WO2023248689A1 - Climacteric disorder ameliorating agent - Google Patents

Climacteric disorder ameliorating agent Download PDF

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Publication number
WO2023248689A1
WO2023248689A1 PCT/JP2023/019237 JP2023019237W WO2023248689A1 WO 2023248689 A1 WO2023248689 A1 WO 2023248689A1 JP 2023019237 W JP2023019237 W JP 2023019237W WO 2023248689 A1 WO2023248689 A1 WO 2023248689A1
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Prior art keywords
improving agent
menopausal
silkworm
extract
disorder improving
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PCT/JP2023/019237
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French (fr)
Japanese (ja)
Inventor
志穂 齋藤
大輔 斉藤
紀明 小森
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第一工業製薬株式会社
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Publication of WO2023248689A1 publication Critical patent/WO2023248689A1/en

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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
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • 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 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
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/062—Ascomycota
    • A61K36/066—Clavicipitaceae
    • A61K36/068—Cordyceps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • 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
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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

Definitions

  • the present invention relates to a menopausal disorder improving agent.
  • Menopause is an indeterminate complaint syndrome with autonomic and psychogenic causes that appears during menopause, and is caused not only by physical changes such as decreased expression of endocrine hormones (follicular hormones; estrogen), but also by changes in the social environment. Stress caused by change is also believed to be involved. Furthermore, in recent years, early-onset menopause, which can occur in people's 20s and 30s, has been attracting attention. The symptoms of menopause are diverse, and include muscle loss, irritability, and sleep disorders, as well as an accumulation of irritability, depression, anxiety, and fatigue. From this point of view, the development of menopausal disorder-improving agents that can prevent or improve menopausal disorders has been widely conducted (for example, Patent Document 1, etc.).
  • an object of the present invention is to provide a novel menopausal disorder improving agent.
  • the present invention includes, for example, the subject matter described in the following sections.
  • Item 1 A climacteric disorder improving agent containing powder or extract of Silkworm.
  • Section 2 Item 2.
  • the menopausal disorder improving agent according to item 1 which is used for at least one selected from the group consisting of prevention or improvement of muscle mass loss, prevention or improvement of nervousness, suppression of irritability, and suppression of depression.
  • Section 3 Item 2.
  • the menopausal disorder improving agent according to item 1 or 2 which is in the form of a food or drink composition.
  • Section 4 Item 2.
  • the menopausal disorder improving agent according to Item 1 or 2 which is in the form of a nutritional supplement composition.
  • Section 5 Item 2.
  • the menopausal disorder improving agent according to item 1 or 2 which is in the form of a food additive.
  • Section 6 Use of powder or extract of Silkum chinensis for producing the menopausal disorder improving agent according to any one of items 1 to 5 above.
  • Section 7 A method of administering powder or extract of Silkophora anagitake to a subject in need of prevention or improvement of menopausal disorders.
  • Item 8 Powder or extract of Silkophora anagitake for use in the prevention or amelioration of menopausal symptoms.
  • a menopausal disorder improving agent can be provided.
  • Such a menopausal disorder improving agent can prevent or improve menopausal disorder.
  • results of a test example using the menopausal disorder improving agent obtained in the example are the results of a test example using the menopausal disorder improving agent obtained in the example. These are the results of a test example using the menopausal disorder improving agent obtained in the example. These are the results of a test example using the menopausal disorder improving agent obtained in the example. These are the results of a test example using the menopausal disorder improving agent obtained in the example.
  • the present invention includes a menopausal disorder improving agent containing Silkophora anagitake or an extract thereof.
  • the menopausal disorder improving agent of the present invention has Silkorophyllacea chinensis as an essential ingredient, or has an extract of Silkum chinensis as an essential ingredient.
  • the menopausal disorder improving agent of the present invention can also contain both Silkophora anagitake and an extract thereof.
  • Silkworm or an extract thereof is an active ingredient in a menopausal disorder improving agent.
  • Silkworm P. tenuipes is a P. tenuipes (also called “Cordyceps sinensis") that grows parasitic on silkworms.
  • Silkworm pupae are obtained using silkworm pupae as hosts.
  • Silkworm can be obtained, for example, from a commercial product or by cultivation. There are no particular limitations on the method for cultivating the silkworm, and for example, a wide variety of known cultivation methods can be applied.
  • a specific method for cultivating Silkworm fungus is exemplified by a method in which silkworm larvae and silkworm pupae are heat sterilized and then inoculated with Cordyceps sinensis fungi.
  • Silkworm can also be cultivated by the method disclosed in JP-A No. 2005-237201.
  • silkworm larvae or silkworm pupae before forming cocoons are boiled and then dried, and the resulting dried silkworm powder is mixed with beans, grains, seaweeds, and mushrooms.
  • a food dry powder is prepared by mixing with at least one kind of dry powder selected from the group consisting of: A culture medium is added to this dry food powder, kneaded, and spread on the bottom of the growth box to create a medium. The medium is sealed in an inoculation bag, heat sterilized, and Cordyceps sinensis is inoculated into the medium. By doing so, you can grow silkworms.
  • the dry silkworm powder may be 50 to 90% by mass.
  • the method for obtaining such powder is not particularly limited, and for example, a wide variety of known methods can be employed.
  • powder of Silkworm can be obtained by freeze-drying and pulverizing Silkworm.
  • Silkworm powder can be obtained using only the fruiting bodies of Silkophora chinensis, and it is preferable to obtain Bombyx mori powder using the fruiting bodies and a host (eg, silkworm).
  • the method for obtaining such an extract is not particularly limited, and for example, a wide variety of known methods can be employed.
  • a method for extracting Silkophora anagitake includes a method of obtaining an extract of Silkum chinensis by cutting, crushing, and/or drying the Silkum chinensis as it is, and then extracting or extracting with an appropriate solvent.
  • the type of solvent used for extraction is not particularly limited, and examples include water, lower alcohols such as methanol, ethanol, and isopropanol, polyhydric alcohols such as propylene glycol and 1,3-butylene glycol; ketones such as acetone, and diethyl ether. ; dioxane; acetonitrile; esters such as ethyl acetate; other examples include dimethyl sulfoxide, xylene, benzene, and chloroform.
  • the preferred solvent is water, preferably hot water.
  • the temperature of the hot water may be 60°C or higher, 70°C or higher, 80°C or higher, or 90°C or higher.
  • a preferred method for obtaining an extract of Silkophora anagitake is extraction using the above-mentioned hot water.
  • an extract is prepared by adding water or the above-mentioned hot water to the dry powder of Bombyx mori and stirring at a temperature of 60°C or more and 80°C or less for a predetermined time, for example, 1 hour or more and 5 hours or less. Then, by filtering this extract and drying (for example, spraying) the obtained filtrate, an extract of Silkophora anagitake can be obtained.
  • the dry powder can be obtained, for example, by freeze-drying Silkophora anagitake.
  • the mixing ratio of the dry powder and water or hot water is not particularly limited, and for example, 5 to 20 parts by mass of water or hot water can be used per 1 part by mass of the dry powder, preferably 7 to 15 parts by mass. Department.
  • the amount of water in the extract of Silkworm is not particularly limited, and may be, for example, 20% by mass or less, preferably 10% by mass or less, and 8% by mass or less. % or less, more preferably 5% by mass or less.
  • the menopausal disorder improving agent may contain any other ingredients in addition to the powder of Silkophora anagitake or its extract.
  • Types of other ingredients include, for example, various additives that can be included in known menopausal disorder improving agents, such as excipients, binders, disintegrants, lubricants, wetting agents, fluidizing agents, and preservatives. Examples include surfactants, stabilizers, diluents, solubilizers, tonicity agents, bactericidal agents, preservatives, flavoring agents, flavoring agents, coloring agents, perfumes, and the like.
