WO2009097512A1 - Compositions phytopharmaceutiques pour traiter une inflammation et des affections et maladies associées à une inflammation - Google Patents

Compositions phytopharmaceutiques pour traiter une inflammation et des affections et maladies associées à une inflammation Download PDF

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Publication number
WO2009097512A1
WO2009097512A1 PCT/US2009/032615 US2009032615W WO2009097512A1 WO 2009097512 A1 WO2009097512 A1 WO 2009097512A1 US 2009032615 W US2009032615 W US 2009032615W WO 2009097512 A1 WO2009097512 A1 WO 2009097512A1
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extract
herbal composition
weight
composition according
standardized
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PCT/US2009/032615
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English (en)
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Yi Shi
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Innovative Drug Discovery Inc.
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    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236—Ligusticum (licorice-root)
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/539—Scutellaria (skullcap)
    • 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)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/718—Coptis (goldthread)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger

Definitions

  • This invention relates to herbal pharmaceutical compositions and supplements that can be used to prevent and treat inflammation.
  • the present invention is based on novel combinations of herbal extracts to prepare herbal pharmaceutical compositions and herbal supplements for treating inflammation.
  • the invention also relates to methods for using such herbal pharmaceutical compositions and supplements to treat a variety of diseases which have an inflammatory component.
  • a variety of chronic diseases have inflammation as an underlying or additional component. Treatment of the inflammation may therefore be useful, and sometimes essential, to cure the disease.
  • a variety of chronic inflammatory diseases, cardiovascular diseases, neurological diseases, bone and joint diseases, muscular and skeletal diseases, cancers and diabetes and obesity related complications have inflammatory components.
  • compositions and methods of the present invention may be used for preventing and treating diseases in which inflammation is a common basis or contributing cause to the disease.
  • compositions and methods of the present invention may be used as both pharmaceutically active and supplement preparations to prevent or treat inflammation and the various diseases that result from inflammation.
  • the present invention relates to an herbal pharmaceutical composition or herbal supplement composition which comprises a water extract of Coptis chinensis (Chinese goldthread), a hydroalcoholic extract of Ligusticum chuanxiong (Ligustici wallichii or Ligusticum sinenses), a standardized hydroalcoholic extract of Curcuma longa (turmeric), and a standardized hydroalcoholic extract of Scutellaria baicalensis (Chinese skullcap).
  • the herbal composition above may be formulated such that it comprises from about 10% to about 30% by weight of the extract of (Rhizome) Coptis chinensis; from about 10% to about 30% by weight of the extract of (Rhizome) Ligusticum chuanxiong; from about 10% to about 40% by weight of the extract of (Rhizome) Curcuma longa; and from about 10% to about 30% by weight of the extract of (Radix) Scutellaria baicalensis.
  • the herbal formulation above may be prepared wherein Rhizome Coptis chinensis is extracted by water at a weight ratio of about 10 parts of dried raw herb per 1 part of extract; Rhizome Ligusticum chuanxiong is extracted by water and alcohol at a weight ratio of about 10 parts of dried raw herb per 1 part of extract; Rhizome Curcuma longa is extracted by water and alcohol at a weight ratio of 50-100 parts of dried raw herb per 1 part of extract; Radix Scutellaria baicalensis is extracted by water and alcohol at a weight ratio of about 8-10 parts of dried raw herb per 1 part of extract.
  • the extract of Rhizome Coptis chinensis may comprise Berberine; the extract of Rhizome Ligusticum chuanxiong may comprise ligustrazine; the extract of Rhizome Curcuma longa may comprise Curcumin; and the extract of Radix Scutellaria baicalensis may comprise Baicalin.
  • compositions of the present invention include the compositions presented above and further include one or more herbs selected from a water extract of Sophora flavescens, a hydroalcoholic extract of Ginkgo biloba leaves; a hydroalcoholic extract of Boswellia serrata oleo-gum-resin, a water extract of Astragalus membranaceus root, a water extract of Eucommia ulmoides cortex, a hydroalcoholic extract of Milk thistle seeds, a hydroalcoholic extract of Angelica sinensis root, a water extract of Lycium barbarum fruit, a hydroalcoholic extract of Astragauls membranaceus radix, a hydroalcoholic extract of Saw palmetto fruit, a hydroalcoholic extract of Angelica sinensis root, and a hydroalcoholic extract of Rhodiola rosea root.
  • a water extract of Sophora flavescens a hydroalcoholic extract of Ginkgo biloba leaves
  • the present invention provides a method of preventing or treating inflammation in a mammal comprising administrating to the mammal an herbal pharmaceutical composition comprising: a water extract of Coptis chinensis (Chinese goldthread), a hydroalcoholic extract of Ligusticum chuanxiong (Ligustici wallichii or Ligusticum sinenses), a standardized hydroalcoholic extract of Curcuma longa (Turmeric), and a standardized hydroalcoholic extract of Scutellaria baicalensis (Chinese skullcap).
