Composition for improving symptoms of hair loss as well as preparation method and application of composition

Abstract

The invention relates to a makeup and eating homologous composition for improving hair quantity reduction and a preparation method and application thereof.The composition comprises ginseng, ornithogalum caudatum, cornu cervi pantotrichum and phellinus igniarius, through the multi-boundary synergistic effect of plant, animal and microorganism source active ingredients, hair aplastic disorder and metabolic disorder in a weak state can be effectively improved, and the makeup and eating homologous composition has the advantages that the makeup and eating homologous effect is achieved; meanwhile, the anti-aging and immunoregulation functions are realized.

Description

Technical Field

[0001] This invention relates to a composition for improving symptoms of hair loss, its preparation method, and its application. Background Technology

[0002] The main causes of hair loss include genetics, malnutrition, unhealthy lifestyle, scalp damage, and infection. Genetic factors are one of the most common causes of hair loss; if many people in a family have hair loss, their offspring are more likely to have similar problems. Malnutrition, especially a lack of trace elements such as calcium, zinc, and iron, can also lead to hair loss. Unhealthy lifestyle habits, such as staying up late for extended periods, high stress levels, and an unbalanced diet, can also affect hair health. Scalp damage and infections, such as folliculitis and tinea capitis, can damage hair follicles, leading to hair loss.

[0003] Traditional hair loss prevention products, such as Polygonum multiflorum extract and minoxidil, mostly target only the hair follicles and lack intervention for the systemic metabolic imbalance caused by weakness. Single-source active ingredients often have low bioavailability; for example, ginsenosides have a bioavailability of no more than 15%. Plant or animal extracts, being single-source ingredients, have limited targets and are unlikely to produce synergistic effects. Existing hair loss prevention products lack a systemic solution for diffuse hair loss induced by weakness (chronic fatigue, aging). Summary of the Invention

[0004] To address the aforementioned technical problems, this invention provides a composition for improving symptoms of hair loss, a method for preparing the composition, and its application.

[0005] The technical solution adopted in this invention is: a composition for improving symptoms of hair loss, comprising ginseng, tiger eye evergreen, deer antler and mulberry fungus.

[0006] Preferably, it includes 30-45% ginseng extract, 20-30% tiger eye evergreen extract, 15-25% deer antler extract, and 10-20% mulberry extract.

[0007] Preferably, ginseng extract is obtained by low-temperature plasma treatment; tiger eye evergreen extract is obtained by aqueous two-phase separation technology; deer antler extract is obtained by low-temperature enzymatic hydrolysis technology; and mulberry extract is obtained by graded purification method.

[0008] The use of compositions that improve symptoms of hair loss in functional foods, pharmaceuticals, or cosmetics that improve sub-health-related hair loss.

[0009] Preferably, the composition is prepared into one or more of the following: a highly bioavailable nanoemulsion, a functional beverage, a sports functional beverage, a probiotic compound beverage, a topical nanospray, a spray, a compound soft capsule, an oral liquid, a nano-transdermal microemulsion, and an anti-hair loss shampoo.

[0010] A pharmaceutical composition comprising an oral formulation and a transdermal formulation, wherein both the oral formulation and the transdermal formulation comprise a composition for improving symptoms of hair loss.

[0011] Preferably, the oral formulation is an immediate-release tablet; the transdermal formulation is a transdermal microneedle.

[0012] A food composition comprising a composition that improves symptoms of hair loss.

[0013] A cosmetic product comprising a composition that improves symptoms of hair loss.

[0014] The advantages and positive effects of this invention are: it provides a cosmetic-food homologous composition that integrates active ingredients from plant, animal and microbial sources, forming a cross-border synergistic system. Each component can work synergistically to produce a multi-border synergistic mechanism, which can be used to improve hair regeneration disorders and metabolic disorders in a weakened state, and also has anti-aging and immune regulation functions.

[0015] The composition is prepared into dosage forms such as tablets, functional beverages, topical nanosprays, composite soft capsules, oral liquids, and nano-transdermal microemulsions to form a circadian rhythm-adapted dosing regimen with the transdermal microneedle system. Attached Figure Description

[0016] Figure 1 The effect of the composition on the hair follicle density improvement rate;

[0017] Figure 2 The effect of the composition on the shortening rate of fatigue recovery time;

[0018] Figure 3 Effect of the composition on DPPH radical scavenging rate;

[0019] Figure 4 Before and after photos of microneedle patch treatment (8 weeks); Left: Before use; Right: After use;

[0020] Figure 5 Before and after comparison of using nano spray; Left: before use; Right: after use;

[0021] Figure 6 Before and after placebo administration; Left: before administration; Right: after administration. Detailed Implementation

[0022] The embodiments of the present invention will now be described with reference to the accompanying drawings.

