Controle de qualidade físico-químico e biodisponibilidade relativa em ratos de suspensões orais de naproxeno sódico obtidas de farmácias de manipulação na cidade do Natal RN

Compounded medicines have been reported by the ANVISA due to decreased of the therapeutic response or toxicity of these formulations. The aim of this work was to investigate the physicochemical quality control among naproxen sodium oral suspensions 25 mg/mL obtained from six compounding pharmacies (A, B, C, D, E and F) and the manufactured suspension (R). In the quality control test, the tests of pH, content, homogeneity, volume and physical and organoleptic characteristics were performed according to the Brazilian Pharmacopoeia. The analytical method for determination of naproxen in suspensions was validate. This method showed excellent precision, accuracy, linearity and specificity. In the content test the suspensions B, C and E showed lower value and the F suspension showed a high value of the content. The products C and E were disapproved in the description of the physical and organoleptic characteristics test. In the pH test, three suspensions were outside specifications (C, E and F). Only the products R, A and D showed satisfactory results in these tests and therefore they were approved for relative bioavailability test. The R, A and D suspensions were orally administered to Wistar rats and the blood samples were taken at time intervals of 10, 20, 40, 60 min, 3, 4, 6, 24 and 48 h. The plasma samples were immediately stored at 80 ºC until analysis of HPLC. The bioanalytical method validation showed specificity, linearity (R2 0.9987), precision, accuracy, good recovery and stability. The chromatographic conditions were: flow rate of 1.2 mL.min-1 with a mobile phase of acetonitrile : sodium phosphate buffer pH 4.0 (50:50, v/v) at 280 nm, using a C18 column. The confidence interval of 90% for the Cmax and AUCt ratio was within the range of 80 - 125% proposed by the FDA. Only one suspension, obtained from the compounding pharmacy D, was considered bioequivalent to the rate of absorption under the conditions proposed by this study. Thus, the results indicate the need for strict supervision from the relevant authorities to ensure the patient safety and the quality of compounded drugs by pharmacies

Metodologia para avaliação do tempo de cozimento e características tecnológicas associadas em diferentes cultivares de mandioca

O consumo culinário de raízes de mandioca é bastante generalizado em todo o mundo, sendo essa raiz amplamente utilizada na forma cozida, assada, frita ou integrando pratos mais complexos. O objetivo deste trabalho foi definir metodologia, avaliar o tempo de cozimento e algumas características associadas a este processo em 26 cultivares de mandiocas. Avaliaram-se os seguintes parâmetros avaliados foram cor da entrecasca; cor da polpa; dificuldade de soltar a entrecasca; dificuldade de palitar; porcentagem de água absorvida/perdida em relação ao peso dos toletes durante o processo de cozimento; cor dos toletes cozidos; formações de pontuações brancas no interior do tolete; formação de gel em volta dos toletes e tempo de cozimento observado para cozimento de 13 palitos. Ao final da avaliação concluiu-se que as melhores cultivares para utilização como mandioca de mesa foram a SRT-1105 (Mico), Milagrosa RG, Mantiqueira, IAC 522-30, IAC 576-70, sendo a última a que apresentou melhor resultado no teste de cozimento.

Desenvolvimento e validação de método analítico para determinação de teor de ácido gálico e catequina no fitoterápico sanativo® por cromatografia líquida de alta eficiência

The herbal medicine Sanativo® is produced by the Pernambucano Laboratory since 1888 with indications of healing and hemostasis. It is composed of a fluid extract about Piptadenia colubrina, Schinus terebinthifolius, Cereus peruvianus and Physalis angulata. Among the plants in their composition, S. terebinthifolius and P. colubrina have in common phenolic compounds which are assigned most of its pharmacological effects. The tannins, gallic acid and catechin were selected as markers for quality control. The aim of this study was the development and validation of analytical method by HPLC/UV/DAD for the separation and simultaneous quantification of gallic acid (GAC) and catechin (CTQ) in Sanativo®. The chromatographic system was to stationary phase, C-18 RP column, 4,6 x 150 mm (5 mm) under a temperature of 35 ° C, detection at 270 and 210 nm. The mobile phase consisted of 0.05% trifluoroacetic acid and methanol in the proportions 88:12 (v/v), a flow rate of 1 ml/min. The analytical method presented a retention factor of 0.30 and 1.36, tail factor of 1.8 and 1.63 for gallic acid and catechin, respectively, resolution of 18.2, and theoretical plates above 2000. The method validation parameters met the requirements of Resolution n º 899 of May 29, 2003, ANVISA. The correlation coefficient of linear regression analysis for GAC and CTQ from the standard solution was 0.9958 and 0.9973 and when performed from the Sanativo® 0.9973 and 0.9936, the matrix does not interfere in the range 70 to 110 %. The limits of detection and quantification for GAC and CQT were 3.25 and 0.863, and 9.57 and 2.55 mg/mL, respectively. The markers, GAC and CQT, showed repetibility (coefficient of variation of 0.94 % and 2.36 %) and satisfactory recovery (100.02 ± 1.11 % and 101.32 ± 1.36 %). The method has been characterized selective and robust quantification of GAC and CTQ in the Sanativo® and was considered validated

