A traditional Chinese medicine compound anti-hair loss and hair growth spray based on scalp lipid barrier repair and follicle microenvironment regulation and a preparation method thereof

Abstract

This invention discloses a traditional Chinese medicine compound anti-hair loss and hair growth spray based on scalp lipid barrier repair and hair follicle microenvironment regulation, and its preparation method. The preparation method includes: preparing an aqueous phase containing glycerin, 1,3-butanediol, and low-molecular-weight sodium hyaluronate; mixing ceramide NP, phytosterols, and safflower seed oil to obtain a lipid barrier repair phase; pre-dispersing sodium bis(lauramide-glutamine)lysine, and emulsifying it with the aqueous phase and the lipid barrier repair phase; then adding extracts of Platycladus orientalis leaves, Polygonum multiflorum, Eclipta prostrata, ginseng, panthenol, zinc pyrrolidone carboxylate, and p-hydroxyacetophenone, adjusting the pH, filtering, and filling to obtain the finished product. This invention, through the synergistic effect of a lipid barrier repair module, a traditional Chinese medicine hair follicle microenvironment regulation module, and a gentle penetration delivery module, can improve the scalp barrier state, promote the delivery of active ingredients to the scalp and hair follicle area, and enhance the anti-hair loss and hair growth care effect.

Description

Technical Field

[0001] This invention relates to the fields of cosmetics and scalp care technology, and in particular to a traditional Chinese medicine compound anti-hair loss and hair growth spray based on scalp lipid barrier repair and hair follicle microenvironment regulation, and its preparation method. Background Technology

[0002] Hair loss is a common scalp and hair health problem. Androgenetic alopecia (AGA) is closely related to factors such as the continuous effect of dihydrotestosterone (DHT) on hair follicles, decreased scalp barrier function, abnormal sebum secretion, inflammatory responses, and imbalances in the hair follicle microenvironment. Existing hair loss prevention and hair regrowth products often use compound extracts of plants or traditional Chinese medicines such as arborvitae leaves, Polygonum multiflorum, ginger, and ginseng, primarily improving hair loss through cleansing and oil control, scalp nourishment, or local blood circulation promotion. While these solutions offer some care benefits, most formulas remain at the level of simply layering active ingredients, lacking a systematic and synergistic regulation of the scalp lipid barrier, DHT-related factors, and the hair follicle microenvironment. This results in insufficient stability of the anti-hair loss effect, making it difficult to meet the comprehensive needs of long-term scalp care and hair loss prevention and regrowth.

[0003] Furthermore, existing anti-hair loss sprays often add ethanol, high proportions of propylene glycol, or other penetration enhancers to improve the transdermal or follicular delivery efficiency of active ingredients. However, such penetration-enhancing systems can easily cause scalp dryness, stinging, or barrier damage, potentially exacerbating discomfort for those with sensitive scalps. On the other hand, existing products generally focus on oil control while neglecting the replenishment of physiological lipids such as ceramides, sterols, and essential fatty acids necessary for a healthy scalp, making it difficult to effectively repair the scalp lipid barrier and maintain a stable hair follicle growth environment. Therefore, it is necessary to provide a preparation method for an anti-hair loss and hair growth spray that combines scalp lipid barrier repair, hair follicle microenvironment regulation, and gentle delivery capabilities to improve the product's efficacy stability, safety, and industrial application value. Summary of the Invention

[0004] To address the aforementioned issues, this invention proposes a traditional Chinese medicine compound anti-hair loss and hair growth spray based on scalp lipid barrier repair and hair follicle microenvironment regulation, as well as its preparation method. This achieves triple effects of scalp barrier repair, DHT inhibition, and hair follicle activation, while also possessing high safety and an excellent user experience.

[0005] This invention can be achieved through the following technical solutions: A method for preparing a traditional Chinese medicine compound anti-hair loss and hair growth spray based on scalp lipid barrier repair and hair follicle microenvironment regulation includes the following steps: S1. Heat deionized water to 40-50°C, add glycerol, 1,3-butanediol and low molecular weight sodium hyaluronate, stir to dissolve, and obtain the aqueous phase. S2. Ceramide NP, phytosterol and safflower seed oil are mixed and stirred at 40-50℃ to obtain the lipid barrier repair phase; S3. Disperse sodium di(lauramide-glutamine)lysine in deionized water at 40-50°C to obtain a pre-dispersion of the penetrant; add the lipid barrier repair phase to the aqueous phase for homogenization and emulsification to obtain an emulsion system; S4. Cool the emulsified system to 30-40°C, add Platycladus orientalis leaf extract, Polygonum multiflorum extract, Eclipta prostrata extract, ginseng extract, panthenol, zinc pyrrolidone carboxylate, and the pre-dispersion of the penetrant. After stirring and mixing, add p-hydroxyacetophenone, and adjust the pH to 4.5-5.5 with citric acid or sodium citrate. After defoaming, filtering, and filling, the barrier repair type traditional Chinese medicine anti-hair loss and hair growth spray is obtained.

