Anti-hair loss and hair growth composition and application thereof

Abstract

The invention provides an anti-hair loss and hair growth composition and application thereof, the composition comprises exosome freeze-dried powder, collagen freeze-dried powder and a traditional Chinese medicine extract, the exosome freeze-dried powder is obtained by extracting exosome from umbilical cord or umbilical cord blood and freeze-drying; the traditional Chinese medicine extract is selected from at least two of a lucid ganoderma extract, a ginseng extract, a honeysuckle flower extract and a polygonum multiflorum extract. The preparation formed by the hair loss prevention and hair growth composition can promote the generation of hair follicle cells, and stimulate hair follicles to enter a growth period while repairing the hair follicles, so that the growth of new hair is promoted, the problem of hair loss is remarkably improved, and the hair is densified and blackened.

Description

Technical Field

[0001] The invention belongs to the field of biology and medicine technology, and specifically relates to an anti-hair loss and hair growth composition and application thereof. Background Art

[0002] Hair loss is a very common skin disease. As the pace of life in modern society accelerates dramatically, long-term staying up late and irregular diets lead to poor blood circulation in the scalp, which prevents nutrients from being transported to the hair roots. Hair loss has become more common and serious, which has a great impact on people's mental health and daily life, and thus seriously affects their quality of life.

[0003] Most hair growth products on the market today are western medicines such as minoxidil and finasteride, which will inevitably cause side effects if used for a long time; and surgical hair transplants may have surgical risks. Therefore, hair growth products that are mainly based on natural products and combined with products around cells can help people avoid the above risks.

[0004] The main components of exosomes are proteins, nucleic acids and lipids. Most types of cells can secrete exosomes, which play an important regulatory role in intercellular communication, disease transmission and tissue repair. Exosomes are widely present in the immune response of organisms. Exosomes can promote immune responses by mediating pro-inflammatory responses. In short, exosomes transmit various biological information and play an important biological role by specifically binding to receptor cells. At present, there are reports of the use of exosomes, traditional Chinese medicine ingredients, plant ingredients, etc. in combination for anti-hair loss and hair growth products, such as CN202210465316.2, but from the content disclosed, the products disclosed in this patent do not have anti-hair loss effects. Therefore, it is necessary to further study the application prospects of exosomes in anti-hair loss products. Summary of the invention

[0005] The purpose of the present invention is to provide an anti-hair loss and hair growth composition and its application. The preparation formed by the composition can promote the generation of hair follicle cells and stimulate hair follicles to enter the growth phase, thereby significantly improving the problem of hair loss.

[0006] In order to achieve the above technical objectives, the technical solutions adopted in this application are as follows:

[0007] In a first aspect, the present invention provides an anti-hair loss and hair growth composition, comprising exosome freeze-dried powder, collagen freeze-dried powder, and a traditional Chinese medicine extract, wherein the exosome freeze-dried powder is obtained by extracting exosomes from an umbilical cord or umbilical cord blood and freeze-drying; the traditional Chinese medicine extract is selected from at least two of a Ganoderma lucidum extract, a ginseng extract, a honeysuckle extract, and a Polygonum multiflorum extract.

[0008] Preferably, in the composition, the mass ratio of the lyophilized exosome powder, the lyophilized collagen powder and the traditional Chinese medicine extract is 1-3:2-6:2-6, more preferably 1-2:3-4:2-5.

[0009] Preferably, the lyophilized collagen powder is at least one of type I collagen lyophilized powder, type II collagen lyophilized powder, and type III collagen lyophilized powder, more preferably type III collagen lyophilized powder.

[0010] Preferably, the Chinese herbal medicine extract is a compound of at least two of Ganoderma lucidum extract, ginseng extract, honeysuckle extract and Polygonum multiflorum extract, and the compound mass ratio is 3-6:0.5-4:0.5-4.

[0011] Preferably, the Chinese herbal extract is Ganoderma lucidum extract, ginseng extract, honeysuckle extract, and Polygonum multiflorum extract, and the mass ratio of the above components is 1-3:0.5-1.5:4-6:2-4, and more preferably 2:1:4:3.

[0012] In a second aspect, the present invention provides use of the anti-hair loss and hair growth composition described in the first aspect in the preparation of an anti-hair loss and hair growth product.

