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WO2004069262A1 - Composition a base d'herbes medicinales contenant commiphora mukul, allium sativum et curcuma longa - Google Patents

Composition a base d'herbes medicinales contenant commiphora mukul, allium sativum et curcuma longa Download PDF

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Publication number
WO2004069262A1
WO2004069262A1 PCT/IB2004/000284 IB2004000284W WO2004069262A1 WO 2004069262 A1 WO2004069262 A1 WO 2004069262A1 IB 2004000284 W IB2004000284 W IB 2004000284W WO 2004069262 A1 WO2004069262 A1 WO 2004069262A1
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WO
WIPO (PCT)
Prior art keywords
herbal composition
composition
extract
mixtures
herbal
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2004/000284
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English (en)
Other versions
WO2004069262A8 (fr
Inventor
Kour Chand Jindal
Canakapalli Bhaktavastala Rao
Muthiah Ramanathan
Bhojaraj Suresh
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Orchid Pharma Ltd
Original Assignee
Orchid Chemicals and Pharmaceuticals Ltd
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 Orchid Chemicals and Pharmaceuticals Ltd filed Critical Orchid Chemicals and Pharmaceuticals Ltd
Publication of WO2004069262A1 publication Critical patent/WO2004069262A1/fr
Publication of WO2004069262A8 publication Critical patent/WO2004069262A8/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8962Allium, e.g. garden onion, leek, garlic or chives
    • 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)
    • A61K36/32Burseraceae (Frankincense family)
    • A61K36/328Commiphora, e.g. mecca myrrh or balm of Gilead
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9066Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Definitions

