ES2285910B1 - PROCEDURE FOR THE ELABORATION OF THE FORMULA OF SODIUM HYALURONATE FOR THE HEALING AND CICATRIZATION OF WOUNDS. - Google Patents
PROCEDURE FOR THE ELABORATION OF THE FORMULA OF SODIUM HYALURONATE FOR THE HEALING AND CICATRIZATION OF WOUNDS. Download PDFInfo
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- ES2285910B1 ES2285910B1 ES200502190A ES200502190A ES2285910B1 ES 2285910 B1 ES2285910 B1 ES 2285910B1 ES 200502190 A ES200502190 A ES 200502190A ES 200502190 A ES200502190 A ES 200502190A ES 2285910 B1 ES2285910 B1 ES 2285910B1
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- polyethylene glycol
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- sodium hyaluronate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
Abstract
Procedimiento para elaborar la fórmula de hialuronato sódico para curar heridas, con una fórmula de hialuronato sódico 1,5% y polietilenglicol en cantidad suficiente para 100 g, con un primer paso para elaboración del excipiente con dos tipos de polietilenglicol, uno sólido al 15% (polietilenglicol 4000) y otro líquido al 85% (polietilenglicol 400), se pesan ambas cantidades con balanza de precisión y se introducen en un vaso de precipitados calentando en un baño maría hasta fundir ambas bases, procediéndose seguidamente a introducir en un mortero de vidrio 1,5 g de la sal sódica de ácido hialurónico previamente pesados, cuyo material de granulado blanco, debe ser trabajado con la maza del mortero hasta su completa pulverización y una vez molido se adiciona una pequeña cantidad de polietilenglicol líquido 400 y se mezcla bien, adicionando a esta base el excipiente previamente preparado cuando alcanza la temperatura ambiente, obteniendo una pasta para pomada de uso tópico.Procedure for preparing the sodium hyaluronate formula to heal wounds, with a 1.5% sodium hyaluronate formula and polyethylene glycol in sufficient quantity for 100 g, with a first step to elaborate the excipient with two types of polyethylene glycol, a solid 15% (polyethylene glycol 4000) and another 85% liquid (polyethylene glycol 400), both quantities are weighed with precision scales and placed in a beaker by heating in a water bath until both bases are melted, then being introduced into a glass mortar 1.5 g of the previously weighed sodium salt of hyaluronic acid, whose white granulate material must be worked with the mortar hammer until it is completely sprayed and once ground a small amount of liquid polyethylene glycol 400 is added and mixed well, adding to this base the excipient previously prepared when it reaches room temperature, obtaining a topical ointment paste ico.
Description
Procedimiento para la elaboración de la fórmula de hialuronato sódico para la curación y cicatrización de heridas.Procedure for the preparation of the formula of sodium hyaluronate for the healing and healing of wounds
La presente invención se refiere a un preparado de ácido hialurónico para la obtención de una pomada de uso tópico para la curación de heridas, obtenida por la asociación de productos químicos en la medida adecuada para la obtención del producto adecuado para la pronta curación y cicatrización de cualquier tipo de herida.The present invention relates to a preparation of hyaluronic acid to obtain an ointment for topical use for wound healing, obtained by the association of chemical products to the extent appropriate for obtaining product suitable for prompt healing and healing of Any type of injury.
La sustancia fundamental del tejido conectivo, que se encuentra entre las fibras de colágena, con las que forma complejos funcionalmente muy importantes para el tejido conectivo, se dispone entre los fibroblastos, depositándose en el lecho de la herida y está constituida por las glucoproteinas fibrosas y los glucosaminglicanos que son mucopolisacáridos ácidos.The fundamental substance of connective tissue, which is among the collagen fibers, with which it forms Functionally important complexes for connective tissue, it is arranged between the fibroblasts, depositing in the bed of the wound and consists of fibrous glycoproteins and glucosaminglicans that are acidic mucopolysaccharides.
Desde los trabajos de Berenson, sabemos que los glucosaminglicanos son sintetizados en el aparato de Golpe de los fibroblastos, que han emigrado al foco de lesión. Químicamente son polímeros constituidos por unidades disacarídicas, compuestas en su mayor porcentaje, por una hexosamina básica, la glucosalina o galactosamina y por un ácido úronico, generalmente el ácido glucurónico, poseyendo gran cantidad de bases sulfatadas lo que le confiere una gran importancia funcional.From Berenson's work, we know that glycosaminglicans are synthesized in the Coup apparatus of fibroblasts, which have migrated to the site of injury. Chemically are polymers constituted by disacarid units, composed in their higher percentage, for a basic hexosamine, glucosaline or galactosamine and by a uric acid, usually the acid glucuronic, possessing a large amount of sulfated bases which It confers great functional importance.