[0023] This invention relates to a composition for improving hair loss symptoms, its preparation method, and its application, particularly suitable for improving hair loss symptoms in a weakened state. It provides a food-derived composition comprising ginseng, tiger's eye evergreen, deer antler, and turmeric. This food-derived composition, which integrates active ingredients from plant, animal, and microbial sources, allows for synergistic effects among its components, creating a multi-dimensional synergistic mechanism. It can be used to improve hair regeneration disorders and metabolic disturbances in a weakened state, while also possessing anti-aging and immune-regulating functions.

[0024] The composition comprises three types of active ingredients: ginsenosides, *Aglaonema edulis* polysaccharides (plant), deer antler polypeptides (animal), and *Phellinus linteus* flavonoids (microorganism). The composition includes 30-45% ginseng extract, 20-30% *Aglaonema edulis* extract, 15-25% deer antler extract powder, and 10-20% *Phellinus linteus* extract. The complementary metabolism of these cross-functional ingredients covers multiple pathways, including energy metabolism, hair follicle stem cell activation, and inflammation suppression, thus improving hair loss symptoms related to sub-health conditions.

[0025] Among them, plant extracts including ginsenoside Rg3 can increase the antioxidant molecule taurine, activate the AMPK pathway, improve energy metabolism, and activate mitochondrial energy; plant extracts including tiger eye aglaonema polysaccharide can activate the Nrf2 / ARE pathway, upregulate the expression of superoxide dismutase (SOD) and glutathione (GSH), and improve antioxidant stress; animal extracts including deer antler polypeptide can promote the proliferation of dermal papilla cells, increase hair follicle stem cell markers (such as Lgr5), reduce the aging marker β-galactosidase, promote the expression of cell cycle regulatory proteins (such as Cyclin D1), increase the vitality of hair follicle stem cells, inhibit dermal papilla cell senescence, and promote dermal papilla platelet proliferation; and microbial extracts including Phellinus linteus flavonoids have the effect of inhibiting the NF-κB inflammatory pathway, reducing the expression of inflammatory factors (such as TNF-α), achieving T cell homeostasis, and regulating immune balance.

[0026] Ginseng extract was obtained by low-temperature plasma treatment; Tiger Eye Evergreen extract was obtained by aqueous two-phase separation technology; Deer Antler extract was obtained by low-temperature enzymatic hydrolysis technology; and Phellinus linteus extract was obtained by graded purification method.

[0027] The preparation method of ginseng extract (saponins) is as follows:

[0028] Step 1-1: Pretreatment of ginseng raw materials; After drying, the ginseng is pulverized to 120-150μm and sieved for later use;

[0029] Steps 1-2: Low-temperature plasma pretreatment; treat for 150 seconds under vacuum of 80-95 Pa, discharge power of 420-430 W, and gas flow rate of 150 mL / min to destroy cell walls and release active ingredients.

[0030] Steps 1-3: Water extraction and homogenization; add deionized water at a material-to-liquid ratio of 1:30-50 g / mL, homogenize at 3000 r / min for 10 minutes, and then extract in an 80℃ water bath for 90 minutes.

[0031] Steps 1-4: Fractional membrane separation; First, microfiltration is performed using a filter membrane with a pore size of 200-800 nm to remove large molecular impurities; then, ultrafiltration is performed with a pore size of 2-10 KD to retain ginsenosides; finally, nanofiltration is performed to retain molecular weights of 300-1000 Da for further purification.

[0032] Steps 1-5: Drying and testing; the concentrated solution is subjected to rotary evaporation and freeze drying to obtain high-purity ginsenosides (total saponin content ≥65%).

[0033] The preparation method of Tiger Eye Evergreen Extract (Polysaccharide) is as follows:

[0034] Step 2-1: Pre-treatment of Tiger Eye Evergreen raw materials; Dry the raw materials, pulverize them to 40-80 mesh, and sieve them for later use;

[0035] Step 2-2: Ultrasonic-assisted extraction; add the pulverized *Aglaonema edulis* to a eutectic solvent aqueous solution at a material-to-liquid ratio of 1:20-40 (g / mL). The eutectic solvent aqueous solution is a mixture of choline chloride and N,N'-dimethylurea at a molar ratio of 1:1; sonicate at 200-400W power, temperature 50-70℃, time 20-50 min; centrifuge at 4000 rpm for 10 min, and collect the supernatant.

