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CN116035992A - Composition with hair growth and fixation function, preparation method and application - Google Patents

Composition with hair growth and fixation function, preparation method and application Download PDF

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CN116035992A
CN116035992A CN202310078305.3A CN202310078305A CN116035992A CN 116035992 A CN116035992 A CN 116035992A CN 202310078305 A CN202310078305 A CN 202310078305A CN 116035992 A CN116035992 A CN 116035992A
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hair
parts
composition
hair growth
fixation
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CN116035992B (en
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韩鹤友
程一林
程晓紊
孙双鸽
陈顺亚
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Jiangsu Xiehe Transformation Medical Research Institute Co ltd
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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
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/63Steroids; Derivatives thereof
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
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    • A61K8/67Vitamins
    • A61K8/671Vitamin A; Derivatives thereof, e.g. ester of vitamin A acid, ester of retinol, retinol, retinal
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    • A61K8/67Vitamins
    • A61K8/676Ascorbic acid, i.e. vitamin C
    • AHUMAN NECESSITIES
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    • 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
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
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    • 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
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    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
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    • A61K2800/59Mixtures
    • A61K2800/592Mixtures of compounds complementing their respective functions
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    • AHUMAN NECESSITIES
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    • 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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Abstract

The invention discloses a composition with functions of growing and fixing hair, a preparation method and application, and belongs to the technical field of growing and fixing hair. The composition comprises the following raw materials in parts by weight: the main components comprise 1020 to 3050 parts of protein and 22.4 to 140 parts of nutrition enhancer; the functional components comprise 20-200 parts of powdered plant sterol ester, 100-500 parts of millet extract, 100-500 parts of rhizoma polygonati powder, 100-400 parts of mulberry powder and 100-500 parts of Aronia melanocarpa fruit powder; auxiliary ingredients, including 200-1800 parts of flavoring agent. The composition has no toxic or side effect, can promote metabolism and proliferation of hair follicle cells, can effectively promote formation of hair follicle melanin, shortens the time of hair follicle entering into growing period from resting period and growing hair, and can strengthen the tightness of hair in scalp, thereby achieving the effects of preventing hair loss and fixing hair.

Description

一种具有生发固发功能的组合物、制备方法和应用Composition with hair growth and fixation function, preparation method and application

技术领域Technical Field

本发明属于生发固发技术领域,具体涉及一种具有生发固发功能的组合物、制备方法和应用。The present invention belongs to the technical field of hair growth and fixation, and specifically relates to a composition with hair growth and fixation functions, a preparation method and application thereof.

背景技术Background Art

据统计显示,脱发已呈越来越普遍化、低龄化趋势。According to statistics, hair loss is becoming more and more common and is occurring at younger ages.

市面上宣称具有生发固发功能的产品较多,然而这些产品在生发固发效果方面均不是很理想;而且大部分生发产品为洗护类产品,其它产品较少,然而洗护类产品由于需要具备清洁功能,会不可避免地添加表面活性剂、调理剂等会对头发造成损伤的化学成分,因此,亟需一种生发固发效果好的具有生发固发功能的组合物。There are many products on the market that claim to have the function of hair growth and hair fixation. However, these products are not very ideal in terms of hair growth and hair fixation effects. Moreover, most of the hair growth products are shampoo and conditioner products, and other products are relatively few. However, since shampoo and conditioner products need to have a cleaning function, it is inevitable to add surfactants, conditioners and other chemical ingredients that may damage the hair. Therefore, there is an urgent need for a composition with good hair growth and hair fixation effects and a hair growth and hair fixation function.

发明内容Summary of the invention

为解决现有技术中的上述问题,本发明提供了一种具有生发固发功能的组合物、制备方法和应用。In order to solve the above problems in the prior art, the present invention provides a composition with hair growth and fixation function, a preparation method and application thereof.

为实现上述目的,本发明提供了如下技术方案:To achieve the above object, the present invention provides the following technical solutions:

本发明技术方案之一:一种具有生发固发功能的组合物,所述具有生发固发功能的组合物原料按重量份数计包括:One of the technical solutions of the present invention: a composition with the function of hair growth and fixation, wherein the raw materials of the composition with the function of hair growth and fixation include, by weight:

Figure SMS_1
Figure SMS_1

进一步地,所述蛋白质包括小分子肽和氨基酸;所述小分子肽按重量份数计包括牛骨胶原蛋白肽500~1500份和水解胶原蛋白肽500~1500份;所述氨基酸按重量份数计包括牛磺酸20~50份。Furthermore, the protein includes small molecule peptides and amino acids; the small molecule peptides include 500-1500 parts of bovine collagen peptides and 500-1500 parts of hydrolyzed collagen peptides by weight; and the amino acids include 20-50 parts of taurine by weight.

进一步地,所述营养强化剂为维生素类强化剂和矿物质类强化剂。Furthermore, the nutritional enhancers are vitamin enhancers and mineral enhancers.

更进一步地,所述维生素类强化剂按重量份数计包括维生素A 0.2~10份,维生素C10~50份,维生素E1~10份和酵母粉10~50份;所述矿物质类强化剂按重量份数计包括富马酸亚铁1~10份和氧化锌0.2~10份。Furthermore, the vitamin enhancer includes 0.2-10 parts of vitamin A, 10-50 parts of vitamin C, 1-10 parts of vitamin E and 10-50 parts of yeast powder by weight; the mineral enhancer includes 1-10 parts of ferrous fumarate and 0.2-10 parts of zinc oxide by weight.

进一步地,所述粉末植物甾醇酯为β-谷甾醇酯,化学式为C47O2H80Furthermore, the powdered phytosterol ester is β-sitosterol ester, and the chemical formula is C 47 O 2 H 80 .

进一步地,所述小米提取物的制备方法为:将小米粉碎,加水提取,提取液浓缩,冷冻干燥得到所述小米提取物。Furthermore, the preparation method of the millet extract is: crushing the millet, adding water to extract, concentrating the extract, and freeze-drying to obtain the millet extract.

进一步地,所述调味剂按重量份数计包括赤藓糖醇100~500份和西柚粉100~500份。Furthermore, the flavoring agent comprises 100 to 500 parts of erythritol and 100 to 500 parts of grapefruit powder by weight.

本发明技术方案之二:上述具有生发固发功能的组合物的制备方法,包括以下步骤:The second technical solution of the present invention: The preparation method of the above-mentioned composition having the function of hair growth and fixation comprises the following steps:

(1)按重量份称取各原料,过筛备用;(1) Weigh each raw material by weight, sieve and set aside;

(2)将步骤(1)称取的营养强化剂和调味剂混合,得到混合原料A;(2) mixing the nutritional enhancer and flavoring agent weighed in step (1) to obtain a mixed raw material A;

(3)将步骤(1)称取的蛋白质、功效成分置于制粒机中搅拌,以酒精为粘合剂进行制粒,之后流化床干燥,整粒机整粒,得到混合原料B;(3) placing the protein and functional ingredients weighed in step (1) in a granulator and stirring, granulating with alcohol as a binder, and then fluidized bed drying and granulating with a granulator to obtain a mixed raw material B;

(4)将步骤(2)得到的混合原料A与步骤(3)得到的混合原料B混合,过筛,得到所述具有生发固发功能的组合物。(4) Mixing the mixed raw material A obtained in step (2) and the mixed raw material B obtained in step (3), and sieving them to obtain the composition having the function of hair growth and fixation.

进一步地,步骤(1)中,所述过筛为过40~100目筛。Furthermore, in step (1), the sieving is through a 40-100 mesh sieve.

