A hair-growing traditional Chinese medicine composition with strong hair root growing capacity and a preparation method thereof

Abstract

The present application relates to a kind of strong and tough hair root hair growth traditional Chinese medicine composition and preparation method thereof, belong to traditional Chinese medicine hair growth preparation technical field.Composition contains by black sesame, walnut kernel, almond, radix polygoni multiflori preparated by CFU / mL plant lactobacillus fermentation in specific proportion Compound traditional Chinese medicine fermentation extract, also compound rehmannia glutinosa, angelica sinensis, cypress leaf, ginkgo leaf extract, etc., according to the specified ratio composition.Preparation is treated by raw material, fermentation, enzymatic extraction, compound deployment etc.Step.The composition is free of chemical solvent and minoxidil, no irritation, absorption is fast, excellent stability, strong and tough hair growth effect is remarkable, can be used for preparing hair growth liquid, hair growth cream, hair nourishing essence, etc..

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine hair growth preparation technology, and relates to a hair growth traditional Chinese medicine composition for strengthening hair roots and its preparation method. Background Technology

[0002] Minoxidil, a peripheral vasodilator, promotes hair growth by stimulating hair follicles to transition from the resting to the anagen phase, thus prolonging the anagen phase. However, its formulations have significant drawbacks: to ensure solubility and transdermal absorption, commercially available minoxidil formulations (such as 5% minoxidil tincture) typically use a propylene glycol-ethanol-water mixed solvent system, with propylene glycol accounting for 30-40% and ethanol for 50-60%. This system easily leads to several problems: firstly, it causes a strong greasy feeling, as the high viscosity of propylene glycol makes the scalp sticky after application, affecting the user experience; secondly, it causes significant skin irritation; and thirdly, the solvent is highly volatile, with rapid ethanol evaporation easily leading to scalp dryness and damaging the scalp barrier function. Furthermore, minoxidil itself has low transdermal absorption efficiency (only 5-8%) and a high relapse rate after discontinuation, limiting its long-term use.

[0003] Traditional Chinese medicine (TCM) believes that hair loss is related to liver and kidney deficiency and blood and qi weakness, and treatment often focuses on nourishing blood, promoting blood circulation, and tonifying the liver and kidneys. Many traditional Chinese medicines have the effects of tonifying the liver and kidneys, replenishing essence and blood, cooling blood, promoting blood circulation, and darkening hair, and are often used for hair loss and graying. In summary, this paper proposes a hair-growth-strengthening TCM composition and its preparation method, which is based on the multi-dimensional strengthening of hair roots and hair-growth-preserving effects of various TCM compositions. Summary of the Invention

[0004] The purpose of this invention is to provide a hair growth traditional Chinese medicine composition for strengthening hair roots and its preparation method. The composition uses black sesame seeds, walnut kernels, almonds, Polygonum multiflorum, Rehmannia glutinosa, Angelica sinensis, Platycladus orientalis leaves, and Ginkgo biloba leaves as raw materials. The utilization rate of active ingredients is improved through fermentation with specific strains, and the compound refined extracts are combined to achieve synergistic effects, ultimately achieving a comprehensive effect of non-irritating, high stability, strengthening hair roots and efficient hair growth.

[0005] The objective of this invention can be achieved through the following technical solutions:

[0006] A hair growth herbal composition for strengthening hair roots, comprising a compound fermented extract of traditional Chinese medicine.

[0007] As a preferred embodiment of the present invention, the compound traditional Chinese medicine fermentation extract is prepared by fermentation extraction of black sesame seeds, walnut kernels, almonds, and Polygonum multiflorum using Lactobacillus plantarum, wherein the concentration of Lactobacillus plantarum is [missing information]. CFU / mL.

[0008] As a preferred embodiment of the present invention, the composition further comprises Rehmannia glutinosa extract, Angelica sinensis extract, Platycladus orientalis leaf extract, and Ginkgo biloba leaf extract.

[0009] As a preferred embodiment of the present invention, the composition comprises, by weight, 20-40 parts of compound Chinese herbal fermentation extract, 5-12 parts of Rehmannia glutinosa extract, 4-10 parts of Angelica sinensis extract, 3-8 parts of Platycladus orientalis leaf extract, 2-6 parts of Ginkgo biloba leaf extract, 0.05-0.2 parts of preservative, and the remainder being deionized water.

