CN113134089B

CN113134089B - Composition containing biological polysaccharide and application thereof

Info

Publication number: CN113134089B
Application number: CN202110064686.0A
Authority: CN
Inventors: 郭宏亮; 庄秀园; 朱斌念; 郭晓宇; 叶榛; 吴佳迪
Original assignee: Perman Zhejiang Biotechnology Co ltd
Current assignee: Perman Zhejiang Biotechnology Co ltd
Priority date: 2020-01-17
Filing date: 2021-01-18
Publication date: 2024-02-06
Anticipated expiration: 2041-01-18
Also published as: CN113134087B; CN113134088A; CN113134087A; CN113134088B; CN113134089A

Abstract

The invention provides a composition containing biological polysaccharide and application thereof. Specifically, the composition comprises: component (a): beta-glucan; and component (b): chemical stripping agents; component (c): no or skin penetrating agent; and (d) a pharmaceutically or cosmetically acceptable carrier; the weight ratio of the component (a) to the component (b) is 1:1-40. The composition of the invention can promote hair growth and/or prevent alopecia.

Description

Composition containing biological polysaccharide and application thereof

Technical Field

The invention relates to the technical field of biology, in particular to a composition containing biological polysaccharide and application thereof.

Background

With the development of society, people increasingly aim at their own external image, and the health conditions of skin and hair directly influence the confidence of people. However, due to lifestyle and environmental changes, premature and excessive hair loss phenomena have become common.

For example, the trend of low age, which has occurred, has become a nuisance for many young people. Alopecia is often manifested by rapid hair loss, slow growth, severe pathological alopecia, even no longer hair growth in natural state, and patients are in a state of scanty hair or baldness for a long time after alopecia, bear huge psychological stress, and thus seriously affect quality of life.

Accordingly, there is a need in the art to develop a composition that can rapidly promote hair growth and/or improve scalp health.

Disclosure of Invention

It is an object of the present invention to provide a composition which can promote hair growth and/or improve skin health rapidly.

In a first aspect of the invention there is provided the use of a composition for the preparation of a composition or formulation for promoting hair growth and/or preventing hair loss;

wherein the composition comprises:

component (a): beta-glucan; and

component (b): chemical stripping agents;

component (c): no or skin penetrating agent; and

(d) A pharmaceutically or cosmetically acceptable carrier;

wherein the chemical stripping agent is a compound selected from the group consisting of: fruit acid, lactic acid, citric acid, glycolic acid, tartaric acid, salicylic acid, acetic acid, trichloroacetic acid, retinoic acid, phenol, resorcinol, or combinations thereof;

the weight ratio of the component (a) to the component (b) is 1:1-40;

and the pH of the composition is 2.0-9.0, preferably 3.0-8.5, preferably 4.0-8.0, preferably 4.5-7.5.

In another preferred embodiment, the salt comprises a pharmaceutically acceptable salt or a cosmetically acceptable salt.

In another preferred embodiment, the composition or formulation is in the form of a transdermal dosage form, a subcutaneous dosage form, preferably selected from the group consisting of: microneedles (e.g., microneedle arrays), nanoemulsions.

In a second aspect of the present invention, there is provided a composition comprising:

component (a): beta-glucan; and

component (b): chemical stripping agents;

component (c): no or skin penetrating agent; and

(d) A pharmaceutically or cosmetically acceptable carrier;

the weight ratio of the component (a) to the component (b) is 1:1-40.

In another preferred embodiment, the pH of the composition is from 2.0 to 9.0, preferably from 3.0 to 8.5, preferably from 4.0 to 8.0, preferably from 4.5 to 7.5, such as 5, 5.5, 6.0 or 6.5.

In another preferred embodiment, the weight ratio of component (a) to component (b) in the composition is from 1:1 to 20, preferably from 1:1 to 10, more preferably from 1:1 to 5, such as 1:2, 1:3 or 1:4.

In another preferred embodiment, the chemical exfoliating agent is selected from the group consisting of: sodium L-lactate, lactic acid, salicylic acid, or a combination thereof; preferably, L-sodium lactate.

In another preferred embodiment, the weight ratio of component (a) to component (c) is from 1:0 to 1:30, preferably from 1:0.05 to 1:15.

In another preferred embodiment, the pH of the composition is from 5 to 6.5, preferably from 5.5 to 6.5.

In another preferred embodiment, the weight ratio of component (a) to component (b) is from 1:2 to 30, more preferably from 1:3 to 20, still more preferably from 1:3 to 10.

In another preferred embodiment, the ingredients (a) and (b) comprise from 0.01 to 40wt%, preferably from 0.05 to 20wt%, more preferably from 0.1 to 5wt%, such as 0.3wt%, 0.5wt%, 0.8wt%, 1wt% or 2wt% of the total weight of the composition.

In another preferred embodiment, the component (a) comprises 0.001 to 5wt%, preferably 0.01 to 2wt%, more preferably 0.02 to 1wt%, more preferably 0.05 to 0.5wt%, such as 0.01wt%, 0.02wt%, 0.03wt%, 0.05wt%, 0.08wt%, 0.1wt%, 0.2wt%, 0.3wt% or 0.4wt% of the total weight of the composition.

In another preferred embodiment, the component (b) comprises 0.01 to 35wt%, preferably 0.05 to 25wt%, more preferably 0.1 to 10wt%, more preferably 0.2 to 3wt%, more preferably 0.5 to 2wt%, such as 0.3wt%, 0.6wt%, 0.8wt%, 1.0wt%, 1.2wt%, 1.5wt% or 1.8wt% of the total weight of the composition.

In another preferred embodiment, the composition is used to improve stretch marks.

In another preferred embodiment, the skin penetrating agent is selected from the group consisting of: water, azones, sulfoxides, pyrrolidinones, fatty acids and esters thereof, amino acids and esters thereof, alcohols, polyols, terpenes, cyclodextrins, phospholipids, surfactants, or combinations thereof.

In another preferred embodiment, the skin penetrating agent is present in an amount of 0 to 10wt%, preferably 0.1 to 5wt%, more preferably 0.2 to 2wt%, such as 0.4wt%, 0.5wt%, 0.6wt%, 0.8wt%, 1.0wt%, based on the total weight of the composition.

In another preferred embodiment, the skin penetrating agent is selected from the group consisting of: azone, menthol, lauryl alcohol, or combinations thereof.

In another preferred embodiment, the composition further comprises a substance selected from the group consisting of: moisturizers, anti-inflammatory agents, preservatives, pH modifiers, chelating agents, water, fragrances, or combinations thereof.