[0013] In a third aspect, the present invention provides an anti-hair loss and hair growth gel preparation, comprising the composition described in the first aspect, and further comprising carbomer, glycerol, butylene glycol, EDTA 2Na, sodium hyaluronate, triethanolamine and a solvent, wherein the weight percentage of each component is: 5-20% of the composition, 25-30% of carbomer, 2-5% of glycerol, 1-3% of butylene glycol, 0.03-0.05% of EDTA 2Na, 0.02%-0.04% of sodium hyaluronate, 0.4-0.6% of triethanolamine, and the balance is sterile deuterium-depleted water.

[0014] Preferably, the components are composed of 7-15% of the composition, 26-28% of carbomer, 2-4% of glycerol, 2-3% of butylene glycol, 0.04-0.05% of EDTA 2Na, 0.02%-0.04% of sodium hyaluronate, 0.5-0.6% of triethanolamine, and the balance is sterile deuterium-depleted water.

[0015] Preferably, the carbomer is carbomer 940.

[0016] In a fourth aspect, the present invention provides a method for preparing the gel preparation described in the third aspect, comprising the following steps: first, mixing glycerol, sodium hyaluronate and EDTA 2Na, then adding sterile deuterium-depleted water to mix, then adding carbomer, mixing at 60±5° C. for 20 to 40 minutes, cooling, then adding butanediol and the composition to mix, and finally adding triethanolamine to mix until a transparent matrix is ​​formed.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] The present invention utilizes exosomes and rationally formulates a prescription to form an anti-hair loss and hair growth composition that can significantly improve the problem of hair loss. The preparation formed by the composition can promote the generation of hair follicle cells, repair hair follicles and stimulate hair follicles to enter the growth phase, thereby promoting new hair growth, significantly improving the problem of hair loss and making hair thicker and darker. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is the appearance diagram of alopecia areata mice in the animal experiment of the present invention.

[0020] Figure 2 The figure shows the hair growth of each group of mice in the animal experiment of the present invention.

[0021] Figure 3 This is a comparison chart of the effects before and after use of typical case 1, where Figure A is before use; Figure B is after 3 months of use.

[0022] Figure 4 This is a comparison chart of the effects before and after using Typical Case 2.

[0023] Figure 5 This is a comparison chart of the effects before and after use of Typical Case 3, where Figure A is before use; Figure B is after one and a half months of use. DETAILED DESCRIPTION

[0024] In a specific embodiment of the present invention, the preparation method of the ganoderma lucidum extract is as follows: cut the ganoderma lucidum into slices, mix the sliced ​​ganoderma lucidum with water at a mass ratio of 1:40, heat to 80°C, and keep for 2 hours. Filter the heated mixture through a 100um cell sieve and a 0.22 filter membrane in sequence, concentrate the obtained extract, and finally dry the purified extract to obtain a powder of the ganoderma lucidum extract.

[0025] In a specific embodiment of the present invention, ginseng extract, honeysuckle extract and Polygonum multiflorum extract were purchased from a certain biological technology company in Shaanxi.

[0026] In a specific embodiment of the present invention, the method for preparing exosomes is as follows:

[0027] A. Transfer the NK cell culture supernatant (purchased from a medical beauty clinic in Songshan Lake, Dongguan, extracted from the umbilical cord or umbilical cord blood) to a 500ml centrifuge cup and centrifuge at 2000rpm for 30min, collect the supernatant, discard the precipitate, and remove the cell debris and large protein impurities in the supernatant.

[0028] B. Transfer the supernatant to a new 500 ml centrifuge tube and centrifuge at 4000 rpm for 30 min.

[0029] C. Filter and collect the liquid using a 0.2 μm filter to obtain exosomes, and freeze-dry the exosomes for later use.

[0030] In the description of the present invention, it should be noted that, if the specific conditions are not specified in the examples, the experiments were carried out according to conventional conditions or the conditions recommended by the manufacturer. The reagents or instruments used, if the manufacturer is not specified, are all conventional products that can be purchased commercially.

[0031] The present invention is further described in detail below in conjunction with specific embodiments, which are intended to explain the present invention rather than to limit it.

[0032] Example 1

[0033] The present embodiment provides an anti-hair loss and hair growth composition, which is composed of exosome freeze-dried powder, collagen freeze-dried powder, and traditional Chinese medicine extracts in a mass ratio of 2:4:2, wherein the collagen freeze-dried powder is type I collagen freeze-dried powder, and the traditional Chinese medicine extracts are ganoderma lucidum extract and ginseng extract in a mass ratio of 1:1.

