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WO1996009059A1 - Procede et composition ameliores destines au traitement des ulceres - Google Patents

Procede et composition ameliores destines au traitement des ulceres Download PDF

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Publication number
WO1996009059A1
WO1996009059A1 PCT/AU1995/000625 AU9500625W WO9609059A1 WO 1996009059 A1 WO1996009059 A1 WO 1996009059A1 AU 9500625 W AU9500625 W AU 9500625W WO 9609059 A1 WO9609059 A1 WO 9609059A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
milk
banana
eggs
naturally occurring
Prior art date
Application number
PCT/AU1995/000625
Other languages
English (en)
Inventor
Brian A. Hills
Original Assignee
The University Of New England
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 The University Of New England filed Critical The University Of New England
Priority to AU35976/95A priority Critical patent/AU3597695A/en
Publication of WO1996009059A1 publication Critical patent/WO1996009059A1/fr

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Classifications

    • 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
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans

Definitions

  • the present invention relates to a method and composition for the prevention, cure and/or soothing of gastro-intestinal ulcers and non-ulcer dyspepsia in mammals in need of such treatment. More particularly the invention relates to a method and composition that can utilise only naturally occurring food grade ingredients.
  • ulcers can form in several parts of the GI tract, e.g. duodenal ulcers, those causing the greatest problem clinically are those forming in the highly acidic conditions of the stomach where the secretion of hydrochloric acid from glands in the stomach wall can lower the pH to about 2.
  • stomach ulcers are caused by the back- diffusion of hydrogen ions, i.e. acid, into the stomach lining.
  • the hydrogen-ion-pump inhibitors and H2 blockers are particularly effective in treating stomach ulcers acutely, but the relapse rate can be as high as 100% over two years (Brit. Med. J., 284: 621, 1982).
  • the patient can be maintained ulcer-free by continually dispensing the acid- suppressing drugs but that raises a new set of problems. Firstly there is the very high cost of continued medication. Secondly there are the side-effects which include excessive gain of weight and gynaecomastia (very unacceptable to males) while there are reports of carcenoid formation in animals subjected to prolonged elevation of pH. Intuitively, it is undesirable to suppress the normal secretion of acid needed to kill bacteria and other unwanted pathogens present in the flora and fauna normally ingested.
  • the major clinical need is for natural foods or a mixture thereof which can be used to maintain the serious ulcer patient who has been successfully treated in the acute phases with H2 antagonists or hydrogen-ion-pump inhibitors.
  • H2 antagonists or hydrogen-ion-pump inhibitors In the general population there is also a real need for a simple remedy to avoid the mild ulceration which can form during stressful periods when our stomachs secrete more acid than usual.
  • the present invention has previously found that gastro-intestinal ulcers may be prevented, cured and/or soothed by the internal administration to a patient of an effective amount of a composition containing a dispersion of ripe banana in milk (see Australian patent specification B29902/89). This previous invention was predicated upon the discovery of lamellar bodies of phospholipid in bananas.
  • the present invention relates to a new composition and method that builds on and extends the previously described invention. Disclosure of the Invention
  • the present invention consists, in a first aspect, in a method for the prevention, curing and/or soothing of gastro-intestinal ulcers or other gastro-intestinal erosion in mammals in need of such treatment, comprising administering orally to such a mammal an effective amount of a composition containing an effective proportion of a naturally occurring phospholipid present in the form of the lamellar bodies and an effective proportion of a naturally occurring hydrophobic protein, the composition being dispersed in a naturally occurring and nutritionally acceptable carrier.
  • the present invention consists in a composition for the prevention, curing and/or soothing of gastro-intestinal ulcers in mammals comprising a composition containing an effective proportion of a naturally occurring phospholipid present in the form of lamellar bodies and an effective proportion of a naturally occurring hydrophobic protein.