  • the present invention relates to a herbal composition for use in the treatment and / or prophylaxis of hypercholesterolemia, atherosclerosis, hyperlipidemia and hypertension in mammals.
  • the composition comprises a synergistic mixture of extracts of three herbs selected from a group of
  • Yeh et. al Lipids 1994, 29(3) 189-193 describes reduction of plasma lipids using garlic.
  • Singh et. al Cardiovascular Drug Ther. 1994, 8(4) 659-664 describes hypolipidemic effect of Commiphora mukul as an adjunct to dietary therapy in patients with hypercholesterolemia.
  • US patent No. 6,162,438 discloses an edible herbal composition for use as agents for controlling hypercholesterolemia, atherosclerosis, hyperlipidemia and hypertension in mammals.
  • the edible composition is a mixture or at least six, preferably at least three herbs selected from the group consisting of Terminalia arjuna, Cynara scolymus, Zingibar officinale, Allium sativum, Crataegus oxycantha, Curcuma longa, Boerhaavia diffusa and Trigonella foenumgraecum.
  • the composition preferably contains the herbs in approximately equal amounts.
  • 5,707,631 are directed to a therapeutic herbal composition including Trigonella foenumgraecum seed, Syzygium aromataticum fruit, Allium sativum bulb, Cinnamomum zeylanicum bark, Saussurea costus root and Euphorbia lathyris bud; the U.S. patent discloses the foregoing herbs in combination with sodium chloride (preferably sea salt).
  • US patent No. 5,900,240 discloses an edible composition comprising a mixture of at least two herbs selected from the group consisting of Syzygium cumini, Gymnema sylvestre, Momordica charantia and Solanum melongena.
  • the herbal mixtures are useful as dietary supplements and are especially useful for lowering the blood glucose level in mammals, particularly humans suffering from diabetes mellitus.
  • the main objective of the present invention is to provide a herbal composition for use in the treatment and / or prophylaxis of hypercholesterolemia, atherosclerosis, hyperlipidemia and hypertension in mammals.
  • Yet another objective of the present invention is to provide a herbal composition, which produces no adverse effects and may be taken in multiple daily doses over prolonged period of time.
  • the present invention relates to a herbal composition
  • a herbal composition comprising a synergistic mixture of extracts of three herbs selected from a group of Commiphora mukul (guggul), Allium sativum (garlic) and Curcuma longa (turmeric).
  • the herbal composition contains pharmaceutically acceptable ingredients.
  • the herbal composition is useful in the treatment and/or prophylaxis of hypercholesterolemia, atherosclerosis, hyperlipidemia and hypertension in mammals.
  • a synthetic pharmaceutical composition comprising curcumin, allin and guggulosterone and other pharmaceutically acceptable ingredients.
  • the curcuma extract contains
  • garlic extract contains 2 to 4% allin and guggul extract contains 3 to 10% guggulosterone, as the active constituents.
  • the pharmaceutically acceptable excipients are selected from diluents, disintegrants, lubricants, binders, glidants and preservatives.
  • the diluents used are selected from dicalcium phosphate (DCP), microcrystalline cellulose (MCC), starch, magnesium oxide and the like or mixtures thereof.
  • the disintegrant used is selected from sodium starch glycollate (SSG), cross-carmellose sodium (CCS) and the like or mixtures thereof.
  • the binders used are selected from povidone, hydroxypropyl methylcellulose (HPMC) and the like or mixtures thereof.
  • the lubricants used are selected from magnesium stearate, talc, hydrogenated vegetable oils and the like or mixtures thereof.
  • the glidants used are selected from colloidal silicon dioxide (aerosil), talc and the like or mixtures thereof.
  • the preservatives used are selected from parabens such as methylparaben, ethylparaben, propylparaben; sodium benzoate, sorbic acid and the like; or mixtures thereof.
  • the total amount of herbal extract in the composition may be present in the range of 20 to 80 % based on the weight of the composition, with the balance being the other pharmaceutically acceptable ingredients.
  • the individual extracts in the herbal composition may be present in therapeutically acceptable ratio, preferable ratios are 3:3:2, 2:3:2, 3:2:2, 2:2:3, 1:1:1, 1:2:2, 1:3:3, 1:2:3 or 1:3:2.
  • the extract of garlic appears in light brown colour with characteristic odour, which is freely soluble in water.
  • the extract of guggul appears in light to dark brown colour, sticky to touch, which is insoluble in water.
  • Curcuma longa extract appears in orange yellow colour with characteristic odour, which is insoluble in water.
  • the herbal composition of the present invention may be used in the form of tablet, capsule, syrup, suspension, dry powders etc.
  • a process for the preparation of tablets or capsules containing herbal composition comprising the steps of : i) mixing garlic, curcuma extracts and diluents, ii) adding to the mixture obtained in step (i) a solution of guggul extract and preservatives dissolved in isopropyl alcohol, iii) granulating the mixture obtained in step (ii) using conventional granulator iv) drying the granules using conventional drier, v) sifting the granules vi) drying the granules, vii) adding disintegrants, glidants, lubricants and blending the mixture and viii) compressing into tablets or filling into capsules.
  • the tablets may be administered as such or as coated tablet.
  • the coating may be done using conventional coating techniques such as film coating, enteric coating, sugar coating etc.
  • the dosage of the herbal compositions of the invention to be ingested will vary, depending on factors such as severity of the hypertension, hypercholesterolemia and hyperlipidemia, age, diet, physical condition and body weight of the patient, etc. As a general guide, it is expected that patients with a body weight in the range of 60-90 kg would ingest about 100-1,000 mg/day of the herbal compositions. It is to be understood that these dosage levels are only general guides and the proper dosage level for individual patients may vary considerably depending on the factors indicated above.
  • Garlic 150 g
  • curcuma extract 100 g
  • microcrystalline cellulose 91.8 g
  • starch 350 g
  • guggul extract 150 g
  • propylparaben 0.2 g
  • sorbic acid 1 g
  • the granules were dried at 60 °C in fluidized bed dried, sifted through ASTM # 20, milled through multimill and sifted through ASTM # 20.
  • sodium starch glycollate (35 g) and cross- carmeilose sodium (70 g), colloidal silicon dioxide (20 g) and magnesium stearate (5 g) were added followed by blending and then compressed the blend using conventional tabletting machine to obtain tablets.
  • Garlic 100 g
  • curcuma extract 150 g
  • microcrystalline cellulose 91.8 g
  • starch 350 g
  • guggul extract 100 g
  • propylparaben 0.2 g
  • sorbic acid 1 g
  • the granules were dried at 60 °C in fluidized bed dried, sifted through ASTM # 20, milled through multimill and sifted through ASTM # 20.
  • sodium starch glycollate (35 g) and cross- carmeilose sodium (70 g), colloidal silicon dioxide (20 g) and magnesium stearate (5 g) were added followed by blending and then compressed the blend using conventional tabletting machine to obtain tablets.
  • the herbal composition of the present invention lowered random trigfyceri.de, cholesterol and increased HDL. This was demonstrated by in vivo animal experiments. Triton induced hyperlipidemia
  • the systemic administration of the surfactant triton to rats resulted in elevation of cholesterol and triglyceride.
  • Wistar rats weighing 180 to 200 g were starved for 18 hrs and then injected intraperitoneally 200 mg/kg of triton.
  • the test drugs were administered simultaneously along with triton.
  • the blood samples were collected at the time intervals of 24h and 48h after the administration of the herbal composition and the blood cholesterol, triglyceride and HDL levels were calculated using the conventional formulae. The results are shown in table 1.
  • White New Zealand rabbits were supplemented with 2% of cholesterol and continued at this regiment for a period of 10 weeks.
  • Drugs were administered as a fine suspension on 0.3% CMC and administered orally using oral catheter tube, once daily during the last four weeks of the study.
  • the blood was withdrawn from the ear marginal vein before and after treatment and the plasma was separated to estimate the blood lipid profile. The results are shown in table 3.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne une composition à base d'herbes médicinales destinées à être utilisée dans le traitement et/ou la prophylaxie de l'hypercholestérolémie, l'athérosclérose, l'hyperlipidémie ainsi que l'hypertension chez les mammifères. La composition contient un mélange synergique d'extraits de trois herbes médicinales choisies dans un groupe de Commiphora mukul, Allium sativum et Curcuma longa.
PCT/IB2004/000284 2003-02-07 2004-02-05 Composition a base d'herbes medicinales contenant commiphora mukul, allium sativum et curcuma longa Ceased WO2004069262A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN112/MAS/2003 2003-02-07
IN112CH2003 2003-02-07

