Composition for improving alopecia and application thereof

Abstract

The invention belongs to the technical field of cosmetics, personal care and medicines, and particularly relates to a composition for improving alopecia and application thereof. Specifically, the composition for improving alopecia is prepared from the following components in parts by mass: 2.5 to 5.0 parts of an angelica keiskei extracting solution and 0.1 to 0.25 part of sodium hyaluronate disaccharide. According to the invention, the angelica keiskei extracting solution and the sodium hyaluronate disaccharide are combined for use, and the synergistic effect of the angelica keiskei extracting solution and the sodium hyaluronate disaccharide is accidentally found, so that the effects can be exerted on a plurality of biological pathways, namely, hair follicle degeneration caused by pressure stress is inhibited, and hair follicle cell proliferation is promoted, so that comprehensive protection on alopecia, especially pressure stress alopecia is realized; therefore, the method has good practical application value.

Description

Technical Field

[0001] This invention belongs to the fields of cosmetics, personal care and pharmaceutical technology, and specifically relates to a composition for improving hair loss and its application. Background Technology

[0002] The information disclosed in this background section is intended only to enhance understanding of the overall background of the invention and is not necessarily to be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

[0003] Hair loss has become a widespread problem affecting hundreds of millions of people worldwide. In recent years, with the accelerated pace of modern life, mental stress has become a significant factor impacting public health, and its role in skin and hair diseases has increasingly attracted scientific attention. Numerous clinical observations and basic research have shown that long-term or acute psychological stress is a crucial environmental factor inducing and exacerbating hair loss. The core biological mechanism lies in the fact that stress activates the hypothalamic-pituitary-adrenal (HPA) axis, leading to a sustained increase in the secretion of glucocorticoids—primarily cortisol. High levels of cortisol have been shown to directly affect hair follicles, producing multiple negative effects: it can induce premature entry of hair follicles into the regression and resting phases, inhibit the proliferation and differentiation of dermal papilla cells, and disrupt the local immune microenvironment of the hair follicles, ultimately leading to increased hair loss and decreased hair density.

[0004] Meanwhile, traditional hair loss prevention strategies mainly focus on androgenetic alopecia. While core drugs like minoxidil and finasteride have some efficacy, they suffer from limitations such as single-target action, limited effectiveness, and unpredictable side effects, and their application in the cosmetics field is restricted. More importantly, these traditional approaches lack targeted interventions for stress-mediated hair loss mechanisms. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the present invention aims to provide a composition for improving stress-induced hair loss and its application. Specifically, the present invention combines Ashitaba extract with sodium hyaluronate disaccharide, unexpectedly discovering a synergistic effect between the two, exerting effects on multiple biological pathways—both inhibiting stress-induced hair follicle degeneration and promoting hair follicle cell proliferation, thereby achieving comprehensive protection against hair loss. Based on the above research results, the present invention is thus completed.

[0006] To achieve the above-mentioned technical objectives, the present invention provides the following technical solution: In a first aspect, the present invention provides a composition for improving hair loss, comprising, by weight parts: 2.5-5.0 parts of Ashitaba extract and 0.1-0.25 parts of sodium disaccharide hyaluronic acid.

[0007] The Ashitaba extract is composed of Ashitaba ( Angelica keiskei It was obtained through steps such as water extraction, alcohol precipitation, and water precipitation.

[0008] The sodium hyaluronate disaccharide is available commercially.

[0009] Through experimental verification, the present invention demonstrates that the above composition can improve hair loss by promoting the proliferation of dermal papilla cells, increasing the expression levels of ALP and Versican genes, and downregulating cortisol levels.

[0010] A second aspect of the present invention provides a method for preparing the above-described composition, the method comprising the step of mixing the Ashitaba extract with sodium hyaluronate disaccharide.

[0011] A third aspect of the invention provides the use of the above-described composition in the preparation of a product for improving hair loss. In this invention, the product can be a pharmaceutical or cosmetic product. The product can be used to alleviate hair follicle damage caused by stress and improve hair loss. Specifically, it significantly inhibits hair loss and promotes hair follicle recovery by regulating the hair follicle microenvironment under stress.

