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Item Motorização terapêutica do metotrexato sob altas doses, em pacientes portadores de leucemia linfoblástica aguda(Universidade Federal de Goiás, 2008-09-29) LELES, Raphael Nunes; CUNHA, Luiz Carlos da; http://lattes.cnpq.br/6349547031976679Methotrexate (MTX) is a drug with high toxicity, used in high doses for the treatment of neoplasic diseases. Therapeutic concentrations preserve the effectiveness, but higher values increases the toxicity risks. The aim of this article was to develop and validate an analytical method on HPLC-PDA to measure methotrexate plasma levels on children affected by LLA. The analytical method was performed with a mobile phase composed by acetic acid 0,1%:methanol:acetonitrile in concentration gradients during the analysis. The validation parameters were: specificity, relative recovery, lowest (LLQ) and higher limits of quantification, precision (Intra-assay standard deviation), accuracy, log time stability, calibration curve and co-validation. Biological samples were collected from 7 patients hospitalized on Araújo Jorge Hospital totaling 42 blood samples used to estimate the pharmacokinetic parameters. As results we obtained a method with a flow-rate of 1.5 mL/min, the methotrexate and teophyllin detection were observed in 304 and 271 nm respectively, in 13 minutes of carryover. The relative recovery was about 71%, LLQ about 0,1 μg/Ml. Intra-assay standard deviation was 11% for LLQ and no more than 14,88% for other concentrations; the accuracy was 97,63% and the long time stability was confirmed in human blood with a -20º C freezing. As pharmacokinetic parameters, we estimate the total clearance (3,03 L/h), constant of elimination (0,2586 h-1), a distribution volume of 12,57 L, half-life time as 2,73 h and median AUCT (for area under the time vs concentratrion curve) of 626,493 μgh/mL. As conclusion, the analytical method proved to be high efficient to detect and to quantify the drug on human blood, and we observed the high variability of the pharmacokinetic parameters, showing the importance of realize the therapeutic drug monitoring.Item Desenvolvimento analítico e farmacotécnico de formas farmacêuticas sólidas de isoflavona de soja(Universidade Federal de Goiás, 2010-03-05) OLIVEIRA, Stela Ramirez de; LIMA, Eliana Martins; http://lattes.cnpq.br/7248774319455970Isoflavones are flavonoids found in abundance in grains of soy (Glycine max L.) and its derivatives. These substances have estrogen like structure and weakly estrogenic action. They are used for treatment of menopause symptoms as an alternative to conventional hormone replacement therapies, because they cause fewer side effects. Soy isoflavones are amongst herbal products of great interest to obtain solid dosage forms. High assay variability of isoflavones in commercially available capsules and tablets shows the need of appropriate drug development and quality control for this herbal product. The aim of this work was drug development and quality control of soy isoflavone solid dosage forms, using standardized dry extract of soy. To evaluate the quality of the extract microbiologic and assay analysis of this drug s markers were performed. Results obtained from microbiological test did not show microbiologic contamination of the extract, as Escherichia coli, Staphylococcus aureus, Candida albicans and Aspergillus niger did not grow. To evaluate assay and dissolution percentage of both markers analytical methodology for quantification of daidzein and genistein by high performance liquid chromatography was developed, and also a method to analyze dissolution profile of the obtained tablets. Isocratic method was used for chromatographic analysis of the markers, with mobil phase of methanol with 0.1% of acetic acid, water with 0.1% of acetic acid and acetonitrile in proportion 64:32:4, flow of 0.7 mL/min and temperature of 30°C. At this condition, peaks were symmetric, had resolution lower than 2, with retention times of 3,13 and 3,72 for daidzein and genistein, respectively. Assay evaluation of the markers daidzein and genistein showed that concentrations in the extract were 27,8% and 11,1%, respectively. To accomplish preformulation study, thermal analysis and powder and granules flow evaluation were made. Six formulations of isoflavone tablets were developed, one by direct compression and five by wet granulation. Results of thermal analysis showed no possible extract interactions between tested excipients and extract. Wet granulation was the best method to obatain tablets, because it presented the best compressional properties with flow velocity between 4,5 and 6,7 s/100g and compressibility between 