Otimização evalidação de métodos analíticos para a determinação simultânea de tuberculostáticos (4-FDC) por CLAE/DAD e CLUE/ DAD

Tuberculosis is a serious disease, but curable in practically 100% of new cases, since complied the principles of modern chemotherapy. Isoniazid (ISN), Rifampicin (RIF), Pyrazinamide (PYR) and Chloride Ethambutol (ETA) are considered first line drugs in the treatment of tuberculosis, by combining the highest level of efficiency with acceptable degree of toxicity. Concerning USP 33 - NF28 (2010) the chromatography analysis to 3 of 4 drugs (ISN, PYR and RIF) last in average 15 minutes and 10 minutes more to obtain the 4th drug (ETA) using a column and mobile phase mixture different, becoming its industrial application unfavorable. Thus, many studies have being carried out to minimize this problem. An alternative would use the UFLC, which is based with the same principles of HPLC, however it uses stationary phases with particles smaller than 2 μm. Therefore, this study goals to develop and validate new analytical methods to determine simultaneously the drugs by HPLC/DAD and UFLC/DAD. For this, a analytical screening was carried out, which verified that is necessary a gradient of mobile phase system A (acetate buffer:methanol 94:6 v/v) and B (acetate buffer:acetonitrile 55:45 v/v). Furthermore, to the development and optimization of the method in HPLC and UFLC, with achievement of the values of system suitability into the criteria limits required for both techniques, the validations have began. Standard solutions and tablets test solutions were prepared and injected into HPLC and UFLC, containing 0.008 mg/mL ISN, 0.043 mg/mL PYR, 0.030 mg.mL-1 ETA and 0.016 mg/mL RIF. The validation of analytical methods for HPLC and UFLC was carried out with the determination of specificity/selectivity, analytical curve, linearity, precision, limits of detection and quantification, accuracy and robustness. The methods were adequate for determination of 4 drugs separately without interfered with the others. Precise, due to the fact of the methods demonstrated since with the days variation, besides the repeatability, the values were into the level required by the regular agency. Linear (R> 0,99), once the methods were capable to demonstrate results directly proportional to the concentration of the analyte sample, within of specified range. Accurate, once the methods were capable to present values of variation coefficient and recovery percentage into the required limits (98 to 102%). The methods showed LOD and LOQ very low showing the high sensitivity of the methods for the four drugs. The robustness of the methods were evaluate, facing the temperature and flow changes, where they showed robustness just with the preview conditions established of temperature and flow, abrupt changes may influence with the results of methods

Prováveis consequências do abrandamento da metodologia de erradicação do cancro cítrico no Estado de São Paulo

Recentemente a Secretaria de Agricultura e Abastecimento do estado de São Paulo abrandou os critérios relacionados à erradicação do cancro cítrico. em abril de 2009 mais de 99,8% dos talhões comerciais de laranjeiras doces estavam livres da doença em São Paulo. Abrandar a metodologia de erradicação significa comprometer esse elevado nível de sanidade dos pomares e a competitividade da citricultura, com reflexos negativos financeiros e ambientais. Diante desses fatos sugere-se: a) que a erradicação da doença volte a ser feita como anteriormente utilizada; ou b) a adoção de uma nova metodologia de erradicação, mais efetiva na supressão da doença, quando em novos levantamentos amostrais de cancro cítrico em São Paulo forem encontradas incidências de talhões comerciais com a doença superiores a 0,36%. Essa incidência foi calculada comparando-se pelo teste de Duncan (P<0,05) os levantamentos amostrais de cancro cítrico realizados de 1999 a 2009. A diferença mínima significativa encontrada foi de 0,28. A menor incidência do cancro cítrico em São Paulo foi de 0,08%, observada em 2001. Dessa forma, como alternativa, propõe-se a adoção de uma metodologia mais drástica de erradicação do cancro cítrico quando em um novo levantamento amostral for detectado mais que 0,36% de talhões comerciais com cancro cítrico.