[0036] Steps 2-3: Aqueous phase separation; add potassium dihydrogen phosphate to the supernatant at a mass-to-volume ratio of 3:10, allow to stand and separate into layers, then centrifuge to separate the eutectic solvent phase (containing saponins) and the potassium dihydrogen phosphate phase (containing polysaccharides).

[0037] Steps 2-4: Purification and drying; Dialyze the polysaccharide phase to remove a molecular weight cutoff of 8-14 kDa, freeze-dry to obtain high-purity polysaccharide (purity ≥80%).

[0038] The preparation method of deer antler extract (polypeptide) is as follows:

[0039] Step 3-1: Raw material pretreatment; Dry the deer antlers and then pulverize them to 20-50 mesh, then sieve them for later use;

[0040] Step 3-2: Low-temperature enzymatic extraction; add the pulverized deer antler to a sodium acetate buffer solution with a pH of 5.0-6.0 at a material-to-liquid ratio of 1:20-40 (g / mL); then add neutral protease (enzyme activity 10000-20000 U / g raw material), and enzymatically hydrolyze at 40-50℃ for 3-5 hours; centrifuge at 4000 rpm for 15 min and collect the supernatant;

[0041] Step 3-3: Fractional membrane separation and purification; First, ultrafiltration is performed, using a 10 kDa membrane to retain the target peptide (5-10 kDa) and remove small molecule impurities; then nanofiltration is performed, using a 3 kDa membrane to further concentrate and remove salts and residual enzyme activity.

[0042] Steps 3-4: Drying and freezing; Stabilization of active components of deer antler; The concentrate is dried by rotary evaporation to remove moisture, and freeze-drying combined with trehalose protection technology is used to achieve an IGF-1 activity retention rate of 95%.

[0043] The preparation method of Phellinus linteus extract (flavonoids) is as follows:

[0044] Step 4-1: Liquid fermentation culture; The strain selected is Phellinus linteus. After fermentation, the mycelium is collected, dried, and pulverized to 80-120 mesh.

[0045] Step 4-2: Low-temperature plasma pretreatment; the mycelial powder is treated for 120-180 seconds under vacuum of 80-95 Pa, discharge power of 420-430 W, and air intake of 150 mL / min to destroy the cell wall and release flavonoids.

[0046] Step 4-3: Ultrasonic-assisted extraction; add 60% ethanol solution at a material-to-liquid ratio of 1:15-25 (g / mL); sonicate at 300-500W power, temperature 40-50℃, time 20-40 min; centrifuge at 5000 rpm for 10 min, and collect the supernatant;

[0047] Step 4-4: Fractional purification; First, use macroporous resin column chromatography; AB-8 resin, wash with water until colorless, then elute impurities with 40% ethanol and flavonoids with 95% ethanol; then perform membrane separation; ultrafiltration (5KD) to remove macromolecules, and nanofiltration (300Da) to concentrate flavonoids.

[0048] Steps 4-5: Drying and testing; the concentrated liquid is subjected to rotary evaporation and freeze drying to obtain high-purity Sanghuang flavonoids (total purity ≥80%).

[0049] Strict quarantine and ultrafiltration processes are applied to all raw materials in the composition to ensure no risk of allergenization.

[0050] In some embodiments of the present invention, the composition can be prepared into oral and transdermal formulations, respectively. The oral formulation may be an immediate-release tablet (disintegration time < 3 min), and the transdermal formulation may be loaded with an HA-PEG complex microneedle array. This composition can improve the overall condition through oral administration and act directly on the hair follicles through topical application, achieving a combined internal and external anti-hair loss effect; this composition is particularly suitable for hair loss in a weakened state.

[0051] In other embodiments of the present invention, the composition can also be prepared into various products such as highly bioavailable nanoemulsions, functional beverages, sports drinks, probiotic complex drinks, topical nanosprays, antioxidant sprays, complex soft capsules, anti-aging oral liquids, and nano-transdermal microemulsions. In addition to existing oral and transdermal formulations, the development of daily care products such as shampoos and conditioners can be considered to improve user compliance and ease of use.

[0052] The present invention will now be described with reference to the accompanying drawings. Experimental methods not specifically described in terms of operation steps are performed in accordance with the corresponding product manuals. Unless otherwise specified, the instruments, reagents, and consumables used in the embodiments can be purchased from commercial companies.

