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JP7671433B2 - Composition with hair growth and hair restoration function, its production method and use - Google Patents
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JP7671433B2 - Composition with hair growth and hair restoration function, its production method and use - Google Patents

Composition with hair growth and hair restoration function, its production method and use Download PDF

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JP7671433B2
JP7671433B2 JP2023079729A JP2023079729A JP7671433B2 JP 7671433 B2 JP7671433 B2 JP 7671433B2 JP 2023079729 A JP2023079729 A JP 2023079729A JP 2023079729 A JP2023079729 A JP 2023079729A JP 7671433 B2 JP7671433 B2 JP 7671433B2
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韓鶴友
程一林
程曉紊
孫雙鴿
陳順亞
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江蘇協合轉化醫學研究院有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97Cosmetics 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
    • A61K8/9783Angiosperms [Magnoliophyta]
    • A61K8/9794Liliopsida [monocotyledons]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/27Zinc; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/46Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur
    • A61K8/466Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur containing sulfonic acid derivatives; Salts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/63Steroids; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64Proteins; Peptides; Derivatives or degradation products thereof
    • A61K8/65Collagen; Gelatin; Keratin; Derivatives or degradation products thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/67Vitamins
    • A61K8/671Vitamin A; Derivatives thereof, e.g. ester of vitamin A acid, ester of retinol, retinol, retinal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/67Vitamins
    • A61K8/676Ascorbic acid, i.e. vitamin C
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/67Vitamins
    • A61K8/678Tocopherol, i.e. vitamin E
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97Cosmetics 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
    • A61K8/9728Fungi, e.g. yeasts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97Cosmetics 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
    • A61K8/9783Angiosperms [Magnoliophyta]
    • A61K8/9789Magnoliopsida [dicotyledons]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q5/00Preparations for care of the hair
    • A61Q5/12Preparations containing hair conditioners
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q7/00Preparations for affecting hair growth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/59Mixtures
    • A61K2800/592Mixtures of compounds complementing their respective functions
    • A61K2800/5922At least two compounds being classified in the same subclass of A61K8/18
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/805Corresponding aspects not provided for by any of codes A61K2800/81 - A61K2800/95
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/84Products or compounds obtained by lyophilisation, freeze-drying

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  • Cosmetics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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Description

本発明は、発毛・育毛技術の分野に属するものであり、特に発毛・育毛機能を有する組成物、調製方法及び用途に関する。 The present invention belongs to the field of hair growth and hair restoration technology, and in particular relates to a composition having hair growth and hair restoration functions, a preparation method, and uses.

男性の4人に1人、女性の8人に1人が脱毛しているという統計もある。また、ある調査によると、現在1990年以降に生まれた人の脱毛率は39.3%を超えている。脱毛はすでにますます一般化、低年齢化の傾向を呈している。 Statistics show that one in four men and one in eight women experience hair loss. Also, according to one survey, the current hair loss rate for people born after 1990 exceeds 39.3%. Hair loss is already becoming more and more common, and is occurring at younger ages.

市場では発毛・育毛機能を有する製品が多いと宣伝されているが、これらの製品は発毛・育毛効果の面ではあまり理想的ではない。その上、大部分の発毛製品は洗浄保護類製品で、他の製品は少ないが、洗浄保護類製品は洗浄機能を備える必要があるため、必然的に界面活性剤、コンディショニング剤など髪にダメージを与える化学成分を添加することになるため、発毛・育毛する効果の良い発毛・育毛する機能を持つ組成物が早急に必要とされている。 Although there are many products on the market that are advertised as having hair growth and hair care functions, these products are not ideal in terms of hair growth and hair care effects. In addition, most hair growth products are cleaning and protection products, and there are few other products, but cleaning and protection products must have cleaning functions, so they inevitably add chemical ingredients that damage hair, such as surfactants and conditioning agents, so there is an urgent need for a composition with hair growth and hair care functions that has good hair growth and hair care effects.

本発明は、発毛・育毛する効果の良い,発毛・育毛する機能を持つ組成物を発明することを目的とするものである。 The purpose of the present invention is to invent a composition that is effective in promoting hair growth and hair development and has the function of promoting hair growth and hair development.

上記目的を達成するために、本発明は以下のような技術方案を提案する。
本発明の1つ目の技術方案:発毛・育毛機能を有する組成物であって、前記発毛・育毛機能を有する組成物の原料は、重量部で次のものを含む。
さらに、蛋白質は、低分子ペプチドとアミノ酸とを含み、低分子ペプチドは、重量部で、500~1500部のウシコラーゲンペプチドと、500~1500部の加水分解コラーゲンペプチドとを含み、アミノ酸は、重量部で、20~50部のタウリンを含む。
さらに、栄養強化剤はビタミン類強化剤とミネラル類強化剤である。
さらに、ビタミン類強化剤は、重量で0.2~10部のビタミンA、10~50部のビタミンC、1~10部のビタミンEおよび10~50部の酵母粉末を含み、ミネラル類強化剤は、重量部で、フマル酸第一鉄1~10部および酸化亜鉛0.2~10部を含む。
さらに、粉末フィトステロールエステルは、化学式C47O2H80のβ-シトステロールエステルである。
さらに、アワ抽出物の調製方法は、アワを粉砕し、水で抽出し、抽出物を濃縮し、凍結乾燥してアワ抽出物を得る。
さらに、調味剤は、重量部で、エリスリトール100~500部およびグレープフルーツ粉末100~500部を含む。
In order to achieve the above object, the present invention proposes the following technical solution:
The first technical solution of the present invention is a composition having hair growth and hair care functions, and the raw materials of the composition having hair growth and hair care functions include, in parts by weight, the following:
Further, the protein comprises low molecular weight peptides and amino acids, the low molecular weight peptides comprising, by weight, 500 to 1500 parts of bovine collagen peptides and 500 to 1500 parts of hydrolyzed collagen peptides, and the amino acids comprising, by weight, 20 to 50 parts of taurine.
Further, nutritional supplements include vitamin supplements and mineral supplements.
Additionally, the vitamin supplement includes, by weight, 0.2-10 parts vitamin A, 10-50 parts vitamin C, 1-10 parts vitamin E, and 10-50 parts yeast powder, and the mineral supplement includes, by weight, 1-10 parts ferrous fumarate and 0.2-10 parts zinc oxide.
Additionally, the powdered phytosterol ester is a β-sitosterol ester having the chemical formula C47O2H80.
Furthermore, the method for preparing the foxtail millet extract includes grinding foxtail millet, extracting it with water, concentrating the extract, and freeze-drying it to obtain the foxtail millet extract.
Additionally, the flavorings include, by weight, 100-500 parts erythritol and 100-500 parts grapefruit powder.

