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US20150065441A1 - Pharmaceutical composition for prevention or treatment of cognitive function disorders comprising spinosyn - Google Patents

Pharmaceutical composition for prevention or treatment of cognitive function disorders comprising spinosyn Download PDF

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Publication number
US20150065441A1
US20150065441A1 US14/361,243 US201214361243A US2015065441A1 US 20150065441 A1 US20150065441 A1 US 20150065441A1 US 201214361243 A US201214361243 A US 201214361243A US 2015065441 A1 US2015065441 A1 US 2015065441A1
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US
United States
Prior art keywords
spinosin
pharmaceutical composition
acid
prevention
cognitive impairments
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.)
Abandoned
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US14/361,243
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English (en)
Inventor
Jong Hoon Ryu
Hyung Eun Lee
Sam Sik Kang
Ju Sun Kim
So Young Lee
Do Hoon Kim
Dong Sup Kim
Seung Hee Kim
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DAE HWA PHARMA Co Ltd
MINISTRY OF FOOD AND DRUG SAFETY
Original Assignee
DAE HWA PHARMA Co Ltd
MINISTRY OF FOOD AND DRUG SAFETY
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Application filed by DAE HWA PHARMA Co Ltd, MINISTRY OF FOOD AND DRUG SAFETY filed Critical DAE HWA PHARMA Co Ltd
Assigned to UNIVERSITY-INDUSTRY COOPERATION GROUP OF KYUNG HEE UNIVERSITY reassignment UNIVERSITY-INDUSTRY COOPERATION GROUP OF KYUNG HEE UNIVERSITY ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LEE, HYUNG EUN, RYU, JONG HOON
Assigned to SNU R&DB FOUNDATION reassignment SNU R&DB FOUNDATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KANG, SAM SIK, KIM, JU SUN, LEE, SO YOUNG
Assigned to MINISTRY OF FOOD AND DRUG SAFETY reassignment MINISTRY OF FOOD AND DRUG SAFETY ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KIM, DO HOON, KIM, DONG SUP, KIM, SEUNG HEE
Assigned to DAE HWA PHARMA. CO., LTD. reassignment DAE HWA PHARMA. CO., LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: UNIVERSITY-INDUSTRY COOPERATION GROUP OF KYUNG HEE UNIVERSITY
Assigned to DAE HWA PHARMA. CO., LTD. reassignment DAE HWA PHARMA. CO., LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SNU R&DB FOUNDATION
Assigned to MINISTRY OF FOOD AND DRUG SAFETY reassignment MINISTRY OF FOOD AND DRUG SAFETY CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: KOREA FOOD & DRUG ADMINISTRATION
Publication of US20150065441A1 publication Critical patent/US20150065441A1/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A23L1/3014—
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
    • A23L2/52—Adding ingredients
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • 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)
    • A61K36/42—Cucurbitaceae (Cucumber 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)
    • A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • 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)
    • A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
    • A61K36/725—Ziziphus, e.g. jujube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to a pharmaceutical composition comprising spinosin for prevention and treatment of cognitive impairments. More particularly, the present invention relates to a pharmaceutical composition which can improve memory and learning ability, thus effectively preventing and treating disorders such as dementia and amnesia.
  • Dementia that is a typical disease of cognitive impairments is a pathological condition that needs to be distinguished from normal aging and is classified into Alzheimer's disease, vascular dementia, and other dementias caused by alcoholism, trauma, sequelae of Parkinson's disease, etc.
  • Alzheimer's disease is one of chronic psychiatric disorders including disorders of higher cerebral functions such as loss of memory, impaired consciousness, spatiotemporal chaos, thinking ability, arithmetic ability, judgment, common sense, etc. Moreover, it has been reported that Alzheimer's disease also occurs in relatively young people and most frequently occurs in elderly people as the incidence is increased two times for each increase of 5 years in the range of 65 to 85 years old. While the pathogenesis of Alzheimer's disease is not clearly known, a decrease in acetylcholine function in the central nervous system most commonly occurs, and thus therapeutic methods of administering acetylcholine precursors or drugs that inhibit the degradation of acetylcholine to increase the concentration of acetylcholine in the brain have been used.