In another preferred embodiment, the composition further comprises a humectant.

In another preferred embodiment, the humectant is selected from the group consisting of: d-panthenol, allantoin, xanthan gum, hyaluronic acid, 1, 3-butanediol, octylglycol, glycerol, polyglutamic acid, aloe vera gel, silicone oil, horse oil, sheep oil, ceramide, chitosan amine, sodium pyrrolidone carboxylate, or a combination thereof.

In another preferred embodiment, the humectant is present in an amount of from 0 to 15wt%, preferably from 2 to 12wt%, more preferably from 5 to 10wt%, such as 3wt%, 4wt%, 5wt%, 6wt%, 7wt%, 8wt% based on the total weight of the composition.

In another preferred embodiment, the composition further comprises an anti-inflammatory agent.

In another preferred embodiment, the anti-inflammatory agent is selected from the group consisting of: antibiotics, bacteriostats, benzoyl peroxide, plant bactericidal and bacteriostatic components, glucocorticoids, azelaic acid, nicotinamide, sulfur, resorcinol, swertiamarin, or a combination thereof, preferably swertiamarin, or a combination thereof.

In another preferred embodiment, the anti-inflammatory agent is present in an amount of 0 to 10wt%, preferably 0.1 to 8wt%, more preferably 0.2 to 5wt%, such as 0.0001wt%, 0.0003wt%, 0.0005wt%, 0.01wt%, 0.5wt%, 1wt%, 2wt%, 3wt%, or 5wt%, based on the total weight of the composition.

In another preferred embodiment, the composition further comprises a substance selected from the group consisting of: chitosan, lecithin, or a combination thereof.

In another preferred embodiment, the composition further comprises a liposome/nanoparticle forming agent, such as a phospholipid, lecithin, cholesterol, glycerol monooleate, or a combination thereof.

In another preferred embodiment, the composition may further contain additional additives, representative examples include (but are not limited to): oil control agents, hair softeners, vitamin E, vitamin B5, vitamin H, biotin tripeptides, caffeine, palmitoyl pentapeptides, stem cell extracts, or combinations thereof.

In another preferred embodiment, the composition further comprises a hair growth promoting active selected from the group consisting of: chemically synthesized hair tonic, natural hair tonic, active polypeptide having hair tonic effect, or a combination thereof.

In another preferred embodiment, the chemically synthesized germinal drug is selected from the group consisting of: finasteride, cimetidine, busulfan, flutamide, minoxidil, or a combination thereof.

In another preferred embodiment, the natural hair restorer is selected from the group consisting of the following traditional Chinese medicines and extracts thereof: fructus Ligustri Lucidi, polygoni Multiflori radix, folium Platycladi, atractylodis rhizoma, rhizoma Pinelliae, bupleuri radix, pericarpium Citri Tangerinae, radix Paeoniae Rubra, radix et rhizoma Rhei, rehmanniae radix, poria, glycyrrhrizae radix, ramulus Cinnamomi, coptidis rhizoma, scutellariae radix, herba Centellae, curcuma rhizome, flos Lonicerae, fructus forsythiae, radix moutan root/bark, burdock, folium Eriobotryae, herba Taraxaci, ginseng radix, cortex Mori, rhizoma Dioscoreae, fructus crataegi, mume fructus, flos Chrysanthemi Indici, coicis semen, fructus Gardeniae Preparatum, fructus Aurantii Immaturus, caulis Bambusae in Taenia, rhizoma Zingiberis recens, semen Sesami Niger, or combinations thereof.

In another preferred embodiment, the active polypeptide is selected from the group consisting of: vascular endothelial growth factor, epidermal growth factor, aspartic acid-serine repeat polypeptide, or a combination thereof.

In another preferred embodiment, the beta-glucan is beta-D-glucan.

In another preferred embodiment, the beta-glucan is beta-1, 3-glucan, preferably beta-1, 3-glucan having beta-1, 6-branches.

In another preferred embodiment, the beta-glucan has a structure as shown in formula I,

wherein l is an integer of 0 or more, preferably 1 to 100, 0 to 50, 0 to 10, more preferably 0 to 3, still more preferably 1 to 2, still more preferably 1; m is an integer of 0 or more, preferably 0 to 19, more preferably 0 to 4, still more preferably 0 to 1, still more preferably 0; n is an integer of 3 or more, preferably 30 to 60000, more preferably 100 to 10000.

In another preferred embodiment, the beta-glucan has a branching Degree (DB) of 0.02-0.8, preferably 0.1-0.5, preferably 0.25-0.4, more preferably 0.2-0.4.

In another preferred embodiment, the beta-glucan comprises beta-glucan having a triple helix stereo structure.

In another preferred embodiment, the content of beta-glucan of the triple helix stereo structure is 80%,90%,95% based on the total molar amount of beta-glucan.

In another preferred embodiment, the beta-1, 3-backbone of the beta-glucan is the main body of a triple helix stereo structure.

In another preferred embodiment, the beta-1, 6-branch of the beta-glucan is located outside the triple helix stereo structure.

In another preferred embodiment, the molecular weight of the beta-glucan is ≡2kD, preferably 2kD-40000kD, more preferably 20kD-20000kD.

In another preferred example, the molecular weight of the beta-glucan may be 5kD to 35000kD;10kD-30000kD;50kD-25000kD;100kD-20000kD;200kD-18000kD;400kD-16000kD;500kD-14000kD;1000kD-12000kD;2000kD-4000kD;3000kD-5000kD;4000kD-6000kD;5000kD-7000kD;6000kD-8000kD;7000kD-9000kD; or 8000kD-10000kD.

In another preferred embodiment, the β -glucan is selected from the group consisting of: schizophyllum commune beta-glucan, lentinus edodes beta-glucan, sclerotium beta-glucan, grifola frondosa beta-glucan, pleurotus ostreatus polysaccharide, mushroom beta-glucan, yeast beta-glucan, or a combination thereof.

In another preferred embodiment, the beta glucan is schizophyllan beta glucan.

In another preferred embodiment, the lentinula edodes beta-glucan is a beta-glucan with 2 beta-1, 6-branches per 5 beta-1, 3-backbones, and 1 glucose residue per branch.

In another preferred embodiment, the beta glucan (or active ingredient) is not or does not contain oat beta glucan.

In another preferred embodiment, the beta-glucan has a purity of not less than 70%, preferably not less than 90%, more preferably not less than 95%, still more preferably not less than 99%.

In another preferred embodiment, the beta glucan is in solid form or in liquid form, such as beta glucan solid particles or powder, or an aqueous beta glucan solution.

