Departamento: Departamento de Fármacos e Medicamentos
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Faculdade de Ciências Farmacêuticas
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Campus: Araraquara
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PublicaçãoArtigo 
Acesso Aberto Controle de qualidade e obtenção de extratos de espécies vegetais do cerrado brasileiro com potencial etnofarmacológico(2013) Cardoso, Cássia Regina Primila ; Salgado, Hérida Regina Nunes
; Vilegas, Wagner ; Universidade Federal do Mato Grosso (UFMT) ; Universidade Estadual Paulista (Unesp) ANVISA (National Health Surveillance Agency) has published in recent years, laws that regulate the stages of the control of plants derivatives, including tests of macro and microscopic botanical identification, phytochemical determination, tests of authenticity and purity, microbiological testing, among other parameters. All the analytical procedures of plant drugs control required by law must be based on the Brazilian Pharmacopoeia, other Pharmacopoeias recognized by ANVISA or quality control guides of plant species published by the World Health Organization (WHO). This study aimed to evaluate some pharmacognostic, phytochemical screening and microbiological control of plant species of the Brazilian cerrado, which have indicated ethnopharmacological: Byrsonima intermedia (Bi), Bauhinia holophylla (Bh) and Myrcia bella (Mb). In addition, certain parameters were determined for obtaining extracts from plants sprayed and dried. These data are important to obtain new scientific information from Brazilian plants with therapeutic potential.PublicaçãoArtigo Methods for qualitative analysis of cefazolin sodium raw material and pharmaceutical product(Scientific and Academic Publishing, 2013) Pedroso, Tahisa Marcela; Salgado, Hérida Regina Nunes ; Universidade Estadual Paulista (Unesp) In this work we studied qualitative methods for analysis and identification of cefazolin sodium, β-lactam antimicrobial for parenteral use, belonging to the group of first-generation cephalosporin, used as a therapeutic agent and for the surgical prophylaxis, in the pharmaceutical form of powder lyophilized for injectable solution. Qualitative analysis was performed by solubility, melting point, pH determination, thin layer chromatography, ultraviolet spectroscopy, infrared spectroscopy and high performance liquid chromatography, allowing the identification of sample. These methods were reproducible and quick to identify cefazolin sodium, which can be used routinely in analysis of quality control in pharmaceutical laboratories.PublicaçãoArtigo Development of an innovative, ecological and stability-indicating analytical method for semiquantitative analysis of ampicillin sodium for injection by thin layer chromatography (TLC)(2014) Tótoli, Eliane Gandolpho; Salgado, Hérida Regina Nunes ; Universidade Estadual Paulista (Unesp) Ampicillin sodium is a β-lactam antimicrobial agent for parenteral use, widely used in many parts of the world and recommended by the World Health Organization. There are some methods described in the literature to identify ampicillin sodium employing Thin-Layer Chromatography (TLC). However, these methods are complex and require the use of solvents potentially toxic to the operators and environment. This paper describes the validation of an innovative semiquantitative method for the analysis of ampicillin sodium in powder for injectable solution, using TLC. This technique does not use toxic or expensive solvents, which is one great advantage over the described TLC analytical methods. This fact contributes to minimize the generation of toxic organic solvent waste by the industry and thereby reduces the impact of its activities on the environment. The method involved the use of a mobile phase comprised by a mixture of ethanol and water (90:10, v/v) and the stationary phase was silica gel impregnated in aluminum. Stress degradation studies of the pharmaceutical product were conducted under conditions of hydrolysis (acid, basic, and aqueous), oxidation and photolysis. The spots were detected by exposing the dry plate to UV chamber (254 nm) and/or iodine vapor and analyzed semiquantitatively by HPLC-UV. The method was successfully validated according to the ICH guidelines and Brazilian legislation, showing to be able to semiquantify ampicillin sodium in powder for injection preparation and it can be used as an environmentally friendly alternative for the routine analysis in quality control.PublicaçãoArtigo Acesso Aberto Desenvolvimento de metodologia qualitativa para identificação de ceftazidima(Universidade Estadual Paulista (Unesp), 2010-11-27) Moreno, ANDREIA HARO; Salgado, Hérida Regina Nunes ; Universidade Estadual Paulista (Unesp) A partir deste estudo, métodos para análise qualitativa foram desenvolvidos a fim de identificar ceftazidima em matéria-prima e em formulações farmacêuticas. Esses métodos incluíram testes físico-químicos baseados em propriedades químicas por reações