Atividade espasmolítica da nova fórmula de um medicamento fitoterápico- Funchicórea®, pó: ensaio farmacológico de estabilidade para controle de qualidade biológico

Abstract

Funchicórea® is a traditional Brazilian herbal medicine used in folk medicine for over 50 years, indicated for constipation and intestinal colic in newborns. The traditional use of the product subsidizes its safety and effectiveness. However, the current legislation recommends the performance of tests that prove the safety, efficacy and stability of the formulation. Thus, in 2012, the first study was carried out in the cardiovascular pharmacology laboratory at UFPB, proving that funchicórea® promoted increased intestinal transit in constipated mice of both sexes and reduced spasmodic activity in guinea pig ileum. However, in 2020, ANVISA demanded the modification of the formulation with the discontinuation of fennel oil and with that requested new studies to prove the maintenance of biological activity, as well as accelerated and long-term stability tests. Therefore, this study aimed to evaluate the spasmolytic activity, in the ileum of rats, of the new formulation of the herbal product Funchicórea®, based on the Resolution of the Collegiate Board of Directors - RDC No. 26, of May 13, 2014 and RDC No. 318, of November 6, 2019 that advocate the registration of herbal medicines and stability studies. In addition, evaluate its antioxidant mechanism of action. With the results, we observed that the change of the formulation of funchicórea®, did not change its potency and effectiveness. In its mechanism of action, it was possible to verify that in the DPPH tests (in vitro), funchicórea® has a low oxidizing effect. However, when there is the induction of oxidative stress through Ang II, in the iliac strips, the formulation demonstrates potent attenuation of ROS production, with an effect compared to the NADPH inhibitor, apocynin. During the long-term stability tests for twelve months and accelerated six and nine months, a standardization of the funchicórea® effect was observed over time, that is, maintenance of potency and efficacy. Thus, it is concluded that the new formulation of funchicórea® is effective and stable during the year and has a possible mechanism of antioxidant action.