WO2000043022A1 - Utilization of formulations based on water-soluble fractions of phlebodium decumanum(exply-37) and polypodium leucotomos as nutritional supplement in the prevention and reversion of excessive physical effort syndrome - Google Patents

Utilization of formulations based on water-soluble fractions of phlebodium decumanum(exply-37) and polypodium leucotomos as nutritional supplement in the prevention and reversion of excessive physical effort syndrome Download PDF

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WO2000043022A1
WO2000043022A1 PCT/ES2000/000021 ES0000021W WO0043022A1 WO 2000043022 A1 WO2000043022 A1 WO 2000043022A1 ES 0000021 W ES0000021 W ES 0000021W WO 0043022 A1 WO0043022 A1 WO 0043022A1
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exply
rhizome
formulations
water
soluble fraction
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PCT/ES2000/000021
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Spanish (es)
French (fr)
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Miguel Yesares Ferrer
Carlos De Teresa Galvan
Antonio Alcaide Garcia
Miguel Enrique Yesares Morillas
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Helsint, S.A.L.
Helechos Internacional Honduras, S.A. De C.V.
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Publication of WO2000043022A1 publication Critical patent/WO2000043022A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/11—Pteridophyta or Filicophyta (ferns)
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system

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  • the present invention relates to the use of formulations based on water-soluble fractions of the varieties of Phlebodium decumanum (exply-37) and Polypodium leucotomos grown in the HELSINT SAL plantation, near the YOJOA lake (Honduras), in prevention and reversal of physical overexertion syndrome in general and of the athlete in particular.
  • These formulations improve endurance and physical potency, restore and maintain immune balance by preventing the appearance of opportunistic infections, protect, in extreme conditions of exertion, exhaustion and tissue damage, especially in bone, muscle and cartilaginous lesions, and reduce the healing time when such injuries have occurred.
  • the present invention relates to a new use of the formulations and described in the aforementioned patent applications, in the prevention and reversal of physical overexertion syndrome. It also covers new formulations that may contain, EXPLY-37, alone or mixed with a water-soluble fraction of Phlebodium decumanum rhizome, and Phlebodium decumanum rhizome, or a water-soluble fraction of frond or frond and rhizome of Polypodium leucotomos, together with one or more of the following components of an amino acid nature: acetylcysteine carboxymethylcysteine glutamine carnitine acetylcarnitine creatinol phosphate arginine thiazolidinecarboxylate.
  • New formulations for oral administration have been obtained containing EXPLY-37 or, alternatively, EXPLY-37 with one or more of the aforementioned amino acid components, to which may be incorporated: a) Water-soluble fraction of Phlebodium decumanum rhizome. b) Rhizome powder of Phlebodium decumanum. c) Water soluble fraction and rhizome powder of Phlebodium decumanum.
  • Formulations based on Polypodium leucotomos may contain, on the other hand, water-soluble fraction of frond, or frond and rhizome, with or without rhizome of Polypodium leucotomos, added or not, of one or more of the aforementioned amino acid components.
  • Preferred formulations are syrups with excipients, soft gelatin capsules containing liquid forms without excipients, hard gelatin capsules containing solid powder, sachets and tablets.
  • the methods used in the prevention and reversal of physical overexertion syndrome in general and in the athlete, in particular, include oral administration of said formulations at daily doses of 1 to 5 grams of EXPLY-37 and 2 to 4 grams. of water soluble fraction of frond of Polypodium leucotomos.
  • the daily dose of each of these components will be within the usual use range.
  • the present invention is directed to obtaining formulations based on EXPLY-37, and water-soluble fractions of Polypodium leucotomos and their use orally, in the prevention and reversal of physical overexertion syndrome. They find special application in athletes undergoing continuous training, in avoidance of exhaustion in extreme conditions of stress and the appearance of opportunistic infections and bone, muscle and cartilaginous tissue damage, and to accelerate the recovery process when that tissue damage has taken place. .
  • the Phlebodium decumanum plant grown on the plantation owned by
  • EXPLY-37 water-soluble fraction of fronds
  • solid formulations containing EXPLY-37 only or with water-soluble fraction of rhizome and rhizome of Phlebodium decumanum and of liquid formulations containing EXPLY- 37 only and EXPLY-37 with soluble fraction rhizome Plebodium decumanum, are described in Spanish patent applications Nos 9701693 and 9801139.
  • composition of the new formulations may also contain one or more of the aforementioned amino acid components, are described below.
  • SOLID FORMULATIONS They may contain:
  • EXPLY-37 (or EXPLY-37 + water soluble fraction of rhizome of Phlebodium decumanum) 2
  • One or more of the aforementioned amino acid components consists of the following steps: a) Dissolution of the amino acid component in water at a controlled pH b) Incorporation of the rhizome powder into an aqueous solution containing EXPLY-37 (or EXPLY-37 + water-soluble fraction of rhizome of Phlebodium decumanum). c) Mixing and homogenization of the solution of a) and the suspension b).
  • LIQUID FORMULATIONS They may contain:
  • EXPLY-37 (or EXPLY-37 + water-soluble fraction of rhizome of Phlebodium decumanum) together with one or more of the aforementioned amino acid components. Its preparation consists of the following steps: a) Dissolution of the amino acid component in water at controlled pH. b) Dissolution of EXPLY-37 (or EXPLY-37 + water soluble fraction of Phlebodium decumanum). c) Mixing, homogenization and volume reduction of solutions a) and b) to an appropriate concentration. d) Conditioning of the final solution obtained in c) in the form of soft gelatin capsules without excipients, syrups and drinkable ampoules. B) Polypodium leucotomos
  • formulations based on EXPLY-37 are described below, although not limited to Phlebodium decumanum, being equally valid for Polypodium leucotomos.
  • Examples 1 to 6 reproduce the formulations already described in Spanish patent applications numbers 9701693 and 9801139.
  • Examples 7 to 9 illustrate the new formulations containing some of the amino acid components.
