WO2023248688A1 - Testosterone secretagogue - Google Patents

Testosterone secretagogue Download PDF

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Publication number
WO2023248688A1
WO2023248688A1 PCT/JP2023/019236 JP2023019236W WO2023248688A1 WO 2023248688 A1 WO2023248688 A1 WO 2023248688A1 JP 2023019236 W JP2023019236 W JP 2023019236W WO 2023248688 A1 WO2023248688 A1 WO 2023248688A1
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Prior art keywords
testosterone
extract
powder
silkworm
present
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PCT/JP2023/019236
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French (fr)
Japanese (ja)
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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 WO2023248688A1 publication Critical patent/WO2023248688A1/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
    • 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
    • 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
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/63—Arthropods
    • A61K35/64—Insects, e.g. bees, wasps or fleas
    • 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
    • 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
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26—Androgens

Definitions

  • the present invention relates to a testosterone secretion promoter.
  • Testosterone is one of the male hormones, and it has a great influence on maintaining mental and physical vitality, sexual function, memory, cognition, etc., and is also important not only for men but also for women. Since it is a hormone, it has received a lot of attention in recent years. Testosterone levels tend to decrease with age, leading to problems such as loss of muscle mass and loss of vitality, and in the long term can lead to metabolic diseases such as diabetes and metabolic syndrome. From this viewpoint, development of testosterone secretion promoters for improving testosterone levels has been widely conducted (for example, Patent Document 1, etc.).
  • an object of the present invention is to provide a novel testosterone secretion promoter.
  • the present inventors discovered for the first time that the powder or extract of Silkophora anagitake has the ability to promote testosterone secretion, leading to the completion of the present invention.
  • the present invention includes, for example, the subject matter described in the following sections.
  • Item 1 A testosterone secretion stimulant containing powder or extract of Silkworm.
  • Section 2 The testosterone secretion promoter according to claim 1, which is in the form of a food or drink composition.
  • Section 3 The testosterone secretion enhancer according to claim 1, which is in the form of a nutritional supplement composition.
  • Section 4 The testosterone secretion promoter according to claim 1, which is in the form of a food additive.
  • Section 5 Use of a powder or extract of Silkophora anagitake for producing the testosterone secretion enhancer according to any one of items 1 to 4 above.
  • Section 6 A method of administering powder or extract of Silkworm to a subject who needs to promote testosterone secretion.
  • Section 7 Powder or extract of Silkophora anagitake for use in promoting testosterone secretion.
  • a testosterone secretion promoter can be provided.
  • Such a testosterone secretion promoter can promote the secretion of testosterone, thereby increasing the testosterone level and maintaining the testosterone level.
  • the measurement results of the testosterone concentration before and after ingestion are shown.
  • (a) shows the change in testosterone concentration after ingestion in a male test subject
  • (b) shows the change in testosterone concentration in a female test subject after ingestion.
  • 2 is a graph showing changes in testosterone concentration according to age, where (a) is a graph showing changes in testosterone concentration according to age in men, and (b) is a graph showing changes in testosterone concentration in women according to age.
  • the present invention includes a testosterone secretion promoter containing Silkophora anagitake or an extract thereof.
  • the testosterone secretion promoter of the present invention has Silkorophyllacea chinensis as an essential ingredient, or has an extract of Silkum chinensis as an essential ingredient.
  • the testosterone secretion enhancer of the present invention can also contain both Silkophora anagitake and an extract thereof.
  • Silkworm or an extract thereof is an active ingredient in the testosterone secretion promoter.
  • 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).
  • 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, and others such as 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 water content in the extract of Silkum chinensis is not particularly limited, and can 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 testosterone secretion enhancer can 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 may be included in known testosterone secretion promoters, 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 testosterone secretion promoter may also include known testosterone secretion promoters in addition to the powder of Silkophora anagitake or an extract thereof.
  • the content ratio of Silkophora anagitake or its extract contained in the testosterone secretion promoter 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 testosterone secretion promoter 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 testosterone secretion promoter of the present invention is preferably taken orally, for example, and may be taken in other ways.