  • the present methods are of particular utility in the treatment of gastro-intestinal ulcers and other gastro- intestinal erosion such as gastro-oesophageal reflux (heartburn) and non-ulcer dyspepsia in man, however, it could be used to treat other mammalian animals.
  • the method and composition may be used to ensure the maintenance of a satisfactory protective phospholipid layer in the gastro-intestinal tract and thereby prevent gastro-intestinal ulcers forming.
  • the composition according to this invention and utilised in the method includes a naturally occurring phospholipid present in the form of lamellar bodies.
  • Lamellar bodies are biological stores of highly surface active phospholipid found in animal and plant cells and are described in more detail in B.A. Hills "The Biology of Surfactant” Cambridge University Press 1988 pp 48-51.
  • the most suitable source of lamellar bodies is fruit or vegetables containing such bodies.
  • Most preferably the lamellar bodies are obtained from ripe bananas and are included in the composition by the inclusion of the flesh of the ripe banana fruit in the composition.
  • the banana fruit will have a ripeness of at least stage 7, more preferably stage 8, of the banana growers ripeness scale which ranges from 1 for green to 8 for brown fully mature bananas (see Von Loesecke H.W., "Economic Crops” in Kertesz Z.I, Ed. “Bananas” 2nd Edition, New York, Interscience 1950:108-109).
  • An alternative index of ripeness is the sugar content and on this basis a sugar content of at least 17% by weight, and preferably 20% by weight, is preferred.
  • banana or other fruit or vegetables are used as the source of the phospholipid it is desirable that the fruit or vegetables are dried or frozen rapidly after being peeled or otherwise prepared.
  • the fruit are preferably steamed, rapidly heated or dipped in dilute hypochlorite solution to prevent enzymes turning it brown. This drying or freezing may take place either before or after mixing of the phospholipid components with the other components of the composition.
  • the phospholipid will be naturally occurring and will therefore vary to some extent in composition, however, the phospholipids will typically be straight chained and largely saturated.
  • the predominant and most surface active component will normally be L- ⁇ - dipalmitoyl phosphatidyl choline (DPPC) .
  • DPPC dipalmitoyl phosphatidyl choline
  • phosphatidylethanolamine, phosphatidylserine and phosphatidylinositol will also be present.
  • the composition also contains a naturally occurring source of a hydrophobic protein.
  • the hydrophobic proteins are also called proteolipids in the literature. They are proteins typically extractable from their source with a strongly non-polar solvent such as chloroform or ether.
  • the hydrophobic proteins are associated inter alia with the myelination of axons (nerve fibres) as well as the expansion of the lung at birth. In the latter situations the hydrophobic proteins play a major role in the location of phospholipids at the air-aqueous interface of the neonatal lung upon switching to ventilation by air.
  • hydrophobic proteins may be useful in assisting in the adsorption of phospholipids at a solid surface. He further postulated that such hydrophobic proteins may be present in birds eggs as the developing embryo in the egg must have a rapidly developing nervous system with myelination proceeding very rapidly. He found by experiment that such eggs did indeed contain such hydrophobic protein and that hydrophobic protein does facilitate the adsorption of phospholipids onto solid surfaces. It is therefore a particularly preferred aspect of the invention that the hydrophobic protein component of the composition comprises or is derived from the eggs of birds.
  • the eggs may be whole eggs or egg yolks and may be added to the composition in a wet or dried form.
  • the eggs may be fractionated to increase the proportion of hydrophobic protein in the egg derived material added to the composition.
  • the most readily obtained and economically most advantageous eggs are those derived from chickens, however, eggs from any other avian species could be used with substantially equal effect.
  • Other sources of hydrophobic protein may also be used such as the eggs of non-avian species or the lungs and other suitable tissue of young mammalian animals or the embryos thereof.
  • the components of the composition are preferably dispersed in a suitable carrier for oral administration to the consumer.
  • This carrier may be an aqueous solution of any suitable type but preferably comprises milk, cream or another dairy based liquid.
