US20130123212A1 - Anti-fatigue composition, formulation and use thereof - Google Patents

Anti-fatigue composition, formulation and use thereof Download PDF

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Publication number
US20130123212A1
US20130123212A1 US13/812,485 US201113812485A US2013123212A1 US 20130123212 A1 US20130123212 A1 US 20130123212A1 US 201113812485 A US201113812485 A US 201113812485A US 2013123212 A1 US2013123212 A1 US 2013123212A1
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United States
Prior art keywords
protopanoxadiol
barbarum polysaccharide
lycium
fatigue
lycium barbarum
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Abandoned
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US13/812,485
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English (en)
Inventor
Changjiang Xu
Weiguo Jia
Chunying Yu
Wenjing Zhang
Qiyuan Han
Qiang Ge
Qinlin Wang
Zirong Yang
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SHANG HAI INNOVATIVE RESEARCH CENTER OF TRADITIONAL CHINESE MEDICINE
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SHANG HAI INNOVATIVE RESEARCH CENTER OF TRADITIONAL CHINESE MEDICINE
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Assigned to SHANG HAI INNOVATIVE RESEARCH CENTER OF TRADITIONAL CHINESE MEDICINE reassignment SHANG HAI INNOVATIVE RESEARCH CENTER OF TRADITIONAL CHINESE MEDICINE ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GE, QIANG, HAN, QIYUAN, JIA, WEIGUO, WANG, QINLIN, YANG, ZIRONG, YU, CHUNYING, ZHANG, WENJING, XU, CHANGJIANG
Publication of US20130123212A1 publication Critical patent/US20130123212A1/en
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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
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • 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)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815—Lycium (desert-thorn)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • 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
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/06—Free radical scavengers or antioxidants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • 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
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/31—Foods, ingredients or supplements having a functional effect on health having an effect on comfort perception and well-being