  • the testosterone secretion promoter of the present invention can be ingested or administered to humans or animals (excluding humans; the same applies hereinafter), and can promote the secretion of testosterone to increase the testosterone level, or can increase the testosterone level by promoting the secretion of testosterone. can result in value maintenance. Therefore, the testosterone secretion promoter of the present invention can be suitably used for controlling testosterone levels.
  • the intake (administration) amount of the testosterone secretion enhancer of the present invention is not particularly limited as long as the desired effect is achieved, and depends on the physique, age, symptoms, application form, purpose of use, etc. of the subject (or subject animal). It can be set as appropriate.
  • the daily intake (administration) amount of the testosterone secretion enhancer 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 testosterone secretion promoter 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 testosterone secretion promoter. Such food and drink compositions are suitably used for promoting testosterone secretion.
  • 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 testosterone secretion promoter of the present invention can be in the form of a nutritional supplement. That is, the present invention also encompasses nutritional supplement compositions containing testosterone secretagogues. Such a nutritional supplement composition is suitably used for promoting testosterone secretion.
  • the nutritional supplement composition can be used, for example, as a supplement, and is suitable as a so-called doctor's supplement.
  • the testosterone secretion promoter of the present invention can be in the form of a food additive. That is, the present invention also includes food additives containing testosterone secretion promoters. Such food additives are suitably used for promoting testosterone secretion.
  • the food in the food additive is exemplified by the same types as the food in the food/beverage composition described above.
  • the testosterone secretion promoter 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.
  • testosterone secretion enhancer of the present invention is in the form of a pharmaceutical (e.g., 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 testosterone secretion promoter.
  • 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 promoting testosterone secretion.
  • the powder or extract of Silkworm in such a method is the same as that contained in the testosterone secretion promoter of the present invention.
  • the subject in need of testosterone secretion promotion is a human or a non-human animal.
  • the present invention also encompasses a powder or extract of Silkophora anagitake for use in promoting testosterone secretion.
  • a powder or extract of Silkophora anagitake is similar to the powder or extract of Silkum chinensis contained in the testosterone secretion promoter 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 testosterone secretion promoter sample was prepared by filling 200 mg of the obtained silkworm powder into hard capsules.
  • Testosterone concentration was measured by collecting saliva from 20 subjects (14 men, 6 women) selected through screening, using a test kit (HP Testing) owned by Hormone Testing LLC. This test measures the concentration of free testosterone from saliva samples, and is a test method known to have a correlation with blood concentration.
  • the study design was an open-label asymmetric study (no placebo setting). First, the testosterone concentration before ingestion of the testosterone secretion enhancer was recorded, and then, starting from the following week, for 4 weeks, the subjects were asked to ingest the sample obtained in Example 1 twice a day, and each intake consisted of 4 capsules. (The daily intake was 1,600 mg as silkworm powder).
  • the testosterone concentration of each subject was measured at 2nd and 4th week from the start of intake, and the promotion of testosterone secretion was evaluated. Specifically, before starting intake (week 0), the testosterone concentration was measured a total of three times on Monday, Wednesday, and Friday, and then intake was started on the first Monday (week 1), and the following Testosterone concentration was measured a total of three times on Monday, Wednesday, and Friday, and the average value was calculated, which was taken as the measured value for the second week of intake. Next, no measurement was made in the third week, but the testosterone concentration was measured three times in total on Monday, Wednesday, and Friday in the fourth week, and the average value was calculated, which was taken as the measured value in the fourth week after the start of intake.
  • FIG. 1 shows the change in testosterone concentration after ingestion by a male subject (FIG. 1(a)) and the change in testosterone concentration after ingestion by a female subject (FIG. 1(b)).
  • the vertical axis is the testosterone concentration
  • base means the testosterone concentration before ingestion of the testosterone secretion promoter.
  • FIG. 2 is a graph showing changes in testosterone concentration by age group, where (a) is a graph showing changes in testosterone concentration by age group for men, and (b) is a graph showing changes in testosterone concentration for women by age group.