本発明の2つ目の技術方案:上記の発毛・育毛機能を有する組成物の調製方法は、
各原料を重量部で量り、ふるいにかけておくステップ(1)と、
ステップ(1)で計量された栄養強化剤と調味剤とを混合して混合原料Aを得るステップ(2)と、
ステップ(1)で計量した蛋白質、効能成分を造粒機で攪拌し、アルコールをバインダーとして造粒した後、流動層乾燥し、整粒機で整粒して混合原料Bを得るステップ(3)と、
ステップ(2)で得られた混合原料Aと、ステップ(3)で得られた混合原料Bとを混合し、篩をかけることにより、発毛・育毛機能を有する組成物を得るステップ(4)と、
を含む。
さらに、ステップ(1)において、前記ふるいが40~100メッシュのふるいである。
さらに、ステップ(2)において、混合物は、等量増分混合物である。
さらに、ステップ(3)において、攪拌回転数が200回転/分以上500回転/分以下であり、アルコールの使用量は、濃度70~95%のアルコール280~480質量部を2?10分以内に噴霧することであり、流動層乾燥温度は51~58℃、時間は25~35分であり、整粒機は20メッシュ整粒機である。
さらに、ステップ(4)において、前記ふるいが40~100メッシュのふるいであることを特徴とする。
The second technical solution of the present invention: The method for preparing the composition having the above-mentioned hair growth and hair care function includes:
(1) weighing each ingredient by weight and sieving it;
A step (2) of mixing the nutritional enhancer and the seasoning measured in the step (1) to obtain a mixed raw material A;
Step (3) of mixing the protein and active ingredient measured in step (1) in a granulator, granulating the mixture using alcohol as a binder, and then fluidized bed drying and granulating the mixture in a granulator to obtain mixed raw material B;
Step (4) of mixing the mixed raw material A obtained in step (2) and the mixed raw material B obtained in step (3) and sieving the mixture to obtain a composition having hair growth and hair care functions;
Includes.
Furthermore, in step (1), the sieve is a 40 to 100 mesh sieve.
Further, in step (2), the mixture is an equal volume increment mixture.
Furthermore, in step (3), the stirring speed is 200 rpm or more and 500 rpm or less, the amount of alcohol used is 280 to 480 parts by mass of alcohol with a concentration of 70 to 95%, sprayed within 2 to 10 minutes, the fluidized bed drying temperature is 51 to 58°C, the time is 25 to 35 minutes, and the sieving machine is a 20 mesh sieving machine.
Furthermore, in step (4), the sieve is a sieve of 40 to 100 mesh.

本発明の3つ目の技術方案は、上記の発毛・育毛機能を有する組成物の発毛・育毛における応用である。
従来技術と比較して、本発明は以下の有益な効果を有する。
(1)毛包が休止期から成長期に入るまでの時間を短縮することができ、発毛時間を速めることができ、発毛促進効果が顕著である発毛・育毛機能を有する組成物、
(2)本発明により調製された発毛・育毛機能を有する組成物は、毒性・副作用がなく、毛包の新生を促進するのに有効である、
(3)本発明は、オーブン乾燥ではなく流動層造粒を採用し、オーブン乾燥に比べて、流動状態が均一で、乾燥が均一で、材料表面への損傷が少なく、粉体がより粗くなる利点がある。熱効率が高く省エネ効果が高く、オーブン乾燥より30~60%省エネできる。
The third technical solution of the present invention is the application of the above-mentioned composition having hair growth and hair care functions in hair growth and hair care.
Compared with the prior art, the present invention has the following beneficial effects:
(1) A composition having hair growth and hair development functions that can shorten the time it takes for hair follicles to enter the anagen phase from the resting phase, accelerate hair growth time, and have a significant hair growth promotion effect;
(2) The composition having hair growth and hair development function prepared by the present invention has no toxicity or side effects and is effective in promoting the neogenesis of hair follicles.
(3) The present invention adopts fluidized bed granulation instead of oven drying, which has the advantages of more uniform fluidization, more uniform drying, less damage to the material surface, and coarser powder than oven drying. It has high thermal efficiency and energy saving effect, and can save 30-60% energy compared to oven drying.

本発明の加水分解コラーゲンペプチドは、ヒト皮膚の必要な構成物質の1つに属し、皮膚の水潤を効果的に保証することができ、皮膚の引き締めを増加することができる。髪の中で最も主要な蛋白質はケラチンであり、コラーゲンはおそらく体内の発毛蛋白質を支持して増加することができ、これは髪を補強し、髪の成長を促進し、脱毛を防ぐことができる。
また、本出願が2種類のコラーゲンペプチドを選択したのは、1種類は動物の皮から抽出されたコラーゲンペプチドであり、1種類は骨由来のコラーゲンペプチドであり、アミノ酸成分とペプチドセグメントが異なり、互いに補完することができるためである。
本発明に添加されたタウリンは、損傷した毛髪を修復する作用だけでなく、毛髪成長因子の産生を増加させ、毛髪の成長を促進する作用も有する。タウリンは、ヒトの毛髪サイクルに作用し、成長期間を延長し、濃密で丈夫な毛髪を作り出すことができ、成長因子IGF-1の産生を増加させることができる。
本発明に添加された多種類のビタミンは、頭皮の栄養を増加させ、毛包細胞の代謝を促進し、さらに頭髪の成長を促進する作用を有する。
本発明に添加された酵母粉末にはビタミンH及びナイアシンが含まれており、ビタミンHは別名ビオチンとも呼ばれ、人体の自然な成長、発育及び正常な人体機能の健康維持に必要な栄養素であり、毛包細胞の代謝を直接制御することができ、また、摂取量や代謝に影響を与えることにより間接的に毛包の発育に影響を与えることができる。
また、酵母粉に含まれているナイアシンも同様に人体に不可欠な栄養成分であり、人体の正常な成長と発育を促進する上で重要な役割を果たしており、鉄の吸収と血球の生成を促進し、皮膚の正常な機能を維持することができる。
本発明は、フマル酸第一鉄を添加し、鉄元素は、頭皮および毛包の細胞を含む身体の各細胞に酸素を供給する。
本発明は、体内の複数の酵素の補助因子である酸化亜鉛、または体内の抗酸化酵素の重要な成分であり、血球細胞の活性を強化することができ、毛髪の成長およびケラチンの合成に必要な微量元素である酸化亜鉛を添加する。
本発明に添加された植物ステロールエステル粉末は、植物ステロールと脂肪酸とのエステル化反応又はトランスエステル化反応によりを製造されたものである。ステロールエステルは体内でステロールと脂肪酸に転化できるので、その生理機能は植物ステロールと脂肪酸の二つの部分が持っている生理機能を含む。植物ステロールエステルは人体に吸収されやすく、使用効率は普通の植物ステロールよりはるかに高く、アンドロゲンの産生を抑制することで脱毛を防ぐことができる。
本発明で添加されるアワ抽出物は、アワから抽出された希少油、具体的にはミレチン(化学式:C31H52O)であり、希少油は毛包の根元に作用し、細胞の代謝と増殖を促進し、発毛を維持することができ、損傷した頭皮に栄養を与えて修復できる。健康な髪のための優れた土台を作り、抗炎症および抗毒性効果もある。
本発明により添加された黄精粉は腎経に帰するものであり、精髄充填の効果があり、腎虚型脱毛症等の治療に優れた効果がある。
本発明に添加された桑の実の粉は、補腎益精、烏発生発毛の効果を有しており、老衰、早白髪、脱毛、円形脱毛、枯れの症状に適している。桑の実は食品であると同時に薬品でもある。中国薬典の記録によると、須髪早白を治療する作用がある、桑の実の中に豊富なプロアントシアニジンを豊富に含んで、プロアントシアニジンは毛包の隆起部の幹細胞を活性化して、休止期の毛包を成長期に転化させて、毛髪の再生を促進することができる。
本発明に添加された黒果腺リブウラジロナナカマドの果実粉末は、多種類のビタミン、抗酸化成分、ミネラル元素を豊富に含み、頭部の血行を改善する効果を有する。
The hydrolyzed collagen peptide of the present invention belongs to one of the necessary components of human skin, and can effectively guarantee the moisture of the skin and increase the firmness of the skin. The most important protein in hair is keratin, and collagen can possibly support and increase the hair growth protein in the body, which can strengthen hair, promote hair growth and prevent hair loss.
In addition, the present application selected two types of collagen peptides because one type is a collagen peptide extracted from animal skin and the other is a collagen peptide derived from bone, which have different amino acid components and peptide segments and can complement each other.
The taurine added in the present invention not only has the effect of repairing damaged hair, but also has the effect of increasing the production of hair growth factors and promoting hair growth.Taurine acts on the human hair cycle, can extend the growth period, create thick and strong hair, and can increase the production of the growth factor IGF-1.
The various vitamins added in the present invention have the effect of increasing nutrition of the scalp, promoting the metabolism of hair follicle cells, and further promoting hair growth.
The yeast powder added in the present invention contains vitamin H and niacin. Vitamin H, also known as biotin, is a nutrient necessary for the natural growth and development of the human body and for maintaining normal bodily functions. It can directly control the metabolism of hair follicle cells, and indirectly affect the development of hair follicles by affecting their intake and metabolism.
In addition, the niacin contained in yeast powder is also an essential nutrient for the human body, and plays an important role in promoting normal growth and development of the human body, promoting iron absorption and blood cell production, and maintaining normal skin function.
The present invention adds ferrous fumarate, elemental iron provides oxygen to every cell in the body, including the cells of the scalp and hair follicles.
The present invention adds zinc oxide, which is a cofactor for several enzymes in the body, an important component of antioxidant enzymes in the body, can enhance the activity of blood cells, and is a trace element necessary for hair growth and keratin synthesis.
The phytosterol ester powder added in the present invention is produced by esterification or transesterification between phytosterol and fatty acid. Sterol ester can be converted into sterol and fatty acid in the body, so its physiological functions include the physiological functions of both phytosterol and fatty acid. Phytosterol ester is easily absorbed by the human body, and its utilization efficiency is much higher than that of ordinary phytosterol, and it can prevent hair loss by suppressing the production of androgen.
The foxtail extract added in this invention is a rare oil extracted from foxtail, specifically milletin (chemical formula: C31H52O), which acts on the root of the hair follicle, promotes cell metabolism and proliferation, can maintain hair growth, nourish and repair damaged scalp, create a good foundation for healthy hair, and also has anti-inflammatory and anti-toxic effects.
The added Astragalus persicae powder according to the present invention is related to the kidney meridian, has the effect of filling the essence, and is effective in treating kidney deficiency alopecia and the like.
The mulberry powder added in the present invention has the effect of replenishing kidney and promoting vitality, and is suitable for the symptoms of senility, premature graying, hair loss, alopecia areata, and withering. Mulberry is both food and medicine. According to the records in the Chinese Pharmacopoeia, it has the effect of treating premature graying of hair. Mulberry is rich in proanthocyanidins, which can activate the stem cells in the bulge of hair follicles, transform the resting hair follicles into the growth phase, and promote hair regeneration.
The black-glanded rib Rowan fruit powder added in the present invention is rich in various vitamins, antioxidants and mineral elements, and has the effect of improving blood circulation in the head.

