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WO2004017979A2 - Medicament, food supplement, and fodder additive - Google Patents

Medicament, food supplement, and fodder additive Download PDF

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Publication number
WO2004017979A2
WO2004017979A2 PCT/EP2003/009068 EP0309068W WO2004017979A2 WO 2004017979 A2 WO2004017979 A2 WO 2004017979A2 EP 0309068 W EP0309068 W EP 0309068W WO 2004017979 A2 WO2004017979 A2 WO 2004017979A2
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WO
WIPO (PCT)
Prior art keywords
medicament
feed additive
additive according
food supplement
prebiotics
Prior art date
Application number
PCT/EP2003/009068
Other languages
German (de)
French (fr)
Other versions
WO2004017979A3 (en
Inventor
Wilhelm Berkulin
Ivo Pischel
Original Assignee
Finzelberg Gmbh & Co. Kg
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Finzelberg Gmbh & Co. Kg filed Critical Finzelberg Gmbh & Co. Kg
Priority to AU2003266285A priority Critical patent/AU2003266285A1/en
Priority to EP03792330A priority patent/EP1530479A2/en
Publication of WO2004017979A2 publication Critical patent/WO2004017979A2/en
Publication of WO2004017979A3 publication Critical patent/WO2004017979A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K20/00Accessory food factors for animal feeding-stuffs
    • A23K20/10Organic substances
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K20/00Accessory food factors for animal feeding-stuffs
    • A23K20/10Organic substances
    • A23K20/111Aromatic compounds
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K20/00Accessory food factors for animal feeding-stuffs
    • A23K20/10Organic substances
    • A23K20/116Heterocyclic compounds
    • A23K20/121Heterocyclic compounds containing oxygen or sulfur as hetero atom
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K20/00Accessory food factors for animal feeding-stuffs
    • A23K20/10Organic substances
    • A23K20/163Sugars; Polysaccharides
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K20/00Accessory food factors for animal feeding-stuffs
    • A23K20/10Organic substances
    • A23K20/174Vitamins
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K20/00Accessory food factors for animal feeding-stuffs
    • A23K20/10Organic substances
    • A23K20/179Colouring agents, e.g. pigmenting or dyeing agents
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K50/00Feeding-stuffs specially adapted for particular animals
    • A23K50/10Feeding-stuffs specially adapted for particular animals for ruminants
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K50/00Feeding-stuffs specially adapted for particular animals
    • A23K50/20Feeding-stuffs specially adapted for particular animals for horses
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K50/00Feeding-stuffs specially adapted for particular animals
    • A23K50/30Feeding-stuffs specially adapted for particular animals for swines
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23KFODDER
    • A23K50/00Feeding-stuffs specially adapted for particular animals
    • A23K50/60Feeding-stuffs specially adapted for particular animals for weanlings
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105Plant extracts, their artificial duplicates or their derivatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/733Fructosans, e.g. inulin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/87Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9064Amomum, e.g. round cardamom
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9068Zingiber, e.g. garden ginger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to a pharmaceutical, a food supplement and a feed additive.
  • Prebiotics are non-digestible food components that have a beneficial effect on the growth and activity of individual or a limited number of (positive) intestinal bacteria and thus improve human or animal health.
  • Prebiotics change the intestinal microflora by influencing the intestinal milieu, not by oral bacteria.
  • Prebiotics are neither hydrolyzed nor absorbed in the upper area of the margin-intestinal tract. They are available in the large intestine as a fermentable substrate or as a growth substance for individual bacterial strains. These bacterial strains include Lactobacillii, Bifidobacteria and Eubacteria, which have health-promoting properties.
  • prebiotics In contrast to fiber such as starch, hemicelluloses, pectin and plant gums, prebiotics have a specificity for health-promoting bacteria, while common dietary fibers can also promote growth and metabolic activity of potentially harmful germs.
  • Typical prebiotics are fructooligosaccharides such as inulin and oligofructose, some synthetic galactose-containing oiigosaccharides and soybean oiigosaccharides.
  • Inulin consists of a mixture of different fructose chains, the shorter chain fraction is called oligofructose. Inulin occurs in over 36,000 plant species, some of which are also used for human consumption. For example, chicory contains 15 to 20% inulin and oligofructose, garlic 9 to 16%, wheat 1 to 4%, Jerusalem artichoke 16 to 20%, leek 3 to 10%, rye 0.5 to 1 %, in asparagus 1 to 30%, in onions 2 to 6% and in bananas 0.3 to 0.7%.
