WO2021246200A1 - 筋萎縮抑制剤 - Google Patents

筋萎縮抑制剤 Download PDF

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Publication number
WO2021246200A1
WO2021246200A1 PCT/JP2021/019349 JP2021019349W WO2021246200A1 WO 2021246200 A1 WO2021246200 A1 WO 2021246200A1 JP 2021019349 W JP2021019349 W JP 2021019349W WO 2021246200 A1 WO2021246200 A1 WO 2021246200A1
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group
day
muscle
mice
cynaropicrin
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PCT/JP2021/019349
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English (en)
French (fr)
Japanese (ja)
Inventor
朋志 濱田
賢一 伊藤
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一丸ファルコス株式会社
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Priority to JP2022528744A priority Critical patent/JPWO2021246200A1/ja
Priority to CN202180039909.6A priority patent/CN115768417A/zh
Publication of WO2021246200A1 publication Critical patent/WO2021246200A1/ja

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    • 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
    • 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
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
    • 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

Definitions

  • the present invention relates to a material for suppressing muscular atrophy and the like.
  • Muscle atrophy is broadly divided into disuse muscle atrophy and progressive muscle atrophy. Among them, disuse muscle atrophy is a remarkable change in skeletal muscle caused by long-term inactivity, and the muscle fiber diameter. Quantitative changes such as atrophy and qualitative changes such as type transitions at the muscle fiber and muscle protein levels, such as cast fixation due to long-term resting beds and fractures, microgravity exposure (life in space, etc.), It is caused by an aging process or the like (Patent Document 1).
  • Non-Patent Document 1 Non-Patent Document 1
  • Non-Patent Document 2 A method for preventing and / or ameliorating muscular atrophy (a method other than exercise) is also required for the patient.
  • the present invention is to provide a material (agent) for suppressing muscular atrophy for use in humans and the like.
  • the present invention has been made to solve the above problems, and the present inventor has invented the present invention as a result of searching for a natural substance (artichoke or the like) having an action of suppressing muscle atrophy.
  • the present invention includes the following embodiments.
  • cynaropicrin is preferably ingested from 0.01 mg / kg / day to 12.0 mg / kg / day per day for a human adult.
  • the agent of the present invention and the like can be used to suppress muscular atrophy in humans and the like.
  • Cynaropicrin (PubChem CID: 119093) is a type of sesquiterpene and has the following (formula I) :. It is a compound represented by and has a molecular formula of C 19 H 22 O 6 .
  • Artichoke Artichoke
  • Globe artichoke scientific name Cynana scorymus
  • Cynana scorymus is a perennial plant belonging to the genus Cynara in the family Asteraceae.
  • the Japanese name for artichoke is thistle (Korean thistle).
  • an extract of flowers, leaves, stems, branches, branches and leaves, above-ground parts or whole plants of artichoke is used, but in the present invention, artichoke is preferable from the viewpoint of containing a larger amount of the above-mentioned cynaropicrin. It is preferred to use leaf or artichoke extracts.
  • the extraction solvent for obtaining the extract of artichoke used in the present invention is, for example, water, lower alcohols (methanol, ethanol, 1-propanol, 2-propanol, 1-butanol, 2-butanol, etc.), liquid polyhydric alcohols (2-butanol, etc.).
  • the above extract may be used as it is in the extracted solution, or may be used after being concentrated, diluted, filtered, decolorized with activated carbon, deodorized, ethanol precipitation, etc., if necessary. Further, the extracted solution may be subjected to treatments such as concentrated drying, spray drying and freeze-drying, and used as a dried product.
  • the daily intake of the artichoke extract used in the present invention can be appropriately adjusted depending on the form of intake, purpose of use, age, body weight, etc., but the desired effect (muscle) In order to exert the effect of suppressing atrophy, etc.), the artichoke extract is converted into a dry product per day for human adults, preferably 10 mg / kg / day or more, more preferably 25 mg / kg / day or more, still more preferably.
  • the daily intake of synaropicrin used in the present invention can be appropriately adjusted depending on the form of intake, purpose of use, age, body weight, etc., but the desired effect (muscle atrophy) In order to exert an inhibitory effect, etc.), the amount of cinaropicrine per day for human adults is preferably 0.01 mg / kg / day or more, more preferably 0.025 mg / kg / day or more, and more preferably 0.05 mg / kg. / Day or more, more preferably 0.10 mg / kg / day or more, more preferably 0.25 mg / kg / day or more, still more preferably 0.50 mg / kg / day or more, and in humans or the like at the time of ingestion. From the viewpoint of safety and the like, it is preferably 12.0 mg / kg / day or less, more preferably 9.00 mg / kg / day or less, and further preferably 6.00 mg / kg / day or less.
  • the artichoke extract used in the present invention can be produced, for example, by the following production methods of Production Example 1 and Production Example 2.
  • the artichoke extract described in the following Examples is the artichoke extract produced in the following Production Example 1.
  • the form of the agent for suppressing muscular atrophy (material for suppressing muscular atrophy) according to the present invention is not particularly limited, and examples thereof include a liquid form, a solid form, and a powder form. Can be mentioned.