本発明の実施例又は従来技術の技術方案をより明確に説明するために、以下では、実施例に使用される図面を簡単に説明する。以下の説明における図面は本発明のいくつかの実施例であり、当業者にとって、創造的な労働を行うことなく、これらの図面に基づいて、他の図面を得ることが可能である。
図1は、検体3#を投与したマウスの背部毛髪の変化図である。 図2は、低用量の検体を投与したマウスの背部の毛髪の変化図である。 図3は、高用量の検体を投与したマウスの背部の毛髪の変化図である。 図4は、陽性対照試料を投与したマウスの背部毛髪の変化図である。 図5は、陰性対照試料を投与したマウスの背部毛髪の変化図である。 図6は、投与サンプル3#、低用量サンプル、高用量サンプル、陽性対照サンプルと陰性対照サンプルの鏡下新生毛包数の統計図である。 図7は、投与された試料3#のHE染色図であり、(a)は7日間マウス皮膚組織学的HE染色図であり、(b)は14日間マウス皮膚組織学的HE染色図であり、(c)は28日間マウス皮膚組織学的HE染色図であり、(d)は56日マウス皮膚組織学的HE染色図である。 図8は、低用量の検体を投与したHE染色図であり、(a)は7日間のマウス皮膚組織学的HE染色図であり、(b)は14日間のマウス皮膚組織学的HE染色図であり、(c)は28日間のマウス皮膚組織学的HE染色図であり、(d)は56日間のマウス皮膚組織学的HE染色図である。 図9は、高用量の検体を投与したHE染色図であり、(a)は7日間のマウス皮膚組織学的HE染色図であり、(b)は14日間のマウス皮膚組織学的HE染色図であり、(c)は28日間のマウス皮膚組織学的HE染色図であり、(d)は56日間のマウス皮膚組織学的HE染色図である。 図10は、投与陽性対照試料のHE染色図であり、(a)は7日間マウス皮膚組織学的HE染色図であり、(b)は14日間マウス皮膚組織学的HE染色図であり、(c)は28日間マウス皮膚組織学的HE染色図であり、(d)は56日マウス皮膚組織学的HE染色図である。 図11は、投与陰性対照試料のHE染色図であり、(a)は7日間マウス皮膚組織学的HE染色図であり、(b)は14日間マウス皮膚組織学的HE染色図であり、(c)は28日間マウス皮膚組織学的HE染色図であり、(d)は56日マウス皮膚組織学的HE染色図である。
In order to more clearly describe the embodiments of the present invention or the technical solutions of the prior art, the drawings used in the embodiments are briefly described below. The drawings in the following description are some embodiments of the present invention, and those skilled in the art can obtain other drawings based on these drawings without creative labor.
FIG. 1 shows changes in the back hair of mice administered sample 3#. FIG. 2 shows changes in hair on the back of mice administered a low dose of a test substance. FIG. 3 shows changes in hair on the back of mice administered a high dose of a test substance. FIG. 4 is a graph showing changes in the back hair of mice administered with a positive control sample. FIG. 5 is a graph showing changes in the back hair of mice administered with a negative control sample. FIG. 6 is a statistical graph showing the number of newly generated hair follicles under the microscope for the administration sample 3#, the low-dose sample, the high-dose sample, the positive control sample and the negative control sample. FIG. 7 shows HE staining images of administered sample 3#, (a) is a histological HE staining image of mouse skin after 7 days, (b) is a histological HE staining image of mouse skin after 14 days, (c) is a histological HE staining image of mouse skin after 28 days, and (d) is a histological HE staining image of mouse skin after 56 days. FIG. 8 shows HE staining images of mouse skin after administration of a low dose of a sample, where (a) is a histological HE staining image of mouse skin after 7 days, (b) is a histological HE staining image of mouse skin after 14 days, (c) is a histological HE staining image of mouse skin after 28 days, and (d) is a histological HE staining image of mouse skin after 56 days. FIG. 9 shows HE staining images of mouse skin after administration of a high dose of a sample, where (a) is a histological HE staining image of mouse skin after 7 days, (b) is a histological HE staining image of mouse skin after 14 days, (c) is a histological HE staining image of mouse skin after 28 days, and (d) is a histological HE staining image of mouse skin after 56 days. FIG. 10 shows HE staining images of the administered positive control sample, (a) is a histological HE staining image of mouse skin after 7 days, (b) is a histological HE staining image of mouse skin after 14 days, (c) is a histological HE staining image of mouse skin after 28 days, and (d) is a histological HE staining image of mouse skin after 56 days. FIG. 11 shows HE staining images of the administered negative control sample, (a) is a histological HE staining image of mouse skin after 7 days, (b) is a histological HE staining image of mouse skin after 14 days, (c) is a histological HE staining image of mouse skin after 28 days, and (d) is a histological HE staining image of mouse skin after 56 days.

