HRP20030816A2 - Capsulated herbal composition as auxilary medicament against diabetes mellitus type (i) and (ii) - Google Patents
Capsulated herbal composition as auxilary medicament against diabetes mellitus type (i) and (ii) Download PDFInfo
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- HRP20030816A2 HRP20030816A2 HR20030816A HRP20030816A HRP20030816A2 HR P20030816 A2 HRP20030816 A2 HR P20030816A2 HR 20030816 A HR20030816 A HR 20030816A HR P20030816 A HRP20030816 A HR P20030816A HR P20030816 A2 HRP20030816 A2 HR P20030816A2
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- mass
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- radix
- active substance
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- 239000000203 mixture Substances 0.000 title claims description 17
- 239000003814 drug Substances 0.000 title claims description 3
- 206010012601 diabetes mellitus Diseases 0.000 title description 3
- 239000013543 active substance Substances 0.000 claims description 20
- 238000000034 method Methods 0.000 claims description 17
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 13
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 8
- 239000000284 extract Substances 0.000 claims description 8
- 235000017879 Nasturtium officinale Nutrition 0.000 claims description 6
- 240000005407 Nasturtium officinale Species 0.000 claims description 6
- 244000274883 Urtica dioica Species 0.000 claims description 6
- 241000196324 Embryophyta Species 0.000 claims description 5
- 238000005469 granulation Methods 0.000 claims description 5
- 230000003179 granulation Effects 0.000 claims description 5
- 239000007921 spray Substances 0.000 claims description 5
- 239000008240 homogeneous mixture Substances 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 240000000073 Achillea millefolium Species 0.000 claims description 3
- 235000007754 Achillea millefolium Nutrition 0.000 claims description 3
- 101800004637 Communis Proteins 0.000 claims description 3
- 241000628997 Flos Species 0.000 claims description 3
- 241000721662 Juniperus Species 0.000 claims description 3
- 241000218213 Morus <angiosperm> Species 0.000 claims description 3
- 240000000249 Morus alba Species 0.000 claims description 3
- 235000008708 Morus alba Nutrition 0.000 claims description 3
- 241000209490 Nymphaea Species 0.000 claims description 3
- 235000016791 Nymphaea odorata subsp odorata Nutrition 0.000 claims description 3
- 244000046052 Phaseolus vulgaris Species 0.000 claims description 3
- 235000010627 Phaseolus vulgaris Nutrition 0.000 claims description 3
- 240000001949 Taraxacum officinale Species 0.000 claims description 3
- 235000005187 Taraxacum officinale ssp. officinale Nutrition 0.000 claims description 3
- 206010067584 Type 1 diabetes mellitus Diseases 0.000 claims description 3
- 235000009108 Urtica dioica Nutrition 0.000 claims description 3
- 240000000851 Vaccinium corymbosum Species 0.000 claims description 3
- 235000003095 Vaccinium corymbosum Nutrition 0.000 claims description 3
- 235000017537 Vaccinium myrtillus Nutrition 0.000 claims description 3
- 244000126014 Valeriana officinalis Species 0.000 claims description 3
- 235000013832 Valeriana officinalis Nutrition 0.000 claims description 3
- 235000021014 blueberries Nutrition 0.000 claims description 3
- 235000013399 edible fruits Nutrition 0.000 claims description 3
- 239000004615 ingredient Substances 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 3
- 239000013049 sediment Substances 0.000 claims description 3
- 235000016788 valerian Nutrition 0.000 claims description 3
- 239000000419 plant extract Substances 0.000 claims description 2
- 238000005507 spraying Methods 0.000 claims description 2
- 230000008719 thickening Effects 0.000 claims description 2
- 239000007903 gelatin capsule Substances 0.000 claims 1
- 239000002994 raw material Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 239000002775 capsule Substances 0.000 description 14
- 238000002360 preparation method Methods 0.000 description 7
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 6
- 239000008103 glucose Substances 0.000 description 6
- 229910021536 Zeolite Inorganic materials 0.000 description 5
- 239000008280 blood Substances 0.000 description 5
- 210000004369 blood Anatomy 0.000 description 5
- HNPSIPDUKPIQMN-UHFFFAOYSA-N dioxosilane;oxo(oxoalumanyloxy)alumane Chemical compound O=[Si]=O.O=[Al]O[Al]=O HNPSIPDUKPIQMN-UHFFFAOYSA-N 0.000 description 5
- 239000010457 zeolite Substances 0.000 description 5
- 235000019441 ethanol Nutrition 0.000 description 3