[0012] In a fourth aspect, the present invention provides a cosmetic product comprising at least the above-described composition. Therefore, the cosmetic product is capable of effectively preventing hair loss and promoting hair follicle health under stress conditions.

[0013] According to the cosmetic of the present invention, the amount of the composition added is 0.1-10.25% based on the total mass of the cosmetic. in / on (e.g., 0.1%, 0.25%, 2.5%, 3.5%, 5%, 5.25%, 8%, 10.25%, etc., without specific limits here.)

[0014] The cosmetics may also contain any other ingredients permitted in the cosmetics field, including but not limited to emulsifiers, emollients, moisturizers, cooling agents, skin conditioners, thickeners, and preservatives.

[0015] Furthermore, by rationally adding the above-mentioned raw material components, this invention can also be used to prepare different cosmetic formulations, such as essence spray, essence water, essence liquid, essence lotion, essence serum, shampoo, conditioner, hair mask, scalp care liquid, etc., without making specific limitations here.

[0016] The beneficial technical effects of one or more of the above technical solutions are as follows: (1) The anti-hair loss composition obtained by the above technical solution can significantly cope with the effects of stress, promote the proliferation of hair papilla cells and increase the expression of ALP and Versican genes, and downregulate cortisol levels, thereby achieving an effective anti-hair loss effect; (2) This invention provides a hair loss prevention composition, the main component of which is Ashitaba extract, combined with a small amount of sodium hyaluronate disaccharide as a synergistic agent. Ashitaba extract is rich in various active plant ingredients, which can regulate the microenvironment of hair follicles and inhibit hair loss; the two work synergistically to exert effects on multiple biological pathways—inhibiting hair follicle degeneration caused by stress and promoting hair follicle cell proliferation, thereby achieving comprehensive protection against hair loss. This composition provides a more significant and lasting hair loss prevention effect through a multi-target, synergistic mechanism.

[0017] (3) The preparation method of the anti-hair loss composition skin care cosmetic prepared by the above technical solution is simple and easy to implement. Through human efficacy test, it has a good effect on improving hair loss, and therefore has good practical application value. Detailed Implementation

[0018] It should be noted that the following detailed description is illustrative and intended to provide further explanation of the invention. Unless otherwise specified, 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 pertains.

[0019] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0020] In a typical embodiment of the present invention, a composition for improving stress-induced hair loss is provided, comprising, by weight, 2.5-5.0 parts of Ashitaba extract and 0.1-0.25 parts of sodium disaccharide hyaluronic acid.

[0021] The Ashitaba extract is composed of Ashitaba ( Angelica keiskei It was obtained through steps such as water extraction, alcohol precipitation, and water precipitation.

[0022] Specifically, the Ashitaba extract is prepared using the following method: S1. Take Ashitaba medicinal material, add 8-10 times the amount of water and boil to extract, then sieve to obtain the filtrate. Furthermore, the extraction can be performed in 2-3 times. In one specific embodiment of the present invention, water is added and boiled twice for extraction. The first extraction is performed with 10 times the amount of water for 2 hours and then filtered through an 80-mesh sieve. The second extraction is performed with 8 times the amount of water for 1 hour and then filtered through an 80-mesh sieve. S2. Concentrate the obtained filtrate under reduced pressure to a clear extract with a relative density of 1.05 to 1.15 (60°C); S3. Add ethanol to the clear paste until the alcohol content is 40-50%, stir, and then refrigerate at low temperature (e.g., 4℃±2℃) and let it stand. S4. Take the alcohol precipitation supernatant from step S3, filter it, and recover the ethanol until the relative density of the concentrated liquid is 1.05 to 1.15 (60℃). S5. After adding water and stirring, the solution is refrigerated at low temperature (4℃±2℃) and allowed to stand to obtain the water-precipitated solution. S6. The water-sediment is filtered and then boiled.