clássicas de coloração e testes instrumentais, tais como cromatografia em camada delgada, calorimetria e espectroscopia no ultravioleta. Os resultados foram obtidos diretamente através de identificação visual pela coloração desenvolvida e pela análise dos espectros obtidos nos testes instrumentais. Esses métodos mostraram-se reprodutíveis e rápidos para identificar ceftazidima na presença de outros antibióticos -lactâmicos, podendo ser usados rotineiramente em análises de controle de qualidade. Palavras-chave: Análise qualitativa. Controle de qualidade. Ceftazidima. ABSTRACT Qualitative methods for the identification of ceftazidime In this study, qualitative analytical methods were developed for the identification of ceftazidime in raw material and in pharmaceutical formulations. These methods included physicochemical tests based on chemical properties, performed by classical colorimetric reactions, and instrumental tests, such as thin-layer chromatography, calorimetry and ultraviolet spectroscopy. Results were obtained directly, through the visual identification of the drug by the color developed, and by analyzing the spectra obtained. These methods proved to be reproducible and fast means of identifying ceftazidime in the presence of other beta-lactam antibiotics and may be used for routine quality control tests. Keywords: Qualitative analysis. Quality control. Ceftazidime.PublicaçãoArtigo A importância da atenção farmacêutica após a verificação da qualidade microbiológica de medicamentos contendo paracetamol encontrados em algumas residências de Américo Brasiliense - SP(2011) Tótoli, Eliane Gandolpho ; Stain, Samaria Nascimento ; Salgado, Hérida Regina Nunes; Moreno, Andréia de Haro ; Centro Universitário de Araraquara (Uniara) ; Universidade Estadual Paulista (Unesp) It is known that a high microbial count can compromise the stability of medicines, thus reducing their therapeutic efficacy. This work tried to demonstrate that the microbial contamination can be directly related to the inadequate handling of the medicines stored in homes, making it possible to draw strategies to reduce the possible risks of medical therapy offering correct information and advising. The objective of this work was to evaluate the quality of the medicines containing paracetamol found in the residences of Américo Brasiliense-SP, using the microbial analysis of non-sterile method described in the Brazilian Pharmacopoeia (1988). The medicine samples (30 samples) were obtained directly from the interviewed local residents, who had received new medicine bottles of the same product. An analysis of viable microorganisms (bacteria and fungus) was carried out to identify pathogens found in the collected samples. Although 90% of the analyzed samples have shown some microbial contamination, the results indicated the absence of pathogenic microorganisms, and the total count of viable microorganisms was below the maximum value for non-sterile (104 UFC/g or mL). It was also verified that the local residents stored the medicines in appropriate places, according to the orientations received when they bought the medicines in pharmacies and drugstores, showing the importance of information for the correct use and conservation of pharmaceuticals.PublicaçãoArtigo A critical review of the properties of fusidic acid and the analytical methods for its determination(Taylor and Francis Online, 2015) Curbete, Mariane Machado; Salgado, Hérida Regina Nunes ; Universidade Estadual Paulista (Unesp) Fusidic acid, an antibiotic produced from the Fusidium coccineum fungus, belongs to the class of steroids, but has no corticosteroid effects. It is indicated for the treatment of infections caused by methicillin-resistant Staphylococcus aureus strains. The aim of this study was to search for the properties of fusidic acid published so far in the literature, as well as the methods developed for its determination in biological samples and pharmaceutical formulations. From the findings, we can conclude that fusidic acid has been used for decades and is indicated for the treatment of serious infections caused by Gram-positive microorganisms to this day. Furthermore, it is a hypoallergenic agent, has low toxicity, shows low resistance, and has no cross-resistance with other clinically used antibiotics. The analytical method of high-performance liquid chromatography has been widely used, since it can reduce the cost and time of analysis, making it more viable for routine quality control in the pharmaceutical industry.PublicaçãoArtigo Microbiological assay for the determination of azithromycin in ophthalmic solutions(2005-06-01) Salgado, Hérida Regina Nunes; Roncari, Ana Flávia Ferreira ; Universidade Estadual Paulista (Unesp) The validation of a simple, sensitive and specific agar diffusion bioassay, applying cylinder-plate method, for the determination of the antibiotic azithromycin in ophthalmic solutions is described. Using a strain of Bacillus subtilis ATCC 9372 as the test organism, azithromycin at