  • the three bar graphs for each age group on the horizontal axis indicate, from the left, the testosterone concentration before intake, the second week after the start of intake, and the fourth week after the start of intake.
  • the testosterone secretion enhancer containing the Silkworm extract has the effect of increasing testosterone levels.
  • the average testosterone levels for men in their 30s to 70s were 116 (for men in their 30s), 101 (for men in their 40s), and 92. (in their 50s), 61 (in their 70s), and women in their 40s, 29 (in their 50s), 31 (in their 50s), and 18 (in their 60s). A significant effect of increasing the value was observed.

Abstract

Provided is a novel testosterone secretagogue.　A testosterone secretagogue according to the present invention contains a powder or extract of Paecilomyces tenuipes. This testosterone secretagogue promotes the secretion of testosterone and can cause an increase in a testosterone level, the maintenance of a testosterone level, and the like. A testosterone secretagogue according to the present invention is preferably in the form of a food and drink composition, a nutritional supplementary food composition, or a food additive.

Description

テストステロン分泌促進剤Testosterone secretion enhancer
　本発明は、テストステロン分泌促進剤に関する。 The present invention relates to a testosterone secretion promoter.
　テストステロンは、男性ホルモンの１つであり、精神的／肉体的な元気さの維持、性機能、記憶力、認知力などに大きく影響を与えるものであり、また、男性のみならず女性においても重要なホルモンであることから近年、多くの関心が寄せられている。テストステロンは、加齢によってその値が低下する傾向にあり、これにより筋量低下、活力減退等の問題が生じ、長期的には、糖尿病、メタボリックシンドローム等の代謝疾患を引き起こし得る。この観点から、テストステロン値を向上させるためのテストステロン分泌促進剤の開発が広く行われている（例えば、特許文献１等）。 Testosterone is one of the male hormones, and it has a great influence on maintaining mental and physical vitality, sexual function, memory, cognition, etc., and is also important not only for men but also for women. Since it is a hormone, it has received a lot of attention in recent years. Testosterone levels tend to decrease with age, leading to problems such as loss of muscle mass and loss of vitality, and in the long term can lead to metabolic diseases such as diabetes and metabolic syndrome. From this viewpoint, development of testosterone secretion promoters for improving testosterone levels has been widely conducted (for example, Patent Document 1, etc.).
特開２０１３－１８１０３１号公報Japanese Patent Application Publication No. 2013-181031
　上記事情より、新規なテストステロン分泌促進剤が求められているところ、本発明は、新規なテストステロン分泌促進剤を提供することを課題とする。 Due to the above circumstances, a novel testosterone secretion promoter is required, and an object of the present invention is to provide a novel testosterone secretion promoter.
　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テストステロン分泌促進を有す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 to achieve the above object, the present inventors discovered for the first time that the powder or extract of Silkophora anagitake has the ability to promote testosterone secretion, 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、テストステロン分泌促進剤。
項２
飲食品組成物の形態である、請求項１に記載のテストステロン分泌促進剤。
項３
栄養補助食品組成物の形態である、請求項１に記載のテストステロン分泌促進剤。
項４
食品添加剤の形態である、請求項１に記載のテストステロン分泌促進剤。
項５
前記項１～４のいずれか１項に記載のテストステロン分泌促進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６
テストステロン分泌促進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７
テストステロン分泌促進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 testosterone secretion stimulant containing powder or extract of Silkworm.
Section 2
The testosterone secretion promoter according to claim 1, which is in the form of a food or drink composition.
Section 3
The testosterone secretion enhancer according to claim 1, which is in the form of a nutritional supplement composition.
Section 4
The testosterone secretion promoter according to claim 1, which is in the form of a food additive.
Section 5
Use of a powder or extract of Silkophora anagitake for producing the testosterone secretion enhancer according to any one of items 1 to 4 above.
Section 6
A method of administering powder or extract of Silkworm to a subject who needs to promote testosterone secretion.
Section 7
Powder or extract of Silkophora anagitake for use in promoting testosterone secretion.