- 230000002349 favourable effect Effects 0.000 description 3
- 239000012467 final product Substances 0.000 description 3
- 239000007789 gas Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 230000008020 evaporation Effects 0.000 description 2
- 238000001704 evaporation Methods 0.000 description 2
- 238000007710 freezing Methods 0.000 description 2
- 230000008014 freezing Effects 0.000 description 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 2
- 208000001072 type 2 diabetes mellitus Diseases 0.000 description 2
- 206010014476 Elevated cholesterol Diseases 0.000 description 1
- 208000035150 Hypercholesterolemia Diseases 0.000 description 1
- 102000004877 Insulin Human genes 0.000 description 1
- 108090001061 Insulin Proteins 0.000 description 1
- 239000012675 alcoholic extract Substances 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 230000005802 health problem Effects 0.000 description 1
- 229940125396 insulin Drugs 0.000 description 1
- 150000002772 monosaccharides Chemical class 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 150000003626 triacylglycerols Chemical class 0.000 description 1
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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/288—Taraxacum (dandelion)
-
- 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
- A61K36/13—Coniferophyta (gymnosperms)
- A61K36/14—Cupressaceae (Cypress family), e.g. juniper or cypress
-
- 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)
- A61K36/185—Magnoliopsida (dicotyledons)
-
- 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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
-
- 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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/45—Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
-
- 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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- 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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/51—Gentianaceae (Gentian family)
-
- 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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
- A61K36/605—Morus (mulberry)
-
- 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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/84—Valerianaceae (Valerian family), e.g. valerian
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1664—Compounds of unknown constitution, e.g. material from plants or animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- 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)
Description
Područje na koje se izum odnosi The field to which the invention relates
Ovaj izum se odnosi na područje farmaceutike, pobliže na područje ljekovitih biljnih pripravaka. Prema međunarodnoj klasifikaciji patenata predmetni izum označen je klasifikacijskim simbolom A61K 35/78. Medicinski pripravci koji sadrže tvari ili produkte njihovih reakcija s neodređenim sastavom, pri čemu se radi o tvarima iz biljaka. This invention relates to the field of pharmaceuticals, more specifically to the field of herbal medicinal preparations. According to the international classification of patents, the subject invention is marked with the classification symbol A61K 35/78. Medicinal preparations containing substances or products of their reactions with an undetermined composition, where these are substances from plants.
Tehnički problem Technical problem
Tehnički problem, čije je rješenje razotkriveno u ovoj patentnoj prijavi sastoji se u pronalaženju jeftinijeg i jednostavnijeg načina dobivanja i proizvodnje aktivne supstancije koja je opisana u sklopu patentne prijave istog prijavitelja, objavljene pod brojem WO 99/55351, kao i u pronalaženju efikasnijeg farmaceutskog pripravka na bazi navedene aktivne supstancije, kao i optimizacija postupka dobivanja i proizvodnje istog pripravka. The technical problem, the solution of which is revealed in this patent application, consists in finding a cheaper and simpler way of obtaining and producing the active substance that is described in the patent application of the same applicant, published under the number WO 99/55351, as well as in finding a more efficient pharmaceutical preparation based on the mentioned active substances, as well as the optimization of the process of obtaining and producing the same preparation.
Osim toga, ova patentna prijava rješava i problem liječenja dijabetes melitusa tipa I. In addition, this patent application also solves the problem of treating type I diabetes mellitus.