  • the milk or other dairy based liquid is preferably mixed with the other ingredients in a fresh state and is then rapidly frozen or dried to yield a saleable product.
  • powdered milk produce may be mixed with the other components in a dried state. It is preferred that the banana and milk are mixed prior to drying with the egg being added either fresh before drying or as a dried powder after drying.
  • the preferred milk based liquid is a fat and cholesterol reduced and calcium enriched milk product sold in New South Wales, Australia under the registered trade mark "Shape".
  • the milk and banana are most preferably mixed in a weight/volume ratio of 1:1 i.e. 1 gm of banana is mixed with 1 ml of milk and then dried however this ratio may be varied widely, preferably within the range 8:1 to 1:8. Obviously if other sources of phospholipid are used and other carriers used the ratio could change dramatically, however, the ratios described above may be used as a guide for further routine experimentation of suitable ratios.
  • the egg content may vary widely within the preferred range of 20:1 to 1:20 but, more preferably one part by weight of dried egg yolk powder is added to nine parts by weight of dried banana milk powder. If other sources of hydrophobic proteins and phospholipid are used similar effective ratios would form a starting point for the routine determination of the most effective dose and ratio.
  • polyvalent metal cations such as zinc or calcium may be added to the composition as such polyvalent cations are believed to stabilise the protective phospholipid layer in the gastro-intestinal tract.
  • freeze drying is an appropriate method for treating the banana/milk or egg/banana/milk mixture it is preferably spray dried.
  • the mixture is preferably rapidly heated at the inlet valve of the spray drier. This temperature may not be optimal but it does afford a degree of pasteurisation which is desirable.
  • the heated pure ⁇ is preferably passed through the inlet nozzle directly onto a rapidly spinning disc. This disc disperses the jets of puree into a fine mist in which droplets lose water as they are held in the upward current of air flowing through the dryer.
  • the dried droplets collect at the base of the dryer as a powder.
  • the animal model used was the standard non-pylorus- ligated rat. Wistar rats were starved for 18h. before experimentation during which coprophagy was prevented by keeping each animal in a tube just too small for it to turn around. There was no ligation of the pylorus in these trials so as to avoid variability in acid secretion induced by surgical intervention.
  • the rats were lightly anaesthetised in an atmosphere of 50:50 02:C02 when the test product was administered as a suspension in water via a stomach tube. Control rats were administered 1ml. of water. The rats were given a dose of 5% thiopentone sodium as a maintenance anaesthetic. After lh. the acid insult was administered by stomach tube, consisting of lml.
  • the dose was 250mg in lml water for a 270gm rat.
  • the rats were killed 2h. later by a lethal dose of sodium pentobarbitone after which the stomachs were excised and laid flat on a light box with the mucosal side uppermost.
  • the damage was then assessed by strongly illuminating the mucosa and projecting an image into a video-camera from which the ulcerated area could be clearly defined by colour enhancement.
  • the ulcerated area was then determined as a percentage of total mucosal area by computerised topography. This process, together with identical colour enhancement of controls, was felt to minimise, if not eliminate, any operator bias.
  • Ripe bananas were rapidly dispersed in a dairy product being a calcium enriched fat reduced milk sold under the registered trade mark "SHAPE" when the temperature is immediately raised and the puree injected into a spray-drier to produce a banana/dairy (BD) product.
  • BD banana/dairy
  • whole eggs (minus shell) or egg yolks are also incorporated into the ⁇ ure6 to be sprayed to produce an egg- banana-dairy (EBD) product.
  • the spray-dried powder is continuously removed from the drier. If egg was not added to the initial puree, then egg-yolk powder is mixed with the BD product by tumbling the two powders together to produce a mixed powdered egg/banana/dairy product (PEBD) .
  • PEBD mixed powdered egg/banana/dairy product
  • PE is more effective than raw egg yolk (E) in enhancing the efficacy of fresh banana dispersed in dairy product, further reducing mean ulcerated area by XA£ £_2
  • PE spray-dried egg-yolk powder
  • BD spray-dried banana/dairy product
  • EBD co-spray-drying

