WO2004012753A1 - Composition pharmaceutique contenant de l'huile de nigelle, de lin et de bourrache - Google Patents

Composition pharmaceutique contenant de l'huile de nigelle, de lin et de bourrache Download PDF

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Publication number
WO2004012753A1
WO2004012753A1 PCT/IB2003/003054 IB0303054W WO2004012753A1 WO 2004012753 A1 WO2004012753 A1 WO 2004012753A1 IB 0303054 W IB0303054 W IB 0303054W WO 2004012753 A1 WO2004012753 A1 WO 2004012753A1
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WIPO (PCT)
Prior art keywords
oil
mass
composition
acid
black cumin
Prior art date
Application number
PCT/IB2003/003054
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English (en)
Inventor
Helfried Hans Rudolf Crede
Original Assignee
Helfried Hans Rudolf Crede
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 Helfried Hans Rudolf Crede filed Critical Helfried Hans Rudolf Crede
Priority to AU2003255863A priority Critical patent/AU2003255863A1/en
Publication of WO2004012753A1 publication Critical patent/WO2004012753A1/fr

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Classifications

    • 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)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/20Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • 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)
    • A61K36/30Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
    • 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)
    • A61K36/55Linaceae (Flax family), e.g. Linum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00General protective or antinoxious agents
    • A61P39/06Free radical scavengers or antioxidants