进一步地,步骤(2)中,所述混合为等量递增混合。Furthermore, in step (2), the mixing is equal and incremental mixing.

进一步地,步骤(3)中,所述搅拌转数为200~500转/min;所述酒精用量为于2~10min内喷洒70~95%酒精280~480质量份;所述流化床干燥温度为51~58℃,时间为25~35min;所述整粒机为20目整粒机。Furthermore, in step (3), the stirring speed is 200 to 500 rpm; the alcohol dosage is 280 to 480 parts by weight of 70 to 95% alcohol sprayed within 2 to 10 minutes; the fluidized bed drying temperature is 51 to 58° C., and the drying time is 25 to 35 minutes; and the granulator is a 20-mesh granulator.

进一步地,步骤(4)中,所述过筛为过40~100目筛。Furthermore, in step (4), the sieving is through a 40-100 mesh sieve.

本发明技术方案之三:上述具有生发固发功能的组合物在生发固发方面的应用。The third technical solution of the present invention: application of the above-mentioned composition with hair growth and hair fixation function in hair growth and hair fixation.

与现有技术相比,本发明具有以下有益效果:Compared with the prior art, the present invention has the following beneficial effects:

(1)本发明制备的具有生发固发功能的组合物能够缩短毛囊从休止期进入生长期的时间,能够加快长出毛发的时间,对毛发生长具有显著的促进作用;(1) The composition with hair growth and fixation function prepared by the present invention can shorten the time for hair follicles to enter the growth phase from the resting phase, accelerate the time for hair to grow, and has a significant promoting effect on hair growth;

(2)本发明制备的具有生发固发功能的组合物无毒副作用,且能够有效促进毛囊新生;(2) The composition with hair growth and hair fixation function prepared by the present invention has no toxic side effects and can effectively promote the regeneration of hair follicles;

(3)本发明采用流化床制粒,而非烘箱干燥,其优点相对烘箱干燥,流态匀称,干燥均匀,对物料表面的损伤小,粉体更加疏松;热效率高,节能效果好,比烘箱干燥可节能30~60%。(3) The present invention adopts fluidized bed granulation instead of oven drying. Compared with oven drying, the present invention has the advantages of uniform flow state, uniform drying, less damage to the surface of the material, and looser powder; high thermal efficiency and good energy-saving effect, which can save 30-60% energy compared with oven drying.

本发明添加的水解胶原蛋白肽属于人体皮肤必要的一种组成物质,可以有效的保证皮肤的水润,增加皮肤的紧致,且头发中最主要的蛋白为角蛋白,胶原蛋白可能支持并增加体内的生发蛋白。这可以帮助加固头发,促进头发生长,防止脱发;The hydrolyzed collagen peptide added in the present invention is a necessary component of human skin, which can effectively ensure the moisture of the skin and increase the firmness of the skin. The main protein in hair is keratin, and collagen may support and increase the hair growth protein in the body. This can help strengthen hair, promote hair growth, and prevent hair loss;

此外本申请选用两种胶原蛋白肽是由于一种为动物皮提取的胶原蛋白肽,一种为骨来源的胶原蛋白肽,氨基酸成分和肽段有所不同,可互为补充;In addition, the present application selects two types of collagen peptides because one is a collagen peptide extracted from animal skins, and the other is a collagen peptide derived from bones, which have different amino acid compositions and peptide segments and can complement each other;

本发明添加的牛磺酸不仅具有修复受损头发的作用,还具有增加头发生长因子的生成并促进头发生长的作用。牛磺酸可增加生长因子IGF-1的产生,该因子可作用于人的毛发周期,延长生长期,并产生浓密而结实的头发;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 factor and promoting hair growth. Taurine can increase the production of growth factor IGF-1, which can act on the human hair cycle, prolong the growth period, and produce thick and strong hair;

本发明添加的多种维生素,能增加头皮营养,促进毛囊细胞代谢,进而促进头发生长的作用;The multivitamins added in the present invention can increase the nutrition of the scalp, promote the metabolism of hair follicle cells, and thus promote the growth of hair;

本发明添加的酵母粉中含有维生素H和烟酸,其中含有的维生素H又名生物素,是一种维持人体自然生长、发育和正常人体机能健康必要的营养素,能够直接调控毛囊细胞的代谢,也可通过影响采食量或代谢间接影响毛囊发育;The yeast powder added in the present invention contains vitamin H and nicotinic acid. The vitamin H contained therein is also called biotin, which is a nutrient necessary for maintaining the natural growth, development and normal function of the human body. It can directly regulate the metabolism of hair follicle cells and can also indirectly affect the development of hair follicles by affecting the food intake or metabolism.

此外,酵母粉中含有的烟酸同样是人体中不可缺少的营养成分,在促进人体的正常生长发育上起着重要的作用,能够促进铁吸收和血细胞的生成,维持皮肤的正常功能;In addition, the niacin contained in yeast powder is also an indispensable nutrient for the human body. It plays an important role in promoting the normal growth and development of the human body. It can promote iron absorption and blood cell production and maintain the normal function of the skin.

本发明添加了富马酸亚铁,铁元素为身体的每一个细胞提供氧气,包括头皮和毛囊中的细胞;The present invention adds ferrous fumarate, which provides oxygen to every cell in the body, including the cells in the scalp and hair follicles;

本发明添加了氧化锌,锌是体内多种酶的辅助因子,还是体内抗氧化酵素的重要成分,可强化血球细胞活性,是毛发生长、角蛋白合成所必需的微量元素;The present invention adds zinc oxide, which is a cofactor of multiple enzymes in the body and an important component of antioxidant enzymes in the body. It can enhance the activity of blood cells and is a trace element necessary for hair growth and keratin synthesis.

本发明添加的粉末植物甾醇酯是由植物甾醇与脂肪酸通过酯化反应或转酯化反应制得。甾醇酯能够在人体内转化成甾醇和脂肪酸,所以其生理功能包括植物甾醇和脂肪酸两部分所具有的生理功能。植物甾醇酯更容易被人体吸收,使用效率远远高于普通的植物甾醇,可通过抑制雄激素的产生来防止脱发;The powdered phytosterol ester added in the present invention is prepared by esterification reaction or transesterification reaction of phytosterol and fatty acid. Sterol ester can be converted into sterol and fatty acid in the human body, so its physiological function includes the physiological functions of phytosterol and fatty acid. Phytosterol ester is more easily absorbed by the human body, and its use efficiency is much higher than that of ordinary phytosterol, and it can prevent hair loss by inhibiting the production of androgen;

本发明添加的小米提取物,是一种从黍米中提取的稀有油脂,具体为黍素(化学式:C31H52O),该稀有油脂作用于毛囊根部,能加快细胞的代谢与增殖,使头发保持生长,并能滋养和修复受损的头皮,为健康发质创造良好的基础条件,同时还具有抗炎和抗毒性的作用;The millet extract added in the present invention is a rare oil extracted from millet, specifically millet extract (chemical formula: C 31 H 52 O). The rare oil acts on the roots of hair follicles, can accelerate cell metabolism and proliferation, keep hair growing, nourish and repair damaged scalp, create good basic conditions for healthy hair quality, and also has anti-inflammatory and anti-toxic effects;

本发明添加的黄精粉归肾经,有益精填髓之功效,对治疗肾虚型脱发等有很好的效果;The polygonatum powder added in the present invention belongs to the kidney meridian, has the effect of replenishing essence and filling marrow, and has a good effect on treating kidney deficiency type hair loss and the like;