[0053] Example 1: Preparation of the composition

[0054] The composition includes ginseng extract, tiger eye evergreen extract, deer antler extract and mulberry extract.

[0055] 1.1 Preparation of ginseng extract (saponins)

[0056] Step 1: Raw material pretreatment; After drying, ginseng is pulverized to 120-150μm and sieved for later use.

[0057] Step 2: Low-temperature plasma pretreatment; treat for 150 seconds under vacuum of 80-95 Pa, discharge power of 420-430 W, and gas flow rate of 150 mL / min to destroy the cell wall and release active ingredients.

[0058] Step 3: Water extraction and homogenization; add deionized water at a material-to-liquid ratio of 1:30-50 g / mL, homogenize (3000 r / min, 10 minutes), and then extract in a water bath at 80℃ for 90 minutes.

[0059] Step 4: Fractional membrane separation; First, microfiltration is performed using a filter membrane with a pore size of 200-800 nm to remove large molecular impurities; then, ultrafiltration is performed with a pore size of 2-10 KD to retain ginsenosides; finally, nanofiltration is performed to retain molecular weights of 300-1000 Da for further purification.

[0060] Step 5: Drying and testing; the concentrated solution is subjected to rotary evaporation and freeze drying to obtain high-purity ginsenosides (total saponin content ≥65%).

[0061] 1.2 Preparation of Tiger Eye Evergreen Extract (Polysaccharide)

[0062] Step 1: Raw material pretreatment; dry the raw materials, pulverize them to 40-80 mesh, and sieve them for later use.

[0063] Step 2: Ultrasonic-assisted extraction; add the pulverized *Aglaonema edulis* to an aqueous solution of eutectic solvent (choline chloride / N,N'-dimethylurea, molar ratio 1:1) at a material-to-liquid ratio of 1:20-40 (g / mL); sonicate at 200-400W power, 50-70℃ temperature, for 20-50 minutes; centrifuge at 4000rpm for 10 minutes and collect the supernatant.

[0064] Step 3: Aqueous phase separation; add potassium dihydrogen phosphate to the supernatant at a mass-to-volume ratio of 3:10, allow to stand and separate into layers, then centrifuge to separate the eutectic solvent phase (containing saponins) and the potassium dihydrogen phosphate phase (containing polysaccharides).

[0065] Step 4: Purification and drying; Dialyze the polysaccharide phase to remove a molecular weight cutoff of 8-14 kDa, freeze-dry to obtain high-purity polysaccharide (purity ≥80%).

[0066] 1.3 Preparation of Deer Antler Extract (Polypeptide)

[0067] Stabilization of active components in deer antler: Using freeze-drying combined with trehalose protection technology, the IGF-1 activity retention rate reached 95%.

[0068] Step 1: Raw material pretreatment; after drying the deer antler, grind it to 20-50 mesh and sieve it for later use.

[0069] Step 2: Low-temperature enzymatic extraction; add the pulverized deer antler to a sodium acetate buffer solution with a pH of 5.0-6.0 at a material-to-liquid ratio of 1:20-40 (g / mL); then add neutral protease (enzyme activity 10,000-20,000 U / g raw material), and enzymatically hydrolyze at 40-50℃ for 3-5 hours; centrifuge at 4000 rpm for 15 minutes and collect the supernatant.

[0070] Step 3: Fractional membrane separation and purification; First, ultrafiltration is performed, using a 10 kDa membrane to retain the target peptide (5-10 kDa) and remove small molecule impurities; then nanofiltration is performed, using a 3 kDa membrane to further concentrate and remove salts and residual enzyme activity.

[0071] Step 4: Drying and freezing; The concentrate is dried by rotary evaporation to remove moisture, then freeze-dried, and trehalose is added to achieve freeze-drying protection, with IGF-1 activity retention rate reaching 95%.

[0072] 1.4 Preparation of Phellinus linteus extract (flavonoids)

[0073] Step 1: Liquid fermentation culture; The strain selected is the Phellinus linteus strain ("Qianjifang No. 1" patented strain), and the culture conditions are temperature 25±1℃, pH 5.5-6.0, dissolved oxygen ≥80%, and fermentation cycle of 20 days; collect the mycelium, dry and pulverize it to 80-120 mesh.

[0074] Step 2: Low-temperature plasma pretreatment; the mycelial powder is treated for 120-180 seconds under vacuum of 80-95 Pa, discharge power of 420-430 W, and air intake of 150 mL / min to destroy the cell wall and release flavonoids.