[0010] As a preferred embodiment of the present invention, the mass ratio of black sesame seeds, walnut kernels, almonds, and Polygonum multiflorum in the compound fermented Chinese herbal extract is (1.8-2.5):(1.2-1.8):(0.8-1.2):(0.8-1.2).

[0011] As a preferred embodiment of the present invention, the fermentation conditions of the compound traditional Chinese medicine fermentation extract are: fermentation temperature 30-35℃, fermentation time 48-72h, pH value of fermentation system 5.5-6.5, and material-liquid ratio 1:(10-15).

[0012] A method for preparing a hair growth herbal composition that strengthens hair roots, as described above, includes the following steps:

[0013] W1. Take black sesame seeds, walnuts, almonds, and Polygonum multiflorum, wash and dry them separately until the moisture content is ≤8%, grind them and pass them through an 80-100 mesh sieve, and mix them in proportion to obtain mixed raw material powder;

[0014] W2. Mix the mixed raw material powder with deionized water according to the material-to-liquid ratio, adjust the pH to 5.5-6.5, sterilize and cool to 30-35℃, inoculate with Lactobacillus plantarum culture, and ferment at a constant temperature of 30-35℃ for 48-72 hours to obtain fermentation broth;

[0015] W3. Add 0.1-0.3% (by weight) of cellulase to the fermentation broth, enzymatically hydrolyze at 45-50℃ for 1-2 hours, then heat to 80-85℃ for 2-3 hours, filter, and concentrate the filtrate at 60℃ to a relative density of 1.10-1.15 to obtain the compound Chinese medicine fermentation extract.

[0016] W4. Compound formulation: Take the compound Chinese herbal fermentation extract, Rehmannia glutinosa extract, Angelica sinensis extract, Platycladus orientalis leaf extract and Ginkgo biloba leaf extract according to the mass ratio, add humectant, preservative and the balance deionized water, stir at 30-40℃ for 30-60 min, homogenize and filter to obtain the hair growth Chinese herbal composition.

[0017] As a preferred embodiment of the present invention, the sterilization conditions in step W2 are high-pressure sterilization at 121°C for 20-30 minutes; the homogenization pressure in step W4 is 20-30 MPa, and the homogenization time is 10-15 minutes.

[0018] In a preferred embodiment of the present invention, the preservative is sodium benzoate.

[0019] As a preferred technical solution of the present invention, the application of the hair-strengthening herbal composition for hair growth in the preparation of hair growth liquid, hair growth lotion, and hair nourishing essence.

[0020] The beneficial effects of this invention are:

[0021] (1) It is completely free of minoxidil and chemical solvents such as propylene glycol and ethanol. It uses Chinese herbal extracts and water-based system. It has been verified by skin irritation test. The rabbit skin irritation score is 0. It does not cause itching, redness or other discomfort when tested on humans. It is absorbed within 3 minutes after application and leaves no sticky residue.

[0022] (2) Excellent stability. After 30 days of accelerated storage at 45℃, the total retention rate of active ingredients is ≥90%, the pH change is ≤0.3, and there is no stratification or precipitation. After 30 days of storage under 4500 lux light, the total retention rate of active ingredients is ≥88%.

[0023] (3) Animal experiments showed that after 21 days of use on a mouse hair removal model, the hair growth score reached 4.5-4.8 and the hair papilla cell proliferation rate increased by 65-70%; after 8 weeks of human trial, the hair volume growth rate increased by 15-18% and the hair root tensile strength increased by 20-25%, with significant hair growth strengthening effect. Detailed Implementation

[0024] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the following detailed description of the specific implementation methods, structures, features, and effects of the present invention, in conjunction with embodiments, is provided below.

[0025] Some of the raw materials were purchased from the following sources:

[0026] Black sesame seeds, walnuts, almonds, Polygonum multiflorum, Rehmannia glutinosa, Angelica sinensis, Platycladus orientalis leaves, and Ginkgo biloba leaves are all commonly available in the market.

[0027] Rehmannia glutinosa extract (Shanxi Liangxu Biotechnology Co., Ltd.)

[0028] Angelica sinensis extract (Shanxi Yirun Biotechnology Co., Ltd.)

[0029] Arborvitae leaf extract (Shanxi Ente Biotechnology Co., Ltd.)

