Análise microbiológica de matérias primas e formulações farmacêuticas magistrais
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Data
2005-12
Título da Revista
ISSN da Revista
Título de Volume
Editor
Marize Campos Valadares
Resumo
In agreement with Good Manufacturing Practice, pharmaceutical products must have a quality
according to specifications set by official compendia assuring their use. The microbiological quality of raw material
employed in pharmaceutical and cosmetic formulations is very important to achieve efficacy and safety. In this work it
was done the heterotrophic bacteria count, the total viable aerobic count, yeasts and moulds count, detection of
pathogenic bacteria in samples of purified water, plant raw materials, natural products and in formula base of creams,
lotions and gels. The applied methods and the specifications were based on Pharmacopeas or World Health
Organization.The results showed that 86.3% of analysed samples were according to the parameters. The
microbiological quality of deionizated water demonstrated a problem to pharmacies and it was verified that 65% of
them were above the specifications. It was found that 97.17% of the formulations were with microbial counts in the
permited limit. The plant raw materials and natural products showed values of 3.51% and 10.5%, respectively in
disagreement with the specifications. The obtained data demonstrated that the Good Manufacturing Practice applied to pharmacies contribute to microbiological quality of the pharmaceutical products, however, critical points must be
solved, as the quality of the deionizated water used must be improved.
Descrição
Palavras-chave
Controle de qualidade microbiológico, Água deionizada, Matéria-prima vegetal, Produtos farmacêuticos semi-acabados, Microbiological quality control, Pharmaceutical products, Vegetable raw material, Deionizated water
Citação
ANDRADE, Flávia R. O.; SOUZA, Aline A.; ARANTES, Maria do Carmo Batista; PAULA, José Realino de; BARA, Maria Teresa Freitas. Análise microbiológica de matérias primas e formulações farmacêuticas magistrais. Revista Eletrônica de Farmácia, Goiânia, v. 2, n. 2, p. 38-44, jul./dez. 2005. Disponível em: <https://www.revistas.ufg.br/REF/article/view/1948/1882>.