  • the menopausal disorder improving agent may also contain known menopausal disorder improving agents in addition to the Silkworm powder or extract thereof.
  • the content ratio of Silkworm or its extract contained in the menopausal disorder improving agent is not particularly limited, and can be set, for example, in the range of 0.1% by mass or more and 100% by mass or less in terms of solid content.
  • the lower limit of the content ratio is, for example, 1% by mass or more, 2% by mass or more, 5% by mass or more, 10% by mass or more, 15% by mass or more, 20% by mass or more, 30% by mass or more, 40% by mass or more, 50% by mass or more. It can be 99% by mass or less, 95% by mass or less, 90% by mass or less, 80% by mass or less, 70% by mass or less, or 60% by mass. It can be as follows. These lower and upper limits may be combined arbitrarily.
  • the form of the menopausal disorder improving agent of the present invention is not particularly limited, and examples thereof include semi-solid, solid, liquid, and the like. Specific forms include powder, fine granules, granules, tablets, capsules, troches, chewables, gels, creams, pastes, mousses, liquids, emulsions, suspensions, and syrups. Ru.
  • the menopausal disorder improving agent of the present invention is preferably ingested orally, for example, and may be ingested in other ways.
  • the menopausal disorder improving agent of the present invention can be ingested or administered to humans or animals (excluding humans; the same applies hereinafter), and can improve menopausal disorders or prevent menopausal disorders. Therefore, the menopausal disorder improving agent of the present invention can be suitably used for improving or preventing menopausal disorders.
  • the menopausal disorder improving agent of the present invention can act not only on women but also on men.
  • the menopausal disorder improving agent of the present invention prevents or improves muscle mass loss, prevents or improves nervousness, suppresses irritability, suppresses melancholy, prevents or ameliorates bone density loss, prevents or ameliorates depression, It is preferably used for at least one selected from the group consisting of prevention or improvement of concentration loss, prevention or improvement of sleep disorders, prevention or improvement of body fat increase, and prevention or improvement of anemia. It is more preferable to use it for at least one selected from the group consisting of prevention or amelioration of loss of appetite, prevention or amelioration of irritability, suppression of irritability, and suppression of melancholy.
  • the intake (administration) amount of the menopausal disorder improving agent of the present invention is not particularly limited as long as the desired effect is achieved, and depends on the physique, age, symptoms, form of application, purpose of use, etc. of the subject (or subject animal). It can be set as appropriate.
  • the daily intake (administration) amount of the menopausal disorder improving agent is 1 mg to 8000 mg, 10 mg to 4000 mg, 100 mg to 3000 mg, and 500 mg in terms of dry weight of Silkworm or extract thereof, based on an adult weighing 60 kg. It can be set in the range of ⁇ 2000 mg, etc.
  • the number of times of intake (administration) is arbitrary, and for example, the intake (administration) may be a single intake (administration) or multiple times per day.
  • the menopausal disorder improving agent of the present invention can be in the form of a food or drink composition. That is, the present invention also includes food and drink compositions containing a menopausal disorder improving agent. Such food and drink compositions are suitably used for improving or preventing menopausal disorders.
  • Food and beverages include not only general foods, but also foods with health claims (specifically, foods for specified health uses, foods with nutritional function claims, and foods with functional claims), foods for the sick, supplements, and the like.
  • the food and drink composition can be preferably applied to, for example, liquid, gel, or solid foods.
  • beverages e.g., fruit juice drinks, vegetable juices, soft drinks, alcoholic drinks, carbonated drinks, sports drinks, tonic drinks, energy drinks, etc.
  • confectionery e.g., snacks, rice crackers, chocolate, gummies, etc.
  • candy e.g., jelly, pudding, Japanese sweets, Western sweets, etc.
  • seasonings e.g., soy sauce, miso, mirin-style seasoning, mixed spices, sauce, soup, sauce, ketchup, etc.
  • dressings e.g., udon
  • noodles e.g., udon
  • examples include foods such as buckwheat noodles, spaghetti, etc.), meat and fish processed foods (for example, sausages, sausages, ham, hamburgers, etc.), and dairy products (yogurt, milk, cheese, cream, butter, etc.).
  • the menopausal disorder improving agent of the present invention can be in the form of a nutritional supplement. That is, the present invention also includes a nutritional supplement composition containing an agent for improving menopausal symptoms. Such a nutritional supplement composition is suitably used for improving or preventing menopausal symptoms.
  • the nutritional supplement composition can be used, for example, as a supplement, and is suitable as a so-called doctor's supplement.
  • the menopausal disorder improving agent of the present invention can be in the form of a food additive. That is, the present invention also includes food additives containing menopausal disorder improving agents. Such food additives are suitably used for improving or preventing menopausal symptoms.
  • the food in the food additive is exemplified by the same types as the food in the food/beverage composition described above.
  • the menopausal disorder improving agent of the present invention can be used not only for the above-mentioned foods (including health foods and health promoters), nutritional supplements, and food additives, but also for medicines, cosmetics, feeds, and the like.
  • the menopausal disorder improving agent of the present invention is in the form of a pharmaceutical (for example, when it is a pharmaceutical composition)
  • a pharmaceutically acceptable excipient may be combined with the powder or extract of Silkophora anagitake, if necessary. Can be done.
  • the present invention also encompasses the use of powder or extract of Silkworm. That is, the present invention encompasses the use (or method of use) of powder or extract of Silkworm for producing the menopausal disorder improving agent.
  • the present invention also encompasses a method of administering powder or extract of Silkophora anagitake. That is, the present invention encompasses a method of administering powder or extract of Silkworm to a subject in need of improving or preventing menopausal symptoms.
  • the powder or extract of Silkworm in such a method is the same as the powder or extract of Silkhophana anagitake contained in the menopausal disorder improving agent of the present invention.
  • the subject in need of improvement or prevention of menopausal symptoms is a human or a non-human animal.
  • the present invention also encompasses a powder or extract of Silkophora anagitake for use in ameliorating or preventing menopausal disorders.
  • a powder or extract of Silkum chinensis is the same as the powder or extract of Silkum chinensis contained in the menopausal disorder improving agent of the present invention.
  • each configuration (property, structure, function, etc.) described in each embodiment of the present disclosure may be combined in any manner. That is, the present disclosure includes all subject matter consisting of all combinations of the combinable structures described in this specification.
  • Example 1 Silkworm powder was obtained by freeze-drying the silkworm Pupae obtained using the silkworm pupa as a host and pulverizing it with a mixer. A sample of a menopausal disorder improving agent was prepared by filling 200 mg of the obtained silkworm powder into hard capsules.
  • Example 2 Twenty subjects (14 men, 6 women) selected through screening were made to ingest the sample obtained in Example 1 twice a day for 4 weeks. Each intake was 4 capsules (daily intake of 1,600 mg as silkworm powder). The following questionnaire was administered to each subject before intake, 2 weeks after intake, and 4 weeks after intake, and each question in the questionnaire was answered as ⁇ None'' (1 point
  • Q9 I have physical fatigue, lack of energy, decreased overall ability, decreased activity, and decreased interest in leisure activities. Feeling lethargic, lacking a sense of accomplishment, and having to force myself to do something.
  • Q10 My muscle strength has decreased. I feel like I'm getting weaker.
  • Q11 I feel depressed and easily depressed. Sad. I feel like I'm about to cry. There is a loss of motivation and a feeling of helplessness. I have severe mood swings.
  • Q12 I feel "burned out" and "at rock bottom.”
  • Q6 was used as an index to judge irritability
  • Q7 was used as an index to judge nervousness
  • Q10 was used as an index for muscle weakness
  • Q11 was used as an index for determining depression.
  • Figures 1 to 4 show scores based on the questionnaire results of 20 subjects (expressed as 1 to 20 on the horizontal axis) for Q6 (irritability), Q7 (irritability), Q10 (muscle weakness), and Q11 (depression), respectively. (vertical axis).
  • the three bar graphs for each subject 1 to 20 on the horizontal axis indicate the scores based on the questionnaire results from the left, before intake, 2 weeks after the start of intake, and 4 weeks after the start of intake. ing.

