WO2005034973A1 - Composition d'herbes en capsule servant de medicament auxiliaire pour lutter contre le diabete sucre de type (i) et (ii) - Google Patents

Composition d'herbes en capsule servant de medicament auxiliaire pour lutter contre le diabete sucre de type (i) et (ii) Download PDF

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Publication number
WO2005034973A1
WO2005034973A1 PCT/HR2004/000033 HR2004000033W WO2005034973A1 WO 2005034973 A1 WO2005034973 A1 WO 2005034973A1 HR 2004000033 W HR2004000033 W HR 2004000033W WO 2005034973 A1 WO2005034973 A1 WO 2005034973A1
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WO
WIPO (PCT)
Prior art keywords
root
mixture
tincture
temperature
fact
Prior art date
Application number
PCT/HR2004/000033
Other languages
English (en)
Inventor
Vladimir Leko
Original Assignee
Vladimir Leko
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 Vladimir Leko filed Critical Vladimir Leko
Priority to EP04769072A priority Critical patent/EP1675604A1/fr
Publication of WO2005034973A1 publication Critical patent/WO2005034973A1/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)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/288Taraxacum (dandelion)
    • 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
    • A61K36/13Coniferophyta (gymnosperms)
    • A61K36/14Cupressaceae (Cypress family), e.g. juniper or cypress
    • 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)
    • 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)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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)
    • A61K36/45Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
    • 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)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • 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)
    • A61K36/51Gentianaceae (Gentian family)
    • 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)
    • A61K36/60Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605Morus (mulberry)
    • 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)
    • A61K36/84Valerianaceae (Valerian family), e.g. valerian
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1664Compounds of unknown constitution, e.g. material from plants or animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

  • This invention refers to the field of pharmacy, and more closely, it refers to the medicament against diabetes mellitus type I and II, and even more precisely, it refers to the medicament against diabetes mellitus type based on a herbal composition as an active substance.
  • the subject invention is marked with the classification symbol A 61 K 35/78- Medical preparations containing substances or products of their reactions with undefined composition, whereby substances from herbs are in question.
  • a technical problem, the solution of which is disclosed in this patent application, consists in finding cheaper and simplier way of obtaining and optimisation of proces of production substance that is disclosed within patent application with publication No. WO 99/55351.
  • Unexpectitly, obtained composition has shown improved efficiency in treatment of diabetes mellitus type II in comparation with composition described in aforsaid patent application. Also surprisigly, in contrast to composition dislosed in WO 99/55351, according to present invention obtained composition has biological activity against diabetes mellitus type I as well.
  • 99/55351 comprises evaporation in the vacuum in the timely linear temperature gradient, following with, by liquid air, freezing of evaporated suspension on -186°C, with lyophilization as last step in process. It was been found that amount of obtained active substance substantially vary with small variation of timely linear temperature gradient substantially. Further, freezing of evaporated suspension on -186°C causes quality problems (namely obtained active substance in hygroscopic) and cost of production final product becomes unexpectedly high. Finally, implementetion of high pressures can cause plastic deformation of particles and deformation of intramolecular forces. As consequence biological activity can be damaged and quality fluctuation of final product, that was noticed, will be developed.
  • zeolite as compound in pharmaceutical preperation disclosed in WO 99/55351 often comprises Pb2 ⁇ s. Purification of zeolite from Pb2 ⁇ 5 traces makes final product production cost higher.
  • zeolite was changed by root of chicory, and instead of natural miccrocellulose in pharmaceutical preparation, according to the invention, pulvis powder of herbal composition described in patent application WO 99/55351 was charged.
  • active substance is obtained from extract made from herbal composition that comprises following usitnjeni and dried ingredients:
  • centaury Plant of centaury (Centaurii umbellatum, Gentianaceae) 10-15% by weight (wt.) root of dandelion (Teraxacum officinale, Asteraceae) 6-12 % by wt. fruit of juniper (Juniperi communis L., Cupresaceae) 5-8% by wt. plant of nettle (Urticae dioidca L, Urticaceae) 5- 10% by wt. root of nettle (Urticae dioica L, Urticaceae) 5-10% by wt. root of chicory (Cichorium intybus L, Cichoriaceae) 12-20% by wt.
  • the active substance from the herbal composition is obtained in the following way: the herbal composition which is made of dried and ground to 40 ⁇ 5 mesh ingredients is to be covered in 60% ethanol at the room temperature. For the purpose of extraction, the mixture is left to rest for 28 days in a covered container, at the room temperature and pressure.
  • the herbal tincture is then obtained by decanting the liquid above the sediment.
  • the alcoholic tincture obtained in that way was exposed to whirling spray granulation, with spraying with anhydrous gas under pressure 1-3 barr, during 30-40 minutes.
  • Temperature of gas is at least 10°C higher than entering temperature of the tincture. Gas was provided by two-phase nozzle. Entering tempeature of tincture is, in prefe ed embodyment of the invention, 25 ⁇ 5° C, and temperature of the gas is 48 ⁇ 3° C.
  • Gas used for spraying can be oxigen.
  • Active substance obtained by aforesaid process has to be mixed, until homogeneous mixture, with pulvis powder of herbal composition, root of chicory and Mg-stearate to for obtaining pharmaceutical preparation.
  • Steps needed for active principle preparation and for preparation of pharmaceutical preparation are as follows:
  • centaury Centaurii umbellatum, Gentianaceae 10- 15% by weight (wt.) root of dandelion (Taraxacum officinale, Asteraceae) 6- 12 % by wt. fruit of juniper (Juniperi communis L, Cupresaceae) 5-8 % by wt. plant of nettle (Urticae dioica L, Urticaceae) 5-10 % by wt. root of nettle ( Urticae dioica L, Urticaceae) 5- 10 % by wt. root of chicory (Cichorium intybus L, Cichoriaceae) 12-20 % by wt.
  • Obtained alcoholic tincture is entered to apparatus for whirling spray granulation on temperature of 25 ° C.
  • apparatus alcoholic tincture is to be sprayed with anhydrous air, which has a temperature around 48 ° C. Air was provided in the apparatus with two phase nozzle.
  • apparatus alcoholic tincture has to be increased in density for factor 5. Spaying with air is applied under pressure of 3 barr. All procedure can be done with WSG-GLATT-50. 282 mg of alcoholic extract produces 56,4 mg dried powder of active substance.
  • capsules can consist 200 mg or 480 mg pharmaceutical preparation described above.