Los glucosaminglicanos se encuentran unidos en forma covalente lábil con un proteoglucano o proteína portadora teniendo la constancia de que la síntesis de los glucosaminglicanos se realiza a mayor velocidad que la de la colágena.The glucosaminglicanos are united in labile covalent form with a proteoglycan or carrier protein bearing in mind that the synthesis of glycosaminglicans It is done at a faster rate than that of the collagen.
Respecto a la función de los glucosaminglicanos se piensa que interacciones electrostáticas entre los grupos químicos electronegativos de las cadenas laterales sulfatadas de los glucosaminglicanos y los aminoácidos electropositivos del colágeno son responsables de organizar los componentes macromoleculares de las matrices extracelulares mediante la estabilización del tejido conectivo.Regarding the role of glycosaminglicans it is thought that electrostatic interactions between the groups electronegative chemicals of sulfated side chains of glucosaminglicans and electropositive amino acids of collagen are responsible for organizing the components macromolecular extracellular matrices by means of stabilization of connective tissue.
De igual manera, las cargas negativas de los glucosaminglicanos harán que también interacciones fuertemente con las moléculas de agua, siendo por este motivo, por el que sus elevados momentos bipolares les permiten formar una matriz fuertemente hidratada que cumple la función de resistir las fuerzas de compresión, mientras que al colágeno le corresponde el aporte de la resistencia a la tensión. Las dos funciones de resistir a la compresión y a la tensión, influyen entre sí, ya que la debilidad a la compresión sobrecarga a las fibras colágenas que pueden fragmentarse al faltarles el almohadillado hidráulico de los glucosaminglicanos.Similarly, the negative charges of glycosaminglicans will also make you strongly interact with the water molecules, being for this reason, why their high bipolar moments allow them to form a matrix strongly hydrated that fulfills the function of resisting forces compression, while the contribution of collagen corresponds to Tensile strength The two functions of resisting the compression and tension, influence each other, since the weakness to compression overload to collagen fibers that can fragment by missing the hydraulic padding of the glycosaminglicans
El procedimiento para la elaboración de la fórmula de hialuronato sódico, comprende el preparado de sal sódica de ácido hialurónico al 1,5%, en base de polietilenglicol 4000 y 400, ha demostrado clínicamente una gran eficacia en la síntesis de la sustancia fundamental del tejido conjuntivo de granulación, así como en la estimulación de la aparición del nuevo epitelio; todo ello durante el proceso de cicatrización de las heridas y especialmente en su fase anabólica.The procedure for the elaboration of the Sodium hyaluronate formula, includes the preparation of sodium salt 1.5% hyaluronic acid, based on polyethylene glycol 4000 and 400, clinically demonstrated great efficacy in the synthesis of the fundamental substance of the granulation connective tissue as well as in the stimulation of the appearance of the new epithelium; all this during the wound healing process and especially in its anabolic phase.
La aportación del preparado a lo ya existente se fundamenta especialmente en su concentración de ácido hialurónico del 1,5%. Aunque inicialmente se utilizaron otras concentraciones al 0,5%, 10/0 y 2%, resultando la concentración del 1,5% la que mejores resultados terapéuticos conseguía, a la vez que no aparecían otras reacciones adversas.The contribution of the preparation to the existing is especially based on its concentration of hyaluronic acid 1.5% Although other concentrations were initially used at 0.5%, 10/0 and 2%, resulting in the concentration of 1.5% which better therapeutic results achieved, while not other adverse reactions appeared.
De igual manera, el excipiente seleccionado, el polietilenglicol 4000 y 400, constituye el vehículo hidrosoluble idóneo, para la distribución homogénea, tanto de la sustancia activa el ácido hialurónico, como de la totalidad del compuesto.Similarly, the selected excipient, the polyethylene glycol 4000 and 400, constitutes the water-soluble vehicle suitable for the homogeneous distribution of both the substance activates hyaluronic acid, as of the entire compound.
La concentración de ácido hialurónico al 1,5% ha demostrado su efectividad terapéutica, lo que no ocurre a otras concentraciones más bajas, mientras que concentraciones más altas han presentado problemas de sensibilización cutánea, especialmente del tipo de las dermatitis, que a la concentración referida del 1,5% en ninguno de los casos ha presentado problemas de ninguna etiología.The 1.5% hyaluronic acid concentration has proven therapeutic effectiveness, which does not happen to others lower concentrations, while higher concentrations have had skin sensitization problems, especially of the type of dermatitis, which at the referred concentration of 1.5% in none of the cases has presented problems of any etiology.
A su vez, el preparado de ácido hialurónico, puede asociarse a preparados de colágena, potenciando su eficacia terapéutica, de manera que el ácido hialurónico es el responsable de participar activamente en la síntesis de la sustancia fundamental proporcionándole a la colágena sintetizada un entorno ideal para conseguir un gran resultado cicatricial.In turn, the hyaluronic acid preparation, It can be associated with collagen preparations, enhancing its effectiveness therapeutic, so that hyaluronic acid is responsible to actively participate in the synthesis of the substance fundamental providing the synthesized collagen with an environment Ideal to achieve a great scar result.