　本発明によれば、テストステロン分泌促進剤を提供することができる。斯かるテストステロン分泌促進剤により、テストステロンの分泌が促進され、テストステロン値の上昇、テストステロン値の維持等をもたらすことができる。 According to the present invention, a testosterone secretion promoter can be provided. Such a testosterone secretion promoter can promote the secretion of testosterone, thereby increasing the testosterone level and maintaining the testosterone level.
摂取前後のテストステロン濃度の測定結果を示し、（ａ）は男性の被験者の摂取後のテストステロン濃度変化、（ｂ）は女性の被験者の摂取後のテストステロン濃度変化を示している。The measurement results of the testosterone concentration before and after ingestion are shown. (a) shows the change in testosterone concentration after ingestion in a male test subject, and (b) shows the change in testosterone concentration in a female test subject after ingestion. 年代別のテストステロン濃度変化であって、（ａ）は男性、（ｂ）は女性の年代別のテストステロン濃度変化を示すグラフである。2 is a graph showing changes in testosterone concentration according to age, where (a) is a graph showing changes in testosterone concentration according to age in men, and (b) is a graph showing changes in testosterone concentration in women according to age.
　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テストステロン分泌促進剤を包含する。 The present invention includes a testosterone secretion promoter containing Silkophora anagitake or an extract thereof.
　本発明のテストステロン分泌促進剤は、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。本発明のテストステロン分泌促進剤は、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。テストステロン分泌促進剤において、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 testosterone secretion promoter of the present invention has Silkorophyllacea chinensis as an essential ingredient, or has an extract of Silkum chinensis as an essential ingredient. The testosterone secretion enhancer of the present invention can also contain both Silkophora anagitake and an extract thereof. Silkworm or an extract thereof is an active ingredient in the testosterone secretion promoter.
　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.
　テストステロン分泌促進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 testosterone secretion promoter 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).
　テストステロン分泌促進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。 When the testosterone secretion enhancer contains an extract of Silkophora anagitake, 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, and others such as 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.
　テストステロン分泌促進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 testosterone secretion stimulant contains an extract of Silkum chinensis, the water content in the extract of Silkum chinensis is not particularly limited, and can 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.
　テストステロン分泌促進剤は、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、公知のテストステロン分泌促進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。テストステロン分泌促進剤は、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テストステロン分泌促進剤も含むことができる。 The testosterone secretion enhancer can 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 may be included in known testosterone secretion promoters, 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 testosterone secretion promoter may also include known testosterone secretion promoters in addition to the powder of Silkophora anagitake or an extract thereof.
　テストステロン分泌促進剤に含まれる、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 Silkophora anagitake or its extract contained in the testosterone secretion promoter 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.
　本発明のテストステロン分泌促進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 testosterone secretion promoter 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.
　本発明のテストステロン分泌促進剤は、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 testosterone secretion promoter of the present invention is preferably taken orally, for example, and may be taken in other ways.
　本発明のテストステロン分泌促進剤は、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、テストステロンの分泌を促進させてテストステロン値を上昇させることができ、あるいは、テストステロン値の維持をもたらすことができる。従って、本発明のテストステロン分泌促進剤は、テストステロン値を制御する用途に好適に使用することができる。 The testosterone secretion promoter of the present invention can be ingested or administered to humans or animals (excluding humans; the same applies hereinafter), and can promote the secretion of testosterone to increase the testosterone level, or can increase the testosterone level by promoting the secretion of testosterone. can result in value maintenance. Therefore, the testosterone secretion promoter of the present invention can be suitably used for controlling testosterone levels.
　本発明のテストステロン分泌促進剤の摂取（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日当たりのテストステロン分泌促進剤の摂取（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 testosterone secretion enhancer of the present invention is not particularly limited as long as the desired effect is achieved, and depends on the physique, age, symptoms, application form, 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 testosterone secretion enhancer 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.
　本発明のテストステロン分泌促進剤は、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、テストステロン分泌促進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、テストステロン分泌促進用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 testosterone secretion promoter 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 testosterone secretion promoter. Such food and drink compositions are suitably used for promoting testosterone secretion. 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.).