[0034] Example 2

[0035] The present embodiment provides an anti-hair loss and hair growth composition, which is composed of exosome freeze-dried powder, collagen freeze-dried powder, and traditional Chinese medicine extracts, which are compounded in a mass ratio of 2:4:2, wherein the collagen freeze-dried powder is type I collagen freeze-dried powder, and the traditional Chinese medicine extracts are Ganoderma lucidum extract and Polygonum multiflorum extract, which are compounded in a mass ratio of 1:1.

[0036] Example 3

[0037] The present embodiment provides an anti-hair loss and hair growth composition, which is composed of exosome freeze-dried powder, collagen freeze-dried powder, and Chinese medicine extracts, which are compounded in a mass ratio of 2:4:2, wherein the collagen freeze-dried powder is type I collagen freeze-dried powder, and the Chinese medicine extracts are ginseng extract and Polygonum multiflorum extract, which are compounded in a mass ratio of 1:1.

[0038] Example 4

[0039] This embodiment provides an anti-hair loss and hair growth composition, which is different from Embodiment 2 in that the Chinese herbal extracts are honeysuckle extract, ganoderma lucidum extract and Polygonum multiflorum extract compounded in a mass ratio of 2:1:1.

[0040] Example 5

[0041] This embodiment provides an anti-hair loss and hair growth composition, which is different from Embodiment 4 in that the collagen freeze-dried powder is type II collagen freeze-dried powder.

[0042] Example 6

[0043] This embodiment provides an anti-hair loss and hair growth composition, which is different from Embodiment 4 in that the collagen freeze-dried powder is type III collagen freeze-dried powder.

[0044] Example 7

[0045] This embodiment provides an anti-hair loss and hair growth composition, which is different from Embodiment 6 in that the Chinese herbal extracts are Ganoderma lucidum extract, ginseng extract, honeysuckle extract, and Polygonum multiflorum extract compounded in a mass ratio of 1:1:4:1.

[0046] Example 8

[0047] This embodiment provides an anti-hair loss and hair growth composition, which is different from Embodiment 7 in that the Chinese herbal extracts are Ganoderma lucidum extract, ginseng extract, honeysuckle extract, and Polygonum multiflorum extract compounded in a mass ratio of 2:1:4:3.

[0048] Comparative Example 1

[0049] The difference between the composition of this comparative example and Example 1 is that the collagen freeze-dried powder is replaced with sodium hyaluronate.

[0050] Comparative Example 2

[0051] The difference between the composition of this comparative example and Example 1 is that there is no lyophilized exosome powder.

[0052] Animal experiments

[0053] The compositions of Examples 1 to 8 and Comparative Examples 1 to 2 were prepared into solutions with a total concentration of 20% using sterile water (applied to mice in test groups 1 to 10, respectively), and the model group corresponded to test group 11.

[0054] Alopecia areata mouse modeling: Prepare 33 SPF grade KM mice, 6 to 8 weeks old, half male and half female, with intact hair, and randomly divided into 11 groups, 3 mice in each group. All mice were adaptively fed for 7 days, after which all mice were taken out, and about 0.05g of imiquimod cream was taken with a clean medical cotton swab and evenly applied to the skin of the neck, with an application range of about 1.5cm×1.5cm, 3 times a week. Before each application of the drug, the local area was cleaned with saline to remove the residual drug from the previous application. The drug was administered for 30 to 50 days until an alopecia areata area of ​​>1cm×1cm was formed at the administration site, and the modeling was successful. Figure 1 Shown is the appearance of one of the alopecia areata mice, with the bald spots clearly visible.

[0055] The corresponding solution was applied to test groups 1 to 10, twice a day, 5 mL each time, and no treatment was given to model group 11. The solution was applied for 60 consecutive days, and the hair growth of mice was observed. The results showed that test group 8 had the best effect, and the mice grew thick hair again in the alopecia areata area; the mice in test groups 7 and 6 also grew more new hair, but the effect was slightly worse than that of test group 8. The amount of hair in test groups 1 to 5 increased, which was larger than that in test group 8. A small amount of hair was generated in test groups 9 and 10, while the model group (test group 11) had only a few sparse hairs.

[0056] It can be seen that the prescriptions of Examples 1 to 8 of the present invention all have hair growth effects, among which Examples 6 to 8 have better effects, and Example 8 has the best effect. The formula of Example 8 was selected in subsequent experiments to develop an anti-hair loss and hair growth gel preparation, and further carry out subsequent clinical trials.

