WO2020226022A1 - 育毛・発毛用外用剤 - Google Patents

育毛・発毛用外用剤 Download PDF

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Publication number
WO2020226022A1
WO2020226022A1 PCT/JP2020/015912 JP2020015912W WO2020226022A1 WO 2020226022 A1 WO2020226022 A1 WO 2020226022A1 JP 2020015912 W JP2020015912 W JP 2020015912W WO 2020226022 A1 WO2020226022 A1 WO 2020226022A1
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Prior art keywords
aspergillus
hair growth
fermented
alopecia
extract
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PCT/JP2020/015912
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English (en)
French (fr)
Japanese (ja)
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正博 山元
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一般社団法人夢源
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Priority to JP2021518323A priority Critical patent/JP7170357B2/ja
Publication of WO2020226022A1 publication Critical patent/WO2020226022A1/ja

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    • 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
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/82—Theaceae (Tea family), e.g. camellia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9728—Fungi, e.g. yeasts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9794—Liliopsida [monocotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/14—Drugs for dermatological disorders for baldness or alopecia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q7/00—Preparations for affecting hair growth
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/14—Fungi; Culture media therefor
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/20—Bacteria; Culture media therefor
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P60/00—Technologies relating to agriculture, livestock or agroalimentary industries
    • Y02P60/80—Food processing, e.g. use of renewable energies or variable speed drives in handling, conveying or stacking
    • Y02P60/87—Re-use of by-products of food processing for fodder production

Definitions

  • the present invention relates to an external skin agent for hair growth and hair growth and a therapeutic agent for alopecia, which contains a fermented aspergillus or an extract of the fermented aspergillus.
  • Jiuqu is steamed rice, rice bran, wheat, beans, etc. and propagated aspergillus.
  • rice jiuqu rice that propagates aspergillus.
  • Jiuqu is known to have the function of producing various types of enzymes that enable the production of fermented foods, but it is not limited to this type of field, and research on new functions of aspergillus and its functions. Development of based applications is underway by the inventor of the present application.
  • Patent Document 2 it is reported that a feed obtained by fermenting grains or the like with Jiuqu bacteria promotes the growth of animals, and in Patent Document 3, a Jiuqu fermentation composition obtained by inoculating tea leaves with Jiuqu bacteria and culturing them. Has been reported to have antioxidant activity.
  • Patent No. 2733980 Patent No. 611416 International Publication No. 2015/11039
  • minoxidil which is a hair growth component described in Patent Document 1
  • side effects such as a decrease in blood pressure may occur. Therefore, it is expected to provide a new material having higher safety and excellent hair growth / growth effect.
  • Patent Documents 2 and 3 describe fermented koji products obtained by fermenting grains and tea leaves with aspergillus, and the fermented koji products can be used for treating alopecia and promoting hair growth and hair growth. It has not been examined to be used for this purpose, and its effectiveness was unknown.
  • an object of the present invention is to provide an external preparation for hair growth / hair growth and a therapeutic agent for alopecia, which are highly safe and have an excellent hair growth / hair growth effect. There is.
  • the external preparation for hair growth and hair growth or the therapeutic agent for alopecia of the present invention contains a fermented aspergillus fermented with aspergillus or an extract of this fermented aspergillus.
  • This fermented aspergillus and the extract of this fermented aspergillus have an excellent hair growth promoting effect, and further, alopecia such as androgenetic alopecia (male pattern hair loss, androgenetic alopecia) and senile alopecia. It is also useful for treatment, prevention or improvement.
  • the above-mentioned fermented Jiuqu product uses a raw material derived from tea leaves, grains or beans as a fermented raw material. As a result, a suitable raw material for the fermented aspergillus is selected.
  • the above-mentioned aspergillus is black aspergillus or white aspergillus.
  • a suitable aspergillus that brings about a fermented aspergillus that is an active ingredient of the external preparation for hair growth and hair growth of the present invention or the therapeutic agent for alopecia is selected.
  • the external preparation for hair growth / hair growth or the therapeutic agent for alopecia of the present invention further contains lactic acid bacteria.
  • the extract of the fermented aspergillus in the present invention is the water or hydroalcohol-containing extract of the fermented aspergillus.