  • acetylcholinesterase (hereinafter, ‘AChE’) inhibitors have been used alone or in combination with existing cholinesterase inhibitors, and examples of such drugs include tacrine, donepezil, rivastigmine, galantamine, etc. While these drugs are acetylcholinesterase inhibitors, they only slow the progression of diseases, but have little effect on the treatment and have limited therapeutic potential at the beginning of the disease, and thus made efforts have been made to develop drugs that treat the underlying cause of Alzheimer's disease (Terry and Buccafusco, 2003; Kar et al., 2004; Akhondzadeh et al., 2008; Cummings et al., 2008; Voss et al., 2008).
  • Vascular dementia is mostly caused by damage to the brain cells due to lack of blood supply to certain parts of the brain caused by cerebral arteriosclerosis.
  • the causes of the vascular dementia and Alzheimer's disease are different, but they are the same in that they cause damage to memory and learning ability.
  • the present inventors have studied to develop an effective medicine for prevention or treatment of cognitive impairments such as dementia and found herbal extracts and their active ingredients which can effectively improve memory and learning ability, thus completing the present invention.
  • An object of the present invention is to provide a pharmaceutical composition comprising spinosin for prevention or treatment of cognitive impairments.
  • Another object of the present invention is to provide a pharmaceutical composition comprising a spinosin-containing herbal extract for prevention or treatment of cognitive impairments.
  • Still another object of the present invention is to provide a food composition comprising spinosin for prevention or improvement of cognitive impairments.
  • Yet another object of the present invention is to provide a food composition comprising a spinosin-containing herbal extract for prevention or improvement of cognitive impairments.
  • Still yet object of the present invention is to provide a pharmaceutical composition comprising spinosin for prevention or treatment of degenerative brain diseases.
  • a further object of the present invention is to provide a pharmaceutical composition comprising a spinosin-containing herbal extract for prevention or treatment of degenerative brain diseases.
  • Another further object of the present invention is to provide a method for preventing or treatment of cognitive impairments or degenerative brain diseases, the method comprising administering to a subject in need thereof a composition comprising spinosin.
  • the present invention relates to a pharmaceutical composition comprising spinosin for prevention or treatment of cognitive impairments.
  • Spinosin represented by the above formula 1 can prevent or treat cognitive impairments. More particularly, the spinosin represented by the above formula 1 can improve memory and learning ability, thus effectively preventing and treating cognitive impairments.
  • the pharmaceutical composition comprising spinosin of the present invention can significantly improve learning ability, space perception ability, and memory in animal models with memory impairment induced by scopolamine, and thus exhibits excellent activity in the prevention or treatment of cognitive impairments and is particularly useful for the improvement of dementia and amnesia.
  • Spinosin represented by the above formula 1 may be obtained from various types of herbal medicines.
  • the spinosin represented by the above formula 1 may be obtained from Zizyphus jujuba Mill var. inermis, Zizyphus jujuba Mill var. hoonensis, Zizyphus jujuba Mill var.
  • spinosa Passiflora edulis flavicarpa, Cayaponia tayuya, Desmodium tortuosum, Wilbrandia ebracteata, Strophioblachia fimbricalyx, Clutia abyssinica, Saccharopolyspora spinosa , or mixtures thereof, and may preferably be obtained from zizyphi spinosi semen, the seeds of Zizyphus jujuba Mill var. spinosa.
  • Spinosin represented by the above formula 1 may be obtained from an extract of the above-described herbal medicines or mixtures thereof, and the spinosin represented by the above formula 1 may preferably be obtained from a water, methanol, ethanol, butanol, or hexane extract of the above-described herbal medicines or mixtures thereof.
  • the spinosin represented by the above formula 1 may be obtained from an extract of zizyphi spinosi semen, the seeds of Ziziphus jujuba Mill var. spinosa.
  • the spinosin represented by the above formula 1 may be obtained from an extract of an ethanol extract of zizyphi spinosi semen, the seeds of Zizyphus jujuba Mill var. spinosa.
  • the cognitive impairments refer to diseases caused by impaired functions such as memory, space perception ability, judgment, executive function, linguistic ability, etc. and may include, for example, Alzheimer's disease, vascular dementia, other dementias caused by various factors alcoholism, trauma, sequelae of Parkinson's disease, etc., or amnesia.
  • the cognitive impairment may be Alzheimer's disease.
  • the pharmaceutical composition comprising spinosin of the present invention can effectively inhibit scopolamine-induced memory impairments in mice even with a small amount.
  • the spinosin is an ingredient contained in the above-described herbal medicines and can effectively prevent or treat cognitive impairments without side effects.
  • the spinosin may be administered once or several times at a daily dose of about 1 mg to 120 mg for an adult, preferably at a daily dose of 30 mg to 120 mg.