Definitions

  • the present invention belongs to medicine field, particularly relates to an anti-fatigue composition, formulation and use thereof.
  • the fatigue is defined that: the body's physiological processes can not maintain its function at a certain degree or the organs can not maintain its predetermined exercise intensity.
  • Fatigue is classified as central nervous system fatigue, nerve-muscle joint fatigue and peripheral fatigue of the limbs. Fatigue is a comprehensive physiological process involving many physiological and biochemical factors, and it's a normal physiological phenomenon inevitably occurring at a certain stage of the mental activity or physical activity of the body. It marks a temporary decline of the original work ability of the body, and may be an indication indicating the body develops to an injury status.
  • CFS Chronic Fatigue Syndrome
  • CFS is a group of syndrome, which takes long-term durable fatigue as prominent manifestation, accompanying with non-specific manifestations of low fever, headache, sore throat, muscle and joint pain, inattention, memory decline, sleep disorders, depression and the like, generally nothing abnormal is detected in physical examination and routine examination (Holmes G O, Kaplan J E, Gantz N M, et al. Chronic Fatigue Syndrome: A Working Case Definition. Ann Intern Med, 1988, 108(3): 387-389; Fukuda K, Straus S E, Hickie I, et al. The Chronic Fatigue Syndrome: A Comprehensive Approach to Definition and Study. Ann Intern Med, 1994, 121(12): 953-959).
  • CFS is more likely to happen in people at the age group of 20-50 years old, and more common in women.
  • CFS significantly affects work and living of a subject and gains great concern in the medical field.
  • Lycium chinense which is ripe fruit of a deciduous small shrub of Lycium plants in Solanaceae family, is a traditional Chinese herb medicine having effects of strengthening with tonics, replenishing vital essence, dispelling rheumatism, invigorating Yang, strengthening muscles and bones etc. It is recorded in an ancient Chinese medical book named Dietetic Materia Medica that, ripe fruits of Lycium chinense have the functions of “strengthening muscles to endure hard work, dispelling rheumatism, nourishing and benefiting muscles and bones, benefiting human body, and removing asthenic disease”.
  • Lycium chinense fruits the active ingredient of Lycium chinense fruits is lycium barbarum polysaccharide which has the functions of reducing the level of blood sugar and blood fat, improving immunity, antioxidation and anti-fatigue etc.
  • literatures reporting the anti-fatigue effect of Lycium chinense fruits as follows:
  • Protopanoxadiol is aglycon of ginsenoside diol set, including 20(S)-protopanoxadiol and 20(R)-protopanoxadiol, which are enantiomers to each other and are represented by the following formulas.
  • 20(S)-protopanoxadiol which does not occur naturally, is a metabolite of ginsenoside in the body.
  • Chinese Patent Application No. CN200610027507.1 discloses the anti-depression activity of 20(S)-protopanoxadiol;
  • Chinese Patent Application No. CN200610027508.6 discloses the anti-intestinal cancer activity of 20(S)-protopanoxadiol;
  • Chinese Patent Application No. CN200610131959.4 discloses novel use of ginsenoside Rh2 for anti-fatigue;
  • Chinese Patent Application No. CN200610017063.3 discloses anti-fatigue effect of a composition comprising ginseng, coffee and tea. The single use of 20(S)-protopanoxadiol for anti-fatigue has not been reported yet.
  • the object of the invention is to provide an anti-fatigue composition. Another object of the invention is to provide a formulation comprising the composition.
  • Still another object of the invention is to provide use of the composition.
  • the anti-fatigue composition according to the invention consists of 20(S)-protopanoxadiol and lycium barbarum polysaccharide.
  • the weight ratio of the 20(S)-protopanoxadiol and lycium barbarum polysaccharide is 0.01-50 to 60-480.
  • the weight ratio of the 20(S)-protopanoxadiol and lycium barbarum polysaccharide is 0.01-5 to 120-480.
  • the invention also provides a formulation comprising the above composition, wherein the formulation consists of the composition and pharmaceutically acceptable excipient, and the formulation may be in form of tablets, pills, capsules, granules or oral solution.
  • the pharmaceutically acceptable excipient is one or more selected from the group consisting of filler, disintegrating agent, adhesive, lubricant, diluent, sweetener, flavoring agent, coloring agent, emulsifier and suspending agent.
  • the filler is one or more selected from the group consisting of lactose, sucrose, dextrin, mannitol, sorbitol, microcrystalline cellulose and starch.
  • the disintegrating agent is selected from the group consisting of microcrystalline cellulose, starch, low substituted hydroxypropyl cellulose and crosslinked polyvinylpyrrolidone.
  • the adhesive is selected from the group consisting of polyvinylpyrrolidone, starch and ethanol.
  • the lubricant is selected from the group consisting of magnesium stearate, sodium lauryl sulfate, silica and talc.
  • the diluent is selected from the group consisting of water, ethanol, propylene glycol and glycerol.
  • the sweetener is one or more selected from the group consisting of glucose, fructose, sucrose, maltose, starch sugar and lactose.
  • the instant invention further provides use of the above composition and formulation thereof in the preparation of medicaments and healthcare products for anti-fatigue.
  • the fatigue may result from various causes.
  • the fatigue results from diseases.
  • the fatigue results from cancer or depression.
  • composition according to the invention which consists of 20(S)-protopanoxadiol and lycium barbarum polysaccharide has a synergistic effect in anti-fatigue.
  • 20(S)-protopanoxadiol provide by Shanghai innovative Research Center of Traditional Chinese Medicine, batch number: 20050606-1, purity: 94%; lycium barbarum polysaccharide: provided by Shanghai KangZhou Fungi Extract Co. Ltd., polysaccharide content ⁇ 30%.
  • mice are randomly divided into 19 groups by weight, 20 mice per each group; the detailed groups are as follows:
  • lycium barbarum polysaccharide 120 mg/kg
  • lycium barbarum polysaccharide 240 mg/kg
  • lycium barbarum polysaccharide 480 mg/kg
  • 0.2ml/10 g of drug is administrated by gavage every day; for normal control group, 0.2 ml/10 g of distilled water is administrated by gavage every day; once a day, 30 days in total.
  • the end of the tail of each mouse is loaded with copper wires corresponding to 6% of its body weight, then the mouse is put in a swimming box to swim, the time from start of swimming to death of the mouse is recorded, i.e. the mice burden swimming time; the water depth in the swimming box is 30cm or more, and water temperature is 23+1.0° C.
  • mice burden swimming test is conducted with drug dosages of 0.01-5 mg/kg of 20(S)-protopanoxadiol and 120-480 mg/kg of lycium barbarum polysaccharide, the results are shown in Table 1:
  • Table 1 show that: as compared with normal group, lycium barbarum polysaccharide can prolong the mice burden swimming time at different levels, the composition consisting of 20(S)-protopanoxadiol and lycium barbarum polysaccharide in a weight ratio of 0.01-5 to 120-480 can prolong the mice burden swimming time at different levels (P ⁇ 0.01, P ⁇ 0.05); as compared with the effect of 20(S)-protopanoxadiol or lycium barbarum polysaccharide, the composition consisting of 20(S)-protopanoxadiol and lycium barbarum polysaccharide in a weight ratio of 0.01-5 to 120-480 can also prolong the mice burden swimming time at different levels (P ⁇ 0.01, P ⁇ 0.05).
  • lactose 500 g is added to 4 g of 20(S)-protopanoxadiol and 2000 g of lycium barbarum polysaccharide, followed by mixing uniformly, taking 70% ethanol as adhesive, granulating, drying, and then adding 10 g of magnesium stearate and tabletting to obtain tablets.
  • lactose 200 g is added to 8 g of 20(S)-protopanoxadiol and 2000 g of lycium barbarum polysaccharide, followed by mixing uniformly, taking 70% ethanol as adhesive, granulating and filling in capsule to obtain the capsules.
  • Tween-80 100 g of Tween-80 is added to 16 g of 20(S)-protopanoxadiol and 2000 g of lycium barbarum polysaccharide, followed by grinding to form primary emulsion, adding water to a volume of 5000 ml to obtain the oral solution.
  • the anti-fatigue composition according to the invention consists of 20(S)-protopanoxadiol and lycium barbarum polysaccharide.
  • the experiments show that the composition can apparently prolong the swimming time of mice with weight loading, i.e. it exerts an obvious synergistic effect in anti-fatigue.
  • the composition according to the invention can be used in the preparation of anti-fatigue medicaments and healthcare products; it provides a novel method of relieving fatigue and possesses industrial applicability.