  • the method for producing an external agent for hair growth / hair growth or a therapeutic agent for alopecia of the present invention includes a step of inoculating a fermentation raw material derived from tea leaves, grains or beans with Jiuqu, and fermenting the fermentation raw material with this Jiuqu. It has a process of obtaining a fermented product of Jiuqu.
  • an external preparation for hair growth / hair growth or a treatment for alopecia which has an excellent hair growth-promoting effect and is useful for treating, preventing or improving alopecia such as androgenetic alopecia and senile alopecia. can get.
  • the method for producing the external agent for hair growth / hair growth or the therapeutic agent for alopecia of the present invention is a step of inoculating a fermentation raw material derived from tea leaves, grains or beans with aspergillus and lactic acid bacteria, and the aspergillus and the lactic acid bacteria. It has a step of fermenting the fermentation raw material to obtain a fermented product of Jiuqu. As a result, an external preparation for hair growth / hair growth or a therapeutic agent for alopecia having an excellent hair growth promoting effect can be obtained.
  • the growth of the aspergillus is promoted and the fermentation by the aspergillus is stably carried out, so that a stable and highly active fermented aspergillus can be obtained and the fermentation period can be shortened.
  • the above-mentioned aspergillus is black aspergillus or white aspergillus.
  • a suitable aspergillus that brings about a fermented aspergillus that is an active ingredient of the external preparation for hair growth and hair growth of the present invention or the therapeutic agent for alopecia is selected.
  • the method for producing an external agent for hair growth / hair growth or a therapeutic agent for alopecia of the present invention may include a step of extracting the obtained fermented aspergillus with water or hydroalcohol to obtain an extract of the fermented aspergillus. preferable.
  • an external preparation for hair growth / hair growth or a therapeutic agent for alopecia having the following excellent effects.
  • the method for producing the fermented aspergillus P1 includes a step S0 for preparing a fermented raw material, a step S1 for adding water to the fermented raw material to absorb water, and a step S2 for steaming the fermented raw material. It is roughly composed of a step S3 of inoculating the steamed fermented raw material with aspergillus and a step S4 of performing fermentation.
  • a plant-derived raw material is selected as the fermentation raw material in the present invention, and plant leaves, stems, roots, flowers and fruits can be used as the fermentation raw material.
  • tea leaves, grains or beans are preferably used, and tea leaves are particularly preferably used as a fermentation raw material.
  • Grains include rice, corn, wheat, barley, rye, oats, sorghum, buckwheat and other minor cereals.
  • tea leaves include not only tea leaves but also stems and branches collected from tea plants.
  • raw tea leaves as they are collected are preferably used, but the tea leaves that have been heat-treated immediately after collection and the oxidase contained in the tea leaves after collection.
  • Oolong tea or black tea obtained by oxidatively fermenting tea leaves in the above, and further fermented tea may be used.
  • tea grounds after decoction of these green tea, oolong tea, black tea and the like can also be used. Further, in order to improve the efficiency of the subsequent steaming treatment and the culture of aspergillus, it is preferable that the tea leaves and tea stems are crushed to a certain size so as not to be too large.
  • water absorption treatment step S1 Next, the water absorption treatment step S1 will be described.
  • water is added to the fermentation raw material, or the fermentation raw material is immersed in water to absorb water.
  • the water absorption amount is adjusted so that, for example, when tea leaves are used as a fermentation raw material, the water content of the tea leaves is 20 to 60%, preferably 30 to 50%.
  • the fermentation raw material absorbed in the above step is placed in a steamer, covered, and the steamer is heated to heat the fermentation raw material with steam.
  • the steaming treatment time is preferably about 30 minutes to 120 minutes, more preferably about 45 minutes to 90 minutes, and particularly preferably about 60 minutes.
  • Aspergillus can be propagated efficiently.
  • the raw material that has been steamed is taken out from the steamer, spread evenly on a table, and cooled to about 30 to 40 ° C. This makes it possible to inoculate the fermented raw material with Jiuqu.
  • the step S3 of inoculating (sowing) the aspergillus into the fermentation raw material will be described.
  • aspergillus is inoculated into the fermentation raw material cooled through the above-mentioned steaming step.
  • the aspergillus is a microorganism mainly used for producing fermented aspergillus foods, and specific examples thereof include black aspergillus, white aspergillus and yellow aspergillus.