[0023] In step S6, filtration is performed using a filter plate and a PP membrane (0.45μm) in sequence. Furthermore, cosmetic excipients are added to the filtrate, including any one or more of 1,2-hexanediol, p-hydroxyacetophenone, and disodium EDTA.

[0024] Furthermore, the Ashitaba extract also includes a mixing step in step S7, specifically: when the liquid obtained in step S6 is cooled to about 40°C, it is filtered and then 1,3-butanediol is added and stirred to obtain the medicinal solution. Furthermore, the Ashitaba extract also includes the dispensing step S8, which specifically involves filtering the prepared medicinal solution through a 200-mesh sieve and then filling it into containers.

[0025] The sodium hyaluronate disaccharide is available commercially.

[0026] Through experimental verification, the present invention demonstrates that the above composition can improve hair loss by promoting the proliferation of dermal papilla cells, increasing the expression levels of ALP and Versican genes, and downregulating cortisol levels.

[0027] In another specific embodiment of the present invention, a method for preparing the above composition is provided, the method comprising the step of mixing the Ashitaba extract and sodium hyaluronate disaccharide.

[0028] In another specific embodiment of the present invention, the above composition is provided for use in the preparation of a product for improving stress-induced hair loss. In this invention, the product can be a pharmaceutical or cosmetic product. The product can be used to alleviate hair follicle damage caused by stress and improve hair loss. Specifically, it significantly inhibits hair loss and promotes hair follicle recovery by regulating the hair follicle microenvironment under stress.

[0029] In another specific embodiment of the present invention, a cosmetic is provided, the cosmetic comprising at least the above-described composition. Therefore, the cosmetic can effectively prevent hair loss and promote hair follicle health under stress conditions.

[0030] According to the cosmetic of the present invention, the amount of the composition added is 0.1-10.25% based on the total mass of the cosmetic. in / on (e.g., 0.1%, 0.25%, 2.5%, 3.5%, 5%, 5.25%, 8%, 10.25%, etc., without specific limits here.)

[0031] The cosmetics may also contain any other ingredients permitted in the cosmetics field, including but not limited to emulsifiers, emollients, moisturizers, cooling agents, skin conditioners, thickeners, and preservatives.

[0032] Furthermore, by rationally adding the above-mentioned raw material components, this invention can also be used to prepare different cosmetic formulations, such as essence spray, essence water, essence liquid, essence lotion, essence serum, shampoo, conditioner, hair mask, scalp care liquid, etc., without making specific limitations here.

[0033] The following examples further illustrate the present invention, but do not constitute a limitation thereof. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the invention. Test methods in the following examples, unless otherwise specified, are generally performed under conventional conditions.

[0034] It should be noted that the sodium hyaluronate disaccharide (molecular weight 400 Da) and hydrolyzed sodium hyaluronate (molecular weight below 10 kDa) used in the embodiments and comparative examples of this invention were both purchased from Shandong Focus Freda Biotechnology Co., Ltd. The trade name for sodium hyaluronate disaccharide is "Huanling 400", and the trade name for hydrolyzed sodium hyaluronate is "Hyaoligo". ® Hydrolyzed sodium hyaluronate.

[0035] The preparation method of Ashitaba extract in this embodiment of the invention includes: S1. Extraction: Take Ashitaba medicinal material, add water and boil to extract twice. For the first extraction, add 10 times the amount of water and extract for 2 hours, then filter through an 80-mesh sieve. For the second extraction, add 8 times the amount of water and extract for 1 hour, then filter through an 80-mesh sieve.

[0036] S2. Concentration: Combine the two filtrates and concentrate them under reduced pressure at 80℃ and -0.09MPa to obtain a clear extract with a relative density of 1.05~1.15 (60℃).

[0037] S3, Alcohol Precipitation: Add 75% ethanol to the clear extract until the alcohol content is 50%, stir for 30 minutes, and refrigerate (4℃±2℃) for 12 hours.

