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Redalyc.Toxicología Aguda Oral Del Extracto Lipídico De Acrocomia

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Redalyc.Toxicología Aguda Oral Del Extracto Lipídico De Acrocomia Revista CENIC. Ciencias Biológicas ISSN: 0253-5688 [email protected] Centro Nacional de Investigaciones Científicas Cuba Gutiérrez Martínez, Ariadne; Nodal Flores, Carlos; Bucarano Lliteras, Isury; Goicochea Carrero, Eddy Toxicología aguda oral del extracto lipídico de Acrocomia crispa en ratones NMRI Revista CENIC. Ciencias Biológicas, vol. 47, núm. 1, enero-mayo, 2016, pp. 21-26 Centro Nacional de Investigaciones Científicas Ciudad de La Habana, Cuba Disponible en: http://www.redalyc.org/articulo.oa?id=181244353003 Cómo citar el artículo Número completo Sistema de Información Científica Más información del artículo Red de Revistas Científicas de América Latina, el Caribe, España y Portugal Página de la revista en redalyc.org Proyecto académico sin fines de lucro, desarrollado bajo la iniciativa de acceso abierto Revista CENIC Ciencias Biológicas, Vol. 47, No. 1, pp. 21-26, enero-mayo, 2016. Toxicología aguda oral del extracto lipídico de Acrocomia crispa en ratones NMRI Ariadne Gutiérrez Martínez, Carlos Nodal Flores, Isury Bucarano Lliteras, Eddy Goicochea Carrero. Departamento de Farmacología y Toxicología, Centro de Productos Naturales. Centro Nacional de Investigaciones Científicas. Calle 198 entre 19 y 21, Atabey, Playa, Habana, Cuba. [email protected] Recibido: 5 de noviembre de 2015. Aceptado: 18 de febrero de 2016. Palabras clave: ácidos grasos, Acrocomia crispa, D-005, ratones, toxicidad aguda. Key words: fatty acids, Acrocomia crispa, D-005, mice, acute toxicity. RESUMEN. El D-005 es un extracto lipídico del fruto de A. crispa (palma corojo), que contiene una mezcla de ácidos grasos, principalmente láurico, oleico, mirístico y palmítico. El tratamiento con D-005 por vía oral redujo el agrandamiento prostático inducido por testosterona en ratas. Se realizó el ensayo de toxicidad del D-005 con el objetivo de determinar los efectos tóxicos del D-005 administrado por vía oral, a ratones NMRI de ambos sexos. Se utilizó el método de las clases de toxicidad aguda, administrando una dosis de 2 000 mg/kg de peso corporal. Luego de la única administración, los animales fueron observados diariamente durante 14 d. Las variables analizadas fueron: mortalidad y signos clínicos, peso corporal, consumo de alimento y observaciones macroscópicas. No existieron diferencias significativas en ninguna de estas variables entre el grupo tratado y el control en ninguno de los sexos. No se evidenció ningún efecto tóxico relacionado con el tratamiento. El D-005 presentó una toxicidad intrínseca baja, mostrando una toxicidad superior a los 2 000 mg/kg de peso corporal, dosis a la que no se evidenciaron signos indicativos de toxicidad en ninguno de los sexos, por lo que su toxicidad se puede declarar como no clasificable según el método de las clases de toxicidad aguda. ABSTRACT. D-005 is a lipid extract from the fruits of A. crispa (corojo palm tree) that contains a reproducible mixture of fatty acids, like lauric, oleic, mirystic and palmitic acids. Oral treatment with D-005 reduced prostate enlargement induced with testosterone in rats. The toxicity assay of D-005 was performed in order to determine the toxic effects of D-005 orally administered to NMRI mice from both sex. Oral acute toxicity of D-005 (2 000 mg/kg) was researched in accordance with the acute toxic class method. Animals after a single administration were observed daily during 14 d. Thus, data analysis of mortality, clinical observations, body weight, and gross pathological changes did not show significant differences between control and treated groups in any sex. No evidence of treatment-related toxicity was detected. The oral acute toxicity of D-005 was considered as unclassified according to the acute toxic class method, since a dose of 2 000 mg/kg did not induce deaths or signs of toxicity. INTRODUCCIÓN La Hiperplasia Prostática Benigna (HPB) es una patología que puede afectar a los hombres fundamentalmente 50 años y cuya frecuencia aumenta con la edad.1 Consiste en un agrandamiento benigno de la próstata debido a un crecimiento excesivo y no controlado. Este crecimiento puede causar obstrucción y propicia el desarrollo de síntomas del tracto bajo urinario (STBU).2,3 La principal terapia farmacológica de la HPB la constituyen los inhibidores de la 5 -reductasa prostática,1,4-7 los 1,4,5,8,9 antagonistas de (ADR)-1, y la terapia combinada con ambos, recomendada en casos que presentan HPB severa o refractaria.10-12 El tratamiento de la HPB también incluye alternativas fitoterapéuticas, en especial los extractos lipídicos de los frutos de Serenoa repens (Saw palmetto) (ELSP) de la familia Arecaceae.13-16 21 Revista CENIC Ciencias Biológicas, Vol. 47, No. 1, pp. 21-26, enero-mayo, 2016. En Cuba existen numerosas palmas de la misma familia de Saw palmetto, dentro de las cuales se destaca la palma real (Roystonea regia), de cuyos