Anti-inflamatório, controle de qualidade, ensaios físico-químicos, farmacopeia brasileira
Resumo
Introdução: A prednisona é um glicocorticoide utilizado para o tratamento de artrite, hepatite e doenças autoimunes. Alguns lotes de medicamentos podem não cumprir com rigor os padrões de qualidade exigidos, o que pode resultar em ineficácia terapêutica ou toxicidade. Portanto, o controle de qualidade visa assegurar a eficácia de produtos farmacêuticos. Objetivo: Avaliar a qualidade da matéria-prima e de comprimidos de prednisona através dos testes preconizados pela Farmacopeia Brasileira 6ª edição (2019) para determinação dos padrões de qualidade. Material e métodos: A matéria-prima de prednisona procedeu-se da empresa distribuidora de insumos e o medicamento genérico da prednisona foi adquirido em uma drogaria em Campo Grande – MS. As análises designadas para matéria-prima foram: organoléptica, reação colorimétrica, ponto de fusão, solubilidade e cromatografia em camada delgada (CCD); enquanto para os comprimidos foram realizadas as análises organoléptica, peso médio, friabilidade, dureza e desintegração. Resultados: Quanto às análises organolépticas, a prednisona matériaprima possuía característica de pó amorfo, entretanto, a Farmacopeia descreve a aparência da prednisona como pó cristalino, evidenciando uma divergência; já os comprimidos estavam íntegros e as embalagens em boas condições. Formaram-se as colorações esperadas para a reação colorimétrica: laranja seguido de verde-azulado. A faixa de fusão obtida foi de 230ºC à 245ºC e estava em divergência com a literatura. A amostra apresentou-se muito pouco solúvel em água. Na CCD, obtiveram-se os fatores de retenção (Rf) de 0,6 para a matéria-prima e 0,5 para a amostra comercial. O peso médio + DPR (%) obtido foi de 217mg ± 6,03; friabilidade de 0,63; dureza média (N) de 43,65 e desintegração (min) de 06 min e 30 segundos. Ao todo, os resultados mostraram-se satisfatórios, observando que as amostras foram aprovadas na maioria dos ensaios. Conclusão: Diante desses resultados, a matéria-prima e os comprimidos não apresentaram desvios dos padrões de qualidade pré-estabelecidos, mostrando-se seguros e eficazes.
Publicado
2021-04-29
Como Citar
Silva, L. B., Ikeda, N. S., Rocco, . L. C., Oshiro, M. B., & Sversut, R. A. (2021). AVALIAÇÃO DA QUALIDADE FÍSICO-QUÍMICA DA MATÉRIAPRIMA E DOS COMPRIMIDOS GENÉRICOS DE PREDNISONA. Revista Multidisciplinar Em Saúde, 2(1), 30. https://doi.org/10.51161/rems/1046
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