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Abstract

Provided is a novel climacteric disorder ameliorating agent.　A climacteric disorder ameliorating agent according to the present invention includes a powder or an extract of Paecilomyces tenuipes. Such climacteric disorder ameliorating agent can prevent or ameliorate climacteric disorders. The climacteric disorder ameliorating agent according to the present invention preferably takes the form of a food/beverage composition, the form of a nutrition supplement food composition, or the form of a food additive.

Description

更年期障害改善剤Menopausal disorder improvement agent
　本発明は、更年期障害改善剤に関する。 The present invention relates to a menopausal disorder improving agent.
　更年期障害は、更年期に現れる自律神経性や心因性を成因とする不定愁訴症候群であり、内分泌ホルモン（卵胞ホルモン；エストロゲン）の発現減少といった身体的変化がもたらすだけでなく、社会的な環境の変化などによるストレスも関係しているとされている。また、近年は、２０～３０代にかけて発症し得る若年性更年期障害も注目されている。更年期障害で現れる症状は多種多様であり、例えば、筋量低下、神経過敏、睡眠障害を引き起こし、また、イライラ感、憂鬱感、不安感、疲労感も蓄積される。この観点から更年期障害を予防又は改善させることを可能とする更年期障害改善剤の開発が広く行われている（例えば、特許文献１等）。 Menopause is an indeterminate complaint syndrome with autonomic and psychogenic causes that appears during menopause, and is caused not only by physical changes such as decreased expression of endocrine hormones (follicular hormones; estrogen), but also by changes in the social environment. Stress caused by change is also believed to be involved. Furthermore, in recent years, early-onset menopause, which can occur in people's 20s and 30s, has been attracting attention. The symptoms of menopause are diverse, and include muscle loss, irritability, and sleep disorders, as well as an accumulation of irritability, depression, anxiety, and fatigue. From this point of view, the development of menopausal disorder-improving agents that can prevent or improve menopausal disorders has been widely conducted (for example, Patent Document 1, etc.).
特開２０２０－１５６５２１号公報Japanese Patent Application Publication No. 2020-156521
　上記事情より、更年期障害改善剤が求められているところ、本発明は、新規な更年期障害改善剤を提供することを課題とする。 Due to the above circumstances, there is a need for a menopausal disorder improving agent, and an object of the present invention is to provide a novel menopausal disorder improving agent.
　本発明者らは、上記目的を達成すべく鋭意研究を重ねた結果、カイコハナサナギタケの粉末又は抽出物が更年期障害を予防又は改善できることを初めて見出し、本発明を完成するに至った。 As a result of intensive research aimed at achieving the above object, the present inventors discovered for the first time that powder or extract of Silkworm anagitake can prevent or improve menopausal symptoms, leading to the completion of the present invention.
　すなわち、本発明は、例えば、以下の項に記載の主題を包含する。
項１
カイコハナサナギタケの粉末又は抽出物を含む、更年期障害改善剤。
項２
筋量低下の予防又は改善、神経過敏の予防又は改善、イライラ感の抑制及び憂鬱感の抑制からなる群より選択される少なくとも１種のために用いられる、項１に記載の更年期障害改善剤。
項３
飲食品組成物の形態である、項１又は２に記載の更年期障害改善剤。
項４
栄養補助食品組成物の形態である、項１又は２に記載の更年期障害改善剤。
項５
食品添加剤の形態である、項１又は２に記載の更年期障害改善剤。
項６
前記項１～５のいずれか１項に記載の更年期障害改善剤を製造するためのカイコハナサナギタケの粉末又は抽出物の使用。
項７
更年期障害の予防又は改善が必要な対象にカイコハナサナギタケの粉末又は抽出物を投与する方法。
項８
更年期障害の予防又は改善における使用のためのカイコハナサナギタケの粉末又は抽出物。 That is, the present invention includes, for example, the subject matter described in the following sections.
Item 1
A climacteric disorder improving agent containing powder or extract of Silkworm.
Section 2
Item 2. The menopausal disorder improving agent according to item 1, which is used for at least one selected from the group consisting of prevention or improvement of muscle mass loss, prevention or improvement of nervousness, suppression of irritability, and suppression of depression.
Section 3
Item 2. The menopausal disorder improving agent according to item 1 or 2, which is in the form of a food or drink composition.
Section 4
Item 2. The menopausal disorder improving agent according to Item 1 or 2, which is in the form of a nutritional supplement composition.
Section 5
Item 2. The menopausal disorder improving agent according to item 1 or 2, which is in the form of a food additive.
Section 6
Use of powder or extract of Silkum chinensis for producing the menopausal disorder improving agent according to any one of items 1 to 5 above.
Section 7
A method of administering powder or extract of Silkophora anagitake to a subject in need of prevention or improvement of menopausal disorders.
Item 8
Powder or extract of Silkophora anagitake for use in the prevention or amelioration of menopausal symptoms.
　本発明によれば、更年期障害改善剤を提供することができる。斯かる更年期障害改善剤により、更年期障害の予防又は改善をもたらすことができる。 According to the present invention, a menopausal disorder improving agent can be provided. Such a menopausal disorder improving agent can prevent or improve menopausal disorder.
実施例で得た更年期障害改善剤を用いた試験例の結果である。These are the results of a test example using the menopausal disorder improving agent obtained in the example. 実施例で得た更年期障害改善剤を用いた試験例の結果である。These are the results of a test example using the menopausal disorder improving agent obtained in the example. 実施例で得た更年期障害改善剤を用いた試験例の結果である。These are the results of a test example using the menopausal disorder improving agent obtained in the example. 実施例で得た更年期障害改善剤を用いた試験例の結果である。These are the results of a test example using the menopausal disorder improving agent obtained in the example.
　以下、本発明の実施形態について詳細に説明する。なお、本明細書中において、「含有」及び「含む」なる表現については、「含有」、「含む」、「実質的にからなる」及び「のみからなる」という概念を含む。 Hereinafter, embodiments of the present invention will be described in detail. Note that, in this specification, the expressions "contain" and "comprising" include the concepts of "containing", "containing", "consisting essentially of", and "consisting only".
　本発明は、カイコハナサナギタケ又はその抽出物を含む更年期障害改善剤を包含する。 The present invention includes a menopausal disorder improving agent containing Silkophora anagitake or an extract thereof.