  • EXAMPLE 1 50 Kg of fresh rhizomes of Phlebodium decumanum devoid of villi are immersed, successively, in dilute solution of active chlorine, deionized water, absolute ethanol and sterile deionized water. They are then dried in a fluid bed dryer at 40-50 ° C for 2 hours. They are ground and sifted until a fine powder is obtained. At 22.5 kg of crushed and sieved rhizome, they are gradually incorporated in a stainless steel mixer with a capacity of 100 L, 7.5 kg of EXPLY-37, and mixed until obtaining a homogeneous mass that is dried in an oven of trays at a temperature of 40-50 ° C for 24 hours. The powder is screened by an 18 mesh mesh.
  • Capsules containing 300 mg are prepared with this powder.
  • the final mixture is prepared with 25.5 kg of crushed, sieved and dried rhizome, and 18.5 kg of EXPLY-37. Once dry, hard gelatin capsules containing 440 mg of powder are prepared.
  • EXAMPLE 4 A homogeneous mixture of 7.8 kg of Sacharum officinarum fluid extract and 190 g of extract extract is prepared in a stainless steel reactor-mixer equipped with a paddle stirrer at stirring speed of 20 revolutions per minute (rpm). Glycirrhiza glabra (licorice). 10 g of citric acid are incorporated into the homogeneous mass. Finally, with stirring and at 37 ° C, 2 kg of EXPLY-37 are added until homogenization. A syrup containing 200 mg of EXPLY-37 per gram is obtained.
  • Example 4 The steps described in Example 4 are followed. At the end 1 kg of EXPLY-37 and 1 kg of rhizome extract are added, obtaining a syrup with a total extract concentration of 200 mg / g.
  • Syrups with a composition of 50 to 500 mg of total extract per gram can also be obtained, the total extract being the mixture in varying proportions (50:50 to 95: 5) of EXPLY-37 and rhizome extract.
  • Syrup concentration 200 mg / mL, expressed in EXPLY-37 or in EXPLY-37 + rhizome extract. Following the same technique, syrups have been prepared containing a wide range of concentrations (20 to 500 mg / mL).
  • EXAMPLE 7 Solid formulations containing EXPLY -37 (or EXPLY-37 + rhizome extract in proportions that can vary from 5: 5 to 95: 5).
  • 20 Kg. of arginine thiazolidine carboxylate are dissolved in 50 1 of deionized water at a temperature between 20 and 40 ° C.
  • b) They are incorporated, with slow stirring and at a temperature not exceeding 40 ° C, 25.5 Kg. of rhizome powder to an aqueous solution containing 18.5 kg of EXPLY-37 in a total volume of 30 liters.
  • the solution a) and the suspension b) are mixed and homogenized.
  • the resulting suspension is evaporated under reduced pressure and at a temperature below 40 ° C until a homogeneous powder is obtained.
  • e) The powder, homogenized, dries to humidity below 8%.
  • Amounts of this dry powder are used to prepare capsules containing 200 to 500 mg. , 500 mg sachets. and 1,000 mg. , and tablets of 250, 500, 750 and 1,000 mg.
  • EXPLY-37 or EXPLY-37 + water-soluble fraction of rhizome of Phlebodium decumanum
  • rhizome powder
  • EXPLY-37 (or EXPLY-37 + water-soluble fraction of rhizome of Phlebodium decumanum) 10 to 30 Kg.
  • EXPLY-37 syrup (or EXPLY-37 + water-soluble fraction of Phlebodium decumanum rhizome) containing L-carnitine, with a final composition of:
  • EXPLY-37 200 mg./ mi.
  • L- carnitine 100 mg / mi
  • An aqueous solution of 10 kg of l-carnitine is prepared in 50 L of deionized water, slightly acidified with hydrochloric acid. 20 kg of EXPLY-37 (or EXPLY-37 + water-soluble fraction of Phlebodium decumanum) are diluted separately with 20 L of deionized water. The two solutions are mixed, adjusting the final volume to 100 L.
  • formulations can be prepared with the following amounts of each component:
  • EXPLY-37 (or EXPLY-37 + water-soluble fraction of rhizome of Phlebodium decumanum in proportions that can vary from 5: 5 to 9: 1) 10 to 30 Kg.
  • Hb Hemoglobin

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Abstract

The formulations disclosed in the invention may contain water-soluble fractions of frond and rhizome of varieties of Phlebodium decumanum (EXPLY-37) and Polypodium leucotomos cultivated in the HE LSINT S.A.L. plantation near Yojoa lake (Honduras), and optionally rhizome of Phlebodium decumanum and Polypodium leucotomos and one or more amino acid components. Said formulations improve resistance and physical strength, restore and maintain immunologic balance by preventing the emergence of opportunistic infections, provide protection against exhaustion and tissue damage, especially bone, muscular and cartilaginous injuries under extreme effort conditions and reduce healing time once said injuries have occurred.

Description

EMPLEO DE FORMULACIONES A BASE DE FRACCIONES HIDROSOLUBLES DE PHLEBODIUM DECUMANUM (EXPLY-37) Y POLYPODIUM LEUCOTOMOS COMO COMPLEMENTO NUTRICIONAL EN LA PREVENCIÓN Y REVERSIÓN DEL SÍNDROME DE SOBREESFUERZO FÍSICOUSE OF FORMULATIONS BASED ON HYDRO-Soluble FRACTIONS OF PHLEBODIUM DECUMANUM (EXPLY-37) AND POLYPODIUM LEUCOTOMOS AS NUTRITIONAL COMPLEMENT IN THE PREVENTION AND REVERSION OF THE PHYSICAL OVERFLOW SYNDROME
CAMPO DE LA INVENCIÓNFIELD OF THE INVENTION
La presente invención se refiere al empleo de formulaciones a base de fracciones hidrosolubles de las variedades de Phlebodium decumanum (exply-37) y de Polypodium leucotomos cultivadas en la plantación de HELSINT S.A.L., en las proximidades del lago YOJOA (Honduras), en la prevención y reversión del síndrome de sobreesfuerzo físico en general y del deportista en particular. Estas formulaciones mejoran la resistencia y la potencia física, restauran y mantienen el equilibrio inmunológico evitando la aparición de infecciones oportunistas, protegen, en condiciones extremas de esfuerzo, de la extenuación y del daño tisular, especialmente en lesiones óseas, musculares y cartilaginosas, y reducen el tiempo de curación cuando se han producido tales lesiones.The present invention relates to the use of formulations based on water-soluble fractions of the varieties of Phlebodium decumanum (exply-37) and Polypodium leucotomos grown in the HELSINT SAL plantation, near the YOJOA lake (Honduras), in prevention and reversal of physical overexertion syndrome in general and of the athlete in particular. These formulations improve endurance and physical potency, restore and maintain immune balance by preventing the appearance of opportunistic infections, protect, in extreme conditions of exertion, exhaustion and tissue damage, especially in bone, muscle and cartilaginous lesions, and reduce the healing time when such injuries have occurred.
