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Previous issue date: 2008 / Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde / Todos produtos injetáveis devem estar livres de pirogênio. Existem dois métodos oficiais para a detecção da contaminação pirogênica: o teste em coelhos e o teste do Lisado do Amebócito de Limulus (LAL), também denominado como ensaio de endotoxina. Entretanto, o LAL tem como limitação detectar somente endotoxinas e sofrer interferências do ajuste do pH, por cátions que neutralizam as cargas negativas das endotoxinas, das altas concentrações de sais, por quelantes que capturam cátions bivalentes e etc. No caso das análises de produtos biológicos (soros hiperimunes, hemoderivados etc), não há reação, possibilitando a resposta de resultados falsos negativos. O Instituto Nacional de Controle de Qualidade em Saúde (INCQS) analisa diversos produtos injetáveis, entre eles, os soros hiperimunes (antivenenos, anti-rábico, anti-tetânico etc) que são distribuídos pelo Programa Nacional de Imunização(PNI/MS) aos postos de saúde. Pela Farmacopéia Brasileira, coelhos que tenham recebido estes produtos no teste de pirogênio não podem ser reutilizados com outros produtos biológicos. Este fato implica na utilização de um grande número de animais para estas análises. / Injectable products must to be free of any kind of pyrogenic contamination. Two methods are the official ones for testing this contamination: the Rabbit Test and the Limulus Amoebocyte Lysate Test (LAL) or so called, Endotoxin Assay. However, LAL is limited only for detecting endotoxin, besides suffering some kind of interferences, it is not possible to test biological products, such as hyperimmune sera, blood derivates etc), since these products produce false-negative results. The National Institute of Quality Control in Health (INCQS) perform analysis of a great variety of injectable products, among them, we find anti-venom, anti-rabies and anti-tetanus sera. The Brazilian Pharmacopoeia states that rabbit which have received previous injection of a biological products is not allowed to be re-used in another assay for the same kind of product. This fact implies on using a great number of animals. Due to the lack of information in the scientific literature about the re-use of rabbits which have received previous injection of hyperimmune sera, this study was elaborated using an experimental design where animals were divided into four groups that received from a single injection of 1ng/mL spiked sera up to a group that received 3 negative sera injections in a 48 hours interval and challenged on day 7 with spiked serum. Results showed that the response to the positive stimulus did not presented significant statistical difference, independently of the amount of negative sera previously injected. So, it was possible to conclude that for Anti-Bothrops, Anti-rabies and Anti-tetanus sera it is possible to reuse rabbits for 4 times within a 7-day period.
| Identifer | oai:union.ndltd.org:IBICT/oai:www.arca.fiocruz.br:icict/9266 |
| Date | January 2008 |
| Creators | Freitas, Carlos Borges Rolim |
| Contributors | Zamith, Helena Pereira da Silva, Miranda, Ana Luiza Palhares de, Mattos, Rita de Cássia Oliveira da Costa, Delgado, Isabella Fernandes, Delgado, Isabella Fernandes |
| Source Sets | IBICT Brazilian ETDs |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, info:eu-repo/semantics/masterThesis |
| Source | reponame:Repositório Institucional da FIOCRUZ, instname:Fundação Oswaldo Cruz, instacron:FIOCRUZ |
| Rights | info:eu-repo/semantics/openAccess |
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