Terezinha de Jesus Andreoli Pinto

Occurrence of toxigenic fungi in herbal drugs

O aumento no consumo de produtos naturais transformou seu uso em um problema de Saude Publica devido a possibilidade do acesso a produtos sem adequadas condicoes de uso. A preocupacao com a qualidade dos produtos naturais e devida a potencialidade de contaminacao por fungos e ao risco da presenca de micotoxinas. Noventa e uma amostras de plantas medicinais foram avaliadas quanto a contaminacao fungica e ao potencial micotoxigenico de Aspergillus e Penicillium isolados nestas amostras. Os resultados indicaram que a micoflora predominante esteve distribuida entre 10 generos. Entretanto, 89,9% dos isolados corresponderam aos generos Aspergillus e Penicillium, extremamente importantes do ponto de vista micotoxicologico. Verificou-se que 21,97% dos isolados de Aspergillus e Penicillium demonstraram capacidade para produzir aflatoxinas (42,9%), ocratoxina A (22,4%) e citrinina (34,7%). A presenca de fungos toxigenicos representa risco potencial de contaminacao com micotoxinas e considerando o aumento no consumo de produtos de origem vegetal como alternativa terapeutica, e necessario estabelecer padroes para a presenca de fungos toxigenicos em drogas vegetais a fim de reduzir os riscos a saude do consumidor.

Nanoemulsion: process selection and application in cosmetics--a review.

In recent decades, considerable and continuous growth in consumer demand in the cosmetics field has spurred the development of sophisticated formulations, aiming at high performance, attractive appearance, sensorial benefit and safety. Yet despite increasing demand from consumers, the formulator faces certain restrictions regarding the optimum equilibrium between the active compound concentration and the formulation base taking into account the nature of the skin structure, mainly concerning to the ideal penetration of the active compound, due to the natural skin barrier. Emulsion is a mixture of two immiscible phases, and the interest in nanoscale emulsion has been growing considerably in recent decades due to its specific attributes such as high stability, attractive appearance and drug delivery properties; therefore, performance is expected to improve using a lipid‐based nanocarrier. Nanoemulsions are generated by different approaches: the so‐called high‐energy and low‐energy methods. The global overview of these mechanisms and different alternatives for each method are presented in this paper, along with their benefits and drawbacks. As a cosmetics formulation is reflected in product delivery to consumers, nanoemulsion development with prospects for large‐scale production is one of the key attributes in the method selection process. Thus, the aim of this review was to highlight the main high‐ and low‐energy methods applicable in cosmetics and dermatological product development, their specificities, recent research on these methods in the cosmetics and consideration for the process selection optimization. The specific process with regard to inorganic nanoparticles, polymer nanoparticles and nanocapsule formulation is not considered in this paper.

Avaliação da contaminação microbiana em drogas vegetais

The increasing consumption of natural drugs has made their use a Public Health issue, due to the possibility of accessing products without quality. The concern about quality is mainly due to the potential microbiological contamination of the products, by their natural origin. Ninety-one samples of sixty-five herbal species were evaluated in relation to microbial contamination. Results indicated that 92.3% of the herbal drugs failed to comply with the pharmacopeial parameters of acceptance and therefore, it suggests that regulatory and educational measures are needed in order to guarantee the quality of these products.

Sterilization by pure oxygen plasma and by oxygen-hydrogen peroxide plasma: an efficacy study.

Plasma is an innovative sterilization method characterized by a low toxicity to operators and patients, and also by its operation at temperatures close to room temperatures. The use of different parameters for this method of sterilization and the corresponding results were analyzed in this study. A low-pressure inductive discharge was used to study the plasma sterilization processes. Oxygen and a mixture of oxygen and hydrogen peroxide were used as plasma source gases. The efficacy of the processes using different combinations of parameters such as plasma-generation method, type of gas, pressure, gas flow rate, temperature, power, and exposure time was evaluated. Two phases were developed for the processes, one using pure oxygen and the other a mixture of gases. Bacillus subtilis var. niger ATCC 9372 (Bacillus atrophaeus) spores inoculated on glass coverslips were used as biological indicators to evaluate the efficacy of the processes. All cycles were carried out in triplicate for different sublethal exposure times to calculate the D value by the enumeration method. The pour-plate technique was used to quantify the spores. D values of between 8 and 3 min were obtained. Best results were achieved at high power levels (350 and 400 W) using pure oxygen, showing that plasma sterilization is a promising alternative to other sterilization methods.