[0030] Ginkgo biloba extract (Peptide Biotechnology (Xi'an) Co., Ltd.)

[0031] Lactobacillus plantarum (MICROBIOLOGICS®-LYFO DISK-01144L, China Industrial Microbial Culture Collection Center)

[0032] Saccharomyces cerevisiae (China Industrial Microbial Culture Collection Center CICC 1307).

[0033] Example 1

[0034] 1. Preparation of compound traditional Chinese medicine fermentation extract

[0035] Raw material pretreatment: Accurately weigh 20.0g of black sesame seeds, 15.0g of walnut kernels, 10.0g of almonds, and 10.0g of Polygonum multiflorum. Ultrasonically clean the black sesame seeds with deionized water (200W, 5min) to remove surface dust and grease; manually peel the seed coat from the walnut kernels and rinse twice with deionized water; soak the almonds in deionized water for 30min, remove the seed coat, and then rinse; slice the Polygonum multiflorum and ultrasonically clean it with deionized water (200W, 10min) to remove surface dirt. Place the four processed raw materials separately in an electric constant temperature drying oven and dry at 62℃ for 8 hours, turning them every 2 hours to ensure even heating. After drying, the moisture content of all materials was measured to be 6.5%. The dried raw materials were placed into an ultra-fine pulverizer, and the pulverization time was set to 3 minutes and the rotation speed to 8000 r / min. After pulverization, the raw materials were passed through a 100-mesh standard sieve (sieve aperture 150μm), and the sieve material was collected. The mixture was then mixed in proportion using an electronic balance (accuracy 0.01g) and stirred for 10 minutes until homogeneous to obtain mixed raw material powder.

[0036] Fermentation treatment: Accurately weigh 55.0 g of the mixed raw material powder, add 660 mL of deionized water (material-to-liquid ratio 1:12), pour into a 5 L fermenter, adjust the pH of the system to 6.0 with 1 mol / L citric acid solution, and stir well. Seal the fermenter and place it in an autoclave, set the temperature to 121℃ and the pressure to 0.1 MPa, and sterilize for 25 min. After sterilization, remove the fermenter and place it on a sterile operating table to cool to 32℃. Inoculate 3 × 10⁻⁶ cells / day using a sterile syringe. 8 Inoculate with a CFU / mL *Lactobacillus plantarum* culture (2% of the total fermentation volume). After inoculation, gently shake the fermenter to ensure even distribution of the culture. Place the fermenter in a constant temperature incubator at 32℃ for static fermentation for 60 hours. During fermentation, turn on the agitator every 12 hours, setting the speed to 200 rpm and stirring for 10 minutes to promote mass transfer. After fermentation, remove the fermentation broth; it should appear as a brownish-yellow turbid liquid with no off-odors.

[0037] Extraction and purification: Transfer the fermentation broth to a 2L beaker. Accurately weigh 1.32g of cellulase (enzyme activity 5000U / g) using an electronic balance. Dissolve the cellulase in a small amount of deionized water and slowly add it to the fermentation broth. Stir with a magnetic stirrer for 5 minutes to ensure uniform enzyme dispersion. Place the beaker in a constant temperature water bath at 48℃ and incubate for 1.5 hours, stirring every 20 minutes for 2 minutes each time. After incubation, raise the water bath temperature to 82℃ and incubate for 2.5 hours, stirring every 30 minutes for 3 minutes each time. After extraction, filter the extract through a 400-mesh filter cloth (pore size 38μm), collect the filtrate, and remove the filter residue (the residue was dried and weighed, yield approximately 12%). The filtrate was poured into a rotary evaporator, the temperature was set to 60℃ and the vacuum degree to 0.08MPa, and the concentration was carried out under reduced pressure until the relative density was 1.12 (measured by a densitometer at 60℃) to obtain a compound Chinese herbal fermentation extract, which was a brownish-black viscous liquid, for later use.