[0075] Step 3: Ultrasonic-assisted extraction; add 60% ethanol solution at a material-to-liquid ratio of 1:15-25 (g / mL); sonicate at a power of 300-500W, a temperature of 40-50℃, and a time of 20-40 minutes; centrifuge at 5000 rpm for 10 minutes and collect the supernatant.

[0076] Step 4: Fractional purification; First, use macroporous resin column chromatography; AB-8 resin, wash with water until colorless, then elute impurities with 40% ethanol and flavonoids with 95% ethanol; then perform membrane separation; ultrafiltration (5KD) to remove macromolecules, and nanofiltration (300Da) to concentrate flavonoids.

[0077] Step 5: Drying and testing; the concentrate is subjected to rotary evaporation and freeze drying to obtain high-purity Sanghuang flavonoids (total purity ≥80%).

[0078] The various extracts prepared by the above method were compounded and dry-granulated according to the following proportions: 35% ginseng extract, 25% tiger eye evergreen extract, 20% deer antler extract, and 20% mulberry extract, to obtain target composition A.

[0079] 1.5 Accelerated Stability Test

[0080] The activities of ginsenosides Rg3, OSW-1, and IGF-1 were detected under accelerated stability testing conditions of 40℃ / 75%RH for 6 months. The results are shown in Table 1, indicating that the content of active ingredients in each raw material is relatively stable.

[0081] Table 1. Accelerated stability test data

[0082]

[0083] Example 2: Functional Study of the Composition

[0084] 2.1 Verification of the function of composition A in delaying fatigue-induced hair loss in mice

[0085] The effect of composition A in delaying fatigue-induced hair loss in mice was evaluated. First, a chronic fatigue mouse model was established. Twenty mice were selected and divided into an experimental group and a control group. The experimental group was given 200 mg / kg / day of composition A, while the control group was given the same amount of Rhodiola rosea extract (containing rhodioloside). The mice were instructed to swim under load for 45 minutes daily for 14 consecutive days. The exhaustion swimming time and muscle lactic acid clearance rate were measured in both groups. After continued feeding, the time to first hair loss was observed in both groups.

[0086] The results showed that, compared with the control group, the average exhaustion swimming time of the experimental group mice was prolonged by 62% (vs model group p<0.01); the muscle lactic acid clearance rate was increased to 89% of the normal level (72% in the Rhodiola rosea group); and hair loss was delayed in the experimental group mice, with the first hair loss time delayed by 5.2 days (p<0.05).

[0087] 2.2 Animal Model Validation

[0088] Twenty aged mice aged 20-24 months were selected and divided into an experimental group and a control group. The experimental group was treated with the drug for 30 consecutive days at a daily dose of 10 mg / kg; the control group received no treatment. The hair growth period of the two groups of mice was compared. The hair growth period of the control group was 12 days, while that of the experimental group was prolonged to 20 days, and the cross-sectional area of ​​muscle fibers increased by 25% (LipidTOX staining).

[0089] 2.3 Verification of the mechanism at the cellular level

[0090] A human dermal papilla cell (DPC) oxidative stress model was established by treating DPCs with 200 μM H2O2 for 6 h. The model cells were divided into a control group and a treatment group. The control group received no treatment, while the treatment group received 50 μg / mL of composition A. β-catenin nuclear translocation rate, IL-6 secretion, and K15 expression were measured. The results showed that, compared to the control group, the treatment group exhibited a 3.8-fold increase in β-catenin nuclear translocation rate, indicating activation of the Wnt / β-catenin pathway; IL-6 secretion decreased by 74%, indicating inhibition of the senescence-associated secretory phenotype (SASP); and the treatment group showed a 2.3-fold upregulation of the hair follicle stem cell marker (K15) compared to the control group.

[0091] Example 3: Clinical safety assessment of the composition

[0092] 3.1 Reproductive toxicity test

[0093] Twenty pregnant mice were selected and divided into an experimental group and a control group, with 10 mice in each group. The pregnant mice in the experimental group were administered composition A by gavage at a dose of 500 mg / kg / day until day 18 of gestation. The control group received no treatment. The rate of fetal malformations was assessed. Results showed that the rate of fetal malformations in the experimental group was 0%, while the rate in the control group was 0.2%, with no statistically significant difference in body weight; indicating that composition A has no reproductive toxicity.

[0094] 3.2 Genotoxicity test:

[0095] Composition A was tested using the Ames test, and the reversion mutation rate of strains TA98 and TA100 was <2.0 (negative determination); Composition A was tested using the micronucleus test, and the micronucleus rate was 0.12‰ (0.09‰ in the solvent control group); indicating that composition A has no genotoxicity.