Stanje tehnike State of the art
Dobivanje aktivne supstancije koja se koristi za liječenje dijabetes melitusa tipa II iz biljne mješavine razotkriveno je u sklopu patentne prijave WO 99/55351. U istoj prijavi razotkriven je i farmaceutski pripravak koji sadrži aktivnu tvar, prirodnu mikrocelulozu, prirodni zeolit, monosaharide i Mg stearat u omjerima 16,7 : 22,2 : 50,0 : 9,7 : 1,4. Ista prijava razotkriva nam i postupak dobivanja tog farmaceutskog pripravka. Obtaining an active substance used for the treatment of type II diabetes mellitus from a herbal mixture is disclosed in patent application WO 99/55351. In the same application, a pharmaceutical preparation containing an active substance, natural microcellulose, natural zeolite, monosaccharides and Mg stearate in the proportions 16.7 : 22.2 : 50.0 : 9.7 : 1.4 was disclosed. The same application reveals to us the procedure for obtaining that pharmaceutical preparation.
Opis izuma Description of the invention
Postupak dobivanja aktivne supstancije prema patentnoj prijavi WO 99/55351 podrazumijeva evaporaciju u vakuumu uz vremenski linearni gradijent, te smrzavanje evaporacijom dobivene suspenzije zrakom na -186°C, nakon čega je slijedila liofilizacija. Primjenom izuma iznašlo se kako varijacije vremenskog temperaturnog gradijenta u bitnome utječe na iskorištenje, dok smrzavanje na -186°C utječe na kvalitetu (tako dobivena aktivna tvar je jako higroskopna s problematičnom nasipnom gustoćom) kao i na troškove proizvodnje konačnog proizvoda koje naravno bitno poskupljuje. Nadalje primijećena varijacibilnost kakvoće konačnog proizvoda može se pripisati i primjeni visokih tlakova koji izazivaju plastičnu deformaciju čestica, te deformaciju intramolekularnih sila čime se narušava biološka aktivnost istih. The procedure for obtaining the active substance according to patent application WO 99/55351 involves evaporation in a vacuum with a time linear gradient, and freezing the suspension obtained by evaporation with air at -186°C, followed by lyophilization. By applying the invention, it was found that the variation of the time temperature gradient significantly affects the utilization, while freezing to -186°C affects the quality (the active substance thus obtained is very hygroscopic with problematic bulk density) as well as the production costs of the final product, which of course significantly increases the price. Furthermore, the observed variability of the quality of the final product can be attributed to the application of high pressures that cause plastic deformation of the particles, and the deformation of intramolecular forces, which impairs their biological activity.
Osim toga, primijećeno je da zeolit koji je sastojak farmaceutskog pripravka opisanog u WO 99/55351 često puta sadrži olovni pentoksid. Čišćenje zeolita od tragova olovnog pentoksida također predstavlja značajno poskupljenje troškova proizvodnje konačnog proizvoda. In addition, it has been observed that the zeolite which is an ingredient of the pharmaceutical composition described in WO 99/55351 often contains lead pentoxide. Cleaning the zeolite from traces of lead pentoxide also represents a significant increase in the production costs of the final product.
Navedeni nedostaci uklonjeni su manje agresivnom metodom pripravljanja aktivne supstancije i farmaceutskog pripravka kao i promjenom nosača, punila i ostalih pomoćnih tvari. Tako je zeolit zamijenjen korijenom vodopije (Cichorii radix), a umjesto prirodne mikroceluloze u farmaceutski pripravak prema ovom izumu stavlja se fino samljeveni pulvis biljne mješavine opisane u patentnoj prijavi WO 99/55351. The mentioned shortcomings were removed by a less aggressive method of preparing the active substance and pharmaceutical preparation, as well as by changing the carrier, filler and other auxiliary substances. Thus, the zeolite was replaced by the root of cichorii (Cichorii radix), and instead of natural microcellulose, finely ground pulvis of the herbal mixture described in the patent application WO 99/55351 is added to the pharmaceutical preparation according to this invention.
Tim postupcima otklonjeni su svi navedeni nedostaci izuma razotkrivenog u citiranoj prijavi. With these procedures, all the mentioned defects of the invention disclosed in the cited application were eliminated.
