WO2024172002A1 - エルゴチオネインを含有する血管拡張用組成物 - Google Patents

エルゴチオネインを含有する血管拡張用組成物 Download PDF

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Publication number
WO2024172002A1
WO2024172002A1 PCT/JP2024/004716 JP2024004716W WO2024172002A1 WO 2024172002 A1 WO2024172002 A1 WO 2024172002A1 JP 2024004716 W JP2024004716 W JP 2024004716W WO 2024172002 A1 WO2024172002 A1 WO 2024172002A1
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WIPO (PCT)
Prior art keywords
ergothioneine
composition
salt
present
blood pressure
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Ceased
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PCT/JP2024/004716
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English (en)
French (fr)
Japanese (ja)
Inventor
諒 勝部
友美 中村
寿栄 鈴木
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Suntory Holdings Ltd
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Suntory Holdings Ltd
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Priority to CN202480011225.9A priority Critical patent/CN120640988A/zh
Priority to JP2025501138A priority patent/JPWO2024172002A1/ja
Publication of WO2024172002A1 publication Critical patent/WO2024172002A1/ja
Anticipated expiration legal-status Critical
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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 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
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids

Definitions

  • the present invention relates to a vasodilator composition containing ergothioneine.
  • circulatory function is an important function for maintaining a healthy body. It is believed that by consuming foods that maintain or improve circulatory function on a daily basis, it is possible to improve not only circulatory function, but also related symptoms such as blood pressure, stiff shoulders, headaches, poor circulation, and decreased cerebral circulation.
  • K ATP-sensitive potassium channels close when the intracellular ATP concentration increases, and open when the ATP concentration decreases or the intracellular ADP concentration increases.
  • K ATP channels close when the intracellular ATP concentration increases, and open when the ATP concentration decreases or the intracellular ADP concentration increases.
  • KCOs Potassium channel openers
  • Patent Document 1 discloses a blood vessel wall strengthening agent that contains soy protein and/or ergothioneine as active ingredients, and describes how subjects who applied the blood vessel wall strengthening agent under their eyes experienced improved blood flow and reduced dark circles under the eyes.
  • Patent Document 1 does not disclose anything about the vasodilatory action of ergothioneine or its effect on K ATP channels.
  • the present invention aims to provide a composition for vasodilating blood vessels.
  • L-ergothioneine or a salt thereof has a vasodilatory effect.
  • the present invention relates to the following compositions for vasodilating blood vessels.
  • a composition for dilating a blood vessel comprising ergothioneine or a salt thereof as an active ingredient.
  • the composition described in [1] above which is used for preventing or ameliorating hypertension.
  • the composition described in [1] or [2] above which dilates blood vessels via ATP-sensitive potassium channels.
  • composition according to any one of [1] to [5] above, which is labeled with at least one function selected from the group consisting of "dilates blood vessels to maintain blood flow", “promotes blood circulation”, “prevents or improves high blood pressure”, “prevents or improves stiff shoulders”, “prevents or improves headaches”, “prevents or improves poor circulation”, “prevents reduced cerebral circulation” and “improves cerebral circulation”.
  • a method for dilating blood vessels comprising administering ergothioneine or a salt thereof to a subject.
  • the present invention provides a composition for vasodilating blood vessels.
  • FIG. 1 is a graph evaluating the substrate binding inhibitory activity of L-ergothioneine to an ATP-sensitive potassium channel.
  • FIG. 2 is a graph showing the change in diastolic blood pressure in the test food group and the control food group.
  • FIG. 3 is a graph showing the change in systolic blood pressure in the test food group and the control food group.
  • the vasodilator composition of the present invention contains ergothioneine or a salt thereof as an active ingredient.
  • the vasodilator composition of the present invention will also be referred to as the composition of the present invention.
  • Ergothioneine is a type of sulfur-containing amino acid.
  • ergothioneine is preferably L-ergothioneine.