  • black aspergillus is a mold of the genus Aspergillus that forms black or dark brown conidia (a type of asexual spore) used in the production of distilled liquor such as awamori in Okinawa and sweet potato shochu in Kagoshima. It refers to a group. Specifically, although not particularly limited, Aspergillus awamori val kawachi (Kawachi black aspergillus), Aspergillus ryukyuensis, Aspergillus awamori, Aspergillus cytoy, Aspergillus inui, Aspergillus Usami, Aspergillus aures, etc. Can be mentioned.
  • Aspergillus kawachii refers to a group of molds of the genus Aspergillus that form white ocher conidia, and specific examples thereof include Aspergillus kawachii.
  • Aspergillus is a group of molds of the genus Aspergillus that form yellow or yellow-green conidia, and is a microorganism mainly used for producing sake, miso, soy sauce, and the like. Specific examples thereof include, but are not limited to, Aspergillus oryzae and Aspergillus sojae.
  • black aspergillus or white aspergillus from the viewpoint of excellent hair growth promoting effect and also having a pH adjusting action for the aspergillus itself to produce citric acid.
  • Aspergillus awamori var. Kawachii Aspergillus awamori var. Kawachii, Aspergillus luchuensis or Aspergillus inuii, Aspergillus inuii, and Aspergillus kawachii, which are white aspergillus.
  • Kawachi black aspergillus is particularly preferable.
  • the inoculation of these aspergillus can be carried out, for example, by mixing the aspergillus with the fermentation raw material in a sterilized bag and stirring the mixture. It is preferable to inoculate the spores of the aspergillus, and it is preferable to inoculate the aspergillus by adding the spores of the aspergillus to 500,000 or more, preferably 1 million or more, with respect to 1 g (dry weight) of the fermentation raw material. For example, when the number of spores contained in 1 g of seed koji is 2 billion, about 0.5 g (0.05% by weight) of seed koji may be added to 1 kg of the fermentation raw material. After inoculating the fermented raw material with Jiuqu, it is preferable to stir well to disperse the Jiuqu throughout the raw material.
  • lactic acid bacteria used in lactic acid bacterium fermented food can be used, for example, Lactobacillus casei, Lactobacillus fermentum, Lactobacillus bulgaricus, etc.
  • Lactobacillus genus Bifidobacterium bifidum and other Bifidum bacteria, Lactococcus lactis and other Lactobacillus genus, Enterococcus faecium and other Enterococcus genus.
  • a lactic acid bacterium that has been cultured in advance may be used, and about 0.1% by weight may be added as a bacterial cell to 1 kg of the fermentation raw material.
  • the fermented aspergillus obtained by fermenting aspergillus and lactic acid bacteria contains various enzymes produced by aspergillus and lactic acid bacteria, as well as aspergillus and its spores and lactic acid bacteria.
  • step S4 in which the aspergillus inoculated into the fermentation raw material is cultured and fermented will be described.
  • aspergillus is propagated on the raw material inoculated with aspergillus.
  • the fermentation raw material to which Jiuqu is added is placed in a culture room kept at about 30 ° C. Fermentation progresses as time passes, and the temperature of fermented raw materials such as tea leaves rises. However, aspergillus generally becomes difficult to grow when the temperature exceeds 40 ° C.
  • the amount of ventilation is adjusted so that the temperature is maintained at 30 ° C. to 42 ° C., preferably 30 ° C. to 40 ° C.
  • the fermentation temperature is appropriately adjusted depending on the type of aspergillus used for fermentation. Specifically, when black aspergillus or white aspergillus is selected as the aspergillus, as an example, the temperature of the fermentation raw material such as tea leaves is adjusted to 35 ° C. to 40 ° C. by ventilation for 12 to 30 hours from the start of culture. To do. After that, the temperature is adjusted to be slightly lower so as to be 30 ° C. to 35 ° C. by adjusting the ventilation volume in the same manner, and a total of 1 to 4 days, preferably 36 to 72 hours, more preferably. The time point of culturing for about 40 to 60 hours is defined as the completion of the fermented aspergillus P1.
  • a machine capable of washing the raw materials, absorbing water, steaming, inoculating the fermented aspergillus and fermenting (jiuqu) in the same device (for example, drum type automatic). It is also possible to use a koji making device, etc.).