Publications (2)

Publication Number Publication Date
WO2004069262A1 true WO2004069262A1 (fr) 2004-08-19
WO2004069262A8 WO2004069262A8 (fr) 2005-03-17

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2004/000284 Ceased WO2004069262A1 (fr) 2003-02-07 2004-02-05 Composition a base d'herbes medicinales contenant commiphora mukul, allium sativum et curcuma longa

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Country Link
WO (1) WO2004069262A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2876912A1 (fr) * 2004-10-25 2006-04-28 Nuxe Sa Lab Nouvelle utilisation de guggulipides en therapeutique et en cosmetique
WO2006045932A3 (fr) * 2004-10-22 2006-08-31 Nuxe Lab Nouvelle utilisation d'huile de chaulmoogra et de guggulipides en therapeutique et en cosmetique.
US7759391B2 (en) * 2007-10-08 2010-07-20 Chungbuk National University Industry Academic Cooperation Foundation Pharmaceutical composition comprising thiacremonone for treating colon cancer
US20130115290A1 (en) * 2010-04-26 2013-05-09 Angel Manuel Gago De Santos Compositions for the symptomatic relief of stomach pain or gastrooesophageal reflux
WO2015068112A3 (fr) * 2013-11-06 2015-08-13 Anil Kumar Sharma Composition à base d'herbes pour le traitement de l'hypertension et de troubles apparentés
WO2021255760A1 (fr) * 2020-06-18 2021-12-23 Indian Council Of Medical Research Formulation à base de plantes pour le traitement du syndrome ménopausique

Non-Patent Citations (10)