  • the dose of the spinosin can be appropriately adjusted depending on the condition of a patient, such as the patient's severity, age, sex, weight, etc., and the formulation, administration route, and administration period.
  • the present invention relates to a pharmaceutical composition for prevention and treatment of cognitive impairments, comprising spinosin represented by the above formula 1 and an extract of Zizyphus jujuba Mill var. inermis, Zizyphus jujuba Mill var. hoonensis, Zizyphus jujuba Mill var. spinosa, Passiflora edulis flavicarpa, Cayaponia tayuya, Desmodium tortuosum, Wilbrandia ebracteata, Strophioblachia fimbricalyx, Clutia abyssinica, Saccharopolyspora spinosa , or mixtures thereof.
  • the above-mentioned Zizyphus jujuba Mill var. inermis, Zizyphus jujuba Mill var. hoonensis, Zizyphus jujuba Mill var. spinosa, Passiflora edulis flavicarpa, Cayaponia tayuya, Desmodium tortuosum, Wilbrandia ebracteata, Strophioblachia fimbricalyx, Clutia abyssinica , and Saccharopolyspora spinosa comprise spinosin represented by the above formula 1. Therefore, the composition comprising an extract of the above-described herbal medicines can prevent or treat cognitive impairments, like the spinosin, and has no side effects because it is a herbal extract.
  • the pharmaceutical composition of the preset invention may comprise an extract of Zizyphus jujuba Mill var. spinosa , preferably a water, hexane, ethanol, methanol, butanol, or the mixture thereof extract of the seeds of Ziziphus jujuba Mill var. spinosa , more preferably an ethanol extract.
  • the spinosin-containing herbal extract can effectively prevent or treat cognitive impairments without side effects.
  • the herbal extract of the present invention comprises spinosin and thus can significantly improve learning ability, space perception ability, and memory in animal models with memory impairment induced by scopolamine, and thus exhibits excellent activity in prevention or treatment of cognitive impairments and is particularly useful for the improvement of dementia and amnesia.
  • the pharmaceutical composition of the present invention may comprise the herbal extract in an amount of 0.1 to 50 wt % with respect to the total weight of the composition.
  • the content is not necessarily limited thereto, but may vary depending on the patient's condition and the type and progression of the disease.
  • the herbal extract may be administered once or several times at a daily dose of about 10 mg to 1200 mg for an adult, preferably at a daily dose of 300 mg to 1200 mg.
  • the dose of the herbal extract may be appropriately adjusted depending on the condition of a patient, such as the patient's severity, age, sex, weight, etc., and the formulation, administration route, and administration period.
  • the pharmaceutical composition comprising the spinosin represented by the above formula 1 or the spinosin-containing herbal extract has no toxicity and side effects and thus can be used with confidence even when taken for a long time for the purpose of prevention or treatment.
  • the present invention relates to a pharmaceutical composition comprising a pharmaceutically acceptable salt of spinosin for prevention or treatment of cognitive impairments or degenerative brain diseases.
  • pharmaceutically acceptable salt refers to salts commonly used in the pharmaceutical industry, such as inorganic ion salts formed with potassium, sodium, magnesium, etc., inorganic acid salts formed with hydrochloric acid, nitric acid, phosphoric acid, bromic acid, iodic acid, perchloric acid, tartaric acid, sulfuric acid, etc., organic acid salts formed with acetic acid, trifluoroacetic acid, citric acid, maleic acid, succinic acid, oxalic acid, benzoic acid, tartaric acid, fumaric acid, mandelic acid, propionic acid, lactic acid, glycolic acid, gluconic acid, galacturonic acid, glutamic acid, glutaric acid, glucuronic acid, aspartic acid, ascorbic acid, carbonic acid, vanillic acid, hydroio
  • the cognitive impairments may be dementia or amnesia
  • the degenerative brain diseases may be Parkinson's disease, stroke, stroke, or Huntington's disease.
  • the pharmaceutical composition of the present invention may further comprise pharmaceutically acceptable additives such as diluents, binders, disintegrants, lubricants, pH-adjusting agents, antioxidants, and solubilizers within the range where effects of the present invention are not impaired.
  • pharmaceutically acceptable additives such as diluents, binders, disintegrants, lubricants, pH-adjusting agents, antioxidants, and solubilizers within the range where effects of the present invention are not impaired.