  • the obtained fermented Jiuqu product P1 is a so-called "Koji” in which Jiuqu is propagated in the fermentation raw material.
  • This fermented aspergillus P1 is excellent in hair growth and promotion of hair growth, and can treat, prevent or ameliorate alopecia.
  • the fermented aspergillus P1 obtained by the above step is in a state of containing a certain amount of water, but the water can be removed by natural drying or low-temperature dehumidifying drying. It is also possible to pulverize the fermented Jiuqu P1 from which water has been removed into powder or granules.
  • the fermented aspergillus P1 By reducing the water content of the fermented aspergillus P1, it is possible to suppress the activity and growth of aspergillus and lactic acid bacteria in the fermented aspergillus P1, and by further refrigerating, the fermented aspergillus P1 can be stored for a long period of time. It becomes. Even when the water is once removed, the hair growth and hair growth promoting functions of the fermented aspergillus P1 can be effectively maintained.
  • the method for producing the fermented aspergillus extract P2 according to the embodiment of the present invention is the step S5 of adding an extraction solvent to the fermented aspergillus P1 obtained in the above steps S1 to S4. It is roughly composed of.
  • an extraction solvent is added to the fermented aspergillus P1 to perform an extraction treatment to obtain an extract P2 of the fermented aspergillus.
  • the extraction solvent is not particularly limited as long as it can extract a component having a hair growth promoting action from the fermented aspergillus P1, but water or hydroalcohol is preferable from the viewpoint of extraction efficiency and ease of handling.
  • examples of the alcohol used for the hydrous alcohol include ethanol, isopropanol, 1,3-butylene glycol, propylene glycol, glycerin and the like, and one or a combination of two or more of these can be used. is there.
  • a fermentation broth obtained by alcoholic fermentation it is also possible to use a fermentation broth obtained by alcoholic fermentation.
  • brewed liquor or distilled liquor obtained by distilling the brewed liquor can be used, and among these, distilled liquor can be preferably used.
  • the distilled liquor include those derived from grain raw materials such as rice, wheat and corn, those derived from potatoes, those derived from sugar cane, those derived from date palm fruits and the like.
  • the distilled liquor derived from the fruit of date palm contains ethyl palmitate, which is a component that is particularly mild to the skin and is gentle on the skin, and therefore can be selected as a suitable extraction solvent for the production of external preparations.
  • the alcohol concentration of the hydrous alcohol is preferably 1 to 50 v / v%, more preferably 3 to 30 v / v%, and particularly preferably 5 to 15 v / v%.
  • water is used as the extraction solvent, it is preferable to use water that has been sterilized by high-pressure steam sterilization, filtration sterilization, or the like. By using the sterilized water, it is possible to prevent the contamination of various germs, and it is possible to stably extract useful components such as various proteins and enzymes contained in the fermented aspergillus P1.
  • the extraction solvent contains other components such as a pH adjuster, a preservative, and an extraction aid as long as it does not interfere with the extraction of useful components from the fermented aspergillus P1. It is also possible.
  • the fermentation temperature is preferably about 0 to 30 ° C, and preferably about 2 to 20 ° C. Is more preferable, and 4 to 10 ° C. is particularly preferable.
  • the extraction time is preferably about 2 hours to 5 days, more preferably about 6 hours to 3 days, and particularly preferably about 12 hours to 1.5 days.
  • the residue is removed by decantation, centrifugation, filtration, etc. to obtain the extract P2 of the fermented aspergillus.
  • the extract P2 of the fermented aspergillus of the present invention in addition to the extract P2 of the fermented aspergillus obtained in the extraction step S5, the extract P2 is made into a concentrated solution by a concentration treatment such as concentration under reduced pressure, and the fermentation of aspergillus
  • the extract P2 of the product is also subjected to a drying treatment such as a freeze-drying treatment to be solid or powdered.
  • the external agent for hair growth / hair growth or the therapeutic agent for alopecia of the present invention contains the fermented aspergillus P1 fermented with the above-mentioned aspergillus or the extract P2 of the fermented aspergillus as an active ingredient, and has a hair growth action and development. It has a hair-promoting effect and an effect of treating, preventing or ameliorating various alopecia such as androgenetic alopecia and senile alopecia. Therefore, the external preparation containing the fermented aspergillus or the fermented aspergillus extract of the present invention is for pharmaceuticals, quasi-drugs and hair for preventing, treating or ameliorating symptoms such as thinning hair and hair loss and alopecia.