[0006] Preferably, based on a total mass of 100 parts, the barrier-repairing traditional Chinese medicine anti-hair loss and hair growth spray comprises the following raw materials in parts by mass: ceramide NP 0.5-2.0 parts, phytosterols 0.1-0.8 parts, safflower seed oil 0.2-1.2 parts, arborvitae leaf extract 2.0-4.0 parts, Polygonum multiflorum extract 1.5-3.0 parts, Eclipta prostrata extract 1.0-1.5 parts, ginseng extract 0.8-1.0 parts, sodium di(lauramide-glutamine)lysine 0.3-0.8 parts, 1,3-butanediol 2.0-5.0 parts, glycerin 1.0-3.0 parts, low molecular weight sodium hyaluronate 0.05-0.2 parts, panthenol 0.2-1.0 parts, zinc pyrrolidone carboxylate 0.1-0.5 parts, p-hydroxyacetophenone 0.3-0.8 parts, with the remainder being deionized water.

[0007] Preferably, the safflower seed oil contains no less than 70% α-linolenic acid.

[0008] Preferably, the 5α-reductase inhibition rate of the Platycladus orientalis leaf extract is not less than 30%, the stilbene glycoside content of the Polygonum multiflorum extract is not less than 2.0%, the total flavonoid content of the Eclipta prostrata extract is not less than 1.5%, and the ginseng extract contains not less than 5.0% ginsenosides.

[0009] Preferably, the molecular weight of the low molecular weight sodium hyaluronate is not higher than 100,000 Da.

[0010] Preferably, in step S1, the preparation temperature of the aqueous phase is 45°C and the stirring time is 10-20 min; in step S2, the preparation temperature of the lipid barrier repair phase is 45°C and the stirring time is 5-15 min.

[0011] Preferably, in step S3, the rotation speed of homogenization emulsification is 6000-10000 rpm, and the homogenization time is 3-8 min.

[0012] Preferably, in step S4, after cooling the emulsion system to 35°C, add the extracts of Platycladus orientalis leaves, Polygonum multiflorum, Eclipta prostrata, ginseng, panthenol, zinc pyrrolidone carboxylate, and a pre-dispersion of the penetrant, and stir for 15–30 min.

[0013] Preferably, in step S4, filtration is performed using a 0.22 μm filter membrane, and filling is performed by filling into a spray container.

[0014] The beneficial effects of this invention are: This invention constructs a scalp lipid barrier repair module using ceramide NP, phytosterols, and safflower seed oil. This module replenishes the physiological lipids required by the scalp, improves the scalp lipid barrier status, and reduces the adverse effects of external stimuli and DHT-related factors on the hair follicle microenvironment. Simultaneously, this invention selects extracts of Platycladus orientalis leaves, Polygonum multiflorum, Eclipta prostrata, and ginseng to form a traditional Chinese medicine-based hair follicle microenvironment regulation module. These extracts work synergistically to regulate DHT-related factors, provide nutrient supply to hair follicles, soothe the scalp, and nourish the hair, avoiding the problems of unclear action direction and insufficient efficacy stability caused by simply stacking traditional Chinese medicines. Furthermore, this invention uses sodium di(lauramide-glutamine)lysine as a mild penetration delivery component and improves its dispersion uniformity in the system through a pre-dispersion process. This facilitates the delivery of active ingredients of traditional Chinese medicine to the scalp stratum corneum and hair follicle area, while reducing the dryness, stinging, and barrier damage problems that may be caused by traditional ethanol or high-proportion penetration enhancers. The preparation process of this invention is characterized by mild overall conditions, avoiding high-temperature treatment during the addition of active ingredients, thus minimizing the loss of active components from traditional Chinese medicine. Furthermore, the process is simple, highly adaptable to equipment, and easily scaled up for industrial production in existing cosmetic lines. The resulting spray is a weakly acidic, water-based system, offering a gentle and refreshing feel, and providing benefits such as scalp barrier repair, improvement of the hair follicle microenvironment, and anti-hair loss and hair growth care. Attached Figure Description