  • This method may comprise orally administering the composition in an amount and for a time period sufficient to reduce the inflammation.
  • the methods of the present invention may be used to prevent or treat an inflammation-associated cardiovascular and muscular disease selected from the group consisting of coronary artery disease, carotid artery disease, peripheral artery disease, cerebral artery disease, migraine, fibromyalgia, hypertension, stroke, erectile dysfunction, cardiomyopathy, and heart failure.
  • an inflammation-associated cardiovascular and muscular disease selected from the group consisting of coronary artery disease, carotid artery disease, peripheral artery disease, cerebral artery disease, migraine, fibromyalgia, hypertension, stroke, erectile dysfunction, cardiomyopathy, and heart failure.
  • the methods of the present invention may be used to prevent or treat an inflammation-associated neurological and neurodegenerative disease selected from the group consisting of depression, chronic fatigue syndrome, sleep disorders, Alzheimer's disease, dementia, Parkinson's disease, and amyotrophic lateral sclerosis.
  • the methods of the present invention may be used to prevent or treat an inflammation-associated disease selected from the group consisting of inflammatory bowel disease (IBD), chronic obstructive pulmonary disease (COPD), rheumatoid arthritis (RA), psoriasis, lupus, chronic pancreatitis, hepatitis, fatty liver disease, cirrhosis, nephritis, kidney dysfunction, cervicitis, pelvic and vaginal inflammation, prostatitis, and benign prostatic hyperplasia.
  • IBD inflammatory bowel disease
  • COPD chronic obstructive pulmonary disease
  • RA rheumatoid arthritis
  • psoriasis psoriasis
  • lupus chronic pancreatitis
  • hepatitis hepatitis
  • fatty liver disease cirrhosis
  • nephritis nephritis
  • kidney dysfunction cervicitis
  • the methods of the present invention may be used to prevent or treat an inflammation-associated bone and skeletal disease selected from the group consisting of osteoporosis, osteoarthritis, degenerative disc disease, and muscular dystrophy.
  • the methods of the present invention may be used to prevent or treat metabolic diseases and complications selected from the group consisting of type 2 diabetes, insulin resistance, and metabolic syndrome.
  • the methods of the present invention may be used to prevent or treat cancer selected from the group consisting of lung cancer, colon cancer, liver cancer, breast cancer, stomach cancer, gall bladder cancer, prostate cancer, ovarian cancer, cervical cancer and leukemia.
  • the herbal compositions of the present invention may be administered externally in an amount and for a time period sufficient to reduce inflammation.
  • the external administration of the herbal compositions of the present invention may be used to prevent or treat an external infection selected from the group consisting of bacterial infection, yeast infection, fungal infection, and viral infection.
  • Figure 1 provides examples of formulations which may be used for specific disease states.
  • YS701 is a basic formulation, which includes four essential herbs. This figure also illustrates ten additional formulations derived from YS701. Each formulation includes one or two additional herbal extracts.
  • Figure 2 is a flowchart illustrating an herbal ratio extraction (RE) using water extraction.
  • Figure 3 is a flowchart illustrating an herbal ratio extraction (RE) using ethanol extraction.
  • FIG. 4 is a flowchart illustrating a standardized herbal extract (SE) of Curcuma longa. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • the present invention is directed to herbal pharmaceutical compositions and supplements which are used to treat and prevent a variety of diseases, in particular, diseases that involve inflammation.
  • the invention also provides methods for using these pharmaceutical compositions and supplements.
  • Inflammation is a normal response of the body to protect tissues from infection, injury or disease.
  • the inflammatory response begins with the production and release of chemical agents by cells in the infected, injured, or diseased tissue. These agents cause redness, swelling, pain, heat and loss of function. Inflamed tissues generate additional signals that recruit inflammatory cells to the site of inflammation. These cells destroy any infective or injurious agent, and remove cellular debris from damaged tissue. In acute situations, or at low levels, inflammation deals with the abnormality and promotes healing. When chronically sustained at high levels, inflammation can seriously damage viable host tissue.
  • the present invention is directed to an herbal pharmaceutical composition
  • an herbal pharmaceutical composition comprising a water extract of Coptis chinensis (Chinese goldthread), a hydroalcoholic extract of Ligusticum chuanxiong (Ligustici wallichii or Ligusticum sinenses), a standardized hydroalcoholic extract of Curcuma longa (turmeric), and a standardized hydroalcoholic extract of Scutellaria baicalensis (Chinese skullcap).
  • compositions of the present invention may be added to the compositions of the present invention to prevent or treat specific inflammation-related diseases.
  • additional herbs and active ingredients are discussed below.
  • a variety of extraction methods are known in the art to obtain an herbal extract. Such methods include extraction of the full spectrum of desired ingredients using a solvent which can be water, alcohol, or a mixture of water and alcohol.
  • a solvent which can be water, alcohol, or a mixture of water and alcohol.