本発明の様々な例示的な実施形態をここで詳細に説明するが、この詳細な説明は、本発明を限定するものではなく、本発明のいくつかの態様、特徴、および実施形態のより詳細な説明として理解されるべきである。本発明に記載された用語は、単に特別な実施形態を説明するためのものであり、本発明を限定するためのものではないことが理解されるべきである。
また、本発明における数値範囲については、範囲の上限値と下限値との間の各中間値も具体的に開示されているものと理解されるべきである。記載された値または記載された範囲内の中間値と、他の記載された値または記載された範囲内の中間値との間のそれぞれの小さい範囲も、本発明に含まれる。これらの小範囲の上限及び下限は、独立して範囲内に含まれてもよいし、範囲内から除外されてもよい。
別段の記載がない限り、本明細書で使用されるすべての技術用語および科学用語は、本発明に記載された分野の従来の技術者が一般的に理解するものと同じ意味を有する。本発明は、好ましい方法および材料のみを説明するが、本発明の実施または試験において、本明細書に記載された方法および材料と類似または同等の任意の方法および材料を使用することもできる。本明細書に記載されたすべての文献は、その文献に関連する方法および/または材料を開示および説明するための引用によって組み込まれる。組み込まれた文献の何れかと抵触する場合は、明細書の内容を優先する。
本発明の範囲または精神から逸脱することなく、本発明の明細書の具体的な実施形態に様々な改良および変更を加えることができることは、当業者にとって自明である。本発明の明細書から得られる他の実施形態は、当業者にとって自明である。本発明の説明および実施形態は例示的なものにすぎない。
本文中で使用されている「含む」、「含む」、「持つ」、「含む」などについては、すべて開放的な用語であり、すなわち含むことを意味するが、これに限定されない。
本発明の実施形態における「部」は、特段の説明がなければ「重量部」である。
Various exemplary embodiments of the present invention will now be described in detail, but this detailed description should not be understood as limiting the present invention, but as a more detailed description of some aspects, features, and embodiments of the present invention. It should be understood that the terms described in the present invention are merely for describing particular embodiments, and are not intended to limit the present invention.
It is also to be understood that for any numerical ranges herein, each intermediate value between the upper and lower limits of the range is specifically disclosed. Each smaller range between a stated value or intermediate value within a stated range and any other stated value or intermediate value within a stated range is also included in the invention. The upper and lower limits of these smaller ranges may independently be included or excluded within the range.
Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by a person of ordinary skill in the art to which the present invention relates. The present invention describes only preferred methods and materials, but any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All documents described herein are incorporated by reference to disclose and describe the methods and/or materials related to the documents. In case of conflict with any of the incorporated documents, the contents of the specification shall prevail.
It will be apparent to those skilled in the art that various modifications and variations can be made in the specific embodiments of the present specification without departing from the scope or spirit of the present invention. Other embodiments will be apparent to those skilled in the art from the present specification. The description and embodiments of the present invention are illustrative only.
As used herein, the terms "including,""including,""having,""including," and the like are all open-ended terms, i.e., meaning including, but not limited to.
In the embodiments of the present invention, "parts" are "parts by weight" unless otherwise specified.

以下の実施例において、前記粉末植物ステロールエステルは特許CN201410445798.0に従って調製される。
以下の実施形態では、アワ抽出物の調製方法は以下の通りである:
1)アワを37℃の熱風乾燥箱に入れて24時間乾燥し、80目のふるいに粉砕する。
2)ステップ1)ふるいにかけたアワと水の原料液比を1:10にして50℃の条件下で1h渦抽出し、抽ろ過を2回繰り返し、それぞれろ液とろかすを収集する。
3)ステップ2)で得られた濾液を固形分25~35%に濃縮して濃縮液を得る。
4)ステップ3)で得られた濃縮液を凍結乾燥して得られたアワ抽出物であって、凍結乾燥のパラメーターは、水分を6%以下に保つことである。
以下の実施形態に記載の桑の実の粉、黒果腺リブナナカマド果実粉末及び黄精粉末は市販品であり、桑の実の粉、黒果腺リブナナカマド果実粉末中のプロアントシアニジン含有量は10%であり、黄精粉末中の黄精多糖類含有量は15%である。
以下の実施形態において、ウシのコラーゲンペプチドおよび加水分解コラーゲンペプチドは、市販品であり、いずれも、95%のタンパク質含有量を有する食品素材である。
以下の実施形態に記載されているビタミンAは、市販されており、食品レベルの添加物であり、有効物質含有量は32.5万IU/gである。
以下の実施形態では、ビタミンCは市販されており、食品レベルの添加物であり、有効な物質の含有量は97%である。
以下の実施形態において、タウリンおよびフマル酸第一鉄は市販されており、いずれも食品レベルの添加物であり、有効な物質の含有量は99%である。
以下の実施形態において、ビタミンEは市販されており、有効成分の含有量が50%である食品レベルの添加物である。
以下の実施形態に記載の酵母粉末は、市販品であり、有効物質であるナイアシン含有量が40mg/g、ビオチン含有量が300ppmである。
以下の実施形態では、「等量増分混合」という用語は、使用量が最も少ない原料と等量の他の原料とを等量増分して均一に混合した後、混合後に等量の他の原料を加えて均一に混合し、この倍量増分を全ての原料の混合が完了するまで行うことを意味する。
In the following examples, the powdered plant sterol ester is prepared according to patent CN201410445798.0.
In the following embodiment, the method for preparing the foxtail millet extract is as follows:
1) Put the millet into a hot air drying box at 37℃ and dry for 24 hours, then crush it through an 80-mesh sieve.
2) Step 1) The sieved millet and water were mixed in a liquid ratio of 1:10 and extracted at 50℃ for 1 hour using a vortex. Extraction was then repeated twice, and the filtrate and residue were collected.
3) The filtrate obtained in step 2) is concentrated to a solid content of 25-35% to obtain a concentrated liquid.
4) A foxtail millet extract obtained by freeze-drying the concentrate obtained in step 3), the parameters of which are to keep the moisture content below 6%.
The mulberry powder, black-gland-rib rowan fruit powder and yellow ash powder described in the following embodiments are commercially available products, and the proanthocyanidin content in the mulberry powder and black-gland-rib rowan fruit powder is 10%, and the yellow ash polysaccharide content in the yellow ash powder is 15%.
In the following embodiments, bovine collagen peptides and hydrolyzed collagen peptides are commercially available products, both of which are food ingredients with a protein content of 95%.
The vitamin A described in the following embodiments is commercially available and is a food-grade additive with an active substance content of 325,000 IU/g.
In the following embodiment, the Vitamin C is a commercially available, food-grade additive with an active substance content of 97%.
In the following embodiments, taurine and ferrous fumarate are commercially available and are both food-grade additives with 99% active substance content.
In the following embodiment, Vitamin E is a commercially available, food-grade additive with an active ingredient content of 50%.
The yeast powder described in the following embodiments is a commercially available product, and contains 40 mg/g of niacin and 300 ppm of biotin, both of which are active substances.
In the following embodiments, the term "equal increment mixing" means that the least amount of the ingredient is mixed uniformly with an equal amount of another ingredient in equal increments, and then an equal amount of the other ingredient is added after mixing and mixed uniformly, and this double increment process is continued until all ingredients are mixed.

(1)表1中の1#に記載された重量部に基づいて各原料を量り、40メッシュのふるいにかけておく。
(2)ステップ(1)で計量した栄養強化剤と調味剤とを同量ずつ混合して混合原料Aを得る。
(3)ステップ(1)で計量した蛋白質及び効能成分を造粒機で攪拌し、アルコールを結合剤として造粒した後、流動床乾燥し、20メッシュ整粒機で整粒して混合原料Bを得、攪拌回転数を200回転/分とし、アルコール使用量を2min以内に70%アルコール280部、流動床乾燥温度51℃、時間25分とする。
(4)ステップ(2)で得られた混合原料Aと、ステップ(3)で得られた混合原料Bとを混合し、40メッシュのふるいを通過させて発毛・育毛機能を有する組成物を得る。
(1) Weigh out each ingredient based on the weight parts listed in 1# of Table 1, and sieve through a 40 mesh sieve.
(2) The nutritional enhancer and seasoning measured in step (1) are mixed in equal amounts to obtain mixed raw material A.
(3) The protein and active ingredients measured in step (1) are stirred in a granulator, granulated using alcohol as a binder, then fluidized-bed dried and sized in a 20-mesh granulator to obtain mixed raw material B. The stirring speed is set to 200 rpm, the amount of alcohol used is 280 parts of 70% alcohol within 2 minutes, the fluidized-bed drying temperature is set to 51°C, and the drying time is set to 25 minutes.
(4) The mixed raw material A obtained in step (2) is mixed with the mixed raw material B obtained in step (3) and passed through a 40 mesh sieve to obtain a composition having hair growth and hair care functions.