　本発明のテストステロン分泌促進剤は、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、テストステロン分泌促進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、テストステロン分泌促進用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 testosterone secretion promoter of the present invention can be in the form of a nutritional supplement. That is, the present invention also encompasses nutritional supplement compositions containing testosterone secretagogues. Such a nutritional supplement composition is suitably used for promoting testosterone secretion. The nutritional supplement composition can be used, for example, as a supplement, and is suitable as a so-called doctor's supplement.
　本発明のテストステロン分泌促進剤は、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、テストステロン分泌促進剤を含む食品添加剤も包含する。斯かる食品添加剤は、テストステロン分泌促進用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 testosterone secretion promoter of the present invention can be in the form of a food additive. That is, the present invention also includes food additives containing testosterone secretion promoters. Such food additives are suitably used for promoting testosterone secretion. The food in the food additive is exemplified by the same types as the food in the food/beverage composition described above.
　本発明のテストステロン分泌促進剤は、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 testosterone secretion promoter 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.
　本発明のテストステロン分泌促進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 testosterone secretion enhancer of the present invention is in the form of a pharmaceutical (e.g., 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、前記テストステロン分泌促進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 testosterone secretion promoter.
　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、テストステロン分泌促進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、本発明のテストステロン分泌促進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。テストステロン分泌促進が必要な対象は、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 promoting testosterone secretion. The powder or extract of Silkworm in such a method is the same as that contained in the testosterone secretion promoter of the present invention. The subject in need of testosterone secretion promotion is a human or a non-human animal.
　また、本発明はテストステロン分泌促進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、本発明のテストステロン分泌促進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 promoting testosterone secretion. Such a powder or extract of Silkophora anagitake is similar to the powder or extract of Silkum chinensis contained in the testosterone secretion promoter 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、テストステロン分泌促進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 testosterone secretion promoter sample was prepared by filling 200 mg of the obtained silkworm powder into hard capsules.
　（試験例）
　テストステロン濃度の測定は、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）の唾液採取により、ホルモンテスティング合同会社所有の検査キット（ＨＰテスティング）を用いて測定した。本検査は、唾液検体から遊離テストステロンの濃度を測定するものであり、血液中濃度と相関があることが知られた検査法である。試験デザインは、非盲検非対称試験（プラセボ設定なし）とした。まず、テストステロン分泌促進剤の摂取前のテストステロン濃度を記録し、その後、翌週から４週間にわたって、被験者に実施例１で得られたサンプルを一日２回摂取させ、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。摂取開始から２週目及び４週目の各被験者のテストステロン濃度を測定し、テストステロン分泌促進について評価した。具体的には、摂取を開始する前（０週目）は、月曜日、水曜日及び金曜日の計３回テストステロン濃度を測定し、その後、最初の月曜日に摂取を開始し（１週目）、次の月曜日、水曜日及び金曜日の計３回テストステロン濃度を測定して平均値を算出し、摂取開始２週目の測定値とした。次いで、３週目は測定をせず、４週目の月曜日、水曜日及び金曜日の計３回テストステロン濃度を測定して平均値を算出し、摂取開始４週目の測定値とした。 (Test example)
Testosterone concentration was measured by collecting saliva from 20 subjects (14 men, 6 women) selected through screening, using a test kit (HP Testing) owned by Hormone Testing LLC. This test measures the concentration of free testosterone from saliva samples, and is a test method known to have a correlation with blood concentration. The study design was an open-label asymmetric study (no placebo setting). First, the testosterone concentration before ingestion of the testosterone secretion enhancer was recorded, and then, starting from the following week, for 4 weeks, the subjects were asked to ingest the sample obtained in Example 1 twice a day, and each intake consisted of 4 capsules. (The daily intake was 1,600 mg as silkworm powder). The testosterone concentration of each subject was measured at 2nd and 4th week from the start of intake, and the promotion of testosterone secretion was evaluated. Specifically, before starting intake (week 0), the testosterone concentration was measured a total of three times on Monday, Wednesday, and Friday, and then intake was started on the first Monday (week 1), and the following Testosterone concentration was measured a total of three times on Monday, Wednesday, and Friday, and the average value was calculated, which was taken as the measured value for the second week of intake. Next, no measurement was made in the third week, but the testosterone concentration was measured three times in total on Monday, Wednesday, and Friday in the fourth week, and the average value was calculated, which was taken as the measured value in the fourth week after the start of intake.
