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[PMID]:29273907
[Au] Autor:Ghiasvand AR; Nouriasl K; Yazdankhah F
[Ad] Endereço:Department of Chemistry, Lorestan University, Khoramabad, Lorestan Province, 6713817133, Iran. a_ghiasvand@yahoo.com.
[Ti] Título:Comparison of the atmospheric- and reduced-pressure HS-SPME strategies for analysis of residual solvents in commercial antibiotics using a steel fiber coated with a multiwalled carbon nanotube/polyaniline nanocomposite.
[So] Source:Anal Bioanal Chem;410(2):361-371, 2018 Jan.
[Is] ISSN:1618-2650
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:A low-cost, sensitive and reliable reduced-pressure headspace solid-phase microextraction (HS-SPME) setup was developed and evaluated for direct extraction of residual solvents in commercial antibiotics, followed by determination by gas chromatography with flame ionization detection (GC-FID). A stainless steel narrow wire was made porous and adhesive by platinization by a modified electrophoretic deposition method and coated with a polyaniline/multiwalled carbon nanotube nanocomposite. All experimental variables affecting the extraction efficiency were investigated for both atmospheric-pressure and reduced-pressure conditions. Comparison of the optimal experimental conditions and the results demonstrated that the reduced-pressure strategy leads to a remarkable increase in the extraction efficiency and reduction of the extraction time and temperature (10 min, 25 °Ï¹ vs 20 min, 40 °Ï¹). Additionally, the reduced-pressure strategy showed better analytical performances compared with those obtained by the conventional HS-SPME-GC-FID method. Limit of detections, linear dynamic ranges, and relative standard deviations of the reduced-pressure HS-SPME procedure for benzene, toluene, ethylbenzene, and xylene (BTEX) in injectable solid drugs were obtained over the ranges of 20-100 pg g , 0.02-40 µg g , and 2.8-10.2%, respectively. The procedure developed was successful for the analysis of BTEX in commercial containers of penicillin, ampicillin, ceftriaxone, and cefazolin. Graphical abstract Schematic representation of the developed RP-HS-SPME setup.
[Mh] Termos MeSH primário: Compostos de Anilina/química
Antibacterianos/análise
Nanocompostos/química
Nanotubos de Carbono/química
Microextração em Fase Sólida/instrumentação
Solventes/análise
Xilenos/análise
[Mh] Termos MeSH secundário: Pressão Atmosférica
Contaminação de Medicamentos
Desenho de Equipamento
Nanocompostos/ultraestrutura
Nanotubos de Carbono/ultraestrutura
Solventes/isolamento & purificação
Aço/química
Xilenos/isolamento & purificação
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Aniline Compounds); 0 (Anti-Bacterial Agents); 0 (Nanotubes, Carbon); 0 (Solvents); 0 (Xylenes); 0 (polyaniline); 12597-69-2 (Steel)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171224
[St] Status:MEDLINE
[do] DOI:10.1007/s00216-017-0726-7


  2 / 9738 MEDLINE  
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[PMID]:28470986
[Au] Autor:Wang L; Wang Y; Chai Y; Kang Y; Sun C; Zeng S
[Ad] Endereço:Institute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, 310058, China.
[Ti] Título:Nickel(II)-assisted enantiomeric differentiation and quantitation of tadalafil by direct electrospray ionization mass spectrometry.
[So] Source:J Mass Spectrom;52(7):411-416, 2017 Jul.
[Is] ISSN:1096-9888
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:A facile method based on electrospray mass spectrometry was established and validated for the differentiation of enantiomeric tadalafil isomers without using chiral chromatographic separation. The enantiomers were coupled with a chiral selector to form diastereomeric complex ions. Nickel-tadalafil complexes, [Ni (tadalafil)(l-Trp)-H] , produced a characteristic fragment ion at m/z 524 by loss of 1-methyl-1,6-dihydropyrazine-2,5-dione via collision-induced dissociation. The relative abundance of this fragment ion to the precursor contributed to differentiate tadalafil enantiomers, and energy-resolved product-ion spectra were applied to determine the molar composition of tadalafil in the mixture (R,R and S,S) as well. In addition, the other two forms of stereomeric isomers of tadalafil (R,S and S,R) could be also distinguished and analyzed by this method. The method was validated in different types of mass spectrometers (AB quadrupole time-of-flight and Bruker ion trap) and also verified by a chiral high-performance liquid chromatography coupled with quadrupole time-of-flight. The chiral determination of tadalafil using MS method proved to be rapid (1-min run time for each sample) and to have the same accuracy and precision comparable to chiral liquid chromatography mass spectrometry methods. This method provides an alternative to commonly used chromatographic technique for chiral determination and is particularly useful in rapid screening in enantioselective synthesis and enantiomeric impurity detection in pharmaceutical industry. Copyright © 2017 John Wiley & Sons, Ltd.
[Mh] Termos MeSH primário: Complexos de Coordenação/análise
Níquel/química
Inibidores da Fosfodiesterase 5/análise
Tadalafila/análise
[Mh] Termos MeSH secundário: Cromatografia Líquida de Alta Pressão/métodos
Complexos de Coordenação/química
Contaminação de Medicamentos
Conformação Molecular
Inibidores da Fosfodiesterase 5/química
Espectrometria de Massas por Ionização por Electrospray/métodos
Estereoisomerismo
Tadalafila/química
[Pt] Tipo de publicação:JOURNAL ARTICLE; VALIDATION STUDIES
[Nm] Nome de substância:
0 (Coordination Complexes); 0 (Phosphodiesterase 5 Inhibitors); 742SXX0ICT (Tadalafil); 7OV03QG267 (Nickel)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170505
[St] Status:MEDLINE
[do] DOI:10.1002/jms.3939