ANTECEDENTES DE LA INVENCIÓNBACKGROUND OF THE INVENTION
El sobreesfuerzo físico y sobreentrenamiento pueden producir una disfunción del sistema inmune caracterizada por una reducción de la actividad de las células NK, un incremento de los niveles de ciertas citocinas tales como TNF-α, γ-IFN, IL-2, IL- 6, conjuntamente con fatiga y pérdida de masa muscular (muscle wasting) y "síndrome de bajos niveles de cisteína y glutamina" ( W. Dróge y cois., The FASEB journal 1997, 11, 1077-1089 ). Estos síntomas evocan los observados en situaciones clínicas muy complejas, tales como SIDA y cáncer.Physical overexertion and overtraining can produce a dysfunction of the immune system characterized by a reduction in the activity of NK cells, an increase in the levels of certain cytokines such as TNF-α, γ-IFN, IL-2, IL-6, together with fatigue and loss of muscle mass (muscle wasting) and "syndrome of low levels of cysteine and glutamine" (W. Dróge and cois., The FASEB journal 1997, 11, 1077-1089). These symptoms evoke those observed in very complex clinical situations, such as AIDS and cancer.
La obtención de formulaciones a base de EXPLY-37, una fracción hidrosoluble de los frondes de la variedad de Phlebodium decumanun cultivada en la plantación del lago Yojoa, en el norte de Honduras y su utilización en enfermos de SIDA y cáncer han sido reivindicadas en las solicitudes de patente española nos. 9701693 y 9801139.Obtaining formulations based on EXPLY-37, a water-soluble fraction of the fronds of the Phlebodium decumanun variety grown on the Yojoa lake plantation in northern Honduras and its use in AIDS and cancer patients have been claimed in the Spanish patent applications nos. 9701693 and 9801139.
La presente invención se refiere a un nuevo uso de las formulaciones ya descritas en las citadas solicitudes de patente, en la prevención y reversión del síndrome de sobreesfuerzo físico. Abarca, asimismo, a nuevas formulaciones que pueden contener, EXPLY-37, sólo o mezclado con fracción hidrosoluble de rizoma de Phlebodium decumanum, y rizoma de Phlebodium decumanum, o una fracción hidrosoluble de fronde o de fronde y rizoma de Polypodium leucotomos, junto con uno o varios de los siguientes componentes de naturaleza aminoácida: acetilcisteína carboximetilcisteína glutamina carnitina acetilcarnitina creatinol fosfato tiazolidíncarboxilato de arginina.The present invention relates to a new use of the formulations and described in the aforementioned patent applications, in the prevention and reversal of physical overexertion syndrome. It also covers new formulations that may contain, EXPLY-37, alone or mixed with a water-soluble fraction of Phlebodium decumanum rhizome, and Phlebodium decumanum rhizome, or a water-soluble fraction of frond or frond and rhizome of Polypodium leucotomos, together with one or more of the following components of an amino acid nature: acetylcysteine carboxymethylcysteine glutamine carnitine acetylcarnitine creatinol phosphate arginine thiazolidinecarboxylate.
COMPENDIO DE LA INVENCIÓNSUMMARY OF THE INVENTION
Se han obtenido nuevas formulaciones para administración oral que contienen EXPLY-37 o, alternativamente, EXPLY-37 con uno o varios de los componentes de naturaleza aminoácida citados, a las que se pueden incorporar: a) Fracción hidrosoluble de rizoma de Phlebodium decumanum. b) Polvo de rizoma de Phlebodium decumanum. c) Fracción hidrosoluble y polvo de rizoma de Phlebodium decumanum.New formulations for oral administration have been obtained containing EXPLY-37 or, alternatively, EXPLY-37 with one or more of the aforementioned amino acid components, to which may be incorporated: a) Water-soluble fraction of Phlebodium decumanum rhizome. b) Rhizome powder of Phlebodium decumanum. c) Water soluble fraction and rhizome powder of Phlebodium decumanum.
Las formulaciones a base de Polypodium leucotomos pueden contener, por otra parte, fracción hidrosoluble de fronde, o de fronde y rizoma, con o sin rizoma de Polypodium leucotomos, adicionadas, o no, de uno o varios de los componentes aminoácidos mencionados.Formulations based on Polypodium leucotomos may contain, on the other hand, water-soluble fraction of frond, or frond and rhizome, with or without rhizome of Polypodium leucotomos, added or not, of one or more of the aforementioned amino acid components.
Las formulaciones preferidas son jarabes con excipientes, cápsulas de gelatina blanda que contienen formas líquidas sin excipientes, cápsulas de gelatina dura conteniendo polvo sólido, sobres y comprimidos. Los métodos usados en la prevención y reversión del síndrome de sobreesfuerzo físico en general y en el deportista, en particular, comprenden la administración oral de dichas formulaciones a dosis diarias de 1 a 5 gramos de EXPLY-37 y de 2 a 4 gramos de fracción hidrosoluble de fronde de Polypodium leucotomos. Cuando las formulaciones contienen, además, acetilcisteina, carboximetilcisteina, glutamina, carnitina, acetilcarnitina, creatinol fosfato o tiazolidincarboxilato de arginina, la dosis diaria de cada uno de estos componentes se encontrará dentro del rango de uso habitual.Preferred formulations are syrups with excipients, soft gelatin capsules containing liquid forms without excipients, hard gelatin capsules containing solid powder, sachets and tablets. The methods used in the prevention and reversal of physical overexertion syndrome in general and in the athlete, in particular, include oral administration of said formulations at daily doses of 1 to 5 grams of EXPLY-37 and 2 to 4 grams. of water soluble fraction of frond of Polypodium leucotomos. When the formulations also contain acetylcysteine, carboxymethylcysteine, glutamine, carnitine, acetylcarnitine, creatinol phosphate or arginine thiazolidinecarboxylate, the daily dose of each of these components will be within the usual use range.