　図１は、男性の被験者の摂取後のテストステロン濃度変化（図１（ａ））及び女性の被験者の摂取後のテストステロン濃度変化（図１（ｂ））を示している。なお、図１において、縦軸はテストステロン濃度であり、「ｂａｓｅ」は、テストステロン分泌促進剤の摂取前のテストステロン濃度を意味する。 FIG. 1 shows the change in testosterone concentration after ingestion by a male subject (FIG. 1(a)) and the change in testosterone concentration after ingestion by a female subject (FIG. 1(b)). In addition, in FIG. 1, the vertical axis is the testosterone concentration, and "base" means the testosterone concentration before ingestion of the testosterone secretion promoter.
　図２は、年代別のテストステロン濃度変化であって、（ａ）は男性、（ｂ）は女性の年代別のテストステロン濃度変化を示すグラフである。なお、図２のグラフでは、横軸の各年代における３つの棒グラフは左から順に摂取前、摂取開始から２週目、摂取開始から４週目のテストステロン濃度を示している。 FIG. 2 is a graph showing changes in testosterone concentration by age group, where (a) is a graph showing changes in testosterone concentration by age group for men, and (b) is a graph showing changes in testosterone concentration for women by age group. In the graph of FIG. 2, the three bar graphs for each age group on the horizontal axis indicate, from the left, the testosterone concentration before intake, the second week after the start of intake, and the fourth week after the start of intake.
　図１及び図２の結果から、カイコハナサナギタケ抽出物を含むテストステロン分泌促進剤にはテストステロン値を上昇させる作用が存在することが確認された。３０代から７０代までの各年代のテストステロン値の平均値（２０名ないし１０名のデータをランダムに抽出して平均値を算出）が男性で１１６（３０代）、１０１（４０代）、９２（５０代）、６１（７０代）、女性で２９（４０代）、３１（５０代）、１８（６０代）であることを考えれば、カイコハナサナギタケ抽出物を含むテストステロン分泌促進剤は、テストステロン値を上昇させる作用が有意に見られた。 From the results shown in Figures 1 and 2, it was confirmed that the testosterone secretion enhancer containing the Silkworm extract has the effect of increasing testosterone levels. The average testosterone levels for men in their 30s to 70s (randomly extracting data from 20 to 10 people and calculating the average) were 116 (for men in their 30s), 101 (for men in their 40s), and 92. (in their 50s), 61 (in their 70s), and women in their 40s, 29 (in their 50s), 31 (in their 50s), and 18 (in their 60s). A significant effect of increasing the value was observed.
　以上の結果は、本発明のテストステロン分泌促進剤は、テストステロン値の上昇又はテストステロン値の維持をもたらすことができることを支持している。 The above results support that the testosterone secretion promoter of the present invention can increase or maintain testosterone levels.

Claims (4)

  1. カイコハナサナギタケの粉末又は抽出物を含む、テストステロン分泌促進剤。 A testosterone secretion stimulant containing powder or extract of Silkworm.
  2. 飲食品組成物の形態である、請求項１に記載のテストステロン分泌促進剤。 The testosterone secretion promoter according to claim 1, which is in the form of a food or drink composition.
  3. 栄養補助食品組成物の形態である、請求項１に記載のテストステロン分泌促進剤。 The testosterone secretion enhancer according to claim 1, which is in the form of a nutritional supplement composition.
  4. 食品添加剤の形態である、請求項１に記載のテストステロン分泌促進剤。 The testosterone secretion promoter according to claim 1, which is in the form of a food additive.
PCT/JP2023/019236 2022-06-23 2023-05-24 Testosterone secretagogue WO2023248688A1 (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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