  3 / 9738 MEDLINE  
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[PMID]:29390396
[Au] Autor:Eguchi H; Hotta F; Kuwahara T; Nakayama-Imaohji H; Kusaka S; Shimomura Y
[Ad] Endereço:Department of Ophthalmology, Kindai University Sakai Hospital, Harayamadai, Minami-ku, Sakai, Osaka, Japan.
[Ti] Título:Acute keratoconjunctivitis due to contamination of contact lens care solution with histamine-producing Raoultella species: A case report.
[So] Source:Medicine (Baltimore);96(50):e9310, 2017 Dec.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Contact lens storage cases are known to be contaminated by a significant number of bacteria. However, histamine-producing Raoultella species has not been reported to contaminate contact lens storage case. PATIENT CONCERNS: A 27-year-old woman with keratoconjunctivitis that developed in the left eye owing to a cosmetic contact lens and poor hygiene was referred to our hospital. The corrected visual acuity was hand motion. DIAGNOSES: Corneal infection other than Acanthamoeba keratitis (AK) and corneal hypoxia were excluded. INTERVENTIONS: We initiated empirical therapy for AK, although no cysts or trophozoites were detected in the cornea and in the lens care solution. Analysis of 16S rDNA sequences from the lens care solution yielded the highest homology with Raoultella species, which are histamine-producing bacteria. Histamine was estimated to be 492 ng/mL in the lens care solution. OUTCOMES: Her clinical course was distinct from that of usual AK cases. The corrected visual acuity increased up to (1.2) only 5 days after initiating empirical therapy. LESSONS: To our knowledge, this is the first report to indicate an association between histamine-producing bacteria and keratoconjunctivitis. We should pay an attention to the microbial contamination of contact lens storage cases by histamine producing bacteria.
[Mh] Termos MeSH primário: Soluções para Lentes de Contato
Contaminação de Medicamentos
Infecções por Enterobacteriaceae/microbiologia
Enterobacteriaceae/isolamento & purificação
Ceratoconjuntivite/microbiologia
[Mh] Termos MeSH secundário: Adulto
Diagnóstico Diferencial
Feminino
Seres Humanos
Acuidade Visual
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Contact Lens Solutions)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180203
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000009310


  4 / 9738 MEDLINE  
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[PMID]:28834048
[Au] Autor:Hill DA; Leahy AB; Sciasci J; O'Neill SP; Reilly A; Balamuth N; Seeholzer SH; Spergel JM; Brown-Whitehorn TF
[Ad] Endereço:Department of Pediatrics, Division of Allergy and Immunology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
[Ti] Título:Medication contaminants as a potential cause of anaphylaxis to vincristine.
[So] Source:Pediatr Blood Cancer;65(1), 2018 Jan.
[Is] ISSN:1545-5017
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Vincristine (VCR) is a vinca alkaloid and common chemotherapeutic that is used to treat multiple pediatric and adult malignancies. Despite its common use, cases of anaphylaxis to VCR are rare and typically isolated to a single individual. We report a series of eight patients with adverse reactions to VCR over the course of 11 months at a single institution, four of which progressed to anaphylaxis and one of which resulted in cardiac arrest. Mass spectrometry analysis of medication lots was performed to test for possible contaminant(s). Our findings highlight the risk of anaphylaxis during therapy with VCR.
[Mh] Termos MeSH primário: Anafilaxia
Contaminação de Medicamentos
Neoplasias/tratamento farmacológico
Vincristina/administração & dosagem
Vincristina/efeitos adversos
[Mh] Termos MeSH secundário: Adolescente
Anafilaxia/induzido quimicamente
Anafilaxia/mortalidade
Criança
Pré-Escolar
Feminino
Seres Humanos
Lactente
Masculino
Espectrometria de Massas
Fatores de Risco
Vincristina/análise
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
5J49Q6B70F (Vincristine)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170824
[St] Status:MEDLINE
[do] DOI:10.1002/pbc.26761