DESCRIPCIÓN DETALLADA DE LA INVENCIÓNDETAILED DESCRIPTION OF THE INVENTION
La presente invención está dirigida a la obtención de formulaciones a base de EXPLY-37, y de fracciones hidrosolubles de Polypodium leucotomos y a su uso por vía oral, en la prevención y reversión del síndrome de sobreesfuerzo físico. Encuentran aplicación especial en deportistas sometidos a entrenamiento continuo, en evitación de la extenuación en condiciones extremas de esfuerzo y de la aparición de infecciones oportunistas y daño tisular óseo, muscular y cartilaginoso, y para acelerar el proceso de recuperación cuando ese daño tisular ha tenido lugar. La planta Phlebodium decumanum, cultivada en la plantación propiedad deThe present invention is directed to obtaining formulations based on EXPLY-37, and water-soluble fractions of Polypodium leucotomos and their use orally, in the prevention and reversal of physical overexertion syndrome. They find special application in athletes undergoing continuous training, in avoidance of exhaustion in extreme conditions of stress and the appearance of opportunistic infections and bone, muscle and cartilaginous tissue damage, and to accelerate the recovery process when that tissue damage has taken place. . The Phlebodium decumanum plant, grown on the plantation owned by
Helsint S.A.L. ( lago Yojoa, Honduras), la obtención de EXPLY-37, (fracción hidrosoluble de frondes), de formulaciones sólidas conteniendo EXPLY-37 sólo o con fracción hidrosoluble de rizoma y rizoma de Phlebodium decumanum, y de formulaciones líquidas conteniendo EXPLY-37 sólo y EXPLY-37 junto con fracción hidrosoluble de rizoma de Plebodium decumanum, se encuentran descritas en las solicitudes de patente española nos 9701693 y 9801139.Helsint SAL (Lake Yojoa, Honduras), obtaining EXPLY-37, (water-soluble fraction of fronds), of solid formulations containing EXPLY-37 only or with water-soluble fraction of rhizome and rhizome of Phlebodium decumanum, and of liquid formulations containing EXPLY- 37 only and EXPLY-37 with soluble fraction rhizome Plebodium decumanum, are described in Spanish patent applications Nos 9701693 and 9801139.
Por procedimientos análogos se obtienen igualmente las fracciones hidrosolubles de fronde y rizoma de Polypodium leucotomos, igualmente cultivada en la citada plantación del lago Yojoa (Honduras). La composición de las nuevas formulaciones pudiendo contener, además, uno o varios de los componentes de naturaleza aminoácida citados, se describen a continuación.Similarly, water-soluble frond and rhizome fractions of Polypodium leucotomos are also obtained, also cultivated in the aforementioned plantation of Lake Yojoa (Honduras). The composition of the new formulations may also contain one or more of the aforementioned amino acid components, are described below.
1. FORMULACIONES SÓLIDAS Pueden contener :1. SOLID FORMULATIONS They may contain:
A) Phlebodium decumanumA) Phlebodium decumanum
> Rizoma de Phlebodium decumanum 2 EXPLY-37 (o EXPLY-37 + fracción hidrosoluble de rizoma de Phlebodium decumanum) 2 Uno o varios de los componentes aminoácidos citados. El procedimiento de obtención de estas formulaciones consta de las siguientes etapas: a) Disolución del componente aminoácido en agua a pH controlado b) Incorporación del polvo de rizoma a una disolución acuosa conteniendo EXPLY-37 (o EXPLY-37+ fracción hidrosoluble de rizoma de Phlebodium decumanum). c) Mezcla y homogeneización de la disolución de a) y la suspensión b). d) Evaporación del disolvente hasta obtención de un polvo sólido húmedo. e) Secado del residuo sólido. f) Acondicionamiento del polvo en forma de cápsulas de gelatina dura, sobres y comprimidos que pueden contener entre 100 mg. y 1.000 mg. de polvo seco.> Rhizome of Phlebodium decumanum 2 EXPLY-37 (or EXPLY-37 + water soluble fraction of rhizome of Phlebodium decumanum) 2 One or more of the aforementioned amino acid components. The procedure for obtaining these formulations consists of the following steps: a) Dissolution of the amino acid component in water at a controlled pH b) Incorporation of the rhizome powder into an aqueous solution containing EXPLY-37 (or EXPLY-37 + water-soluble fraction of rhizome of Phlebodium decumanum). c) Mixing and homogenization of the solution of a) and the suspension b). d) Evaporation of the solvent until obtaining a wet solid powder. e) Drying of the solid residue. f) Conditioning of the powder in the form of hard gelatin capsules, sachets and tablets that may contain between 100 mg. and 1,000 mg. of dry powder
B) Polypodium leucotomos >- Rizoma de Polypodium leucotomos Fracción hidrosoluble de fronde o de fronde y rizoma de Polypodium leucotomos >- Uno o varios de los componentes de naturaleza aminoácida citadosB) Polypodium leucotomos> - Rhizome of Polypodium leucotomos Water-soluble fraction of frond or frond and rhizome of Polypodium leucotomos> - One or more of the aforementioned amino acid components
2. FORMULACIONES LÍQUIDAS Pueden contener :2. LIQUID FORMULATIONS They may contain:
A) Phlebodium decumanumA) Phlebodium decumanum
EXPLY-37 (o EXPLY-37 + fracción hidrosoluble de rizoma de Phlebodium decumanum) junto con uno o varios de los componentes aminoácidos citados. Su preparación consta de las siguientes etapas: a) Disolución del componente aminoácido en agua a pH controlado. b) Disolución de EXPLY-37 (o EXPLY-37 + fracción hidrosoluble de Phlebodium decumanum) . c) Mezcla, homogeneización y reducción de volumen de las disoluciones a) y b) hasta una concentración adecuada. d) Acondicionamiento de la solución final obtenida en c) en forma de cápsulas de gelatina blanda sin excipientes, jarabes y ampollas bebibles. B) Polypodium leucotomosEXPLY-37 (or EXPLY-37 + water-soluble fraction of rhizome of Phlebodium decumanum) together with one or more of the aforementioned amino acid components. Its preparation consists of the following steps: a) Dissolution of the amino acid component in water at controlled pH. b) Dissolution of EXPLY-37 (or EXPLY-37 + water soluble fraction of Phlebodium decumanum). c) Mixing, homogenization and volume reduction of solutions a) and b) to an appropriate concentration. d) Conditioning of the final solution obtained in c) in the form of soft gelatin capsules without excipients, syrups and drinkable ampoules. B) Polypodium leucotomos
Fracción hidrosoluble de fronde, o de fronde y rizoma, adicionada o no de uno o varios de los componentes de naturaleza aminoácida citados.Water soluble fraction of frond, or frond and rhizome, added or not of one or more of the aforementioned amino acid components.