  • the external preparation of the present invention contains a fermented product of Jiuqu, which is also used in food production, as an active ingredient, it is highly safe and can be easily and safely used regardless of age, gender, chronic condition, etc. Is.
  • the content of the fermented aspergillus P1 in the external preparation for hair growth / growth or the therapeutic agent for alopecia of the present invention is preferably about 0.1% by weight to 20% by weight, preferably about 0.3% by weight to 10% by weight. More preferably, about 1% by weight to 5% by weight is particularly preferable.
  • the extract P2 of the fermented aspergillus the extract (extract) P2 of the fermented aspergillus obtained through the extraction step S5 shall be applied as an external agent for hair growth / hair growth or a therapeutic agent for alopecia.
  • the extract is obtained by adding 0.1 g to 30 g of fermented aspergillus P1 (dried product) to be extracted to 100 mL of the extraction solvent. It is more preferable that the extract is obtained by adding 0.5 g to 15 g of fermented aspergillus P1 (dried product), and more preferably 1 g to 10 g of fermented aspergillus P1 (dried product) is added to the extract. It is particularly preferable that it is a liquid.
  • the extract (extract) P2 of the fermented aspergillus is not applied as an external preparation for hair growth and hair growth, 0.1 g to 30 g of the fermented aspergillus P1 (dried product) is applied per 100 mL of the external preparation. It is preferable that the extract P2 obtained by extraction is blended, and the extract P2 obtained by extracting 0.5 g to 15 g of fermented aspergillus P1 (dried product) is blended. It is preferable that the extract P2 obtained by extracting 1 g to 10 g of the fermented aspergillus P1 (dried product) is blended.
  • the amount of the external preparation for hair growth / growth or the therapeutic agent for alopecia of the present invention varies depending on the target improvement or therapeutic effect, symptom, size of affected area, administration method, age, dosage form of the external preparation, and the like. Although it cannot be unconditionally specified, the daily usage amount is usually preferably 0.1 to 20 mL (g), more preferably 0.3 to 10 mL (g), and particularly preferably 0.5 to 5 mL (g).
  • the pH of the external preparation for hair growth / growth or the therapeutic agent for alopecia of the present invention is preferably adjusted to 4.0 to 6.5 in consideration of safety on the skin.
  • the pH of the external preparation can be adjusted by using an appropriate acid or base usually blended in the external preparation as long as the effect of the present invention is not impaired.
  • pH adjusters include acids such as hydrochloric acid, lactic acid, phosphoric acid, tartaric acid, malic acid or gluconic acid, bases such as diisopropanolamine, triisopanolamine, sodium hydroxide, sodium citrate or arginine. It is possible to use one type or a combination of two or more types.
  • the fermented aspergillus contains citric acid, so that the preparation is easily weakly acidic. be able to.
  • the external preparation for hair growth and hair growth or the therapeutic agent for alopecia of the present invention may contain various components usually used for external preparations as long as the effects of the present invention are not impaired. Examples thereof include vasodilators, blood circulation promoters, surfactants, antihistamines, anti-inflammatory agents, thickeners, vitamins, amino acids, moisturizers, preservatives, antibacterial agents, fragrances and pigments.
  • the external preparation of the present invention may contain hair growth / hair growth components other than the fermented aspergillus P1 and the fermented aspergillus extract P2. Examples of other hair growth / growth components include minoxidil, adenosine, and Swertia japonica extract.
  • the external preparation for hair growth and hair growth or the therapeutic agent for alopecia of the present invention shall be applied to various external preparations by a conventionally used method as a dosage form usually applied to the scalp and skin.
  • a conventionally used method as a dosage form usually applied to the scalp and skin.
  • liquids such as tonics and lotions, aerosols, gels, ointments, creams and emulsions. It can also be applied to shampoos, soaps, conditioners and the like.