* Cited by examiner, † Cited by third party
Title
ABSTR 13TH ANNU CONF INDIAN PHARMACOL SOC JAMMU-TAWI INDIA SEPT 30-OCT 2 1980 P. B2-.., 1980 *
ABSTR 13TH ANNU CONF INDIAN PHARMACOL SOC,JAMMU-TAWI,INDIA,SEPT 30-OCT 2,1980. P. ABSTR-12., 1980 *
ARORA R B ET AL: "LIPOTAB A POLYPHARMACEUTICAL PLANT DRUG COMBINATION IN HYPERLIPIDEMIA AND HYPERCHOLESTREMIA", INDIAN JOURNAL OF PHARMACOLOGY, XX, XX, vol. 16, no. 1, 28 December 1983 (1983-12-28), pages 22, XP009029469, ISSN: 0253-7613 *
BARNES J: "(4) hyperlipidaemia", PHARMACEUTICAL JOURNAL 10 AUG 2002 UNITED KINGDOM, vol. 269, no. 7210, 10 August 2002 (2002-08-10), pages 193 - 195, XP001181754, ISSN: 0031-6873 *
DATABASE BIOSIS [online] BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; 1984, SRIVASTAVA M ET AL: "EFFECT OF HYPOCHOLESTEROLEMIC AGENTS OF PLANT ORIGIN ON CATECHOLAMINE BIOSYNTHESIS IN NORMAL AND CHOLESTEROL FED RABBITS", XP002283792, Database accession no. PREV198580097863 *
DATABASE NAPRALERT [online] GODHWANI J D ET AL: "MODIFICATION OF IMMUNOLOGICAL RESPONSE BY GARLIC , GUGGAL AND TUMERIC:AN EXPERIMENTAL STUDY IN ALBINO RATS", XP002283790, retrieved from STN Database accession no. 92:83942 *
DATABASE NAPRALERT [online] GODHWANI J L ET AL: "MODIFICATION OF IMMUNOLOGICAL RESPONSE BY GARLIC , GUGGAL AND TURMERIC:AN EXPERIMENTAL STUDY IN ANIMALS", XP002283789, retrieved from STN Database accession no. 92:85456 *
DATABASE NAPRALERT [online] GODHWANI J L ET AL: "MODIFICATION OF INNUMOLOGICAL PESPONSE BY GARLIC , GUGGAL AND TURMERIC:AN EXPERIMENTAL STUDY IN ANIMALS", XP002283791, retrieved from STN Database accession no. 92:82694 *
JOURNAL OF BIOSCIENCES (BANGALORE), vol. 6, no. 3, 1984, pages 277 - 282, ISSN: 0250-5991 *
PROC INDIAN PHARMACOL SOC 1980 P. ABSTR-I-2., 1980 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006045932A3 (fr) * 2004-10-22 2006-08-31 Nuxe Lab Nouvelle utilisation d'huile de chaulmoogra et de guggulipides en therapeutique et en cosmetique.
FR2876912A1 (fr) * 2004-10-25 2006-04-28 Nuxe Sa Lab Nouvelle utilisation de guggulipides en therapeutique et en cosmetique
US7759391B2 (en) * 2007-10-08 2010-07-20 Chungbuk National University Industry Academic Cooperation Foundation Pharmaceutical composition comprising thiacremonone for treating colon cancer
US20130115290A1 (en) * 2010-04-26 2013-05-09 Angel Manuel Gago De Santos Compositions for the symptomatic relief of stomach pain or gastrooesophageal reflux
WO2015068112A3 (fr) * 2013-11-06 2015-08-13 Anil Kumar Sharma Composition à base d'herbes pour le traitement de l'hypertension et de troubles apparentés
WO2021255760A1 (fr) * 2020-06-18 2021-12-23 Indian Council Of Medical Research Formulation à base de plantes pour le traitement du syndrome ménopausique

Also Published As

Publication number Publication date
WO2004069262A8 (fr) 2005-03-17

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