  • the diluents may include sugar, starch, microcrystalline cellulose, lactose (lactose hydrate), glucose, D-mannitol, alginate, alkaline earth metal salt, clay, polyethylene glycol, calcium anhydrous hydrogen phosphate, and mixtures thereof; and the binders may include starch, microcrystalline cellulose, highly dispersive silica, mannitol, D-mannitol, sucrose, lactose hydrate, polyethylene glycol, polyvinylpyrrolidone (povidone), polyvinylpyrrolidone copolymer (copovidone), hypromellose, hydroxypropylcellulose, natural gum, synthetic gum, copovidone, gelatin, and mixtures thereof.
  • the disintegrants may include starches or modified starches such as sodium starch glycolate, corn starch, potato starch, pregelatinized starch, etc.; clays such as bentonite, montmorillonite, veegum, etc.; celluloses such as microcrystalline cellulose, hydroxypropylcellulose, carboxymethylcellulose, etc.; algins such as sodium alginate, alginic acid, etc.; crosslinked celluloses such as croscarmellose sodium, etc.; gums such as guar gum, xanthan gum, etc.; crosslinked polymers such as crosslinked polyvinylpyrrolidone (crospovidone), etc.; effervescent agents such as sodium bicarbonate, citric acid, etc.; and mixtures thereof.
  • starches or modified starches such as sodium starch glycolate, corn starch, potato starch, pregelatinized starch, etc.
  • clays such as bentonite, montmorillonite, veegum, etc.
  • the lubricants may include talc, stearic acid, magnesium stearate, calcium stearate, sodium lauryl sulfate, hydrogenated vegetable oil, sodium benzoate, sodium stearyl fumarate, glyceryl behenate, glyceryl monorate, glyceryl monostearate, glyceryl palmitostearate, colloidal silicon dioxide, and mixtures thereof.
  • the pH-adjusting agents may include acidifying agents such as acetic acid, adipic acid, ascorbic acid, sodium ascorbate, sodium etherate, malic acid, succinic acid, tartaric acid, fumaric acid, and citric acid, and basifying agents such as precipitated calcium carbonate, aqueous ammonia, meglumine, sodium carbonate, magnesium oxide, magnesium carbonate, sodium citrate, and tribasic calcium phosphate.
  • acidifying agents such as acetic acid, adipic acid, ascorbic acid, sodium ascorbate, sodium etherate, malic acid, succinic acid, tartaric acid, fumaric acid, and citric acid
  • basifying agents such as precipitated calcium carbonate, aqueous ammonia, meglumine, sodium carbonate, magnesium oxide, magnesium carbonate, sodium citrate, and tribasic calcium phosphate.
  • the antioxidants may include dibutyl hydroxy toluene, butylated hydroxyanisole, tocopherol acetate, tocopherol, propyl gallate, sodium hydrogen sulfite, and sodium pyrosulfite.
  • the solubilizers that may be used in a prior-release compartment of the present invention may include sodium lauryl sulfate, polyoxyethylene sorbitan fatty acid esters such as polysorbate, docusate sodium, poloxamer, etc.
  • the pharmaceutical composition comprising spinosin or the spinosin-containing herbal extract according to the present invention may be formulated into solid dosage forms such as tablets, pills, powders, granules, capsules, etc., and these solid dosage forms may be prepared by mixing spinosin or the spinosin-containing herbal extract with one or more excipients such as starch, calcium carbonate, sucrose or lactose, gelatin, etc. Moreover, lubricants such as magnesium stearate, talc, etc. may be used in addition to simple excipients.
  • the pharmaceutical composition may be formulated into liquid dosage forms such as suspensions, liquid for internal use, emulsions, syrups, etc., and various excipients such as humectants, sweeteners, aromatics, preservatives, etc. in addition to water and liquid paraffin may be used for the formulation of the liquid dosage forms.
  • liquid dosage forms such as suspensions, liquid for internal use, emulsions, syrups, etc.
  • excipients such as humectants, sweeteners, aromatics, preservatives, etc. in addition to water and liquid paraffin may be used for the formulation of the liquid dosage forms.
  • the pharmaceutical composition comprising spinosin or the spinosin-containing herbal extract according to the present invention may include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, and suppositories.
  • Suitable non-aqueous solutions and suspensions may include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate.
  • Bases for the suppositories may include Witepsol, macrogol, Tween 61, cacao butter, laurin butter, glycerogelatine, etc.
  • the term “administration” refers to the introduction of the composition for prevention and treatment of cognitive impairments according to the present invention to a patient in any appropriate way, and the composition for prevention and treatment of cognitive impairments according to the present invention may be administered via any conventional administration route as long as the composition can reach a target tissue.