　本発明の更年期障害改善剤は、カイコハナサナギタケを必須成分とし、あるいは、カイコハナサナギタケの抽出物を必須成分とする。本発明の更年期障害改善剤は、カイコハナサナギタケ及びその抽出物の両方を含むこともできる。更年期障害改善剤において、カイコハナサナギタケ又はその抽出物は有効成分である。 The menopausal disorder improving agent of the present invention has Silkorophyllacea chinensis as an essential ingredient, or has an extract of Silkum chinensis as an essential ingredient. The menopausal disorder improving agent of the present invention can also contain both Silkophora anagitake and an extract thereof. Silkworm or an extract thereof is an active ingredient in a menopausal disorder improving agent.
　カイコハナサナギタケは、カイコに寄生して生育したハナサナギタケ（Ｐ．ｔｅｎｕｉｐｅｓ、「冬虫夏草」とも称される）である。カイコハナサナギタケは、カイコ蛹を宿主として得られる。 Silkworm P. tenuipes is a P. tenuipes (also called "Cordyceps sinensis") that grows parasitic on silkworms. Silkworm pupae are obtained using silkworm pupae as hosts.
カイコハナサナギタケは、例えば、市販品から入手することができ、あるいは、栽培に
より入手することもできる。カイコハナサナギタケを栽培する方法は特に限定されず、例えば、公知の栽培方法を広く適用することができる。 Silkworm can be obtained, for example, from a commercial product or by cultivation. There are no particular limitations on the method for cultivating the silkworm, and for example, a wide variety of known cultivation methods can be applied.
　カイコハナサナギタケの具体的な栽培方法としては、カイコの幼虫やカイコの蛹を加熱滅菌処理した後、冬虫夏草の菌を植菌して育成する方法が例示される。 A specific method for cultivating Silkworm fungus is exemplified by a method in which silkworm larvae and silkworm pupae are heat sterilized and then inoculated with Cordyceps sinensis fungi.
　また、特開２００５－２３７２０１号公報に開示される方法でカイコハナサナギタケを栽培することもできる。この公報に記載される方法では、繭を形成する前のカイコの幼虫又はカイコの蛹を煮沸し、次いで、乾燥させ、これにより得られるカイコ乾燥粉末と、豆類、穀類、海藻類及びキノコ類からなる群より選ばれる少なくとも１種の乾燥粉末とを混合して食物乾燥粉末を調製する。この食物乾燥粉末に培養液を加えて混練してから育成箱の底部に敷き詰めて培地を作成し、この培地を、植菌袋に封入して加熱滅菌処理した後、培地に冬虫夏草の菌を接種して、カイコハナサナギタケを育成することができる。前記食物乾燥粉末において、カイコ乾燥粉末は５０～９０質量％とすることができる。 Additionally, Silkworm can also be cultivated by the method disclosed in JP-A No. 2005-237201. In the method described in this publication, silkworm larvae or silkworm pupae before forming cocoons are boiled and then dried, and the resulting dried silkworm powder is mixed with beans, grains, seaweeds, and mushrooms. A food dry powder is prepared by mixing with at least one kind of dry powder selected from the group consisting of: A culture medium is added to this dry food powder, kneaded, and spread on the bottom of the growth box to create a medium.The medium is sealed in an inoculation bag, heat sterilized, and Cordyceps sinensis is inoculated into the medium. By doing so, you can grow silkworms. In the food dry powder, the dry silkworm powder may be 50 to 90% by mass.
　更年期障害改善剤がカイコハナサナギタケの粉末を含む場合、斯かる粉末を得る方法は特に限定されず、例えば、公知の方法を広く採用することができる。例えば、カイコハナサナギタケを凍結乾燥させ、粉砕することで、カイコハナサナギタケの粉末を得ることができる。ハナサナギタケの子実体のみを用いてカイコハナサナギタケの粉末を得ることができ、子実体および宿主（例えば、カイコ）を用いてカイコハナサナギタケの粉末を得ることが好ましい。 When the menopausal disorder improving agent contains Silkworm powder, the method for obtaining such powder is not particularly limited, and for example, a wide variety of known methods can be employed. For example, powder of Silkworm can be obtained by freeze-drying and pulverizing Silkworm. Silkworm powder can be obtained using only the fruiting bodies of Silkophora chinensis, and it is preferable to obtain Bombyx mori powder using the fruiting bodies and a host (eg, silkworm).
　更年期障害改善剤がカイコハナサナギタケの抽出物を含む場合、斯かる抽出物を得る方法は特に限定されず、例えば、公知の方法を広く採用することができる。例えば、カイコハナサナギタケの抽出方法としては、カイコハナサナギタケをそのまま、裁断、粉砕及び／又は乾燥し、搾取又は適宜の溶媒による抽出を行うことで、カイコハナサナギタケの抽出物を得る方法が挙げられる。 In the case where the menopausal disorder improving agent contains an extract of Silkworm silkworm, the method for obtaining such an extract is not particularly limited, and for example, a wide variety of known methods can be employed. For example, a method for extracting Silkophora anagitake includes a method of obtaining an extract of Silkum chinensis by cutting, crushing, and/or drying the Silkum chinensis as it is, and then extracting or extracting with an appropriate solvent.
　抽出に使用する溶媒の種類は特に限定されず、例えば、水、メタノール、エタノール、イソプロパノール等の低級アルコール、プロピレングリコール、１，３－ブチレングリコール等の多価アルコール；アセトン等のケトン類、ジエチルエーテル；ジオキサン；アセトニトリル；酢酸エチルエステル等のエステル類、その他、ジメチルスルホキシド、キシレン、ベンゼン、クロロホルム等が挙げられる。一実施形態において好ましい溶媒は、水であり、好ましくは熱水である。熱水は、６０℃以上であってもよく、７０℃以上であってもよく、８０℃以上であってもよく、９０℃以上であってもよい。 The type of solvent used for extraction is not particularly limited, and examples include water, lower alcohols such as methanol, ethanol, and isopropanol, polyhydric alcohols such as propylene glycol and 1,3-butylene glycol; ketones such as acetone, and diethyl ether. ; dioxane; acetonitrile; esters such as ethyl acetate; other examples include dimethyl sulfoxide, xylene, benzene, and chloroform. In one embodiment the preferred solvent is water, preferably hot water. The temperature of the hot water may be 60°C or higher, 70°C or higher, 80°C or higher, or 90°C or higher.
　カイコハナサナギタケの抽出物を得る好ましい方法として、前記熱水を用いた抽出である。この方法では、カイコハナサナギタケの乾燥粉末に、水又は前記熱水を加え、６０℃以上８０℃以下の温度で所定の時間、例えば、１時間以上５時間以下の時間で撹拌して抽出液を調製し、この抽出液を濾過して得られた濾液を乾燥（例えば、スプレー噴霧）することにより、カイコハナサナギタケの抽出物を得ることができる。 A preferred method for obtaining an extract of Silkophora anagitake is extraction using the above-mentioned hot water. In this method, an extract is prepared by adding water or the above-mentioned hot water to the dry powder of Bombyx mori and stirring at a temperature of 60°C or more and 80°C or less for a predetermined time, for example, 1 hour or more and 5 hours or less. Then, by filtering this extract and drying (for example, spraying) the obtained filtrate, an extract of Silkophora anagitake can be obtained.