  • inulin is obtained commercially from chicory roots.
  • Other commercially available fructooligosaccharides are enzymatically synthesized from sucrose.
  • Inulin is glucose-free and indigestible in the human small intestine.
  • fructooligosaccharides are fermented microbially to short-chain fatty acids, especially to acetate, propionate, butyrate and L-lactic acid.
  • inulin is used for solid and liquid preparations in order to influence viscosity, freezing point, liquid content, color and emulsifiability of foods as well as gel formation and yellowing.
  • Inulin is very hygroscopic.
  • the hygroscopicity has the disadvantage that the preparation, for example a beverage powder, clumps after a short time.
  • the object of the present invention was to provide a more manageable inulin without losing its health-promoting properties.
  • the invention therefore relates, on the one hand, to a dietary supplement or pharmaceutical containing antioxidants of plant origin and prebiotics.
  • the prebiotics used according to the invention can be poly- or oligosaccharides which are of vegetable, synthetic and / or fermentative origin. Particularly preferred prebiotics are selected from the group consisting of fructooligosaccharides, inulin, oligofructose, galactooligosaccharides, transgalactosyloligosaccharides (TOS), lactulose, lactosucrose, glucooligosaccharides (GOS), xylooligosaccharide / Ixomaccharide (XOSaccharide), gentosolcharide (XOSaccharide), gentosolcharide (XOSaccharide), and XOS oligosaccharide (XOSaccharide) maltooligosaccharides.
  • the antioxidants used according to the invention are of vegetable origin, and preferably components of plant extracts from grape seeds and extracts from lamiaceae, in particular rosemary.
  • the antioxidants used according to the invention preferably originate from the substance classes of proanthocyanidins, anthocyanins, polyphenols, phenolic acids, flavonoids, protease inhibitors, sulfides, carotenoids, ascorbates, lignans, quinones and / or selenium compounds. Mixtures can also be used.
  • the agent according to the invention preferably contains about 5 to 20% by weight of antioxidants and 75 to 90% by weight of prebiotics.
  • the ratio of the weights of antioxidants to prebiotics is preferably between 1:20 and 1: 3, preferably between 1:15 and 1: 5, even more preferably between 1:12 and 1: 8.
  • the product according to the invention is preferably free from probiotics, in particular probiotic bacterial strains, since these can negatively influence the shelf life of the product.
  • the agent according to the invention can contain further substances, in particular from the group of pharmaceutical formulation auxiliaries and / or biologically active substances.
  • Typical formulation auxiliaries are, for example, silicon dioxide, dicalci umphosphate, maltodextrin, cellulose derivatives such as microcrystalline cellulose (MCC), etc.
  • Typical other active substances are plant substances without an antioxidative and / or prebiotic effect, for example substances with an anti-inflammatory effect such as ginger and cardamon extract or oil, as well as medicinal and silica.
  • the preparation is obtained by a special manufacturing process (cf. WO 03/09515, with priority among others EP 02 000 740.7).
  • the prebiotic is spray-dried, while the antioxidants and optionally formulation aids are added in dry form.
  • the prebiotic is coated with a layer of the antioxidants.
  • the agent according to the invention is suitable both for the therapy of gastrointestinal complaints, in particular inflammatory processes, such as e.g. Colitis, Crohn's disease, ulcerative colitis, etc., as well as a prophylactic agent, and can e.g. as a food supplement or in the veterinary field as a feed additive, and here, for example, in horses for the treatment and prevention of colic, in the rearing of calves and piglets for the prevention of diarrhea.
  • gastrointestinal complaints in particular inflammatory processes, such as e.g. Colitis, Crohn's disease, ulcerative colitis, etc.
  • a prophylactic agent can e.g. as a food supplement or in the veterinary field as a feed additive, and here, for example, in horses for the treatment and prevention of colic, in the rearing of calves and piglets for the prevention of diarrhea.
  • Another object of the invention is a composition containing inulin and components of plant extracts from grape seeds and / or rosemary, optionally together with the above-mentioned probiotic components or the other substances, in particular in connection with ginger extract or healing earth.
  • the dry product can be filled into hard gelatin capsules as a food supplement.