  • the oral composition according to the present invention is, for example, foods and drinks (including foods with functional claims, foods for specified health uses, supplements, etc.), pharmaceutical products, and the like.
  • the oral composition is a food or drink
  • the form of the food or drink is various foods or drinks such as breads, cakes, noodles, confectionery, jellies, frozen foods, ice creams, dairy products, and beverages.
  • the same forms tablettes, syrups, etc.
  • Various forms of foods contain the active ingredients of the invention alone or with other food materials, solvents, softeners, oils, emulsifiers, preservatives, fragrances, stabilizers, colorants, antioxidants, moisturizers. , Thickeners and the like can be appropriately combined and prepared.
  • the oral composition is a medicinal product
  • the medicinal product is generally easier to assemble a convenient daily dosing regimen that can be adjusted according to the degree of distress
  • the medicinal product forms are, for example, solid or liquid.
  • the solid form include powders, tablets, pills, capsules, cachets, troches, suppositories and dispersible granules.
  • the carrier is generally a micronized solid that is a mixture with the micronized active ingredient.
  • the active ingredient is generally mixed with a carrier having the required binding capacity in an appropriate proportion and molded into the desired shape and size.
  • Suitable carriers include, for example, magnesium carbonate, magnesium stearate, talc, sugar, lactose, pectin, dextrin, starch, gelatin, tragacant, methylcellulose, sodium carboxymethylcellulose, low melting point wax, cocoa butter and the like.
  • the drug may be an excipient, a stabilizer, a preservative, a binder, a disintegrant, a hydrocarbon, a fatty acid, an alcohol, an ester, a pH adjuster, as necessary, as long as the desired effect is not impaired.
  • Preservatives and other components can also be contained.
  • Muscle atrophy is the loss of muscle. When muscles atrophy, so does muscle strength. Muscle atrophy may be, for example, due to a disease of the muscle itself (myogenic muscular atrophy) or due to a disorder of the motor nerves that directly transmit motor commands to the muscle (neurogenic muscular atrophy). Generally, in muscle diseases, the muscles from the shoulders to the upper arms and from the waist to the thighs (proximal muscles) tend to atrophy, but in neurological diseases, the muscles at the tips of the limbs (distal muscles of the limbs) tend to atrophy. Typical muscle diseases include hereditary muscle diseases such as muscular dystrophy and inflammatory muscle diseases such as polymyositis and dermatomyositis. Most neurogenic muscular atrophy is caused by peripheral nerve damage (neuropathy), which also has a variety of causes, including trauma and compression, inflammatory and hereditary.
  • the unit% of the numerical value indicating the content of the component or the like contained in the agent or the like of the present invention means mass%.
  • Example 1 Evaluation of muscle atrophy inhibitory effect
  • an evaluation evaluation of the muscle atrophy inhibitory effect of an oral composition containing cynaropicrin was performed. This evaluation was performed by measuring the weight of the soleus muscle.
  • the experimental method is described below. First, 40 5-week-old male KKAy mice (Nippon Claire Co., Ltd.) were obtained. The KKAy mouse is a model mouse for diabetes. The obtained mice were bred normally for one week (breeding with normal food and water freely).
  • Control group A group in which 500 mg / kg / day of dextrin (Matsutani Chemical Industry Co., Ltd., maltodextrin (paindex # 1)), which is a dietary fiber, was given to the mice by drinking water.
  • -Group 1 A group in which 100 mg / kg / day of the artichoke leaf hot water extract prepared according to Production Example 1 was given to the mice by drinking water. That is, a group in which cynaropicrin was given 1.0709 mg / kg / day by drinking water. Giving 1.0709 mg / kg / day of cynaropicrin to mice is a human equivalent dose (HED) 12.3 (Document "Guide for Industry Estimating the Maximum Safety Intial Based on "Healthy Volunters”), when converted to the dose to human adults, it is to give 0.0871 mg / kg / day to human adults.
  • HED human equivalent dose
  • -Group 2 A group in which 300 mg / kg / day of the artichoke leaf hot water extract prepared according to Production Example 1 was given to the mice by drinking water. That is, a group in which cynaropicrin was given 3.2127 mg / kg / day by drinking water. Giving cynaropicrin to mice at 3.2127 mg / kg / day is 0.2612 mg of cynaropicrin to human adults when converted to the dose to human adults based on the human equivalent dose (HED) 12.3 in the mice. It is to give / kg / day.
  • HED human equivalent dose
  • -Group 3 A group in which 500 mg / kg / day of the artichoke leaf hot water extract prepared according to Production Example 1 was given to the mice from drinking water. That is, a group in which cynaropicrin was given 5.3545 mg / kg / day by drinking water. Giving 5.3545 mg / kg / day of cynaropicrin to mice is 0.4353 mg of cynaropicrin to human adults when converted to the dose to human adults based on the human equivalent dose (HED) 12.3 in the mice. It is to give / kg / day.
  • HED human equivalent dose
  • mice After the 7-week breeding, the weight of the mice was measured and the soleus muscle was removed from each group of mice under anesthesia. The weight of the removed soleus muscle was measured.
  • the measurement results are described below.
  • the soleus muscles (left and right soleus muscles) of each group (10 animals each) were measured one by one.
  • the results measured below are the average (g) of the total amount of left and right soleus muscles per animal in each group.
  • the control group was 0.0167 (g)
  • group 1 was 0.01745 (g)
  • group 2 was 0.0175625 (g)
  • group 3 was 0.017075 (g).