[0096] Example 4: Verification of multi-component synergistic effect

[0097] To investigate the efficacy of each component in the composition, different comparative examples were designed to compare the differences in the efficacy of promoting hair follicle density and relieving fatigue in compositions including all components but with some components to be removed. Composition A prepared in Example 1 was used as the experimental group. In the preparation process of Example 1, ginseng extract was removed to form Comparative Example 1; Phellinus linteus extract was removed to form Comparative Example 2; deer antler extract was removed to form Comparative Example 3; and Aglaonema edulis extract was removed to form Comparative Example 4. A certain brand of anti-hair loss shampoo was purchased as Comparative Example 5. The four groups of mice were evaluated according to the experimental procedure of Example 2, and the rate of increase in hair follicle density and the rate of reduction in fatigue recovery time were measured; the results are shown in Table 2.

[0098] Table 2 Validation results of multi-component synergistic effect

[0099]

[0100] The data in the table show that composition A has a significant effect on improving hair follicle density, which is significantly higher than that of comparative examples 1-5, and also has a significant effect on shortening fatigue recovery time.

[0101] Human dermal papilla cells (DPCs) were used as a cell model after TNF-α-induced inflammation. The cells were treated with composition A, composition B (without ginseng extract and evergreen extract), composition C (without deer antler extract), and composition D (without Phellinus linteus extract). After 12 hours of culture, the secretion levels of IL-6 and IL-1β in each group were measured by ELISA. The results showed that the IL-6 level decreased by 72% in the composition-treated groups, significantly better than the single-component groups (35% decrease, p<0.01).

[0102] Example 5: Formulation of the composition

[0103] 5.1 Preparation of oral tablets

[0104] Composition A (25% by weight) obtained in Example 1 was mixed with 30% microcrystalline cellulose, 35% maltodextrin, 5% HPMC, 2% magnesium stearate, and 3% sodium dodecyl sulfate, and wet granulated to obtain oral tablets with a tablet weight of 500 mg and a disintegration time of <10 min. Oral dosage form: 1 tablet (500 mg / tablet) daily for 3 consecutive months.

[0105] 5.2 Preparation of scalp microneedle patches

[0106] Dissolve composition A obtained in Example 1 in water. HA-PEG complex microneedle array, drug loading 1.0 mg / cm³. 2 Transdermal efficiency ≥80% (Franz diffusion cell test). The preparation method is as follows:

[0107] Step 1: Preparation of HA-PEG composite hydrogel; Dissolve the composition in Example 1 in water, mix the HA solution and PEG solution in a ratio of 3:5, add the crosslinking agent BDDE, and stir at 35-40℃ for 2 hours to form a hyaluronic acid hydrogel. A photoinitiator can also be added, and after mixing in the dark, the crosslinking reaction is initiated by ultraviolet light irradiation (365 nm wavelength, 10-20 minutes).

[0108] Unreacted low-molecular-weight HA, crosslinking agent, and NaOH were removed by rinsing with 95% ethanol, and the mixture was ground and sieved through a 300-mesh sieve to obtain crosslinked particles.

[0109] Step 2: Microneedle mold preparation; mix polydimethylsiloxane (PDMS) prepolymer and curing agent, degas under vacuum and cure at high temperature to form a sheet. Use laser engraving or photolithography to etch the needle tip shape (such as conical or barbed), and the needle height is usually 300-500 μm.

[0110] Step 3: Microneedle array molding; fill the PDMS mold cavity with HA-PEG composite hydrogel suspension (volume concentration 20%); centrifuge to assist filling to ensure uniformity, and cure at room temperature overnight.

[0111] The microneedle array was separated using a blade, washed with purified water to remove residual solvent, and dried to obtain a scalp microneedle patch, which was then sealed and stored.

[0112] Microneedle patches are used once a week for 8 weeks to promote localized hair follicle regeneration. Results are as follows... Figure 4 As shown, after 8 weeks of treatment, the user's hair showed significant improvement.

[0113] Example 6: Preparation of Functional Beverages

[0114] Dissolve composition A in purified water (solid-to-liquid ratio 1:20), add xylitol (5%) to adjust the taste; pasteurize at 72℃ for 15 seconds, and aseptically fill into 100 mL / bottle ready-to-drink beverages.

[0115] The prepared ready-to-drink beverage was subjected to stability testing. The ready-to-drink beverage can be stored at room temperature for 6 months, and the retention rate of active ingredients is ≥90% (HPLC detection).