[0015] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used in conjunction with embodiments of the invention to explain the invention and do not constitute a limitation thereof. In the drawings: Figure 1 The spray is for preventing hair loss and promoting hair growth; Figure 2 To improve the scalp barrier repair and penetration efficiency of the spray. Detailed Implementation

[0016] The following provides a detailed description of the embodiments of the present invention: These embodiments are implemented based on the technical solution of the present invention, and provide detailed implementation methods and processes. However, the scope of protection of the present invention is not limited to the following embodiments. Experimental methods in the following embodiments that do not specify specific conditions are generally performed under conventional conditions.

[0017] Example 1: A method for preparing a traditional Chinese medicine compound anti-hair loss and hair growth spray based on scalp lipid barrier repair and hair follicle microenvironment regulation, comprising the following steps: S1. Weigh out 1.0 part of glycerol, 2.0 part of 1,3-butanediol, 0.05 part of low molecular weight sodium hyaluronate, and 89.95 parts of deionized water based on a total mass of 100 parts. The molecular weight of the low molecular weight sodium hyaluronate is not higher than 100,000 Da. Take a portion of the deionized water and add it to an emulsifying pot. Heat the pot to 45°C and add glycerol, 1,3-butanediol, and low molecular weight sodium hyaluronate in sequence. Stir for 10 minutes until the solution is uniformly dissolved to obtain the aqueous phase. S2. Weigh 0.5 parts of ceramide NP, 0.1 parts of phytosterol, and 0.2 parts of safflower seed oil, wherein the α-linolenic acid content in the safflower seed oil is not less than 70%; add ceramide NP, phytosterol, and safflower seed oil to the oil phase pot, stir at 45°C for 5 min to mix and melt evenly to obtain the lipid barrier repair phase; S3. Weigh 0.3 parts of sodium di(lauramide-glutamine)lysine and add it to partially deionized water at 40°C. Stir and disperse to obtain a pre-dispersion of the penetrant. Slowly add the lipid barrier repair phase obtained in step S2 to the aqueous phase obtained in step S1 and homogenize and emulsify at 6000 rpm for 3 min to obtain an emulsion system. S4. Cool the emulsified system obtained in step S3 to 35℃, add 2.0 parts of Platycladus orientalis leaf extract, 1.5 parts of Polygonum multiflorum extract, 1.0 part of Eclipta prostrata extract, 0.8 parts of ginseng extract, 0.2 parts of panthenol, 0.1 parts of zinc pyrrolidone carboxylate, and the pre-dispersion solution of the penetrant obtained in step S3, and stir for 15 min; wherein, the 5α-reductase inhibition rate of Platycladus orientalis leaf extract is not less than 30%, the content of stilbene glycoside in Polygonum multiflorum extract is not less than 2.0%, the total flavonoid content in Eclipta prostrata extract is not less than 1.5%, and the ginsenoside content in ginseng extract is not less than 5.0%; then add 0.3 parts of p-hydroxyacetophenone, stir and mix, adjust the pH to 4.5 with citric acid or sodium citrate, filter through a 0.22 μm filter membrane after defoaming, and fill into a spray container to obtain a traditional Chinese medicine compound anti-hair loss and hair growth spray.