[0038] S4. Concentration: Take the supernatant, filter it using a plate and frame filter, and recover the ethanol until the relative density of the concentrate is 1.05 to 1.15 (60℃).

[0039] S5. Water precipitation: Add purified water to 1 times the amount of medicinal material (water to medicinal material mass ratio of 1:1) and stir for 15 minutes. Refrigerate (4℃±2℃) and let stand for 12 hours to obtain water precipitation solution.

[0040] S6. Boiling: The water-precipitated liquid is filtered using a filter plate and a PP membrane (0.45μm). 5% of the weight of 1,2-hexanediol, 5% of the weight of p-hydroxyacetophenone, and 1% of the weight of disodium EDTA are added to the filtrate. The volume of purified water is increased to 8 times the weight of the ashtray. The mixture is heated to boiling for 30 minutes, and stirring is started until the solids are completely dissolved.

[0041] S7. Mixing: Cool the liquid to about 40°C, filter it using a filter plate + PP membrane (0.45μm), add 1,3-butanediol at twice the amount of Ashitaba medicinal material, and stir to mix for 15 minutes.

[0042] S8. Dispensing: Filter the prepared medicine solution through a 200-mesh sieve, and then fill it into plastic buckets.

[0043] The minoxidil used in the comparative examples of this invention was purchased from Sigma-Aldrich. The Platycladus orientalis leaf extract was obtained from Mingren Freda Pharmaceutical Co., Ltd.

[0044] The Platycladus orientalis leaf extract in the comparative example of this invention was obtained by the following method: S1. Extraction: Take dried Thuja orientalis leaves and pulverize them to 50 mesh. Weigh the prescribed amount of medicinal material, add 10 times the amount of water and 1,3-propanediol mixed solution (water:1,3-propanediol=80:20, w / w), stir and extract at 70℃ for 1.5 hours, filter through an 80-mesh sieve, and collect the filtrate.

[0045] S2. Concentration: Concentrate under reduced pressure at 60℃ and -0.08MPa to obtain a clear paste with a relative density of 1.05~1.10 (60℃).

[0046] S3, Compounding: Add 0.5% (by weight of the extract) of PEG-40 hydrogenated ricin and 0.03% (by weight of the extract) of disodium EDTA to the concentrate, and stir until completely dissolved.

[0047] S4. Volume Adjustment and Homogenization: Add purified water to the predetermined weight, and process the mixture using a high-shear homogenizer at 4000 rpm for 15 minutes to ensure uniform mixing.

[0048] S5. Filtration and dispensing: Filter the prepared medicinal solution through a 1.0μm microporous membrane, and then fill it into a sterile plastic bucket to obtain the finished product of Platycladus orientalis leaf extract.

[0049] Example: The specific methods are shown in Table 1 below, calculated by mass parts. The preparation method is as follows: Ashitaba extract and sodium hyaluronate disaccharide are mixed according to the dosages of each embodiment and comparative example, and dissolved in purified water.

[0050] Table 1. List of components for specific embodiments and comparative examples.

[0051] Example 7: Anti-hair loss serum (containing the composition of Example 6). The above composition was used to prepare a serum product containing this anti-hair loss composition. The raw material components and formulations are shown in Table 2.

[0052] Table 2. Raw material composition and proportions of the anti-hair loss essence (including the composition of Example 6)

[0053] Preparation method of anti-hair loss serum (including the composition of Example 6): S1: Add phase A raw materials separately, heat to 80~85℃ and stir to dissolve, and start cooling after all dissolves; S2: When the temperature drops to about 45℃, add phase B raw material, stir and disperse evenly, and continue to cool down after it is completely dissolved; S3: When the temperature drops to 35℃, add the C phase raw material, stir to dissolve and disperse evenly to obtain the essence product.

[0054] Comparative Example 11: Anti-hair loss serum (containing minoxidil), the raw material composition and formulation are shown in Table 3.