In another preferred embodiment, the particle size of the beta-glucan particles or powder is 20mm or less, preferably 0.001-10mm, more preferably 0.01-5mm, more preferably 0.1-2mm.

In another preferred embodiment, the solubility of the beta-glucan (particles or powder) in water (100 g) at 25 ℃ is ≡0.0001g, preferably 0.01-50g, more preferably 0.1-10g.

In another preferred example, the solubility of the beta-glucan (particles or powder) in water (100 g) at 25 ℃ may be 0.1-100g;0.2-90g;0.5-80g;1-50g; alternatively, the solubility may be 0.1-0.3g;0.2-0.4g;0.3-0.5g;0.4-0.6g;0.5-0.7g;0.6-0.8g;0.7-0.9g;0.8-1g; or 1-3g;2-4g;3-5g;4-6g;5-7g;6-8g;7-9g; or 8-10g.

In another preferred embodiment, the β -glucan (water) solution is of high viscosity; preferably, the aqueous beta-glucan solution (at 25 ℃) having a mass concentration of 0.5% has a viscosity of not less than 40 mPas, more preferably 100-10000 mPas, still more preferably 500-2000 mPas.

In another preferred example, the aqueous beta-glucan solution (25 ℃) having a mass concentration of 0.5% may have a viscosity of 50 to 10000 mPa-s; 100-9000 mPa.s; 200-8000 mPa.s; 300-7000 mPas; 400-6000 mPa.s; 450-5000 mPa.s; 500-5000 mPa.s; 550-4000 mPa.s; 600-3000 mPa.s; 650-2000 mPa.s; or 700-1500 mPas.

In another preferred embodiment, the aqueous solution of beta-glucan having a mass concentration of 1% has a high clarity or high light transmittance, and the aqueous solution of beta-glucan having a mass concentration of 1% has a light transmittance of 50% or more, preferably 80% or more, preferably 85% or more, more preferably 95% or more.

In another preferred embodiment, the composition is in a dosage form selected from the group consisting of: transdermal dosage forms, subcutaneous dosage forms, preferably selected from the group consisting of: microneedles (e.g., microneedle arrays), nanoemulsions.

In another preferred embodiment, the dosage form of the composition is selected from the group consisting of: solutions, gels, creams, emulsions, liposomes, microemulsions, nanoemulsions, nanoparticles, nanospheres, liquid crystal spheres, vehicles, alcohol liposomes, vesicles, microneedles (e.g., microneedle arrays), patches (transdermal patches), or combinations thereof.

In another preferred embodiment, the dosage form of the composition is selected from the group consisting of: hair growth and/or anti-hair loss lotion, hair growth and/or anti-hair loss ointment, hair growth and/or anti-hair loss drug or dressing, shampoo, hair cream or conditioner, hair gel, mousse, paint, hair cream, hair mask, hair dye, eyebrow regrowth agent, eyelash regrowth agent or eyelash nutrition agent, hair care essence, scalp care agent, nano microsphere, microneedle (e.g., microneedle array), or combinations thereof.

In another preferred embodiment, the composition comprises:

0.01-2 parts by weight of component (a);

0.1 to 5 parts by weight of component (b);

0-4 parts by weight of a skin penetrating agent;

0-15 parts by weight of a humectant;

0-10 parts by weight of an anti-inflammatory agent;

0-0.5 parts by weight of a preservative;

wherein the weight ratio of the component (a) to the component (b) is 1:1-40.

In another preferred embodiment, the composition comprises:

0.01-2wt% of component (a);

0.1-5wt% of component (b);

0-4wt% skin penetration agent;

0-15wt% of a humectant;

0-10wt% of an anti-inflammatory agent;

0-0.5wt% preservative;

the balance being water, wherein the weight ratio of the component (a) to the component (b) is 1:1-40.

In a third aspect of the present invention, there is provided a patch comprising:

a substrate having disposed thereon an array of microneedles having tips, wherein the microneedles comprise a composition according to the second aspect of the invention.

In another preferred embodiment, the microneedle further comprises a water-soluble polymer.

In another preferred embodiment, the water-soluble polymer is selected from the group consisting of: dextran, polyethylene glycol, polyvinylpyrrolidone, dextrin, hydroxyethyl starch, cellulose derivatives, polyvinyl alcohol, or combinations thereof.

In another preferred embodiment, the microneedles may have a length of 0.2-5mm, preferably 0.5-2.5mm, below the stratum corneum.

In a fourth aspect of the present invention, there is provided a method of promoting hair regrowth and/or hair growth comprising the steps of:

the composition of the second aspect of the invention is administered to a subject in need thereof.

In another preferred embodiment, the method of administration is selected from the group consisting of: transdermal, subcutaneous and/or transdermal absorption.

In another preferred embodiment, the composition may be applied by a method selected from the group consisting of: painting, massaging, physical sanding, injection, electroporation, thermal perforation, ultrasound introduction, microneedle array introduction, nanoplate introduction, laser introduction, ion introduction, magnetic introduction, electrode scanning system introduction, transdermal application, or combinations thereof.

In another preferred embodiment, the subject is a mammal.

In another preferred embodiment, the subject is selected from the group consisting of: human, murine, cat or dog.

In a fifth aspect of the invention, there is provided a method of administering a β -glucan comprising the steps of: the beta-glucan or a composition containing the beta-glucan is introduced into the skin by subcutaneous administration and/or transdermal absorption.

In another preferred embodiment, the method of administration is for using the beta-glucan to promote hair growth and/or prevent hair loss.

In another preferred embodiment, the method is selected from the group consisting of: physical transdermal techniques, chemical transdermal techniques, biological transdermal techniques, transdermal iontophoresis techniques, or combinations thereof.

It is understood that within the scope of the present invention, the above-described technical features of the present invention and technical features specifically described below (e.g., in the examples) may be combined with each other to constitute new or preferred technical solutions. And are limited to a space, and are not described in detail herein.

Drawings

Fig. 1 shows the hair growth of volunteer D after application of the composition of the present invention in example 4 of the present invention, wherein the left graph is before application and the right graph is after 8 weeks of application.

Fig. 2 shows the hair growth per square centimeter of the area of hair loss in volunteer E after application of the composition of the present invention in example 5 of the present invention.

Fig. 3 shows the hair growth per square centimeter of the area of hair loss in volunteer F after application of the composition of the present invention in example 6 of the present invention.

Fig. 4 shows the hair growth per square centimeter of the area of hair loss in volunteer H after application of the composition of the present invention in example 7 of the present invention.