(1)表1中の2#に記載された重量部に基づいて各原料を量り、100目のふるいにかけておく。
(2)ステップ(1)で計量した栄養強化剤と調味剤とを同量ずつ混合して混合原料Aを得る。
(3)ステップ(1)で計量した蛋白質及び効能成分を造粒機で攪拌し、アルコールを結合剤として造粒した後、流動床乾燥し、20メッシュ整粒機で整粒して混合原料Bを得る。攪拌回転数は500回転/分、アルコール量は95%アルコールを10min以内に480部、流動床乾燥温度は58℃、時間は35分である。
(4)ステップ(2)で得られた混合原料Aと、ステップ(3)で得られた混合原料Bとを100メッシュのふるいにかけて混合し、発毛・育毛機能を有する組成物を得る。
(1) Weigh out each ingredient based on the weight parts listed in #2 in Table 1, and sieve through a 100-mesh sieve.
(2) The nutritional enhancer and seasoning measured in step (1) are mixed in equal amounts to obtain mixed raw material A.
(3) The protein and active ingredients measured in step (1) are mixed in a granulator, granulated using alcohol as a binder, then fluidized-bed dried and sized in a 20-mesh granulator to obtain mixed raw material B. The mixing speed is 500 rpm, the amount of alcohol is 480 parts of 95% alcohol within 10 minutes, the fluidized-bed drying temperature is 58°C, and the drying time is 35 minutes.
(4) Mix the mixed raw material A obtained in step (2) and the mixed raw material B obtained in step (3) by sieving through a 100 mesh sieve to obtain a composition having hair growth and hair care functions.

(1)表1中の3#に記載された重量部に基づいて各原料を量り、60目のふるいにかけておく。
(2)ステップ(1)で計量した栄養強化剤と調味剤とを同量ずつ混合して混合原料Aを得る。
(3)ステップ(1)で計量した蛋白質及び効能成分を造粒機で攪拌し、アルコールを結合剤として造粒した後、流動床乾燥し、20メッシュ整粒機で整粒して混合原料Bを得、攪拌回転数350rp/min、アルコール用量85%アルコール300部を5.5分以内に、流動床乾燥温度55℃、時間30分で噴霧する。
(4)ステップ(2)で得られた混合原料Aと、ステップ(3)で得られた混合原料Bとを混合し、60メッシュ篩を通過させて発毛・育毛機能を有する組成物を得る。
(1) Weigh out each ingredient based on the weight parts listed in 3# in Table 1, and sieve it through a 60-mesh sieve.
(2) The nutritional enhancer and seasoning measured in step (1) are mixed in equal amounts to obtain mixed raw material A.
(3) The protein and active ingredients measured in step (1) are mixed in a granulator, granulated using alcohol as a binder, then fluidized-bed dried and sized in a 20-mesh granulator to obtain mixed raw material B, which is sprayed with 300 parts of 85% alcohol within 5.5 minutes at a mixing speed of 350 rp/min and a fluidized-bed drying temperature of 55°C for 30 minutes.
(4) The mixed raw material A obtained in step (2) and the mixed raw material B obtained in step (3) are mixed and passed through a 60 mesh sieve to obtain a composition having hair growth and hair care functions.

対比例1Comparative Example 1

実施例3との違いは、ステップ(1)が表2中4#に記載された重量分で各原料を計量し、60メッシュでふるいにかけたものであることである。 The difference from Example 3 is that in step (1), each raw material was weighed out according to the weight amount shown in 4# in Table 2 and sieved through a 60 mesh screen.

対比例2Comparative Example 2

実施例3との違いは、ステップ(1)が表2中の5#に記載された重量分で各原料を計量し、60メッシュでふるいにかけたものであることである。 The difference from Example 3 is that in step (1), each raw material was weighed out according to the weight amount shown in 5# in Table 2 and sieved through a 60 mesh sieve.

対比例3Comparative Example 3

実施例3との違いは、ステップ(1)が表2中6#に記載された重量分で各原料を計量し、60メッシュでふるいにかけたものであることである。 The difference from Example 3 is that in step (1), each raw material was weighed out according to the weight amount shown in 6# in Table 2 and sieved through a 60 mesh sieve.

対比例4Comparative Example 4

実施例3との違いは、ステップ(1)が表2中の7#に記載された重量分で各原料を計量し、60メッシュでふるいにかけたものであることである。 The difference from Example 3 is that in step (1), each raw material was weighed according to the weight amount shown in 7# in Table 2 and sieved through a 60 mesh sieve.

対比例5Comparative Example 5

実施例3との違いは、ステップ(1)が表2中の8#に記載された重量分で各原料を計量し、60メッシュでふるいにかけたものであることである。 The difference from Example 3 is that in step (1), each raw material was weighed out according to the weight amount shown in 8# in Table 2 and sieved through a 60 mesh sieve.

対比例6Comparative Example 6

実施例3との違いは、ステップ(1)が表2中の9シャープに記載された重量部で核原料を計量し、60メッシュでふるいにかけたものであることである。 The difference from Example 3 is that in step (1), the core raw material was weighed out in the parts by weight shown in Table 2 (number 9) and sieved through a 60 mesh sieve.

対比例7Comparative Example 7

実施例3との違いは、ステップ(1)が表2の10#に記載された重量分で各原料を計量し、60メッシュでふるいにかけたものであることである。 The difference from Example 3 is that in step (1), each raw material was weighed out according to the weight amount shown in 10# of Table 2 and sieved through a 60 mesh screen.

対比例8Comparative Example 8

実施例3との違いは、ステップ(1)が表2の11#に記載された重量分で各原料を計量し、60メッシュでふるいにかけておくことである。 The difference from Example 3 is that in step (1), each raw material is weighed out by weight as shown in 11# of Table 2 and sieved through a 60 mesh sieve.

対比例9Comparative Example 9

実施例3との違いは、ステップ(1)が表2の12#に記載された重量分で各原料を計量し、60メッシュでふるいにかけておくことである。 The difference from Example 3 is that in step (1), each raw material is weighed out according to the weight amount shown in #12 of Table 2 and sieved through a 60 mesh sieve.

対比例10Comparative Example 10

実施例3との違いは、ステップ(1)で桑の実の粉を黒豆粉末に置き換えたことである。
The difference from Example 3 is that mulberry flour was replaced with black bean powder in step (1).

効果検証
一、処方箋の効果検証
(一)被験者の選択
入選基準と除外基準に基づいて合格者を選択する。
Effectiveness Verification 1. Effectiveness Verification of the Prescription (1) Selection of Subjects Select successful subjects based on the inclusion and exclusion criteria.