[0116] Selected participants drank one bottle of ready-to-drink beverage daily for eight consecutive weeks. After this period, their hair density increased to 98 hairs / mm². 2 (Baseline value 65 roots / mm) 2 Plasma alanine levels returned to normal.

[0117] Example 7: Preparation of External Nanoparticle Spray

[0118] Composition A, phospholipids, cholesterol, polysorbate 80, and glycerol were dissolved in purified water and homogenized under high pressure (1500 bar, 3 cycles) to form uniform phospholipid-cholesterol nanoliposomes (particle size 80-120 nm) with an encapsulation rate ≥85%. After filtration and sterilization, the nanoliposomes were dispensed into 10 mL spray bottles.

[0119] The transdermal efficiency of the prepared nano-spray was verified by using a Franz diffusion cell transdermal experiment. The results showed that the cumulative transdermal amount reached 75% after 6 hours, indicating that the nano-spray has good transdermal performance.

[0120] Subjects were selected to use the nano-spray twice daily. After 4 weeks, the hair regrowth rate in the test area increased by 68% (vs. 22% in the placebo group (blank prescription, i.e., without composition A)). Figure 5 and Figure 6 The study compared the hair growth of subjects after 4 weeks of using the nano-spray and the placebo, respectively. The comparison showed that after 4 weeks of using the nano-spray, hair growth was significantly improved; after 4 weeks of using the placebo, there was no improvement, demonstrating that the composition has the effect of promoting hair growth.

[0121] Example 8: Preparation of Compound Soft Capsules

[0122] Composition A (oil phase carrier is MCT oil) is encapsulated in a gelatin shell. The contents are encapsulated in a gelatin shell (glycerol:water = 1:1), with a filling amount of 500 mg / capsule; the moisture content after drying is ≤5% (determined by Karl Fischer method); thus obtaining a qualified soft capsule.

[0123] Bioavailability of the compound soft capsules was tested. Rat pharmacokinetic experiments showed that the peak plasma concentration of deer antler polypeptide in the soft capsule group (C0.05) was significantly higher. maxThe efficacy was 1.8 times higher than that of the tablet group (p<0.05).

[0124] Example 9: Preparation of Oral Liquid

[0125] Composition A (10%) and grape seed extract (5%) were mixed, with the remainder being water. The mixture was homogenized (2000 rpm, 40°C) to obtain composition A. Xylitol (5%) was added to adjust the sweetness. The mixture was pasteurized (70°C, 20 seconds) and filled into 10 mL / vial oral liquid with a shelf life of 12 months (accelerated test verification).

[0126] Selected subjects, after 60 days of continuous use, showed a 35% increase in serum SOD activity (vs. baseline) and a 28% improvement in skin elasticity index.

[0127] Example 10: Preparation of Nano-Transdermal Microemulsion

[0128] The raw materials include Composition A (3%-5%), lecithin (3%), ethyl oleate (5%), oleic acid (6%), Tween 80 (30%), propylene glycol (5%), glycyrrhizin (3%), and the remainder is water. The oil phase, aqueous phase, and surfactant are mixed and then passed through a Y-type or Z-type microchannel (pore size 50-100 μm) of a microfluidic apparatus to form a supersonic jet. High-speed collisions generate shear force, cavitation effect, and high-frequency vibration, refining the particles to the nanoscale (target particle size 20-200 nm). According to Franz diffusion cell testing, the transdermal penetration rate reached 82% after 8 hours (vs. 45% for ordinary emulsions).

[0129] Apply topically twice daily. After 4 weeks of application, hair follicle density increased to 105 hairs / cm². 2 (Baseline value 65 roots / cm) 2 )‎.

[0130] Example 11: Sports Functional Beverage

[0131] Composition A (0.5-1%), electrolytes (sodium 5 mmol / L, potassium 3 mmol / L), and β-alanine (0.5%) are mixed and aseptically cold-filled (pH 3.5-4.0). Natural flavoring (lemon extract 0.1%) is added to obtain a sports functional beverage.

[0132] When athletes were selected as subjects to drink the product, their endurance exercise time increased by 22% and their peak blood lactate levels decreased by 18%.

[0133] Example 12: Probiotic Complex Beverage

[0134] The active ingredients include composition A (1-2%), Lactobacillus plantarum (10%), and other active ingredients. 8The compound beverage was prepared using conventional methods, containing CFU / mL and fructooligosaccharides (5%). Probiotics promote the metabolic conversion of ginsenosides (increasing bioavailability by 40%), and deer antler polypeptides enhance intestinal barrier function.