  • Example 1 80 kg of dry product from Example 1 are mixed with 20 kg of rosemary extract and mixed with 10% silicified microcrystalline ceilulose (MCC) ProSolv ® , compacted. The granulate is filled into hard gelatin capsules and marketed as a dietary supplement.
  • MCC microcrystalline ceilulose
  • inulin spray solution with 42% dry matter 300 kg are spray dried at 210 ° C air inlet temperature and 40 bar nozzle pressure.
  • 12.6 kg of grape seed extract, 6.3 kg of rosemary extract and 126 kg of silica are powdered into the dryer.
  • 259 kg of dry product are obtained.
  • 247 kg of dry product are mixed with 2.5 kg of ginger extract and 0.5 kg of caramon oil.
  • the end product is used as a feed additive in horses for the prevention and treatment of colic.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Polymers & Plastics (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Animal Husbandry (AREA)
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  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
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Abstract

The invention relates to a medicament, food supplement, or fodder additive containing plant-based antioxidants and prebiotics.

Description

Arznei-, Nahrunqsergänzunqsmittel und Futtermittelzusatz Medicines, nutritional supplements and feed additives
Die vorliegende Erfindung betrifft ein Arzneimittel, ein Nahrungsergänzungsmit- tel und einen Futtermittelzusatz.The present invention relates to a pharmaceutical, a food supplement and a feed additive.
Präbiotika sind nichtverdauliche Nahrungsmittelbestandteile, die durch Stimula- tion von Wachstum und Aktivität einzelner oder einer begrenzten Zahl (positiver) Darmbakterien günstig beeinflussen und dadurch die Gesundheit des Menschen oder des Tieres verbessern.Prebiotics are non-digestible food components that have a beneficial effect on the growth and activity of individual or a limited number of (positive) intestinal bacteria and thus improve human or animal health.
Präbiotika verändern die Mikroflora des Darms durch Beeinflussung des intesti- nalen Milieus, nicht durch orale Zuführung von Bakterien. Präbiotika werden im oberen Bereich des Margen-Darm-Traktes weder hydrolisiert noch absorbiert. Sie stehen im Dickdarm als fermentierbares Substrat bzw. als Wuchsstoff für einzelne Bakterienstämme zur Verfügung. Diese Bakterienstämme sind unter anderem Lactobacillii, Bifidobacteria und Eubacteria, die gesundheitsfördernde Eigenschaften haben.Prebiotics change the intestinal microflora by influencing the intestinal milieu, not by oral bacteria. Prebiotics are neither hydrolyzed nor absorbed in the upper area of the margin-intestinal tract. They are available in the large intestine as a fermentable substrate or as a growth substance for individual bacterial strains. These bacterial strains include Lactobacillii, Bifidobacteria and Eubacteria, which have health-promoting properties.
Präbiotika haben im Unterschied zu Ballaststoffen wie Stärken, Hemicellulosen, Pektin und Pflanzengummis eine Spezifität für gesundheitsfördernde Bakterien, während übliche Baliaststoffe auch Wachstums- und Stoffwechselaktivität potentiell gesundheitsschädlicher Keim fördern können.In contrast to fiber such as starch, hemicelluloses, pectin and plant gums, prebiotics have a specificity for health-promoting bacteria, while common dietary fibers can also promote growth and metabolic activity of potentially harmful germs.
Typische Präbiotika sind Fruktooligosaccharide wie Inulin und Oligofruktose, einige synthetische galaktosehaltige Oiigosaccharide und Oiigosaccharide aus Sojabohnen.Typical prebiotics are fructooligosaccharides such as inulin and oligofructose, some synthetic galactose-containing oiigosaccharides and soybean oiigosaccharides.
Das am meisten verwendete Präbiotikum ist Inulin. Inulin besteht aus einem Gemisch verschiedener Fruktoseketten, die kürzerkettige Fraktion wird als Oligofruktose bezeichnet. Inulin kommt in über 36.000 Pflanzenarten vor, von denen einige auch der menschlichen Ernährung dienen. So sind zum Beispiel in Chicoree 15 bis 20% Inulin und Oligofruktose enthalten, in Knoblauch 9 bis 16%, in Weizen 1 bis 4%, in Topinambur 16 bis 20%, in Lauch 3 bis 10%, in Roggen 0,5 bis 1%, in Spargel 1 bis 30%, in Zwiebeln 2 bis 6% und in Bananen 0,3 bis 0,7%.The most common prebiotic is inulin. Inulin consists of a mixture of different fructose chains, the shorter chain fraction is called oligofructose. Inulin occurs in over 36,000 plant species, some of which are also used for human consumption. For example, chicory contains 15 to 20% inulin and oligofructose, garlic 9 to 16%, wheat 1 to 4%, Jerusalem artichoke 16 to 20%, leek 3 to 10%, rye 0.5 to 1 %, in asparagus 1 to 30%, in onions 2 to 6% and in bananas 0.3 to 0.7%.