Povrh toga, neočekivano se utvrdilo u provedenim testovima na dobrovoljcima bolje djelovanje pripravaka koji su dobiveni na taj način koji je opisan u ovoj prijavi i to za 7-10%. On top of that, it was unexpectedly established in the conducted tests on volunteers that the preparations obtained in the manner described in this application were 7-10% more effective.
Postupak za dobivanje aktivne tvari iz ekstrakta dobivenog iz biljne mješavine koju čine slijedeći usitnjeni i osušeni sastojci: The procedure for obtaining the active substance from the extract obtained from the herbal mixture consisting of the following chopped and dried ingredients:
biljka kičice (Centaurii herba) 10-15 masenih % centaurii herba (Centaurii herba) 10-15% by mass
korijen maslačka (Taraxaci radix) 6-12 masenih % dandelion root (Taraxaci radix) 6-12 mass %
plod borovice (Juniperi communis fructus) 5-8 masenih % juniper fruit (Juniperi communis fructus) 5-8 mass %
biljka koprive (Urticae herba) 5-10 masenih % nettle plant (Urticae herba) 5-10 mass %
korijen koprive (Urticae radix) 5-10 masenih % nettle root (Urticae radix) 5-10 mass %
korijen vodopije (Cichorii radix) 12-20 masenih % Watercress root (Cichorii radix) 12-20% by mass
list crnog duda (Morus n. Folium) 5-10 masenih % black mulberry leaf (Morus n. Folium) 5-10 mass %
cvijet stolisnika (Achilleae millefolii flos) 2-5 masenih % yarrow flower (Achilleae millefolii flos) 2-5 mass %
list borovnice (Vaccinii myrtilli folium) 4-10 masenih % blueberry leaf (Vaccinii myrtilli folium) 4-10 mass %
komuška graha (Phaseoli fructus sine semeni) 10-20 masenih % Komuska beans (Phaseoli fructus sine semeni) 10-20 mass %
korijen odoljena (Valerianae officinalis radix) 5-10 masenih % valerian root (Valerianae officinalis radix) 5-10 mass %
izvodi se prema ovom izumu na način da se navedena biljna mješavina prelije sa 60% etanolom na sobnoj temperaturi i ostavi stajati u zatvorenoj posudi kroz 28 dana nakon čega se dekantira tekućina iznad sedimenta, te da se preostali biljni ekstrakt podvrgne ugušćivanju vrtložnom sprej granulacijom uz nasprejavanje bezvodnim plinom pod tlakom 1-3 bara, pri čemu je temperatura plina barem za 10°C viša od ulazne temperature ekstrakta, kroz vremenski period od 30-40 min. Plin se u aparat za vrtložnu sprej granulaciju WSG-GLATT-50 uvodi dvoaznom mlaznicom. Ulazna temperatura aktivne supstancije iznosi, u povoljnoj izvedbi izuma, 25±5°C, dok temperatura kisika iznosi, u povoljnoj izvedbi izuma, 48±3°C. is carried out according to this invention in such a way that the mentioned plant mixture is poured with 60% ethanol at room temperature and left to stand in a closed container for 28 days, after which the liquid above the sediment is decanted, and that the remaining plant extract is subjected to thickening by vortex spray granulation with spraying with anhydrous gas under a pressure of 1-3 bar, whereby the gas temperature is at least 10°C higher than the inlet temperature of the extract, for a period of 30-40 min. The gas is introduced into the device for vortex spray granulation WSG-GLATT-50 with a double nozzle. The inlet temperature of the active substance is, in a favorable embodiment of the invention, 25±5°C, while the oxygen temperature is, in a favorable embodiment of the invention, 48±3°C.
Tako dobivena aktivna supstancija miješa se do homogene smjese s pulvisom biljne mješavine, korijenom vodopije (Cichorii radix) i Mg-stearatom da bi se dobio farmaceutski pripravak. The active substance obtained in this way is mixed to a homogeneous mixture with the pulvis of the herbal mixture, the root of watercress (Cichorii radix) and Mg-stearate to obtain a pharmaceutical preparation.