frutos se ha obtenido un extracto lipídico (D-004) con efectos similares a los del ELSP.17- 20 La palma corojo presenta analogías en su origen taxonómico y en la composición química de los aceites obtenidos de sus frutos con el ELSP y el D-004, lo cual vislumbra la utilidad potencial del aceite de A. crispa en el manejo de la HPB. El D-005 es un extracto lipídico del fruto de A. crispa (palma corojo), palma endémica de la familia Arecaceae, que contiene una mezcla de ácidos grasos, principalmente láurico, oleico, mirístico y palmítico y en menores proporciones esteárico, caprílico, cáprico y palmitoleico.21,22 El tratamiento oral con D-005 durante 14 d resultó efectivo en reducir el agrandamiento prostático inducido por T en ratas.23 Además, el D-005 presentó efectos anti-inflamatorios en modelos in vitro, así como también mostró efectos antioxidantes in vivo.23,24 Ambos efectos podrían resultar beneficios adicionales sobre la próstata hipertrofiada. Tomando en consideración los efectos farmacológicos promisorios del D-005 en modelos de hiperplasia prostática e inflamación, los resultados negativos obtenidos en las evaluaciones del D-005 por el método de las clases en ratas y que los estudios agudos en una segunda especie roedora forman parte de la batería de pruebas que integran la primera etapa de la investigación de una nueva sustancia propuesta como medicamento; se evaluó la toxicidad del D-005 en ratones NMRI por el método de las clases de toxicidad aguda con el objetivo de clasificar la toxicidad aguda oral del aceite saponificado de los frutos de A. crispa (palma corojo) y determinar si la administración de dosis únicas produce afectaciones no reversibles, de modo que se detecten en los sobrevivientes. MATERIALES Y MÉTODOS Animales Se emplearon ratones NMRI procedentes del Centro de Producción de Animales de Laboratorio (CENPALAB, Cuba), adultos jóvenes de 6-7 semanas, de ambos sexos, cuyo peso corporal oscilaba entre 20-23 g al inicio del estudio. Se utilizó esta especie roedora por ser una de las más empleadas en los estudios agudos, por otra parte, de esta línea se tienen amplios conocimientos en nuestro laboratorio. Los animales se adaptaron durante siete días a las condiciones del laboratorio: temperatura 20-25 ºC, humedad entre 50-70 % y ciclos de luz- oscuridad de 12 h. El alimento que se les administró durante toda la experiencia fue pienso estándar para esta especie preparado en el CENPALAB. El acceso al agua y al alimento fue ad libitum. Toda la manipulación de los animales se realizó de acuerdo con los principios éticos para el uso de los animales de Laboratorio recomendados en los lineamientos internacionales y en la República de Cuba, plasmados en los Procedimientos Normalizados de Trabajo establecidos en el Centro de Productos Naturales. El protocolo de aprobación por el Comité de ética para el trabajo con animales de experimentación fue el 013/2014. Sustancia de ensayo El material vegetal fue obtenido en mayo de 2014 en el municipio Playa de la Habana, a partir de diferentes ejemplares de A. crispa, autentificados por especialistas del herbario del Jardín Botánico Nacional y con número de introducción: 1982-1031. El D-005 es el aceite saponificado de los frutos de la A. crispa, suministrado por el Laboratorio de Química Extractiva del CPN, con su correspondiente información relativa a la pureza y a las condiciones de estabilidad (2 años). La sustancia es un líquido aceitoso, de color amarillo translucido, que fue almacenado en frasco ámbar de cristal y mantenido en lugares frescos y protegidos de la luz. Se utilizó el lote S100614 con un 92,07 % de pureza en función del contenido total de los ácidos grasos libres (caprílico 0,90 %, cáprico 2,20 %, láurico 36,43 %, mirístico 12,60 %, palmítico 8,10 %, palmitoleico 0,08 %, esteárico 2,67 % y oleico 29,07 %). La preparación de las soluciones se realizó 2 horas antes de la administración en función del peso corporal. El D-005 fue administrado en forma de emulsión usando Tween 65 (Sigma, USA) al 2 % como vehículo, el cual fue empleado en los estudios de farmacología experimental y de amplio uso en la industria farmacéutica, carente de toxicidad asociada. Se realizó una administración única mediante intubación gástrica, en ayunas, en el horario de la mañana. Se empleó la vía oral por ser la que coincide con la utilizada en la terapéutica y además fue la empleada en el resto de las evaluaciones de toxicología y farmacología preclínica realizadas. Además, esta vía es la recomendable en el caso de productos a administrar por vía oral en que no se conozcan todos los aspectos de su farmacocinética. Grupos experimentales Teniendo en cuenta las evaluaciones farmacológicas y toxicológicas que se han realizado con esta sustancia en los cuales se han utilizado determinados niveles de dosis, sin que se haya manifestado ningún cuadro clínico indicativo de daño inducido por la sustancia, y las características propias de este método experimental se inició el estudio por la 22 Revista CENIC Ciencias Biológicas, Vol.
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