Evaluación del extracto hidroalcohólico de Passiflora mixta y pre formulación de un elixir.

Abstract

The current research work aimed to assess the hydro alcoholic extract to 85% of Passiflora mixta and the pre formulation of an elixir; the quality standards of the vegetable matter were assessed according to the specifications of the Spanish Farmacopea. The hydro alcoholic extract was gotten by percolation and the quality control was performed according to the methodology suggested in the Ecuadorian Phyto pharmaceuticals Norm. It was determined the presence of chemical group by means of phytochemical screening; it was made the presumptive identification of glycosylated flavonoids by Chromatography of Thin Layer (CTL); Whole Phenols and flavonoids were quantified in the extract of P. mixta; by means of the essay of catchment of free radicals with the radical 2,2-difenil-1-picrilhydrazil. (DPPH*) the antioxidant activity of the extract was determined, it was also made stability environment. The control of quality of the excipients was made regarding the parameters stated in the American Farmacopea. The elixirs to pH 4,5 and 6 were bottled in amber containers and were subjected to an accelerated stability study at 45°C for 30 days, by means of chromatographic and spectrumphotometrical analysis, the degradation of flavonoids in the formulas was proved and finally, with the official microbiological analysis it was guaranteed the quality of the final product, according to the methodology of the USP 28. The phenolic content was 495 mg GAE/ mL of extract, flavonoids were 24,008 mg QE/ mL extract of P. mixta and the IC 50 was 168,14 µl/mL. It is concluded that the elixir to pH5 showed a concentration of 23,21 mg QE/mL close to the value of the P. mixta extract. It is recommended to carry out an accelerated stability study in the long run to verify that the organoleptic and physical-chemical characteristics of the product do not get altered.