[0018] Example 2: A method for preparing a traditional Chinese medicine compound anti-hair loss and hair growth spray based on scalp lipid barrier repair and hair follicle microenvironment regulation, comprising the following steps: S1. Weigh out 2.0 parts of glycerol, 3.5 parts of 1,3-butanediol, 0.125 parts of low molecular weight sodium hyaluronate, and 82.575 parts of deionized water, based on a total mass of 100 parts. The molecular weight of the low molecular weight sodium hyaluronate is not higher than 100,000 Da. Add a portion of the deionized water to an emulsifying pot, heat to 45°C, and add glycerol, 1,3-butanediol, and low molecular weight sodium hyaluronate in sequence. Stir for 15 minutes until the solution is uniformly dissolved to obtain the aqueous phase. S2. Weigh 1.25 parts of ceramide NP, 0.45 parts of phytosterol, and 0.7 parts of safflower seed oil, wherein the α-linolenic acid content in the safflower seed oil is not less than 70%; add ceramide NP, phytosterol, and safflower seed oil to the oil phase pot, stir at 45°C for 10 min to mix and melt evenly to obtain the lipid barrier repair phase; S3. Weigh 0.55 parts of sodium di(lauramide-glutamine)lysine and add it to partially deionized water at 45°C. Stir and disperse to obtain a pre-dispersion of the penetrant. Slowly add the lipid barrier repair phase obtained in step S2 to the aqueous phase obtained in step S1 and homogenize and emulsify at 8000 rpm for 5.5 min to obtain an emulsion system. S4. Cool the emulsified system obtained in step S3 to 35℃, add 3.0 parts of Platycladus orientalis leaf extract, 2.25 parts of Polygonum multiflorum extract, 1.25 parts of Eclipta prostrata extract, 0.9 parts of ginseng extract, 0.6 parts of panthenol, 0.3 parts of zinc pyrrolidone carboxylate, and the pre-dispersion solution of the penetrant obtained in step S3, and stir for 22.5 min; wherein, the 5α-reductase inhibition rate of Platycladus orientalis leaf extract is not less than 30%, the content of stilbene glycoside in Polygonum multiflorum extract is not less than 2.0%, the content of total flavonoids in Eclipta prostrata extract is not less than 1.5%, and the content of ginsenosides in ginseng extract is not less than 5.0%; then add 0.55 parts of p-hydroxyacetophenone, stir and mix, adjust the pH to 5.0 with citric acid or sodium citrate, filter through a 0.22 μm filter membrane after defoaming, and fill into spray containers to obtain a traditional Chinese medicine compound anti-hair loss and hair growth spray.

[0019] Example 3: A method for preparing a traditional Chinese medicine compound anti-hair loss and hair growth spray based on scalp lipid barrier repair and hair follicle microenvironment regulation, comprising the following steps: S1. Weigh out 3.0 parts of glycerol, 5.0 parts of 1,3-butanediol, 0.2 parts of low molecular weight sodium hyaluronate, and 75.2 parts of deionized water based on a total mass of 100 parts. The molecular weight of the low molecular weight sodium hyaluronate is not higher than 100,000 Da. Take a portion of the deionized water and add it to an emulsifying pot. Heat the pot to 45°C and add glycerol, 1,3-butanediol, and low molecular weight sodium hyaluronate in sequence. Stir for 20 minutes until the mixture is evenly dissolved to obtain the aqueous phase. S2. Weigh 2.0 parts of ceramide NP, 0.8 parts of phytosterol, and 1.2 parts of safflower seed oil, wherein the α-linolenic acid content in the safflower seed oil is not less than 70%; add ceramide NP, phytosterol, and safflower seed oil to the oil phase pot, stir at 45°C for 15 min to mix and melt evenly to obtain the lipid barrier repair phase; S3. Weigh 0.8 parts of sodium di(lauramide-glutamine)lysine and add it to partially deionized water at 50°C. Stir and disperse to obtain a pre-dispersion of the penetrant. Slowly add the lipid barrier repair phase obtained in step S2 to the aqueous phase obtained in step S1 and homogenize and emulsify at 10,000 rpm for 8 min to obtain an emulsion system. S4. Cool the emulsified system obtained in step S3 to 35℃, add 4.0 parts of Platycladus orientalis leaf extract, 3.0 parts of Polygonum multiflorum extract, 1.5 parts of Eclipta prostrata extract, 1.0 part of ginseng extract, 1.0 part of panthenol, 0.5 parts of zinc pyrrolidone carboxylate, and the pre-dispersion solution of the penetrant obtained in step S3, and stir for 30 min; wherein, the 5α-reductase inhibition rate of Platycladus orientalis leaf extract is not less than 30%, the content of stilbene glycoside in Polygonum multiflorum extract is not less than 2.0%, the content of total flavonoids in Eclipta prostrata extract is not less than 1.5%, and the content of ginsenosides in ginseng extract is not less than 5.0%; then add 0.8 parts of p-hydroxyacetophenone, stir and mix, adjust the pH to 5.5 with citric acid or sodium citrate, filter through a 0.22 μm filter membrane after defoaming, and fill into a spray container to obtain a traditional Chinese medicine compound anti-hair loss and hair growth spray.

[0020] Comparative Example 1: The difference between this comparative example and Example 1 is that no lipid barrier repair phase is set.