BESTATIGUNGSKOPIE Typischerweise wird Inulin kommerziell aus Chicoree-Wurzeln gewonnen. Andere kommerziell erhältliche Fruktooligosaccharide werden enzymatisch aus Saccharose synthetisiert. Inulin ist glucosefrei und im menschlichen Dünndarm unverdaulich. Im Dickdarm werden Fruktooligosaccharide mikrobiell zu kurzket- tigen Fettsäuren fermentiert, insbesondere zu Acetat, Propionat, Butyrat und L- Milchsäure.BESTATIGUNGSKOPIE Typically, inulin is obtained commercially from chicory roots. Other commercially available fructooligosaccharides are enzymatically synthesized from sucrose. Inulin is glucose-free and indigestible in the human small intestine. In the large intestine, fructooligosaccharides are fermented microbially to short-chain fatty acids, especially to acetate, propionate, butyrate and L-lactic acid.
Technologisch wird Inulin für feste und flüssige Zubereitungen eingesetzt um Viskosität, Gefrierpunkt, Flüssigkeitsgehalt, Farbe und Emulgierbarkeit von Lebensmitteln sowie Gelbildung und Gelbindung zu beeinflussen.Technologically, inulin is used for solid and liquid preparations in order to influence viscosity, freezing point, liquid content, color and emulsifiability of foods as well as gel formation and yellowing.
Von besonderem Interesse ist seine Fähigkeit, in höheren Konzentrationen (über 20%) in Wasser cremige Produkte mit fettartigem Mundgefühl zu bilden, die als energiearme, hitzestabile und geschmacksneutrale Fettersatzstoffe dienen können.Of particular interest is its ability to form creamy products with a greasy mouthfeel in higher concentrations (over 20%) in water, which can serve as low-energy, heat-stable and tasteless fat substitutes.
Inulin ist stark hygroskopisch. Die Hygroskopozität bringt für viele Fertigformu- lierungen den Nachteil mit, dass das Präparat, zum Beispiel ein Getränkepulver, nach kurzer Zeit verklumpt.Inulin is very hygroscopic. For many finished formulations, the hygroscopicity has the disadvantage that the preparation, for example a beverage powder, clumps after a short time.
Aufgabe der vorliegenden Erfindung war es ein besser handhabbares Inulin bereit zu stellen, ohne dass dieses seine gesundheitsfördernde Eigenschaften verliert.The object of the present invention was to provide a more manageable inulin without losing its health-promoting properties.
Überraschenderweise wurde gefunden, dass durch Kombination von Inulin mit Antioxidantien pflanzlicher Herkunft eine höhere Inertheit gegenüber der Aufnahme von Feuchtigkeit und dem Effekt des Verklumpens erreicht wird.Surprisingly, it was found that by combining inulin with antioxidants of plant origin, a higher inertness towards the absorption of moisture and the effect of clumping is achieved.
Dabei zeigte sich überraschenderweise, dass eine Kombination auch anderer Präbiotika mit Antioxidantien als Nahrungsergänzungs- und Arzneimittel, insbe- sondere im Bereich der Behandlung entzündlicher Prozesse im Darmbereich eingesetzt werden kann. Gegenstand der Erfindung ist daher zum einen ein Nahrungsergänzungs- oder Arzneimittel enthaltend Antioxidantien pflanzlicher Herkunft und Präbiotika.Surprisingly, it was found that a combination of other prebiotics with antioxidants as dietary supplements and medicinal products can be used, particularly in the area of the treatment of inflammatory processes in the intestinal area. The invention therefore relates, on the one hand, to a dietary supplement or pharmaceutical containing antioxidants of plant origin and prebiotics.
