas

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World Journal of Gastroenterology 2023年第26期29卷 4136-4155页

作者： Henrique Souza-Tavares Carolline Santos Miranda Isabela Macedo Lopes Vasques-Monteiro Cristian Sandoval Daiana Araujo Santana-Oliveira Flavia Maria silva-Veiga aline Fernandes-da-silva Vanessa Souza-Mello Department of Anatomy Rio de Janeiro State UniversityRio de Janeiro 20551030Brazil Escuela de Tecnología Médica Facultad de SaludUniversidad Santo TomásOsorno 5310431Chile Departamento de Ciencias Preclínicas Universidad de la FronteraTemuco 4780000Chile

The world is experiencing reflections of the intersection of two pandemics:Obesity and coronavirus disease *** prevalence of obesity has tripled since 1975 worldwide,representing substantial public health costs due to its *** adipose tissue is the initial site of obesity *** excessive energy intake,it undergoes hyperplasia and hypertrophy until overt inflammation and insulin resistance turn adipocytes into dysfunctional cells that send lipotoxic signals to other *** pancreas is one of the organs most affected by *** lipotoxicity becomes chronic,there is an increase in insulin secretion by pancreatic beta cells,a surrogate for type 2 diabetes mellitus(T2DM).These alterations threaten the survival of the pancreatic islets,which tend to become dysfunctional,reaching exhaustion in the long *** for the liver,lipotoxicity favors lipogenesis and impairs beta-oxidation,resulting in hepatic *** silent disease affects around 30%of the worldwide population and can evolve into end-stage liver *** therapy for hepatic steatosis remains to be defined,peroxisome proliferator-activated receptors(PPARs)activation copes with T2DM *** PPARs are transcription factors found at the intersection of several metabolic pathways,leading to insulin resistance relief,improved thermogenesis,and expressive hepatic steatosis mitigation by increasing mitochondrial *** review aimed to update the potential of PPAR agonists as targets to treat metabolic diseases,focusing on adipose tissue plasticity and hepatic and pancreatic remodeling.

关键词： Obesity Insulin resistance Peroxisome proliferator-activated receptors Pancreas Hepatic steatosis Adipose tissue

Acaricidal activity of Derris floribunda essential oil and its main constituent

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Asian Pacific Journal of Tropical Biomedicine 2017年第9期7卷 791-796页

作者： Ana Claudia Fernandes Amaral aline de SRamos Marcia Reis Pena Jose Luiz Pinto Ferreira Jean Michel SMenezes Geraldo JNVasconcelos Neliton Marques da silva Jefferson Rocha de Andrade silva Lab de Plantas Medicinais e Derivados Depto de Quimica de Produtos NaturaisFarmanguinhosFundacao Oswaldo CruzRio de JaneiroRJBrazil Lab de Entomologia e Acarologia Agricola Faculdade de Ciencias AgrariasUniversidade Federal do AmazonasManausAMBrazil Lab de Cromatografia Depto de QuímicaUniversidade Federal do AmazonasManausAMBrazil 4Instituto de Ciencias Exatas e TecnologiaUniversidade Federal do AmazonasItacoatiaraAMBrazil

Objective: To evaluate the acaricidal activity of the essential oil obtained from roots of Derris floribunda(D. floribunda)(Miq.) Benth, and its main constituent nerolidol against the Mexican mite Tetranychus mexicanus(T. mexicanus)(Mc Gregor).Methods: The essential oil from the roots of D. floribunda collected in the Amazon region(Brazil) was obtained by hydrodistillation. Its chemical composition was determined by GC–MS analysis. The acaricidal activities of this essential oil and nerolidol,were evaluated by recording the number of dead females(mortality) and eggs(fertility).Results: The essential oil showed sesquiterpenes as major volatile components. Nerolidol, the main component, represented 68.5% of the total composition of the essential oil. D. floribunda essential oil and nerolidol showed acaricidal activity, with LC_(50) of9.61 mg/m L air and 9.2 mg/m L air, respectively, over a 72 h period. In addition, both the essential oil and nerolidol significantly reduced the fecundity of T. ***: Due to the economic importance of T. mexicanus and the lack of new pesticides, our data are very promising in the search for efficient and safer acaricidal products. Furthermore, this is the first report about the chemical composition and bioactivity of the essential oil of the Amazon plant species D. floribunda.

关键词： Acaricidal activity Essential oil Nerolidol Organic agriculture Sesquiterpenes Timb