  • the salt of ergothioneine is not particularly limited as long as it is a pharmacologically acceptable salt or a salt acceptable for food and drink, and may be either an acid salt or a basic salt.
  • acid salts include inorganic acid salts such as hydrochloride, sulfate, nitrate, and phosphate; organic acid salts such as acetate, citrate, maleate, malate, oxalate, lactate, succinate, fumarate, and propionate.
  • basic salts include alkali metal salts such as sodium salt and potassium salt; alkaline earth metal salts such as calcium salt and magnesium salt.
  • Ergothioneine or its salts are not limited in any way by their form or manufacturing method. Ergothioneine or its salts may be chemically synthesized or extracted and purified from natural products. L-ergothioneine is found in large amounts in Golden/Yellow Oyster Mushroom (scientific name: Pleurotus cornucopiae var. citrinopileatus), a mushroom of the Pleurotus genus in the Pleurotus family.
  • L-ergothioneine is found in white button mushrooms, crimini mushrooms, portabella mushrooms, and other mushrooms (Agaricus bisporus), grey oyster mushrooms (Pleurotus ostreatus), shiitake mushrooms (Lentinula edodes), and maitake mushrooms (Grifola frondosa). dosa), Ganoderma lucidum, Yamabushitake (Hericium erinaceus), Yanagimatsutake (Agrocybe aegerita), Chanterelle (Cantharellus cibarius), Porcini (Boletus edulis), and Morchella esculenta are also found in mushrooms. When obtaining L-ergothioneine from natural products, it is preferable to extract it from Tamogitake mushroom. Ergothioneine or a salt thereof can also be produced by microbial fermentation. Ergothioneine or a salt thereof may be isolated.
  • L-ergothioneine or its salts are compounds that are found in natural products and foods and beverages, and are consumed as food. For this reason, from the standpoint of safety, it is believed that ergothioneine or its salts pose few problems, even when taken over a long period of time. According to the present invention, a highly safe vasodilator composition can be provided.
  • L-ergothioneine inhibited the binding of substrates to the ATP-sensitive potassium (KATP) channel, and intake of L-ergothioneine reduced diastolic and systolic blood pressure compared to when it was not taken.
  • KATP ATP-sensitive potassium
  • ergothioneine dilates blood vessels via the K ATP channel.
  • Ergothioneine or a salt thereof can dilate blood vessels via the K ATP channel.
  • Ergothioneine or a salt thereof has the effect of lowering blood pressure by dilating blood vessels.
  • the composition of the present invention has a vasodilatory effect and is used to prevent or improve a condition or disease for which vasodilatory action is effective.
  • Prevention of a condition or disease includes preventing onset, delaying onset, reducing the incidence, reducing the risk of onset, and the like.
  • Improvement of a condition or disease includes recovering a subject from a condition or disease, alleviating the symptoms of a condition or disease, improving the symptoms of a condition or disease, delaying or preventing the progression of a condition or disease, and the like.
  • Recovery includes partial recovery.
  • Examples of conditions or diseases for which vasodilation is effective in preventing or improving include high blood pressure, stiff shoulders, headache, poor circulation, decreased cerebral circulation, etc.
  • the vasodilatory effect is expected to prevent or improve high blood pressure, stiff shoulders, headache, poor circulation, and decreased cerebral circulation.
  • the composition of the present invention is preferably used for preventing or ameliorating hypertension.
  • the composition of the present invention may be either an oral composition or a parenteral composition, but is preferably an oral composition.
  • Specific examples of the oral composition include food and drink, oral medicine, quasi-drug, feed, etc., and are preferably food and drink or oral medicine, more preferably food and drink.
  • the composition of the present invention may be a material or preparation to be used by being blended with food and drink, medicine, quasi-drug, feed, etc.
  • compositions of the present invention can be used for either therapeutic (medical) or non-therapeutic (non-medical) purposes.
  • Non-therapeutic is a concept that does not include medical procedures, i.e., surgery, treatment, or diagnosis of humans.