本发明添加的桑葚粉具有补肾益精、乌发生发之功效,适用于未老先衰、须发早白、头发脱落、斑秃、头发枯萎的症状;桑葚是药食同源目录中的一种材料,据药典记载,具有治疗须发早白的作用;桑葚中富含丰富的原花青素,原花青素可能通过激活毛囊隆突部的干细胞,诱导休止期毛囊向生长期转化,促进毛发再生;The mulberry powder added in the present invention has the effects of nourishing the kidney and replenishing the essence, and promoting hair growth, and is suitable for treating symptoms of premature aging, premature graying of hair, hair loss, alopecia areata, and hair withering; mulberry is a material in the catalog of medicine and food homology, and according to the pharmacopoeia, it has the effect of treating premature graying of hair; mulberry is rich in proanthocyanidins, and proanthocyanidins may activate stem cells in the bulge of hair follicles, induce the transformation of resting hair follicles to growth phase, and promote hair regeneration;

本发明添加的黑果腺肋花楸果粉富含多种维生素、抗氧化成分和矿质元素,具有改善头部血液循环之功效。The aronia melanocarpa fruit powder added by the invention is rich in various vitamins, antioxidant components and mineral elements, and has the effect of improving the blood circulation of the head.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

图1为给药试样3#的小鼠背部毛发变化图;FIG1 is a diagram showing the changes in the back hair of mice treated with sample 3#;

图2为给药低剂量试样的小鼠背部毛发变化图;FIG2 is a diagram showing the changes in the back hair of mice administered with a low-dose sample;

图3为给药高剂量试样的小鼠背部毛发变化图;FIG3 is a diagram showing the changes in the back hair of mice administered with a high-dose sample;

图4为给药阳性对照试样的小鼠背部毛发变化图;FIG4 is a diagram showing the changes in the back hair of mice administered with a positive control sample;

图5为给药阴性对照试样的小鼠背部毛发变化图;FIG5 is a diagram showing the changes in the back hair of mice administered with a negative control sample;

图6为给药试样3#、低剂量试样、高剂量试样、阳性对照试样和阴性对照试样的镜下新生毛囊数量统计图;FIG6 is a statistical diagram of the number of newly formed hair follicles under a microscope for the drug-administered sample 3#, the low-dose sample, the high-dose sample, the positive control sample, and the negative control sample;

图7为给药试样3#的HE染色图,其中(a)为7天小鼠皮肤组织学HE染色图,(b)为14天小鼠皮肤组织学HE染色图,(c)为28天小鼠皮肤组织学HE染色图,(d)为56天小鼠皮肤组织学HE染色图;Figure 7 is a HE staining image of the administration sample 3#, wherein (a) is a 7-day mouse skin histological HE staining image, (b) is a 14-day mouse skin histological HE staining image, (c) is a 28-day mouse skin histological HE staining image, and (d) is a 56-day mouse skin histological HE staining image;

图8为给药低剂量试样的HE染色图,其中(a)为7天小鼠皮肤组织学HE染色图,(b)为14天小鼠皮肤组织学HE染色图,(c)为28天小鼠皮肤组织学HE染色图,(d)为56天小鼠皮肤组织学HE染色图;FIG8 is a HE staining image of a low-dose sample, wherein (a) is a 7-day mouse skin histological HE staining image, (b) is a 14-day mouse skin histological HE staining image, (c) is a 28-day mouse skin histological HE staining image, and (d) is a 56-day mouse skin histological HE staining image;

图9为给药高剂量试样的HE染色图,其中(a)为7天小鼠皮肤组织学HE染色图,(b)为14天小鼠皮肤组织学HE染色图,(c)为28天小鼠皮肤组织学HE染色图,(d)为56天小鼠皮肤组织学HE染色图;FIG9 is a HE staining image of a high-dose sample, wherein (a) is a 7-day mouse skin histological HE staining image, (b) is a 14-day mouse skin histological HE staining image, (c) is a 28-day mouse skin histological HE staining image, and (d) is a 56-day mouse skin histological HE staining image;

图10为给药阳性对照试样的HE染色图,其中(a)为7天小鼠皮肤组织学HE染色图,(b)为14天小鼠皮肤组织学HE染色图,(c)为28天小鼠皮肤组织学HE染色图,(d)为56天小鼠皮肤组织学HE染色图;Figure 10 is a HE staining image of the administration positive control sample, wherein (a) is a 7-day mouse skin histological HE staining image, (b) is a 14-day mouse skin histological HE staining image, (c) is a 28-day mouse skin histological HE staining image, and (d) is a 56-day mouse skin histological HE staining image;

图11为给药阴性对照试样的HE染色图,其中(a)为7天小鼠皮肤组织学HE染色图,(b)为14天小鼠皮肤组织学HE染色图,(c)为28天小鼠皮肤组织学HE染色图,(d)为56天小鼠皮肤组织学HE染色图。Figure 11 is the HE staining image of the negative control sample, wherein (a) is the HE staining image of the mouse skin histology at 7 days, (b) is the HE staining image of the mouse skin histology at 14 days, (c) is the HE staining image of the mouse skin histology at 28 days, and (d) is the HE staining image of the mouse skin histology at 56 days.

具体实施方式DETAILED DESCRIPTION

现详细说明本发明的多种示例性实施方式,该详细说明不应认为是对本发明的限制,而应理解为是对本发明的某些方面、特性和实施方案的更详细的描述。应理解本发明中所述的术语仅仅是为描述特别的实施方式,并非用于限制本发明。Now, various exemplary embodiments of the present invention are described in detail, which should not be considered as a limitation of the present invention, but should be understood as a more detailed description of certain aspects, characteristics and embodiments of the present invention. It should be understood that the terms described in the present invention are only for describing specific embodiments and are not used to limit the present invention.

另外,对于本发明中的数值范围,应理解为还具体公开了该范围的上限和下限之间的每个中间值。在任何陈述值或陈述范围内的中间值以及任何其他陈述值或在所述范围内的中间值之间的每个较小的范围也包括在本发明内。这些较小范围的上限和下限可独立地包括或排除在范围内。In addition, for the numerical range in the present invention, it is understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Each smaller range between the intermediate value in any stated value or stated range and any other stated value or intermediate value in the range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

除非另有说明,否则本文使用的所有技术和科学术语具有本发明所述领域的常规技术人员通常理解的相同含义。虽然本发明仅描述了优选的方法和材料,但是在本发明的实施或测试中也可以使用与本文所述相似或等同的任何方法和材料。本说明书中提到的所有文献通过引用并入,用以公开和描述与所述文献相关的方法和/或材料。在与任何并入的文献冲突时,以本说明书的内容为准。Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and/or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

在不背离本发明的范围或精神的情况下,可对本发明说明书的具体实施方式做多种改进和变化,这对本领域技术人员而言是显而易见的。由本发明的说明书得到的其他实施方式对技术人员而言是显而易见的。本发明说明书和实施例仅是示例性的。It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to those skilled in the art. The present invention description and examples are exemplary only.

关于本文中所使用的“包含”、“包括”、“具有”、“含有”等等,均为开放性的用语,即意指包含但不限于。The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

本发明实施例中所述“份”若无特殊说明均为“重量份数”。The “parts” in the embodiments of the present invention are “parts by weight” unless otherwise specified.

