Farmacovigilância em fitoterapia: qualidade de drogas vegetais e fitoterápicos empregados em doenças do aparelho digestivo em São Luís, Maranhão, Brasil

Abstract

The use of plants and/or their derived products is an important therapeutic resource being on the rise worldwide, stimulated by difficult access to health services, cultural legacy, tendency to self-medication, fads and widespread misrepresentation of the absence of side effects and contraindication. But in the analysis of the increase of the use of vegetal products for therapeutic purposes it is verified that the quality of such products is worrisome, mainly due to the problems of authenticity, purity and integrity of the vegetal raw materials which contribute to poor product quality. Whereas several plants and their derived preparations have been widely used popularly in uncertified digestive disorders; this work aims to evaluate the conditions of commercialization and quality of vegetal drugs and phytotherapeutic preparations for such disorders made available in pharmacies in the city of São Luís, Maranhão, Brazil. Based on data from the State Pharmacy Council of the State of Maranhão, 11 pharmacies (F1 - F11) were selected to investigate marketing conditions, using semi-structured interviews with pharmacists, pharmacy owners or auxiliaries. Maytenus ilicifolia Mart. ex Reissek (espinheira santa) e Baccharis trimera (Less.) DC. (carqueja) were identified as the most commercialized plant species. In the next step, samples of these products were obtained, in the form of capsules of the vegetal drug or the dry extract, followed by an experimental study for quality evaluation. The results allowed us to detect inadequate marketing conditions in selected pharmaceutical establishments, highlighting serious sanitary infractions. There was a difference in staining between the samples, as well as the presence of arthropods in a sample of the pharmacy identified as F1. In the evaluation of the water content, all samples had a moisture percentage above 5%. The analysis of purity and integrity of the samples showed poor quality, and the presence of the analytical marker(s) and/or active(s) defined in the specialized literature was not evidenced. Thus, the results allow us to highlight the need for greater supervision, surveillance and quality control of plant material for medicinal purposes made available for commercialization.