  • the composition may be administered orally, intraperitoneally, intravenously, intramuscularly, subcutaneously, intradermally, intranasally, intrapulmonary, rectally, intracavitary, intraperitoneally, or intradurally, but not limited thereto.
  • the composition may be administered by oral, rectal, or intravenous, intramuscular, subcutaneous, endometrial, or intracerebroventricular injection.
  • the pharmaceutical composition according to the present invention may be administered once or several times a day at regular intervals.
  • composition according to the present invention may further comprise other active ingredients effective for the treatment of the cognitive impairments.
  • the pharmaceutical composition according to the present invention may be used alone or in combination with various methods such as hormone therapy, drug therapy, etc., for the prevention or treatment of the cognitive impairments.
  • the present invention relates to a food composition
  • a food composition comprising spinosin represented by the above formula 1, a pharmaceutically acceptable salt thereof, or a spinosin-containing herbal extract for prevention or improvement of the cognitive impairments.
  • the food composition according to the present invention may further comprise additives commonly used in food compositions, health functional foods, or beverages.
  • the food composition of the present invention may comprise sweeteners such as white sugar, crystalline fructose, glucose, D-sorbitol, mannitol, isomaltooligosaccharide, stevioside, aspartame, acesulfame potassium, sucralose, etc., acidifiers such as anhydrous citric acid, DL-malic acid, succinic acid, and salts thereof, preservatives such as benzoic acid and derivatives thereof, various nutrients, vitamins, minerals (electrolyte), flavoring agents such as synthetic and natural flavoring agents, coloring agents and fillers (cheese, chocolate, etc.), pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners, pH-adjusting agents, stabilizers, preservatives, glycerin, alcohol, carbonators used in carbonated drinks, etc.
  • the food composition of the present invention may comprise fruit pulp for preparation of natural fruit juices and vegetable juices. This additive
  • the food composition of the present invention may further comprise flavoring agents or natural carbohydrates.
  • suitable natural carbohydrates may include monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, polysaccharides such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol.
  • suitable flavoring agents may include natural flavoring agents such as thaumatin and stevia extracts (rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents such as saccharin and aspartame.
  • the natural carbohydrate may be contained in an amount of about 1 to 20 g, preferably about 5 to 12 g with respect to 100 mL of the composition.
  • the food composition comprising spinosin or the spinosin-containing herbal extract according to the present invention may be prepared in the form of powders, granules, tablets, capsules, or beverages and used as foods, beverages, gums, teas, vitamin complexes, health supplement foods, etc.
  • composition comprising spinosin or the spinosin-containing herbal extract according to the present invention may be added to drugs, foods, beverages, etc. for prevention and treatment of the cognitive impairments.
  • the composition comprising spinosin or the spinosin-containing herbal extract according to the present invention may be added to food, beverages, gums, teas, vitamin complexes, health supplement foods, etc.
  • the food composition comprising spinosin or the spinosin-containing herbal extract according to the present invention may be added to foods or beverages for prevention or improvement of the cognitive impairments.
  • the composition of the present invention may be added in an amount of 1 to 5 wt % with respect to the total weight of the food and may be added in an amount of 0.02 to 10 g, preferably 0.3 g to 1 g, with respect to 100 mL of the beverage.
  • the present invention provides a pharmaceutical composition comprising spinosin for prevention or treatment of a degenerative brain diseases.
  • the spinosin represented by the above formula 1 can effectively prevent or treat cerebral infarction, stroke, Parkinson's disease, or Huntington's disease.
  • the present invention provides a pharmaceutical composition comprising a spinosin-containing herbal extract for prevention or treatment of degenerative brain diseases.
  • the spinosin-containing herbal extract can effectively prevent or treat cerebral infarction, stroke, Parkinson's disease, or Huntington's disease.
  • the herbal extract may be obtained from Zizyphus jujuba Mill var. inermis, Zizyphus jujuba Mill var. hoonensis, Zizyphus jujuba Mill var.
  • spinosa Passiflora edulis flavicarpa, Cayaponia tayuya, Desmodium tortuosum, Wilbrandia ebracteata, Strophioblachia fimbricalyx, Clutia abyssinica, Saccharopolyspora spinosa , or mixtures thereof, and may preferably be obtained from the seeds of Zizyphus jujuba Mill var. spinosa.