  • composition of the present invention may contain any additives and any components in addition to ergothioneine or a salt thereof, so long as the effects of the present invention are not impaired. These additives and components may be selected depending on the form of the composition.
  • additives that can generally be used in oral compositions such as foods and beverages, pharmaceuticals, quasi-drugs, and feeds may be used.
  • the production method thereof is not particularly limited, and they can be produced by a general method.
  • the form of the oral composition of the present invention is not particularly limited, and may be a solid (powder, granules, tablet, etc.), liquid, paste, etc.
  • various foods and drinks can be made by blending ergothioneine or a salt thereof with ingredients that can be used in foods and drinks (e.g., food ingredients, food additives used as necessary, etc.).
  • the foods and drinks are not particularly limited, and examples include general foods and drinks, health foods, health supplements, health drinks, functional foods, foods for specified health uses, and foods and drinks for sick people.
  • the above health foods, health supplements, functional foods, foods for specified health uses, etc. can be used in various formulation forms, such as fine granules, tablets, granules, powders, capsules, chewable agents, dry syrups, syrups, liquids, beverages, drinks, and liquid diets.
  • composition of the present invention when used as a drug or quasi-drug, for example, ergothioneine or a salt thereof can be mixed with a pharmacologically acceptable carrier and additives added as necessary to produce a drug or quasi-drug in various dosage forms.
  • a pharmacologically acceptable carrier such as, for example, ergothioneine or a salt thereof
  • Such carriers, additives, etc. may be any pharmacologically acceptable carriers that can be used in drugs or quasi-drugs, and examples of such carriers, additives, etc. include one or more of excipients, binders, disintegrants, lubricants, antioxidants, colorants, etc.
  • dosage forms for drugs or quasi-drugs include oral and non-oral (transdermal, transmucosal, enteral, injection, etc.) administration forms.
  • composition of the present invention When the composition of the present invention is used as a drug or quasi-drug, it is preferable to use an oral drug or oral quasi-drug.
  • dosage forms for oral administration of drugs or quasi-drugs include liquids, tablets, powders, fine granules, granules, sugar-coated tablets, capsules, suspensions, emulsions, chewables, etc.
  • Dosage forms for parenteral administration include, for example, injections, drops, ointments, lotions, patches, suppositories, nasal preparations, and pulmonary preparations (inhalants).
  • the pharmaceutical product may be a pharmaceutical product for non-human animals.
  • feed When the composition of the present invention is used as feed, ergothioneine or a salt thereof may be blended into the feed.
  • Feed also includes feed additives. Examples of feed include livestock feed for cows, pigs, chickens, sheep, horses, etc.; small animal feed for rabbits, rats, mice, etc.; and pet food for dogs, cats, small birds, etc.
  • the subject to which the composition of the present invention is ingested or administered is not particularly limited, and is preferably a human or a non-human mammal, more preferably a human.
  • the subject of administration includes a subject who needs or desires vasodilation; a subject who needs or desires to prevent or improve a condition or disease for which vasodilation is effective for the prevention or improvement. Examples of such subjects include middle-aged and elderly people.
  • the composition of the present invention is suitably used as a composition for vasodilation for middle-aged and elderly people; a composition for preventing or improving a condition or disease for middle-aged and elderly people for which vasodilation is effective for the prevention or improvement.
  • Middle-aged and elderly people include elderly people.
  • Middle-aged and elderly people may be, for example, humans aged 40 years or older.
  • elderly people are preferred as the subject.
  • Elderly people may be, for example, humans aged 60 years or older or 65 years or older.
  • the subject of administration may be a healthy person.
  • the composition of the present invention can also be used for healthy people for the purpose of, for example, vasodilation; prevention or improvement of a condition or disease for which vasodilation is effective for the prevention or improvement.
  • a particularly preferred subject is a healthy human aged 60 years or older and younger than 75 years, and a most preferred subject is a healthy human aged 60 years or older and younger than 65 years.
  • the content of ergothioneine or a salt thereof in the composition of the present invention is not particularly limited and can be set depending on the form, etc.