Definitions

  • This invention relates to an enteral pharmaceutical composition for the treatment of multiple sclerosis.
  • Multiple sclerosis is caused by damage to the myelin sheath which covers the axons of neurons. Nerve signals travel from neuron to neuron via axons.
  • the myelin sheath serves as an insulation against signal loss to neighbouring tissue. A damaged myelin sheath leads to a distortion or complete disappearance of signals.
  • the myelin sheath is sub-divided into distinct sections which are separated from each other by nodes, which are called "Nodes of Ranvier".
  • Nodes of Ranvier The latter's function is to speed up the transmission of nerve signals.
  • Damage to the myelin sheath therefore not only distorts or leads to the complete loss of nerve signals, but also slows down their transmission from neuron to neuron. This, in essence, is the nature of the phenomenon known as multiple sclerosis. As the damage to the myelin sheaths progresses, the patient affected by the disease loses control of essential body functions: loss of balance, slow and shaky walking patterns, speech impediment, even loss of bladder control and other symptoms.
  • Myelin is a very complex substance, consisting of various fats, fatty acids, phospho-lipids, proteins and even cholesterol.
  • an enteral pharmaceutical composition containing black cumin oil (nigella saliva), flax oil (olelum lini) and borage oil (borago officinalis) for the treatment of multiple sclerosis.
  • the invention also relates to a method of treating multiple sclerosis using the aforementioned pharmaceutical composition, and to the use of black cumin oil, flax oil and borage oil in a method of making a medicament for use in a method of treating multiple sclerosis.
  • the composition typically contains 70 to 80% by mass, preferably 75% by mass flax oil; 10% to 20% by mass, preferably 15% by mass black cumin oil; and 5% to 15% by mass, preferably 10% by mass borage oil.
  • an enteral pharmaceutical composition for treating multiple sclerosis the composition containing 65% to 75% by mass polyunsaturated fatty acids wherein one of the polyunsaturated fatty acids is gamma-linolenic acid.
  • the other polyunsaturated fatty acids may be selected from alpha-linolenic acid and linoleic acid.
  • the composition contains 1% to 10 % by mass gamma- linolenic acid.
  • the pharmaceutical composition contains, by mass of the composition:
  • Alpha-Linolenic Acid 40% to 50%, preferably 45%
  • Gamma-Linolenic Acid 1 % to 5%, preferably 2%
  • the composition also contains enzymes, preferably desaturase enzymes such as delta-6-desaturase.
  • the composition also contains vitamins, preferably vitamins B3, B6 and C, and minerals, preferably zinc and magnesium.
  • This invention relates to an enteral pharmaceutical composition for the treatment of multiple sclerosis.
  • the pharmaceutical composition includes black cumin oil (nigella sativa), flax oil (oleium lini), borage oil (borago officinalis) and vitamins and minerals.
  • Black cumin oil is composed of the following fatty acids by mass:
  • Flax oil is composed of the following fatty acids by mass: Omega 3 (Linolenic) 60.1 %
  • Borage oil is composed of the following fatty acids by mass: Gamma-Linolenic acid 22%
  • the flax oil, borage oil and black cumin oil are mixed at a percentage 75%, 10% and 15% by mass respectively to provide a medicinal composition according to the invention. These percentages may vary, depending on the individual's requirements.
  • the composition When taken enterally the composition has been shown to treat multiple sclerosis successfully.
  • the dosage of the composition depends on the severity of the multiple sclerosis and the patient, but a usual dosage is 20ml to 40ml per day, typically 20ml per day.
  • composition of the invention provides an abundance of polyunsaturated fatty acids which are believed to be the building materials for the formation of myelin, the breakdown of which is believed to be the root cause of multiple sclerosis.
  • This abundance of fatty acids is provided by the flax oil, the black cumin oil and the borage oil.
  • the enzymes required for essential fatty acids metabolism are delta-6, delta-5 and delta-4-desaturase, of which delta-6-desaturase is the most important because if its function is impaired for whatever reasons, the other two enzymes have nothing to work with. It may also be that delta-6-desaturase is not produced by the body in sufficient quantities, which leads to the same malfunction.
  • the borage oil contains gamma-linolenic acids, a substance normally produced in the human body by the enzyme delta-6-desaturase acting on dietary linoleic acid through a process known as desaturation and elongation.
  • gamma-linolenic acid is therefore available for subsequent metabolic conversions even if no or to little delta-6-desaturase is present.
  • Borage seeds are also a source of delta-6- desaturase, thus making a basic supply of delta-6-desaturase available for the relevant conversions of fatty acids, not only into gamma-linolenic acid but also dihomo-gamma-linolenic acid, from which arachidonic acid and other essential fatty acid derivatives are formed.
  • Enzymes require so-called co-factors in order to properly perform their functions.
  • the co- factors are the vitamins B3, B6, and C and the minerals zinc and magnesium. Even an abundance of enzymes will not be able to effect the proper essential- fatty-acid metabolisms even if only one of the co-factors is not available in sufficient quantities. As a consequence, the complex end products of said metabolism, arachidonic acid with 4 double bonds, and docosahexaenoic acid, with 6 double bonds, will not be available in sufficient quantities.
  • fatty acids are "brain fatty acids", meaning that they are incorporated into various brain structures, playing a vital role in the formation of myelin, and the transmission of nerve signals.
  • Multiple sclerosis sufferers are therefore not only affected by a lack of available essential fatty acids, but also by a lack of available enzymes and/or a lack of available co-factors.
  • Borage seeds contain the enzyme delta-6-desaturase, which is therefore made available through the oil, as an oil-soluble substance and/or through seed particles which are purposely left in the oil after cold-pressing. Therefore, even if a patient is lacking the enzyme delta-6-desaturase, it is made available through the borage oil and seed component of the present invention.
  • 750ml flax oil is mixed with 100ml of borage oil and 150ml of black cumin oil to provide a preparation which is made up by the following by mass of the composition:
  • composition also comprised 0,1g vitamin B6, 0,1g vitamin B3, 5g vitamin C, 14g magnesium and 0,6g zinc.
  • Example 2
  • Example 1 She began using the composition described in Example 1 at a dosage of 20ml per day. Her condition improved after 4 to 6 weeks. Approximately 3 months after beginning to use the composition of the invention she was practically symptom free and after 15 months she was still practically symptom free.
  • Example 1 In May 2002, the patient started using the composition of Example 1 at a dosage of 20ml per day. Within 4 months, his condition had improved to such an extent that he was practically symptom-free.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne une composition pharmaceutique entérale destinée au traitement de la sclérose en plaques. Ladite composition comporte notamment de l'huile de nigelle (nigella sativa), de lin (oleium lini) et de bourrache (borago officinalis), des vitamines et des minéraux. Prise par voie entérale, la composition permet de traiter avec succès la sclérose en plaques. Son dosage dépend de la gravité de la sclérose en plaques et du patient, le dosage habituel étant néanmoins de 20 ml à 40 ml par jour.
PCT/IB2003/003054 2002-07-31 2003-07-31 Composition pharmaceutique contenant de l'huile de nigelle, de lin et de bourrache WO2004012753A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003255863A AU2003255863A1 (en) 2002-07-31 2003-07-31 Pharmaceutical composition containing black cumin oil, flax oil and borago oil