1.入選基準
(1)25~45歳、健康な男性または女性。
髪の長さは5~40cm。
(2)脱毛が多いと軽度の薄毛の悩みがあり、しかも60回の櫛毛法による脱毛数が10本より多く、2週間の準備期間後も10本より多い者。
(3)1ヶ月以内にカラーリング、パーマ、スタイリング等の特殊な美髪処理を行ったことがない者。
2.除外基準
(1)妊娠中若しくは授乳中の女性又は近日中に妊娠準備計画を有する者。
(2)精神病又は心疾患を有する者、あるいは長期の睡眠、感情制御障害がある者。
(3)この三箇月以内に脱毛防止の効果を有する化粧品その他の当該効果又は発毛の効果を有する製品を使用した者。
(4)頭髪の成長に影響を及ぼす薬物を6箇月近くの間に服用し又は局所的に使用したことがある者。
3.被験者制限
(1)被験者のスクリーニングと試験期間中、各回の訪問前48±4時間以内に髪を洗うことができず、かつ各回の訪問前に髪を洗わない時間が基本的に一致しており、訪問当日に自分で髪を梳くことができない。
(2)試験期間中、毎回の訪問評価の前2週間以内に散髪しないこと。
(3)試験期間中はいかなるヘアケアと整髪処置を行うことができず、またいかなる脱毛防止、発毛方面の治療を受けることができない。
(4)試験期間中は元の生活習慣を維持し、感情の変動が大きいことを避ける必要がある。
1. Selection Criteria (1) Healthy male or female, aged 25-45 years old.
Hair length is 5 to 40 cm.
(2) Those who suffer from mild hair thinning and have lost more than 10 hairs after 60 combing sessions, and who still have more than 10 hairs after a two-week preparation period.
(3) Those who have not undergone any special hair treatments such as coloring, perming, or styling within the past month.
2. Exclusion Criteria
(1) Pregnant or breastfeeding women or those planning to become pregnant in the near future.
(2) Persons with mental or heart illness, or long-term sleep or emotional regulation disorders.
(3) A person who has used cosmetics with hair loss prevention effects or other products with the effect of preventing hair loss or promoting hair growth within the past three months.
(4) Subjects who have taken or used topically any drug that affects hair growth for nearly six months.
3. Subject Restrictions (1) During the screening and study period, subjects were not able to wash their hair within 48±4 hours before each visit, and the time period during which they did not wash their hair before each visit was basically consistent. They were not able to comb their hair by themselves on the day of the visit.
(2) During the study period, participants were not allowed to have their hair cut within 2 weeks prior to each evaluation visit.
(3) During the trial period, you may not engage in any hair care or styling procedures or receive any hair loss prevention or hair growth treatments.
(4) During the study period, participants should maintain their original lifestyle and avoid large emotional fluctuations.

(二)被験物質
試験サンプル:実施例1~3および対比例1-10の割合で調製した組成物。
使用方法:被験者に対して無作為に試験サンプルを配布し、そして被験者に対してサンプル使用指導を行い、被験者が試験期間内に試験対象物を正しく使用することを保証し、試験対象物を12週間使用し、試験期間中に被験者に使用時間と使用過程中のいかなる不快感と不良反応症状を記録することを要求する。
(II) Test substances Test samples: compositions prepared in the proportions of Examples 1 to 3 and Comparative Examples 1 to 10.
Method of use: The test samples were randomly distributed to the subjects, and the subjects were given instructions on how to use the samples to ensure that they used the test objects correctly during the test period. The test objects were required to be used for 12 weeks, and the subjects were required to record the time of use and any discomfort or adverse reaction symptoms during the use process during the test period.

(三)試験器材
櫛:櫛の歯の密度が適度(歯の間隔0.9~1.1mm)、櫛の歯の長さが2.0~3.0cm、櫛の長さが10cm以上(櫛の柄を含まない)、全体の試験過程の中で必ず同じ規格と材質の櫛を使用して、毎回使用後『医療机関の消毒技術規範』(WS-T 367-2012)の中の関連要求を参照して消毒を行う。
(3) Testing Equipment Comb: The comb teeth have appropriate density (tooth spacing 0.9-1.1mm), the comb teeth length is 2.0-3.0cm, and the comb length is 10cm or more (not including the comb handle). Combs of the same specifications and materials must be used throughout the entire testing process, and disinfected after each use in accordance with the relevant requirements in the Disinfection Technical Specification for Medical Institutions (WS-T 367-2012).

(四)試験の流れ
必要に応じて被験者を募集し、同時に60回のヘアコーム法を採用して脱毛数をカウントし、記録した。
合格した被験者には2週間の準備期間を行い、準備期間には0.9%塩化ナトリウム溶液を使用した、準備期間終了後に再度60回コーム法を行い、脱毛数が10本以上の者は正式な試験に入る。
正式な試験に選ばれた被験者は層化無作為法により12グループに分け、試験結果に影響を与える可能性のある要素、例えば、性別、年齢、髪の長さ、脱毛の深刻度などのバランスを確保した。
入選した被験者に対して、製品を使用する前の毛髪の基礎値の評価を行い、脱毛カウント、記録を含む。製品の使用後4週間、8週間、12週間後に再度同じ評価とテストを実施する。
(4) Study procedure Subjects were recruited as needed, and the number of hair loss was counted and recorded using the 60-times hair comb method.
Those who passed the test were given a two-week preparation period, during which a 0.9% sodium chloride solution was used. After the preparation period, the combing method was repeated 60 times, and those with 10 or more hairs lost were allowed to move on to the official test.
Subjects selected for the formal trial were divided into 12 groups using a stratified randomization method to ensure balance of factors that may influence the trial results, such as gender, age, hair length, and severity of hair loss.
Selected subjects will undergo a baseline evaluation of hair growth before using the product, including hair loss counts and records, and will then undergo the same evaluation and testing again 4, 8, and 12 weeks after using the product.

(五)脱毛カウント:被験者が訪問・訪問するたびに研修を受けたスタッフが60回の櫛毛法を用いて被験者の髪を梳き、脱毛した髪をカウントし、記録する。 (5) Hair loss count: At each visit, trained staff will comb the subject's hair using the combing method 60 times, and count and record the amount of hair that has fallen out.

(六)試験結果
処方効果の検証結果を表3に示す。
(6) Test Results The results of the formulation effect verification are shown in Table 3.

(七)結論
表3のデータによると、実施例1~3の12週間後の脱毛回数の差(製品使用前の脱毛回数?製品使用12週間後の脱毛回数)は対比例1~10より高く、実施例1~3の脱毛防止効果は対比例1~10より優れている。また、実施例1~3のうち、実施例3の脱毛防止効果は、実施例1、実施例2よりも優れている。
(7) Conclusion According to the data in Table 3, the difference in the number of hair removal times after 12 weeks in Examples 1 to 3 (number of hair removal times before using the product - number of hair removal times after 12 weeks using the product) is higher than that in Comparative Examples 1 to 10, and the hair removal prevention effect of Examples 1 to 3 is superior to that of Comparative Examples 1 to 10. In addition, among Examples 1 to 3, the hair removal prevention effect of Example 3 is superior to that of Examples 1 and 2.

二、用量効果の検証
(一)実験材料及び方法
1.マウスのグループ分け:
マウス齢38~40d、体重15~20gのC57BL/6Jマウス(SPF級)50匹(中国南方医科大学実験動物センターから提供)を適応的に3日間飼育した後、ランダムに10匹ずつ5群に分け、投与前24時間にマウスの背部の毛を剃り、その毛が休止期から成長期に入るよう誘導した。
2.サンプル構成:
実施例3で調製した組成物1.54gを20mLの水に完全に溶解し、試料3#を得る。
実施例3で調製した組成物0.77gを20mLの水に完全に溶解して、低用量の試料を得る。
実施例3で調製した組成物3.08gを20mLの水に完全に溶解し、高用量の試料を得る。
フェナステリド固体を0.2%フェナステリド溶液に配置し、陽性対照試料を得る。
塩化ナトリウム固体を0.9%塩化ナトリウム溶液に配置し、陰性対照試料を得る。
3.投与
試験片3#および4群の対照試験片を5群のマウスにそれぞれ投与し、1日1回0.2mLずつ8週間投与した。
II. Dose-effect verification (1) Experimental materials and methods
1. Grouping of mice:
Fifty C57BL/6J mice (SPF grade) aged 38-40 days and weighing 15-20 g (provided by the Experimental Animal Center of Southern Medical University, China) were reared for three days in an adaptive manner and then randomly divided into five groups of 10 mice each. The hair on the backs of the mice was shaved 24 hours prior to administration to induce the hair to go from the telogen phase to the anagen phase.
2. Sample configuration:
1.54 g of the composition prepared in Example 3 is completely dissolved in 20 mL of water to obtain sample 3#.
0.77 g of the composition prepared in Example 3 is completely dissolved in 20 mL of water to obtain a low-dose sample.
3.08 g of the composition prepared in Example 3 is completely dissolved in 20 mL of water to obtain a high dose sample.
Fenasteride solids are placed in a 0.2% finasteride solution to provide a positive control sample.
Sodium chloride solid is placed in a 0.9% sodium chloride solution to provide a negative control sample.
3. Administration Test specimen 3# and the control specimen of group 4 were administered to five groups of mice, respectively, at 0.2 mL once a day for 8 weeks.