  • the content of ergothioneine or a salt thereof in the composition of the present invention, calculated as ergothioneine, is, for example, preferably 0.0001% by weight or more, more preferably 0.001% by weight or more, and is preferably 90% by weight or less, more preferably 50% by weight or less.
  • the content of ergothioneine or a salt thereof in the composition of the present invention is preferably 0.0001 to 90% by weight, more preferably 0.001 to 50% by weight, calculated as ergothioneine.
  • the content of ergothioneine or a salt thereof can be measured by high performance liquid chromatography (HPLC).
  • the amount converted into ergothioneine or a similar expression means the amount of ergothioneine, and in the case of a salt of ergothioneine, means the value obtained by multiplying the number of moles of the salt by the molecular weight of ergothioneine.
  • composition of the present invention can be ingested or administered in a suitable manner according to its form.
  • the composition of the present invention is preferably ingested orally (administered orally).
  • the dosage (which can also be called the intake amount) of the composition of the present invention is not particularly limited, and may be any amount that provides a vasodilatory effect, and may be set appropriately according to the dosage form, administration method, subject weight, etc.
  • the dosage when the composition of the present invention is orally ingested or administered to a human (adult), the dosage is preferably 2 mg or more, more preferably 5 mg or more, even more preferably 7 mg or more, and preferably 50 mg or less, more preferably 25 mg or less, and even more preferably 20 mg or less, per day, as the dosage of ergothioneine or a salt thereof (in ergothioneine equivalent). In one embodiment, the dosage of the composition of the present invention is preferably 2 to 50 mg, more preferably 5 to 25 mg, even more preferably 5 to 20 mg, and even more preferably 7 to 20 mg, per day, as the dosage of ergothioneine or a salt thereof (in ergothioneine equivalent), for a human (adult).
  • the above amount it is preferable to ingest or administer the above amount once or more times a day, for example, once a day or in several divided doses (for example, 2 to 3 times). In one embodiment, it is preferable to orally ingest or administer the above amount of ergothioneine or a salt thereof to a human.
  • the above dosage may be per 60 kg of body weight.
  • the composition of the present invention can be used to ingest or administer the above amount of ergothioneine or a salt thereof to a human, for example, per 60 kg of body weight per day.
  • composition of the present invention preferably contains 2 to 50 mg of ergothioneine or a salt thereof per daily intake for an adult, more preferably 5 to 25 mg, even more preferably 5 to 20 mg, and particularly preferably 7 to 20 mg, of ergothioneine.
  • the composition of the present invention may be labeled with, for example, an indication of its function of dilating blood vessels; or an indication of a function exerted by vasodilation.
  • the composition of the present invention may be labeled with at least one function selected from the group consisting of, for example, "dilates blood vessels to maintain blood flow,””promotes blood circulation,””prevents or improves high blood pressure,””prevents or improves stiff shoulders,””prevents or improves headaches,””prevents or improves poor circulation,””prevents reduced cerebral circulation,” and “improves cerebral circulation.”
  • the composition of the present invention is preferably a food or drink to which the above-mentioned label is attached.
  • the above-mentioned label may be a label indicating that the composition is used to obtain the above-mentioned function.
  • the above-mentioned label may be attached to the composition itself, or to a container or packaging of the composition.
  • L-ergothioneine inhibits the binding of substrates to K ATP channels. Therefore, ergothioneine or a salt thereof can also be used as an active ingredient for inhibiting substrate binding to K ATP channels.
  • the composition of the present invention may also be used as a substrate binding inhibitor for K ATP channels.
  • a substrate binding inhibitor for K ATP channels that contains ergothioneine or a salt thereof as an active ingredient is also one aspect of the present invention.
  • the present invention also encompasses the following methods.
  • a method for dilating blood vessels comprising administering ergothioneine or a salt thereof to a subject.
  • the method may be a therapeutic or a non-therapeutic method.