La fórmula se compone de hialuronato sódico a 1,5% y polietilenglicol en cantidad suficiente para la obtención de 100 g, utilizando para su obtención vaso de precipitados, mortero y maza de vidrio, probeta, varilla de vidrio y espátula, balanza de precisión y recipiente para baño maría.The formula is composed of sodium hyaluronate a 1.5% and polyethylene glycol in sufficient quantity to obtain 100 g, using a beaker, mortar and glass mace, test tube, glass rod and spatula, balance precision and water bath container.
La preparación galénica comprende un primer paso que consiste en la elaboración del excipiente. Para ello se utilizan dos tipos de polietilenglicol, uno sólido al 15% (polietilenglicol 4000) y otro líquido al 85% (polietilenglicol 400). Se pesan ambas cantidades con ayuda de la balanza y se introducen en un vaso de precipitados. Calentando ambos excipientes en un baño maría se consigue fundir ambas fases para su mezclado.The galenic preparation comprises a first step which consists in the elaboration of the excipient. To do this they use two types of polyethylene glycol, one solid at 15% (polyethylene glycol 4000) and another 85% liquid (polyethylene glycol 400). Both quantities are weighed with the help of the balance and introduced into a beaker. Heating both excipients in a water bath you can melt both phases for your mixed.
En un mortero de vidrio se introducen 1,5 g de sal sódica de ácido hialurónico, previamente pesados. Se trata de un granulado blanco que deberá ser trabajado con la maza del mortero hasta su completa pulverización. Una vez bien molido se adiciona una pequeña cantidad de polietilenglicol 400 líquido y se mezcla bien hasta adquirir una perfecta homogeneidad.In a glass mortar 1.5 g of Sodium salt of hyaluronic acid, previously weighed. Is about a white granulate that must be worked with the mace of the mortar until completely sprayed. Once well ground it add a small amount of liquid polyethylene glycol 400 and it Mix well until you get a perfect homogeneity.
Como fase final para la obtención del acabado de la fórmula prevista para su utilización, a la sal sódica de ácido hialurónico con la mezcla de una pequeña cantidad de polietilenglicol 400, se le adiciona el excipiente previamente preparado, cuando alcanza la temperatura ambiente, consiguiendo una pasta de uso tópico conformando una pomada para la curación y cicatrización de las heridas.As the final phase for obtaining the finish of the formula intended for use, to the acidic sodium salt hyaluronic with mixing a small amount of polyethylene glycol 400, the excipient is added previously prepared, when it reaches room temperature, getting a topical paste forming an ointment for healing and wound healing.
Estimando ampliamente descritas todas y cada una de las partes, composiciones y preparados que constituyen el procedimiento para la elaboración de la fórmula de hialuronato sódico para la curación y cicatrización de heridas objeto del presente registro, solamente nos resta consignar la posibilidad de que en la fórmula obtenida podrán incluirse diversos componentes aromáticos o de otro tipo que permitan mejorar su acabado, siempre que los ingredientes adicionados y sus diversas composiciones incorporadas no sean capaces de alterar los puntos esenciales de que es objeto el presente registro de Patente de Invención.Estimating widely described each and every one of the parts, compositions and preparations that constitute the procedure for the preparation of the hyaluronate formula sodium for the healing and healing of wounds subject to present record, we only have to record the possibility of that in the formula obtained various components may be included aromatic or other that allow to improve its finish, always that the added ingredients and their various compositions incorporated may not alter the essential points that The present invention patent register is the subject.
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ES200502190A ES2285910B1 (en) | 2005-09-08 | 2005-09-08 | PROCEDURE FOR THE ELABORATION OF THE FORMULA OF SODIUM HYALURONATE FOR THE HEALING AND CICATRIZATION OF WOUNDS. |
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ES200502190A ES2285910B1 (en) | 2005-09-08 | 2005-09-08 | PROCEDURE FOR THE ELABORATION OF THE FORMULA OF SODIUM HYALURONATE FOR THE HEALING AND CICATRIZATION OF WOUNDS. |
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ES2285910B1 true ES2285910B1 (en) | 2008-12-16 |
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JPH05194248A (en) * | 1991-05-24 | 1993-08-03 | Takeda Chem Ind Ltd | External preparation for preventing and treating dermatitis |
JPH08217666A (en) * | 1995-02-10 | 1996-08-27 | Mikimoto Pharmaceut Co Ltd | Oil-in-water type cream base |
CA2430130A1 (en) * | 2000-11-28 | 2002-06-06 | Focal, Inc. | Polyalkylene glycol viscosity-enhancing polymeric formulations |
US20040137079A1 (en) * | 2003-01-08 | 2004-07-15 | Cook James N. | Contact lens and eye drop rewetter compositions and methods |
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