(二)実験結果
1.マウスの体重変化
測定中に7dごとにマウスの体重を測定し、記録し、平均±標準偏差で表示し、具体的な結果は表4に示す。
上の表4のデータから、全検査過程において、5組のマウスの体重変化傾向はほぼ一致し、マウスはすべて異常がなかったことがわかった。
(2) Experimental Results
1. Changes in Mouse Body Weight During the measurement, the body weight of each mouse was measured and recorded every 7 days, and expressed as the average ± standard deviation. The specific results are shown in Table 4.
The data in Table 4 above shows that the weight change trends of the five groups of mice were almost consistent throughout the entire testing process, and all the mice were normal.

2.マウスの皮膚の変化と毛が生えてくるまでの時間
各グループのマウスの脱毛部位の皮膚と毛の成長状況を毎日観察し、具体的な毛の成長状況を図1~図5に示し(7dごとに撮影)、そして各マウスの脱毛部位の皮膚の色がピンクから黒に変わる時間と毛が生え始める時間を記録し、平均値±標準偏差で表し、具体的な結果を表5に示す。
図1は、検体3#を投与したマウスの背部毛髪の変化図である。
図2は、低用量の検体を投与したマウスの背部の毛髪の変化図である。
図3は、高用量の検体を投与したマウスの背部の毛髪の変化図である。
図4は、陽性対照試料を投与したマウスの背部毛髪の変化図である。
図5は、陰性対照試料を投与したマウスの背部毛髪の変化図である。
2. Changes in mouse skin and time until hair growth The skin and hair growth at the hair removal site of mice in each group were observed daily, and the specific hair growth status is shown in Figures 1 to 5 (photographs were taken every 7 days). The time when the skin color at the hair removal site of each mouse changed from pink to black and the time when hair started to grow were recorded and expressed as the average value ± standard deviation. The specific results are shown in Table 5.
FIG. 1 shows changes in the back hair of mice administered sample 3#.
FIG. 2 shows changes in hair on the back of mice administered a low dose of a test substance.
FIG. 3 shows changes in hair on the back of mice administered a high dose of a test substance.
FIG. 4 is a graph showing changes in the back hair of mice administered with a positive control sample.
FIG. 5 is a graph showing changes in the back hair of mice administered with a negative control sample.

上図より、試料3#D14では皮膚が灰色化しているマウスが2匹、毛が生えているマウスが2匹、D21では明らかに毛が生えているマウスが4匹、背中の60%に毛が生えているマウスが1匹、背中が全部生えているマウスが3匹であることが分かる。
低用量試料ではD14で1匹のマウスが皮膚が灰色になり、D21で5匹のマウスが毛が生え、その中で背中の70%の領域に毛が生えているのが2匹、背中の80%の領域に毛が生えているのが2匹であることを発見した。
高用量試料ではD14で5匹のマウスの背中に毛が生えていて、D21で5匹のマウスの毛が生えていることを発見し、その中で3匹のマウスの背中の90%の領域に毛が生えていて、2匹のマウスの背中が全部生えていることを発見した。
陽性対照試料では、D14では4匹のマウスが皮膚が灰色化し、1匹は明らかに毛が生えており、D21では6匹のマウスが背部の90%の領域に毛が生えていることが認められた。
陰性対照試料では、D14で皮膚が灰色化したマウスが2匹、D21では背中の70%に毛が生えたマウスが3匹、背中の90%に毛が生えたマウスが2匹確認された。
From the above figure, it can be seen that in sample 3#D14, there were two mice with gray skin and two mice with hair, and in D21, there were four mice with obvious hair, one mouse with hair growing on 60% of its back, and three mice with hair growing on its entire back.
In the low-dose sample, one mouse had gray skin at D14, and five mice had hair at D21, of which two had hair over 70% of their backs and two had hair over 80% of their backs.
In the high-dose sample, we found that five mice had hair on their backs at D14 and five mice had hair on their backs at D21, of which three mice had hair over 90% of their backs and two mice had hair over the entire back.
In the positive control samples, at D14, 4 mice had gray skin and 1 mouse was clearly hairy, and at D21, 6 mice were found to have hairy areas covering 90% of their backs.
In the negative control samples, 2 mice had gray skin at D14, 3 mice had hair growth on 70% of their backs, and 2 mice had hair growth on 90% of their backs at D21.

上の表5のデータから、陰性対照試験片と比べて、試験片3#、高用量試験片および陽性対照試験片は成長期に入り、毛が生えた時間をある程度短縮したことがわかった、このうち、試料3#は、毛包が休止期から成長期に入り、発毛するまでの時間をより有意に短縮した。 From the data in Table 5 above, it can be seen that compared with the negative control test strip, test strip 3#, high dose test strip and positive control test strip shortened the time to enter the anagen phase and hair growth to a certain extent, among which, sample 3# more significantly shortened the time from the hair follicle entering the anagen phase to hair growth.

3マウス背部皮膚組織学的検査
7日目、14日目、28日目、56日目に投与24時間後に人道的に処刑し、毎回2匹を処刑し、剃毛区の同じ部位で皮膚標本を取り、固定し、通常の標本作製を行い、HE染色し、顕微鏡で観察された新生毛包の数は平均値で表し、具体的な結果は表6~表9及び図6に示す。
3. Mouse Dorsal Skin Histological Examination
On the 7th, 14th, 28th, and 56th days, the mice were humanely killed 24 hours after administration. Two mice were killed each time, and skin samples were taken from the same areas of the shaved areas, fixed, and prepared as usual. They were stained with HE staining, and the number of newly formed hair follicles observed under a microscope was expressed as an average value. The specific results are shown in Tables 6 to 9 and Figure 6.

試験片3#、低用量試験片、高用量試験片、陽性対照試験片と陰性対照試験片のHE染色図を図7~図11に示す。
図7は試料3#のHE染色図であり、(a)は7日間マウス皮膚組織学的HE染色図であり、(b)は14日間マウス皮膚組織学的HE染色図であり、(c)は28日間マウス皮膚組織学的HE染色図であり、(d)は56日マウス皮膚組織学的HE染色図である。
図8は低用量試料のHE染色図であり、(a)は7日間のマウス皮膚組織学的HE染色図であり、(b)は14日間のマウス皮膚組織学的HE染色図であり、(c)は28日間のマウス皮膚組織学的HE染色図であり、(d)は56日間のマウス皮膚組織学的HE染色図である。
図9は高用量試料のHE染色図であり、(a)は7日間マウス皮膚組織学的HE染色図であり、(b)は14日間マウス皮膚組織学的HE染色図であり、(c)は28日間マウス皮膚組織学的HE染色図であり、(d)は56日マウス皮膚組織学的HE染色図である。
図10は陽性対照試験片のHE染色図であり、(a)は7日間マウス皮膚組織学的HE染色図、(b)は14日間マウス皮膚組織学的HE染色図、(c)は28日間マウス皮膚組織学的HE染色図、(d)は56日マウス皮膚組織学的HE染色図である。
図11は陰性対照試料のHE染色図であり、(a)は7日間マウス皮膚組織学的HE染色図、(b)は14日間マウス皮膚組織学的HE染色図、(c)は28日間マウス皮膚組織学的HE染色図、(d)は56日マウス皮膚組織学的HE染色図である。
The HE staining patterns of test specimen 3#, the low-dose test specimen, the high-dose test specimen, the positive control test specimen and the negative control test specimen are shown in Figures 7 to 11.
FIG. 7 shows HE staining images of sample 3#, (a) is a histological HE staining image of mouse skin after 7 days, (b) is a histological HE staining image of mouse skin after 14 days, (c) is a histological HE staining image of mouse skin after 28 days, and (d) is a histological HE staining image of mouse skin after 56 days.
FIG. 8 shows HE staining images of low-dose samples, where (a) is a histological HE staining image of mouse skin after 7 days, (b) is a histological HE staining image of mouse skin after 14 days, (c) is a histological HE staining image of mouse skin after 28 days, and (d) is a histological HE staining image of mouse skin after 56 days.
FIG. 9 shows HE staining images of high-dose samples, (a) is a histological HE staining image of mouse skin after 7 days, (b) is a histological HE staining image of mouse skin after 14 days, (c) is a histological HE staining image of mouse skin after 28 days, and (d) is a histological HE staining image of mouse skin after 56 days.
FIG. 10 shows HE staining images of positive control test pieces, where (a) is a histological HE staining image of mouse skin after 7 days, (b) is a histological HE staining image of mouse skin after 14 days, (c) is a histological HE staining image of mouse skin after 28 days, and (d) is a histological HE staining image of mouse skin after 56 days.
FIG. 11 shows HE staining images of negative control samples, where (a) is a histological HE staining image of mouse skin after 7 days, (b) is a histological HE staining image of mouse skin after 14 days, (c) is a histological HE staining image of mouse skin after 28 days, and (d) is a histological HE staining image of mouse skin after 56 days.