In Vitro Release Kinetics of Antituberculosis Drugs from Nanoparticles Assessed Using a Modified Dissolution Apparatus

The aim of this study was to assess the in vitro release kinetics of antituberculosis drug-loaded nanoparticles (NPs) using a “modified” cylindrical apparatus fitted with a regenerated cellulose membrane attached to a standard dissolution apparatus (modifiedcylinder method). The model drugs that were used were rifampicin (RIF) and moxifloxacin hydrochloride (MX). Gelatin and polybutyl cyanoacrylate (PBCA) NPs were evaluated as the nanocarriers, respectively. The dissolution and release kinetics of the drugs from loaded NPs were studied in different media using the modified cylinder method and dialysis bag technique was used as the control technique. The results showed that use of the modified cylinder method resulted in different release profiles associated with unique release mechanisms for the nanocarrier systems investigated. The modified cylinder method also permitted discrimination between forced and normal in vitro release of the model drugs from gelatin NPs in the presence or absence of enzymatic degradation. The use of dialysis bag technique resulted in an inability to differentiate between the mechanisms of drug release from the NPs in these cases. This approach offers an effective tool to investigate in vitro release of RIF and MX from NPs, which further indicate that this technique can be used for performance testing of nanosized carrier systems.

Monitoração de propaganda e publicidade de medicamentos: âmbito de São Paulo

A Organizacao Mundial de Saude (OMS) tem por objetivo o controle politico de acesso, de qualidade/seguranca e de uso racional, no que se refere a medicamentos. Este ultimo item salienta a relevante questao do uso incorreto de medicamentos induzido por promocoes que visam exclusivamente a lucros. O presente trabalho apresenta os resultados de um projeto cujo objetivo foi acompanhar e analisar, do ponto de vista legal e farmacologico, as informacoes veiculadas por diferentes meios de comunicacao atraves da propaganda, auxiliando a ANVISA na monitoracao de propaganda e publicidade de medicamentos de venda livre ou com receita medica, bem como, dando suporte as medidas corretivas pertinentes, visando a garantir a seguranca sanitaria de produtos, servicos e, principalmente, da populacao. O projeto abrangeu cinco regioes brasileiras, sob a responsabilidade de quatorze universidades. Para atingir o objetivo proposto, realizou-se, durante 12 meses, a coleta do material publicitario: 55,1% retirado de (dois pontos) consultorios medicos, hospitais publicos e congressos, 15,8% de jornais e revistas, 8,9% de emissoras de radio e 20,2% de televisao. A analise do material foi realizada tendo por base a RDC no 102, publicada em 01/12/2000 (em vigor desde o dia 01/06/2001), e as demais legislacoes sanitarias vigentes, bem como a bibliografia cientifica aplicavel. Os resultados obtidos para produto de venda livre revelaram que 3,6% dos produtos veiculados nos anuncios analisados nao eram registrados na ANVISA (Artigo 4o, inciso I) e que 17,5% das campanhas publicitarias nao apresentaram a principal contra-indicacao do medicamento (Artigo 3o, inciso I). Observou-se, ainda, que 15,5% do material analisado estimulavam e/ou induziam ao uso indiscriminado de medicamentos, cujo consumo exige prescricao medica e que 38,5% das campanhas de vendas com receita medica nao apresentavam o numero do registro no Ministerio da Saude. Tais resultados serao importantes para o aperfeicoamento das medidas regulatorias e a implementacao de politicas de educacao e conscientizacao referentes a publicidade de medicamentos. Os dados obtidos igualmente evidenciam a importância do monitoramento desse tipo diferenciado de publicidade a fim de garantir informacoes reais aos consumidores, cuja saude pode ser posta em risco em consequencia de propaganda enganosa.

Comparison of three experimental designs employed in gentamicin microbiological assay through agar diffusion

Gentamicin is a broad-spectrum antibiotic complex produced by actinomycetes belonging to Micromonospora genus and classified among aminoglycoside antibiotics, used in the treatment of serious infections derived from Gram-negative microorganisms. Alterations of their antimicrobial activity not shown in chemical assays can be evaluated through microbiological assays. The aim of this work was to compare 5 x 1, 2 x 2 and 3 x 1 experimental designs, evaluating validation parameters of specificity, linearity, range, precision, and accuracy for each experimental design in different levels of concentration, presentation, and lots. It consisted of 81 assays (in 3 replicas) of gentamicin microbiological dosage. The concentrations of the solutions used were employed in a range from 1.0 μg/mL to 5.0 μg/mL, diluted in phosphate buffer 0.1 M pH 8.0. Antibiotic medium number 11 was used, with Staphyloccocus epidermis (ATCC 12228). 21ml of medium were used as base layer and 4 ml of medium inoculated at 1% were used as surface layer. The dishes were incubated for 18 hours at 37 ± 1 oC. The three designs employed showed adequate specificity for analysis of dermatological cream and injectable solution containing gentamicin sulphate. They also showed accuracy and linearity in the range evaluated, but not a significant difference concerning precision. The results were compared by means of the determination of the rates of measurement system capacity. The statistical analysis demonstrated that there is no significant difference among the results obtained through 5 x 1, 2 x 2, and 3 x 1, being these equivalent and interchangeable.