  • the present invention also encompasses the following uses: Use of ergothioneine or a salt thereof for dilating blood vessels.
  • the use may be a therapeutic use or a non-therapeutic use.
  • By administering ergothioneine or a salt thereof to a subject it is possible to dilate blood vessels.
  • the preferred embodiment of ergothioneine or a salt thereof is the same as that of the composition of the present invention described above.
  • ergothioneine or a salt thereof one type of ergothioneine or a salt thereof may be used, or two or more types may be used.
  • the above use is preferably in a human or a non-human mammal, more preferably in a human.
  • ergothioneine or a salt thereof may be used in an amount that provides the desired effect (which may also be referred to as an effective amount).
  • the preferred dosage and administration subjects of ergothioneine or a salt thereof are the same as those of the composition of the present invention described above.
  • Ergothioneine or a salt thereof may be administered as is, or as a composition containing it.
  • the composition of the present invention described above may be used.
  • the present invention also includes the use of ergothioneine or a salt thereof for the manufacture of a composition for dilating a blood vessel.
  • the present invention also includes use of ergothioneine or a salt thereof for producing a composition for preventing or ameliorating hypertension.
  • the present invention also relates to ergothioneine or a salt thereof for use in the prevention or amelioration of hypertension.
  • a numerical range expressed by a lower limit and an upper limit includes the lower limit and the upper limit.
  • a range expressed by "1 to 2" means 1 to 2, including 1 and 2.
  • the upper and lower limits may be in any combination.
  • Example 1 (Assessment of substrate binding inhibitory activity of ATP-sensitive potassium channel) To evaluate the molecular target on which L-ergothioneine acts, an in vitro assay for the ATP-sensitive potassium (KATP) channel was performed. The in vitro assay was performed under contract to Eurofins Panlabs. The test was performed as follows.
  • the membrane fraction was filtered and washed, and the substrate binding inhibitory activity of L-ergothioneine was evaluated using radioactivity as an indicator.
  • the radioactivity of the membrane fraction increases when there is a large amount of [ 3 H]glibenclamide bound to the K ATP channel.
  • FIG. 1 is a graph evaluating the substrate binding inhibitory activity of L-ergothioneine to an ATP-sensitive potassium channel.
  • the horizontal axis indicates the concentration ( ⁇ M) of L-ergothioneine.
  • the substrate binding inhibitory activity (%) of the K ATP channel was determined by the following procedure. The radioactivity of the membrane fraction in the reaction solution not containing L-ergothioneine (control) was taken as 100%, and the relative activity (%) of the membrane fraction in the reaction solution to which L-ergothioneine was added (100 ⁇ M or 1000 ⁇ M) relative to the control was determined from the radioactivity of the membrane fraction in the reaction solution to which L-ergothioneine was added.
  • the radioactivity of the membrane fraction is weakened. Then, the substrate binding inhibitory activity (%) of the K ATP channel was determined by subtracting the relative activity (%) of the membrane fraction in the control when L-ergothioneine was added from the radioactivity (100%) of the membrane fraction.
  • L-ergothioneine showed binding inhibitory activity against the K ATP channel for its substrate, glibenclamide. It is known that opening of K ATP channels causes blood vessels to dilate, and it is speculated that L-ergothioneine exerts a vasodilatory effect via K ATP channels.
  • Example 2 (Assessment of blood pressure in humans) For the purpose of evaluating the effect of a supplement containing ergothioneine on human blood pressure, a placebo-controlled, randomized, double-blind, parallel-group comparative study was conducted in healthy men and women aged 60 years or older and under 65 years (9 in the test food group, 10 in the control food group, a total of 19 people) who were asked to take a capsule containing 8 mg of ergothioneine (test food) or a capsule without ergothioneine (control food) once daily for 12 weeks.