Fig. 5 shows scalp hair growth of volunteers after application of the composition of the present invention in example 11 of the present invention.

Detailed Description

The present inventors have made extensive and intensive studies and, as a result, have provided a composition containing beta-glucan through a large number of screening and testing. The composition of the present invention significantly improves the effect of using beta-glucan, for example, significantly increases the speed of promoting hair growth, by combining (a) beta-glucan with (b) a chemical exfoliating agent. And the composition is prepared into a form suitable for transdermal or subcutaneous administration, so that the beta-glucan of the invention enters the skin, and the hair growth speed can be further improved. The present invention has been completed on the basis of this finding.

Studies have shown that little promotion of hair growth is observed with either the chemical exfoliating agent alone, the moisturizing agent alone, or the skin penetrating agent alone. In addition, when component (a) is used alone, a part of the β -glucan species (e.g., oat β -glucan) hardly shows a promoting effect on hair growth, whereas a part of the β -glucan species (e.g., schizophyllum beta-glucan) has a promoting effect on hair growth to some extent, but the promoting effect tends to be slow, and a very long time (e.g., about 3 to 6 months or more) is required.

The present inventors have unexpectedly found that when a specific ratio is used, the components (a) and (b) can act synergistically, thereby significantly promoting hair growth. Experiments show that the composition of the invention can not only remarkably improve the effect of promoting hair growth (promoting fluff regeneration, promoting black hair regeneration, improving the quantity or density of new fluff, improving the quantity or density of new black hair, or a combination thereof), but also remarkably shorten the time of promoting hair growth of various hair loss subjects (shortening at least 1/2 on average).

When specific transdermal dosage forms such as microneedles are employed (e.g., with the addition of skin promoters) or transdermal iontophoresis techniques are employed, it is unexpected that the compositions of the present invention can produce significant hair growth promoting effects, including promoting fluff and promoting black hair growth, in the hair loss areas of the head of some patients with long-term alopecia in 4-6 weeks. This suggests that the composition containing the components (a) and (b) of the present invention, through reasonable compounding of the active ingredients, on one hand, significantly delays or eliminates the progress of hair loss, and on the other hand, enables the hair loss process to be fundamentally reversed, thereby achieving the effects of significantly promoting fluff and black hair to be regenerated, and the hair-growth promoting effect which can be achieved only by 6 to 12 months when the component (a) is used alone is generated by as short as 6 to 8 weeks.

Terminology

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

As used herein, when used in reference to a specifically recited value, the term "about" means that the value can vary no more than 1% from the recited value. For example, as used herein, the expression "about 100" includes 99 and 101 and all values therebetween (e.g., 99.1, 99.2, 99.3, 99.4, etc.).

As used herein, the term "comprising" or "including" can be open, semi-closed, and closed. In other words, the term also includes "consisting essentially of …," or "consisting of ….

As used herein, "preventing" and "treating" include delaying and stopping the progression of a disease, or eliminating a disease, and do not require 100% inhibition, elimination, and reversal. In some embodiments, the composition or formulation of the invention prevents, reduces, inhibits, and/or reverses, for example, at least about 10%, at least about 30%, at least about 50%, or at least about 80% of a related disease, symptom, as compared to the level observed in the absence of the composition or formulation of the invention.

Beta-glucan

Beta-glucan is a natural polysaccharide, and a considerable variety of beta-glucan can be found in natural environments, usually in cell walls of special species of bacteria, yeasts, fungi (ganoderma lucidum) and also in the coating of higher plant seeds. The production method of the beta-glucan mainly comprises two methods, one is directly extracted from grains such as oat or fruiting body fungi such as mushrooms; and secondly, the beta-glucan is obtained by liquid fermentation of fungi or bacteria and extraction processing of fermentation liquor.

As used herein, "beta-glucan of the invention", "biopolysaccharide of the invention" are used interchangeably and refer primarily to the beta-glucan of the first aspect of the invention, which is selected from the group consisting of: schizophyllum commune beta-glucan, lentinus edodes beta-glucan, sclerotium beta-glucan, grifola frondosa beta-glucan, pleurotus ostreatus polysaccharide, mushroom beta-glucan, yeast beta-glucan, or a combination thereof; preferably schizophyllum beta-glucan.

As used herein, "schizophyllum beta-glucan" refers to beta-glucan derived from schizophyllum. Typically, the schizophyllum beta-glucan of the present invention is derived from the fermentation product of schizophyllum.

In another preferred embodiment, the structure of the beta-glucan is shown in formula I.

In another preferred embodiment, the beta glucan has good stability.

In another preferred embodiment, the beta-glucan (particles or powder) has good water solubility and/or natural solubility.

In another preferred example, the beta-glucan solution is a solution of beta-glucan in water, i.e., an aqueous beta-glucan solution.

In another preferred embodiment, the aqueous solution of 1% by mass of beta-glucan has a high clarity or high light transmittance, and the light transmittance of the 1% by mass of the aqueous solution of beta-glucan is greater than or equal to 50%, preferably greater than or equal to 80%, preferably greater than or equal to 85%, more preferably greater than or equal to 95%;

In another preferred embodiment, the beta-glucan solution has good stability.

In another preferred embodiment, the β -glucan is derived from higher plants or various bacteria, fungi.

Healthy hair follicles are the basis for scalp and hair health. The beta-glucan disclosed by the invention not only can promote hair growth and prevent alopecia, but also can help the scalp resist external injury and invasion (such as fungi and the like), effectively prevent and treat head skin problems such as folliculitis, pimple, seborrheic dermatitis and the like, and promote scalp health.

In addition, the beta-glucan has good coating property, can coat hair, protects the hair and improves hair quality while effectively locking water, has good conditioning function on hair, and has the effects of resisting static electricity, increasing hair softness, improving dry and wet combability, reducing hair entanglement and the like.

Alopecia

As used herein, the term "alopecia" or "alopecia" refers to insufficient hair growth and partial or complete hair loss, including but not limited to androgenic alopecia or male pattern alopecia, toxic alopecia, alopecia areata, telogen effluvium, alopecia due to endocrine disrupts, metabolic disorders or malnutrition, drug induced alopecia, mechanical alopecia, alopecia complicated with skin disorders, cicatricial alopecia, congenital alopecia, and trichotillomania.