[0055] Table 3. Raw material composition and ratio of anti-hair loss serum (containing minoxidil)

[0056] Preparation method of anti-hair loss serum (containing minoxidil): S1: Add the raw materials in phase A separately, heat to 80~85℃ and stir to dissolve, and start cooling after all the raw materials have been dissolved; S2: When the temperature drops to about 45℃, add phase B component, stir to disperse evenly, and continue to cool down after complete dissolution; S3: Dissolve minoxidil in ethanol and propylene glycol beforehand. When the temperature drops to 35°C, add phase C components, stir to dissolve and disperse evenly to obtain the serum product.

[0057] Comparative Example 12: The formulation does not contain any of the components of the composition of Example 6, and the remaining components and preparation methods are the same as in Example 7.

[0058] Experiment 1: ALP, Versican gene expression, EDU, and cortisol levels. The experiment used dermal papilla cells as the model cell line. According to the test groups, when the cell deposition rate in the 6-well plates reached 80%–90%, drug administration was performed in each group, with 3 replicates per group. 2 mL of culture medium was added to each well of the blank control group, 2 mL of culture medium containing corticosteroids to each well of the negative control group, 2 mL of culture medium containing corticosteroids and vitamin E to each well of the positive control group, and 2 mL of culture medium containing corticosteroids and the corresponding concentration of the sample to each well of the sample group. After drug administration, the 6-well plates were placed in an incubator (37℃, 5% CO2) for 24 h.

[0059] According to the test grouping, when the cell deposition rate in the 6-well plate reached 80%~90%, the drug was administered to the groups, with 3 replicates per group. 2 mL of culture medium was added to each well of the blank control group, 2 mL of culture medium containing corticosteroids to each well of the negative control group, 2 mL of culture medium containing corticosteroids and vitamin E to each well of the positive control group 1, and 2 mL of culture medium containing corticosteroids and the corresponding concentration of the sample to each well of the sample group. After drug administration, the 6-well plate was placed in an incubator (37℃, 5% CO2) and incubated for 48 h.

[0060] ELISA test: After incubation, collect the culture medium into centrifuge tubes. After collection, freeze the samples for ELISA detection at -80°C and perform detection and analysis according to the ELISA kit (Abcam) instructions.

[0061] Immunofluorescence detection: The sample was fixed with 4% paraformaldehyde for 30 minutes. Immunofluorescence detection was performed, and the images were photographed and analyzed under a microscope.

[0062] Fluorescence colorimetric assay: Add EDU reagent (final concentration 10µM), incubate for 4 h, fix with 4% paraformaldehyde for 30 min, wash with PBS for 8 min; after washing, according to BeyoClick... ™ Follow the instructions for the EdU-555 cell proliferation assay kit to perform the assay and take photos.

[0063] Calculation of enhancement rate and inhibition rate:

[0064]

[0065] GraphPadPrism was used for plotting, and the results are expressed as Mean ± SD. Comparisons between groups were performed using... t -test statistical analysis. All statistical analyses are two-tailed. P A value <0.05 is considered statistically significant. P A value <0.01 is considered highly significant.

[0066] Use the King's formula to calculate the synergistic effect. E(a+b) represents the combined inhibition / promotion rate, and Ea and Eb represent the individual inhibition / promotion rates, respectively. CI values ​​between 0.85 and 1.15 indicate simple additive effects; values ​​between 1.15 and 20 indicate enhancement; values ​​>20 indicate significant enhancement; CI values ​​between 0.85 and 0.55 indicate antagonism; values ​​<0.55 indicate significant antagonism.

[0067] Table 4 Test Plan

[0068] (Note: ALP is alkaline phosphatase, a key marker of hair follicle growth phase; Versican is a multifunctional proteoglycan, and stress accelerates its degradation; EDU is the dermal papilla cell proliferation rate; cortisol is a glucocorticoid, and long-term stress leads to elevated cortisol levels.)

