BIOLOGICAL METHOD FOR MEASURING THE IN VITRO ACTIVITY OF CHLORHEXIDINE GLUCONATE

The present patent protects a method for easily determining in the laboratory the activity of chlorhexidine gluconate, an antiseptic used in the medical or veterinary field. There is a difference between concentration and activity in an antiseptic, i.e., the molecules thereof may have interactions that inactivate the same when being brought into contact with multiple additives of the commercial production, such as dyes, flavor agents or aromas, and the packing material. The present method brings into contact the chlorhexidine gluconate of the commercial preparation with a microorganism under culture and compares the microbial inhibition with that produced by controls of standardized concentrations of the antiseptic. The method results of great utility for tracking and quality areas of manufacturers, since they may guarantee that their additives or containers have not affected the activity of chlorhexidine gluconate, as well as the activity time for reestablishing the expiration dates. The inventive method may also determine which substances enhance the activity of an antiseptic, the method requiring minimal technical and safety elements in the laboratory. Finally, this method is still required even in those laboratories with complex methods of analysis, such as mass spectrometry, for guaranteeing the presence of chlorhexidine gluconate and for detecting if the activity of the same has been affected by additives or processes in the production step. Nuestra patente protege un método para determinar de manera sencilla en el laboratorio la actividad del gluconato de clorhexidina, un antiséptico usado en el campo médico o veterinario. No es lo mismo concentración que actividad de un antiséptico; esto es, sus moléculas pueden tener interacciones que la inactiven en contacto con múltiples aditivos de la producción comercial, tales como colorantes, saborizantes o aromas, así como con el material de envasado. Nuestro método enfrenta al gluconato de clorhexidina de la preparación comercial contra un microorganismo en cultivo, y compara su inhibición microbiana contra la que producen controles de concentraciones estandarizadas del antiséptico. El método resulta de utilidad para las áreas de rastreo y calidad de los fabricantes, pues pueden asegurar que sus aditivos o envases no han afectado la actividad del gluconato de clorhexidina, así como el tiempo de actividad para restablecer fechas de caducidad. También puede determinar qué sustancias potencian la actividad de