　斯かる抽出方法において、前記乾燥粉末は、例えば、カイコハナサナギタケを凍結乾燥することで得ることができる。前記乾燥粉末と水又は熱水との混合割合は特に限定されず、例えば、乾燥粉末１質量部に対して水又は熱水を５～２０質量部使用することができ、好ましくは７～１５質量部である。 In such an extraction method, the dry powder can be obtained, for example, by freeze-drying Silkophora anagitake. The mixing ratio of the dry powder and water or hot water is not particularly limited, and for example, 5 to 20 parts by mass of water or hot water can be used per 1 part by mass of the dry powder, preferably 7 to 15 parts by mass. Department.
　更年期障害改善剤がカイコハナサナギタケの抽出物を含む場合、カイコハナサナギタケの抽出物中の水分量は特に限定されず、例えば、２０質量％以下とすることができ、１０質量％以下が好ましく、８質量％以下がより好ましく、５質量％以下がさらに好ましい。 When the menopausal disorder-improving agent contains an extract of Bombyx mori, the amount of water in the extract of Silkworm is not particularly limited, and may be, for example, 20% by mass or less, preferably 10% by mass or less, and 8% by mass or less. % or less, more preferably 5% by mass or less.
　更年期障害改善剤は、カイコハナサナギタケの粉末又はその抽出物以外に、任意の他の成分を含むことができる。他の成分の種類は、例えば、公知の更年期障害改善剤に含まれ得る各種添加剤を挙げることができ、賦形剤、結合剤、崩壊剤、滑沢剤、湿潤剤、流動化剤、保存剤、界面活性剤、安定剤、希釈剤、溶解剤、等張化剤、殺菌剤、防腐剤、矯味剤、矯臭剤、着色剤、香料等が例示される。更年期障害改善剤は、カイコハナサナギタケの粉末又はその抽出物以外に公知の更年期障害改善剤も含むことができる。 The menopausal disorder improving agent may contain any other ingredients in addition to the powder of Silkophora anagitake or its extract. Types of other ingredients include, for example, various additives that can be included in known menopausal disorder improving agents, such as excipients, binders, disintegrants, lubricants, wetting agents, fluidizing agents, and preservatives. Examples include surfactants, stabilizers, diluents, solubilizers, tonicity agents, bactericidal agents, preservatives, flavoring agents, flavoring agents, coloring agents, perfumes, and the like. The menopausal disorder improving agent may also contain known menopausal disorder improving agents in addition to the Silkworm powder or extract thereof.
　更年期障害改善剤に含まれる、カイコハナサナギタケ又はその抽出物の含有割合は特に限定されず、例えば、固形分換算で、０．１質量％以上１００質量％以下の範囲で設定することができる。前記含有割合の下限は、例えば、１質量％以上、２質量％以上、５質量％以上、１０質量％以上、１５質量％以上、２０質量％以上、３０質量％以上、４０質量％以上、５０質量％以上、６０質量％以上または７０質量％以上とすることができ、上限は９９質量％以下、９５質量％以下、９０質量％以下、８０質量％以下、７０質量％以下、又は６０質量％以下とすることができる。これらの下限及び上限は任意に組み合わせられる。 The content ratio of Silkworm or its extract contained in the menopausal disorder improving agent is not particularly limited, and can be set, for example, in the range of 0.1% by mass or more and 100% by mass or less in terms of solid content. The lower limit of the content ratio is, for example, 1% by mass or more, 2% by mass or more, 5% by mass or more, 10% by mass or more, 15% by mass or more, 20% by mass or more, 30% by mass or more, 40% by mass or more, 50% by mass or more. It can be 99% by mass or less, 95% by mass or less, 90% by mass or less, 80% by mass or less, 70% by mass or less, or 60% by mass. It can be as follows. These lower and upper limits may be combined arbitrarily.
　本発明の更年期障害改善剤の形態は特に限定されず、例えば、半固形、固形、液状等が挙げられる。具体的な形態は、粉末状、細粒状、顆粒状、錠剤状、カプセル状、トローチ、チュアブル、ゲル状、クリーム状、ペースト状、ムース状、液剤、乳剤、懸濁剤、シロップ等が例示される。 The form of the menopausal disorder improving agent of the present invention is not particularly limited, and examples thereof include semi-solid, solid, liquid, and the like. Specific forms include powder, fine granules, granules, tablets, capsules, troches, chewables, gels, creams, pastes, mousses, liquids, emulsions, suspensions, and syrups. Ru.
　本発明の更年期障害改善剤は、例えば、経口摂取されるものであることが好ましく、また、これ以外の摂取であってもよい。 The menopausal disorder improving agent of the present invention is preferably ingested orally, for example, and may be ingested in other ways.
　本発明の更年期障害改善剤は、ヒト又は動物（ヒトを除く。以下同じ。）への摂取又は投与が可能であり、更年期障害の改善をもたらすことができ、あるいは、更年期障害の予防をもたらすことができ、従って、本発明の更年期障害改善剤は、更年期障害を改善又は予防する用途に好適に使用することができる。本発明の更年期障害改善剤は、女性にはもちろんのこと、男性に対しても作用することができる。 The menopausal disorder improving agent of the present invention can be ingested or administered to humans or animals (excluding humans; the same applies hereinafter), and can improve menopausal disorders or prevent menopausal disorders. Therefore, the menopausal disorder improving agent of the present invention can be suitably used for improving or preventing menopausal disorders. The menopausal disorder improving agent of the present invention can act not only on women but also on men.
　とりわけ、本発明の更年期障害改善剤は、筋量低下の予防又は改善、神経過敏の予防又は改善、イライラ感の抑制、憂鬱感の抑制、骨密度低下の予防又は改善、抑うつの予防又は改善、集中力低下の予防又は改善、睡眠障害の予防又は改善、体脂肪増加の予防又は改善、及び、貧血の予防又は改善からなる群より選択される少なくとも１種のために用いられることが好ましく、筋量低下の予防又は改善、神経過敏の予防又は改善、イライラ感の抑制及び憂鬱感の抑制からなる群より選択される少なくとも１種のために用いられることがより好ましい。 In particular, the menopausal disorder improving agent of the present invention prevents or improves muscle mass loss, prevents or improves nervousness, suppresses irritability, suppresses melancholy, prevents or ameliorates bone density loss, prevents or ameliorates depression, It is preferably used for at least one selected from the group consisting of prevention or improvement of concentration loss, prevention or improvement of sleep disorders, prevention or improvement of body fat increase, and prevention or improvement of anemia. It is more preferable to use it for at least one selected from the group consisting of prevention or amelioration of loss of appetite, prevention or amelioration of irritability, suppression of irritability, and suppression of melancholy.