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[PMID]:29216617
[Au] Autor:Akers MJ
[Ad] Endereço:Baxter BioPharma Solutions, Bloomington, Indiana. mjakers356@gmail.com.
[Ti] Título:Basics of Sterile Compounding: Particulate Matter.
[So] Source:Int J Pharm Compd;21(5):395-404, 2017 Sep-Oct.
[Is] ISSN:1092-4221
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:This article focuses on the requirements for particulate matter in sterile products. Topics include particles and quality, particulate matter standards (large- and small-volume injectables), development of the small-volume injectable test, electronic (light obscuration) and microscope testing, and special requirements for particulate matter in biopharmaceutical preparations.
[Mh] Termos MeSH primário: Composição de Medicamentos
Material Particulado/análise
Esterilização
[Mh] Termos MeSH secundário: Contaminação de Medicamentos
Rotulagem de Medicamentos
Injeções
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Particulate Matter)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180220
[Lr] Data última revisão:
180220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171208
[St] Status:MEDLINE


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[PMID]:29361661
[Au] Autor:White RS; Thomson Reuters Accelus.
[Ti] Título:Pharmaceuticals and Medical Devices: FDA Oversight.
[So] Source:Issue Brief Health Policy Track Serv;2017:1-43, 2017 Dec 26.
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Aprovação de Drogas/organização & administração
Legislação de Medicamentos
United States Food and Drug Administration
[Mh] Termos MeSH secundário: Sistemas de Notificação de Reações Adversas a Medicamentos
Contaminação de Medicamentos
Rotulagem de Medicamentos
Drogas em Investigação
Farmacoeconomia
Sistemas Eletrônicos de Liberação de Nicotina
Terapia Genética
Regulamentação Governamental
Seres Humanos
Disponibilidade de Medicamentos Via Internet
Medicamentos sob Prescrição/efeitos adversos
Medicamentos sob Prescrição/economia
Medicamentos sob Prescrição/uso terapêutico
Regeneração
Produtos do Tabaco/legislação & jurisprudência
Estados Unidos
United States Food and Drug Administration/legislação & jurisprudência
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drugs, Investigational); 0 (Prescription Drugs)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180219
[Lr] Data última revisão:
180219
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180124
[St] Status:MEDLINE


  7 / 9738 MEDLINE  
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[PMID]:29223061
[Au] Autor:Wahl O; Cleynhens J; Verbruggen AM; Holzgrabe U
[Ad] Endereço:University of Würzburg, Institute for Pharmacy and Food Chemistry, 97074 Würzburg, Germany.
[Ti] Título:Impurity profiling of N,N'-ethylenebis-l-cysteine diethyl ester (Bicisate).
[So] Source:J Pharm Biomed Anal;150:132-136, 2018 Feb 20.
[Is] ISSN:1873-264X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:A HPLC-UV-CAD method with a HILIC column for impurity profiling of the 99mTc chelating agent bicisate has been developed and evaluated. Bicisate and its impurities were separated by means of isocratic elution on a zwitterionic stationary phase using a mixture of 7.5mmol/L trifluoroacetic acid and acetonitrile (47.5:52.5 V/V) as the mobile phase. Five different bicisate batches of a manufacturer were tested using the method. In addition LC-MS experiments were conducted in order to identify the impurities. The predominant impurities found were the oxidation product (disulfide), the monoester of ethylene dicysteine and an unknown compound with an m/z of 293 in ESI positive mode. A new degradation product of bicisate, bicisate lactam, was identified during sample solution stability assessment.
[Mh] Termos MeSH primário: Cromatografia Líquida de Alta Pressão/métodos
Cisteína/análogos & derivados
Contaminação de Medicamentos
Compostos de Organotecnécio/análise
Compostos Radiofarmacêuticos/análise
[Mh] Termos MeSH secundário: Cromatografia Líquida/métodos
Cisteína/análise
Cisteína/normas
Espectrometria de Massas/métodos
Compostos de Organotecnécio/normas
Compostos Radiofarmacêuticos/normas
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Organotechnetium Compounds); 0 (Radiopharmaceuticals); H25WJA31XE (technetium Tc 99m bicisate); K848JZ4886 (Cysteine)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180130
[Lr] Data última revisão:
180130
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171210
[St] Status:MEDLINE