Die erfindungsgemäß eingesetzten Präbiotika können Poly- oder Oiigosaccharide sein, die pflanzlichen, synthetischen und/oder fermentativen Ursprung sind. Besonders bevorzugte Präbiotika sind ausgewählt aus der Gruppe bestehend aus Fruktooligosaccharide, Inulin, Oligofruktose, Galaktooligosaccharide, Transga- laktosyloligosaccharide (TOS), Laktulose, Laktosucrose, Glukooligosaccharide (GOS), Xylooligosaccharide (XOS), Gentioligosaccharide, Isomaltooligosaccha- ride (IMO) und/oder Maltooligosaccharide.The prebiotics used according to the invention can be poly- or oligosaccharides which are of vegetable, synthetic and / or fermentative origin. Particularly preferred prebiotics are selected from the group consisting of fructooligosaccharides, inulin, oligofructose, galactooligosaccharides, transgalactosyloligosaccharides (TOS), lactulose, lactosucrose, glucooligosaccharides (GOS), xylooligosaccharide / Ixomaccharide (XOSaccharide), gentosolcharide (XOSaccharide), gentosolcharide (XOSaccharide), and XOS oligosaccharide (XOSaccharide) maltooligosaccharides.
Die erfindungsgemäß eingesetzten Antioxidantien sind pflanzlicher Herkunft, und zwar bevorzugt Bestandteile von Pflanzenextrakten aus Traubenkernen und Extrakte aus Lamiaceenarten, insbesondere Rosmarin.The antioxidants used according to the invention are of vegetable origin, and preferably components of plant extracts from grape seeds and extracts from lamiaceae, in particular rosemary.
Die erfindungsgemäß eingesetzten Antioxidantien entstammen bevorzugt den Substanzklassen der Proanthocyanidine, Anthocyanen, Polyphenole, Phenol- säuren, Flavonoide, Protease-Inhibitoren, Sulfide, Carotinoide, Ascorbate, Lignane, Chinonen und/oder Selenverbindungen. Auch Mischungen können eingesetzt werden.The antioxidants used according to the invention preferably originate from the substance classes of proanthocyanidins, anthocyanins, polyphenols, phenolic acids, flavonoids, protease inhibitors, sulfides, carotenoids, ascorbates, lignans, quinones and / or selenium compounds. Mixtures can also be used.
Das erfindungsgemäße Mittel enthält vorzugsweise etwa 5 bis 20 Gew.-% Antioxidantien und 75 bis 90 Gew.-% Präbiotika. Das Verhältnis der Gewichte von Antioxidantien zu Präbiotika liegt vorzugsweise zwischen 1:20 und 1 :3, bevorzugt zwischen 1: 15 und 1:5, noch mehr bevorzugt zwischen 1 : 12 und 1:8.The agent according to the invention preferably contains about 5 to 20% by weight of antioxidants and 75 to 90% by weight of prebiotics. The ratio of the weights of antioxidants to prebiotics is preferably between 1:20 and 1: 3, preferably between 1:15 and 1: 5, even more preferably between 1:12 and 1: 8.
Das erfindungsgemäße Produkt ist vorzugsweise frei von Probiotika, insbesondere probiotischen Bakterienstämmen, da diese die Haltbarkeit des Produktes negativ beeinflussen können.The product according to the invention is preferably free from probiotics, in particular probiotic bacterial strains, since these can negatively influence the shelf life of the product.
Das erfindungsgemäße Mittel kann weitere Stoffe enthalten, insbesondere aus der Gruppe galenischer Formulierungshilfsstoffe und/oder biologisch aktive Substanzen. Typische Formulierungshilfsstoffe sind z.B. Siliziumdioxid, Dicalci- umphosphate, Maltodextrin, Cellulosederivate wie Mikrokristalline Cellulose (MCC), uam.The agent according to the invention can contain further substances, in particular from the group of pharmaceutical formulation auxiliaries and / or biologically active substances. Typical formulation auxiliaries are, for example, silicon dioxide, dicalci umphosphate, maltodextrin, cellulose derivatives such as microcrystalline cellulose (MCC), etc.
Typische weitere aktive Substanzen sind Pflanzenstoffe ohne antioxidative und/oder präbiotische Wirkung, zum Beispiel Stoffe mit entzündungshemmender Wirkung wie beispielweise Ingwer- und Cardamonextrakt oder -öl sowie Heil- und Kieselerde.Typical other active substances are plant substances without an antioxidative and / or prebiotic effect, for example substances with an anti-inflammatory effect such as ginger and cardamon extract or oil, as well as medicinal and silica.