  • the following types of herbal extracts are disclosed: water extract, hydroalcoholic extract, and standardized hydroalcoholic extract.
  • Three process examples are provided ( Figures 2-4).
  • the term "standardized” as used with "standardized water extract” and "standardized hydroalcoholic extract” refers to a substance that is extracted with a standardized procedure which yields consistent ingredient(s) that can be measured and used as reference. This reference may be an active ingredient, or just one that is easily determined.
  • an herbal ratio extract based on water extraction begins with comminution (crushing and grinding into small pieces) of the dried raw material followed by water extraction with heat and pressure for one or more times. This is followed by decompression (relieving pressure) and repeated precipitation and centrifugation steps. After drying (using spray, vacuum or other methods) and removal of impurities by passing through 80 mesh screen, herbal extract (powder) will be sterilized and packed.
  • an herbal ratio extract based on ethanol extraction begins with dried raw herbal material. This material is then crushed into small pieces followed by mixing with water-ethanol mixture in the presence of heat and pressure for one or more times. This is followed by decompression (relieving pressure) and repeated precipitation and centrifugation steps. After drying (using spray, vacuum or other methods) and removal of impurities by passing through 80 mesh screen, herbal extract (powder) will be sterilized and packed.
  • Figure 4 illustrates an exemplary process for a standardized herbal extract, in this example Curcuma longa.
  • the dried raw material is crushed into small particles and extracted through water and alcohol in the presence of heat and pressure for one or more times. This is followed by decompression, percolation (passing through a filtering system) and repeated precipitation and centrifugation steps. After drying (using spray, vacuum or other methods) and removal of impurities by passing through 80 mesh screen, herbal extract will be tested for curcumin.
  • One embodiment of the present invention is an herbal pharmaceutical composition which includes Coptis chinesis, Ligusticum chuanxiong, Curcuma longa (tumeric) and Scutellaria baicalensis.
  • Coptis chinensis is also known as Chinese goldthread or Huang lian. Coptis chinensis has been documented as an herbal medicine for over a thousand years (Shen Nong Ben Cao Jing, 225 BC). According to Chinese pharmacopoeia "Ben Cao Gang Mu” (1596) and Chinese Medical Herbology and Pharmacology, Coptis chinensis is one of the strongest herbs to clear heat, dry dampness, and eliminate toxins. It has been used as a main drug for treating damp-heat syndromes, particularly for intestinal and lung infections.
  • the pharmacological active ingredients of Coptis are in the dried rhizome, which include, but are not limited to, berberine, coptisin, palmatine, jatrorrhizine, epiberberine, wornnine, columbamine, magnoflorine.
  • Pharmacological effects of Coptis include broad spectrum of antibiotic and anti-inflammatory effects. Modern research has revealed various mechanisms underlying anti-inflammatory activity of Coptis. It reduces nitric oxide (NO) generation and expression of inducible nitric oxide synthase (iNOS), blocks NF kappa B dependent pathway, and inhibits proinflammatory cytokines such as TNF-alpha and Interleukin-1 beta. Recent data also suggest other benefits of Coptis. For example, it reduces high blood pressure and blood sugar, lowers cholesterol and decreases oxidative stress.
  • NO nitric oxide
  • iNOS inducible nitric oxide synthase
  • iNOS inducible nitric oxide
  • the rhizome of Coptis chinensis is extracted by water to obtain a full spectrum of water-soluble ingredients.
  • the rhizome Coptis chinensis is preferably extracted by water at a weight ratio of about 10 parts of raw herb per 1 part of water-soluble extract such that, as an example, 10 grams of raw herb yields 1 gram of extract in a solid, preferably powder form following extraction.
  • Ligusticum chuanxiong is also known as Ligustici wallichii, Ligusticum sinenses, or Chuan xiong.
  • Ligusticum chuanxiong improves circulation and has positive effects on the heart and liver functions.
  • Rhizoma Chuanxiong contains volatile oil, alkaloids (e.g., ligustrazine), phenolic substances (e.g., ferulic acid), lactone, vitamin A, folic acid, sterols, sucrose, fatty oil, etc. Active ingredients of Ligusticum chuanxiong exert antibacterial, antifungal and antiinflammatory effects.
  • Ligusticum chuanxiong Additional benefits include inhibition of vascular smooth muscle contraction, increased blood flow in the coronary artery, brain and limbs, improved myocardial hypoxia and microcirculation, reduced myocardial oxygen consumption and prevention of platelet activation and thrombosis.
  • the rhizome of Ligusticum chuanxiong is preferably extracted by water/alcohol mixture.
  • the rhizome of Ligusticum chuaunxiong is preferably extracted by water/alcohol at a weight ratio of about 10 parts dried raw herb per 1 part of extract such that, as an example, 10 grams of raw herb would yield 1 gram of extract in a solid, preferably powder form following the extraction.
  • Curcumae longa is also known as Tumeric, or Jiang huang.
