Diseño de una monografía analítica para el control de la calidad de la biomasa de Digitalis spp obtenida por fuentes biotecnológicas para la producción de digoxina con fines farmacéuticos
Fecha
2021
Autores
Alvarez Montero, María Isabel
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Editor
Universidad Central ¨Marta Abreu¨ de Las Villas. Facultad de Química y Farmacia. Departamento de Farmacia
Resumen
A más de 300 años de su introducción en la práctica médica, los digitálicos mantienen su indicación y vigencia en el tratamiento de la insuficiencia cardiaca. Su importancia radica en que constituyen fármacos irreemplazables para dicho tratamiento y hasta la fecha los productos naturales constituyen su única fuente de obtención. El presente trabajo se propuso diseñar una monografía analítica para el control de la calidad de la biomasa de Digitalis spp obtenida por fuentes biotecnológicas para la producción de digoxina calidad farmacéutica, pues la existente en las farmacopeas no se corresponde con este método de obtención. Para su cumplimiento se realizó una búsqueda bibliográfica en las diferentes farmacopeas y en la literatura científica, acorde a la temática, de las monografías para el control de la calidad de drogas crudas y se diseñaron las técnicas o métodos para conformar dicha monografía. Al realizar la propuesta se consideraron los distintos ensayos analíticos a realizar y la metodología correcta en cada uno de ellos. Para su establecimiento, se analizaron 13 artículos de origen primario, cinco tesis (tres son de diploma, una de maestría, una de doctorado) y seis monografías (una de la European Pharmacopoeia, otra de la British Pharmacopoeia 2013 y cuatro de The United States Pharmacopeia 40). Se propuso incluir el HPLC como técnica de cuantificación de cardenólidos, además del método espectrofotométrico.
More than 300 years after its introduction into medical practice, digitalis maintain their indication and validity in the treatment of heart failure. Their importance lies in the fact that they constitute irreplaceable drugs for said treatment and to date natural products constitute their only source of obtaining it. The present work set out to design an analytical monograph for the control of the quality of the biomass of Digitalis spp obtained by biotechnological sources for the production of pharmaceutical quality digoxin, since the existing one in the pharmacopoeias does not correspond to this method of obtaining. For its fulfillment, a bibliographic search was carried out in the different pharmacopoeias and in the scientific literature, according to the subject, of the monographs for the control of the quality of crude drugs and the techniques or methods were designed to conform said monograph. When making the proposal, the different analytical tests to be carried out and the correct methodology in each of them were considered. For its establishment, 13 articles of primary origin, five thesis (three are for a diploma, one for a master's degree, one for a doctorate) and six monographs (one from the European Pharmacopoeia, another from the British Pharmacopoeia 2013 and four from The United States). It was proposed to include HPLC as a technique for the quantification of cardenolides, in addition to the spectrophotometric method.
More than 300 years after its introduction into medical practice, digitalis maintain their indication and validity in the treatment of heart failure. Their importance lies in the fact that they constitute irreplaceable drugs for said treatment and to date natural products constitute their only source of obtaining it. The present work set out to design an analytical monograph for the control of the quality of the biomass of Digitalis spp obtained by biotechnological sources for the production of pharmaceutical quality digoxin, since the existing one in the pharmacopoeias does not correspond to this method of obtaining. For its fulfillment, a bibliographic search was carried out in the different pharmacopoeias and in the scientific literature, according to the subject, of the monographs for the control of the quality of crude drugs and the techniques or methods were designed to conform said monograph. When making the proposal, the different analytical tests to be carried out and the correct methodology in each of them were considered. For its establishment, 13 articles of primary origin, five thesis (three are for a diploma, one for a master's degree, one for a doctorate) and six monographs (one from the European Pharmacopoeia, another from the British Pharmacopoeia 2013 and four from The United States). It was proposed to include HPLC as a technique for the quantification of cardenolides, in addition to the spectrophotometric method.
Descripción
Palabras clave
Farmacopea, Plantas Medicinales, Género Digitalis ssp., Insuficiencia Cardiaca