  • the present invention provides a method for preventing or treatment of cognitive impairments or degenerative brain diseases, the method comprising administering to a subject in need thereof a composition comprising spinosin or a pharmaceutically acceptable salt thereof.
  • the cognitive impairments may be dementia or amnesia
  • the degenerative brain diseases may be cerebral infarction, stroke, Parkinson's disease, or Huntington's disease.
  • the present invention provides a method for preventing or treatment of cognitive impairments or degenerative brain diseases, the method comprising administering to a subject in need thereof a composition comprising a spinosin-containing herbal extract.
  • the herbal extract may be obtained from Zizyphus jujuba Mill var. inermis, Zizyphus jujuba Mill var. hoonensis, Zizyphus jujuba Mill var.
  • spinosa Passiflora edulis flavicarpa, Cayaponia tayuya, Desmodium tortuosum, Wilbrandia ebracteata, Strophioblachia fimbricalyx, Clutia abyssinica, Saccharopolyspora spinosa , or mixtures thereof, and may preferably be obtained from the seeds of Zizyphus jujuba Mill var. spinosa.
  • the pharmaceutical composition comprising spinosin or a spinosin-containing herbal extract according to the present invention can effectively prevent or treat cognitive impairments.
  • the pharmaceutical composition comprising spinosin or the spinosin-containing herbal extract according to the present invention can significantly improve memory and learning ability, thus effectively prevent or treat dementia.
  • FIG. 1 shows the effect of a pharmaceutical composition comprising spinosin according to the present invention on the improvement of memory and learning ability.
  • FIGS. 2 to 5 are shows the effect of a pharmaceutical composition comprising a spinosin-containing zizyphi spinosi semen extract according to the present invention on the improvement of memory and learning ability.
  • UV spectra were measured using a Hitachi JP/U3010
  • IR spectra were measured using a JASCO FT/IR-5300
  • NMR spectra was measured using a Bruker Avance 400 (400 MHz)
  • FAB Mass spectra were measured using a JEOL JMS-700 mass spectrometer.
  • n-hexane, methanol, and water were added at a volume ratio of 10:9:1 to the ethanol soft ext. of zizyphi spinosi semen prepared in the above Example 1, the mixture was shaken and left to stand overnight to remove the hexane soluble fraction, and then the 90% methanol fraction was concentrated under reduced pressure. Distilled water was added to the concentrated 90% (v/v) methanol fraction, ethyl acetate in an amount equivalent to the distilled water was added, and then the ethyl acetate fraction was removed. n-butanol of an equivalent amount was added to the water layer, and then the n-butanol fraction was concentrated under reduced pressure.
  • n-butanol fraction obtained by concentration under reduced pressure was loaded onto silica gel column and subjected to chromatography (7:1:0.5 ⁇ 7:1.5:0.5 ⁇ 7:2:0.5 ⁇ MeOH) with solutions of methylene chloride, methanol, and water at volume ratios of 7:1:0.5, 7:1.5:0.5, and 7:2:0.5 and methanol as an eluent to obtain thirty small fractions, and the 25 th small fraction containing spinosin was obtained from the thirty small fractions by performing TLC.
  • the 25 th small fraction was loaded onto silica gel column and subjected to chromatography (100:8:6 ⁇ 100:10:7.5 ⁇ 100:12:9) with solutions of ethyl acetate, methanol, and water at volume ratios of 100:8:6, 100:10:7.5, 100:12:9 as an eluent to obtain small fractions, and the 3 rd small fraction containing spinosin was obtained from the small fractions by performing TLC.
  • the physicochemical properties of the spinosin were as follows:
  • 6-week-old ICR mice (Orient Bio Inc., Korea), weighing about 26 to 28 g, were fed with water and food freely available for 5 days in an environment, where the temperature was about 23 ⁇ 2° C., the humidity was about 55 ⁇ 10%, and the light-dark cycle was 12 hours (Animal Laboratory at the College of Pharmacy in Kyung Hee university), and used in the experiments.
  • a passive avoidance test apparatus was prepared for the experiment.
  • the passive avoidance test apparatus was divided into a first space and a second space, a guillotine door was placed between the two spaces, and the first and second spaces are connected by the door.
  • the first space was kept light using illumination, and the second space was kept dark.
  • the floor of the second space kept dark was provided with a grid, and an electric shock of 0.5 mA was applied for 3 seconds through the grid on the floor when the experimental animal moved to the dark space.