[0057] Example 9

[0058] The present embodiment provides an anti-hair loss and hair growth gel preparation, wherein the components are composed of 7% of the composition of Example 8, 27% of carbomer 940, 3% of glycerol, 2% of butylene glycol, 0.04% of EDTA 2Na, 0.03% of sodium hyaluronate, 0.5% of triethanolamine, and the balance is sterile deuterium-depleted water. The preparation method of the gel preparation comprises the following steps: firstly, glycerol, sodium hyaluronate and EDTA 2Na are mixed, then sterile deuterium-depleted water is added, then carbomer 940 is added, mixed at 60±5°C for 20 to 40 minutes, after cooling, butylene glycol is added to the composition and mixed, and finally triethanolamine is added to mix until a transparent matrix is ​​formed.

[0059] Example 10

[0060] This embodiment provides an anti-hair loss and hair growth gel preparation, wherein the components are as follows by weight percentage: 10% of the composition of Example 8, 27% of Carbomer 940, 3% of glycerol, 3% of butylene glycol, 0.05% of EDTA 2Na, 0.04% of sodium hyaluronate, 0.5% of triethanolamine, and the balance is sterile deuterium-depleted water. The preparation method is the same as that of Example 9.

[0061] Embodiment 11

[0062] This embodiment provides an anti-hair loss and hair growth gel preparation, wherein the components are as follows by weight percentage: 15% of the composition of Example 8, 26% of Carbomer 940, 4% of glycerol, 2% of butylene glycol, 0.05% of EDTA 2Na, 0.02% of sodium hyaluronate, 0.6% of triethanolamine, and the balance is sterile deuterium-depleted water. The preparation method is the same as that of Example 9.

[0063] The products of Examples 9 to 11 were tested, and the specific test items were as follows:

[0064] 1) Sterility test for bacteria and fungi: Refer to the Sterility Test Method 1101 of Part III of the Chinese Pharmacopoeia 2020 Edition. The test tubes are all clear and the results meet the requirements.

[0065] 2) Mycoplasma detection: Referring to the Mycoplasma Inspection Method, Method 2, Indicator Cell Culture Method, 3301, General Rules of Part III of the 2020 Edition of the Chinese Pharmacopoeia, the result showed negative, which was in compliance with the regulations.

[0066] 3) Specific virus and non-specific virus detection: Referring to the Microbiological Examination Method in Part III of the Chinese Pharmacopoeia 2020, human specific viruses including HIV, HCV, and HBV were detected, and the results showed negative, which was in compliance with regulations.

[0067] 4) Bacterial endotoxin detection: Refer to the first method of bacterial endotoxin detection method, gel method, in 1143 General Rules of Part III of the 2020 edition of the Chinese Pharmacopoeia. The endotoxin is less than 0.5EU / ml, and the results meet the requirements.

[0068] Example 12 Clinical Trial

[0069] The products prepared in Examples 9 to 11 were subjected to clinical trials, with volunteers with hair loss symptoms as experimental subjects, and hair loss prevention and hair growth experiments were conducted, as follows:

[0070] The groups were divided as follows: volunteers with hair loss symptoms were randomly divided into 3 groups, each group had 50 people, half of them were male and half were female, with an average age of 53 years old, and each embodiment corresponded to a group of volunteers.

[0071] Treatment plan: Apply the products prepared in Examples 9 to 11 to the hair loss area once a day, with a dosage of 2 g / time. After 3 to 6 months of use, observe the hair growth and hair loss effects. The results are shown in Tables 1 and 2:

[0072] Table 1 Experimental results of Examples 9 to 11 (expressed in terms of number of people)

[0073]

[0074] Table 2 Experimental results of Examples 9 to 11 (expressed by percentage of people)

[0075]

[0076] From the data in Table 1 and Table 2, it can be seen that in Examples 9-11, changing the corresponding component concentrations has an effect on the hair growth effect. Overall, the number of people whose hair follicles recovered in the first three months was relatively small. As the use time increased, most of the hair follicles of the 50 people in each group were repaired. Among them, the effect of Example 9 was the most obvious and had the best repair effect on the hair follicles. All 50 people were repaired, and the recovery effects of the products of the three examples were all above 90% under long-term use.