Alopecia is the most common skin disorder in clinic, and the classification method is different from that of alopecia, and the most common method is divided into two major categories of cicatricial alopecia and non-cicatricial alopecia. Wherein the non-scarring alopecia is reversible and the scarring alopecia is permanent. Scarring alopecia is in turn divided into primary and secondary, primary referring to the disease of the hair follicle, and secondary referring to the hair follicle not being the primary site of inflammation. Non-scarring alopecia includes androgenic alopecia, alopecia areata, temporo triangle alopecia, hair-plucking, senile alopecia, telogen effluvium, anagen hair loosening syndrome, infectious alopecia, lipid edema alopecia, common salt alopecia, sugar alopecia, psychogenic alopecia, tumor-associated alopecia, most commonly androgenic alopecia and alopecia areata. The scar alopecia comprises lichen planus, postmenopausal alopecia, lupus erythematosus alopecia, brocq pseudoalopecia areata and scalp split cellulitis.

Composition and method for producing the same

The present invention provides a composition comprising: component (a): beta-glucan; and component (b): chemical stripping agents.

The chemical exfoliating agent exfoliates the epidermis of the skin to some extent, replacing the new epidermis, and thus providing a better condition to the epidermis.

In the present invention, the kind of the chemical stripping agent is not particularly limited, and chemical stripping agents commonly used in the art, such as α -hydroxy acid, β -hydroxy acid, etc., may be used.

Preferably, the chemical stripping agent is a compound selected from the group consisting of: fruit acid, lactic acid, citric acid, glycolic acid, tartaric acid, salicylic acid, acetic acid, trichloroacetic acid, retinoic acid, phenol, resorcinol, or combinations thereof.

Preferably, the weight ratio of component (a) to component (b) is from 1:1 to 40, preferably from 1:2 to 30, more preferably from 1:3 to 20, more preferably from 1:3 to 10.

In another preferred embodiment, the components (a) and (b) comprise from 0.01 to 40wt%, preferably from 0.05 to 20wt%, more preferably from 0.1 to 5wt% of the total weight of the composition.

In the present invention, the ingredient (a) and the ingredient (b) may better exert a synergistic effect when the composition is at a specific pH (2.0 to 9.0), preferably pH of 2.0 to 9.0, preferably 3.0 to 8.5, preferably 4.0 to 8.0, preferably 4.5 to 7.5.

Preferably, the composition of the present invention further comprises ingredient (c): skin penetration agents (also known as penetration enhancers). The skin penetration agent may enhance or accelerate penetration of component (a) and/or component (b) through the skin.

In the present invention, the type of the skin penetrating agent is not particularly limited, and skin penetrating agents commonly used in the art can be used.

Preferably, the skin penetration agent is selected from the group consisting of: water, azones, sulfoxides, pyrrolidinones, fatty acids and esters thereof, amino acids and esters thereof, alcohols, polyols, terpenes, cyclodextrins, phospholipids, surfactants, or combinations thereof.

In another preferred embodiment, the composition further comprises a humectant.

In the invention, D-panthenol, allantoin, sodium pyrrolidone carboxylate, polyalcohol and the like are mainly used as moisturizers, and are helpful for further promoting the beta-glucan to play a role.

Preferably, the humectant is selected from the group consisting of: d-panthenol, allantoin, xanthan gum, hyaluronic acid, 1, 3-butanediol, octylglycol, glycerol, polyglutamic acid, aloe vera gel, silicone oil, horse oil, sheep oil, ceramide, chitosan amine, sodium pyrrolidone carboxylate, or a combination thereof.

In another preferred embodiment, the humectant is present in an amount of from 0 to 15wt%, preferably from 2 to 12wt%, more preferably from 5 to 10wt% based on the total weight of the composition.

The composition of the present invention may further comprise (d) a pharmaceutically or cosmetically acceptable carrier. The composition of the present invention may be suitably selected according to the formulation and use.

Typically, the cosmetically acceptable carrier is selected from the group consisting of: moisturizers, antioxidants, anti-uv agents, preservatives, film formers, oil-soluble gelling agents, organically modified clay minerals, resins, antimicrobial agents, fragrances, salts, pH adjusters, conditioners, thickeners, chelating agents, cooling agents, anti-inflammatory agents, skin beautifying ingredients, vitamins, amino acids, nucleic acids, hormones, inclusion compounds, solvents (such as water), or combinations thereof.

In another preferred embodiment, the anti-inflammatory agent is selected from the group consisting of: antibiotics, bacteriostats, plant bactericidal components, glucocorticoids, benzoyl peroxide, azelaic acid, nicotinamide, sulfur, resorcinol, swertiamarin, witch hazel extract, zinc pyrrolidone carboxylate, or combinations thereof.

In another preferred embodiment, the composition further comprises a liposome and a nanoparticle forming agent, such as a phospholipid, lecithin, cholesterol, glycerol monooleate, or a combination thereof.

In another preferred embodiment, the composition may further comprise other hair growth actives. For example, a germinal active ingredient (but not limited to) selected from the group consisting of: chemically synthesized hair tonic, natural hair tonic, active polypeptide having hair tonic effect, or a combination thereof.

Dosage form

In the present invention, the composition has no particular requirement on the dosage form, and can be prepared into dosage forms commonly used in the art.

In the present invention, when a specific transdermal dosage form such as a microneedle is used, the composition can exert a remarkable hair growth promoting effect in the head hair loss area of some patients suffering from long-term alopecia in 2 to 6 weeks.

Thus, the composition of the present invention is preferably in a dosage form selected from the group consisting of: transdermal administration forms, percutaneous administration forms, subcutaneous administration forms.

Preferably, the dosage form of the composition is selected from the group consisting of (but not limited to): solutions, gels, creams, emulsions, liposomes, microemulsions, nanoemulsions, nanoparticles, nanospheres, liquid crystal spheres, vehicles, alcohol liposomes, vesicles, microneedle arrays, patches (transdermal patches), or combinations thereof.

For example, dosage forms in the form of microneedle arrays can be prepared by combining the compositions of the present invention with suitable carriers (e.g., water-soluble polymers, etc.) using methods commonly practiced in the art for microneedle preparation. The microneedle array delivers the active ingredient in the composition of the present invention to a specific site or a specific skin sub-layer (sublayer) of the skin, particularly a site or sub-layer where hair follicles are located, through micro-tunnels formed in the skin such as the stratum corneum, thereby exerting the hair growth promoting effects of the ingredients (a) and (b). Or the composition of the invention may be administered in conjunction with a device having a microneedle array (e.g., nanocrystalline).

The compositions of the present invention may facilitate absorption by methods commonly used in the art, such as physical transdermal techniques, chemical transdermal techniques, biological transdermal techniques, transdermal iontophoresis techniques, or combinations thereof.

