Ensayos preliminares para la preformulación de un fitofármaco a base de fracciones activas presentes en las hojas de Desmodium molliculum

Abstract

Plant extracts are essential in traditional medicine due to their pharmacological properties; However, information on the stability of Desmodium molliculum extract in phytotherapeutics is scarce. The objective of this study was to establish preliminary trials for the preformulation of a stable oral phytopharmaceutical from active fractions present in the leaves of Desmodium molliculum. The research was experimental, with the raw material being the extract obtained from the percolation of the dry leaves, which after being degreased and lyophilized, was subjected to solubility tests in water and ethanol to determine the vehicle of the phytotherapeutics. to which the physical, chemical, and microbiological stability was evaluated, in addition to the quantification of total polyphenols at the initial time, at fifteen and thirty days under accelerated conditions (40 ± 2 °C and 75 ± 5%). The quantification of total polyphenols was carried out using the Folin-Ciocalteu technique with a wavelength of 765 nm and based on a quercetin calibration curve using the equation y = 5.2068 x + 0.0672, with a coefficient correlation (R²) 0.999. The formulation of two non-sterile oral liquid pharmaceutical forms, syrup and elixir, was carried out based on the solubility obtained, whose results of the quality control of the physical-chemical parameters as well as the quantification of polyphenols of these two formulations reflected significant variability (P <0.05) with respect to time when performing the ANOVA and Tukey tests. The results of the microbiological parameters in the syrup and elixir did not present variability (P>0.05) and met the specifications of the Pharmacopoeia of the United Mexican States.