[0069] Table 5 Summary of ALP Immunofluorescence Analysis Results

[0070] (Note: Relative integrated optical density (IOD) / average cell number reflects ALP content.) t When performing statistical analysis using the -test method, significance compared to group BC is indicated by #. P -Value < 0.05 is represented by #. P -Value < 0.01 is represented by ##; significance compared to the NC group is represented by *. P -value < 0.05 is represented as *. P - Value < 0.01 is represented as **. Experimental Results: As shown in Table 5, after cortisol stimulation, the ALP content in the NC group decreased significantly, indicating that stress affects ALP expression in dermal papilla cells. Compared with the NC group, after cortisol stimulation, the ALP expression level was significantly increased after adding the compositions of Examples 1-6 to the dermal papilla cell stress model. Comparative Examples 1 and 2 showed no significant changes, proving that sodium hyaluronate disaccharide alone does not promote ALP expression. According to the King's Law, the CI values ​​of Examples 5 and 6 were 1.4706 and 1.5416, respectively, indicating that the compositions had a synergistic effect, and the optimal ratio was Example 6. The CI values ​​of Comparative Examples 7 and 8 were 0.8620 and 0.7777, respectively, indicating that the comparative compositions had no synergistic effect and even showed an antagonistic effect.

[0071] Table 6 Summary of Versican Immunofluorescence Analysis Results

[0072] (Note: Relative integrated optical density (IOD) / average cell number reflects the content of Versican.) t When performing statistical analysis using the -test method, significance compared to group BC is indicated by #. P -Value < 0.05 is represented by #. P -Value < 0.01 is represented by ##; significance compared to the NC group is represented by *. P -value < 0.05 is represented as *. P -Value < 0.01 is represented as **. Experimental Results: As shown in Table 6, after cortisol stimulation, the Versican content in the NC group decreased significantly, indicating that stress affects Versican expression in dermal papilla cells. Compared with the NC group, after cortisol stimulation, the addition of the compositions from Examples 1-6 to the dermal papilla cell stress model significantly increased Versican expression. The CI values ​​for Examples 5 and 6 were 1.3539 and 1.6212, respectively, indicating that the compositions had a synergistic effect, with Example 6 being the optimal ratio. The CI values ​​for Comparative Examples 7 and 8 were 0.7285 and 0.5380, respectively, indicating that the comparative compositions had no synergistic effect and even exhibited antagonistic effects.

[0073] Table 7 Summary of EDU fluorescence colorimetric analysis results

[0074] (Note: Use) t When performing statistical analysis using the -test method, significance compared to group BC is indicated by #. P -Value < 0.05 is represented by #. P - Value < 0.01 is represented as ##; significance compared to the NC group is represented by *. P -value < 0.05 indicates as *. P -Value < 0.01 is represented as **. Experimental Results: As shown in Table 7, after cortisol stimulation, the EDU-positive cell rate in the NC group decreased significantly, indicating that stress affects the proliferation of dermal papilla cells. Compared with the NC group, after cortisol stimulation, the EDU-positive cell rate increased significantly after adding the compositions of Examples 1-6 to the dermal papilla cell stress model. According to the King's Law, the CI values ​​for Examples 5 and 6 were 1.3596 and 1.5816, respectively, indicating that the compositions had a synergistic effect, with Example 6 being the optimal ratio. The CI values ​​for Comparative Examples 7 and 8 were 0.5407 and 0.3327, respectively, indicating that the comparative compositions had no synergistic effect and even exhibited antagonistic effects.