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biotechnology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Zoology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne un procédé et une composition permettant de prévenir, de guérir et/ou de calmer les effets des ulcères et autres phénomènes d'érosion gastro-intestinale chez les mammifères nécessitant un tel traitement, y compris l'homme. On administre au sujet une dose efficace d'une composition contenant un phospholipide naturel sous forme de corps lamellaires, et une protéine hydrophobe naturelle dans un excipient naturel, acceptable sur le plan nutritionnel. La composition contient de préférence un mélange, déshydraté et sous forme de poudre, de bananes, d'oeufs et de lait, qui peut être dissous dans du lait ou de l'eau.
PCT/AU1995/000625 1994-09-23 1995-09-22 Procede et composition ameliores destines au traitement des ulceres WO1996009059A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU35976/95A AU3597695A (en) 1994-09-23 1995-09-22 Improved method and composition for the treatment of ulcers

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPM8367A AUPM836794A0 (en) 1994-09-23 1994-09-23 Improved method and composition for the treatment of ulcers
AUPM8367 1994-09-23

Publications (1)

Publication Number Publication Date
WO1996009059A1 true WO1996009059A1 (fr) 1996-03-28

Family

ID=3782886

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU1995/000625 WO1996009059A1 (fr) 1994-09-23 1995-09-22 Procede et composition ameliores destines au traitement des ulceres

Country Status (2)

Country Link
AU (1) AUPM836794A0 (fr)
WO (1) WO1996009059A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005030226A1 (fr) * 2003-09-25 2005-04-07 Lamellar Therapeutics Limited Compositions et procedes pour utiliser des corps lamellaires a des fins therapeutiques
AU2004210207B2 (en) * 2003-02-10 2009-12-10 Provexis (Ibd) Limited Treatment of inflammatory bowel disease
US9173901B2 (en) 2003-09-25 2015-11-03 Lamellar Therapeutics Limited Compositions and methods of using lamellar bodies for modifying linear biological macromolecules

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2990289A (en) * 1988-02-11 1989-08-17 University Of New England, The A method for the prevention, curing and/or soothing of gastro-intestinal ulcers

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2990289A (en) * 1988-02-11 1989-08-17 University Of New England, The A method for the prevention, curing and/or soothing of gastro-intestinal ulcers

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
ADELLE DAVIS, "Let's Get Well", Published 1983, by UNWIN PAPERBACKS (LONDON), Chapter 8, pages 67-68, Chapter 33, 301-303. *
CHEMICAL ABSTRACTS, Volume 104, Number 9, issued March 3, 1986, (Columbus, Ohio, USA), YASUI, WATARU et al., "Calcium-Activated, Phospholipid-Dependent Protein Kinase in Human Gastric Mucosa and Carcinoma", page 510, Abstract No. 66831u; & JPN. J. CANCER RES., 1985, 76(12), 1168-73. *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2004210207B2 (en) * 2003-02-10 2009-12-10 Provexis (Ibd) Limited Treatment of inflammatory bowel disease
WO2005030226A1 (fr) * 2003-09-25 2005-04-07 Lamellar Therapeutics Limited Compositions et procedes pour utiliser des corps lamellaires a des fins therapeutiques
AU2004275550B2 (en) * 2003-09-25 2011-08-18 Lamellar Biomedical Limited Compositions and methods of using lamellar bodies for therapeutic purposes
US9173901B2 (en) 2003-09-25 2015-11-03 Lamellar Therapeutics Limited Compositions and methods of using lamellar bodies for modifying linear biological macromolecules
US9750766B2 (en) 2003-09-25 2017-09-05 Lamellar Biomedical Limited Compositions and methods of using lamellar bodies for modifying linear biological macromolecules

Also Published As

Publication number Publication date
AUPM836794A0 (en) 1994-10-20

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