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Mycology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La présente invention concerne un procédé pour obtenir un principe actif et une préparation pharmaceutique à partir d'un mélange d'herbes comprenant les ingrédients suivants sous forme séchée et broyée: centaurée (Centaurii umbellatum, Gentianaceae) 10-15 % en poids racine de pissenlit (Teraxacum officinale, Asteraceae) 6-12 % en poids fruit de genévrier (Juniperi communis L, Cupresaceae) 5-8 % en poids ortie (Urticae dioica L, Urticaceae) 5-10 % en poids racine d'ortie (Urticae dioica L, Urticaceae) 5-10 % en poids racine de chicorée (Cichorium intybus L, Cichoriaceae) 12-20 % en poids feuille de mûrier noir (Morus nigra L, Moraceae) 5-10 % en poids fleur d'achillée millefeuille (Achilleae millefolium L, Asteraceae) 2-5 % en poids feuille de myrtillier (Vaccinium myrtillus L, Ericaceae) 4-10 % en poids cosse de haricot (Phaseolus vulgaris L, Fabaceae) 10-20 % en poids et racine de valériane (Valeriana officinalis L, Valerianaceae) 5-10 % en poids, chaque pourcentage se rapportant au poids total des ingrédients séchés dans la composition, à température ambiante. Cette invention consiste à effectuer l'extraction de ce mélange dans un récipient recouvert à température et à pression ambiantes pendant 28 jours, à faire décanter la couche supérieure, à filtrer la couche inférieure et à augmenter la densité du mélange d'herbes en effectuant une granulation à pulvérisation tourbillonnaire, tout en pulvérisant un gaz sous une pression située entre 1 et 3 bars, pendant 30-40 minutes, sous réserve que la température du gaz anhydre soit au moins supérieure de 10 °C à la température d'entrée de la teinture.
PCT/HR2004/000033 2003-10-10 2004-10-04 Composition d'herbes en capsule servant de medicament auxiliaire pour lutter contre le diabete sucre de type (i) et (ii) WO2005034973A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP04769072A EP1675604A1 (fr) 2003-10-10 2004-10-04 Composition d'herbes en capsule servant de medicament auxiliaire pour lutter contre le diabete sucre de type (i) et (ii)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
HRP20030816AA HRP20030816B1 (en) 2003-10-10 2003-10-10 Capsulated herbal composition as auxilary medicament against diabetes mellitus type (i) and (ii)
HRP20030816A 2003-10-10