Descontaminação de drogas vegetais empregando irradiação gama e óxido de etileno: aspectos microbianos e químicos

The sanitary quality of vegetal drugs, as well as the use of decontamination methods are important steps towards the consumer safety, mainly due to the fact that these products are usually used by sick and with weak immunocompromised persons. In Brazil, the RDC 48/ 2004 mention the contamination research as well as the efficacy of the decontaminated product. The purpose of this work is to evaluate the effects of ethylene oxide fumigation and gamma irradiation on the microbial burden and some chemical constituents of ginkgo and guarana. The initial microbial burden was 3,2x106, on average, for total aerobic microorganisms and 3,0x105 for fungi. Both methods proved to be effective in the microbial burden reduction. The analyses using high performance liquid chromatography revealed the absence of significant alterations in the flavonol glycosides and caffein contents, respectively for ginkgo and guarana.

Antibiotic microbial assay using kinetic-reading microplate system

O objetivo deste trabalho e determinar as condicoes experimentais ideais para o desenvolvimento de metodologia para a dosagem microbiologica de apramicina empregando microplacas e modo de leitura cinetico e validar o metodo desenvolvido, atraves da avaliacao dos parâmetros de especificidade e seletividade, linearidade, faixa ou intervalo linear, limite de deteccao e quantificacao, exatidao e precisao. O ensaio turbidimetrico e simples: a solucao-teste e adicionada a suspensao de microrganismo-teste em meio de cultura, a mistura e incubada em condicoes apropriadas e o crescimento microbiano e medido por meio de leitura fotometrica. O emprego de metodo de microplacas com leitura cinetica para a dosagem de antibioticos e de interesse consideravel, uma vez que possibilita reduzir quantidade de material e tempo de analise necessarios e permite o ensaio de grande numero de amostras simultaneamente, com leitura e calculo automatizados. As condicoes estabelecidas abrangem curva-padrao de apramicina com concentracoes entre 5 e 35 μg/mL, e emprego de meio de cultura caldo de triptona-soja inoculado com Escherichia coli (ATCC 8739) na proporcao de 5%. Foram obtidos resultados satisfatorios apos 2 horas de incubacao. O metodo desenvolvido apresentou especificidade e seletividade adequadas, linearidade na faixa de 5 a 35 μg/mL, limite de deteccao e quantificacao de 0,1 e 0,4 μg/mL, respectivamente, exatidao (recuperacao = 98,5%) e precisao (DPR = 6,0%) satisfatorias. O ensaio em microplaca agrega caracteristicas dos ensaios microbiologicos (avaliacao da atividade do antibiotico frente a microrganismo-teste sensivel) e fisico-quimicos (facilidade operacional e maior rapidez na obtencao dos resultados).

Antimicrobial activity of four different dental gel formulas on cariogenic bacteria evaluated using the linear regression method

A atividade antimicrobiana de quatro diferentes formulas de gel dental foi avaliada empregando tres microrganismos associados a cariogenese: Streptococcus mutans, Lactobacillus casei e Actinomyces viscosus. A avaliacao preliminar foi efetuada utilizando metodo por difusao em agar. Alem disso, as formulas foram desafiadas empregando cada microrganismo e as determinacoes relativas aos sobreviventes foram efetuadas apos 1, 5, 10, 20 e 30 minutos do desafio. O tempo de reducao decimal (valor-D) foi calculado por meio das curvas obtidas (UFC/mL x tempo), objetivando a comparacao da atividade antimicrobiana entre as formulas. O metodo selecionado para a enumeracao dos sobreviventes foi validado de acordo com compendio oficial. Os resultados revelaram intensa atividade antimicrobiana, inclusive na avaliacao empregando diluicao 1:2 dos produtos para os microrganismos Streptococcus mutans e Lactobacillus casei. Os dados relativos ao Actinomyces viscosus indicaram ausencia de reducao da populacao microbiana no desafio empregando produto diluido (1:2). Os valores-D obtidos foram 0,21, 2,08, 1,93 e 5,79 minutos para as formulas 1, 2, 3 e 4 respectivamente. Apos comparacao dos resultados obtidos, a formula 1 pode ser considerada aquela que apresentou maior atividade antimicrobiana.