APLICAÇÃO DO ENSAIO DE DISSOLUÇÃO NA AVALIAÇÃO DA QUALIDADE DE MEDICAMENTOS FITOTERÁPICOS À BASE DE Passiflora sp / APPLICATION OF TEST TO EVALUATE THE SOLUTION QUALITY OF HERBAL MEDICINES BASED Passiflora sp

AUTOR(ES)
DATA DE PUBLICAÇÃO

2008

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.

ASSUNTO(S)

natural products determination 1. fitoterapia controle de qualidade 2. passiflora sp 3. farmacologia - pesquisa 4. flavonóides 5. teste de, dissolução 6. flora medicinal - indústria flavonoids flavonóides validation farmacologia doseamento quality control validação produtos naturais controle de qualidade

ACESSO AO ARTIGO

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