  • mice prepared in the above section 1) were divided into 7 groups including drug administration groups 1 to 4, to which spinosin was to be administered, and control groups 1 to 3 (10 mice per group).
  • the spinosin of Example 2 was dissolved in 10% Tween 80 (Polyoxyethylene sorbitan monooleate: Sigma, U.S.A.) and administered to drug administration groups 1 to 4 at doses of 2.5 mg/Kg, 5 mg/Kg, 10 mg/Kg, and 20 mg/Kg. Meanwhile, donepezil (Sigma-Aldrich Chemistry Co.) was administered to control group 1 at a dose of 5 mg/Kg, and 10% Tween 80 was administered to control groups 2 and 3 at a dose of 0.15 mL.
  • Tween 80 Polyoxyethylene sorbitan monooleate: Sigma, U.S.A.
  • mice were placed in the first space kept light, and after a seek time of about 20 seconds, the guillotine door was opened, and the latency time taken for the mice to move to the second space kept dark was measured.
  • mice that did not move to the second space kept dark until 60 seconds elapsed after the guillotine door was opened were excluded from the experiment.
  • the latency time taken for the mice in drug administration groups 1 to 4, to which the spinosin prepared in Example 2 was administered, to move the second space was significantly increased compared to that in control group 2 to which only scopolamine was administered.
  • the latency time in drug administration group 1, to which the spinosin was administered at a dose of 2.5 mg/Kg was increased about 20 seconds compared to that in control group 2
  • the latency time in drug administration group 2, to which the spinosin was administered at a dose of 5 mg/Kg was increased about 2.5 times compared to that in control group 2.
  • the memory and learning ability of the mice with memory impairment induced by scopolamine in drug administration groups 3 and 4 was improved to an extent similar to that in control group 1 to which donepezil was administered.
  • the passive avoidance test was performed on drug administration groups 1 to 4 and control groups 1 to 3 by the same method as Experimental Example 1, except that the zizyphi spinosi semen extract extracted with 70% ethanol in Example 1 was dissolved in 10% Tween 80 and administered to drug administration groups 1 to 4 at doses of 25 mg/kg, 50 mg/kg, 100 mg/kg, and 200 mg/kg.
  • the latency time taken for the mice in drug administration groups 1 to 4, to which the spinosin-containing zizyphi spinosi semen extract prepared in Example 1 was administered, to move the second space was significantly increased compared to that in control group 2 to which only scopolamine was administered.
  • the latency time in drug administration groups 1 and 2, to which the spinosin was administered at doses of 25 mg/Kg and 50 mg/Kg, respectively, was increased about 2 times compared to that in control group 2.
  • the memory and learning ability of the mice with memory impairment induced by scopolamine in drug administration groups 3 and 4 was improved to an extent similar to that in control group 1 to which donepezil was administered.
  • the spinosin-containing zizyphi spinosi semen extract prepared in Example 1 can effectively prevent or treat cognitive impairments such as dementia.
  • a Y-maze was prepared for the experiment.
  • the Y-maze had three arms, in which each arm was 42 cm in length, 3 cm in width, and 12 cm in height, the angle formed by three arms was 120 degrees, and the Y-maze was made of black polyvinyl resin.
  • mice prepared in the above section 1) were divided into 5 groups including drug administration groups 1 and 2, to which the zizyphi spinosi semen extract prepared in Example 1 was to be administered, and control groups 1 to 3 (10 mice per group).
  • Example 1 160 mg of the zizyphi spinosi semen extract of Example 1 was dissolved in 4 mL of 10% Tween 80 (Polyoxyethylene sorbitan monooleate: Sigma, U.S.A.) and administered to drug administration groups 1 and 2 at doses of 100 mg/Kg and 200 mg/Kg. Meanwhile, donepezil (Sigma-Aldrich Chemistry Co.) was administered to control group 1 at a dose of 5 mg/Kg, and 10% Tween 80 was administered to control groups 2 and 3 at a dose of 0.15 mL.
  • Tween 80 Polyoxyethylene sorbitan monooleate: Sigma, U.S.A.
  • scopolamine Sigma-Aldrich Chemistry Co.
  • distilled water distilled water was intraperitoneally administered to drug administration groups 1 and 2 and control groups 1 and 2 at a dose of 1 mg/Kg (Ebert, U. et al., Eur. J. Clin. Invest., 28, pp 944-949, 1998), and 0.9% saline solution was intraperitoneally administered to control group 3.