[0075] Table 8 Summary of Cortisol Content Results

[0076] (Note: Use) t When performing statistical analysis using the -test method, significance compared to group BC is indicated by #. P -Value < 0.05 is represented by #. P - Value < 0.01 is represented as ##; significance compared to the NC group is represented by *. P -value < 0.05 indicates as *. P -Value < 0.01 is represented as **. As shown in Table 8, after cortisol stimulation, the cortisol content in the NC group increased significantly, indicating that stress affects the level of cortisol expression in dermal papilla cells. Compared with the NC group, after cortisol stimulation, the expression level of cortisol decreased significantly after adding the compositions of Examples 1-6 to the dermal papilla cell stress model. The inhibition rates of cortisol expression in Comparative Examples 1 and 2 were low, proving that the inhibitory effect of sodium hyaluronate disaccharide alone on cortisol levels was minimal. According to the King's Law, the CI values ​​of Examples 5 and 6 were 1.4501 and 1.5999, respectively, indicating that the compositions had a synergistic effect, and the optimal ratio was Example 6. The CI values ​​of Comparative Examples 7 and 8 were 0.3931 and 0.3148, respectively, indicating that the comparative compositions had an antagonistic effect.

[0077] Experimental Example 2: Evaluation of the anti-hair loss efficacy in humans Testing basis: "Cosmetic Safety Technical Specifications" (2015 Edition) for testing the efficacy of cosmetics in preventing hair loss. method.

[0078] Participants were selected based on a hair loss count greater than 10 strands after 60 combing sessions. Eligible participants underwent a 2-week shampooing period. After the shampooing period, a second 60-comb test was performed; only those with a hair loss count still greater than 10 strands were eligible for the formal trial. Participants in the formal trial were randomly assigned to either the experimental or control group using a stratified randomization method. A total of 93 participants were ultimately selected: Experimental group: 31 participants (16 males, 15 females, aged 27-59 years, mean age 42.6 ± 6.9 years); Control group 1: 31 participants (16 males, 15 females, aged 30-58 years, mean age 42.6 ± 7.1 years); Control group 2: 31 participants (16 males, 15 females, aged 28-58 years, mean age 42.6 ± 7.1 years). All participants met the voluntary inclusion criteria.

[0079] Instructions for use: Apply 3 mL daily. Apply Example 7 evenly to a clean and dried scalp and gently massage with your fingertips for 5 minutes until absorbed naturally. No rinsing is required. Allow to air dry or blow dry. Comparative Examples 11 and 12 were used as controls under the same conditions.

[0080] Testing time: before using the sample, and 4, 8, and 12 weeks after using the sample.

[0081] Testing instruments: 1. Professional digital camera: Sony ZV-E10, 24.2 megapixels. Throughout the test, parameters such as aperture, ISO, and focal length were kept consistent. 2. Comb: Tooth spacing: 1mm, tooth length: 2cm, comb length: 16cm (excluding comb handle). The same specification and material of comb must be used throughout the test. After each use, disinfection should be carried out in accordance with the relevant requirements in the "Technical Specifications for Disinfection of Medical Institutions" (WS-T367-2012).

[0082] Data Analysis: The definitions of terms and related calculation formulas involved in the test results are as follows: Initial value: refers to the base value when no sample is used.

[0083] average value = Where x = individual parameter measurement value, n = number of valid data points The difference from the initial value = T使用后 - T使用前

[0084] Statistical analysis was performed using SPSS Statistics 25 with a two-tailed test and a significance level of α = 0.05.

[0085] Based on the results of the normality test, the difference analysis method is selected for the measurement data: if the measurement values ​​are normally distributed, the t-test method is used for statistical analysis; if they are not normally distributed, the rank-sum test method is used for statistical analysis.

[0086] Experimental conclusion: Based on the data analysis results, at any visit time point during the trial period, compared with before use, the use of the trial product... The number of hair loss cases decreased significantly after using the product. P If the concentration is <0.05, the test product is considered to have anti-hair loss effects. Compared with before use, the overall hair density significantly increased ( PIf the value is less than 0.05, the test product is considered to have the effect of increasing hair density.

[0087] During the trial, if the difference in hair loss count before and after the initial visit (hair loss count at a certain visit after product use - hair loss count before product use) was significantly lower than that in the control group ( P If the value is <0.05, the test sample is considered to have a better anti-hair loss effect than the control product; if the overall hair density difference before and after (hair density at a certain visit time after product use - hair density before product use) is significantly higher than that of the control group ( P <0.05), Therefore, it is believed that the test sample is more effective than the control product in increasing hair density.