  • Tumeric or Jiang huang.
  • the use of Curcuma longa for treatment of different inflammatory diseases has been described in traditional Chinese and Indian medicine for thousands of years.
  • the active component of Curcuma longa responsible for antiinflammatory activity, curcumin was identified almost two centuries ago. Since then, there have been over 1,800 citations in Medline relating to the biologic effect of curcumin.
  • curcumin mediates its effects by modulation of several important molecular targets, including transcription factors (e.g., NF-kappa B, AP-I, Egr- 1, beta-catenin, and PPAR-gamma), enzymes (e.g., COX2, 5-LOX, iNOS, and hemeoxygenase- 1), cell cycle proteins (e.g., cyclin Dl and p21), cytokines (e.g., TNF, IL-I, IL-6, and chemokines), receptors (e.g., EGFR and HER2), and cell surface adhesion molecules.
  • transcription factors e.g., NF-kappa B, AP-I, Egr- 1, beta-catenin, and PPAR-gamma
  • enzymes e.g., COX2, 5-LOX, iNOS, and hemeoxygenase- 1
  • cell cycle proteins e.g., cyclin Dl
  • the rhizome of Curcuma longa is preferably extracted by water/alcohol mixture.
  • the rhizome Curcuma longa is preferably extracted by water/alcohol at a weight ratio of about 50- 100 parts dried raw herb to 1 part hydroalcoholic extract.
  • a standardized extract of Curcumae longa which contains about 95% curcumin, is used to prepare the compositions of the present invention.
  • Scutellaria baicalensis is also known as Chinese skullcap, Scute or Huang qin.
  • Scutellaria baicalensis is one of the most utilized herbs in traditional Chinese medicine. Its root is a rich source of over 35 flavonoids.
  • the main active ingredients modulating inflammation include wogonin, a xanthine oxidase inhibitor, and baicalin; both wogonin and baicalin are potent free radical scavengers.
  • wogonin a xanthine oxidase inhibitor
  • baicalin both wogonin and baicalin are potent free radical scavengers.
  • angiogenesis affect cell growth and apoptosis. Recent research also reveals anti-cancer and anti-allergy effects and benefits for treating diabetes and high blood pressure.
  • the antiinflammatory actions of Scutellaria include reducing production of NO and free radicals, proinflammatory mediators such as cyclooxygenase-2, leukotriene B4 (inhibition of the 5 -lipoxygenase enzyme), interleukin-lbeta, 12-lipoxygenase and prostaglandin E2.
  • the radix of Scutellaria baicalensis is extracted in a water/ alcohol mixture. It is preferable for the compositions of the present invention to have about 10 to about 30% by weight of Scutellaria extract.
  • the Scutellaria baicalensis is extracted at a ratio of about 8-10 parts dried raw herb per 1 part hydroalcoholic extract.
  • a standardized extract of Scutellaria baicalensis which contains about 85-95% baicalin, is used to prepare the compositions of the present invention.
  • the compound will be what is considered to be the active, or one of the active, ingredient(s) present in the herb.
  • Berberine is a constituent of Rhizome Coptis chinensis.
  • berberine is present in the extract used to prepare the compositions of the invention.
  • Ligustrazine is a constituent of Ligusticum chuanxiong and in a preferred embodiment, ligustrazine is present in the extract used to prepare compositions of the present invention.
  • Curcumin is a constituent of Curcuma longa and in a preferred embodiment, Curcumin is present in the extract used to prepare the compositions of the present invention.
  • Baicalin is a constituent of Scutellaria baicalensis, and in a preferred embodiment, Baicalin is present in the extract used to prepare the compositions of the present invention.
  • additional herbs are added to the present composition. These additional herbs may be beneficial in enhancing therapeutic effects for treating certain kinds of disease states or inflammation.
  • a water extract of the radix of Sophora flavescentis is added to the herbal pharmaceutical compositions of the present invention (YS711).
  • the radix Sophora flavescentis comprises about 20 to about 30% of the herbal composition.
  • the radix of Sophora flavescentis is preferably extracted in water at a weight ratio of about 10 parts dried raw herb to 1 part soluble extract.
  • the herbal compositions of the present invention comprise a hydroalcoholic extract of Ginkgo biloba leaves and a hydroalcoholic extract of Boswellia serrata oleo-gum-resin (YS721).
  • the herbal composition comprises about 10 to about 20% by weight of extract of Ginkgo biloba leaves and about 10 to about 30% by weight of extract of Boswellia serrata.
  • a standardized extract of Gingko biloba which contains about 24% glycosides and about 6% terpene lactones
  • a standardized extract of Boswellia serrata oleo-gum-resin which contains about 65 % to about 85% of boswellic acid, are used to prepare the compositions of the present invention.
  • the herbal compositions of the present invention include a water extract of the radix of Astragalus membranaceus and a hydroalcoholic extract of Boswellia serrata oleo-gum-resin (YS731).
