Farmacovigilância em fitoterapia: qualidade de drogas vegetais e fitoterápicos empregados para perda de peso em São Luís, Maranhão, Brasil

Abstract

Plants are used for various diseases, notably the growing popular use for weight loss; this partly reflects the restriction on synthetic products. Situation that brings concern, considering the possible risks and adverse effects to the use of plant species without validation study; also associated with the belief in the innocuous naturalness of these products. Assuming that several plants and their derivative preparations have been widely popularly used without validation, the aim of this paper was to evaluate the quality and the conditions of commercialization of plant drugs and phytotherapeutic preparations for weight loss in São Luís, Maranhão, Brazil; to contribute with Pharmacovigilance actions in Phytotherapy. Based on data from the Regional Council of Pharmacy of the State of Maranhão, 16 pharmacies (F1-F16) were selected to investigate commercialization conditions, using semi-structured interviews with pharmacists, pharmacy owners or assistants pharmacies. Citrus aurantium dulcis L. (red orange), Camellia sinensis L. (green tea), Opuntia ficus-indica L. (Indian fig), Hibiscus sabdariffa L. (hibiscus) and Morus alba L. (blackberry) were identified as the most commercialized plant species. In the next, 06 (six) samples of 03 (three) species frequently marketed in these weight loss establishments were acquired, as follows: Citrus aurantium, Hibiscus sabdariffa and Morus alba , all in capsule form, totaling 18 (eighteen) samples; followed by the quality assessment, based on the integrity (qualitative assessment and determination of chemical constituents) and purity (macroscopic identification, ash content, humidity, microbiological contamination and strange material) parameters. The results showed inadequate marketing conditions in selected pharmaceutical establishments, highlighting serious sanitary infractions, such as: absence of the pharmacist in 02 (two) establishments, corresponding to 12.5%. All samples of dry extract and plant drug capsules of the acquired species proved to be of poor quality regarding purity and integrity parameters, with phytochemical screening and assay of divergent chemical constituents, in disagreement with determinations in the specialized literature, and chromatographic profiles without presence of analytical marker in 61.11% of the samples. All samples of dry extract and plant drug capsules of the acquired species proved to be of poor quality regarding purity and integrity parameters, with phytochemical screening and assay of divergent chemical constituents, in disagreement with determinations in the specialized literature, and chromatographic profiles without presence of analytical marker in 61.11% of the samples. In addition, non-compliance was found for moisture and ash analysis in 12 (twelve) (75.00%) and 09 (nine) (56.25%) of the samples, respectively. Thus, the results of this study show the need for Pharmacovigilance in Phytotherapy, with improvements in the supervision, surveillance and quality control of plant material available for medicinal purposes in the capital of Maranhão.