[0077] Example 13 Typical Case

[0078] Case 1, Chen, male, 53 years old, was diagnosed with alopecia areata for 10 years. During this period, he tried corticosteroids, topical anthralin, and oral methotrexate, but the effect was not good. He used the formula of Example 9 once a day, with a dosage of 2g / time. The hair growth effect after 3 months of use was as follows: Figure 3 As shown, the hair follicles have recovered and grown a lot of hair, some of which are black hair.

[0079] Case 2: Xu, female, 55 years old, with sparse hair, used the formula of Example 9 once a day, with a dosage of 2 g / time. The hair growth effect after more than 4 months of use was as follows: Figure 4 As shown, the hair becomes darker and thicker, and a large amount of new hair grows obviously in the area where hair loss occurs on the top of the head.

[0080] Case 1: Zhang, male, 46 years old, with sparse and gray hair, used the formula of Example 9 once a day, with a dosage of 2 g / time. The hair growth effect after one and a half months of use was as follows: Figure 5 As shown, a lot of thick black hair grows.

[0081] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. An anti-hair loss and hair growth composition, characterized in that: It includes exosome freeze-dried powder, collagen freeze-dried powder, and traditional Chinese medicine extracts. The exosome freeze-dried powder is obtained by extracting exosomes from the umbilical cord or umbilical cord blood and freeze-drying; the traditional Chinese medicine extract is selected from at least two of Ganoderma lucidum extract, ginseng extract, honeysuckle extract, and Polygonum multiflorum extract.

2. The anti-hair loss and hair growth composition according to claim 1, characterized in that: In the composition, the mass ratio of the exosome freeze-dried powder, the collagen freeze-dried powder and the traditional Chinese medicine extract is 1-3:2-6:2-6, preferably 1-2:3-4:2-5.

3. The anti-hair loss and hair growth composition according to claim 1, characterized in that: The collagen freeze-dried powder is at least one of type I collagen freeze-dried powder, type II collagen freeze-dried powder, and type III collagen freeze-dried powder, preferably type III collagen freeze-dried powder.

4. The anti-hair loss and hair growth composition according to any one of claims 1 to 3, characterized in that: The Chinese herbal medicine extract is preferably a compound of at least two of Ganoderma lucidum extract, ginseng extract, honeysuckle extract and Polygonum multiflorum extract, and the compound mass ratio is 3-6:0.5-4:0.5-4.

5. The anti-hair loss and hair growth composition according to any one of claims 1 to 4, characterized in that: The Chinese medicine extracts are ganoderma lucidum extract, ginseng extract, honeysuckle extract and polygonum multiflorum extract, and the mass ratio of the above components is 1-3:0.5-1.5:4-6:2-4, preferably 2:1:4:

3.

6. Use of the anti-hair loss and hair growth composition according to any one of claims 1 to 5 in the preparation of anti-hair loss and hair growth products.

7. An anti-hair loss and hair growth gel preparation, characterized in that: The invention comprises the composition according to any one of claims 1 to 5, and further comprises carbomer, glycerol, butylene glycol, EDTA 2Na, sodium hyaluronate, triethanolamine and a solvent, wherein the weight percentage of each component is as follows: 5-20% of the composition, 25-30% of carbomer, 2-5% of glycerol, 1-3% of butylene glycol, 0.03-0.05% of EDTA 2Na, 0.02%-0.04% of sodium hyaluronate, 0.4-0.6% of triethanolamine, and the balance is sterile deuterium-depleted water.

8. The gel preparation according to claim 7, characterized in that: The components are composed of 7-15% of the composition, 26-28% of carbomer, 2-4% of glycerol, 2-3% of butylene glycol, 0.04-0.05% of EDTA 2Na, 0.02%-0.04% of sodium hyaluronate, 0.5-0.6% of triethanolamine, and the balance is sterile deuterium-depleted water.

9. The anti-hair loss and hair growth gel preparation according to claim 7, characterized in that: The carbomer is carbomer 940.

10. The method for preparing the gel preparation according to any one of claims 7 to 9, characterized in that: The method comprises the following steps: firstly, mixing glycerol, sodium hyaluronate and EDTA 2Na, then adding sterile low-deuterium water and mixing, then adding carbomer, mixing at 60±5°C for 20 to 40 minutes, cooling, then adding butanediol and the composition and mixing, and finally adding triethanolamine and mixing until a transparent matrix is ​​formed.

Images