  • the Astragalus membranceus extract comprises about 10 to about 30% by weight of the herbal composition
  • the Boswellia serrata extract comprises about 10 to about 30% by weight of the herbal composition.
  • a standardized extract of Astragalus membranaceus which contains about 50 to about 70% of polysaccharides
  • a standardized extract of Boswellia serrata oleo-gum-resin which contains about 65 % to about 85% of boswellic acid, are used to prepare the compositions of the present invention.
  • the herbal composition of the present invention contains a water extract of Eucommia ulmoides and a hydroalcoholic extract of Ginkgo biloba leaves (YS741).
  • the herbal composition includes about 10 to about 30% by weight of the extract of Eucommia ulmoides cortex and about 10 to about 20% by weight of extract of Ginkgo biloba leaves.
  • the Eucommia ulmoides cortex is prepared by extraction in water at a weight ratio of about 14 parts dried raw herb to 1 part extract, and the Gingko biloba leaves are prepared by a standardized extract, which contains about 24% glycosides and about 6% terpene lactones.
  • the herbal composition of the present invention includes a water and alcohol extract of Milk thistle seeds (YS751).
  • the Milk thistle comprises about 10 to about 30% by weight of the herbal composition.
  • the Milk thistle is extracted by water and alcohol at a weight ratio of about 20 parts dried raw herb to 1 part extract.
  • a standardized extract of Milk thistle containing about 80% of Silymarin is used to prepare the compositions of the present invention.
  • the herbal composition of the present invention includes a hydroalcoholic extract of Boswellia serrata oleo-gum-resin and a hydroalcoholic extract of Angelica sinensis root (YS761).
  • the Boswellia serrata extract comprises about 10 to about 30% by weight of the herbal composition and, the Angelica sinensis extract comprises about 10 to about 30% by weight of the herbal composition.
  • a standardized extract of Boswellia serrata oleo-gum-resin which contains about 65 % to about 85% of boswellic acid
  • a standardized extract of Angelica sinensis root which contains about 1% of ligustilide and about 0.1-0.3 % of ferulic acid
  • the herbal composition of the present invention includes a water extract of Lycium barbarum fruit and a water extract of the radix of Astragalus membranaceus (YS771).
  • the Lycium barbarum extract comprises about 10 to about 30% by weight of the herbal composition
  • the Astragalus membranaceus extract comprises about 10 to about 30% by weight of the herbal composition.
  • a standardized extract of Lycium barbamm fruit, which contains about 50 % of polysaccharides and a standardized extract of Astragalus membranaceus radix, which contains about 50% to about 70% of polysaccharides, are used to prepare the compositions of the present invention.
  • the herbal composition of the present invention includes a water and alcohol extract of Saw palmetto fruit (YS781).
  • the Saw palmetto extract comprises about 10 to about 30% by weight of the herbal composition.
  • a standardized extract of Saw palmetto fruit which contains about 25-90 % of fatty acids, is used to prepare the compositions of the present invention.
  • the herbal composition of the present invention includes a hydroalcoholic extract of Ginkgo biloba leaves and a water extract of the radix of Astragalus membranaceus radix (YS722).
  • the Ginkgo biloba extract comprises about 10 to about 20% by weight of the herbal composition
  • the Astragalus membranceus extract composes about 10 to about 30% by weight of the herbal composition.
  • a standardized extract of Gingko biloba leaves, which contains about 24% glycosides and about 6% terpene lactones and a standardized extract of Astragalus membranaceus radix, which contains about 50 to about 70% of polysaccharides, are used to prepare the compositions of the present invention.
  • the herbal composition of the present invention includes a hydroalcoholic extract of Ginkgo biloba leaves and a hydroalcoholic extract of Rhodiola rosea root (YS723).
  • the Ginkgo biloba extract comprises about 10 to about 20% by weight of the herbal composition
  • the Rhodiola rosea extract comprises about 10 to about 30% by weight of the herbal composition.
  • a standardized extract of Gingko biloba leaves, which contains about 24% glycosides and about 6% terpene lactones and a standardized extract of Rhodiola rosea root, which contains about 3% of rosavin and about 1% of salidroside, are used to prepare the compositions of the present invention.
  • the present herbal pharmaceutical compositions and supplements are used to treat and/or prevent inflammation.
  • One method of the present invention to prevent or treat inflammation in a mammal comprises administering to the mammal an herbal pharmaceutical composition comprising water-soluble extract of Coptis chinensis, a hydroalcoholic extract of Ligusticum chuanxiong, a standardized hydroalcoholic extract of Curcuma longa and a standardized hydroalcoholic extract of Scutellaria baicalensis.
  • any of the compositions described above may be prepared to treat and/or prevent inflammation.
  • compositions of the present invention may also be used in methods to treat or prevent a variety of external infections (bacteria, yeast, fungus, and virus). Examples of such infection include, but are not limited to, vaginitis, nail fungus, and skin infections with bacterial or yeast.