Desenvolvimento e validação de modelo de previsão para mancha preta dos citros em função de variáveis meteorológicas

A mancha preta dos citros é uma doença causada pelo fungo Guignardia citricarpa que produz lesões em frutos em variedades de laranja doce comerciais, causando a queda precoce dos frutos, diminuindo a produtividade e levando a sua depreciação para o mercado de fruta fresca. O objetivo do trabalho foi desenvolver e validar um modelo de favorabilidade climática da mancha preta dos citros relacionado a ocorrência dos sintomas da doença no Estado de São Paulo. Desenvolveu-se um sistema empírico com base em um banco de dados da ocorrência da doença e das condições climáticas, em campo, nos municípios de Barretos/SP e Gavião Peixoto/SP, durante as Safras 2007/2008 e 2008/2009. A variedade de laranjeira doce utilizada nos experimentos foi a 'Valência' enxertada sobre limoeiro 'Cravo', com 10 anos de idade. Para a incidência da mancha preta foi avaliada a porcentagem de frutos com sintomas na planta e para a severidade, a porcentagem de casca lesionada por fruto. Na análise de regressão as variáveis climáticas e os dados de intensidade de doença de Barretos foram selecionados no procedimento 'stepwise'. As melhores equações de regressão foram selecionadas pelo coeficiente de determinação (R²) e pela significância da regressão no teste F (P < 0,05 e P < 0,01) que resultou na equação Y= -502,43 + 9,61 X10 + 4,78 X30 + 0,54 X46 - 7,9 X50 em que Y=Índice de Favorabilidade, X10 é a temperatura média, X30 é a umidade relativa média, X46 é o molhamento foliar e X50 é a temperatura média durante o molhamento foliar, determinados com dados de intervalos de sete dias. Procedeu-se a validação no campo no município de Gavião Peixoto durante a Safra 2008/2009, realizando a correlação entre a incidência e severidade observadas no experimento e os dados previstos que foram os determinados pela equação, sendo que a correlação mostrou-se positiva para a incidência da doença com um R²=0,87.

Direito fundamental ao tempo razoável do processo judicial: limites e possibilidades de concretização no ordenamento jurídico pátrio

This dissertation aims to address the limits and possibilities of realizing the fundamental right to reasonable time of the Brazilian legal system process. From this perspective, we analyze a reasonable time concept for the process, consistent with the civil homeland process; the relationship between efficiency, effectiveness, legal security and reasonable time of adjudication; a formal recognition of the fundamental right to reasonable time of the procedure in the Constitution of 1988; and the immediate applicability of this fundamental right. As indicated, the crisis of the Judiciary and procedural delay are problems directly related to the limits and possibilities of realization of the fundamental right under study. Moreover, we also present some mechanisms that can be used to overcome these problems. The subject was developed based on constitutional interpretation of fundamental rights, an approach that will always have this concern to be based on a methodology which includes the normative and empirical-dogmatic fields, realizing the fundamental right to reasonable time of the process. We adopted as methodological approach the study of this issue in judicial aspect, more specifically in the field of civil procedure. Finally, we weave through a critical and analytical view, our conclusions, which demonstrate the possibilities of overcoming the limits imposed to immediate implementation of the fundamental right to reasonable time of the process in our legal system

Descrição do movimento da articulação metacarpofalangiana de equinos pela metodologia baseada em videogrametria

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

O processo de invenção de si: um estudo sobre a construção identitária de pedagogas em formação

