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Estado del arte en la estandarización de extractos vegetales
State of the art in the standardization of herbal extracts
Estado da arte na padronização de extratos vegetais
DOI:
https://doi.org/10.15446/rcciquifa.v52n2.110745Keywords:
Estandarización, extractos, plantas medicinales , fitoterapéuticos , control de calidad (es)Standardization , extracts , medicinal plants , phytotherapeutic , quality control (en)
Padronização, extratos , plantas medicinais , fitoterápicos , controle de qualidade (pt)
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Introducción: el aumento en el uso de plantas medicinales ha sido evidenciado en las últimas décadas en todo el mundo, principalmente como extractos vegetales con fines terapéuticos. Para garantizar la calidad y la eficacia de estos extractos se han establecido guías y normativas que reducen la variabilidad de los procesos de obtención y aseguran su estandarización. Objetivo: compilar datos actuales sobre los principales parámetros y metodologías para la estandarización de extractos vegetales y sus definiciones. Metodología: guías de la Organización Mundial de la Salud, Farmacopeas y las bases de datos PubMed, Google Académico, Science Direct y EBSCOHost fueron empleadas para colectar información acerca de la estandarización de extractos. Los documentos fueron seleccionados de acuerdo con su fecha de publicación (1981-2020), utilizando palabras-clave en inglés como “standardization of plant extracts”, “standardization of methodologies” y “guidelines for obtaining standardized products”. Resultados: las farmacopeas y las guías de la Organización Mundial de la Salud son la literatura principal que establecen las metodologías para la estandarización, así como los límites de parámetros relacionados con el control de calidad de extractos vegetales. Los principales parámetros establecidos fueron: evaluación macro y microscópica del material vegetal, materia extraña, contenido de cenizas, contenido de agua, análisis cromatográficos, análisis biológicos y evaluación química cualitativa y cuantitativa. Conclusiones: los principales documentos guías para la estandarización de extractos vegetales son generalmente aceptados en la mayoría de las agencias regulatorias en diferentes países y determinan lineamientos relacionados con las características fisicoquímicas, biológicas y químicas analíticas del material vegetal y de los extractos.
Introduction: The increase in the use of medicinal plants has been evidenced in recent decades throughout the world, mainly as plant extracts with therapeutic purposes. To guarantee the quality and efficacy of these extracts, guidelines, and regulations have been established with the purpose to reduce the variability of obtaining processes and ensure their standardization. Aim: To compile current data on the main parameters and methodologies for the standardization of plant extracts and their definition. Methodology: World Health Organization guidelines, Pharmacopoeias and PubMed, Google Scholar, Science Direct, and EBSCOHost databases were used to collect information about extract standardization. The documents were selected according to their publication date (1981-2020), using keywords in English such as “standardization of plant extracts”, “standardization of methodologies” and “guidelines for obtaining standardized products”. Results: Pharmacopoeias and guidelines of the World Health Organization are the main literature that supported the methodologies for standardization, as well as the limits of parameters related to the quality control of plant extracts. The main parameters established were macro and microscopic evaluation of plant material, foreign matter, ash content, water content, chromatographic analysis, biological analysis, and qualitative and quantitative chemical evaluation. Conclusions: The main guide documents for the standardization of plant extracts are generally accepted by most regulatory agencies in different countries and determine guidelines related to the physicochemical, biological, and analytical chemical characteristics of plant material and extracts.
Introdução: o aumento do uso de plantas medicinais tem sido evidenciado nas últimas décadas em todo o mundo, principalmente na forma de extratos vegetais para fins terapêuticos. Para garantir a qualidade e eficácia desses extratos foram estabelecidos diretrizes e regulamentações que reduzem a variabilidade dos processos de obtenção e garantem sua padronização. Objetivo: compilar dados atuais sobre os principais parâmetros e metodologias de padronização de extratos vegetais e suas definições. Metodologia: diretrizes da Organização Mundial da Saúde, Farmacopeias e bancos de dados PubMed, Google Scholar, Science Direct e EBSCOHost foram usados para coletar informações sobre padronização de extratos. Os documentos foram selecionados de acordo com a data de publicação (1981-2020), utilizando palavras-chave em inglês como “padronização de extratos vegetais”, “padronização de metodologias” e “diretrizes para obtenção de produtos padronizados”. Resultados: farmacopeias e diretrizes da Organização Mundial da Saúde são as principais literaturas que estabelecem as metodologias para padronização, bem como os limites de parâmetros relacionados ao controle de qualidade de extratos vegetais. Os principais parâmetros estabelecidos foram avaliação macro e microscópica do material vegetal, matéria estranha, teor de cinzas, teor de água, análise cromatográfica, análise biológica e avaliação química qualitativa e quantitativa. Conclusões: os principais documentos orientadores para a padronização de extratos vegetais são geralmente aceitos na maioria das agências reguladoras em diferentes países e determinam diretrizes relacionadas às características físico-químicas, biológicas e químicas analíticas de materiais vegetais e extratos.
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