In einer bevorzugten Ausführungsform wird das Präparat durch ein spezielles Herstellungsverfahren (vgl. WO 03/09515, mit Priorität unter anderem der EP 02 000 740.7) erhalten. Bei diesem Verfahren wird das Präbiotikum sprühgetrock- net, während die Antioxidantien und gegebenenfalls Formulierungshilfsstoffe in trockener Form zugesetzt werden.In a preferred embodiment, the preparation is obtained by a special manufacturing process (cf. WO 03/09515, with priority among others EP 02 000 740.7). In this process, the prebiotic is spray-dried, while the antioxidants and optionally formulation aids are added in dry form.
Dabei wird das Präbiotikum mit einer Schicht der Antioxidantien umhüllt.The prebiotic is coated with a layer of the antioxidants.
Das durch dieses Verfahren erhältliche Produkt ist ebenfalls Gegenstand der Erfindung.The product obtainable by this process is also the subject of the invention.
Das erfindungsgemäße Mittel eignet sich sowohl zur Therapie von gastro- intestinalen Beschwerden, insbesondere entzündlichen Prozessen, wie z.B. Coli- tiden, Morbus Crohn, Colitis ulcerosa ua, als auch als prophylaktisches Mittel, und kann z.B. als Nahrungsergänzung oder im Veterinärbereich als Futterzusatzmittel, und hier beispielsweise bei Pferden zur Behandlung und Vorbeu- gung von Koliken, bei der Aufzucht von Kälbern und Ferkeln zur Vorbeugung von Durchfallerkrankungen, eingesetzt werden.The agent according to the invention is suitable both for the therapy of gastrointestinal complaints, in particular inflammatory processes, such as e.g. Colitis, Crohn's disease, ulcerative colitis, etc., as well as a prophylactic agent, and can e.g. as a food supplement or in the veterinary field as a feed additive, and here, for example, in horses for the treatment and prevention of colic, in the rearing of calves and piglets for the prevention of diarrhea.
Ein weiterer Gegenstand der Erfindung ist eine Zusammensetzung enthaltend Inulin und Bestandteilen von Pflanzenextrakten aus Traubenkernen und/oder Rosmarin, gegebenenfalls zusammen mit den oben erwähnten probiotischen Bestandteilen oder den weiteren Stoffen, insbesondere in Verbindung mit Ingwerextrakt oder Heilerde.Another object of the invention is a composition containing inulin and components of plant extracts from grape seeds and / or rosemary, optionally together with the above-mentioned probiotic components or the other substances, in particular in connection with ginger extract or healing earth.
Die Erfindung wird durch die folgenden Beispiele weiter erläutert. BeispieleThe invention is further illustrated by the following examples. Examples
Beispiel 1example 1
300 kg Inulinsprühlösung mit 40,6% Trockensubstanz werden bei 210°C Lufteintrittstemperatur und 40 bar Düsendruck sprühgetrocknet. 53,8 kg Trauben- kernextrakt und 3,6 kg Siliziumdioxid werden pulverförmig in den Trockner eingetragen. Es resultieren 169 kg Trockenprodukt mit einer Zusammensetzung von 68% Inulin, 30% Traubenkernextrakt und 2% Siliziumdioxid.300 kg of inulin spray solution with 40.6% dry substance are spray-dried at 210 ° C air inlet temperature and 40 bar nozzle pressure. 53.8 kg grape seed extract and 3.6 kg silicon dioxide are powdered into the dryer. The result is 169 kg of dry product with a composition of 68% inulin, 30% grape seed extract and 2% silicon dioxide.
Das Trockenprodukt kann als Nahrungsergänzungsmittel in Hartgelatinekapseln gefüllt werden.The dry product can be filled into hard gelatin capsules as a food supplement.
Beispiel 2Example 2
80 kg Trockenprodukt aus Beispiel 1 werden mit 20 kg Rosmarinextrakt gemischt und mit 10 % verkieselter mikrokristalliner Ceilulose (MCC) ProSolv® versetzt, kompaktiert. Das Granulat wird in Hartgelatinekapseln abgefüllt und als Nahrungsergänzungsmittel vermarktet.80 kg of dry product from Example 1 are mixed with 20 kg of rosemary extract and mixed with 10% silicified microcrystalline ceilulose (MCC) ProSolv ® , compacted. The granulate is filled into hard gelatin capsules and marketed as a dietary supplement.
