A scalp anti-inflammatory soothing composition containing guayule extract and its preparation method and application

Abstract

The present application belongs to the technical field of cosmetics, and particularly relates to a scalp anti-inflammatory soothing composition containing guayule extract and a preparation method and application thereof. The composition comprises nanoscale guayule extract, spilanthes acmella extract, hydroxy asperosaponin and beta-glucan. The preparation method of the guayule extract comprises the following steps: homogenizing guayule in a protective solution, then performing differential centrifugation, filtering and sterilizing, ultrafiltration concentration and purification, and screening 30-150 nm fractions to obtain nanovesicle guayule extract. The present application synergistically enhances the effects of nanofication extraction process and specific component proportioning, and has the effects of anti-inflammatory soothing, scalp microecological regulation and barrier repair. The product is mild and stable, and has high transdermal absorption rate. The present application effectively solves the problems of single effect, poor transdermal effect and easy damage to scalp microecology of existing scalp care products, is suitable for sensitive scalp, and has good industrial application prospect.

Description

Technical Field

[0001] This invention belongs to the field of cosmetic technology, and particularly relates to a scalp anti-inflammatory and soothing composition containing almond and chamomile extract, its preparation method and application. Background Technology

[0002] As an extension of human skin, inflammation of the scalp is a core contributing factor to a range of scalp problems, including sensitivity, oiliness, increased dandruff, itching, and redness. Existing anti-inflammatory scalp care products have the following significant limitations: First, the anti-inflammatory ingredients are mostly crude plant extracts with large molecular weights, making it difficult to effectively penetrate the scalp's stratum corneum, resulting in low bioavailability and slow onset of action. Second, some products rely on hormones or potent antibacterial agents, which can relieve symptoms in the short term, but long-term use can disrupt the scalp's microecological balance, leading to recurrent or even worsening inflammation. Third, their efficacy is relatively singular, focusing primarily on antibacterial or oil control, lacking synergistic interventions on inflammatory pathways, nerve sensitivity, and barrier repair. Fourth, research on the application of Alpinia serratifolia, a plant ingredient with potent anti-inflammatory activity, in the field of scalp care is extremely limited, and a standardized extraction and quality control system is lacking.

[0003] Almond-shaped chrysanthemum contains abundant sesquiterpene lactones, flavonoids, and other active molecules, exhibiting significant anti-inflammatory and antibacterial activities. Its extracts can form natural nanovesicle structures of plant-derived extracellular vesicles, composed of a phospholipid bilayer, containing functional proteins, flavonoids, and sesquiterpene lactones, possessing natural and highly effective transdermal properties. However, there are currently no reports on the synergistic application of standardized Almond-shaped chrysanthemum nanovesicle extracts with various soothing and microecological regulating components in scalp anti-inflammatory care. Therefore, developing a multi-effect synergistic product integrating rapid anti-inflammatory effects, soothing sensitivity, microecological regulation, and barrier repair is a technical challenge to be solved in this field. Summary of the Invention

[0004] The purpose of this invention is to overcome the problems of poor transdermal absorption, single efficacy, easy disruption of the microecology, and insufficient compatibility with sensitive skin in existing scalp anti-inflammatory products, and to provide a highly efficient, gentle, stable, and synergistic scalp care composition and its preparation method.

[0005] To achieve the above objectives, the technical solution adopted by the present invention includes: In a first aspect, the present invention provides a scalp anti-inflammatory and soothing composition comprising the following components in parts by weight: 0.1-2 parts of Alpinia serratifolia extract, 0.5-3 parts of Portulaca oleracea extract, 0.05-0.3 parts of asiaticoside and 0.2-1 parts of β-glucan; The preparation method of the almond and chamomile extract includes the following steps: S1. Add Almond and Piper nigrum to a protective solution containing sodium chloride, trehalose and ascorbic acid and homogenize to obtain a homogenate. S2. Centrifuge the homogenate at a differential speed, collect the supernatant, filter to remove bacteria, and then concentrate by ultrafiltration to obtain the concentrate. S3. Purify the concentrate and collect the 30-150nm fraction to obtain the Almond and Vega extract.