Neočekivano, provedbom komparativnih testova, ovako pripravljen farmaceutski pripravak pokazao je 7-10% veću učinkovitost u snižavanju razine glukoze u krvi od pripravka opisanog u patentnoj prijavi WO 99/55351. Unexpectedly, by carrying out comparative tests, the pharmaceutical preparation prepared in this way showed 7-10% greater efficiency in lowering blood glucose levels than the preparation described in patent application WO 99/55351.
Dakle, manje agresivnim postupkom dobivanja, zamjenom zeolita sa korijenom vodopije, prirodne mikroceluloze s pulvisom biljne mješavine opisane u prethodno citiranom dokumentu te usitnjavanjem biljne mješavine prije tretiranja s 60% alkoholom do 40±5 mesha dobiven je farmaceutski pripravak s istom aktivnom tvari, ali s poboljšanom učinkovitošću za 7-10% u odnosu na prethodno opisani pripravak. So, with a less aggressive production process, by replacing zeolite with water lily root, natural microcellulose with pulvis of the plant mixture described in the previously cited document, and by crushing the plant mixture before treatment with 60% alcohol to 40±5 mesh, a pharmaceutical preparation with the same active substance was obtained, but with improved efficiency by 7-10% compared to the previously described preparation.
Osim toga, primijećeno je ljekovito djelovanje u ovoj patentnoj prijavi opisanog izuma na dijabetes melitus tipa I. In addition, the curative effect in this patent application of the described invention on type I diabetes mellitus has been observed.
Primjer izvođenja izuma An example of an embodiment of the invention
Iznijeti primjer samo je jedan od mogućih načina dobivanja aktivne supstancije i farmaceutskog pripravka prema predmetnom izumu i ni u kom slučaju ne sužava opseg predmetnog izuma. The given example is only one of the possible ways of obtaining the active substance and the pharmaceutical preparation according to the present invention and in no case narrows the scope of the present invention.
Koraci potrebni za pripravu aktivne tvari i farmaceutskog pripravka su slijedeći: The steps required for the preparation of the active substance and the pharmaceutical preparation are as follows:
1.) 7,2 kg 60% etilnog alkohola prelije se preko 1 kg biljne mješavine koja se sastoji iz slijedećih komponenti: 1.) 7.2 kg of 60% ethyl alcohol is poured over 1 kg of herbal mixture consisting of the following components:
biljka kičice (Centauri herba) 12,3 masenih % centauri herb (Centauri herba) 12.3 mass %
korijen maslačka (Taraxaci radix) 9,7 masenih% dandelion root (Taraxaci radix) 9.7 mass%
plod borovice (Juniperi communis fructus) 6,2 masenih% juniper fruit (Juniperi communis fructus) 6.2 mass%
biljka koprive (Urticae herba) 7,4 masenih% nettle plant (Urticae herba) 7.4 mass%
korijen koprive (Urticae radix) 7,0 masenih% nettle root (Urticae radix) 7.0 mass%
korijen vodopije (Cichorii radix) 17,7 masenih% watercress root (Cichorii radix) 17.7 mass%
list crnog duda (Morus n. Folium) 7,4 masenih% black mulberry leaf (Morus n. Folium) 7.4 mass%
cvijet stolisnika (Achilleae millefolii flos) 3,5 masenih % yarrow flower (Achilleae millefolii flos) 3.5 mass %
list borovnice (Vaccinii myrtilli folium) 6,6 masenih % blueberry leaf (Vaccinii myrtilli folium) 6.6 mass %
komuška graha (Phaseoli fructus sine semeni) 14,4 masenih% Komuska beans (Phaseoli fructus sine semeni) 14.4 mass%
korijen odoljena (Valerianae officinalis radix) 7,8 masenih% valerian root (Valerianae officinalis radix) 7.8 mass%
2.) navedena biljna mješavina ostavi se stajati u zatvorenoj posudi na sobnoj temperaturi i tlaku 1 bar kroz 28 dana nakon čega se tekućina iznad sedimenta dekantira, pri čemu je prosječno iskorištenje 63 masena %. 2.) the mentioned herbal mixture is left to stand in a closed container at room temperature and a pressure of 1 bar for 28 days, after which the liquid above the sediment is decanted, whereby the average utilization is 63% by mass.