EJEMPLOSEXAMPLES
Se describen a continuación algunos ejemplos de formulaciones a base de EXPLY-37, aunque no limitativos a Phlebodium decumanum, siendo igualmente válidos para Polypodium leucotomos. Los ejemplos 1 a 6 reproducen las formulaciones ya descritas en las solicitudes de patente españolas números 9701693 y 9801139. Los ejemplos 7 a 9 ilustran las nuevas formulaciones conteniendo alguno de los componentes de naturaleza aminoácida.Some examples of formulations based on EXPLY-37 are described below, although not limited to Phlebodium decumanum, being equally valid for Polypodium leucotomos. Examples 1 to 6 reproduce the formulations already described in Spanish patent applications numbers 9701693 and 9801139. Examples 7 to 9 illustrate the new formulations containing some of the amino acid components.
EJEMPLO 1 50 Kg de rizomas frescos de Phlebodium decumanum desprovistos de vellosidades se sumergen, sucesivamente, en disolución diluida de cloro activo, agua desionizada, etanol absoluto y agua desionizada estéril. Se secan a continuación en un secador de lecho fluido a 40-50°C durante 2 horas. Se muelen y tamizan hasta obtener un polvo fino. A 22,5 Kg de rizoma triturado y tamizado se incorporan, paulatinamente, en una amasadora de acero inoxidable de 100 L de capacidad, 7,5 kg de EXPLY-37, y se mezcla hasta obtención de una masa homogénea que se seca en estufa de bandejas a una temperatura de 40-50°C durante 24 horas. El polvo se tamiza por una malla de 18 mesh.EXAMPLE 1 50 Kg of fresh rhizomes of Phlebodium decumanum devoid of villi are immersed, successively, in dilute solution of active chlorine, deionized water, absolute ethanol and sterile deionized water. They are then dried in a fluid bed dryer at 40-50 ° C for 2 hours. They are ground and sifted until a fine powder is obtained. At 22.5 kg of crushed and sieved rhizome, they are gradually incorporated in a stainless steel mixer with a capacity of 100 L, 7.5 kg of EXPLY-37, and mixed until obtaining a homogeneous mass that is dried in an oven of trays at a temperature of 40-50 ° C for 24 hours. The powder is screened by an 18 mesh mesh.
Con este polvo se preparan cápsulas que contienen 300 mg.Capsules containing 300 mg are prepared with this powder.
EJEMPLO 2EXAMPLE 2
Siguiendo un procedimiento análogo al descrito en el Ejemplo 1 , se prepara la mezcla final con 25,5 kg de rizoma triturado, tamizado y seco, y 18,5 kg de EXPLY-37. Una vez seco, se preparan cápsulas de gelatina dura conteniendo 440 mg de polvo.Following a procedure analogous to that described in Example 1, the final mixture is prepared with 25.5 kg of crushed, sieved and dried rhizome, and 18.5 kg of EXPLY-37. Once dry, hard gelatin capsules containing 440 mg of powder are prepared.
EJEMPLO 3EXAMPLE 3
Mediante un procedimiento análogo al descrito en el Ejemplo 1, se prepara una mezcla final que contiene 26,8 kg de rizoma triturado, tamizado y seco, 10 kg de EXPLY-37 y 3,2 kg de extracto de rizoma. Se preparan cápsulas con 400 mg de polvo seco. Las proporciones relativas de EXPLY-37 y extracto de rizoma pueden variar entre amplios límites (50:50 a 95:5).By a procedure analogous to that described in Example 1, a final mixture containing 26.8 kg of crushed, sieved and dried rhizome, 10 kg of EXPLY-37 and 3.2 kg of rhizome extract. Capsules with 400 mg of dry powder are prepared. The relative proportions of EXPLY-37 and rhizome extract can vary between wide limits (50:50 to 95: 5).
EJEMPLO 4 En un reactor-mezclador de acero inoxidable provisto de un agitador de paletas a velocidad de agitación de 20 revoluciones por minuto (rpm) se prepara una mezcla homogénea de 7,8 kg de extracto fluido de Sacharum offícinarum y 190 g de extracto de Glycirrhiza glabra (regaliz). A la masa homogénea se incorporan 10 g de ácido cítrico. Se añaden, finalmente, con agitación y a 37°C, 2 kg de EXPLY-37 hasta homogeneización. Se obtiene un jarabe que contiene 200 mg de EXPLY-37 por gramo.EXAMPLE 4 A homogeneous mixture of 7.8 kg of Sacharum officinarum fluid extract and 190 g of extract extract is prepared in a stainless steel reactor-mixer equipped with a paddle stirrer at stirring speed of 20 revolutions per minute (rpm). Glycirrhiza glabra (licorice). 10 g of citric acid are incorporated into the homogeneous mass. Finally, with stirring and at 37 ° C, 2 kg of EXPLY-37 are added until homogenization. A syrup containing 200 mg of EXPLY-37 per gram is obtained.