  • mice in drug administration groups 1 and 2 and control groups 1 to 3 were carefully placed on one of three arms of the Y-maze, divided into A, B, and C, respectively, and allowed to freely move, and then the arms where the mice entered were recorded. At this time, only the case where the mouse' tail fully entered the arm was recorded as the arm where the experimental animal entered, and the case where the mouse entered the same arm was also recorded.
  • the spinosin-containing zizyphi spinosi semen extract prepared in Example 1 can effectively prevent or treat cognitive impairments such as dementia.
  • a Morris water maze test apparatus was prepared for the experiment.
  • Four labels such as star, square, triangle, and circle were put at regular intervals on a circular pool of 90 cm in diameter and 45 cm in height, and a platform of 29 cm in height was positioned below the star.
  • Water was filled up to 0.5 cm from the platform (water temperature: 21 ⁇ 1° C.) and became cloudy with pigment such that the platform was not visible from the surface of the water.
  • mice prepared in the above section 1) were divided into 5 groups including drug administration groups 1 and 2, to which the zizyphi spinosi semen extract prepared in Example 1 was to be administered, and control groups 1 to 3 (10 mice per group).
  • Example 1 160 mg of the zizyphi spinosi semen extract of Example 1 was dissolved in 4 mL of 10% Tween 80 (Polyoxyethylene sorbitan monooleate: Sigma, U.S.A.) and administered to drug administration groups 1 and 2 at doses of 100 mg/Kg and 200 mg/Kg. Meanwhile, donepezil (Sigma-Aldrich Chemistry Co.) was administered to control group 1 at a dose of 5 mg/Kg, and 10% Tween 80 was administered to control groups 2 and 3 at a dose of 0.15 mL.
  • Tween 80 Polyoxyethylene sorbitan monooleate: Sigma, U.S.A.
  • scopolamine Sigma-Aldrich Chemistry Co.
  • distilled water distilled water was intraperitoneally administered to drug administration groups 1 and 2 and control groups 1 and 2 at a dose of 1 mg/Kg (Ebert, U. et al., Eur. J. Clin. Invest., 28, pp 944-949, 1998), and 0.9% saline solution was intraperitoneally administered to control group 3.
  • the time taken for the mice, put down in one section of the pool, in drug administration groups 1 and 2 and control groups 1 to 3 to reach the platform was measured for 60 seconds. After 30 minutes, the time taken for the mice, repositioned to the original position, to reach the platform was measured until 60 seconds. The above-described process was repeated 4 times, and the average values were obtained. The experiment was performed in the same manner as on the first day while administering the drugs for 4 days, except that the position where the mice were first put down was changed.
  • the time taken for the mice in drug administration groups 1 and 2, to which the spinosin-containing zizyphi spinosi semen extract prepared in Example 1 was administered, to reach the platform was reduced by more than 10 seconds and 25 seconds, respectively, on the 3 rd and 4 th day compared to that in control group 2 to which only scopolamine was administered.
  • the time taken for the mice to reach the platform was reduced compared to that in control group 1 to which donepezil was administered, indicating that the spinosin-containing zizyphi spinosi semen extract prepared in Example 1 had superior memory and learning ability to the donepezil.
  • Powders were prepared by mixing 20 mg of the spinosin-containing zizyphi spinosi semen extract prepared in Example 1, 100 mg of lactose, and 10 mg of talc and packing the mixture in airtight bags.
  • Tablets were prepared by mixing the above ingredients and compressing the mixture into tablets according to a conventional method for preparing tablets.
  • Capsules were prepared by mixing the above ingredients and filling the mixture in gelatin capsules according to a conventional method for preparing capsules.
  • Injections were prepared by mixing the above ingredients to prepare a solution and filling the solution in ampoules (2 mL), followed by sterilization, according to a conventional method for preparing injections.
  • Liquid formulations were prepared by dissolving the above ingredients in purified water, adding a suitable amount of lemon flavor, adding purified water to the mixture to prepare a solution of 100 ml, and loading the solution into brown bottles, followed by sterilization, according to a conventional method for preparing liquid formulations.
  • Health food compositions were prepared according to a conventional method by mixing the above ingredients according to a conventional method for preparing health foods and then preparing granules.
  • Health beverages were prepared by dissolving the above ingredients in purified water to prepare a solution of a 900 mL, stirring and heating the solution at 85° C. for about 1 hour, filtering the solution, filling the solution in sterilized 2 L bottles, sealing and sterilizing the bottles, and keeping the bottles under refrigeration according to a conventional method for preparing health beverages.

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