3.) Dobiveni alkoholni ekstrakt uvodi se u aparat za vrtložnu sprej granulaciju pri temperaturi od 25°C u kojem se nasprejava s bezvodnim zrakom koji ima temperaturu 48°C i koji se u aparat uvodi dvofaznom mlaznicom i ugušćuje za faktor 5. Nasprejavanje zrakom izvodi se pod tlakom od 3 bara. Cijeli postupak izvodi se na WSG-GLATT-50. 282 mg 60% alkoholnog ekstrakta daje 56,4 mg suhe aktivne tvari. 3). is under a pressure of 3 bar. The entire procedure is performed on WSG-GLATT-50. 282 mg of 60% alcoholic extract gives 56.4 mg of dry active substance.
4.) Aktivna tvar, pulvis biljne mješavine, korijen vodopije i Mg- stearat miješaju se u masenom omjeru 16,7: 37,0: 45,0: 1,3 do homogene smjese, te se kapsuliraju u želatinozne kapsule. 4.) The active substance, the pulvis of the herbal mixture, the root of water lily and Mg-stearate are mixed in a mass ratio of 16.7: 37.0: 45.0: 1.3 to a homogeneous mixture, and are encapsulated in gelatinous capsules.
Prema povoljnoj izvedbi izuma kapsule mogu sadržavati 200 mg ili 480 mg. According to a favorable embodiment of the invention, the capsules can contain 200 mg or 480 mg.
Za kapsulu od 200 mg For a 200 mg capsule
Aktivna supstancija 33 mg Active substance 33 mg
Pulvis 74 mg Pulvis 74 mg
Korijen vodopije 90 mg Watercress root 90 mg
Mg- stearat 3 mg Mg-stearate 3 mg
Za kapsulu od 480 mg: For a 480 mg capsule:
Aktivna supstancija 79 mg Active substance 79 mg
Pulvis 37 mg Pulvis 37 mg
Korijen vodopije 216 mg Watercress root 216 mg
Mg- stearat 7 mg Mg-stearate 7 mg
Način doziranja i primjene Method of dosage and application
Za dijabetes melitus tipa II For type II diabetes mellitus
1. Oboljeli kojima je razina glukoze u krvi između 4,5-7 mmol/L trebaju uzimati dva puta dnevno po jednu kapsulu od 200 mg 1. Patients whose blood glucose level is between 4.5-7 mmol/L should take one 200 mg capsule twice a day
2. Oboljeli kojima je razina glukoze u krvi između 7-10 mmol/L trebaju uzimati dva puta dnevno po jednu kapsulu od 480 mg 2. Patients whose blood glucose level is between 7-10 mmol/L should take one 480 mg capsule twice a day
3. Oboljeli kojima je razina glukoze u krvi preko 10 mmol/L trebaju uzimati tri puta dnevno po jednu kapsulu od 480 mg 3. Patients whose blood glucose level is over 10 mmol/L should take one 480 mg capsule three times a day.
Za dijabetes melitus tipa I For diabetes mellitus type I
a) djeca do 10 godina trebaju uzimati jedan puta dnevno po jednu kapsulu od 200 mg a) children up to 10 years old should take one 200 mg capsule once a day
b) djeca starija od 10 godina trebaju uzimati dva puta dnevno po jednu kapsulu od 200 mg b) children older than 10 years should take one 200 mg capsule twice a day
c) odrasli kojima je razina glukoze do 10 mmol/L trebaju uzimati jednom dnevno po jednu kapsulu od 480 mg c) adults whose glucose level is up to 10 mmol/L should take one 480 mg capsule once a day
d) odrasli kojima je razina glukoze u krvi preko 10 mmol/L trebaju uzimati jedan do dvaput dnevno po jednu kapsulu od 480 mg d) adults whose blood glucose level is over 10 mmol/L should take one 480 mg capsule once or twice a day
e) oboljeli koji su rezistentni na inzulin trebaju uzimati kapsule kako je opisano od a) do d) e) patients who are resistant to insulin should take capsules as described from a) to d)
Kod zdravstvenih tegoba koje se pojavljuju uz dijabetes melitus: In the case of health problems that appear with diabetes mellitus:
a) u slučaju povišenog kolesterola potrebno je uzimati dva puta po jednu kapsulu od 200 mg dnevno a) in case of elevated cholesterol, it is necessary to take one capsule of 200 mg twice a day
b) u slučaju visokih triglicerida treba se uzimati dva puta na dan po jednu kapsulu od 480 mg. b) in case of high triglycerides, one capsule of 480 mg should be taken twice a day.