  • Example 1 Preparation of fermented aspergillus in this example
  • Raw tea leaves were used as the fermentation raw material. After water absorption treatment was performed by adding water so that the water content of the tea leaves became about 50%, the tea leaves were placed in a pressurized steam kettle and steamed. The condition of the steaming treatment was 115 ° C. for 60 minutes, and the steaming treatment was performed twice with one cooling in between. After that, the tea leaves are cooled to 30 ° C, and then the seed koji (2 billion spores / 1 g of seed koji) of Aspergillus awamori var. Kawachii is used as a fermentation raw material.
  • lactic acid bacteria Lactobacillus casei
  • the temperature of the tea leaves is adjusted so that the temperature of the tea leaves becomes 35 ° C to 40 ° C by ventilation for 24 hours after the addition of the seed koji, and the ventilation amount is adjusted in the same manner for the subsequent 48 hours.
  • the temperature of the tea leaves was adjusted to be slightly lower so as to be 30 ° C. to 35 ° C.
  • the fermented aspergillus fermented product obtained by koji making for 3 days was subjected to a drying treatment to have a water content of 8%, and this was pulverized to obtain a powdered fermented aspergillus fungus.
  • Example 2 Preparation of fermented aspergillus extract (1)
  • water was used as the extraction solvent.
  • the fermented aspergillus (powdered product after drying) obtained in Example 1 was added at a ratio of 2 g to 100 mL of sterilized water. This was allowed to stand in a refrigerator under the condition of 4 ° C. and extracted for 20 hours. The supernatant was collected to obtain the fermented aspergillus extract (1) used in the following examples.
  • Example 3 Preparation of fermented aspergillus extract (2)
  • an extract of fermented aspergillus (2) was obtained using an extraction solvent containing alcohol.
  • water sterilized by high-pressure steam sterilization at 135 ° C is added to distilled liquor made from nuts palm fruits (trade name: Hayato no Tears, Kintan Sake Brewery Co., Ltd. product, alcohol content 30), and the ethanol concentration is 10v / A v% extraction solvent was prepared.
  • the fermented Jiuqu bacterium obtained in Example 1 was added at a ratio of 2 g to 100 mL of this extraction solvent. This was allowed to stand in a refrigerator under the condition of 4 ° C. and extracted for 20 hours. The supernatant was collected to obtain the fermented aspergillus extract (2) used in the following examples.
  • Example 4 Promotion of hair growth in mice by fermented aspergillus extract (1)
  • Four 8-week-old C3H / HeN female mice were placed in each of the two groups shown in Table 1 below.
  • the back hair of the mouse was shaved with a hair clipper, and the sample solution was applied to the shaved part once a day for 30 days.
  • the coating amount was 0.15 mL / day.
  • sterilized water used as an extraction solvent for producing the fermented aspergillus extract (1) in Example 2 was used as the sample solution of the control group, and the sample solution of the test group was used.
  • the aspergillus fermented product extract (1) obtained in Example 2 was used.
  • the hair growth score was evaluated by a person who could not distinguish between the mouse in the control group and the mouse in the test group, and the bias by the experimenter was excluded.
  • the hair growth scores of the control group and the test group were evaluated at a significance level of 5% by the Mann-Whitney U test. The results are shown in FIG. 2 and Table 3 below.
  • mice in the test group to which the fermented aspergillus extract (1) was applied were clearly superior to the mice in the control group in the hair growth state and hair elongation.
  • the p value comparing the two was p ⁇ 0.05, which was shown to be significant.
  • Example 5 Promotion of hair growth in mice by fermented aspergillus extract (2)
  • Five 8-week-old C3H / HeN female mice were placed in each of the two groups shown in Table 4 below.
  • the back hair of the mouse was shaved with a hair clipper, and the sample solution was applied to the shaved part once a day for 30 days.
  • the coating amount was 0.15 mL / day.
  • the sample solution of the control group includes the extraction solvent (distilled liquor made from nut palm as a raw material (trade name: Hayato)) used when preparing the fermented aspergillus extract (2) in Example 3. Tears, Kinnada Sake Brewery Co., Ltd. product, alcohol content 30), sterilized water was added to make the ethanol concentration 10 v / v%), and the sample solution of the test group was fermented with aspergillus obtained in Example 3.
  • the product extract (2) was used.
  • the hair growth score was evaluated by a person who could not distinguish between the mouse in the control group and the mouse in the test group, and the bias by the experimenter was excluded.