  • groups 1, group 2 and group 3 an increase in soleus muscle weight was confirmed as compared with the control group.
  • Example 2 Evaluation of muscle atrophy inhibitory effect
  • the evaluation (experiment) of the muscle atrophy inhibitory effect of the oral composition containing cynaropicrin was further performed.
  • the evaluation in this experiment 2 was performed by measuring the cross-sectional area ( ⁇ m / pixel) of a predetermined portion of a small bundle of soleus muscle.
  • mice 20 5-week-old male KKAy mice (Nippon Claire Co., Ltd.) were obtained. The obtained mice were bred normally for one week (breeding with normal food and water freely).
  • Control group A group in which 500 mg / kg / day of dextrin (Matsutani Chemical Industry Co., Ltd., maltodextrin (paindex # 1)), which is a dietary fiber, was given to the mice by drinking water.
  • -Group 3 A group in which 500 mg / kg / day of the artichoke leaf hot water extract prepared according to Production Example 1 was given to the mice from drinking water. That is, a group in which cynaropicrin was given 5.3545 mg / kg / day by drinking water. Giving 5.3545 mg / kg / day of cynaropicrin to mice is 0.4353 mg of cynaropicrin to human adults when converted to the dose to human adults based on the human equivalent dose (HED) 12.3 in the mice. It is to give / kg / day.
  • HED human equivalent dose
  • mice After the 7-week breeding, the weight of the mice was measured and the soleus muscle was removed from each group of mice under anesthesia. The cross-sectional area of a predetermined portion of the excised soleus muscle bundle was measured.
  • paraffin sections of each group were prepared by a conventional method from the soleus muscle of the mouse of the control group and the soleus muscle of the mouse of the group 3.
  • the sections were stained with hematoxylin and eosin (HE).
  • HE hematoxylin and eosin
  • 1100 small bundles that could be confirmed in the sections of each group were randomly selected, and the average cross-sectional area of the 1100 pieces was measured.
  • the small bundle was confirmed by observing with an optical microscope at a predetermined magnification.
  • the cross-sectional area was measured by quantifying ( ⁇ m / pixel) using WinROOF.
  • the measurement results are described below. In the control group, it was 2243.72 ( ⁇ m / pixel), whereas in the group 3, it was 2735.45 ( ⁇ m / pixel).
  • FIG. 1 (1) shows the soleus muscle confirmed with an optical microscope (magnification 40 times)
  • FIG. 1 (2) shows a small bundle of soleus muscle confirmed with an optical microscope (magnification 400 times).
  • the bar indicates 1.0 mm (1000 ⁇ m).
  • the bar indicates 100 ⁇ m.
  • mice Male DDY mice (Kiwa Experimental Animal Research Institute) were obtained. The obtained mice were bred normally for one week (breeding with normal food and water freely).
  • Group 4 (normal breeding group): A group in which the dietary fiber dextrin (Matsutani Chemical Industry Co., Ltd., Martodextrin (Paindex # 1)) was given to the mice at 300 mg / kg / day by forced oral administration with a gastric sonde. .. Breeding that gives normal food and drinking water freely, not breeding in a very small space.
  • Group 5 (breeding group in a narrow space): Dextrin (Matsutani Chemical Industry Co., Ltd., Maltodextrin (Paindex # 1)), which is a dietary fiber, was administered to the mouse by forced oral administration with a gastric sonde at 300 mg / kg / day. The given group. Breeding in a small space, free feeding and drinking water.
  • mice A group in which 300 mg / kg / day of artichoke leaf hot water extract prepared according to Production Example 1 was given to the mice by forced oral administration by gastric sonde. That is, a group in which cynaropicrin was given 3.2127 mg / kg / day by drinking water. Breeding in a small space, free feeding and drinking water. Giving cynaropicrin to mice at 3.2127 mg / kg / day is 0.2612 mg of cynaropicrin to human adults when converted to the dose to human adults based on the human equivalent dose (HED) 12.3 in the mice. It is to give / kg / day.
  • HED human equivalent dose
  • Group 7 (breeding group in a narrow space): A group in which 100 mg / kg / day of artichoke leaf hot water extract prepared according to Production Example 1 was given to the mice by forced oral administration with a gastric sonde. That is, a group in which cynaropicrin was given 1.0709 mg / kg / day by drinking water. Breeding in a small space, free feeding and drinking water. Giving 1.0709 mg / kg / day of cynaropicrin to mice is 0.0871 mg / kg / day of cynaropicrin to human adults when converted to the dose to human adults based on the human equivalent dose (HED) 12.3 in mice. It is to give kg / day.
  • HED human equivalent dose
  • mice After breeding for the 4 weeks, the weight of the mice was measured and the soleus muscle was removed from each group of mice under anesthesia. The weight of the removed soleus muscle was measured.
  • the measurement results are described below.
  • the soleus muscles (left and right soleus muscles) of each group (10 animals each) were measured one by one.
  • the results measured below are the average (g) of the total amount of left and right soleus muscles per animal in each group.
  • Group 4 was 0.01054545 (g)
  • group 5 was 0.0099945 (g)
  • group 6 was 0.011722772 (g)
  • group 7 was 0.01086 (g).
  • the value of this group 6 is significant compared to the value of this group 4 (p ⁇ 0.05 in the test by the Tukey-Kramer method), and significant compared to the value of this group 5 (in the test by the Tukey-Kramer method). And p ⁇ 0.01).
  • the soleus muscle ratio (g / kg) per body weight of the mice was also calculated.
  • Group 4 was 0.022989716 (g / kg)
  • Group 5 was 0.021136972 (g / kg)
  • Group 6 was 0.023727774 (g). / Kg)
  • group 7 was 0.021868527.
  • the value of this group 6 was significant (p ⁇ 0.01 by the Tukey-Kramer method test) as compared with the value of this group 5.