[0038] 2. Composition Preparation: Accurately weigh 30.0g of the compound Chinese herbal fermentation extract, 8.0g of Rehmannia glutinosa extract, 6.0g of Angelica sinensis extract, 5.0g of Platycladus orientalis leaf extract, 4.0g of Ginkgo biloba leaf extract, 5.0g of glycerin, and 0.1g of potassium sorbate using an electronic balance, and add them to a 2L beaker. Add deionized water to the beaker to a total mass of 100.0g and stir well. Place the beaker in a constant temperature water bath, set the temperature to 35℃, and stir with a magnetic stirrer for 45 minutes at a speed of 300 rpm to ensure that all components are fully dissolved and mixed. After stirring, transfer the mixture to a high-pressure homogenizer, set the homogenization pressure to 25MPa, and the homogenization time to 12 minutes. Observe the state of the liquid during homogenization; it gradually becomes a clear liquid. After homogenization, filter the liquid through a 0.22μm microporous membrane to remove impurities and large particles. Collect the filtrate to obtain the hair growth Chinese herbal composition, which is a pale yellow clear liquid with no precipitate and a pH of 6.2.

[0039] Example 2

[0040] 1. Preparation of compound traditional Chinese medicine fermentation extract

[0041] Raw material pretreatment: Accurately weigh 25.0g of black sesame seeds, 12.0g of walnut kernels, 12.0g of almonds, and 8.0g of Polygonum multiflorum. Ultrasonically clean the black sesame seeds with deionized water (200W, 5min); peel the seed coat from the walnut kernels and rinse; soak the almonds for 30min, peel, and rinse; slice the Polygonum multiflorum and ultrasonically clean (200W, 10min). Place the four raw materials separately in an electric constant temperature drying oven and dry at 60℃ for 9h, with a moisture content of 7.2%. Grind each raw material separately using an ultrafine pulverizer, pass through a 90-mesh sieve (165μm aperture), and mix them according to the specified ratio for 15min to obtain a mixed raw material powder.

[0042] Fermentation treatment: Weigh 57.0 g of the mixed raw material powder, add 570 mL of deionized water (material-to-liquid ratio 1:10), pour into a 5 L fermenter, and adjust the pH to 5.5 with 1 mol / L citric acid. Autoclave at 121℃ for 20 min, cool to 30℃, and inoculate with 2 × 10⁻⁶ plants. 8 CFU / mL Lactobacillus plantarum culture (inoculum 2%) was statically fermented at 30℃ for 72 hours, with stirring for 10 minutes every 12 hours (stirring speed 200 r / min). The fermentation broth was a brownish-yellow turbid liquid.

[0043] Extraction and purification: 0.57g of cellulase was added to the fermentation broth, and the mixture was enzymatically hydrolyzed at 45℃ for 2 hours, with stirring every 20 minutes. After enzymatic hydrolysis, the temperature was raised to 80℃ for 3 hours of extraction. The mixture was filtered through a 400-mesh filter cloth, and the filtrate was concentrated under reduced pressure at 60℃ to a relative density of 1.10 (60℃) to obtain a compound traditional Chinese medicine fermentation extract.

[0044] 2. Composition Preparation: Accurately weigh 35.0g of the compound Chinese herbal fermentation extract, 6.0g of Rehmannia glutinosa extract, 8.0g of Angelica sinensis extract, 4.0g of Platycladus orientalis leaf extract, 5.0g of Ginkgo biloba leaf extract, 6.0g of glycerol, and 0.08g of phenoxyethanol. Add deionized water to a final volume of 100.0g. Stir magnetically at 30℃ for 60min (300r / min), then transfer to a high-pressure homogenizer and homogenize at 20MPa for 15min. Filter through a 0.22μm microporous membrane to obtain the hair growth composition, which is a pale yellow, clear liquid with a pH of 6.0.

[0045] Example 3

[0046] 1. Preparation of compound traditional Chinese medicine fermentation extract

[0047] Raw material pretreatment: Accurately weigh 18.0g of black sesame seeds, 18.0g of walnut kernels, 8.0g of almonds, and 12.0g of Polygonum multiflorum. Ultrasonically clean the black sesame seeds, remove the seed coat from the walnut kernels and rinse, soak the almonds to remove the seed coat and rinse, and slice the Polygonum multiflorum and ultrasonically clean. Dry each separately at 65℃ for 7 hours, with a moisture content of 7.8%. After ultra-fine pulverization, pass through an 80-mesh sieve (180μm aperture), and mix and stir according to the specified ratio for 12 minutes to obtain a mixed raw material powder.