以下实施例中,所述粉末植物甾醇酯按照专利CN201410445798.0进行制备;In the following examples, the powdered phytosterol esters were prepared according to patent CN201410445798.0;

以下实施例中,所述小米提取物的制备方法为:In the following examples, the preparation method of the millet extract is:

1)将小米置37℃热风干燥箱中烘干24h,粉碎过80目筛;1) Dry the millet in a hot air drying oven at 37°C for 24 hours and grind it through an 80-mesh sieve;

2)将步骤1)过筛后的小米与水按料液比为1∶10在50℃条件下旋涡提取1h,抽滤,重复两次,分别收集滤液及滤渣;2) vortex extraction of the sieved millet in step 1) with water at a solid-liquid ratio of 1:10 at 50° C. for 1 h, and suction filtration, and repeating twice, and collecting the filtrate and the filter residue respectively;

3)将步骤2)得到的滤液浓缩至固含量25~35%得到浓缩液;3) Concentrating the filtrate obtained in step 2) to a solid content of 25-35% to obtain a concentrated solution;

4)将步骤3)得到的浓缩液进行冷冻干燥,得到所述小米提取物,其中冷冻干燥的参数为,保持水分在6%以下;4) freeze-drying the concentrated solution obtained in step 3) to obtain the millet extract, wherein the freeze-drying parameter is to keep the moisture content below 6%;

以下实施例中所述桑葚粉、黑果腺肋花楸果粉和黄精粉为市购,其中桑葚粉、黑果腺肋花楸果粉中原花青素含量为10%,黄精粉中黄精多糖含量为15%;The mulberry powder, Aronia nigra fruit powder and Polygonatum sibiricum powder described in the following examples are commercially available, wherein the content of proanthocyanidins in the mulberry powder and Aronia nigra fruit powder is 10%, and the content of Polygonatum sibiricum polysaccharide in the Polygonatum sibiricum powder is 15%;

以下实施例中所述牛骨胶原蛋白肽和水解胶原蛋白肽为市购,均为食品原料,其蛋白含量为95%;The bovine bone collagen peptide and hydrolyzed collagen peptide described in the following examples are commercially available and are both food raw materials with a protein content of 95%;

以下实施例中所述维生素A为市购,为食品级添加剂,有效物质含量为32.5万IU/g;The vitamin A described in the following examples is commercially available and is a food-grade additive with an effective substance content of 325,000 IU/g;

以下实施例中所述维生素C为市购,为食品级添加剂,有效物质含量为97%;The vitamin C described in the following examples is commercially available and is a food grade additive with an effective substance content of 97%;

以下实施例中所述牛磺酸和富马酸亚铁为市购,均为食品级添加剂,有效物质含量为99%;The taurine and ferrous fumarate described in the following examples are commercially available, both are food grade additives, and the effective substance content is 99%;

以下实施例中所述维生素E为市购,为食品级添加剂,有效成分含量为50%;The vitamin E described in the following examples is commercially available and is a food grade additive with an active ingredient content of 50%;

以下实施例中所述酵母粉为市购,有效物质烟酸含量为40mg/g、生物素含量为300ppm。The yeast powder described in the following examples is commercially available, and has an effective substance niacin content of 40 mg/g and a biotin content of 300 ppm.

以下实施例中,术语“等量递增混合”是指:等量递增为取用量最少的原料和等量的其他原料,混合均匀,之后再加入同混合后等量的其他原料混合均匀,如此倍量增加直至所有原料混合完成。In the following embodiments, the term "mixing in equal amounts in increments" means that the equal amounts are taken as the least amount of raw material and the same amount of other raw materials, mixed evenly, and then the same amount of other raw materials are added and mixed evenly, and the amount is increased in multiples until all the raw materials are mixed.

实施例1Example 1

(1)按表1中1#所记载的重量份称取各原料,过40目筛备用;(1) Weigh each raw material according to the weight portion recorded in 1# in Table 1, and pass it through a 40-mesh sieve for later use;

(2)将步骤(1)称取的营养强化剂和调味剂等量递增混合,得到混合原料A;(2) mixing the nutritional enhancer and flavoring agent weighed in step (1) in equal amounts in increasing amounts to obtain a mixed raw material A;

(3)将步骤(1)称取的蛋白质和功效成分置于制粒机中搅拌,以酒精为粘合剂进行制粒,之后流化床干燥,20目整粒机整粒,得到混合原料B,其中搅拌转数为200转/min,酒精用量为于2min内喷洒70%酒精280份,流化床干燥温度为51℃,时间为25min;(3) placing the protein and functional ingredients weighed in step (1) in a granulator and stirring, granulating with alcohol as a binder, and then fluidized bed drying, granulating with a 20-mesh granulator to obtain a mixed raw material B, wherein the stirring speed is 200 rpm, the alcohol dosage is 280 parts of 70% alcohol sprayed within 2 minutes, the fluidized bed drying temperature is 51° C., and the time is 25 minutes;

(4)将步骤(2)得到的混合原料A与步骤(3)得到的混合原料B混合,过40目筛,得到具有生发固发功能的组合物。(4) Mixing the mixed raw material A obtained in step (2) and the mixed raw material B obtained in step (3), and passing through a 40-mesh sieve to obtain a composition having the function of hair growth and fixation.

实施例2Example 2

(1)按表1中2#所记载的重量份称取各原料,过100目筛备用;(1) Weigh the raw materials according to the weight parts recorded in 2# in Table 1, and pass them through a 100-mesh sieve for later use;

(2)将步骤(1)称取的营养强化剂和调味剂等量递增混合,得到混合原料A;(2) mixing the nutritional enhancer and flavoring agent weighed in step (1) in equal amounts in increasing amounts to obtain a mixed raw material A;

(3)将步骤(1)称取的蛋白质和功效成分置于制粒机中搅拌,以酒精为粘合剂进行制粒,之后流化床干燥,20目整粒机整粒,得到混合原料B,其中搅拌转数为500转/min,酒精用量为于10min内喷洒95%酒精480份,流化床干燥温度为58℃,时间为35min;(3) placing the protein and functional ingredients weighed in step (1) in a granulator and stirring, granulating with alcohol as a binder, and then fluidized bed drying, granulating with a 20-mesh granulator to obtain a mixed raw material B, wherein the stirring speed is 500 rpm, the alcohol dosage is 480 parts of 95% alcohol sprayed within 10 minutes, the fluidized bed drying temperature is 58° C., and the drying time is 35 minutes;

(4)将步骤(2)得到的混合原料A与步骤(3)得到的混合原料B混合,过100目筛,得到具有生发固发功能的组合物。(4) Mixing the mixed raw material A obtained in step (2) with the mixed raw material B obtained in step (3), and filtering through a 100-mesh sieve to obtain a composition having the function of hair growth and fixation.

实施例3Example 3

(1)按表1中3#所记载的重量份称取各原料,过60目筛备用;(1) Weigh the raw materials according to the weight of 3# in Table 1, and pass them through a 60-mesh sieve for later use;

(2)将步骤(1)称取的营养强化剂和调味剂等量递增混合,得到混合原料A;(2) mixing the nutritional enhancer and flavoring agent weighed in step (1) in equal amounts in increasing amounts to obtain a mixed raw material A;

(3)将步骤(1)称取的蛋白质和功效成分置于制粒机中搅拌,以酒精为粘合剂进行制粒,之后流化床干燥,20目整粒机整粒,得到混合原料B,其中搅拌转数为350转/min,酒精用量为于5.5min内喷洒85%酒精300份,流化床干燥温度为55℃,时间为30min;(3) placing the protein and functional ingredients weighed in step (1) in a granulator and stirring, granulating with alcohol as a binder, and then fluidized bed drying, granulating with a 20-mesh granulator to obtain a mixed raw material B, wherein the stirring speed is 350 rpm, the alcohol dosage is 300 parts of 85% alcohol sprayed within 5.5 minutes, the fluidized bed drying temperature is 55° C., and the time is 30 minutes;

(4)将步骤(2)得到的混合原料A与步骤(3)得到的混合原料B混合,过60目筛,得到具有生发固发功能的组合物。(4) Mixing the mixed raw material A obtained in step (2) and the mixed raw material B obtained in step (3), and passing through a 60-mesh sieve to obtain a composition having the function of hair growth and fixation.