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  • Health & Medical Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • Mycology (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Alternative & Traditional Medicine (AREA)
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  • Oil, Petroleum & Natural Gas (AREA)
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  • Neurosurgery (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Biochemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Plant Substances (AREA)
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US13/812,485 2010-07-27 2011-07-27 Anti-fatigue composition, formulation and use thereof Abandoned US20130123212A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201010237955.0 2010-07-27
CN2010102379550A CN101890040B (zh) 2010-07-27 2010-07-27 一种具有抗疲劳作用的组合物及其应用
PCT/CN2011/001233 WO2012013020A1 (zh) 2010-07-27 2011-07-27 一种抗疲劳的组合物及其制剂和应用

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US (2) US20130123212A1 (zh)
EP (1) EP2599490B1 (zh)
JP (1) JP5797268B2 (zh)
KR (1) KR101735151B1 (zh)
CN (1) CN101890040B (zh)
HK (1) HK1182934A1 (zh)
RU (1) RU2559784C2 (zh)
WO (1) WO2012013020A1 (zh)

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CN113041225A (zh) * 2021-03-26 2021-06-29 齐晓慧 含糖分类蒙药粉配方颗粒及其制备方法

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CN109170907A (zh) * 2018-08-30 2019-01-11 泓博元生命科技（深圳）有限公司 一种含有nmn的组合物、应用及运动饮料的制备方法
CN109997946A (zh) * 2019-02-20 2019-07-12 山东佰诺生物科技有限公司 一种复合压片糖果及其制备方法
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CN111529539A (zh) * 2020-04-29 2020-08-14 海南亚洲制药股份有限公司 一种原人参二醇在制备药物中的用途
CN112656870B (zh) * 2021-01-20 2022-07-05 森隆药业有限公司 一种抗疲劳中药组合物及其制备方法和用途
KR20220151393A (ko) 2021-05-06 2022-11-15 도영복 인삼을 함유하는 스트레스 완화용 건강기능성 차 조성물
CN113633657B (zh) * 2021-05-08 2024-03-01 中国人民解放军海军军医大学 一种提高机体抗疲劳、耐缺氧、耐热和耐寒能力的药物组合物及其应用

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WO2012013020A8 (zh) 2013-02-21
HK1182934A1 (zh) 2013-12-13
CN101890040A (zh) 2010-11-24
EP2599490A1 (en) 2013-06-05
KR20130131303A (ko) 2013-12-03
JP5797268B2 (ja) 2015-10-21
EP2599490B1 (en) 2016-05-04
KR101735151B1 (ko) 2017-05-24
WO2012013020A1 (zh) 2012-02-02
EP2599490A4 (en) 2014-01-08
RU2559784C2 (ru) 2015-08-10
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