  • external infections bacteria, yeast, fungus, and virus.
  • infections include, but are not limited to, vaginitis, nail fungus, and skin infections with bacterial or yeast.
  • One embodiment of the present invention which may be used for treating external infections adds a water extract of Sophora flavescentis in addition to the basic four-herb composition (Coptis chinensis, Ligusticum chuanxiong, Curcuma longa and Scutellaria baicalensis) as described above.
  • the Sophora flavescentis extract comprises about 20 to about 40% by weight of the herbal composition.
  • compositions of the present invention may also be used in methods to treat or prevent a variety of neurodegenerative and vascular diseases that have an inflammatory component.
  • diseases include, but are not limited to, Alzheimer's Disease, dementia, Parkinson's Disease, amyotrophic lateral sclerosis, degenerative disc disease, atherosclerosis, coronary artery disease, carotid artery disease, peripheral artery disease, cerebral artery disease, stroke, erectile dysfunction, fibromyalgia, and migraine.
  • One embodiment of the present invention which may be used for treating neurodegenerative diseases adds a standardized extract of Ginkgo biloba leaves and a standardized extract of Boswellia serrata oleo-gum-resin in addition to the basic four-herb composition (Coptis chinensis, Ligusticum chuanxiong, Curcuma longa and Scutellaria baicalensis) as described above.
  • the Ginkgo biloba extract comprises about 10 to about 20% by weight of the herbal composition
  • the Boswellia serrata extract comprises about 10 to about 30% by weight of the herbal composition.
  • compositions of the present invention are used in methods to treat or prevent cancer and diseases that have inflammatory condition as a primary component of the disease and which are seen as "inflammatory" diseases.
  • diseases include, but are not limited to, cancer (lung cancer, colon cancer, liver cancer, breast cancer, stomach cancer, gall bladder cancer, skin cancer, prostate cancer, cervical cancer, and leukemia), Inflammatory Bowel Disease (IBD), Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis (RA), psoriasis, chronic pancreatitis, and lupus.
  • One embodiment of the present invention which may be used for treating inflammatory diseases adds a standardized extract of Astragalus membranaceus radix and a standardized extract of Boswellia serrata oleo-gum-resin to the basic four-herb composition.
  • the Astragalus membranaceus extract comprises about 10 to about 30% by weight of the herbal composition
  • the Boswellia serrata extract comprises about 10 to about 30% by weight of the herbal composition.
  • compositions of the present invention may also be used in methods to prevent or treat high blood pressure, bone and skeletal diseases that have an inflammatory component.
  • diseases include, but are not limited to, hypertension, osteoporosis, osteoarthritis, and periodontitis.
  • One embodiment of the present invention which may be useful for treating hypertension, bone and skeletal diseases adds a water extract of Eucommia ulmoides cortex and a standardized extract of Ginkgo biloba leaves to the basic four-herb composition.
  • the Eucommia ulmoides extract comprises about 10 to about 30% by weight of the herbal composition
  • the Ginkgo biloba extract comprises about 10 to about 20% by weight of the herbal composition.
  • the compositions of the present invention may also be used in methods to treat liver disorders that have an inflammatory component. Examples of such diseases include, but are not limited to, hepatitis, fatty liver disease, cirrhosis, and liver cancer.
  • One embodiment of the present invention which may be useful for treating liver disorders adds a standardized extract of Milk thistle seeds to the basic four-herb composition.
  • the Milk thistle extract comprises about 10 to about 30% by weight of the herbal composition.
  • compositions of the present invention are used in methods to treat or prevent female urogenital diseases that have inflammatory component.
  • diseases include, but are not limited to cervicitis, pelvic and vaginal inflammation.
  • One embodiment of the present invention which may be used for treating female urogenital diseases adds a standardized extract of Boswellia serrata oleo-gum-resin and a standardized extract of Angelica sinensis root to the basic four-herb composition.
  • the Astragalus membranaceus extract comprises about 10 to about 30% by weight of the herbal composition
  • the Boswellia serrata extract comprises about 10 to about 30%o by weight of the herbal composition.
  • compositions of the present invention may also be used in methods to treat kidney diseases and metabolic disorders that have an inflammatory component.
  • diseases include, but are not limited to, nephritis, kidney dysfunction, type-2 diabetes, insulin resistance and metabolic syndrome.
  • One embodiment of the present invention which may be used for treating kidney diseases and metabolic disorders adds a standardized extract of Lycium fruit and a standardized extract of Astragalus membranaceus radix to the basic four-herb composition.
  • the Lycium extract comprises about 10 to about 30% by weight of the herbal composition
  • the Astragalus membranaceus extract comprises about 10 to about 30% by weight of the herbal composition.
  • compositions of the present invention may also be used in methods to treat prostate disorders that have an inflammatory component.
  • diseases include, but are not limited to, prostatitis, benign prostatic hyperplasia, and prostate cancer.