Beispiel 3Example 3
300 kg Inulinsprühlösung mit 42% Trockensubstanz werden bei 210°C Luft- eintrittstemperatur und 40 bar Düsendruck sprühgetrocknet. 12,6 kg Traubenkernextrakt, 6,3 kg Rosmarinextrakt und 126 kg Kieselerde werden pulverförmig in den Trockner eingetragen. Es werden 259 kg Trockenprodukt erhalten. 247 kg Trockenprodukt werden mit 2,5 kg Ingwerextrakt, 0,5 kg Caramonöl gemischt.300 kg of inulin spray solution with 42% dry matter are spray dried at 210 ° C air inlet temperature and 40 bar nozzle pressure. 12.6 kg of grape seed extract, 6.3 kg of rosemary extract and 126 kg of silica are powdered into the dryer. 259 kg of dry product are obtained. 247 kg of dry product are mixed with 2.5 kg of ginger extract and 0.5 kg of caramon oil.
Das Endprodukt wird als Futtermittelzusatz bei Pferden zur Vorbeugung und Behandlung von Koliken eingesetzt. The end product is used as a feed additive in horses for the prevention and treatment of colic.

Claims

Patentansprüche claims
1. Arzneimittel oder Nahrungsergänzungsmittel oder Futtermittelzusatz enthaltend Antioxidantien pflanzlicher Herkunft und Präbiotika.1. Medicines or food supplements or feed additives containing plant-derived antioxidants and prebiotics.
2. Arzneimittel oder Nahrungsergänzungsmittel oder Futtermittelzusatz nach Anspruch 1, dadurch gekennzeichnet, dass die Präbiotika Poly- oder Oiigosaccharide sind.2. Medicament or food supplement or feed additive according to claim 1, characterized in that the prebiotics are poly- or oligosaccharides.
3. Arzneimittel oder Nahrungsergänzungsmittel oder Futtermittelzusatz nach einem der Ansprüche 1 oder 2, dadurch gekennzeichnet, dass die Präbiotika pflanzlichen, synthetischen und/oder fermentativen Ursprungs sind. 3. Medicament or food supplement or feed additive according to one of claims 1 or 2, characterized in that the prebiotics are of plant, synthetic and / or fermentative origin.
4. Arzneimittel oder Nahrungsergänzungsmittel oder Futtermittelzusatz nach mindestens einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass die Präbiotika ausgewählt sind aus der Gruppe bestehend aus Fruktooligosaccharide, Inulin, Oligofruktose, Galaktooligosaccharide, Transgalaktosyloligo- saccharide (TOS), Laktulose, Laktosucrose, Glukooligosaccharide (GOS), Xylooligosaccharide (XOS), Gentioligosaccharide, Isomaltooligosaccharide4. Medicament or food supplement or feed additive according to at least one of claims 1 to 3, characterized in that the prebiotics are selected from the group consisting of fructooligosaccharides, inulin, oligofructose, galactooligosaccharides, transgalactosyloligosaccharides (TOS), lactulose, lactosucrose, glucooligosaccharide GOS), xylooligosaccharides (XOS), gentioligosaccharides, isomaltooligosaccharides
(IMO) und/oder Maltooligosaccharide.(IMO) and / or maltooligosaccharides.
5. Arzneimittel oder Nahrungsergänzungsmittel oder Futtermittelzusatz nach mindestens einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass die Antioxidantien 5 bis 20 Gew.-% und der Gehalt an Präbiotika 75 bis 90 Gew.-% enthält.5. Medicament or food supplement or feed additive according to at least one of claims 1 to 4, characterized in that the antioxidants contain 5 to 20 wt .-% and the prebiotics content 75 to 90 wt .-%.
6. Arzneimittel oder Nahrungsergänzungsmittel oder Futtermittelzusatz nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass keine Probiotika enthalten sind.6. Medicament or food supplement or feed additive according to one of claims 1 to 5, characterized in that no probiotics are contained.