Utilizando distintas cantidades de EXPLY-37 y haciendo las correcciones ponderales correspondientes de excipientes, se obtienen jarabes de concentraciones en EXPLY-37 de 50 a 500 mg por gramo.Using different amounts of EXPLY-37 and making the corresponding weight corrections of excipients, syrups of concentrations in EXPLY-37 of 50 to 500 mg per gram are obtained.
EJEMPLO 5EXAMPLE 5
Se siguen los pasos descritos en el Ejemplo 4. Se agregan al final 1 kg de EXPLY-37 y 1 kg de extracto de rizoma, obteniéndose un jarabe con una concentración total de extracto de 200 mg/g.The steps described in Example 4 are followed. At the end 1 kg of EXPLY-37 and 1 kg of rhizome extract are added, obtaining a syrup with a total extract concentration of 200 mg / g.
Se pueden obtener, igualmente, jarabes con una composición de 50 a 500 mg de extracto total por gramo, siendo el extracto total la mezcla en proporciones variables (50:50 a 95:5) de EXPLY-37 y extracto de rizoma.Syrups with a composition of 50 to 500 mg of total extract per gram can also be obtained, the total extract being the mixture in varying proportions (50:50 to 95: 5) of EXPLY-37 and rhizome extract.
EJEMPLO 6EXAMPLE 6
En un reactor de vidrio provisto de agitador de ancla y velocidad variable, se agregan sucesivamente sobre 2.450 mL de agua desionizada, 5000 g de azúcar invertido, 2.500 g de sorbitol y 50 g de propilenglicol. Cuando la mezcla se ha hecho homogénea, se agregan, con agitación suave y a temperatura de 30 a 40°C, 2,5 kg de EXPLY-37 y 0,5 kg de extracto de rizoma.In a glass reactor equipped with an anchor stirrer and variable speed, 2,450 mL of deionized water, 5000 g of invert sugar, 2,500 g of sorbitol and 50 g of propylene glycol are added successively. When the mixture has become homogeneous, 2.5 kg of EXPLY-37 and 0.5 kg of rhizome extract are added, with gentle stirring and at a temperature of 30 to 40 ° C.
Concentración de jarabe: 200 mg/mL, expresado en EXPLY-37 o en EXPLY- 37+extracto de rizoma. Siguiendo la misma técnica, se han preparado jarabes que contienen un amplio intervalo de concentraciones (20 a 500 mg/mL).Syrup concentration: 200 mg / mL, expressed in EXPLY-37 or in EXPLY-37 + rhizome extract. Following the same technique, syrups have been prepared containing a wide range of concentrations (20 to 500 mg / mL).
EJEMPLO 7 Formulaciones sólidas conteniendo EXPLY -37 ( o EXPLY-37 + extracto de rizoma en proporciones que pueden variar desde 5:5 hasta 95:5). a) Se disuelven 20 Kg. de tiazolidin-carboxilato de arginina en 50 1 de agua desionizada a temperatura entre 20 y 40° C. b) Se incorporan, con agitación lenta y a temperatura no superior a 40°C, 25,5 Kg. de polvo de rizoma a una disolución acuosa que contiene 18,5 Kg de EXPLY-37 en un volumen total de 30 litros. c) Se mezclan y homogeneizan la disolución a) y la suspensión b). d) La suspensión resultante se evapora a presión reducida y a temperatura inferior a 40°C hasta la obtención de un polvo homogéneo. e) El polvo, homogeneizado, se seca hasta humedad inferior a 8%.EXAMPLE 7 Solid formulations containing EXPLY -37 (or EXPLY-37 + rhizome extract in proportions that can vary from 5: 5 to 95: 5). a) 20 Kg. of arginine thiazolidine carboxylate are dissolved in 50 1 of deionized water at a temperature between 20 and 40 ° C. b) They are incorporated, with slow stirring and at a temperature not exceeding 40 ° C, 25.5 Kg. of rhizome powder to an aqueous solution containing 18.5 kg of EXPLY-37 in a total volume of 30 liters. c) The solution a) and the suspension b) are mixed and homogenized. d) The resulting suspension is evaporated under reduced pressure and at a temperature below 40 ° C until a homogeneous powder is obtained. e) The powder, homogenized, dries to humidity below 8%.
Se utilizan cantidades de este polvo seco para preparar cápsulas que contienen de 200 a 500 mg. , sobres de 500 mg. y 1.000 mg. , y comprimidos de 250, 500, 750 y 1.000 mg.Amounts of this dry powder are used to prepare capsules containing 200 to 500 mg. , 500 mg sachets. and 1,000 mg. , and tablets of 250, 500, 750 and 1,000 mg.
EJEMPLO 8EXAMPLE 8
Cápsulas conteniendo EXPLY-37 ( o EXPLY-37 + fracción hidrosoluble de rizoma de Phlebodium decumanum) , polvo de rizoma y creatinol fosfato.Capsules containing EXPLY-37 (or EXPLY-37 + water soluble fraction of rhizome of Phlebodium decumanum), rhizome powder and creatinol phosphate.
Se incorporan a lo largo de 1 hora , con agitación y temperatura ambiente, 20 kg. de creatinol fosfato disueltos en 50 L de agua a la suspensión homogénea resultante de mezclar 25,5 kg. de polvo de rizoma con 18,5 Kg. de EXPLY-37 (o EXPLY-37 + fracción hidrosoluble de rizoma de Phlebodium decumanum). Se evapora a sequedad la suspensión resultante a temperatura no superior a 40°C y 40 mm de presión hasta obtener un polvo homogéneo con una humedad inferior a 10% . Con el polvo obtenido se preparan cápsulas que contienen de 200 a 500 mg de polvo y comprimidos de 250, 500, 750 y 1000 mg.They are incorporated over 1 hour, with stirring and room temperature, 20 kg. of creatinol phosphate dissolved in 50 L of water to the homogeneous suspension resulting from mixing 25.5 kg. of rhizome powder with 18.5 kg of EXPLY-37 (or EXPLY-37 + water-soluble fraction of rhizome of Phlebodium decumanum). The resulting suspension is evaporated to dryness at a temperature not exceeding 40 ° C and a pressure of 40 mm until a homogeneous powder with a humidity of less than 10% is obtained. Capsules containing 200 to 500 mg of powder and tablets of 250, 500, 750 and 1000 mg are prepared with the powder obtained.