[0021] A method for preparing a traditional Chinese medicine compound anti-hair loss and hair growth spray includes the following steps: S1. Preparation of aqueous phase: Weigh 1.0 part of glycerol, 2.0 part of 1,3-butanediol, 0.05 part of low molecular weight sodium hyaluronate, and 90.75 parts of deionized water based on a total mass of 100 parts. The molecular weight of the low molecular weight sodium hyaluronate is not higher than 100,000 Da. Add a portion of the deionized water to an emulsifying pot, heat to 45°C, and add glycerol, 1,3-butanediol, and low molecular weight sodium hyaluronate in sequence. Stir for 10 minutes until the solution is uniformly dissolved to obtain the aqueous phase. S2, Blank oil phase treatment: This step does not add ceramide NP, phytosterols and safflower seed oil, and does not prepare a lipid barrier repair phase; S3. Penetrant pre-dispersion and emulsification: Weigh 0.3 parts of sodium bis(lauramide-glutamine)lysine, add it to partially deionized water at 40℃, stir and disperse to obtain penetrant pre-dispersion; homogenize the aqueous phase obtained in step S1 at 6000 rpm for 3 min to obtain a homogenized system. S4. Active ingredient compounding and finished product preparation: The homogenized system obtained in step S3 was cooled to 35℃, and 2.0 parts of Platycladus orientalis leaf extract, 1.5 parts of Polygonum multiflorum extract, 1.0 part of Eclipta prostrata extract, 0.8 parts of ginseng extract, 0.2 parts of panthenol, 0.1 parts of zinc pyrrolidone carboxylate, and the pre-dispersion solution of the penetrant obtained in step S3 were added and stirred for 15 min. The 5α-reductase inhibition rate of the Platycladus orientalis leaf extract was not less than 30%, the stilbene glycoside content of the Polygonum multiflorum extract was not less than 2.0%, the total flavonoid content of the Eclipta prostrata extract was not less than 1.5%, and the ginsenoside content of the ginseng extract was not less than 5.0%. Then, 0.3 parts of p-hydroxyacetophenone were added, stirred and mixed, and the pH was adjusted to 4.5 with citric acid or sodium citrate. After defoaming, the mixture was filtered through a 0.22 μm filter membrane and filled into spray containers to obtain a control spray.

[0022] Comparative Example 2: The difference between this comparative example and Example 1 is that sodium bis(lauramide-glutamine)lysine is not added.

[0023] A method for preparing a traditional Chinese medicine compound anti-hair loss and hair growth spray includes the following steps: S1. Preparation of aqueous phase: Weigh 1.0 part of glycerol, 2.0 part of 1,3-butanediol, 0.05 part of low molecular weight sodium hyaluronate, and 90.25 parts of deionized water based on a total mass of 100 parts. The molecular weight of the low molecular weight sodium hyaluronate is not higher than 100,000 Da. Take a portion of the deionized water and add it to an emulsifying pot. Heat the pot to 45°C and add glycerol, 1,3-butanediol, and low molecular weight sodium hyaluronate in sequence. Stir for 10 minutes until the solution is uniformly dissolved to obtain the aqueous phase. S2. Preparation of lipid barrier repair phase: Weigh 0.5 parts of ceramide NP, 0.1 parts of phytosterol, and 0.2 parts of safflower seed oil, wherein the α-linolenic acid content in the safflower seed oil is not less than 70%; add ceramide NP, phytosterol, and safflower seed oil to an oil phase pot, stir at 45°C for 5 min to mix and melt evenly to obtain the lipid barrier repair phase; S3, Emulsification: Sodium bis(lauramide-glutamine)lysine is not added, and no pre-dispersion of the penetrant is prepared; the lipid barrier repair phase obtained in step S2 is slowly added to the aqueous phase obtained in step S1, and homogenized and emulsified at 6000 rpm for 3 min to obtain the emulsion system; S4. Active ingredient compounding and finished product preparation: The emulsion system obtained in step S3 was cooled to 35℃, and 2.0 parts of Platycladus orientalis leaf extract, 1.5 parts of Polygonum multiflorum extract, 1.0 part of Eclipta prostrata extract, 0.8 parts of ginseng extract, 0.2 parts of panthenol, and 0.1 parts of zinc pyrrolidone carboxylate were added and stirred for 15 min. The 5α-reductase inhibition rate of the Platycladus orientalis leaf extract was not less than 30%, the stilbene glycoside content of the Polygonum multiflorum extract was not less than 2.0%, the total flavonoid content of the Eclipta prostrata extract was not less than 1.5%, and the ginsenoside content of the ginseng extract was not less than 5.0%. Then, 0.3 parts of p-hydroxyacetophenone were added, stirred and mixed, and the pH was adjusted to 4.5 with citric acid or sodium citrate. After defoaming, the mixture was filtered through a 0.22 μm filter membrane and filled into spray containers to obtain a control spray.