  • One embodiment of the present invention which may be used for treating prostate disorders adds a standardized extract of Saw palmetto fruit to the basic four-herb composition.
  • the Saw palmetto extract comprises about 20 to about 30% by weight of the herbal composition.
  • compositions of the present invention may be used in methods to prevent or treat muscular diseases.
  • muscular diseases are known to have an inflammatory component. Examples of such diseases include, but are not limited to, cardiomyopathy, congestive heart failure, rheumatic heart disease, and muscular dystrophy.
  • One embodiment of the present invention which may be useful for treating muscular diseases adds a standardized extract of Ginkgo biloba leaves and a standardized extract of Astragalus membranaceus radix to the basic four-herb composition.
  • the Ginkgo biloba extract comprises about 10 to about 30% by weight of the herbal composition
  • the Astragalus membranaceus extract comprises about 10 to about 30% by weight of the herbal composition.
  • compositions of the present invention may be used in methods to prevent or treat neurological and mental diseases.
  • a variety of neurological and mental diseases are known to have an inflammatory component. Examples of such diseases include, but are not limited to, major depression, anxiety, chronic fatigue syndrome, migraine, and chronic pain.
  • One embodiment of the present invention which may be useful for treating neurological and mental diseases adds a standardized extract of Ginkgo biloba leaves and a standardized extract of Rhodiola rosea root to the basic four-herb composition.
  • the Ginkgo biloba extract comprises about 10 to about 20% by weight of the herbal composition
  • the Rhodiola rosea extract comprises about 10 to about 30% by weight of the herbal composition.
  • compositions of the present invention may additionally comprise conventional carriers, adjuvants or diluents.
  • the following formulation methods and excipients are merely exemplary and in no way limit the invention.
  • the herbal composition according to the present invention can be provided as a pharmaceutical composition containing pharmaceutically acceptable earners, adjuvants or diluents, e.g., lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starches, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, polyvinyl pyrrolidone, water, methylhydroxy benzoate, propylhydroxy benzoate, talc, magnesium stearate and mineral oil.
  • pharmaceutically acceptable earners, adjuvants or diluents e.g., lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starches, acacia rubber, alginate, gelatin, calcium phosphate,
  • the formulations may additionally include fillers, anti-agglutinating agents, lubricating agents, wetting agents, flavoring agents, emulsifiers, preservatives and the like.
  • the compositions of the invention may be formulated so as to provide quick, sustained or delayed release of the active ingredient after their administration to a patient by employing any of the procedures well known in the art.
  • compositions of the present invention can be dissolved in oils, propylene glycol or other solvents which are commonly used to produce an injection.
  • suitable examples of the carriers include physiological saline, polyethylene glycol, ethanol, vegetable oils, isopropyl myristate, etc., but are not limited to them.
  • the compounds of the present invention can be formulated in the form of ointments and creams.
  • compositions of the present invention may be prepared in any form, such as oral dosage form (powder, tablet, capsule, soft capsule, aqueous medicine, syrup, elixirs pill, powder, sachet, granule), or topical preparation (cream, ointment, lotion, gel, balm, patch, paste, spray solution, aerosol and the like), or injectable preparation (solution, suspension, emulsion).
  • oral dosage form prowder, tablet, capsule, soft capsule, aqueous medicine, syrup, elixirs pill, powder, sachet, granule
  • topical preparation cream, ointment, lotion, gel, balm, patch, paste, spray solution, aerosol and the like
  • injectable preparation solution, suspension, emulsion
  • composition of the present invention in pharmaceutical dosage forms may be used in the form of their pharmaceutically acceptable salts, and also may be used alone or in appropriate association, as well as in combination with other pharmaceutically active compounds.
  • the herbal pharmaceutical composition above is orally administered in an amount and for a time period sufficient to reduce or prevent inflammation.
  • the compositions of the present invention may be administered to prevent inflammation in an animal, preferably a mammal, in particular, a human.
  • the animal may be in need of treatment given an existing disease state or potential to develop a disease state or undesirable inflammation.
  • compositions may be administered in therapeutically-effective amounts.
  • the desirable dose of the composition varies depending on the condition and the weight of the subject, severity, drug form, route and period of administration, and may be chosen by those skilled in the art. Any suitable amount of the herbal composition of the invention may be administered and dosage levels will vary according to the nature of the disease to be treated or prevented and the subject. In general, it is preferable to administer the compositions orally in a daily dosage of at least about 300 mg on a daily basis for about four weeks.
  • the pharmaceutical composition of present invention can be administered to a subject animal such as mammals (rat, mouse, domestic animals or human) via various routes. All modes of administration are contemplated, for example, administration can be made orally, rectally, topically or by intramuscular, subcutaneous, intracutaneous, intrathecal, and epidural modes.
  • compositions of the present invention may also be used as an herbal supplement.
  • supply refers to product taken by mouth that contains a dietary or herbal ingredient and intends to supplement the diet.