　本発明の更年期障害改善剤の摂取（投与）量は、目的とする効果が奏される限り特に限定されず、対象者（又は対象動物）の体格、年齢、症状、適用形態、使用目的等に応じて適宜設定することができる。例えば、１日当たりの更年期障害改善剤の摂取（投与）量は、体重６０ｋｇの成人を基準として、カイコハナサナギタケ又はその抽出物の乾燥重量換算として、１ｍｇ～８０００ｍｇ、１０ｍｇ～４０００ｍｇ、１００ｍｇ～３０００ｍｇ、５００ｍｇ～２０００ｍｇ等の範囲で設定することができる。摂取（投与）回数は任意であり、例えば、１日あたり単回摂取（投与）であってもよく複数回摂取（投与）であってもよい。 The intake (administration) amount of the menopausal disorder improving agent of the present invention is not particularly limited as long as the desired effect is achieved, and depends on the physique, age, symptoms, form of application, purpose of use, etc. of the subject (or subject animal). It can be set as appropriate. For example, the daily intake (administration) amount of the menopausal disorder improving agent is 1 mg to 8000 mg, 10 mg to 4000 mg, 100 mg to 3000 mg, and 500 mg in terms of dry weight of Silkworm or extract thereof, based on an adult weighing 60 kg. It can be set in the range of ~2000 mg, etc. The number of times of intake (administration) is arbitrary, and for example, the intake (administration) may be a single intake (administration) or multiple times per day.
　本発明の更年期障害改善剤は、飲食品組成物の形態とすることができる。すなわち、本発明は、更年期障害改善剤を含む飲食品組成物も包含する。斯かる飲食品組成物は、更年期障害の改善又は予防に好適に用いられるものである。飲食品には、一般食品だけでなく、保健機能食品（具体的には、特定保健用食品、栄養機能食品、機能性表示食品）、病者用食品、サプリメント等が含まれる。 The menopausal disorder improving agent of the present invention can be in the form of a food or drink composition. That is, the present invention also includes food and drink compositions containing a menopausal disorder improving agent. Such food and drink compositions are suitably used for improving or preventing menopausal disorders. Food and beverages include not only general foods, but also foods with health claims (specifically, foods for specified health uses, foods with nutritional function claims, and foods with functional claims), foods for the sick, supplements, and the like.
　飲食品組成物は、例えば、液状、ゲル状あるいは固形状の食品に好ましく適用できる。具体的には、飲料類（例えば、果汁飲料、野菜ジュース、清涼飲料、アルコール飲料、炭酸飲料、スポーツドリンク、滋養強壮ドリンク、栄養ドリンク等）、菓子類（例えば、スナック菓子、米菓、チョコレート、グミ、キャンディー、ゼリー、プリン、和菓子、洋菓子等）、調味料類（例えば、醤油、味噌、みりん風調味料、ミックススパイス、たれ、つゆ、ソース、ケチャップ等）、ドレッシング類、麺類（例えば、うどん、そば、スパゲッティ等）、畜肉魚肉加工食品類（例えば、ソーセージ、ウインナー、ハム、ハンバーグ等）、乳製品類（ヨーグルト、牛乳、チーズ、クリーム、バター等）等の食品を挙げることができる。 The food and drink composition can be preferably applied to, for example, liquid, gel, or solid foods. Specifically, beverages (e.g., fruit juice drinks, vegetable juices, soft drinks, alcoholic drinks, carbonated drinks, sports drinks, tonic drinks, energy drinks, etc.), confectionery (e.g., snacks, rice crackers, chocolate, gummies, etc.) , candy, jelly, pudding, Japanese sweets, Western sweets, etc.), seasonings (e.g., soy sauce, miso, mirin-style seasoning, mixed spices, sauce, soup, sauce, ketchup, etc.), dressings, noodles (e.g., udon, Examples include foods such as buckwheat noodles, spaghetti, etc.), meat and fish processed foods (for example, sausages, sausages, ham, hamburgers, etc.), and dairy products (yogurt, milk, cheese, cream, butter, etc.).
　本発明の更年期障害改善剤は、栄養補助食品の形態とすることができる。すなわち、本発明は、更年期障害改善剤を含む栄養補助食品組成物も包含する。斯かる栄養補助食品組成物は、更年期障害改善又は予防に好適に用いられるものである。栄養補助食品組成物は、例えば、サプリメントに使用でき、いわゆるドクターズサプリメントに好適である。 The menopausal disorder improving agent of the present invention can be in the form of a nutritional supplement. That is, the present invention also includes a nutritional supplement composition containing an agent for improving menopausal symptoms. Such a nutritional supplement composition is suitably used for improving or preventing menopausal symptoms. The nutritional supplement composition can be used, for example, as a supplement, and is suitable as a so-called doctor's supplement.
　本発明の更年期障害改善剤は、食品添加剤の形態とすることができる。すなわち、本発明は、更年期障害改善剤を含む食品添加剤も包含する。斯かる食品添加剤は、更年期障害改善の改善又は予防に好適に用いられるものである。食品添加剤における食品は、前述の飲食品組成物における食品等同様の種類が例示される。 The menopausal disorder improving agent of the present invention can be in the form of a food additive. That is, the present invention also includes food additives containing menopausal disorder improving agents. Such food additives are suitably used for improving or preventing menopausal symptoms. The food in the food additive is exemplified by the same types as the food in the food/beverage composition described above.
　本発明の更年期障害改善剤は、上述の食品用（健康食品及び健康増進剤を包含する）、栄養補助食品用、食品添加剤の他、医薬、化粧品、飼料などとしても用いることができる。 The menopausal disorder improving agent of the present invention can be used not only for the above-mentioned foods (including health foods and health promoters), nutritional supplements, and food additives, but also for medicines, cosmetics, feeds, and the like.
　本発明の更年期障害改善剤が医薬の形態である場合（例えば、医薬組成物である場合）は、カイコハナサナギタケの粉末又は抽出物と共に必要に応じて薬学的に許容可能な賦形剤を組み合わせることができる。 When the menopausal disorder improving agent of the present invention is in the form of a pharmaceutical (for example, when it is a pharmaceutical composition), a pharmaceutically acceptable excipient may be combined with the powder or extract of Silkophora anagitake, if necessary. Can be done.
　本発明は、カイコハナサナギタケの粉末又は抽出物の使用も包含する。すなわち、本発明は、前記更年期障害改善剤を製造するためのカイコハナサナギタケの粉末又は抽出物の使用（又は使用方法）を包含する。 The present invention also encompasses the use of powder or extract of Silkworm. That is, the present invention encompasses the use (or method of use) of powder or extract of Silkworm for producing the menopausal disorder improving agent.
　また、本発明はカイコハナサナギタケの粉末又は抽出物を投与する方法を包含する。すなわち、本発明は、更年期障害の改善又は予防が必要な対象にカイコハナサナギタケの粉末又は抽出物を投与する方法を包含する。斯かる方法におけるカイコハナサナギタケの粉末又は抽出物は、本発明の更年期障害改善剤に含まれるカイコハナサナギタケの粉末又は抽出物と同様である。更年期障害改善又は予防が必要な対象は、ヒト又はヒト以外の動物である。 The present invention also encompasses a method of administering powder or extract of Silkophora anagitake. That is, the present invention encompasses a method of administering powder or extract of Silkworm to a subject in need of improving or preventing menopausal symptoms. The powder or extract of Silkworm in such a method is the same as the powder or extract of Silkhophana anagitake contained in the menopausal disorder improving agent of the present invention. The subject in need of improvement or prevention of menopausal symptoms is a human or a non-human animal.