  • the subjects' blood pressure was evaluated before the start of the study (before starting to take the test food or control food). In addition, after taking the test food or control food for 12 weeks, the subjects' blood pressure was measured again (12th week examination). In principle, blood pressure was measured on the upper arm opposite the dominant arm. Measurements were taken three times in a row in a sitting position after resting for at least 10 minutes after arriving at the facility, and the median of the three measurements was recorded as the measurement on that evaluation day. Blood pressure was measured by a nurse or laboratory technician under the supervision of a physician using a medical electronic blood pressure monitor AVE-1500 Passesa (Shisei Datum Co., Ltd.).
  • Test food Capsules containing the test substance (8 mg of L-ergothioneine)
  • Control food Capsules not containing the test substance
  • the raw materials used in each evaluation food include dextrin, calcium stearate, and hydroxypropyl methylcellulose.
  • the control food was manufactured using the same raw materials as the test food, except that it did not contain the test substance (L-ergothioneine).
  • the average blood pressure (mmHg) of the nine subjects in the test food group was used as the blood pressure of the test food group.
  • the average blood pressure (mmHg) of the ten subjects in the control food group was used as the blood pressure of the control food group.
  • the change in blood pressure ( ⁇ blood pressure (mmHg)) was calculated by subtracting the blood pressure at the pre-trial examination from the blood pressure at the 12th week examination.
  • the change in blood pressure ( ⁇ blood pressure (mmHg)) at the pre-trial examination was set to 0.
  • Figure 2 is a graph showing the change in diastolic blood pressure in the test food group and the control food group.
  • a two-sample t-test **: p ⁇ 0.01 vs. the control food group
  • diastolic blood pressure was significantly reduced in the test food group.
  • black squares ( ⁇ ) represent the test food group
  • white squares ( ⁇ ) represent the control food group.
  • "0W” represents the time of the test before the start of the study
  • "12W” represents the time of the test at 12 weeks.
  • Figure 3 is a graph showing the change in systolic blood pressure in the test food group and the control food group.
  • a two-sample t-test **: p ⁇ 0.01 vs. control food group
  • the rise in systolic blood pressure was more suppressed in the test food group than in the control food group.
  • black squares ( ⁇ ) represent the test food group
  • white squares ( ⁇ ) represent the control food group.
  • "0W” represents the time of the test before the start of the study
  • "12W” represents the time of the test at 12 weeks.

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  • Life Sciences & Earth Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Health & Medical Sciences (AREA)
  • Nutrition Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
PCT/JP2024/004716 2023-02-16 2024-02-13 エルゴチオネインを含有する血管拡張用組成物 Ceased WO2024172002A1 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202480011225.9A CN120640988A (zh) 2023-02-16 2024-02-13 含有麦角硫因的血管扩张用组合物
JP2025501138A JPWO2024172002A1 (https=) 2023-02-16 2024-02-13

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JP2023-022660 2023-02-16
JP2023022660 2023-02-16

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005306775A (ja) * 2004-04-21 2005-11-04 Three-B Co Ltd ペンチトールまたはヘキシトールを有効成分とする血圧降下剤
JP2014223051A (ja) * 2012-07-13 2014-12-04 タカラバイオ株式会社 エルゴチオネインの製造方法
WO2022230494A1 (ja) * 2021-04-26 2022-11-03 サントリーホールディングス株式会社 免疫細胞の代謝促進用組成物
JP2022169385A (ja) * 2021-04-27 2022-11-09 学校法人君が淵学園 タモギタケ又はその処理物を有効成分として含む、脂質代謝改善剤

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005306775A (ja) * 2004-04-21 2005-11-04 Three-B Co Ltd ペンチトールまたはヘキシトールを有効成分とする血圧降下剤
JP2014223051A (ja) * 2012-07-13 2014-12-04 タカラバイオ株式会社 エルゴチオネインの製造方法
WO2022230494A1 (ja) * 2021-04-26 2022-11-03 サントリーホールディングス株式会社 免疫細胞の代謝促進用組成物
JP2022169385A (ja) * 2021-04-27 2022-11-09 学校法人君が淵学園 タモギタケ又はその処理物を有効成分として含む、脂質代謝改善剤

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