表1各原料用量Table 1 Amount of each raw material

Figure SMS_2
Figure SMS_2

对比例1Comparative Example 1

同实施例3,区别在于步骤(1)为按表2中4#所记载的重量份称取各原料,过60目筛备用。Same as Example 3, except that in step (1), each raw material is weighed according to the weight portion recorded in 4# in Table 2, and passed through a 60-mesh sieve for later use.

对比例2Comparative Example 2

同实施例3,区别在于步骤(1)为按表2中5#所记载的重量份称取各原料,过60目筛备用。Same as Example 3, except that in step (1), each raw material is weighed according to the weight portion recorded in 5# in Table 2, and passed through a 60-mesh sieve for later use.

对比例3Comparative Example 3

同实施例3,区别在于步骤(1)为按表2中6#所记载的重量份称取各原料,过60目筛备用。Same as Example 3, except that in step (1), each raw material is weighed according to the weight portion recorded in 6# in Table 2, and passed through a 60-mesh sieve for later use.

对比例4Comparative Example 4

同实施例3,区别在于步骤(1)为按表2中7#所记载的重量份称取各原料,过60目筛备用。Same as Example 3, except that in step (1), each raw material is weighed according to the weight portion recorded in 7# in Table 2, and passed through a 60-mesh sieve for later use.

对比例5Comparative Example 5

同实施例3,区别在于步骤(1)为按表2中8#所记载的重量份称取各原料,过60目筛备用。Same as Example 3, except that in step (1), each raw material is weighed according to the weight portion recorded in 8# in Table 2, and passed through a 60-mesh sieve for later use.

对比例6Comparative Example 6

同实施例3,区别在于步骤(1)为按表2中9#所记载的重量份称取各原料,过60目筛备用。Same as Example 3, except that in step (1), each raw material is weighed according to the weight portion recorded in 9# in Table 2, and passed through a 60-mesh sieve for later use.

对比例7Comparative Example 7

同实施例3,区别在于步骤(1)为按表2中10#所记载的重量份称取各原料,过60目筛备用。The same as Example 3, except that in step (1), each raw material is weighed according to the weight portion recorded in 10# in Table 2, and passed through a 60-mesh sieve for later use.

对比例8Comparative Example 8

同实施例3,区别在于步骤(1)为按表2中11#所记载的重量份称取各原料,过60目筛备用。The same as Example 3, except that in step (1), each raw material is weighed according to the weight portion recorded in 11# in Table 2, and passed through a 60-mesh sieve for later use.

对比例9Comparative Example 9

同实施例3,区别在于步骤(1)为按表2中12#所记载的重量份称取各原料,过60目筛备用。Same as Example 3, except that in step (1), each raw material is weighed according to the weight portion recorded in 12# in Table 2, and passed through a 60-mesh sieve for later use.

对比例10Comparative Example 10

同实施例3,区别在于步骤(1)中以黑豆粉替换桑葚粉。Same as Example 3, except that black bean powder is used to replace mulberry powder in step (1).

表2各原料用量Table 2 Amount of each raw material

Figure SMS_3
Figure SMS_3

Figure SMS_4
Figure SMS_4

效果验证Effect verification

一、处方效果验证1. Verification of prescription effect

(一)受试者的选择1. Selection of subjects

按入选和排除标准选择合格的受试者;Select eligible subjects according to the inclusion and exclusion criteria;

1.入选标准1. Selection criteria

(1)25~45岁,健康男性或女性;(1) 25-45 years old, healthy men or women;

头发长度在5~40cm之间;Hair length is between 5 and 40 cm;

(2)有脱发多和头发轻度稀疏困扰,且按60次梳发法脱发计数大于10根、2周准备期后仍大于10根者;(2) Those who have problems with excessive hair loss and mild hair thinning, and the hair count after 60 combings is greater than 10 and still greater than 10 after a 2-week preparation period;

(3)近1个月内没有进行过染发、烫发、定型等特殊美发处理者;(3) Those who have not undergone any special hair treatments such as hair dyeing, perming, styling, etc. in the past month;

2.排除标准2. Exclusion criteria

(1)妊娠或哺乳期妇女,或近期有备孕计划者;(1) Pregnant or breastfeeding women, or those who are planning to get pregnant in the near future;

(2)患有精神类或心理疾病者;或者有长期睡眠、情绪控制障碍者;(2) Those who suffer from mental or psychological diseases; or those who have long-term sleep or emotion control disorders;

(3)近3个月内使用过具有防脱发功效的化妆品或其他具有此类功效或生发功效的产品者;(3) Those who have used cosmetics with anti-hair loss effects or other products with such effects or hair growth effects in the past three months;

(4)近6个月内服用过或局部使用过任何影响头发生长的药物者;(4) Those who have taken or topically applied any medication that affects hair growth in the past 6 months;

3.受试者限制3. Subject Restrictions

(1)受试者筛选和试验期间每次访视前48±4小时内不能洗头,且每次访视前不洗头发的时间基本保持一致,访视当天不能自行梳发;(1) Subjects should not wash their hair within 48±4 hours before screening and each visit during the trial period, and the time before each visit should be basically the same. Subjects should not comb their hair on their own on the day of the visit.

(2)试验期间每次访视评估前2周内不理发;(2) No haircut within 2 weeks before each visit assessment during the trial;

(3)试验期间不能进行任何头发护理和美发处理措施,也不能接受任何防脱发、生发方面的治疗;(3) During the trial period, patients are not allowed to take any hair care or hairdressing treatments, nor receive any hair loss prevention or hair growth treatments;

(4)试验期间需保持原有的生活习惯,避免情绪波动大;(4) During the trial, you need to maintain your original lifestyle and avoid emotional fluctuations;

(二)受试物(II) Test substances

试验样品:实施例1~3以及对比例1~9制备得到的组合物;Test samples: compositions prepared in Examples 1 to 3 and Comparative Examples 1 to 9;

使用方法:对受试者随机发放试验样品,并对受试者进行样品使用指导,确保受试者在试验周期内正确使用受试物,受试物使用12周,试验期间要求受试者记录使用时间及使用过程中的任何不适感和不良反应症状;Usage: Test samples are randomly distributed to subjects, and they are instructed on the use of samples to ensure that they use the test substances correctly during the test period. The test substances are used for 12 weeks. During the test, subjects are required to record the use time and any discomfort and adverse reaction symptoms during use;

(三)试验器材(III) Test equipment

梳子:梳齿密度适中(齿间距0.9~1.1mm),梳齿长度为2.0~3.0cm,梳子长度不少于10cm(不含梳子把柄),整个试验过程中必须使用同一规格和材质的梳子,每次使用后参照《医疗机构消毒技术规范》(WS-T 367-2012)中相关要求进行消毒;Comb: The tooth density is moderate (tooth spacing 0.9-1.1mm), the tooth length is 2.0-3.0cm, and the comb length is not less than 10cm (excluding the comb handle). The comb of the same specification and material must be used throughout the test. After each use, it must be disinfected in accordance with the relevant requirements of the Technical Specifications for Disinfection of Medical Institutions (WS-T 367-2012);

(四)试验流程(IV) Test process

按照要求招募受试者,同时采用60次梳发法计数脱发数量,并记录;Subjects were recruited as required, and the number of hair loss was counted and recorded using the 60-combing method;

合格受试者进行2周准备期,准备期使用0.9%的氯化钠溶液;准备期结束后再次进行60次梳发法,脱发计数仍大于10根者进入正式试验;Qualified subjects underwent a 2-week preparation period, during which 0.9% sodium chloride solution was used. After the preparation period, the subjects were combed 60 times again. Those with hair loss counts still greater than 10 would enter the formal trial.