This work was developed in the course of Pedagogy, Universidade Federal do Rio Grande do Norte. Aims to understand the process of identity construction of teachers and educators in initial training. We started from the idea that such process was made by a complex and interdependent movement, once it was an inventive phenomenon wrought by individuals who are authors and actors of the story of their "real life" (KAUFMANN). This identity is rooted in the trajectories and social biographical experiences (FERREIRA), relationships with the constructed and accumulated knowledge in this route (CHARLOT) and in the developing of a sense of cultural belonging institutionally constructed (Luckmann, Berger). Then, the training involves relationships with knowledge in several instances, considering the effects, in one hand, the historic-social production and, in another hand, from the positions of subject and their biographical itinerary, existential and formative. We used the methodology of the Comprehensive Interview (KAUFMANN; SILVA), associated with a network of theoretical references, empirical and very analytical and interpretive activity. She researcher also relied on the "sensitive listening" (BARBIER), empathic attitude of "listening / seeing" the subject, and the notion of "intellectual artisan" (MILLS). The individual interviews were supplemented by the Focus Group. The approach was multi-referential (ARDOINO; MACEDO), with the intertwining of different perspectives, allowing a more complex configuration and less reductionist. In the analysis and interpretation we located the starting point, genesis of identity whose dynamics is not rigidly determined, but localized in space-time that precedes entry into the initial training. It is the time of concerns, questions and reflections about what you want to be in the future professional life. In sequence, we saw the route, multifaceted process whose the direction is the increasing involvement of individuals with their training. This training is engendered by the relations with the curricular, extracurricular and discursive knowledge, as simultaneous dynamics of self training and socio training. The self training of the individuals, understanding the critical, ethic and authority reading of their own experiences, is also seen as an exercise of shared responsibility, it assumes that the relationship with others meanings and professor mediation. The socio training refers to the collective subject and turns to the historical production and diversified knowledge, and comprehension of the various training instances. Self training and socio training are both objects of negotiation, because they are provocative of new designs, and cultural and identity maps, mobilizing the senses towards new meanings of themselves and the professional reality. It is in this interdependence between what is historically produced and the experiences of the subjects, who we located the arrival, considering it as a radically incomplete process of the professional identity and the building itself.

Validação interlaboratorial do teste de polarização fluorescente para o diagnóstico sorológico da brucelose bovina

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Desenvolvimento e validação de protótipo das medidas de desenvolvimento humano

To mesure the human performance is a challenge, mainly due to the multidimensional factor movement. Instruments, mostly only assess one dimension of it. Objective: To develop a prototype capable of measuring the skills of human performance and check its validity using method comparison approach. Methods: The study was divided into two stages. The first Prototype was developed and tested simultaneously with an instrument to study the Rectilinear Uniform Motion and Uniformly Miscellaneous. In the second phase the sample consisted of Paralympic basketball athletes (n=09) and karate athletes (n=31) and all agreed to the terms of participation in the research. The evaluation of performance measures was performed with the prototype, the results obtained were compared with the data calculated by a statistical package is used as a reference. Results: All variables calculated by the prototype showed no significant differences when compared with the results calculated by the reference instrument and statistical package. Conclusion: The prototype has been developed and the results obtained in laboratory and field indicate that the prototype can be used for measuring human performance measures, with immediate results without the need for a conventional computer return, provided they fulfill the criteria described

Metodologia alternativa para condução do teste de envelhecimento acelerado em sementes de milho

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Validação de protocolo de assistência para pessoas com úlcera venosa na atenção primária

People with venous ulcers constitute as an important public health problem, its treatment is onerous and require assistance provided by trained professionals, systematized through protocols, however what lies in the assistance is that the management of this group of people differs from that preconized in the scientific literature, interfering with wound healing and quality of life of affected. In this sense, the construction of a assistance protocol specific to people with venous ulcers (VU) can help professionals of the Family Health Strategy both in patient assessment as and in establishment of quality assistance. Thus, this study aimed to analyse the validity of a multiprofessional assistance protocol for people with venous ulcers in primary care by health professionals using Delphi technique. This is a quantitative study, the methodological type conducted in two steps: first step related to integrative literature review to subsidize the development of the protocol, then these aspects were organized and proposed to the judges of the study through the Delphi technique. The study was initiated after approval by the Research Ethics Committee. The first step was performed between August and September 2012, in the virtual library of health, in the page of the Coordination of Improvement of Higher Education Personnel, of Municipal Health Secretariat and international guidelines of associations and in the subsequent step carried out between September 2012 to January 2013, was performed search by Lattes platform of the National Council of Technological and Scientific Development, in order to identify health professionals in Brazil who act as judges of the instrument and then, via online, the form was submitted to them.The sample for the second step was 51 judges in the first round and 35 for the second round Delphi. The analysis was done by adopting Kappa index ≥ 0.81 and Content Validity Index (CVI)> 0.80. In the first submission for the judges, items that did not reach Kappa and CVI established were: request / realization / test results, demographic data, medical history, risk factors, verification of pain / vital signs / pulse / infection signs / lesion location/ edema and pain treatment. After removal of items which have not obtained Kappa or CVI index established, it was found achieving optimal levels of these index for the categories. In the next step was the ressubmissão of protocol to judges through the Delphi technique in it was found that, of the 15 categories of the protocol, 12 presented higher scores in Delphi 2 phase and the other three categories remained the same Kappa and IVC of the previous phase. As for the average of evaluation requirements of the protocol was found that the scores assigned by the judges were higher in the second phase in nine of the 10 items, remaining the same in only one of the items indicating validity of the instrument before the consensus of the judges. Thus, we accepted the alternative hypothesis in this study, as they were obtained in the second Delphi phase the validity index greater than or equal to the Delphi 1 phase. The formulation of this assistance protocol valid and reproducible will enable a reorganization and redesign of assistance, with standardization of actions and continuity of care for persons with venous ulcers in primary health care

