Ensaio de dissolução de fitoterápicos contendo Maytenus ilicifolia Mart ex Reiss (Celastraceae): validação de métodos para quantificação de catequina e epicatequina

• Autor(a) principal: LEAL, Ana Flavia Vasconcelos Borges
• Data de Publicação: 2010
• Tipo de documento: Dissertação
• Idioma: por
• Título da fonte: Repositório Institucional da UFG
• dARK ID: ark:/38995/0013000001g48
• Texto Completo: http://repositorio.bc.ufg.br/tede/handle/tde/2101
• topic: Controle de qualidade; dissolução; Maytenus ilicifolia; fitoterápicos.; 1.Maytenus ilicifolia 2. Dissolução 3. Fitoterápicos; Quality control; dissolution; Maytenus ilicifolia; herbal medicines.; CNPQ::CIENCIAS BIOLOGICAS::FARMACOLOGIA

Maytenus ilicifolia Mart ex Reiss (Celastraceae) popularly known in Brazil as espinheirasanta is used against gastric disorders and ulcers. Quality of herbal medicines is essential to ensure the safety and efficacy of the drug. The dissolution test is an essential tool to assess the quality of herbal medicines in the solid dosage form for oral use. This work aimed to evaluate the dissolution behavior of eleven herbal medicines containing Maytenus ilicifolia, produced with powder or dry extract, purchased in local shops (Goiânia-GO, Brazil). Assay of catechin and epicatechin by high-pressure liquid chromatography (HPLC) and dissolution methods were validated and obtained results allowed the quantification of these markers with precision, accuracy and selectivity. The dissolution profiles have been determined adopting the following conditions: paddle apparatus at 75 rpm and HCl 0.1 M (900 mL at 37°C ± 0.5°C) as dissolution medium. Through the dissolution profiles it has been determined the mathematical model of release (first order), the percentage of catechin and epicatechin dissolved at 45 minutes and the efficiency of dissolution. Capsule containing powder showed rapid release of the markers in the medium (Q>85% in 12 minutes). Tests conducted to verify the quality of herbal medicines were average weight, weight variation, dissolution, chromatographic profile and sensory analysis. It was found that only 45.5% of analyzed herbal medicines products provide satisfactory results. The dissolution test, sensory analysis, average weight, weight variation and chromatographic profile were responsible for noncompliance of, respectively, 18.2%, 18.2%, 18.2%, 9.1% and 36.4% of the samples. Obtained data demonstrated the need to implement these tests in quality control of herbal medicines, so by investigating the release of the active ingredients of these medicines.