  • the herbal supplements are not drugs and can be sold on the market and taken without prescription.
  • the present invention, used at lower dose, may be used as herbal supplement for the prevention of inflammation and disease.
  • YS701 Formulation for treating inflammatory conditions and diseases
  • Curcuma longa rhizome extract (95% Curcuminoids) 150
  • Ligusticum chuanxiong rhizome extract (10: 1) 100
  • YS711 Formulation for treating external inflammatory conditions
  • Curcuma longa rhizome extract (95% Curcuminoids) 10
  • YS721 Formulation for treating neurodegenerative diseases and stroke
  • Curcuma longa rhizome extract (95% Curcuminoids) 150
  • YS731 Formulation for treating cancer and inflammatory diseases
  • Curcuma longa rhizome extract (95% Curcuminoids) 150
  • Ligusticum chuanxiong rhizome extract (10:1) 80 Astragalus membranaceus radix extract (50% Polysaccharides) 125
  • Boswellia serrata oleo-gum-resin extract 100 (65 % of boswellic acid)
  • YS741 Formulation for treating hypertension and bone diseases
  • Curcuma longa rhizome extract (95% Curcuminoids) 150
  • Eucommia ulmoides cortex extract (14:1) 100
  • Ginkgo biloba leaves extract 65 (24% glycosides, 6% terpene lactones, acid ⁇ 5ppm)
  • YS751 Formulation for treating liver disease & hepatitis
  • Curcuma longa rhizome extract (95% Curcuminoids) 150
  • YS761 Formulation for treating female urogenital inflammatory diseases
  • Curcuma longa rhizome extract (95% Curcuminoids) 150
  • YS771 Formulation for treating kidney and metabolic diseases
  • Curcuma longa rhizome extract (95% Curcuminoids) 150
  • Lycium barbarum fruit extract 50 % of polysaccharides
  • Curcuma longa rhizome extract (95% Curcuminoids) 150
  • YS722 Formulation for treating muscular diseases
  • Curcuma longa rhizome extract (95% Curcuminoids) 150
  • Ligusticum chuanxiong rhizome extract (10:1) 80 Astragalus membranaceus radix extract (50% Polysaccharides) 150
  • YS723 Formulation for treating neurological and mental disorders
  • Curcuma longa rhizome extract (95%) Curcuminoids
  • Ligusticum chuanxiong rhizome extract (10:1) 100
  • Rhodiola rosea root extract (3% rosavin, 1 % salidroside) 150

Abstract

L'invention concerne des compositions et des compléments phytopharmaceutiques comprenant : un extrait aqueux de Coptis chinensis (coptide de Chine), un extrait hydroalcoolique de Ligusticum chuanxiong (Ligustici wallichii ou Ligusticum sinenses), un extrait hydroalcoolique standardisé de Curcuma longa (curcuma), et un extrait hydroalcoolique standardisé de Scutellaria baicalensis (scutellaire du Baïkal) et des procédés de prévention et de traitement d'une inflammation et de maladies associées à une inflammation utilisant ces compositions.
PCT/US2009/032615 2008-02-01 2009-01-30 Compositions phytopharmaceutiques pour traiter une inflammation et des affections et maladies associées à une inflammation WO2009097512A1 (fr)

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EP2467018A1 (fr) * 2009-08-20 2012-06-27 Biokab, S.A. DE C.V. Compositions phytoceutiques pour animaux de compagnie
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WO2014112861A1 (fr) * 2013-01-17 2014-07-24 Herbitec (M) Sdn Bhd Composition pharmaceutique antivirale
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WO2014138372A1 (fr) * 2013-03-06 2014-09-12 Primavera Biosciences, Inc. Composition et méthode de traitement de l'arthrose
EP3010928A4 (fr) * 2013-06-17 2017-01-04 Unigen, Inc. Compositions et procédés pour des articulations saines
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CN105675761A (zh) * 2016-02-03 2016-06-15 成都中医药大学 同时测定小檗皮中四种生物碱成分含量的hplc方法
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CN108283687A (zh) * 2018-04-24 2018-07-17 上海中医药大学附属岳阳中西医结合医院 一种防治高血压及心脏受损的药食同源的中药组合物及其应用
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CN110755440A (zh) * 2019-11-20 2020-02-07 中国海洋大学 川芎嗪和甘露糖醛酸的组合物在用于制备治疗血栓性疾病和神经系统疾病的药物中的应用
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CN111603501A (zh) * 2020-05-11 2020-09-01 中国中医科学院中医临床基础医学研究所 一种用于原发性肝癌的中药组合物及其应用
CN111603501B (zh) * 2020-05-11 2022-03-25 中国中医科学院中医临床基础医学研究所 一种用于原发性肝癌的中药组合物及其应用
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CN111743910A (zh) * 2020-07-24 2020-10-09 暨南大学 黄芩苷在制备改善糖尿病肺损伤药物中的应用
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