入选正式试验的受试者按照分层随机法分为12组,确保可能影响试验结果的因素例如:性别、年龄、头发长度、脱发严重程度等的平衡;The subjects selected for the formal trial were divided into 12 groups according to the stratified random method to ensure the balance of factors that may affect the trial results, such as gender, age, hair length, and severity of hair loss;

对入选受试者进行使用产品前毛发基础值评估,包括脱发计数,记录;产品使用后4周、8周、12周后再次进行相同的评估和测试;The selected subjects were evaluated for hair basal values before using the product, including hair loss counts, and recorded; the same evaluation and testing were performed again 4, 8, and 12 weeks after using the product;

(五)脱发计数:受试者每次访视时由经过培训的工作人员采用60次梳发法梳理受试者头发,对脱落头发计数,并记录。(V) Hair loss count: During each visit, trained staff combed the subject's hair 60 times, counted the number of lost hair, and recorded the number.

(六)试验结果(VI) Test results

处方效果验证结果如表3所示;The results of prescription effect verification are shown in Table 3;

表3处方效果验证结果Table 3 Prescription effect verification results

Figure SMS_5
Figure SMS_5

(七)结论VII. Conclusion

根据表3数据可以发现,实施例1~3的12周后脱发计数差值(产品使用前的脱发计数-产品使用12周后的脱发计数)高于对比例1~10,因此,实施例1~3的防脱发功效优于对比例1~10;此外实施例1~3中,实施例3的防脱发效果优于实施例1和实施例2。According to the data in Table 3, it can be found that the difference in hair loss counts after 12 weeks of Examples 1 to 3 (hair loss counts before product use - hair loss counts after 12 weeks of product use) is higher than that of Comparative Examples 1 to 10. Therefore, the anti-hair loss efficacy of Examples 1 to 3 is better than that of Comparative Examples 1 to 10; in addition, among Examples 1 to 3, the anti-hair loss effect of Example 3 is better than that of Examples 1 and 2.

二、剂量效果验证2. Dose effect verification

(一)实验材料及方法1. Experimental Materials and Methods

1.小鼠分组:1. Grouping of mice:

将鼠龄为38~40d,体重为15~20g的C57BL/6J小鼠(SPF级)50只(由南方医科大学实验动物中心提供),在适应性喂养3天后,随机分为5组,每组10只,并在给药前24h剃除小鼠背部毛发,诱导其毛发由休止期进入生长期;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) were randomly divided into five groups of 10 mice each after three days of adaptive feeding. The hair on the back of the mice was shaved 24 hours before administration to induce the hair to enter the growth phase from the resting phase.

2.试样配置:2. Sample configuration:

取1.54g实施例3制备的组合物完全溶解于20mL水中,得到试样3#;1.54 g of the composition prepared in Example 3 was completely dissolved in 20 mL of water to obtain sample 3#;

取0.77g实施例3制备的组合物完全溶解于20mL水中,得到低剂量试样;0.77 g of the composition prepared in Example 3 was completely dissolved in 20 mL of water to obtain a low-dose sample;

取3.08g实施例3制备的组合物完全溶解于20mL水中,得到高剂量试样;3.08 g of the composition prepared in Example 3 was completely dissolved in 20 mL of water to obtain a high-dose sample;

将非那雄胺固体配置为0.2%的非那雄胺溶液,得到阳性对照试样;The finasteride solid is prepared into a 0.2% finasteride solution to obtain a positive control sample;

将氯化钠固体配置为0.9%的氯化钠溶液,得到阴性对照试样;Sodium chloride solid is prepared into a 0.9% sodium chloride solution to obtain a negative control sample;

3.给药3. Drug administration

将试样3#以及四组对照试样分别给药于5组小鼠,给药方法为每天灌胃1次,每次0.2mL,持续8周。Sample 3# and four groups of control samples were administered to five groups of mice, respectively, by oral administration once a day, 0.2 mL each time, for 8 weeks.

(二)实验结果(II) Experimental results

1.小鼠体重变化1. Mouse Weight Changes

检测过程中每隔7d称量小鼠体重并记录,以均值±标准差表示,具体结果如表4所示;During the test, the mice were weighed and recorded every 7 days, and the results were expressed as mean ± standard deviation. The specific results are shown in Table 4;

表4小鼠体重变化(单位:g)Table 4 Changes in mouse body weight (unit: g)

Figure SMS_6
Figure SMS_6

Figure SMS_7
Figure SMS_7

由上表数据可以发现,在整个检测过程中,5组小鼠体重变化趋势基本一致,小鼠均无异常。It can be found from the data in the above table that during the entire testing process, the weight change trends of the five groups of mice were basically the same, and there were no abnormalities in the mice.

2.小鼠皮肤变化和长毛所需时间2. Time required for mouse skin changes and hair growth

每天观察各组小鼠脱毛部位皮肤及毛发生长状况,具体毛发生长状况如图1~5所示(每隔7d进行拍摄),并记录每只小鼠脱毛区皮肤颜色由粉红色变成黑色的时间及开始长毛发的时间,以均值±标准差表示,具体结果如表5所示;The skin and hair growth of the depilatory area of each group of mice were observed every day. The specific hair growth conditions are shown in Figures 1 to 5 (photographed every 7 days), and the time when the skin color of the depilatory area of each mouse changed from pink to black and the time when hair began to grow were recorded, expressed as mean ± standard deviation. The specific results are shown in Table 5;

图1为给药试样3#的小鼠背部毛发变化图;FIG1 is a diagram showing the changes in the back hair of mice treated with sample 3#;

图2为给药低剂量试样的小鼠背部毛发变化图;FIG2 is a diagram showing the changes in the back hair of mice administered with a low-dose sample;

图3为给药高剂量试样的小鼠背部毛发变化图;FIG3 is a diagram showing the changes in the back hair of mice administered with a high-dose sample;

图4为给药阳性对照试样的小鼠背部毛发变化图;FIG4 is a diagram showing the changes in the back hair of mice administered with a positive control sample;

图5为给药阴性对照试样的小鼠背部毛发变化图;FIG5 is a diagram showing the changes in the back hair of mice administered with a negative control sample;

由上图可知,试样3#在D14有2只小鼠皮肤变灰,有2只小鼠已长出毛发,在D21发现有4只小鼠明显长出毛发,其中有1只小鼠背部60%区域长出毛发,有3只小鼠背部全部长出;As shown in the figure above, in sample 3#, the skin of 2 mice turned gray at D14, and 2 mice had grown hair. At D21, 4 mice were found to have obvious hair growth, of which 1 mouse had hair growing on 60% of the back area, and 3 mice had hair growing on the entire back area.

低剂量试样在D14有1只小鼠皮肤变灰,在D21发现有5只小鼠长出毛发,其中有2只小鼠背部70%区域长出毛发,有2只小鼠背部80%区域长出毛发;In the low-dose sample, the skin of one mouse turned gray on D14, and hair grew in five mice on D21, including two mice with hair growing on 70% of their backs and two mice with hair growing on 80% of their backs.