[0048] Fermentation treatment: Weigh 56.0 g of the mixed raw material powder, add 840 mL of deionized water (material-to-liquid ratio 1:15), pour into a 5 L fermenter, and adjust the pH to 6.5 with 1 mol / L citric acid. Autoclave at 121℃ for 30 min, cool to 35℃, and inoculate with 4 × 10⁻⁶ plants. 8 CFU / mL Lactobacillus plantarum culture (inoculum 2%) was statically fermented at 35℃ for 48 hours, with stirring for 10 minutes every 12 hours (stirring speed 200 r / min). The fermentation broth was a brownish-yellow turbid liquid.

[0049] Extraction and purification: 2.52g of cellulase was added to the fermentation broth, and the mixture was enzymatically hydrolyzed at 50℃ for 1 hour, with stirring every 20 minutes. After enzymatic hydrolysis, the temperature was raised to 85℃ for 2 hours of extraction. The mixture was filtered through a 400-mesh filter cloth, and the filtrate was concentrated under reduced pressure at 65℃ to a relative density of 1.15 (60℃) to obtain a compound traditional Chinese medicine fermentation extract.

[0050] 2. Composition Preparation: Accurately weigh 25.0g of the compound Chinese herbal fermentation extract, 10.0g of Rehmannia glutinosa extract, 5.0g of Angelica sinensis extract, 6.0g of Platycladus orientalis leaf extract, 3.0g of Ginkgo biloba leaf extract, 3.0g of glycerin, and 0.15g of potassium sorbate. Add deionized water to a final volume of 100.0g. Stir magnetically at 40℃ for 30min (300r / min), then transfer to a high-pressure homogenizer and homogenize at 30MPa for 10min. Filter through a 0.22μm microporous membrane to obtain the hair growth composition, which is a pale yellow, clear liquid with a pH of 6.3.

[0051] Comparative Example 1

[0052] The compound Chinese herbal fermentation extract in Example 1 was replaced with 100-mesh powder of "20.0g black sesame seeds + 15.0g walnut kernels + 10.0g almonds + 10.0g Polygonum multiflorum" (the preparation method is the same as the crushing and sieving steps of raw material pretreatment in Example 1, but fermentation and extraction purification were not performed). The remaining components and preparation process are the same as in Example 1.

[0053] Comparative Example 2

[0054] In Example 1, Lactobacillus plantarum was replaced with the same concentration of Saccharomyces cerevisiae (3 × 10⁻⁶). 8 (CFU / mL), the rest is the same as in Example 1.

[0055] Comparative Example 3

[0056] The concentration of *Lactobacillus plantarum* in Example 1 was reduced to 5 × 10⁻⁶. 7 CFU / mL, the rest is the same as in Example 1.

[0057] Comparative Example 4

[0058] The raw materials for the compound Chinese herbal fermentation extract were the same as in Example 1, except for Polygonum multiflorum (24.0g black sesame seeds + 18.0g walnut kernels + 13.0g almonds).

[0059] Comparative Example 5

[0060] The Platycladus orientalis leaf extract in Example 1 was replaced with the same weight of Ligustrum lucidum extract, and the rest was the same as in Example 1.

[0061] Comparative Example 6

[0062] Five parts of minoxidil were added to the sample based on Example 1, and the rest were the same as in Example 1.

[0063] Comparative Example 7

[0064] The extraction solvent after fermentation in Example 1 was replaced with 70% ethanol, and the rest was the same as in Example 1.

[0065] Comparative Example 8

[0066] The Angelica extract in Example 1 was removed, and the rest was the same as in Example 1.

[0067] Comparative Example 9

[0068] The fermentation time in Example 1 was shortened to 24 hours, and the rest was the same as in Example 1.

[0069] Comparative Example 10

[0070] The fermentation temperature in Example 1 was increased to 40°C, and the rest was the same as in Example 1.

[0071] Comparative Example 11

[0072] Except for the fermentation and extraction of the eight Chinese herbs in Example 1 (20.0g black sesame, 15.0g walnut, 10.0g almond, 10.0g Polygonum multiflorum, 8.0g Rehmannia glutinosa, 6.0g Angelica sinensis, 5.0g Platycladus orientalis, and 4.0g Ginkgo biloba), the rest were the same as in Example 1.

[0073] Comparative Example 12

[0074] The compound Chinese herbal fermentation extract and commercially available extract in Example 1 were replaced with traditional water extracts of 8 Chinese herbs (the 8 Chinese herbs were mixed and extracted with water at a ratio of 1:12 for 2 hours, and then concentrated to the same concentration). The rest was the same as in Example 1.