　また、本発明は更年期障害の改善又は予防における使用のためのカイコハナサナギタケの粉末又は抽出物を包含する。斯かるカイコハナサナギタケの粉末又は抽出物は、本発明の更年期障害改善剤に含まれるカイコハナサナギタケの粉末又は抽出物と同様である。 The present invention also encompasses a powder or extract of Silkophora anagitake for use in ameliorating or preventing menopausal disorders. Such a powder or extract of Silkum chinensis is the same as the powder or extract of Silkum chinensis contained in the menopausal disorder improving agent of the present invention.
　本開示に包含される発明を特定するにあたり、本開示の各実施形態で説明した各構成（性質、構造、機能等）は、どのように組み合わせられてもよい。すなわち、本開示には、本明細書に記載される組み合わせ可能な各構成のあらゆる組み合わせからなる主題が全て包含される。 In specifying the invention included in the present disclosure, each configuration (property, structure, function, etc.) described in each embodiment of the present disclosure may be combined in any manner. That is, the present disclosure includes all subject matter consisting of all combinations of the combinable structures described in this specification.
　以下、実施例により本発明をより具体的に説明するが、本発明はこれら実施例の態様に限定されるものではない。 Hereinafter, the present invention will be explained in more detail with reference to Examples, but the present invention is not limited to the embodiments of these Examples.
　（実施例１）
　カイコ蛹を宿主として得られるハナサナギタケ（カイコハナサナギタケ）を凍結乾燥し、ミキサーで粉砕することによりカイコハナサナギタケ粉末を得た。得られたカイコハナサナギタケ粉末２００ｍｇをハードカプセルへ充填することで、更年期障害改善剤サンプルとして調製した。 (Example 1)
Silkworm powder was obtained by freeze-drying the silkworm Pupae obtained using the silkworm pupa as a host and pulverizing it with a mixer. A sample of a menopausal disorder improving agent was prepared by filling 200 mg of the obtained silkworm powder into hard capsules.
　（試験例）
　スクリーニングにより選定した被験者２０名（男性１４人、女性６人）に、４週間にわたって、実施例１で得られたサンプルを一日２回摂取させた。１回あたりの摂取では４カプセル（カイコハナサナギタケ粉末として１日摂取量１，６００ｍｇ）とした。摂取前、摂取２週間後及び４週間後に各被験者に下記のアンケートを実施し、アンケートにおける質問毎に「なし１点｜軽度２点｜中程度３点｜重度４点｜極めて重度５点」と点数をつけ、このアンケート結果に基づいて更年期障害改善作用について評価した。
＜アンケート＞
Ｑ１：肉体的、精神的健康状態の低下を感じる自覚症状がある。
Ｑ２：関節痛や筋肉痛がある。腰痛、筋肉痛、手足の痛み、背中全体の痛みなどがある。
Ｑ３：汗をよくかく。思いがけず、突然発汗する。緊張していないのにのぼせる。
Ｑ４：睡眠障害がある。寝付けない。しばしば目が覚める。早く目が覚め、疲れを感じる。睡眠不足があり、眠れない。
Ｑ５：睡眠の欲求が強く、しばしば疲労感がある。
Ｑ６：怒りっぽく、イライラする。小さなことですぐにカッとなる。不機嫌になる。
Ｑ７：神経過敏である。緊張感がある。つねにそわそわして落ち着かない。
Ｑ８：不安症、心配性、パニックになりやすい。
Ｑ９：身体的疲労、活力不足、能力全体の低下、活動の低下、余暇活動への興味の低下が
ある。無気力、達成感がない、何かをするのに無理に奮い立たせないとできない。
Ｑ１０：筋力が低下してきた。弱くなってきたと感じる。
Ｑ１１：憂鬱気味で落ち込みやすい。もの悲しい。泣きそうな感じ。意欲減退、無力感がある。気分の浮き沈みが激しい。
Ｑ１２：「燃え尽きた」「どん底状態にある」と感じる。 (Test example)
Twenty subjects (14 men, 6 women) selected through screening were made to ingest the sample obtained in Example 1 twice a day for 4 weeks. Each intake was 4 capsules (daily intake of 1,600 mg as silkworm powder). The following questionnaire was administered to each subject before intake, 2 weeks after intake, and 4 weeks after intake, and each question in the questionnaire was answered as ``None'' (1 point | Mild 2 points | Moderate 3 points | Severe 4 points | Extremely severe 5 points). A score was given, and the effect on improving menopausal symptoms was evaluated based on the results of this questionnaire.
<Questionnaire>
Q1: I have subjective symptoms of a decline in my physical and mental health.
Q2: I have joint pain or muscle pain. You may experience lower back pain, muscle pain, pain in your limbs, or pain throughout your back.
Q3: I sweat a lot. Suddenly, you start sweating. I get excited even though I'm not nervous.
Q4: I have a sleep disorder. I can't sleep. I wake up often. I wake up early and feel tired. I'm sleep deprived and can't sleep.
Q5: I have a strong need for sleep and often feel tired.
Q6: I get angry and irritated. I get angry easily over small things. Become grumpy.
Q7: I am nervous. I feel nervous. I'm always fidgety and restless.
Q8: I tend to have anxiety, worry, and panic easily.
Q9: I have physical fatigue, lack of energy, decreased overall ability, decreased activity, and decreased interest in leisure activities. Feeling lethargic, lacking a sense of accomplishment, and having to force myself to do something.
Q10: My muscle strength has decreased. I feel like I'm getting weaker.
Q11: I feel depressed and easily depressed. Sad. I feel like I'm about to cry. There is a loss of motivation and a feeling of helplessness. I have severe mood swings.
Q12: I feel "burned out" and "at rock bottom."
　上記アンケートのうち、Ｑ６はイライラ感、Ｑ７は神経過敏、Ｑ１０は筋力低下、Ｑ１１は憂鬱を判断する指標とした。 Of the above questionnaires, Q6 was used as an index to judge irritability, Q7 was used as an index to judge nervousness, Q10 was used as an index for muscle weakness, and Q11 was used as an index for determining depression.
　図１～４は、それぞれＱ６（イライラ感）、Ｑ７（神経過敏）、Ｑ１０（筋力低下）、Ｑ１１（憂鬱）に対する被験者２０名（横軸に１～２０で表記）のアンケート結果に基づく点数（縦軸）を示している。なお、図１～４のグラフでは、横軸の各被験者１～２０における３つの棒グラフは左から順に摂取前、摂取開始から２週間後、摂取開始から４週間後のアンケート結果に基づく点数を示している。 Figures 1 to 4 show scores based on the questionnaire results of 20 subjects (expressed as 1 to 20 on the horizontal axis) for Q6 (irritability), Q7 (irritability), Q10 (muscle weakness), and Q11 (depression), respectively. (vertical axis). In addition, in the graphs of Figures 1 to 4, the three bar graphs for each subject 1 to 20 on the horizontal axis indicate the scores based on the questionnaire results from the left, before intake, 2 weeks after the start of intake, and 4 weeks after the start of intake. ing.
　図１～４の結果より、２０名のうち少なくとも５名以上に改善傾向がみられたことから、更年期障害改善剤の摂取により、筋量低下の改善、神経過敏の改善、イライラ感の抑制及び憂鬱感の抑制効果が発現したことがわかる。 From the results shown in Figures 1 to 4, at least 5 of the 20 patients showed an improvement trend. Therefore, by taking the menopausal disorder improving agent, it was possible to improve muscle mass loss, improve nervousness, suppress irritability, and It can be seen that the effect of suppressing depression was exerted.

