Desarrollo y control de calidad de una forma farmacéutica: ungüento a base de capsaicina. utilizando ají gallinazo (capsicum frutescens).

Abstract

Capsaicin is an active ingredient that is found in the fruit flesh of the Capsicum genus, therefore in thins research, chili pepper (Capsicum frutescens) is taken as a working sample because it originate in Latin America. The sample was cultivated in the Universidad Tecnica de Machala (Ecuador) and the pertinent tests were carried out in the laboratories of the Unidad Academica de Ciencias Quimicas y de la Salud. The objective of the present study is the development of an ointment using gallinazo chili pepper, which complies with the quality parameters specified by the different standards. The organoleptic characteristics of the raw material were determined and according to the results obtained from the physical tests carried out on the dry drug, the sample has a low percentage of humidity (3.13%) and total ash (5.56%); As for the result of the microbiological analysis, this showed the presence of a colony of bacteria, a value that is acceptable according to quality standards. In addition, several analyzes were carried out on the extract, such as the determination of phenolic compounds through the Folin-Ciocalteu method, antioxidant capacity by the method of 2,2-Diphenyl-1-Picrilhydrazil, quantification of capsaicin by high-performance liquid chromatography equipment. , with values of 60.04 mg / GAE g PS for phenols, 60.85% of antioxidant activity scavenger of free radicals and 152.35 ppm of concentration of capsaicin. Two formula were prepared for the development of the ointment, the first is constituted by 88.5% of solid white petrolatum, 0.5% of chili pepper gallinazo extract, 3% of menthol as well as camphor, and 5% of eucalyptus oil; the second formulation contained 84% solid white petrolatum, 1% chilli pepper gallinazo extract, 5% menthol, camphor and eucalyptus oil. The final product was subjected to its respective quality control, such as organoleptic characteristics and microbiological analysis, where the latter confirmed the absence of Gram positive and Gram negative bacterium. The irritation test carried out in experimental animals (rabbits) was applied to the ointment prepared, where insignificant irritation was observed with the absence of erythemas, after 24 hours from the application of the product. A pre-stability study was also developed in the two formulations taking into account the area of extensibility, pH and the centrifuge test, where in the first formulation a result of 29.81 cm2 of area of extensibility was obtained, a pH equal to 6, without phase separation after the centrifugal test; while in the second formulation the results were of 20.73 cm2 of area of extensibility, 4 of pH and without separation of phases with respect to the centrifugal test. At the end of the investigation it was verified that the raw material used is of quality, in the same way it was possible to elaborate the formula for the development of the ointment, which through the different parameters tested showed that the product complies with the quality specified in the standards. This also assure the safety of the same product to be applied to the skin of human beings after having demonstrated a low index of irritability in experimental animals.