[0075] Performance testing

[0076] 1. Physicochemical property testing

[0077] Appearance: Visually inspect the color, clarity, and presence of any sediment in the composition.

[0078] pH value: directly measured using a pH meter (accuracy 0.01).

[0079] Accelerated stability testing: After 30 days of storage in a 45℃ constant temperature incubator, the appearance, pH changes, and retention rate of active ingredients were tested.

[0080] Light stability: Stored in a 4500 lux light box (25℃) for 30 days, with the same test indicators as above.

[0081] Content of active ingredients: determined by HPLC. Chromatographic conditions: C18 column (250 mm × 4.6 mm, 5 μm), mobile phase: methanol-0.1% phosphoric acid water (gradient elution), detection wavelengths: 280 nm (stilbene glycosides), 360 nm (quercetin), 270 nm (ferulic acid), 368 nm (total flavonoids), column temperature: 30 ℃, flow rate: 1.0 mL / min.

[0082] 2. Hair regrowth and strengthening effect test

[0083] Mouse hair growth experiment: After acclimatizing mice for 3 days, hair was removed from a 3cm × 3cm area on the back using an electric shaver. Residual hair was then treated with depilatory cream, ensuring the hair follicles remained intact. The mice were randomly divided into 15 groups (Examples 1-3, Comparative Examples 1-12), with 3 mice in each group. Every morning at 9:00 AM, 0.2 mL of the corresponding group's composition was applied evenly to the depilated area using a sterile cotton swab. The blank control group received an equal volume of deionized water. This application was repeated for 21 consecutive days. On day 21, mice were scored according to a hair growth scoring system (0 points: no new hair; 1 point: <20% area with downy hair; 2 points: 20-40% area with downy hair; 3 points: 40-60% area with short hair; 4 points: 60-80% area with long hair; 5 points: completely covered with long hair). The average score of the 3 mice in each group was taken as the final score.

[0084] Hair papilla cell proliferation rate: Human hair papilla cells were cultured in vitro and seeded in 96-well plates, with 1×10⁶ cells per well. 4 Cells were cultured in 100 μL DMEM medium (containing 10% fetal bovine serum and 1% penicillin-streptomycin) at 37°C for 24 h in a 5% CO2 incubator. The old medium was discarded. The experimental group was added to 100 μL of medium containing the extract of the composition (concentration 100 μg / mL, prepared as powder by freeze-drying and then dissolved in medium), the control group was added to 100 μL of medium without the extract, and the blank group was added to 100 μL of medium only. Each group had 5 replicates. After 48 h of culture, 20 μL of MTT solution (5 mg / mL) was added to each well, and the cells were cultured for another 4 h. The supernatant was discarded, and 150 μL of DMSO was added to each well, shaken for 10 min to dissolve the crystals. The OD value of each well was measured at 490 nm using a microplate reader. The proliferation rate was calculated as (experimental group OD - blank group OD) / (control group OD - blank group OD) × 100%.

[0085] Human Trial: Sixty volunteers with hair loss (aged 25-40, hair loss grade II-III) were recruited, excluding those with scalp diseases, allergies, or who had used hair growth products within the past 3 months. They were randomly divided into 15 groups of 4 people each. Each group applied 1 mL of the corresponding composition twice daily, morning and evening, evenly to the affected area and gently massaging for 30 seconds, for 8 consecutive weeks. Hair volume was measured using a hair image analyzer at weeks 0 and 8, and the hair volume growth rate was calculated as (hair volume at week 8 - hair volume at week 0) / hair volume at week 0 × 100%. The breaking tensile strength of a single hair was measured using a tensile testing device (10 hairs were randomly selected, and the average value was taken). The oiliness sensation (1-5 points, 1 point: no oiliness, 5 points: extremely oily) and the occurrence of itching were recorded during use, and the itching incidence rate was calculated as (number of people experiencing itching / total number of people in the group) × 100%.