Typically, the composition is applied by a method selected from the group consisting of: painting, massaging, physical sanding, injection, electroporation, thermal perforation, ultrasound introduction, microneedle (e.g., microneedle array) introduction, nanoplate introduction, laser introduction, ion introduction, magnetic introduction, electrode scanning system introduction, transdermal patch application, or combinations thereof.

An electrode scanning system (electrode scanning system, ESS), such as a Novosis ESS patch, has an electric field generated only within the patch, thereby avoiding adverse effects such as burning and irritation caused by iontophoresis current passing through the skin.

Preferably, the dosage form of the composition is selected from the group consisting of: hair growth and/or anti-hair loss lotion, hair growth and/or anti-hair loss ointment, hair growth and/or anti-hair loss drug or dressing, shampoo, hair cream or conditioner, hair gel, mousse, paint, hair cream, hair mask, hair dye, eyebrow regrowth agent, eyelash regrowth agent or eyelash nutrition agent, hair care essence, scalp care agent, nano microsphere, microneedle (e.g., microneedle array), or combinations thereof.

The compositions of the present invention may be applied in combination with other methods commonly used in the art: such as massage, physical sanding, laser surgery, etc. The administration may be simultaneous or sequential.

Use of the same

The present invention provides the use of a composition of the invention for the preparation of a composition for promoting hair growth and/or preventing hair loss;

the present inventors have unexpectedly found that when component (a) is used in combination with component (b), both have a remarkable synergistic effect, which effect is remarkably improved compared to the use of component (a) or component (b) alone, for example, a remarkable acceleration in the speed of promoting hair growth.

In another preferred embodiment, the promoting hair growth and/or preventing hair loss comprises promoting telogen phase hair follicles to enter anagen phase.

In another preferred embodiment, the promoting hair growth and/or preventing hair loss comprises: promote proliferation and/or activation of hair papilla cells, delay degeneration of hair follicle cells, or a combination thereof.

In another preferred embodiment, the promoting hair growth comprises promoting hair regeneration and/or hair growth.

In another preferred embodiment, the hair loss comprises genetically determined and/or obtained forms of hair loss.

In another preferred embodiment, the genetically determined or obtained form of hair loss comprises insufficient hair growth, alopecia areata, partial alopecia, total alopecia, hair-plucking, or drug induced alopecia.

In another preferred embodiment, the alopecia comprises seborrheic alopecia and chemical alopecia.

In another preferred embodiment, the alopecia comprises scarring alopecia and/or non-scarring alopecia.

In another preferred embodiment, the scarring alopecia comprises lichen planus, postmenopausal alopecia, lupus erythematosus alopecia, brocq pseudoalopecia areata, scalp split cellulitis, or a combination thereof.

In another preferred example, the non-scarring alopecia comprises androgenic alopecia, alopecia areata, temporotriangular alopecia, hair-plucking, senile alopecia, telogen effluvium, anagen hair loosening syndrome, infectious alopecia, lipedematous alopecia, common salt alopecia, sugar alopecia, tumor-related alopecia, or a combination thereof, preferably androgenic alopecia, alopecia areata, temporotriangular alopecia, hair-plucking, senile alopecia, telogen effluvium, infectious alopecia and/or psychogenic alopecia, more preferably androgenic alopecia, telogen effluvium and/or psychogenic alopecia.

In another preferred example, the non-scarring alopecia comprises androgenic alopecia, alopecia areata, temporotriangular alopecia, hair-plucking, senile alopecia, telogen effluvium, anagen hair loss syndrome, syphilitic alopecia, lipedema alopecia, common salt alopecia, glycogenic alopecia, or a combination thereof, preferably androgenic alopecia and/or alopecia areata.

Preferably, after application of the composition, the time for hair growth is less than or equal to 2 months, preferably 1 week to 1.5 months, more preferably 2 weeks to 1 month. Preferably, the use is continuous, such as 1-3 times per day.

In another preferred embodiment, the "time to grow hair" refers to the time from the start of application of the composition of the present invention to the start of growing hair (fluff or black hair) at the site of hair loss.

In another preferred embodiment, the preventing hair loss comprises preventing hair loss and/or strengthening hair roots.

In another preferred embodiment, the composition may also be used to improve hair quality and/or improve scalp health.

In another preferred embodiment, the improving hair quality comprises repairing hair scales and thickening hair.

In another preferred embodiment, the improving scalp health comprises removing and/or preventing dandruff, relieving itching, repairing damaged scalp or hair follicles, and/or preventing and/or treating scalp inflammation.

In another preferred embodiment, the scalp inflammation is selected from: folliculitis, seborrheic dermatitis, or a combination thereof.

In the present invention, the use and method of the present invention are non-diagnostic and non-therapeutic methods.

The main advantages of the invention include:

(1) In the composition, the beta-glucan and the chemical stripping agent have obvious synergistic effect, and the effect and the acting speed of the beta-glucan can be obviously improved.

(2) The composition of the invention has remarkable effects in treating alopecia and promoting hair growth.

(3) Compared with the prior art that the beta-glucan is added into external preparations such as shampoo, the inventor discovers that the effect of the beta-glucan is better through transdermal and subcutaneous administration, so that the composition has more obvious effect when the composition is in a transdermal, subcutaneous and other administration dosage form.

(4) The invention provides a patch containing the composition and provided with a microneedle array capable of penetrating skin, which can achieve excellent effects without the aid of other expensive equipment, and is low in cost and convenient to use.

(5) The composition has obvious protective effect on skin injury (such as allergy, stinging, itching, erythema and the like) caused by chemical substances.

(6) The composition has obvious protective effect on injuries caused by physical injury transdermal administration modes (such as laser, micro-needles, injection, perforation, nano-wafers and the like), can prevent and/or improve side effects such as allergy, stinging, itching, erythema and the like, and can promote hair growth and/or alopecia and accelerate skin healing.

The invention is further described below in conjunction with the specific embodiments. It is to be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. The experimental methods, in which specific conditions are not noted in the following examples, are generally conducted under conventional conditions or under conditions recommended by the manufacturer. Percentages and parts are by weight unless otherwise indicated.

The experimental methods used in the following examples are conventional methods unless otherwise specified.

Materials, reagents, equipment and the like used in the examples described below are commercially available unless otherwise specified.

The schizophyllum beta-glucan used in the examples of the present invention was identical to the schizophyllum beta-glucan described in CN110090168A example 1.