[0024] Comparative Example 3: The difference between this comparative example and Example 1 is that it does not contain Platycladus orientalis leaf extract, Polygonum multiflorum extract, Eclipta prostrata extract and ginseng extract.

[0025] A method for preparing an anti-hair loss and hair growth spray includes the following steps: S1. Preparation of aqueous phase: Weigh 1.0 part of glycerol, 2.0 part of 1,3-butanediol, 0.05 part of low molecular weight sodium hyaluronate, and 95.05 parts of deionized water based on a total mass of 100 parts. The molecular weight of the low molecular weight sodium hyaluronate is not higher than 100,000 Da. Take a portion of the deionized water and add it to an emulsifying pot. Heat the pot to 45°C and add glycerol, 1,3-butanediol, and low molecular weight sodium hyaluronate in sequence. Stir for 10 minutes until the solution is uniformly dissolved to obtain the aqueous phase. S2. Preparation of lipid barrier repair phase: Weigh 0.5 parts of ceramide NP, 0.1 parts of phytosterol, and 0.2 parts of safflower seed oil, wherein the α-linolenic acid content in the safflower seed oil is not less than 70%; add ceramide NP, phytosterol, and safflower seed oil to an oil phase pot, stir at 45°C for 5 min to mix and melt evenly to obtain the lipid barrier repair phase; S3. Penetrant pre-dispersion and emulsification: Weigh 0.3 parts of sodium di(lauramide-glutamine)lysine and add it to partially deionized water at 40℃. Stir and disperse to obtain a penetrant pre-dispersion. Slowly add the lipid barrier repair phase obtained in step S2 to the aqueous phase obtained in step S1 and homogenize and emulsify at 6000 rpm for 3 min to obtain an emulsion system. S4. Preparation of finished product: Cool the emulsion system obtained in step S3 to 35°C, add 0.2 parts of panthenol, 0.1 parts of zinc pyrrolidone carboxylate and the pre-dispersion of penetrant obtained in step S3, and stir for 15 min; then add 0.3 parts of p-hydroxyacetophenone, stir and mix, adjust the pH to 4.5 with citric acid or sodium citrate, filter through a 0.22 μm filter membrane after defoaming, and fill into spray containers to obtain the comparison spray.

[0026] Performance testing 1. Hair loss prevention and hair growth efficacy test Sixty AGA volunteers (30 men and 30 women) were selected and randomly divided into three groups (sample group, commercially available Chinese herbal anti-hair loss spray group, and blank control group). The treatment was administered twice daily for 12 consecutive weeks.

[0027] (1) Hair loss reduction rate: Subjects exhibiting androgen-related alopecia were selected. For the three days prior to the test, all subjects used a mild shampoo product without anti-hair loss active ingredients and avoided using other anti-hair loss, hair growth, or irritating scalp care products. During the test, subjects were randomly assigned to groups, with each group using the corresponding sample once in the morning and once in the evening for 12 consecutive weeks. The number of hairs lost was counted before and after 12 weeks of use using a standard combing method combined with a shampoo collection method. Specifically, subjects combed their hair at fixed times and with fixed combing frequency, and collected naturally shed hairs during shampooing, recording the average number of hairs lost over three consecutive days. The hair loss reduction rate was calculated as follows: "Hair loss reduction rate = (Average number of hairs lost before use - Average number of hairs lost after use) / Average number of hairs lost before use × 100%".

[0028] (2) Hair density improvement rate: A fixed test area was selected on the top of the subject's head, and images were taken and analyzed using a hair image analysis system. Fixed observation points were marked on the scalp before the test, and images of the same area were collected before use and after 12 weeks of continuous use. The number of hairs per unit area was counted, with the unit being hairs / cm2. At least 3 fixed fields of view were selected for each subject, and the average value was taken as the subject's hair density. The hair density improvement rate was calculated according to "hair density improvement rate = (hair density after use - hair density before use) / hair density before use × 100%" to evaluate the effect of the sample on improving the degree of hair thinning and promoting hair regrowth.