Por un procedimiento similar al descrito en el EJEMPLO 1 y con las cantidades de cada componente que se resumen a continuación , se pueden preparar igualmente cápsulas, sobres y comprimidos de 100 mg. a 1.000 mg. a partir de las siguientes cantidades de EXPLY-37 (o EXPLY-37 + fracción hidrosoluble de rizoma de Phlebodium decumanum) y polvo de rizoma :By a procedure similar to that described in EXAMPLE 1 and with the amounts of each component that are summarized below, they can also be prepared 100 mg capsules, sachets and tablets. at 1,000 mg from the following amounts of EXPLY-37 (or EXPLY-37 + water-soluble fraction of rhizome of Phlebodium decumanum) and rhizome powder:
EXPLY-37 (o EXPLY-37 + fracción hidrosoluble de rizoma de Phlebodium decumanum) 10 a 30 Kg.EXPLY-37 (or EXPLY-37 + water-soluble fraction of rhizome of Phlebodium decumanum) 10 to 30 Kg.
Polvo de rizoma 10 a 30 Kg.Rhizome powder 10 to 30 Kg.
A estas mezclas se pueden incorporar uno o varios de los siguientes componentes:One or more of the following components can be incorporated into these mixtures:
L-carnitina 10 a 20 Kg. Carboximetilcisteína 15 a 30 kgL-carnitine 10 to 20 Kg. Carboxymethylcysteine 15 to 30 kg
L-cistina 20 a 30 kg.L-cystine 20 to 30 kg.
N-acetilcisteina 10 a 20 Kg.N-acetylcysteine 10 to 20 Kg.
L-glutamina 10 a 20 Kg.L-glutamine 10 to 20 Kg.
EJEMPLO 9EXAMPLE 9
Jarabe de EXPLY-37 ( o EXPLY-37 + fracción hidrosoluble de rizoma de Phlebodium decumanum) conteniendo L-carnitina, con una composición final de :EXPLY-37 syrup (or EXPLY-37 + water-soluble fraction of Phlebodium decumanum rhizome) containing L-carnitine, with a final composition of:
EXPLY-37 : 200 mg./ mi. L- carnitina : 100 mg./ miEXPLY-37: 200 mg./ mi. L- carnitine: 100 mg / mi
Se prepara una disolución acuosa de 10 Kg de l-carnitina en 50 L de agua desionizada, ligeramente acidulada con ácido clorhídrico .Se diluyen separadamente 20 kg de EXPLY-37 (o de EXPLY-37 + fracción hidrosoluble de Phlebodium decumanum) con 20 L de agua desionizada. Se mezclan las dos disoluciones, ajustándose el volumen final a 100 L.An aqueous solution of 10 kg of l-carnitine is prepared in 50 L of deionized water, slightly acidified with hydrochloric acid. 20 kg of EXPLY-37 (or EXPLY-37 + water-soluble fraction of Phlebodium decumanum) are diluted separately with 20 L of deionized water. The two solutions are mixed, adjusting the final volume to 100 L.
Por un procedimiento similar al descrito en el EJEMPLO 3 se pueden preparar formulaciones con las siguientes cantidades de cada componente :By a procedure similar to that described in EXAMPLE 3, formulations can be prepared with the following amounts of each component:
EXPLY-37 (o EXPLY-37 + fracción hidrosoluble de rizoma de Phlebodium decumanum en proporciones que pueden variar de 5:5 a 9: 1) 10 a 30 Kg.EXPLY-37 (or EXPLY-37 + water-soluble fraction of rhizome of Phlebodium decumanum in proportions that can vary from 5: 5 to 9: 1) 10 to 30 Kg.
Tiazolidin-carboxilato de arginina 10 a 20 Kg.Arginine thiazolidine carboxylate 10 to 20 Kg.
Carboximetilcisteína 15 a 30 Kg L-cistina 20 a 30 Kg.Carboxymethylcysteine 15 to 30 Kg L-Cystine 20 to 30 Kg.
N-acetilcisteína 10 a 20 Kg.N-acetylcysteine 10 to 20 Kg.
L-glutamina 10 a 20 Kg.L-glutamine 10 to 20 Kg.
RESULTADOSRESULTS
El empleo de distintas formulaciones conteniendo EXPLY-37, ya sea de forma preventiva en condiciones de sobreesfuerzo físico en periodo de entrenamiento o en competición, para revertir los efectos negativos de dicho sobreesfuerzo o para acortar el periodo normal de recuperación de lesiones óseas, musculares y cartilaginosas, ha permitido demostrar:The use of different formulations containing EXPLY-37, either preventively in conditions of physical overexertion during training or in competition, to reverse the negative effects of said overexertion or to shorten the normal recovery period of bone, muscle and cartilaginous, has allowed to demonstrate:
- mantenimiento de un elevado y constante nivel de esfuerzo sin la aparición de desgaste, cansancio, ni de los efectos no deseables asociados al mismo tales como infecciones oportunistas y alteraciones cardiorespiratorias. reversión del síndrome de sobreesfuerzo y de los citados efectos adversos asociados.- Maintenance of a high and constant level of effort without the appearance of wear, fatigue, or the undesirable effects associated with it such as opportunistic infections and cardiorespiratory disorders. reversal of overexertion syndrome and the associated side effects.
- mejora de la resistencia y la potencia física.- improvement of endurance and physical power.