高剂量试样在D14有5只小鼠背部已长出毛发,在D21发现有5只小鼠长出毛发,其中有3只小鼠背部90%区域长出毛发,有2只小鼠背部全部长出;In the high-dose sample, 5 mice had hair growing on their backs at D14, and 5 mice had hair growing on D21, of which 3 mice had hair growing on 90% of their backs, and 2 mice had hair growing on the entire backs.

阳性对照试样在D14有4只小鼠皮肤变灰,有一只明显长出毛发,在D21发现有6只小鼠背部90%区域已长出毛发。In the positive control sample, the skin of 4 mice turned gray at D14, and one mouse had obvious hair growth. At D21, 90% of the back area of 6 mice was found to have hair growth.

阴性对照试样在D14有2只小鼠皮肤变灰,在D21发现有3只小鼠背部70%区域长出毛发,有2只小鼠背部90%区域长出毛发。In the negative control sample, the skin of two mice turned gray on D14, and hair grew on 70% of the back area of three mice and on 90% of the back area of two mice on D21.

表5小鼠皮肤变化和长毛所需时间(单位:d)Table 5 Skin changes and time required for hair growth in mice (unit: d)

Figure SMS_8
Figure SMS_8

Figure SMS_9
Figure SMS_9

由上表数据可以发现,与阴性对照试样相比,试样3#、高剂量试样以及阳性对照试样不同程度的缩短了进入生长期和长出毛发的时间;其中,试样3#更为明显的缩短了毛囊从休止期进入生长期和长出毛发的时间。From the data in the above table, it can be found that compared with the negative control sample, sample 3#, high-dose sample and positive control sample shortened the time to enter the growth phase and grow hair to varying degrees; among them, sample 3# more significantly shortened the time for hair follicles to enter the growth phase and grow hair from the resting phase.

3小鼠背部皮肤组织学检查3 Histological examination of mouse back skin

第7天,第14天,第28天,第56天给药24h后人道处死,每次处死2只,在剃毛区相同部位取皮肤标本,固定,常规制片,HE染色,镜下新生毛囊数量以均值表示,具体结果如表6~9以及图6所示;On the 7th, 14th, 28th and 56th days, the mice were humanely killed 24 hours after administration. Two mice were killed each time. Skin specimens were taken from the same part of the shaved area, fixed, routinely prepared, and HE stained. The number of newly formed hair follicles under the microscope was expressed as the mean value. The specific results are shown in Tables 6 to 9 and Figure 6;

表6 7天小鼠皮肤组织学指标(单位:个)Table 6 Histological indexes of mouse skin at 7 days (unit: piece)

Figure SMS_10
Figure SMS_10

表7 14天小鼠皮肤组织学指标(单位:个)Table 7 Histological indexes of mouse skin at day 14 (unit: piece)

Figure SMS_11
Figure SMS_11

表8 28天小鼠皮肤组织学指标(单位:个)Table 8 Histological indexes of mouse skin at 28 days (unit: piece)

Figure SMS_12
Figure SMS_12

表9 56天小鼠皮肤组织学指标(单位:个)Table 9 Histological indexes of mouse skin at day 56 (unit: piece)

Figure SMS_13
Figure SMS_13

试样3#、低剂量试样、高剂量试样、阳性对照试样和阴性对照试样的HE染色图如图7~11所示:HE staining images of sample 3#, low-dose sample, high-dose sample, positive control sample and negative control sample are shown in Figures 7 to 11:

图7为试样3#的HE染色图,其中(a)为7天小鼠皮肤组织学HE染色图,(b)为14天小鼠皮肤组织学HE染色图,(c)为28天小鼠皮肤组织学HE染色图,(d)为56天小鼠皮肤组织学HE染色图;Figure 7 is a HE staining image of sample 3#, wherein (a) is a 7-day mouse skin histological HE staining image, (b) is a 14-day mouse skin histological HE staining image, (c) is a 28-day mouse skin histological HE staining image, and (d) is a 56-day mouse skin histological HE staining image;

图8为低剂量试样的HE染色图,其中(a)为7天小鼠皮肤组织学HE染色图,(b)为14天小鼠皮肤组织学HE染色图,(c)为28天小鼠皮肤组织学HE染色图,(d)为56天小鼠皮肤组织学HE染色图;FIG8 is a HE staining image of a low-dose sample, wherein (a) is a 7-day mouse skin histological HE staining image, (b) is a 14-day mouse skin histological HE staining image, (c) is a 28-day mouse skin histological HE staining image, and (d) is a 56-day mouse skin histological HE staining image;

图9为高剂量试样的HE染色图,其中(a)为7天小鼠皮肤组织学HE染色图,(b)为14天小鼠皮肤组织学HE染色图,(c)为28天小鼠皮肤组织学HE染色图,(d)为56天小鼠皮肤组织学HE染色图;FIG9 is a HE staining image of a high-dose sample, wherein (a) is a 7-day mouse skin histological HE staining image, (b) is a 14-day mouse skin histological HE staining image, (c) is a 28-day mouse skin histological HE staining image, and (d) is a 56-day mouse skin histological HE staining image;

图10为阳性对照试样的HE染色图,其中(a)为7天小鼠皮肤组织学HE染色图,(b)为14天小鼠皮肤组织学HE染色图,(c)为28天小鼠皮肤组织学HE染色图,(d)为56天小鼠皮肤组织学HE染色图;Figure 10 is a HE staining image of the positive control sample, wherein (a) is a 7-day mouse skin histological HE staining image, (b) is a 14-day mouse skin histological HE staining image, (c) is a 28-day mouse skin histological HE staining image, and (d) is a 56-day mouse skin histological HE staining image;

图11为阴性对照试样的HE染色图,其中(a)为7天小鼠皮肤组织学HE染色图,(b)为14天小鼠皮肤组织学HE染色图,(c)为28天小鼠皮肤组织学HE染色图,(d)为56天小鼠皮肤组织学HE染色图。Figure 11 is the HE staining image of the negative control sample, wherein (a) is the HE staining image of the mouse skin histology at 7 days, (b) is the HE staining image of the mouse skin histology at 14 days, (c) is the HE staining image of the mouse skin histology at 28 days, and (d) is the HE staining image of the mouse skin histology at 56 days.

由图6~11可以发现,From Figures 6 to 11, we can see that

通过小鼠背部皮肤组织学检查发现在D7、D14、D28,阴性对照组在实验整个周期呈下降趋势,在D7毛囊新生数量达到峰值;而3#、高剂量组D14毛囊新生数量达到最大值,至D28毛囊新生数量为0;阳性对照组新生毛囊数量D7达到峰值,整个实验过程呈下降趋势。Histological examination of the back skin of mice revealed that at D7, D14, and D28, the number of new hair follicles in the negative control group showed a downward trend throughout the entire experimental period, and reached a peak on D7; while the number of new hair follicles in the 3# and high-dose groups reached a maximum on D14, and was zero on D28; the number of new hair follicles in the positive control group reached a peak on D7, and showed a downward trend throughout the entire experimental process.

阴性对照组在D7、D14毛囊新生数量均低于3#和阳性对照组,D28阴性对照组新生毛囊数量为0;The number of new hair follicles in the negative control group was lower than that in the 3# and positive control groups at D7 and D14, and the number of new hair follicles in the negative control group was 0 at D28;

低剂量组在D7、D14毛囊新生数量与阴性对照组基本一致,D28毛囊新生数量高于3#和阴性对照组;The number of new hair follicles in the low-dose group was basically the same as that in the negative control group at D7 and D14, and the number of new hair follicles in the low-dose group was higher than that in the 3# and negative control groups at D28;

3#在D7、D14、D28毛囊新生数量显著多于阴性对照组,D7毛囊新生数量高出阴性对照组48.40%,D14毛囊新生数量达到峰值,高出阴性对照组218.00%;The number of new hair follicles in 3# on D7, D14 and D28 was significantly higher than that in the negative control group. The number of new hair follicles on D7 was 48.40% higher than that in the negative control group, and the number of new hair follicles on D14 reached a peak, which was 218.00% higher than that in the negative control group.