7. Arzneimittel oder Nahrungsergänzungsmittel oder Futtermittelzusatz nach mindestens einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass die7. Medicament or food supplement or feed additive according to at least one of claims 1 to 6, characterized in that the
Antioxidantien Bestandteile von Pflanzenextrakten aus Traubenkern und/von Lamiaceenarten, z.B. Rosmarin, sind.Antioxidants constituents of plant extracts from grape seed and / of lamiaceae, e.g. Rosemary, are.
8. Arzneimittel oder Nahrungsergänzungsmittel oder Futtermittelzusatz nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass die Antioxidan- tien den Substanzklassen der Proanthocyanidine, Anthocyanen, Polypheno- le, Phenolsäuren, Flavonoide, , Protease-Inhibitoren, Sulfide, Carotinoide, Ascorbate, Lignane, Chinonen und/oder Selenverbindungen angehören.8. Medicament or food supplement or feed additive according to one of claims 1 to 6, characterized in that the antioxidant tien belong to the substance classes of proanthocyanidins, anthocyanins, polyphenols, phenolic acids, flavonoids, protease inhibitors, sulfides, carotenoids, ascorbates, lignans, quinones and / or selenium compounds.
9. Arzneimittel oder Nahrungsergänzungsmittel oder Futtermittelzusatz nach mindestens einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, dass das9. Medicament or food supplement or feed additive according to at least one of claims 1 to 8, characterized in that the
Arzneimittel oder Nahrungsergänzungsmittel weitere Stoffe ausgewählt aus der Gruppe galenischer Formulierungshilfsstoffe, biologisch aktive Substanzen, z.B. Extrakte mit entzündungshemmenden Eigenschaften enthält.Pharmaceuticals or food supplements further substances selected from the group of galenical formulation auxiliaries, biologically active substances, e.g. Contains extracts with anti-inflammatory properties.
10. Arzneimittel oder Nahrungsergänzungsmittel oder Futtermittelzusatz nach Anspruch 9, dadurch gekennzeichnet, dass der weitere Stoff ein Pflanzenstoff ohne antioxidative und/oder präbiotische Wirkung, ein Stoff mit entzündungshemmende Wirkung wie beispielweise Ingwer- oder Cardamo- nextrakt oder -öl oder Heil- und Kieselerde, ist.10. Medicament or dietary supplement or feed additive according to claim 9, characterized in that the further substance is a plant substance without antioxidative and / or prebiotic effect, a substance with anti-inflammatory effect such as ginger or cardamon extract or oil or medicinal and silica, is.
11. Verfahren zur Herstellung des Arzneimittel oder Nahrungsergänzungsmittels oder Futtermittelzusatz nach mindestens einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass während der Sprühtrocknung des Präbiotikums pulverförmige Antioxidantien sowie gegebenenfalls Formulierungshilfsstoffe in trockener Form zugesetzt werden. 11. A process for the preparation of the medicament or dietary supplement or feed additive according to at least one of claims 1 to 10, characterized in that powdery antioxidants and optionally formulation auxiliaries are added in dry form during the spray drying of the prebiotic.
12. Arzneimittel oder Nahrungsergänzungsmittel oder Futtermittelzusatz nach mindestens einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass es erhältlich ist durch ein Verfahren nach Anspruch 11.12. Medicament or food supplement or feed additive according to at least one of claims 1 to 10, characterized in that it is obtainable by a method according to claim 11.
13. Verwendung des Arzneimittel oder Nahrungsergänzungsmittels oder Futtermittelzusatz nach mindestens einem der Ansprüche 1 bis 10 oder 11 zur Prophylaxe, Prävention, Behandlung von gastro-intestinalen Beschwerden,13. Use of the medicament or food supplement or feed additive according to at least one of claims 1 to 10 or 11 for the prophylaxis, prevention, treatment of gastrointestinal complaints,
Leiden oder Syndromen, insbesondere entzündlichen Prozessen, wie Coliti- den, Morbus Crohn, Colitis ulcerosa ua.Suffering or syndromes, especially inflammatory processes such as colitis, Crohn's disease, ulcerative colitis and others.
14. Zusammensetzung enthaltend Inulin und Bestandteile von Pflanzenextrakten aus Traubenkernen und/oder Rosmarin. 14. Composition containing inulin and components of plant extracts from grape seeds and / or rosemary.
PCT/EP2003/009068 2002-08-16 2003-08-15 Medicament, food supplement, and fodder additive WO2004017979A2 (en)

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