Example 1

Preparation of essence

According to Table 1, compositions I-XII (unit wt%, based on the total weight of the concentrate) were formulated:

table 1 composition formulation table

Example 2

Volunteer hair loss prevention test analysis 1

1. The using method comprises the following steps: during the trial, after the volunteer had washed his/her hair, 0.1% of the schizophyllum commune-derived beta-glucan (I) of example 1 was sprayed on the scalp and gently massaged until absorbed, and the effect of hair growth was observed.

2. Volunteer test results

Volunteer a: women, 29 years old, are pressure alopecia, and have about 150 hair loss per time of hair washing;

during the trial, after the volunteer washes hair once a day, 0.1% of schizophyllum commune-derived beta-glucan (I) is sprayed on the scalp and gently massaged until the change of the hair loss is observed;

as shown in table 2, the growth rates of the new-born hair after the use of composition i for volunteer a were as follows:

TABLE 2 variation of hair growth after volunteer A tested formula I (root/cm ² )

Volunteer B: women, 27 years old, have a postpartum hormonal alopecia, and have about 200 hair loss marks on average each time of hair washing, and the forehead has obvious appearance of alopecia blocks and serious alopecia degree.

During the trial, after the volunteer had washed his/her hair once a day, 0.1% schizophyllum beta-glucan (i) was sprayed on the scalp and gently massaged to absorption, and the change in hair loss was observed.

After trial of volunteer B, the hair loss was significantly reduced after 2 weeks, and after 8 weeks, new hair was found at the bald area, and after 24 weeks, the bald was covered with new hair, and after 48 weeks, the normal hair loss was substantially restored.

The above results indicate that beta-glucan can promote hair growth, but it requires 2-3 months of continuous use to start new hair growth and more than 6 months to restore normal hair volume.

Example 3

Promoting hair growth for androgenic alopecia

Androgenic alopecia is also called seborrheic alopecia, male pattern alopecia or hereditary alopecia, and excessive scalp grease overflows, usually accompanied by increased dandruff, greasy scalp and obvious itching. Androgenic alopecia, which occurs in the young and strong years when sebaceous glands are actively secreting, begins to gradually lose hair from the top of the head, spreads and the forehead, and then spreads over the head. The patient generally has thin and soft hair and is sometimes accompanied by seborrheic dermatitis. The scalp is greasy and bright red, and forms yellow oily scab. Seborrheic alopecia is a permanent alopecia, and after some men develop, the alopecia starts to appear, so that hair is greasy and shiny, dandruff is slowly increased, itching often occurs, sometimes the hair is dry and matt, the hair is shed only by light grasping with hands, and particularly chronic diffuse alopecia can occur at the forehead angles at both sides.

In this and the subsequent examples 4-7 and 9-11, the compositions of the different formulations of example 1 were applied to volunteers of different types of androgenic alopecia and the effect was observed.

Volunteer C: male, 39 years old, androgenic alopecia. During the trial, volunteer C took about 3ml of 0.3% schizophyllum commune-derived beta-glucan solution (formula II) twice a day, and smeared it on the scalp and gently massaged until absorbed. At 16 weeks, the microvilli on the top of the head changed from colorless to black and became strong, making the hair appear thicker than before. After 20 weeks, the microvilli that began to be sparse were gradually stronger, the density was also gradually increased, and after 24 weeks the hair was significantly thicker than before use. The average number of hairs per square centimeter was 35 per 48 weeks, of which 57% were very strong black hairs, 14% were black fine soft hairs, and 28% were black hairs.

TABLE 3 variation of hair growth after volunteer C trial formulation II product (root/cm) ² )

As can be seen from Table 3, for the more refractory androgenic alopecia, a higher concentration of beta-glucan solution was used and the frequency of use increased (twice a day) and continued for 16 weeks, colorless microvilli were gradually darkened and strengthened. The time required for the hair follicle quantity to grow is 24 weeks, and the hair is still thin from 48 weeks, and the normal quantity cannot be recovered.

Example 4

Volunteer D: men, 40 years old, androgenic alopecia, a period of ten years or so, almost all bald in the top of the head before trial, and some hair follicles still remain with thin and soft colorless villi after careful observation. Meanwhile, the volunteer has the problems of serious dandruff, itching and greasiness, and the like, and almost every day hair is washed, otherwise, scalp oil is discharged to enable hair to be attached to the scalp, so that the appearance is very affected.

In the use process of the volunteer, about 3ml of formula IV product is taken twice a day in the morning and evening, the scalp is smeared and lightly massaged until the scalp is absorbed, after 4 weeks, the feedback dandruff and the scalp itching of the volunteer are obviously improved, the improvement of the head oil is obvious, the hair is required to be washed every day before, and the hair can be washed once in 3 days. The hair growth amount is shown in Table 4 and FIG. 1: .

TABLE 4 variation of hair growth after volunteer D tried formula IV product (root/cm) ² )

Example 5

Volunteer E: men, 36 years old, the volunteer did not have hereditary hair loss, but the symptoms of hair loss were very severe, leaving about 40% coverage of hair, especially with scalp exposed at the top of the head. The volunteer uses the nanoemulsion prepared in the formula V, mainly based on lecithin or fractionated phospholipid, and prepares the nanoemulsion/lipid nanoparticle with the particle size of 20-50nm based on the formula IV. The nanoemulsion/lipid nanoparticle can help the active ingredient to be absorbed by skin better. The hair growth effect of this volunteer was also significantly better than that of volunteer D. The amount of hair growth is shown in Table 5 and FIG. 2 for 24 weeks:

TABLE 5 variation of hair growth after E-test of formula V product (root/cm) ² )

Example 6

Volunteer F: men, 28 years old, seborrheic alopecia, with a period of 3 years, currently with a severe posterior forehead hairline, an upward movement of 2cm, an upward movement of both forehead hairlines of about 3.5-4cm, residual hair coverage with sparse hair, and a tendency to continue to fall off. The volunteer uses the formula VI, and in the using process, the hair becomes obviously thicker after 8 weeks, about 3ml of the formula VI is taken twice a day in the morning and evening, and the formula VI is smeared on the scalp and lightly massaged until the formula VI is absorbed. The hair growth amount is shown in Table 6 and FIG. 3:

TABLE 6 variation of hair growth after volunteer F tested formula VI product (root/cm) ² )

Example 7

Volunteer H: women, 45 years old, lose hair at the top of the head, get thinner and see the scalp. According to volunteer expression, daily hair is prone to oil, especially during seasonal alopecia, much, but much less long, so that the hair becomes thinner and the scalp becomes bare. In the trial process, volunteer H took 3ml of formula VIII product twice a day in the morning and evening, and applied it to the scalp and gently massaged until absorbed. According to volunteer feedback, the scalp portion hair was already dense at about 4 months. The area of bare scalp is also reduced. The method is also suitable for chemical stripping as a formula for promoting penetration of products, and young people have faster and better effects because of stronger scalp cell activity. While older volunteers require almost twice as much time to appear to have a significant effect. The amount of hair growth is shown in Table 7 and FIG. 4.