[0088] The test results are shown in Tables 9-12.

[0089] Table 9. Descriptive statistical results of hair loss count (anti-hair loss essence n=31, anti-hair loss essence blank n=31)

[0090] Table 10 Statistical analysis results of hair loss count (anti-hair loss essence n=31, anti-hair loss essence blank n=31)

[0091] Statistical analysis results: "*": The difference is statistically significant ( P <0.05); "-": no statistically significant difference ( P ≥0.05).

[0092] Table 11 Descriptive statistical results of overall hair density (anti-hair loss essence n=31, anti-hair loss essence blank n=31)

[0093] Table 12 Statistical analysis results of overall hair density (anti-hair loss essence n=31, anti-hair loss essence blank n=31)

[0094] Statistical analysis results: "*": The difference is statistically significant ( P <0.05); "-": no statistically significant difference ( P ≥0.05).

[0095] As shown in Tables 9-12, during the 4-12 week test period, the composition of Example 7 significantly improved the amount of hair loss and significantly increased hair density. Therefore, the composition containing this anti-hair loss composition has good anti-hair loss and hair density increasing effects on stress-induced alopecia.

[0096] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A composition for improving hair loss, characterized in that, The product comprises, by weight, 2.5-5.0 parts of Ashitaba extract and 0.1-0.25 parts of sodium hyaluronate disaccharide; The Ashitaba extract is obtained by a process including extraction of Ashitaba leaves with water, alcohol precipitation, and water precipitation.

2. The composition according to claim 1, characterized in that, The Ashitaba extract was prepared using the following method: S1. Take Ashitaba medicinal material, add 8-10 times the amount of water and boil to extract, then sieve to obtain the filtrate. S2. Concentrate the obtained filtrate under reduced pressure to a clear extract with a relative density of 1.05 to 1.15 (60°C); S3. Add ethanol to the clear paste until the alcohol content is 40-50%, stir, and then refrigerate and stand at low temperature. S4. Take the alcohol precipitation supernatant from step S3, filter it, and recover the ethanol until the relative density of the concentrated liquid is 1.05 to 1.15 (60℃). S5. After adding water and stirring, the solution is refrigerated and left to stand at low temperature to obtain the water-precipitated liquid. S6. The water-sediment is filtered and then boiled.

3. The composition according to claim 2, characterized in that, In step S1, the extraction is performed in 2-3 extractions.

4. The composition according to claim 3, characterized in that, The extraction method includes: boiling water twice, first extracting with 10 times the amount of water for 2 hours and filtering through an 80-mesh sieve, and second extracting with 8 times the amount of water for 1 hour and filtering through an 80-mesh sieve.

5. The composition according to claim 2, characterized in that, In steps S3 and S5, the low-temperature refrigeration temperature is 4℃±2℃; the low-temperature refrigeration time is not less than 12 hours.

6. The composition according to claim 2, characterized in that, In step S6, filtration is performed by sequentially filtering with a filter plate and a PP membrane. Furthermore, cosmetic excipients are added to the filtrate, including any one or more of 1,2-hexanediol, p-hydroxyacetophenone, and disodium EDTA.

7. The composition according to claim 2, characterized in that, The Ashitaba extract also includes a mixing step S7, which is: when the liquid obtained in step S6 is cooled to 40°C, it is filtered and then 1,3-butanediol is added and stirred to obtain the medicinal solution. Furthermore, the Ashitaba extract also includes the dispensing step S8, which specifically involves filtering the prepared medicinal solution through a 200-mesh sieve and then filling it into containers.

8. A method for preparing the composition according to any one of claims 1-7, characterized in that, The preparation method includes the step of mixing the Ashitaba extract with sodium hyaluronate disaccharide.

9. Use of the composition according to any one of claims 1-7 in the preparation of a product for improving stress-induced hair loss.

10. A cosmetic product, characterized in that, The cosmetic product comprises at least the composition according to any one of claims 1-7.

Images