図6~図11より、マウス背部皮膚組織学的検査により、D7、D14、D28において、陰性対照群は実験の全周期で下降傾向を呈し、D7で毛包新生数がピークに達した。しかし、3#、高用量グループD14毛包新生数は最大値に達し、D28毛包新生数は0になった、陽性対照群の新生毛包数D7はピークに達し、実験過程全体で減少傾向を呈した。
陰性対照群はD7、D14の毛包新生数はすべて3#と陽性対照群より低く、D28陰性対照群の新生毛包数は0であった。
低用量グループはD7、D14の毛包新生数は陰性対照グループと基本的に一致し、D28の毛包新生数は3#と陰性対照グループより高かった。
3#D7、D14、D28の毛包新生数は陰性対照群より著しく多く、D7の毛包新生数は陰性対照群より48.40%高く、D14の毛包新生数はピークに達し、陰性対照群より218.00%高かった。
高用量グループはD7、D14毛包新生数量が陰性対照グループより多く、D7毛包新生数量は陰性対照グループより19.36%高く、D14毛包新生数量は陰性対照グループより32.15%高く、D28毛包新生数量と陰性対照グループの毛包新生数量はすべて0であった。
陽性対照群はD7がピークに達し、D14後に減少傾向を呈し、D28毛包新生数と陰性対照群の毛包新生数はすべて0であった。
From Figure 6 to Figure 11, the histological examination of the mouse back skin showed that the number of new hair follicles in the negative control group showed a downward trend throughout the entire experimental period on D7, D14, and D28, and reached a peak on D7. However, in the 3# high-dose group, the number of new hair follicles reached a maximum on D14, and the number of new hair follicles on D28 was 0, while the number of new hair follicles in the positive control group peaked on D7 and showed a downward trend throughout the experimental period.
In the negative control group, the number of newly generated hair follicles on D7 and D14 was all 3, which was lower than the positive control group, and the number of newly generated hair follicles in the negative control group on D28 was 0.
The number of hair follicles regenerated in the low-dose group on D7 and D14 was basically the same as that in the negative control group, and the number of hair follicles regenerated on D28 was 3#, which was higher than that of the negative control group.
3# The number of hair follicle neogenesis on D7, D14, and D28 was significantly higher than that of the negative control group. The number of hair follicle neogenesis on D7 was 48.40% higher than that of the negative control group, and the number of hair follicle neogenesis on D14 reached its peak and was 218.00% higher than that of the negative control group.
The high-dose group had higher hair follicle neogenesis numbers on D7 and D14 than the negative control group, with the D7 hair follicle neogenesis number being 19.36% higher than the negative control group, the D14 hair follicle neogenesis number being 32.15% higher than the negative control group, and the D28 hair follicle neogenesis number and the negative control group hair follicle neogenesis number were all 0.
The positive control group peaked on D7 and showed a decreasing tendency after D14, and the number of new hair follicles on D28 and in the negative control group were all zero.

本発明の組成物は、有害な副作用がなく、毛包細胞の代謝・増殖を促進し、毛包の新生を促進し、毛包が休止期から成長期に入るまでの時間を短縮し、顕著な発毛促進作用を有し、頭皮内での毛髪の締まりを強化し、脱毛・定着を防止することができる。 The composition of the present invention has no harmful side effects, promotes the metabolism and proliferation of hair follicle cells, promotes the creation of new hair follicles, shortens the time it takes for hair follicles to enter the anagen phase from the resting phase, has a significant hair growth promoting effect, strengthens the tightness of hair within the scalp, and can prevent hair loss and settling.

上記で述べたように、本発明のより良い具体的な実施形態のためだけに、本発明の保護範囲はこれに限定されるものではなく、本発明の技術的解決手段及びその発明思想に基づいて本発明の開示の技術的範囲内で同等に置換又は変更された技術分野に精通している技術者は、本発明の保護範囲内に含まれるものとする。 As stated above, the scope of protection of the present invention is not limited to the better specific embodiment of the present invention, and any technical person familiar with the technical field that is equivalently replaced or modified within the technical scope of the disclosure of the present invention based on the technical solution of the present invention and its inventive idea shall be included in the scope of protection of the present invention.

Claims (3)

発毛・育毛機能を有する組成物であって、前記発毛・育毛機能を有する組成物の原料は、重量部で、以下の表1:
中の1#、2#又は3#に記載される原料のうちのいずれか1つを含むことを特徴とする発毛・育毛機能を有する組成物。
The composition having a hair growth and hair care function includes ingredients, in parts by weight, as shown in Table 1 below:
A composition having hair growth and hair care functions, characterized by containing any one of the ingredients described in 1#, 2# or 3# .
各原料を重量部で量り、ふるいにかけておくステップ(1)と、
ステップ(1)で計量された栄養強化剤と調味剤とを混合して混合原料Aを得るステップ(2)と、
ステップ(1)で計量した蛋白質、効能成分を造粒機で攪拌し、アルコールをバインダーとして造粒した後、流動層乾燥し、整粒機で整粒して混合原料Bを得るステップ(3)と、
ステップ(2)で得られた混合原料Aと、ステップ(3)で得られた混合原料Bとを混合し、篩をかけることにより、発毛・育毛機能を有する組成物を得るステップ(4)と
を含む請求項1に記載の発毛・育毛機能を有する組成物の調製方法。
(1) weighing each ingredient by weight and sieving it;
A step (2) of mixing the nutritional enhancer and the seasoning measured in the step (1) to obtain a mixed raw material A;
Step (3) of mixing the protein and active ingredient measured in step (1) in a granulator, granulating the mixture using alcohol as a binder, and then fluidized bed drying and granulating the mixture in a granulator to obtain mixed raw material B;
and (4) mixing the mixed raw material A obtained in step (2) with the mixed raw material B obtained in step (3) and sieving the mixture to obtain a composition having hair growth and hair care functions.
ステップ(1)において、前記ふるいが40~100メッシュのふるいであり、ステップ(3)において、攪拌回転数が200回転/分以上500回転/分以下であり、アルコールの使用量は、濃度70~95%のアルコール280~480質量部を2~10分以内に噴霧することであり、流動層乾燥温度は51~58℃、時間は25~35分であり、前記整粒機は20メッシュ整粒機であり、ステップ(4)において、前記ふるいが40~100メッシュのふるいである
ことを特徴とする請求項2に記載の調製方法。
The method according to claim 2, wherein in step (1), the sieve is a 40-100 mesh sieve ; in step (3) , the stirring rotation speed is 200 rpm or more and 500 rpm or less; the amount of alcohol used is 280-480 parts by mass of alcohol having a concentration of 70-95%, sprayed within 2-10 minutes; the fluidized bed drying temperature is 51-58°C, the time is 25-35 minutes; the sieve is a 20 mesh sieve; and in step (4), the sieve is a 40-100 mesh sieve.
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