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PCT/JP2021/019349 2020-06-02 2021-05-21 筋萎縮抑制剤 WO2021246200A1 (ja)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023243210A1 (ja) * 2022-06-13 2023-12-21 丸善製薬株式会社 筋芽細胞増殖促進剤及び筋芽細胞増殖促進用組成物、並びに筋萎縮抑制剤及び筋萎縮抑制用組成物

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005194246A (ja) * 2004-01-09 2005-07-21 Ichimaru Pharcos Co Ltd ＮＦ−κＢ活性化抑制剤
JP2006206532A (ja) * 2005-01-31 2006-08-10 Ichimaru Pharcos Co Ltd ＮＦ−κＢ活性化抑制剤
WO2007106884A2 (en) * 2006-03-15 2007-09-20 Theralogics, Inc. Methods of treating muscular wasting diseases using nf-kb activation inhibitors
CN103641841A (zh) * 2013-12-10 2014-03-19 上海市第六人民医院 倍半萜内酯类化合物及其制备方法和应用
JP2020040884A (ja) * 2018-09-06 2020-03-19 三基商事株式会社 アーティチョーク葉抽出物又はシナロピクリンを含む、筋肉細胞におけるエネルギー代謝の活性化による抗疲労用組成物

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Publication number Priority date Publication date Assignee Title
WO2004112819A1 (en) * 2003-06-13 2004-12-29 Gelstat Corporation Compositions and methods of treatment comprising plant extracts
ES2834986T3 (es) * 2011-01-07 2021-06-21 Anji Pharma Us Llc Terapias basadas en ligandos de receptores quimiosensoriales

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005194246A (ja) * 2004-01-09 2005-07-21 Ichimaru Pharcos Co Ltd ＮＦ−κＢ活性化抑制剤
JP2006206532A (ja) * 2005-01-31 2006-08-10 Ichimaru Pharcos Co Ltd ＮＦ−κＢ活性化抑制剤
WO2007106884A2 (en) * 2006-03-15 2007-09-20 Theralogics, Inc. Methods of treating muscular wasting diseases using nf-kb activation inhibitors
CN103641841A (zh) * 2013-12-10 2014-03-19 上海市第六人民医院 倍半萜内酯类化合物及其制备方法和应用
JP2020040884A (ja) * 2018-09-06 2020-03-19 三基商事株式会社 アーティチョーク葉抽出物又はシナロピクリンを含む、筋肉細胞におけるエネルギー代謝の活性化による抗疲労用組成物

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023243210A1 (ja) * 2022-06-13 2023-12-21 丸善製薬株式会社 筋芽細胞増殖促進剤及び筋芽細胞増殖促進用組成物、並びに筋萎縮抑制剤及び筋萎縮抑制用組成物

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