Claims (10)
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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HRP20030816AA HRP20030816B1 (en) | 2003-10-10 | 2003-10-10 | Capsulated herbal composition as auxilary medicament against diabetes mellitus type (i) and (ii) |
EP04769072A EP1675604A1 (en) | 2003-10-10 | 2004-10-04 | Capsulated herbal composition as auxilary medicament against diabetes mellitus type (i) and (ii) |
PCT/HR2004/000033 WO2005034973A1 (en) | 2003-10-10 | 2004-10-04 | Capsulated herbal composition as auxilary medicament against diabetes mellitus type (i) and (ii) |
Applications Claiming Priority (1)
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HRP20030816AA HRP20030816B1 (en) | 2003-10-10 | 2003-10-10 | Capsulated herbal composition as auxilary medicament against diabetes mellitus type (i) and (ii) |
Publications (2)
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HRP20030816A2 true HRP20030816A2 (en) | 2005-06-30 |
HRP20030816B1 HRP20030816B1 (en) | 2012-05-31 |
Family
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HRP20030816AA HRP20030816B1 (en) | 2003-10-10 | 2003-10-10 | Capsulated herbal composition as auxilary medicament against diabetes mellitus type (i) and (ii) |
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EP (1) | EP1675604A1 (en) |
HR (1) | HRP20030816B1 (en) |
WO (1) | WO2005034973A1 (en) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
HRP20070230B1 (en) * | 2007-05-18 | 2010-05-31 | Leko Vlado | Herbal composition for the prevention and treatmentofdiabetes mellitus type (i) and type (ii) |
CN103223016A (en) * | 2013-05-06 | 2013-07-31 | 赵全成 | Ginseng, mulberry leaf and chicoric acid composition for treating diabetes |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2904935A1 (en) * | 2006-08-18 | 2008-02-22 | Centre Nat Rech Scient | ANTIDIABETIC COMPOSITION CAPABLE OF STIMULATING THE SECRETION OF INSULIN AND INTENDED FOR THE TREATMENT OF DIABETES TYPE 2 (NON-INSULIN-DEPENDENT DIABETES). |
CN108524571A (en) * | 2018-07-21 | 2018-09-14 | 安溪县凤城建金产品外观设计服务中心 | The technique of active ingredient in a kind of milfoil by restricted-access media |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1999055351A1 (en) * | 1998-04-23 | 1999-11-04 | Vladimir Leko | Herbal composition and medicament against diabetes mellitus type ii manufactured thereof |
DE19927537A1 (en) * | 1999-06-16 | 2000-12-21 | Merck Patent Gmbh | Spray drying plant and method of using it |
-
2003
- 2003-10-10 HR HRP20030816AA patent/HRP20030816B1/en not_active IP Right Cessation
-
2004
- 2004-10-04 WO PCT/HR2004/000033 patent/WO2005034973A1/en active Application Filing
- 2004-10-04 EP EP04769072A patent/EP1675604A1/en not_active Withdrawn
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
HRP20070230B1 (en) * | 2007-05-18 | 2010-05-31 | Leko Vlado | Herbal composition for the prevention and treatmentofdiabetes mellitus type (i) and type (ii) |
CN103223016A (en) * | 2013-05-06 | 2013-07-31 | 赵全成 | Ginseng, mulberry leaf and chicoric acid composition for treating diabetes |
Also Published As
Publication number | Publication date |
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WO2005034973A1 (en) | 2005-04-21 |
HRP20030816B1 (en) | 2012-05-31 |
EP1675604A1 (en) | 2006-07-05 |
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