[0029] (3) Hair follicle anagen phase elongation rate: Hair thickness, hair shaft growth status, and hair composition per unit area in the test area were observed using a trichoscopic image analysis system. The proportion of hair in the anagen phase was determined by combining plucking microscopy or non-invasive hair cycle analysis. The proportion of hair in the anagen phase in the test area was measured before use and after 12 weeks of continuous use, and the percentage of hair in the anagen phase to the total number of hairs was recorded. The hair follicle anagen phase elongation rate was calculated as "(proportion of hair in the anagen phase after use - proportion of hair in the anagen phase before use) / proportion of hair in the anagen phase before use × 100%" to evaluate the regulatory effect of the sample on the hair follicle growth cycle.

[0030] (4) DHT level reduction rate: Scalp sebum or stratum corneum samples were collected from a fixed scalp area of ​​the subject. Shampooing and the use of other scalp care products were avoided for 24 hours before sampling. Dihydrotestosterone was extracted from the samples using an appropriate extraction method, and the DHT content was determined by enzyme-linked immunosorbent assay (ELISA). DHT levels were measured before use and after 12 weeks of continuous use. The DHT level reduction rate was calculated as "DHT level reduction rate = (DHT content before use - DHT content after use) / DHT content before use × 100%" to evaluate the regulatory effect of the sample on DHT-related factors.

[0031] Table 1. Hair loss prevention and hair growth effects of the spray

[0032] 2. Scalp Barrier Repair and Penetration Efficiency (1) Transdermal water loss (TEWL) reduction rate: The test was conducted after subjects sat still for 30 minutes in an environment with a temperature of 22±2℃ and a relative humidity of 50±10%. The TEWL value of the fixed scalp area of ​​the subjects was measured using a transdermal water loss meter. The test was conducted before use and after 12 weeks of continuous use. Each test point was measured 3 times and the average value was taken. The TEWL reduction rate was calculated as "TEWL reduction rate = (TEWL value before use - TEWL value after use) / TEWL value before use × 100%" to evaluate the repair effect of the sample on the scalp lipid barrier.

[0033] (2) Permeability of active ingredients: In vitro permeability testing was conducted using a Franz diffusion cell. A biomimetic skin membrane was used as the diffusion membrane. The sample was evenly coated on one side of the supply cell, and phosphate buffer or receiving solution containing an appropriate amount of solubilizer was added to the receiving cell. The test temperature was controlled at 32±1℃ to simulate the surface temperature of the scalp. Samples were taken at 2 h, 4 h, 8 h, 12 h, and 24 h, respectively. The content of Polygonum multiflorum stilbene glycoside in the receiving solution was determined by high performance liquid chromatography, and the cumulative permeability over 24 h was calculated. This index was used to evaluate the promoting effect of sodium bis(lauramide-glutamine)lysine on the delivery of active ingredients of traditional Chinese medicine to the stratum corneum and hair follicle area of ​​the scalp.

[0034] Table 2. Scalp barrier repair and penetration efficiency of the spray

[0035] As shown in Tables 1 and 2, Examples 1-3 all exhibited good effects in preventing hair loss, promoting hair growth, regulating DHT, repairing the scalp barrier, and penetrating active ingredients. Specifically, Example 1 showed an 82.3% reduction in hair loss, a 25.6% increase in hair density, a 38.0% extension of the hair follicle growth phase, a 41.2% reduction in DHT levels, a 65.8% reduction in TEWL, and a 65.3% penetration rate of Polygonum multiflorum stilbene glycosides over 24 hours. These overall results are consistent with the synergistic design of this invention: "scalp lipid barrier repair + hair follicle microenvironment regulation + efficient penetration and delivery." Example 3 used higher amounts of the active ingredients from traditional Chinese medicine and sodium bis(lauramide-glutamine)lysine, therefore its anti-hair loss and penetration-related indicators were slightly better than those of Example 1.