- protección frente al daño tisular, especialmente en lesiones óseas, musculares y cartilaginosas. - la reducción al tiempo de curación de dichas lesiones.- protection against tissue damage, especially in bone, muscle and cartilaginous lesions. - the reduction in the healing time of said lesions.
La TABLA I resume los resultados obtenidos en deportistas seleccionados de distintas ramas del deporte. TABLE I summarizes the results obtained in selected athletes from different branches of the sport.
TABLA I. Empleo de formulaciones de EXPLY-37 en deporte.TABLE I. Use of EXPLY-37 formulations in sport.
Figure imgf000012_0001
Figure imgf000012_0001
FC = Frecuencia CardíacaHR = Heart Rate
RPE = Rate of Perceived Exercise (Escala de Borg)RPE = Rate of Perceived Exercise
Hb = HemoglobinaHb = Hemoglobin
VO2 = Tasa de captación de oxígeno por minuto VO 2 = Rate of oxygen uptake per minute

Claims

REIVINDICACIONES
1. Empleo de formulaciones a base de las variedades de Phlebodium decumanum y de Polypodium leucotomos cultivadas en la plantación de HELSINT S.A.L en las proximidades del lago YOJOA (Honduras), como complemento nutricional en la prevención y reversión del síndrome de sobresfuerzo físico.1. Use of formulations based on the varieties of Phlebodium decumanum and Polypodium leucotomos cultivated in the HELSINT S.A.L plantation near Lake YOJOA (Honduras), as a nutritional supplement in the prevention and reversal of physical strain.
2. Empleo de acuerdo con la reivindicación 1 , caracterizado porque dichas formulaciones pueden comprender una fracción hidrosoluble purificada y estandarizada de fronde de Phlebodium decumanum (EXPLY-37), mezclada o no con una fracción hidrosoluble de rizoma de Phlebodium decumanum, rizoma de Phlebodium decumanum y uno o varios de los siguientes componentes: acetilcisteína, carboximetilcisteína, glutamina, carnitina, acetilcarnitina, creatinolfosfato, tiazolidincarboxilato de arginina.2. Use according to claim 1, characterized in that said formulations may comprise a purified and standardized water-soluble fraction of Phlebodium decumanum frond (EXPLY-37), mixed or not with a water-soluble fraction of Phlebodium decumanum rhizome, Phlebodium decumanum rhizome and one or more of the following components: acetylcysteine, carboxymethylcysteine, glutamine, carnitine, acetylcarnitine, creatinolphosphate, arginine thiazolidinecarboxylate.
3. Empleo de acuerdo con la reivindicación 1, caracterizado porque dichas formulaciones pueden contener una fracción hidrosoluble purificada y estandarizada de fronde de Polypodium leucotoms, mezclada o no con una fracción hidrosoluble de rizoma de Polypodium leucotomos, rizoma de Polypodium leucotomos y uno o varios de los siguientes componentes: acetilcisteína, carboximetilcisteína, glutamina, carnitina, acetilcarnitina, creatinol fosfato, tiazolidincarboxilato de arginina.3. Use according to claim 1, characterized in that said formulations may contain a purified and standardized water soluble fraction of Polypodium leucotoms frond, mixed or not with a water soluble fraction of Polypodium leucotomos rhizome, Polypodium leucotomos rhizome and one or more of The following components: acetylcysteine, carboxymethylcysteine, glutamine, carnitine, acetylcarnitine, creatinol phosphate, arginine thiazolidinecarboxylate.
4. Empleo de acuerdo con la reivindicación 1, caracterizado porque dichas formulaciones pueden ser líquidas o sólidas y acondicionarse en forma de cápsulas de gelatina blanda, cápsulas de gelatina dura, jarabes, sobres y comprimidos.4. Use according to claim 1, characterized in that said formulations can be liquid or solid and conditioned in the form of soft gelatin capsules, hard gelatin capsules, syrups, sachets and tablets.
5. Empleo de acuerdo con la reivindicación 1, caracterizado porque dichas formulaciones son útiles como complemento nutricional en la prevención y reversión del síndrome de sobresfuerzo físico y de los efectos no deseables asociados al mismo, en especial de las infecciones oportunistas, alteraciones cardiorespiratorias y daño tisular, especialmente en lesiones óseas, musculares y cartilaginosas. 5. Use according to claim 1, characterized in that said formulations are useful as a nutritional supplement in the prevention and reversal of physical overstress syndrome and the undesirable effects associated therewith, especially opportunistic infections, cardiorespiratory disorders and damage. tissue, especially in bone, muscle and cartilaginous lesions.
PCT/ES2000/000021 1999-01-22 2000-01-20 Utilization of formulations based on water-soluble fractions of phlebodium decumanum(exply-37) and polypodium leucotomos as nutritional supplement in the prevention and reversion of excessive physical effort syndrome WO2000043022A1 (en)

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EP0503208A1 (en) * 1991-03-08 1992-09-16 Maracuyama International, S.A. Procedure for obtaining a natural water-soluble extract from the leaves and/or rhizomes of various immunologically active ferns
ES2068163B1 (en) * 1994-05-06 1995-09-01 Esp Farmaceuticas Centrum Sa PROCEDURE FOR OBTAINING A PLANT EXTRACT WITH ACTIVITY IN THE TREATMENT OF COGNITIVE DYSFUNCTIONS AND / OR NEUROINMUNES.
ES2088770A1 (en) * 1995-02-23 1996-09-01 Esp Farmaceuticas Centrum Sa A pharmaceutical composition with activity in the treatment of cognitive and/or neuroimmune dysfunctions.
WO1998043499A2 (en) * 1997-04-01 1998-10-08 Sigma-Tau Healthscience S.P.A. Nutritional supplement

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001006873A1 (en) * 1999-07-23 2001-02-01 Sigma-Tau Healthscience S.P.A. Composition for the prevention of muscle fatigue and skeletal muscle adaptation to strenuous exercise
US6602512B1 (en) 1999-07-23 2003-08-05 Sigma-Tau Healthscience S.P.A. Composition for the prevention of muscle fatique and skeletal muscle adaptation of strenuous exercise

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