Claims (5)

  1. カイコハナサナギタケの粉末又は抽出物を含む、更年期障害改善剤。 A climacteric disorder improving agent containing powder or extract of Silkworm.
  2. 筋量低下の予防又は改善、神経過敏の予防又は改善、イライラ感の抑制及び憂鬱感の抑制からなる群より選択される少なくとも１種のために用いられる、請求項１に記載の更年期障害改善剤。 The menopausal disorder improving agent according to claim 1, which is used for at least one selected from the group consisting of prevention or improvement of muscle loss, prevention or improvement of nervousness, suppression of irritability, and suppression of depression. .
  3. 飲食品組成物の形態である、請求項１又は２に記載の更年期障害改善剤。 The menopausal disorder improving agent according to claim 1 or 2, which is in the form of a food or drink composition.
  4. 栄養補助食品組成物の形態である、請求項１又は２に記載の更年期障害改善剤。 The menopausal disorder improving agent according to claim 1 or 2, which is in the form of a nutritional supplement composition.
  5. 食品添加剤の形態である、請求項１又は２に記載の更年期障害改善剤。 The menopausal disorder improving agent according to claim 1 or 2, which is in the form of a food additive.
PCT/JP2023/019237 2022-06-23 2023-05-24 Climacteric disorder ameliorating agent WO2023248689A1 (en)

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Citations (3)

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JP2004300104A (en) * 2003-04-01 2004-10-28 Nasu Bio Farm:Kk Female hormone deficiency remedy
JP2020080857A (en) * 2018-11-14 2020-06-04 株式会社テクノスルガ・ラボ Composition for promoting male hormone secretion
WO2021025103A1 (en) * 2019-08-07 2021-02-11 株式会社 沖縄Ｕｋａｍｉ養蚕 Composition for inhibiting reduction of testosterone and/or dihydrotestosterone

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JP2004300104A (en) * 2003-04-01 2004-10-28 Nasu Bio Farm:Kk Female hormone deficiency remedy
JP2020080857A (en) * 2018-11-14 2020-06-04 株式会社テクノスルガ・ラボ Composition for promoting male hormone secretion
WO2021025103A1 (en) * 2019-08-07 2021-02-11 株式会社 沖縄Ｕｋａｍｉ養蚕 Composition for inhibiting reduction of testosterone and/or dihydrotestosterone

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