高剂量组在D7、D14毛囊新生数量多于阴性对照组,D7毛囊新生数量高出阴性对照组19.36%,D14毛囊新生数量高出阴性对照组32.15%,D28毛囊新生数量和阴性对照组毛囊新生数量均为0;The number of new hair follicles in the high-dose group was higher than that in the negative control group at D7 and D14. The number of new hair follicles on D7 was 19.36% higher than that in the negative control group, and the number of new hair follicles on D14 was 32.15% higher than that in the negative control group. The number of new hair follicles on D28 was both 0 and that in the negative control group.

阳性对照组D7达到峰值,D14后呈下降趋势,D28毛囊新生数量和阴性对照组毛囊新生数量均为0。The peak value was reached in the positive control group on D7, and it showed a downward trend after D14. The number of new hair follicles on D28 and the number of new hair follicles in the negative control group were both 0.

综上所述,本发明的组合物无毒副作用,并能够促进毛囊细胞的代谢与增殖,促进毛囊新生,缩短毛囊从休止期进入生长期的时间,对毛发生长有显著的促进作用,且有助于加强头发在头皮中的紧固度,从而达到防脱固发的目的。In summary, the composition of the present invention has no toxic side effects, and can promote the metabolism and proliferation of hair follicle cells, promote the regeneration of hair follicles, shorten the time for hair follicles to enter the growth phase from the resting phase, has a significant promoting effect on hair growth, and helps to strengthen the firmness of hair in the scalp, thereby achieving the purpose of preventing hair loss and strengthening hair.

以上所述,仅为本发明较佳的具体实施方式,本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明披露的技术范围内,根据本发明的技术方案及其发明构思加以等同替换或改变,都应涵盖在本发明的保护范围内。The above description is only a preferred specific implementation manner of the present invention, and the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, and they should be covered by the protection scope of the present invention.

Claims (10)

1.一种具有生发固发功能的组合物,其特征在于,所述具有生发固发功能的组合物原料按重量份数计包括:1. A composition having the function of promoting hair growth and fixing hair, characterized in that the raw materials of the composition having the function of promoting hair growth and fixing hair include, by weight:
Figure FDA0004073662820000011
Figure FDA0004073662820000011
2.根据权利要求1所述的具有生发固发功能的组合物,其特征在于,所述蛋白质包括小分子肽和氨基酸;所述小分子肽按重量份数计包括牛骨胶原蛋白肽500~1500份和水解胶原蛋白肽500~1500份;所述氨基酸按重量份数计包括牛磺酸20~50份。2. The composition with hair growth and fixation function according to claim 1, characterized in that the protein comprises small molecule peptides and amino acids; the small molecule peptides comprise 500 to 1500 parts of bovine collagen peptides and 500 to 1500 parts of hydrolyzed collagen peptides by weight; and the amino acids comprise 20 to 50 parts of taurine by weight. 3.根据权利要求1所述的具有生发固发功能的组合物,其特征在于,所述营养强化剂为维生素类强化剂和矿物质类强化剂。3. The composition with hair growth and fixation function according to claim 1, characterized in that the nutritional enhancer is a vitamin enhancer and a mineral enhancer. 4.根据权利要求3所述的具有生发固发功能的组合物,其特征在于,所述维生素类强化剂按重量份数计包括维生素A 0.2~10份,维生素C10~50份,维生素E1~10份和酵母粉10~50份;所述矿物质类强化剂按重量份数计包括富马酸亚铁1~10份和氧化锌0.2~10份。4. The composition with hair growth and fixation function according to claim 3, characterized in that the vitamin strengthener comprises, by weight, 0.2 to 10 parts of vitamin A, 10 to 50 parts of vitamin C, 1 to 10 parts of vitamin E and 10 to 50 parts of yeast powder; the mineral strengthener comprises, by weight, 1 to 10 parts of ferrous fumarate and 0.2 to 10 parts of zinc oxide. 5.根据权利要求1所述的具有生发固发功能的组合物,其特征在于,所述粉末植物甾醇酯为β-谷甾醇酯。5. The composition with hair growth and fixation function according to claim 1, characterized in that the powdered phytosterol ester is β-sitosterol ester. 6.根据权利要求1所述的具有生发固发功能的组合物,其特征在于,所述小米提取物的制备方法为:将小米粉碎,加水提取,提取液浓缩,冷冻干燥得到所述小米提取物。6. The composition with hair growth and fixation function according to claim 1, characterized in that the millet extract is prepared by: crushing millet, extracting with water, concentrating the extract, and freeze-drying to obtain the millet extract. 7.根据权利要求1所述的具有生发固发功能的组合物,其特征在于,所述调味剂按重量份数计包括赤藓糖醇500~1200份和西柚粉300~600份。7. The composition with hair growth and fixation function according to claim 1, characterized in that the flavoring agent comprises 500-1200 parts of erythritol and 300-600 parts of grapefruit powder by weight. 8.一种权利要求1~7任一项所述的具有生发固发功能的组合物的制备方法,其特征在于,包括以下步骤:8. A method for preparing the composition having the function of hair growth and fixation according to any one of claims 1 to 7, characterized in that it comprises the following steps: (1)按重量份称取各原料,过筛备用;(1) Weigh each raw material by weight, sieve and set aside; (2)将步骤(1)称取的营养强化剂和调味剂混合,得到混合原料A;(2) mixing the nutritional enhancer and flavoring agent weighed in step (1) to obtain a mixed raw material A; (3)将步骤(1)称取的蛋白质和功效成分置于制粒机中搅拌,以酒精为粘合剂进行制粒,之后流化床干燥,整粒机整粒,得到混合原料B;(3) placing the protein and functional ingredients weighed in step (1) in a granulator and stirring, granulating with alcohol as a binder, and then fluidized bed drying and granulating with a granulator to obtain a mixed raw material B; (4)将步骤(2)得到的混合原料A与步骤(3)得到的混合原料B混合,过筛,得到所述具有生发固发功能的组合物。(4) Mixing the mixed raw material A obtained in step (2) and the mixed raw material B obtained in step (3), and sieving them to obtain the composition having the function of hair growth and fixation. 9.根据权利要求8所述的制备方法,其特征在于,步骤(1)中,所述过筛为过40~100目筛;步骤(2)中,所述混合为等量递增混合;步骤(3)中,所述搅拌转数为200~500转/min;所述酒精用量为于2~10min内喷洒70~95%酒精280~480质量份;所述流化床干燥温度为51~58℃,时间为25~35min;所述整粒机为20目整粒机;步骤(4)中,所述过筛为过40~100目筛。9. The preparation method according to claim 8 is characterized in that, in step (1), the sieving is through a 40-100 mesh sieve; in step (2), the mixing is equal and incremental mixing; in step (3), the stirring speed is 200-500 rpm; the alcohol dosage is 280-480 parts by mass of 70-95% alcohol sprayed within 2-10 minutes; the fluidized bed drying temperature is 51-58°C, and the time is 25-35 minutes; the granulator is a 20-mesh granulator; in step (4), the sieving is through a 40-100 mesh sieve. 10.一种权利要求1~7任一项所述的具有生发固发功能的组合物在生发固发方面的应用。10. Use of the composition having hair growth and fixation function according to any one of claims 1 to 7 in hair growth and fixation.
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