TABLE 7 variation of hair growth after volunteer H tried formulation VIII product (root/cm ² )

Example 8

Volunteer I: men, 39 years old, androgenic alopecia, a history of alopecia around ten years old, now almost all bald in the top of the head and forehead, have carefully observed some hair follicles and some thin and soft colorless villi. The volunteer used formula IV, but it was not just by application, but it was applied transdermally by taking about 3ml twice daily, and massaging, and at two days intervals, the volunteer would apply formula IV to the scalp in combination with a nanocrystalline lead-in device (SPE-10B). By volunteer feedback, dandruff itching was significantly improved after 1 week, and new hair developed after 2 weeks. The amount of hair growth is shown in Table 8.

Table 8 variation in hair growth after volunteer I trial formulation IV product (root/cm) ² )

As can be seen from example 8, the composition of the present invention can be used in conjunction with an introduction device in the form of a microneedle or the like, which can further accelerate scalp improvement and new hair growth rate.

In combination with the description of examples 1 to 8, the present inventors found that, based on the promotion of hair growth by β -glucan, the β -glucan and sodium lactate have a synergistic effect of accelerating hair growth through a large number of screening optimizations, and further surprisingly found that although β -glucan can promote hair growth and strengthen hair by being applied to the skin, the β -glucan is introduced into the scalp through skin penetrating agents and/or physical introduction devices and/or formulation technologies such as lipid microspheres, and synergistic anti-inflammatory substances, the time of accelerating hair growth by β -glucan can be further accelerated, the time of new development can be remarkably shortened, compared with the prior art, the time of new development can be shortened from 2 to 3 months to about the shortest 2 weeks, the increase of 60 to 90%, and the amount of β -glucan can be greatly reduced.

Example 9

In this example, 3 male androgenic alopecia were recruited, with a history of alopecia around 3-5 years. The product prepared by the formula III is used by taking about 3ml of the product twice a day in the morning and evening, and applying and massaging the product on an affected part until the product is absorbed. After 6 months of trial, the alopecia symptoms are not effectively improved, and no new occurrence is caused basically. The case of one volunteer J is as follows: volunteer J, male, 32 years old, history of androgenic alopecia, around 5 years, now with sparse head hair. The product prepared by the formula III is taken to be smeared on an affected part twice a day in the morning and evening, and the product is massaged until the product is absorbed. After trial for 6 months, the alopecia symptoms are not effectively improved, no new occurrence is caused basically, and the hair is sparse.

Comparing the results of example 9 with example 3, it can be seen that, although formulation III is similar to formulation II, the only difference is that: in example 9, formula III employed 0.3% oat beta-glucan, with no significant improvement for 6 months; in example 3, 0.3% schizophyllum beta-glucan was used in formulation II, and after 16 weeks a promoting hair growth was observed. This suggests that there is a significant difference in the effect of beta-glucan from different sources, whereas schizophyllum commune beta-glucan is preferred.

Example 10

In this example, 3 male androgenic alopecia were recruited, with a history of alopecia around 3-5 years. The product prepared by using the formula XI is applied to the affected part by taking about 3ml twice a day in the morning and at night and massaging until absorption. After 6 months of trial, the alopecia symptoms are not effectively improved, and no new occurrence is caused basically.

Comparing the results of example 10 with those of example 4, it can be seen that, although formulation XI is similar to formulation IV, the only difference is that: in example 10, formulation XI used 0.06% of B-glucan from Rhizoctonia cerealis, no significant improvement was observed for 6 months; in example 4, 0.06% schizophyllan beta-glucan was used in formulation IV, and scalp condition was improved after 4 weeks of use, and hair growth promoting effect was observed after 8 weeks of use.

This suggests that there is a significant difference in the effect of beta-glucan from different sources, whereas schizophyllum commune beta-glucan is preferred. Meanwhile, even if used in combination with a chemical exfoliating agent or the like, the sclerotium rolfsii beta-glucan does not have a hair growth effect.

Example 11

Microneedle array patch

The patch with the micro-needle array is prepared by using the component proportion of the formula IV, wherein the needle points of the micro-needles can penetrate into the dermis and below, and the micro-needles comprise soluble macromolecule carriers, can be dissolved and release the components in the formula IV after penetrating into the skin.

In this example, 3 male androgenic alopecia were recruited, with a history of alopecia around 3-5 years. The application method comprises applying about 3ml of formula IV liquid twice per night to affected part, massaging to absorption, and applying the patch with microneedle array to scalp for about 30min at two days.

By volunteer feedback, dandruff itching improved significantly after about 1 week, and after about 2 weeks, new development was observed, which was shown in fig. 5. The composition can be prepared into a micro-needle array and other dosage forms, so that patients can conveniently and safely use the composition without the assistance of professional equipment, and scalp improvement and new growth rate are further accelerated.

All documents mentioned in this application are incorporated by reference as if each were individually incorporated by reference. Further, it will be appreciated that various changes and modifications may be made by those skilled in the art after reading the above teachings, and such equivalents are intended to fall within the scope of the claims appended hereto.

Claims

1. Use of a composition for the preparation of a formulation for promoting hair growth in a human subject suffering from androgenetic alopecia,

Wherein the composition consists of the following components: schizophyllum beta-glucan, L-sodium lactate, D-panthenol, allantoin, xanthan gum, hyaluronic acid, 1, 3-butanediol, glycerol, sodium pyrrolidone carboxylate, azone, preservative, deionized water, and adjusting the final pH to 5.6;

wherein, the schizophyllum commune beta-glucan is 0.06wt%, L-sodium lactate is 0.5wt%, D-panthenol is 0.2wt%, allantoin is 0.2wt%, xanthan gum is 0.1wt%, hyaluronic acid is 0.1wt%, 1, 3-butanediol is 5wt%, glycerin is 2wt%, sodium pyrrolidone carboxylate is 0.1wt%, and azone is 0.5wt%; and is also provided with

The molecular weight of the schizophyllum commune beta-glucan is 3000kD-5000kD.

2. The use according to claim 1, wherein the formulation is in the form of a transdermal or subcutaneous dosage form.

3. The use according to claim 1, wherein the formulation is in the form of a microneedle or nanoemulsion.