16,85% and 26,06%. GU3 formulation, which presented the best performance according to evaluated parameters, made by wet granulation, showed 92,66% and 92,76% of daidzein and genistein, respectively, disintegration of 15 minutes, and its flow was categorized as excellent. In analytical dissolution method development of isoflavone tablets solubility test was performed to define the best medium, and water with 3% of sodium lauryl sulfate dissolved the greatest amount of daidzein and genistein at tested temperature, 37°C, in comparison with the other medium. Other parameters defined through method development were paddle apparatus, stirring speed of 100 rpm and 900 mL of medium volume. Results showed the possibility to obtain promising solid dosage forms to deliver isoflavone, and optimized quality control methodologies to analyze raw material and finished product.Item Obtenção e caracterização do extrato seco Padronizado de Vernonanthura ferruginea (LESS.) H. Rob., Asteraceae (Assa-Peixe)(Universidade Federal de Goiás, 2011-04-18) SILVA, Ezequiane Machado da; CONCEIÇÃO, Edemilson Cardoso da; http://lattes.cnpq.br/7193007113950510; BARA, Maria Teresa Freitas; http://lattes.cnpq.br/3914164125498267Vernonanthura ferruginea (Less.) H. Rob. (Asteraceae), a typical plant of the Brazilian savannah, popularly known as assa-peixe, presented analgesic, antiedematogenic, antioxidant and antiulcer activities in scientific studies. But in literature there are no works related to the production of dried extracts of this plant species. In this work, standardized spray-dried extracts of V. ferruginea were obtained. The work started with the obtainment and characterization powder of the leaves of the V. ferruginea. A hydroalcoholic extract was obtained by percolation using as solvent ethanol 95 % (v/v). The drying experiments followed a 23 + 2 factorial design. The influence of several in-process parameters e. g. extract feed rate, drying air inlet temperature and drying adjuvant ratio, on the dried extracts properties were investigated. The properties investigated were process yield, residual moisture, water activity, total triterpenes content and lupeol content. The lupeol, triterpene related to several pharmacological activities (anti-inflammatory, anticancer, antiulcer, etc), was first time isolated in this species and was used as chemical marker in High Performance Liquid Chromatography (HPLC) quantification assays in all steps of this work. In this way an analytical methodology was validated following Agência Nacional de Vigilância Sanitária (ANVISA Brazilian National Health Surveillance Agency) guidelines. This methodology proved to be selective, linear, sensible, precise, accurate and robust. On the herbal raw material characterization, preliminary phytochemical screening was performed, which confirmed the presence of tannins, flavonoids, triterpenes, saponins, resins and mucilage. Was also observed a mean powder size of 398.97 ± 6.91 μm, as well as moisture, total triterpenes and lupeol contents of 8.25 ± 0.57%, 2.49 ± 0.16% and 0.17 ± 0.01%, respectively. The concentrated hydroalcoholic extract presented density of 0.8364 ± 0.0015 g/mL, solids content of 6.70 ± 0.19%, pH 5.81 ± 0.05, alcoholic content of 87.08 ± 0.80% and a viscosity of 4.93 ± 0.0416 mPas. The levels of total triterpenes and lupeol contents were 22.57 ± 0.94 and 4.31 ± 0.01%, respectively. Results showed drying yields ranging from 10.47 to 30.82%. Also, all dried products showed moisture contents and water activities below 5% and 0.5, respectively. Analysis of variance (ANOVAs) proved that all factors and some of their interactions significantly affected the levels of total triterpenes and lupeol contents. Moreover, the selected condition for obtaining dry extracts of V. ferruginea with adequate physicochemical properties is the one performed with the higher colloidal silicon dioxide ratio (20%), the lower extract feed rate (4mL/min) and the lower drying air inlet temperature (80°C), in which it was obtained levels of total triterpenes and lupeol contents of 7.65 ± 0.27% and 2.47 ± 0.04%, respectively. The dry extract obtained in this condition show high content of spherical particles and its antiulcer activitie in model of ulcer induced by indomethacin was proved. Comparison of powder, hydroalcoholic and dry extract chromatographic (TLC) show that the hydroalcoholic extraction was selective for the extraction of lupeol against other major terpenes and the drying process did not cause changes in the chemical profile of the extract with respect to these substances. Thus, the spray drying can be an attractive e and promising alternative for the development of V. ferruginea phytomedicines.