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ZA200206088 2002-07-31
ZA2002/6088 2002-07-31

Publications (1)

Publication Number Publication Date
WO2004012753A1 true WO2004012753A1 (fr) 2004-02-12

Family

ID=31496348

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2003/003054 WO2004012753A1 (fr) 2002-07-31 2003-07-31 Composition pharmaceutique contenant de l'huile de nigelle, de lin et de bourrache

Country Status (2)

Country Link
AU (1) AU2003255863A1 (fr)
WO (1) WO2004012753A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1713463A2 (fr) * 2004-01-19 2006-10-25 Martek Biosciences Corporation Dysfonctionnement ou d ficit de reelin et techniques associ es
US20100087533A1 (en) * 2007-02-16 2010-04-08 John Allan Howie Composition
WO2022015209A1 (fr) * 2020-07-15 2022-01-20 مهرة المطيري Formulation à base de composants naturels pour traiter la sclérose en plaques

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4058594A (en) * 1974-04-25 1977-11-15 John Williams Immuno-suppressive agents
EP0347056A1 (fr) * 1988-06-10 1989-12-20 Scotia Holdings Plc Compositions d'acides gras essentiels
EP0520624A1 (fr) * 1991-06-03 1992-12-30 Scotia Holdings Plc Composition alimentaire, pharmaceutique et cosmétique contenant di-linoléoyle-mono-gamma linolényle-glycérole
WO2000032211A1 (fr) * 1998-12-03 2000-06-08 Crede, Thomas Preparation pharmaceutique enterale

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4058594A (en) * 1974-04-25 1977-11-15 John Williams Immuno-suppressive agents
EP0347056A1 (fr) * 1988-06-10 1989-12-20 Scotia Holdings Plc Compositions d'acides gras essentiels
EP0520624A1 (fr) * 1991-06-03 1992-12-30 Scotia Holdings Plc Composition alimentaire, pharmaceutique et cosmétique contenant di-linoléoyle-mono-gamma linolényle-glycérole
WO2000032211A1 (fr) * 1998-12-03 2000-06-08 Crede, Thomas Preparation pharmaceutique enterale

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
HARBIGE L S ET AL: "The protective effects of omega-6 fatty acids in experimental autoimmune encephalomyelitis (EAE) in relation to transforming growth factor-beta 1 (TGF-beta1) up-regulation and increased prostaglandin E2 (PGE2) production", CLINICAL AND EXPERIMENTAL IMMUNOLOGY, vol. 122, no. 3, December 2000 (2000-12-01), &, pages 445 - 452, XP002263545, ISSN: 0009-9104 *
TREMLETT H L ET AL: "Nonprescription medicine use in a multiple sclerosis clinic population", BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, vol. 50, no. 1, July 2000 (2000-07-01), &, pages 55 - 60, XP002263546, ISSN: 0306-5251 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1713463A2 (fr) * 2004-01-19 2006-10-25 Martek Biosciences Corporation Dysfonctionnement ou d ficit de reelin et techniques associ es
EP1713463A4 (fr) * 2004-01-19 2009-03-18 Martek Biosciences Corp Dysfonctionnement ou d ficit de reelin et techniques associ es
US20100087533A1 (en) * 2007-02-16 2010-04-08 John Allan Howie Composition
WO2022015209A1 (fr) * 2020-07-15 2022-01-20 مهرة المطيري Formulation à base de composants naturels pour traiter la sclérose en plaques

Also Published As

Publication number Publication date
AU2003255863A1 (en) 2004-02-23

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