[0036] Compared to Example 1, Comparative Example 1, which did not include the lipid barrier repair module composed of ceramide NP, phytosterols, and safflower seed oil, showed a significantly lower TEWL reduction rate, indicating that the lack of the lipid barrier repair module resulted in insufficient improvement of the scalp barrier and further affected the long-term anti-hair loss effect. Comparative Example 2, which did not include sodium bis(lauramide-glutamine)lysine, showed a significantly lower 24-hour penetration rate of Polygonum multiflorum stilbene glycosides, indicating that the penetration delivery module can significantly improve the delivery efficiency of the active ingredients of traditional Chinese medicine. Comparative Example 3, which did not include Platycladus orientalis leaf extract, Polygonum multiflorum extract, Eclipta prostrata extract, and ginseng extract, showed a significant decrease in hair loss reduction rate, hair density increase rate, hair follicle growth phase extension rate, and DHT level reduction rate, indicating that the traditional Chinese medicine hair follicle microenvironment regulation module is an important component in achieving the anti-hair loss and hair growth effects.

[0037] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A method for preparing a traditional Chinese medicine compound anti-hair loss and hair growth spray based on scalp lipid barrier repair and hair follicle microenvironment regulation, characterized in that, Includes the following steps: S1. Heat deionized water to 40-50°C, add glycerol, 1,3-butanediol and low molecular weight sodium hyaluronate, stir to dissolve, and obtain the aqueous phase. S2. Ceramide NP, phytosterol and safflower seed oil are mixed and stirred at 40-50℃ to obtain the lipid barrier repair phase; S3. Disperse sodium di(lauramide-glutamine)lysine in deionized water at 40-50℃ to obtain a penetrant pre-dispersion. The lipid barrier repair phase was added to the aqueous phase and homogenized and emulsified to obtain an emulsion system; S4. Cool the emulsified system to 30-40°C, add Platycladus orientalis leaf extract, Polygonum multiflorum extract, Eclipta prostrata extract, ginseng extract, panthenol, zinc pyrrolidone carboxylate, and the pre-dispersion of the penetrant. After stirring and mixing, add p-hydroxyacetophenone, and adjust the pH to 4.5-5.5 with citric acid or sodium citrate. After defoaming, filtering, and filling, the barrier repair type traditional Chinese medicine anti-hair loss and hair growth spray is obtained.

2. The preparation method according to claim 1, characterized in that, Based on a total mass of 100 parts, the barrier-repairing traditional Chinese medicine anti-hair loss and hair growth spray comprises the following raw materials in parts by weight: ceramide NP 0.5-2.0 parts, phytosterols 0.1-0.8 parts, safflower seed oil 0.2-1.2 parts, arborvitae leaf extract 2.0-4.0 parts, Polygonum multiflorum extract 1.5-3.0 parts, Eclipta prostrata extract 1.0-1.5 parts, ginseng extract 0.8-1.0 parts, sodium di(lauramide-glutamine)lysine 0.3-0.8 parts, 1,3-butanediol 2.0-5.0 parts, glycerin 1.0-3.0 parts, low molecular weight sodium hyaluronate 0.05-0.2 parts, panthenol 0.2-1.0 parts, zinc pyrrolidone carboxylate 0.1-0.5 parts, p-hydroxyacetophenone 0.3-0.8 parts, with the remainder being deionized water.

3. The preparation method according to claim 1, characterized in that, The safflower seed oil contains no less than 70% α-linolenic acid.

4. The preparation method according to claim 1, characterized in that, The 5α-reductase inhibition rate of the Platycladus orientalis leaf extract is not less than 30%, the content of stilbene glycoside in the Polygonum multiflorum extract is not less than 2.0%, the total flavonoid content in the Eclipta prostrata extract is not less than 1.5%, and the content of ginsenoside in the ginseng extract is not less than 5.0%.

5. The preparation method according to claim 1, characterized in that, The molecular weight of the low molecular weight sodium hyaluronate is no higher than 100,000 Da.

6. The preparation method according to claim 1, characterized in that, In step S1, the preparation temperature of the aqueous phase is 45℃ and the stirring time is 10-20 min; in step S2, the preparation temperature of the lipid barrier repair phase is 45℃ and the stirring time is 5-15 min.

7. The preparation method according to claim 1, characterized in that, In step S3, the rotation speed for homogenization and emulsification is 6000-10000 rpm, and the homogenization time is 3-8 min.

8. The preparation method according to claim 1, characterized in that, In step S4, after cooling the emulsion system to 35°C, add the extracts of Platycladus orientalis leaves, Polygonum multiflorum, Eclipta prostrata, ginseng, panthenol, zinc pyrrolidone carboxylate, and a pre-dispersion of the penetrant, and stir for 15-30 minutes.

9. The preparation method according to claim 1, characterized in that, In step S4, filtration is performed using a 0.22 μm filter membrane, and filling is performed by filling the spray container.

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