concentrations ranging from 50.0 to 200.0 μg·mL-1 could be measured in 1.666 7 mg·mL-1 ophthalmic solutions. A prospective validation of the method showed that the method was linear (r = 0.999 9) and precise (RSD = 0.70) and accurate (it measured the added quantities). The results obtained by bioassay method could be statistically calculated by linear parallel model and by means of regression analysis and verified using analysis of variance (ANOVA). We conclude that the microbiological assay is satisfactory for quantification of azithromycin in ophthalmic solutions.PublicaçãoArtigo Acesso Aberto Avaliação da qualidade da água purificada em farmácias magistrais da região de São José do Rio Preto, SP(2011-06-28) Moreno, A. H.; Tozo, G. C G ; Salgado, Hérida Regina Nunes ; Universidade Estadual Paulista (Unesp) Water is the raw material used most in the production of diverse pharmaceutical forms and, being a constituent of the formulation itself, is subject to a number of physico-chemical and microbiological specifications. In addition, it is indispensable for laboratory tests and the cleaning of equipment and apparatus. The aim of this study was to ascertain the degree of physicochemical and microbiological contamination of purified water used in compounding pharmacies in the city of São José do Rio Preto, SP, Brazil. Samples were taken as recommended in the USP Pharmacopeia, with careful aseptic technique, and sent immediately the to quality control laboratory. Physicochemical properties were analyzed, including appearance, pH, conductivity, residue after evaporation, ammonia, calcium, chloride, heavy metals, sulfate and oxidizable substances, and microbiological tests were performed: total aerobic microbial count and detection of total and thermotolerant coliforms and Pseudomonas aeruginosa. Results showed that some parameters did not conform to the standards, especially pH, conductivity, inorganic impurities, oxidizable substances and microbiological test data, in 10%, 17%, 10%, 14% and 20% of the analyzed samples, respectively, This points to the need for greater care in the production and/or storage of purified water in these pharmaceutical establishments.PublicaçãoArtigo Acesso Aberto Photodegradation of sparfloxacin and isolation of its degradation products by preparative HPLC(2005-12-01) Salgado, Hérida Regina Nunes; Moreno, P. R. H. ; Braga, A. L. ; Schapoval, E. E. S. ; Universidade Estadual Paulista (Unesp) ; Universidade de São Paulo (USP) ; Universidade Federal de Sergipe (UFS) ; Universidade Federal do Rio Grande do Sul (UFRGS) Sparfloxacin, a third generation fluoroquinolone derivative, is a potent antibacterial agent active against a wide range of Gram-positive and Gram-negative organisms including Streptococcus pneuinoniae, Staphylococcus aureus, methicillin resistant S. aureus, Legionella spp., Mycoplasina spp., Chlamydia spp. and Mycobacterium spp. A drawback of fluoroquinolones is their photoreactivity. Sparfloxacin has been studied in terms of therapeutic activities. However, there are few published of analytical methods being applied to sparfloxacin. The aim in this study was to determine the photodegradation products of sparfloxacin, when submitted to UV light, and to characterize two of these products, designated SPAX-PDP1 and SPAX-PDP2. An accelerated study of stability in methanol solution was carried out by exposing a solution of sparfloxacin to UV light (peak wavelength 290 nm) for 36 hours at room temperature. The products were analyzed by NMR spectrophotometry, IR spectrometry and mass spectrophotometry. The results suggest that the products isolated here could be used to estimate the degradation of sparfloxacin in a stability study. However, the low activity exhibited by UV-irradiated sparfloxacin is a source of concern that demands further investigation of the mechanism of its photodegradation mechanism.PublicaçãoArtigo Acesso Aberto Rapid turbidimetric assay for quantification of fusidic acid in a dermatological cream(2016-06-01) Curbete, Mariane MacHado; Salgado, Hérida Regina Nunes ; Universidade Estadual Paulista (Unesp) Fusidic acid is an antibiotic steroid widely used for the treatment of serious infections caused by methicillin-resistant Staphylococcus aureus (MRSA) strains. Microbiological methods are indispensable to determine the mean percentage of antimicrobial in medicaments during manufacturing and quality control processes. The aim of this study was to develop and validate a microbiological method for the quantification of fusidic acid in dermatological cream by turbidimetry, using Staphylococcus epidermidis (ATCC 12228) and casoy broth as the culture medium. The validation parameters were in accordance with ICH specifications and demonstrated accuracy, precision, selectivity, and robustness, with linear ranges from 0.25 to 2.25 μg mL-1. This method is an alternative to the diffusion agar assay currently employed to quantify fusidic acid in dermatological cream, since it is sensitive, fast, and more economical.