[0086] 3. Skin Irritation Test: A skin irritation test was conducted on rabbits. After acclimatizing the rabbits for 3 days, the hair in a 5cm × 5cm area on both sides of the back was removed using an electric shaver. The left side was the test area, and the right side was the control area (equal amounts of deionized water were applied). On day 1, 0.5mL of the composition was applied to the test area, covered and fixed with gauze. After 4 hours, the residue was removed, and the skin reaction was observed. The application was repeated daily for 7 consecutive days. The erythema and edema of the skin in the test area were observed 1 hour and 24 hours after the residue was removed each day. The skin was scored according to the standard (0 points: no reaction; 1 point: mild erythema / mild edema; 2 points: obvious erythema / moderate edema; 3 points: severe erythema / severe edema; 4 points: severe erythema + vesicles / ulcers). The average score over 7 days was taken as the final irritation score to determine the irritation level (0 points: no irritation; 0.1-2.0 points: mild irritation; 2.1-4.0 points: moderate irritation; >4.0 points: severe irritation).

[0087] Table 1. Physicochemical properties and stability test data

[0088] Group initial state 45℃ accelerates 30 days 4500 lux of light for 30 days Total retention rate of active ingredients (after acceleration) Example 1 Pale yellow clear liquid, without sediment Clarified, pH change 0.2, no precipitate. Clarified, pH change 0.3, no precipitate. 92.3% Example 2 Pale yellow clear liquid, without sediment Clarified, pH change 0.2, no precipitate. Clarified, pH change 0.3, no precipitate. 91.5% Example 3 Pale yellow clear liquid, without sediment Clarified, pH change 0.3, no precipitate. Clarified, pH change 0.4, no precipitate. 90.1% Comparative Example 1 Turbid liquid with fine sediment Severely turbid, pH change of 0.8, with a large amount of precipitate. Severely turbid, pH change of 0.9, with a large amount of precipitate. 61.2% Comparative Example 2 pale yellow, slightly turbid liquid Turbid, pH change of 0.5, small amount of precipitate. Turbid, pH change 0.6, small amount of precipitate. 72.5% Comparative Example 3 pale yellow, slightly turbid liquid Turbid, pH change 0.4, small amount of precipitate. Turbid, pH change of 0.5, small amount of precipitate. 75.8% Comparative Example 4 pale yellow clear liquid Clarified, pH change 0.3, no precipitate. Clarified, pH change 0.4, no precipitate. 80.2% Comparative Example 5 pale yellow clear liquid Clarified, pH change 0.3, no precipitate. Clarified, pH change 0.4, no precipitate. 81.5% Comparative Example 6 pale yellow clear liquid Clarified, pH change 0.3, no precipitate. Clarified, pH change 0.4, no precipitate. 90.8% Comparative Example 7 pale yellow clear liquid Slightly turbid, pH change 0.4, no precipitation. Slightly turbid, pH change of 0.5, no precipitation. 82.6% Comparative Example 8 pale yellow clear liquid Clarified, pH change 0.3, no precipitate. Clarified, pH change 0.4, no precipitate. 83.4% Comparative Example 9 pale yellow, slightly turbid liquid Turbid, pH change of 0.5, small amount of precipitate. Turbid, pH change 0.6, small amount of precipitate. 70.3% Comparative Example 10 pale yellow, slightly turbid liquid Turbid, pH change 0.6, small amount of precipitate. Turbid, pH change 0.7, small amount of precipitate. 68.7% Comparative Example 11 Dark yellow clear liquid Clarified, pH change 0.3, no precipitate. Clarified, pH change 0.4, no precipitate. 85.6% Comparative Example 12 Brownish-yellow turbid liquid Severely turbid, pH change of 0.7, with a large amount of precipitate. Severely turbid, pH change of 0.8, with a large amount of precipitate. 58.4%

[0089] Table 2 Rabbit Skin Irritation Score

[0090]

[0091] Table 3. Animal and Cell Experiment Data

[0092]

[0093] Table 4. Human Trial Data

[0094] Group Hair volume growth rate (%) Hairline pull force (cN) Greasiness rating Incidence of itching (%) Example 1 18.2 5.8 1.1 0 Example 2 17.5 5.6 1.2 0 Example 3 15.3 5.4 1.0 0 Comparative Example 1 5.1 3.2 2.5 0 Comparative Example 2 8.7 3.8 1.3 0 Comparative Example 3 9.2 3.9 1.2 0 Comparative Example 4 11.5 4.5 1.1 0 Comparative Example 5 11.2 4.4 1.1 0 Comparative Example 6 16.8 5.5 1.2 30 Comparative Example 7 10.3 4.2 1.3 0 Comparative Example 8 12.1 4.6 1.1 0 Comparative Example 9 8.3 3.7 1.2 0 Comparative Example 10 8.0 3.6 1.2 0 Comparative Example 11 13.8 5.0 1.1 0 Comparative Example 12 4.8 3.1 2.6 0