Publications (1)

Publication Number Publication Date
WO2005034973A1 true WO2005034973A1 (fr) 2005-04-21

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PCT/HR2004/000033 WO2005034973A1 (fr) 2003-10-10 2004-10-04 Composition d'herbes en capsule servant de medicament auxiliaire pour lutter contre le diabete sucre de type (i) et (ii)

Country Status (3)

Country Link
EP (1) EP1675604A1 (fr)
HR (1) HRP20030816B1 (fr)
WO (1) WO2005034973A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008142460A2 (fr) * 2007-05-18 2008-11-27 Leko Vlado Nouvelle composition à base d'herbes pour la prévention et le traitement du diabète sucré de type (i) et de type (ii)
JP2010501023A (ja) * 2006-08-18 2010-01-14 サントル、ナショナール、ド、ラ、ルシェルシュ、シアンティフィク、(セーエヌエルエス) チコリ酸および/またはその代謝産物の1つを含有する抗糖尿病組成物
CN108524571A (zh) * 2018-07-21 2018-09-14 安溪县凤城建金产品外观设计服务中心 一种通过浸提法提取蓍草中有效成分的工艺

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103223016B (zh) * 2013-05-06 2014-09-17 长春三德天晟科技有限公司 一种防治糖尿病的人参桑菊组合物

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999055351A1 (fr) * 1998-04-23 1999-11-04 Vladimir Leko Composition a base d'herbes et medicament contre le diabete sucre de type ii fabrique a partir de cette composition
DE19927537A1 (de) * 1999-06-16 2000-12-21 Merck Patent Gmbh Sprühtrocknungsanlage und Verfahren zu ihrer Verwendung

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999055351A1 (fr) * 1998-04-23 1999-11-04 Vladimir Leko Composition a base d'herbes et medicament contre le diabete sucre de type ii fabrique a partir de cette composition
DE19927537A1 (de) * 1999-06-16 2000-12-21 Merck Patent Gmbh Sprühtrocknungsanlage und Verfahren zu ihrer Verwendung

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
SARA K SWANSTON-FLATT ET AL: "Glycaemic effects of traditional european plant treatments for diabetes.Studies in normal and streptozotocin diabetic mice", DIABETES RESEARCH, TEVIOT-KIMPTON PUBLICATIONS, EDINBURGH, GB, vol. 10, no. 3, March 1989 (1989-03-01), pages 69 - 73, XP002112023, ISSN: 0265-5985 *
UHLEMANN H: "KONTINUIERLICHE WIRBELSCHICHT-SPRUEHGRANULATION", CHEMIE. INGENIEUR. TECHNIK, VERLAG CHEMIE GMBH. WEINHEIM, DE, vol. 62, no. 10, October 1990 (1990-10-01), pages 822 - 834, XP000176381, ISSN: 0009-286X *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010501023A (ja) * 2006-08-18 2010-01-14 サントル、ナショナール、ド、ラ、ルシェルシュ、シアンティフィク、(セーエヌエルエス) チコリ酸および/またはその代謝産物の1つを含有する抗糖尿病組成物
WO2008142460A2 (fr) * 2007-05-18 2008-11-27 Leko Vlado Nouvelle composition à base d'herbes pour la prévention et le traitement du diabète sucré de type (i) et de type (ii)
WO2008142460A3 (fr) * 2007-05-18 2009-01-15 Leko Vlado Nouvelle composition à base d'herbes pour la prévention et le traitement du diabète sucré de type (i) et de type (ii)
CN108524571A (zh) * 2018-07-21 2018-09-14 安溪县凤城建金产品外观设计服务中心 一种通过浸提法提取蓍草中有效成分的工艺

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Publication number Publication date
HRP20030816A2 (en) 2005-06-30
HRP20030816B1 (en) 2012-05-31
EP1675604A1 (fr) 2006-07-05

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