Identificação e validação de marcadores microssatélites ligados ao gene Rpp5 de resistência à ferrugem-asiática-da-soja

O objetivo deste trabalho foi identificar novos marcadores microssatélites, ligados ao gene Rpp5 de resistência à ferrugem-da-soja, e validar os marcadores previamente mapeados, para que possam ser utilizados em programas de seleção assistida por marcadores moleculares (SAM). Para tanto, uma população F2 com 100 indivíduos, derivada do cruzamento entre a PI 200526 e a cultivar Coodetec 208, suscetível à ferrugem, foi artificialmente infectada e avaliada quanto à sua reação de resistência à ferrugem. Marcadores microssatélites foram testados nos genitores e em dois bulks contrastantes, para a identificação de marcadores ligados. Dois novos marcadores, potencialmente associados à resistência, foram testados em plantas individuais, e se constatou que eles estão ligados ao gene Rpp5 e estão presentes no grupo de ligação N da soja. A eficiência de seleção foi determinada em relação a todos os marcadores ligados ao gene Rpp5, e a combinação entre os marcadores Sat_275+Sat_280 foi de 100%.

Validação de conteúdo do instrumento para consulta de enfermagem na visita domiciliar às pessoas com lesão medular: um enfoque no autocuidado

This study aimed to validate the contents of an Instrument for Nursing Consultation in the Home Visit of people with Spinal Cord Injury (INCEVDOP-LM), based on the Self-Care Deficit Theory. The methodological development study was conducted with spinal cord injured (SCI) people ascribed in the Family Health Units the city of Natal/RN/Brazil, and with the nurses of these institutions. The study was conducted from Januray 2012 to January 2013 in two phases: the first aimed to identify the need for self-care of persons with SCI, and the second to develop and validate the INCEVDOP-LM. The first phase consisted of a census study of people with SCI living in Natal/RN. In the second phase, a non-probabilistic convencience sample of subjects was selected to form two groups: First stage - Group 1 of the first stage was comprised by 73 adults with SCI diagnosed with paraplegia or tetraplegia, with cognitive function preserved and that were registered to some family health unit; Group 2 of the Second phase was composed of six experts that were nurses with doctoral formation, scientific experience in the area of technology development or assistance to persons with SCI, and with publications in periodicals Qualis A2. Data collection of the first phase was conducted through home visits of people with SCI that responded three instruments: Questionnaire I (comprised of demographic and socioeconomic variables), The Competency Rating Scale for Self-care (ASA) and the Barthel Index (an instrument for evaluation of functional capacity). The research for the second phase was conducted in two stages: I-construction of the INCEVDOP LM; II-validation of the INCEVDOP-LM. The instrument and an evaluation form were forwarded to the experts for the validation. The correlations between the responses were analyzed by the Kappa test, with accepting values of>0.75. The evaluation criteria were: organization, clarity, simplicity, readability, appropriateness of vocabulary, objectivity, accuracy, reliability and suitability and the positive responses with frequency values of≥90% were considered excellent. The chi-square test was used to investigate the differences between proportions. The study attended to the principles of Human Rights CNS Resolution 196/96. Results were reported by means of four articles derived from the study. The findings indicate that the items that showed disagreement among experts (k=0.02) were diagnoses, interventions and evaluation of the nursing features pertaining to the domains of Nutrition, Hygiene, Elimination, Physical, Social and Psychological, and of the Ability to perform work activities feature. Agreement among the experts were reported for the other items, with kappa ranging from 0.72 to 1. After removing items with disagreement, all criteria achieved excellent rates and no significant differences were observed between the proportions of responses of evaluation of experts (p>0.05). We conclude that the instrument shows validity to serve as a guide for nurses to conduct a systematic consultation during the home visit to people with spinal cord injury, with emphasis on self-care. The instrument must go through other levels of validation when applied in the clinical setting