APLICAÇÃO DO ENSAIO DE DISSOLUÇÃO NA AVALIAÇÃO DA QUALIDADE DE MEDICAMENTOS FITOTERÁPICOS À BASE DE Passiflora sp
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Data
2008-10-29
Autores
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Universidade Federal de Goiás
Resumo
Phytomedicines must to have as active ingredients only products derived
from plants. The quality control of these medicines has not yet properly
established criteria even with the growing consumption of these drugs
worldwide. Among the assays to evaluate the quality there is the test of
dissolution, used to examine the release of the active principle from a capsule
or tablet in medium that simulates the place of their absorption. Among the
nature drugs best known there is Passiflora incarnata L., whose possess
sedative action. The C-flavonoid glycosides vitexin and isovitexin are the main
components found in aereal parts of Passiflora sp and are used as markers of
the genus in the tests of quality control. This study was conducted to apply the
test of dissolution to phytotherapy containing passion flower. The method for
quantifying of capsules and tablets used was the spectrophotometric assay
described in British Pharmacopoeia (2007) to the powder of P. incarnata. The
method has been validated for capsules and then used in the tests of
dissolution, with apparatus shovel, 37 C ± 0.5 ° C, speed of 50 rpm in 500 mL of
the medium of dissolution 0.1 M HCl pH 1.2, collecting 50 ml at the end of 30
minutes. We have investigated an alternative method for quantification of total
flavonoids in ultraviolet spectrophotometer , in a wavelength of 269 nm or 350
nm, looking for a more simple and quick method to be used in routine testing,
and because be less polluting and unhealthy. In the tests carried out to quantify
the levels of total flavonoids found for the manipulated capsules were 2% for
powder and 0.975 % for dry extract; for industrialized tablets the levels were
5.5% and 1.52%. The dissolution assay of the pharmaceutical forms at this
study showed that the capsules containing dry extract or powder and one of the
industrialized tablets showed 87%, 75% e 76%, respectively, of dissolution
within 30 minutes of tests. In relation to the proposed alternative method, was
selected the wavelength 350 nm for direct quantification of flavonoids presents
in the phytomedicines and at the medium of dissolution. It can be noted that the
results were consistent and similar to the datas of the validated method: 85% to
dry extract, 80% to powder e 75% to one of the industrialized tablets. Whereas
the phytomedicines represent a niche market and an opportunity for
diversification of the national pharmaceutical industry, it is necessary to defined
parameters of quality to ensure its therapeutic action. So, the studies of
dissolution are an essential tool which helps to ensuring the quality of these
medicines.
Descrição
Palavras-chave
produtos naturais , flavonóides , controle de qualidade , doseamento , validação , natural products , flavonoids , quality control , determination , validation , 1. Fitoterapia Controle de Qualidade 2. Passiflora sp 3. Farmacologia - Pesquisa 4. Flavonóides 5. Teste de, dissolução 6. Flora medicinal - Indústria
Citação
COSTA, Ane Rosalina Trento. APPLICATION OF TEST TO EVALUATE THE SOLUTION
QUALITY OF HERBAL MEDICINES BASED
Passiflora sp. 2008. 108 f. Dissertação (Mestrado em Ciências da Saúde - Farmácia) - Universidade Federal de Goiás, Goiânia, 2008.