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[PMID]:28448888
[Au] Autor:Zhao L; Wang Q; Bie Y; Lu X
[Ad] Endereço:Chengdu Institute of Biology, Chinese Academy of Sciences, Chengdu 610041, China.
[Ti] Título:Isolation, identification and characterization of potential impurities of anidulafungin.
[So] Source:J Pharm Biomed Anal;141:192-199, 2017 Jul 15.
[Is] ISSN:1873-264X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Eight impurities ranging from 0.03 to 0.97% in anidulafungin bulk drug were detected by HPLC. Four impurities (Imp-I, Imp-II, Imp-III and Imp-VIII) among impurities were isolated from the self-prepared or marketed samples of anidulafungin bulk drug by means of preparative HPLC. A thorough study was undertaken to characterize these impurities and based on 1D ( H, C, H-D, DEPT 90 and 135) and 2D (COSY, TOCSY, HSQC, HMBC) NMR and ESI-MS spectral data. Based on the characterization data, Imp-I was found to be known open-chain hydrolysis product formed during the synthesis and degradation. Imp-II and Imp-III was lacked a methyl group at the C-4 and C-8 in anidulafungin, respectively, whereas Imp-VIII contained a methoxy group at the C-23. The latter three new impurities were identified as process-related substances.
[Mh] Termos MeSH primário: Equinocandinas/análise
[Mh] Termos MeSH secundário: Cromatografia Líquida de Alta Pressão
Contaminação de Medicamentos
Espectroscopia de Ressonância Magnética
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Echinocandins); 9HLM53094I (anidulafungin)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180125
[Lr] Data última revisão:
180125
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170428
[St] Status:MEDLINE


  9 / 9738 MEDLINE  
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[PMID]:29281577
[Au] Autor:Woodcock J; Dohm J
[Ad] Endereço:From the Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
[Ti] Título:Toward Better-Quality Compounded Drugs - An Update from the FDA.
[So] Source:N Engl J Med;377(26):2509-2512, 2017 12 28.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Composição de Medicamentos/normas
Contaminação de Medicamentos/legislação & jurisprudência
Legislação de Medicamentos
United States Food and Drug Administration
[Mh] Termos MeSH secundário: Contaminação de Medicamentos/prevenção & controle
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Regulamentação Governamental
Seres Humanos
Meningite Fúngica/epidemiologia
Meningite Fúngica/etiologia
Assistência Farmacêutica
Estados Unidos/epidemiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180115
[Lr] Data última revisão:
180115
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171228
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMp1712905


  10 / 9738 MEDLINE  
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[PMID]:28454189
[Au] Autor:Pawar RS; Handy SM; Cheng R; Shyong N; Grundel E
[Ad] Endereço:Office of Regulatory Science, Center for Food Safety and Applied Nutrition, U. S. Food and Drug Administration, College Park, MD, USA.
[Ti] Título:Assessment of the Authenticity of Herbal Dietary Supplements: Comparison of Chemical and DNA Barcoding Methods.
[So] Source:Planta Med;83(11):921-936, 2017 Jul.
[Is] ISSN:1439-0221
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:About 7 % of the U. S. population reports using botanical dietary supplements. Increased use of such supplements has led to discussions related to their authenticity and quality. Reports of adulteration with substandard materials or pharmaceuticals are of concern because such substitutions, whether inadvertent or deliberate, may reduce the efficacy of specific botanicals or lead to adverse events. Methods for verifying the identity of botanicals include macroscopic and microscopic examinations, chemical analysis, and DNA-based methods including DNA barcoding. Macroscopic and microscopic examinations may fail when a supplement consists of botanicals that have been processed beyond the ability to provide morphological characterizations. Chemical analysis of specific marker compounds encounters problems when these compounds are not distinct to a given species or when purified reference standards are not available. Recent investigations describing DNA barcoding analysis of botanical dietary supplements have raised concerns about the authenticity of the supplements themselves as well as the appropriateness of using DNA barcoding techniques with finished botanical products. We collected 112 market samples of frequently consumed botanical dietary supplements of ginkgo, soy, valerian, yohimbe, and St. John's wort and analyzed each for specific chemical markers (i.e., flavonol glycosides, total isoflavones, total valerenic acids, yohimbine, and hypericins, respectively). We used traditional DNA barcoding techniques targeting the nuclear ITS2 gene and the chloroplast gene A- H on the same samples to determine the presence of DNA of the labelled ingredient. We compared the results obtained by both methods to assess the contribution of each in determining the identity of the samples.
[Mh] Termos MeSH primário: Biomarcadores/análise
Código de Barras de DNA Taxonômico
Suplementos Nutricionais/análise
Plantas Medicinais/química
[Mh] Termos MeSH secundário: DNA de Plantas
Suplementos Nutricionais/normas
Contaminação de Medicamentos
Rotulagem de Medicamentos
Genes de Cloroplastos
Genes de Plantas
Plantas Medicinais/classificação
Controle de Qualidade
[Pt] Tipo de publicação:COMPARATIVE STUDY; EVALUATION STUDIES; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biomarkers); 0 (DNA, Plant)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:171205
[Lr] Data última revisão:
171205
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.1055/s-0043-107881



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