  • the hair growth scores of the control group and the test group were evaluated at a significance level of 5% by the Mann-Whitney U test. The results are shown in FIG. 3 and Table 5 below.
  • mice in the test group to which the fermented aspergillus extract (2) was applied were clearly superior to the mice in the control group in the hair growth state and hair elongation.
  • the p value comparing the two was p ⁇ 0.01, which was shown to be extremely significant.
  • Example 6 Promotion of human hair growth by fermented aspergillus extract (1)
  • the fermented aspergillus extract (1) obtained in Example 2 was packed in a spray bottle, and fermented aspergillus in three subjects A to C shown in Table 6 below.
  • the product extract (1) was administered by spraying the product extract (1) on the head twice a day in the morning and evening and blending it by hand. The administration period was 1 to 3 months.
  • FIG. 4 shows photographs of the heads of each subject before and after administration taken from above.
  • FIG. 4 (A) shows subject A
  • FIG. 4 (B) shows subject B
  • FIG. 4 (C) shows subject C.
  • the lower side is the face side
  • the upper side is the back side.
  • Subject A had androgenetic alopecia mainly having hair loss on the crown before administration, but by using the fermented aspergillus extract (1) for about 3 months, the range of hair loss on the crown was observed. Shrinkage and hair growth in the hair loss range were observed. No skin abnormalities were observed during the period of use for 3 months.
  • Subject B had androgenetic alopecia in which the forehead hairline receded significantly before administration. By using the fermented aspergillus extract (1), this subject B had clear hair growth on the hairline of the forehead. In addition, no abnormalities on the skin were observed during the period of use, and the condition of the scalp was good.
  • Subject C had senile alopecia in which the entire head tended to be thin before administration, but by using the fermented aspergillus extract (1), the overall hair growth and hair became stiff. Occurred, volume up was observed. No skin abnormalities were observed during the period of use. As described above, by using the fermented aspergillus extract of the present invention, hair growth occurred and alopecia was improved. It was also clarified that hair loss was reduced and the hair became stiff and increased in volume. All subjects had no abnormalities on the scalp and were in the same condition as before or better than before administration. From these results, it was shown that the fermented aspergillus and the fermented aspergillus extract of the present invention are excellent in promoting hair growth and hair growth, and can treat, prevent or improve alopecia.
  • Example 7 Promotion of hair growth in mice by fermented aspergillus extract and examination of concentration of fermented aspergillus fermented C3H / HeN female mice 8 weeks old were arranged in 5 to 6 groups in the four groups shown in Table 7 below. The back hair of the mouse was shaved with a hair clipper, and each sample solution was applied to the shaved part once a day for 28 days. The coating amount was 0.15 mL / day. As shown in Table 7 below, sterilized water was used as the sample solution of the control group (control group).
  • the fermented aspergillus (powdered product after drying) obtained in Example 1 was added to the sample solution in the 2% group of the test group at a ratio of 2 g to 100 mL of sterilized water under 4 ° C. conditions. After allowing it to stand in the refrigerator for 20 hours for extraction treatment, the recovered supernatant (extract) was used. Similarly, the supernatant (extract) extracted by adding 4 g of fermented aspergillus to 100 mL of sterilized water was added to the sample solution in the 4% group of the test group, and the sample solution of 8% in the test group was used. , Jiuqu fermented product was added to 100 mL of sterilized water at a ratio of 8 g, and the obtained supernatant (extract) was used.
  • mice in the test group to which the fermented aspergillus extract was applied were clearly superior to the mice in the control group in the hair growth state and hair elongation.
  • a sample solution prepared by adding 2 g (2% group) to 4 g (4% group) of the fermented aspergillus product to be extracted per 100 mL of the solvent is used.
  • a sample solution prepared by adding 8 g (8% group) of fermented Jiuqu, which is the extract, per 100 mL of solvent was used, the hair growth score was further increased. It was found that the hair growth effect increased depending on the concentration of the fermented aspergillus.
  • the present invention provides an external preparation for hair growth / hair growth or a therapeutic agent for alopecia, which is excellent in hair growth and promotion of hair growth and can treat, prevent or improve alopecia. Therefore, the field of hair care cosmetics, pharmaceuticals, and pharmaceutical departments It is widely useful in industries such as foreign products.
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