Obtenção e caracterização de formulação fitoterápica contendo extrato e tintura padronizados de arnica montana l e aesculus hippocastanum l

Abstract

Because of the wide dissemination and use of medicinal plants, industries are producing products based on plant species, such as extracts and tinctures, which are mainly used by pharmacy with handling. However, it is questionable collateral for the vast majority of these products as to their efficacy, safety and quality, and may bring risks to the user's health. So, it is important to perform quality control for herbal products, according to current legislation. The formulation that gave rise to the research is a carbopol gel containing Arnica montana L dye and Aesculus hippocastanum L extract. The present study aimed at obtaining and characterization of said formulation and validate the use of methods of pharmaceutical technology by performing the standardization of Aesculus hippocastanum L extract and Arnica montana L dye, to the physio-chemical evaluation were performed: microbiological control, organo-leptical characterization, determination of pH, density, dry, loss on drying, determine the level solids, rheological behavior, concentration, lyophilization and chemical prospecting of plant inputs. For the phytochemical analysis was performed Thin Layer Chromatography of Arnica tincture (TLC) and Thin Layer Chromatography In Comparative (TLCC) Aesculus extract, Infrared and Thermal Analysis of both extracts as the formulation. For physicochemical characterization and validation of analysis Reports of the two plant species suppliers the results are within the parameters established by the Brazilian Pharmacopoeia Fifth Ed. The microbiologic control was to prove the absence of pathogenic microorganisms, the results indicated microorganisms absence of, for microbial contamination of the inputs can change the stability of the final product and further characterize risk of infection to the user. The chemical prospecting of plant species, was to identify relevant secondary metabolites, in the case of A. hippocastanum indicated the presence of saponins, represented by escin which is responsible for the pharmacological activity, was an important clue to the certification of the authenticity of the raw material in study. The viscosity of vegetable raw materials and formulation were determined by the rheometer of Brookfield, the extracts showed fluid behavior and Newtonian formulation showed a pseudo plastic behavior. The result of the Thin Layer Chromatography (TLC), assisted in the identification of the sample and possible tampering that could have occurred as well as the TLCC served to demonstrate the selectivity of the method as identified the presence of aescin, substance responsible for pharmacological activity Chestnut from India. In the validation of Arnica montana L. dye, it was detected by HPLC the presence of the rutin in the sample in nature with retention time 10.84 min. The infrared analyzes the plant species were observerd bands that may indicate the presence of the major chemical markers in the case Arnica indicated the presence of the rutin and escin in the presence of horse chestnut extract. In the thermal analysis TG / DTA, we can say that the first decomposition event occurred for the samples to 150 ° C, corresponding to weight loss, the values were 6.5 and 8% for the chestnut and arnica respectively. All results were significant for the characterization and quality control, used as benchmark for the standardization of the extract and tincture, the information obtained was also used for the certification of suppliers of extracts and tinctures for drugstores in Belém.