[0095] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A hair growth Chinese medicine composition for strengthening hair roots, characterized in that, The components and contents of the composition are as follows in parts by mass: 20-40 parts of the compound traditional Chinese medicine fermentation extract, 5-12 parts of the prepared rhizome extract, 4-10 parts of the angelica sinensis extract, 3-8 parts of the biota orientalis extract, 2-6 parts of the ginkgo biloba extract, 0.05-0.2 parts of the preservative, and the balance of deionized water; The compound traditional Chinese medicine fermentation extract is prepared by fermenting and extracting black sesame, walnut kernel, almond, and radix falcaliae by lactobacillus plantarum, and the concentration of the lactobacillus plantarum is 1×10 8 -5×10 8 CFU / mL. The mass ratio of black sesame, walnut kernel, almond, and radix polygoni multiflori in the compound traditional Chinese medicine fermentation extract is (1.8-2.5):(1.2-1.8):(0.8-1.2):(0.8-1.2); The preparation method of the compound traditional Chinese medicine fermentation extract is as follows: black sesame, walnut kernel, almond, and radix polygoni multiflori are cleaned, dried to a water content of less than or equal to 8%, crushed, and then sieved through an 80-100 mesh sieve to obtain a mixed raw material powder; the mixed raw material powder is mixed with deionized water at a solid-liquid ratio, the pH is adjusted to 5.5-6.5, and then sterilized and cooled to 30-35°C; a lactobacillus plantarum bacterial solution is inoculated, and then incubated at 30-35°C for 48-72 hours to obtain a fermentation liquid; 0.1-0.3% cellulase by mass is added to the fermentation liquid, and then enzymolysis is performed at 45-50°C for 1-2 hours; then the temperature is raised to 80-85°C for extraction for 2-3 hours; filtration is performed, and the filtrate is concentrated to a relative density of 1.10-1.15 at 60°C to obtain the compound traditional Chinese medicine fermentation extract.

2. The hair growth composition for strengthening hair roots according to claim 1, characterized in that, The preservative is sodium benzoate.

3. A method for preparing the hair growth traditional Chinese medicine composition for strengthening hair roots according to any one of claims 1-2, characterized in that, The method comprises the following steps: W1. black sesame, walnut kernel, almond, and radix polygoni multiflori are cleaned, dried to a water content of less than or equal to 8%, crushed, and then sieved through an 80-100 mesh sieve to obtain a mixed raw material powder; W2. the mixed raw material powder is mixed with deionized water at a solid-liquid ratio, the pH is adjusted to 5.5-6.5, and then sterilized and cooled to 30-35°C; a lactobacillus plantarum bacterial solution is inoculated, and then incubated at 30-35°C for 48-72 hours to obtain a fermentation liquid; W3. 0.1-0.3% cellulase by mass is added to the fermentation liquid, and then enzymolysis is performed at 45-50°C for 1-2 hours; then the temperature is raised to 80-85°C for extraction for 2-3 hours; filtration is performed, and the filtrate is concentrated to a relative density of 1.10-1.15 at 60°C to obtain the compound traditional Chinese medicine fermentation extract; W4. compound formulation: the compound traditional Chinese medicine fermentation extract, the prepared rhizome extract, the angelica sinensis extract, the biota orientalis extract, and the ginkgo biloba extract are taken in parts by mass, a humectant, a preservative, and the balance of deionized water are added, and then stirred at 30-40°C for 30-60 minutes; after homogenization, filtration is performed to obtain the hair growth traditional Chinese medicine composition.

4. The production method according to claim 3, characterized by, The sterilization conditions in step W2 are 121°C high-pressure sterilization for 20-30 minutes; and the homogenization pressure in step W4 is 20-30 MPa, and the homogenization time is 10-15 minutes.

5. The hair growth traditional Chinese medicine composition for strengthening hair roots according to any one of claims 1-2 in the preparation of a hair growth liquid, a hair growth cream, and a hair nourishing essence.

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