[0135] After drinking the product continuously for 4 weeks, the abundance of Bifidobacteria in the gut of the subjects increased by 3.5 times, and the level of short-chain fatty acids in feces increased by 65%.

[0136] Example 13: Antioxidant Spray

[0137] The active combination includes composition A (0.3%), grape seed proanthocyanidins (0.2%), and sodium hyaluronate (0.5%); the nano-sizing process steps are as follows:

[0138] Step 1: After mixing the dispersion of Composition A (2%-3%), Tween-80 (5%-15%), mannitol (5%-10%), pH adjuster (0.5%-1.0%), and stabilizer, the mixture is passed through a Y-type or Z-type microchannel (pore size 50-100 μm) of a high-pressure microfluidic apparatus to form a supersonic jet. The high-speed collision of the two jets generates shear force, cavitation effect, and high-frequency vibration, which refines the drug particles to the nanoscale (typically 80-100 nm).

[0139] Step 2: Post-processing and quality control; The centrifugal purification process involves centrifuging at 10,000-15,000 rpm for 2-4 hours to remove undispersed particles and free drug.

[0140] Verification revealed that the DPPH free radical scavenging rate was ≥90% (IC50). 50 0.12 mg / mL), significantly superior to single-component formulations (IC50). 50 0.35 mg / mL

[0141] Example 14: Anti-hair loss shampoo

[0142] Shampoo ingredients include active ingredients, surfactants, conditioning agents, and auxiliary ingredients. The active ingredients include Composition A (7-10 parts) and piroctone ketone ethanolamine salt (OCT, 1-3 parts); surfactants include sodium lauryl ether sulfate (AES, 10-15 parts) and cocamidopropyl betaine (APG, 8-12 parts); conditioning agents include polydimethylsiloxane (1-3 parts) and deacetylated chitosan (0.5-1 part); auxiliary ingredients include citric acid (0.1-0.3 parts), preservatives (0.1-0.2 parts), and deionized water (balance).

[0143] Mix the surfactant and conditioner according to the mass ratio, stir in a 70°C water bath until emulsified; then add the active ingredients and auxiliary ingredients, homogenize for 30 minutes to obtain the anti-hair loss shampoo; aseptically fill and seal for storage.

[0144] After using the anti-hair loss shampoo to wash your hair, and after 28 days of continuous use, hair loss will be reduced by 40%-60%, and new fine and soft hair will increase. It has been tested on human patches and has no allergic reaction, making it suitable for sensitive scalps.

[0145] The embodiments of the present invention have been described in detail above, but the content described is only a preferred embodiment of the present invention and should not be considered as limiting the scope of the present invention. All equivalent changes and improvements made within the scope of the present invention should still fall within the patent coverage of the present invention.

Claims

1. A composition for improving symptoms of hair loss, characterized in that: This includes ginseng, tiger eye evergreen, deer antler, and mulberry fungus.

2. The composition for improving symptoms of hair loss according to claim 1, characterized in that: It includes 30-45% ginseng extract, 20-30% tiger eye evergreen extract, 15-25% deer antler extract, and 10-20% Phellinus linteus extract.

3. The composition for improving symptoms of hair loss according to claim 2, characterized in that: Ginseng extract was obtained by low-temperature plasma treatment; Tiger Eye Evergreen extract was obtained by aqueous two-phase separation technology; Deer Antler extract was obtained by low-temperature enzymatic hydrolysis technology; and Phellinus linteus extract was obtained by graded purification method.

4. The use of the composition for improving hair loss symptoms as described in any one of claims 1-3 in functional foods, pharmaceuticals or cosmetics for improving sub-health-related hair loss.

5. The application according to claim 4, characterized in that: The composition is prepared into one or more of the following: highly bioavailable nanoemulsions, functional beverages, sports drinks, probiotic complex drinks, topical nanosprays, sprays, complex soft capsules, oral liquids, nano-transdermal microemulsions, and anti-hair loss shampoos.

6. A pharmaceutical composition, characterized in that: The formulations include oral and transdermal preparations, both of which include the composition for improving hair loss symptoms as described in any one of claims 1-3.

7. The pharmaceutical composition according to claim 6, characterized in that: The oral formulation is an immediate-release tablet; the transdermal formulation is a transdermal microneedle.

8. A food composition, characterized in that: The composition comprising any one of claims 1-3 for improving symptoms of hair loss.

9. A cosmetic product, characterized in that: The composition comprising any one of claims 1-3 for improving symptoms of hair loss.

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