avaliação de pirogênios em produtos de uso veterinário pelos testes da hipertermia em coelhos e do lisado de amebócitos do limulus pyrogens in veterinary products by the rabbit pyrogen test and the limulus amoebocyte lysate test

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ID: 164614
2007
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Abstract
Realizou-se a avaliação de pirogênios em produtos veterinários de uso parenteral, pelo método da hipertermia em coelhos, calculando-se, para o teste das amostras, doses com concentrações de três a sete vezes superiores à terapêutica. Preconizou-se como resposta positiva o aumento de temperatura de 0,6°C. Utilizou-se também o ensaio do lisado de amebócitos do Limulus (LAL) por geleificação, semiquantitativo, executando o teste de interferentes, validando o procedimento e estabelecendo a máxima diluição válida para a análise de cada produto. Paralelamente, efetuou-se avaliação comparativa de amostras com o método do LAL cromogênico, quantitativo, demonstrando correlação e reprodutibilidade dos resultados. Avaliaram-se vinte e oito produtos de diferentes classes farmacológicas, observando-se que dois não cumpriram as especificações, sendo reprovados. Sugere-se que as especificações estudadas sejam adotadas, contribuindo para aprimorar o controle de contaminantes, garantindo a qualidade e a segurança dos produtos veterinários.
The rabbit pyrogen test was used to evaluate veterinary products, suggesting the temperature rise of 0.6°C as the ending point for the positive results. The test doses were calculated based on the therapeutic dose increased from three to seven times. The semi-quantitative Limulus amoebocyte lysate (LAL) gel clot test was performed and compared to the LAL spectrophotometric chromogenic, quantitative assay. The comparative evaluation of the samples showed correlation and reproducibility of the results. The interference test was carried out, the procedure validated and the maximum valid dilution established for the analysis of the products without Pharmacopoeial specifications. Two of the twenty-eight products of different pharmacological groups evaluated didn't meet the requirements and were reproved. The specifications investigated are suggested to be used for the purity evaluation of the veterinary parenteral products, as a contribution to assure the quality and safety of the products.
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barth2007cinciaavaliao Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors ;Thiago Barth;Volmir João Dalmora;Felipe Bianchini D'Avila;Sérgio Luiz Dalmora
Journal Trials
Year 2007
DOI
10.1590/S0103-84782007000100030
URL
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0103-84782007000100030
Keywords
rabbit

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