[0006] This invention abandons the conventional methods of preparing plant extracts through high-temperature alcohol extraction and water extraction. Instead, it employs a complete process of low-temperature homogenization, differential centrifugation, ultrafiltration concentration, and fraction screening using a protective solution containing sodium chloride, trehalose, and ascorbic acid. This process yields an Almond-Begonia nanovesicle extract with an average particle size of 30-150 nm and a phospholipid bilayer structure (i.e., Almond-Begonia extract). This process is the core foundation for the efficacy of the entire composition and possesses irreplaceable technical value. On the one hand, the protective solution system can completely preserve the core anti-inflammatory active substances such as flavonoids and sesquiterpene lactones from *Alpinia alpinia*, maximizing the preservation of the raw materials' original anti-inflammatory and antioxidant capabilities. On the other hand, the 30-150nm nanovesicle structure obtained through screening has a high degree of biocompatibility with scalp cell membranes. Unlike ordinary plant extracts that only remain on the surface of the scalp stratum corneum, this nanovesicle can penetrate the dense scalp stratum corneum, reaching the dermis and the inflammatory lesions around the hair follicles, achieving endogenous delivery of active ingredients and significantly improving the bioavailability of active substances. This fundamentally solves the industry problems of poor transdermal penetration, shallow target points, and weak efficacy of existing products. At the same time, these nanovesicles can stably load anti-inflammatory active substances, providing a long-lasting sustained-release effect and extending the soothing effect on the scalp—a technological advantage that ordinary crude extracts of *Alpinia alpinia* cannot achieve.

[0007] Testing revealed that the Alpinia serratifolia nanovesicle extract prepared by this invention possesses clear and stable physicochemical characteristics: the average particle size is controlled within 30-150 nm, and the Zeta potential is -15 to -25 mV; transmission electron microscopy showed that the sample exhibits a complete cup-shaped or spherical vesicle structure, and is rich in phosphatidylcholine, flavonoids, sesquiterpene lactones, and specific plant proteins. The complete structure and enriched active ingredients provide a solid material and structural basis for efficient scalp repair.

[0008] Furthermore, this invention, by defining the compounding range of Alpinia serratifolia extract, Portulaca oleracea extract, asiaticoside, and β-glucan, ensures that each component has a clear role and complementary pharmacological effects, forming a closed-loop efficacy of "rapid anti-inflammatory - immediate soothing of sensitivity - long-lasting barrier repair," achieving a complete repair effect that cannot be achieved by a single ingredient. Specifically, the Alpinia serratifolia nanovesicle extract serves as the core active ingredient, targeting and blocking the NF-κB inflammatory pathway, directly downregulating core inflammatory factors such as IL-6 and TNF-α, and simultaneously clearing scalp free radicals, rapidly relieving acute scalp inflammation such as redness, swelling, burning, and stinging. The alkaloids and flavonoids in the Portulaca oleracea extract synergistically enhance the anti-inflammatory effect of the extract, doubly inhibiting the release of various inflammatory mediators, shortening the time for the resolution of sensitivity and discomfort, and achieving immediate soothing. asiaticoside directionally promotes scalp collagen synthesis and repairs damaged keratin barrier gaps. β-glucan assists in strengthening the scalp's own immune defense and consolidating the barrier structure. The four components, through scientific compounding, can achieve multi-dimensional synergistic repair, enabling the rapid subsidence of acute inflammation, immediate relief of sensitive stinging, and long-term repair of damaged scalp, thus significantly improving the completeness and durability of scalp inflammation improvement.

[0009] Preferably, the total weight ratio of the purslane extract, asiaticoside, and β-glucan is 1-10 times the weight of the almond and chamomile extract.

[0010] Experimental research revealed that the optimized ratio described above is key to balancing the core anti-inflammatory and soothing repair effects of the composition. If the proportion of Almond and Vigna radiata extract is too high, it not only increases raw material costs, but excessive nanovesicles can also cause scalp stickiness and disrupt the scalp's microecology. Conversely, if the proportion is too low, the core anti-inflammatory activity is insufficient, making it difficult to effectively relieve scalp inflammation. The remaining components only provide superficial soothing, leading to recurring inflammation. Within this optimized range, Almond and Vigna radiata nanovesicle extract can fully leverage its transdermal targeted anti-inflammatory advantages. Combined with sufficient amounts of Portulaca oleracea, asiaticoside, and β-glucan, it forms a synergistic system, simultaneously achieving rapid redness reduction and soothing, repairing the scalp barrier, and balancing user experience, long-lasting repair, and production costs.

[0011] Preferably, the composition comprises the following components in parts by weight: 1-2 parts of Alpinia serratifolia extract, 1.5-2.5 parts of Portulaca oleracea extract, 0.15-0.25 parts of asiaticoside and 0.5-0.8 parts of β-glucan.

[0012] Experimental studies have shown that by using the above-mentioned optimized ratio range to precisely quantify and compound each active component, the synergistic effects of the composition, such as anti-inflammatory and soothing properties and barrier repair, can be maximized.

[0013] Preferably, the method for preparing the almond and chamomile extract includes at least one of the following a)-e): a) In step S1, the protective solution comprises the following components at the following mass concentrations: sodium chloride 0.5-1.5%, trehalose 1-3%, and ascorbic acid 0.1-1%; b) In step S1, the specific conditions for homogenization are: homogenizing for 3-8 minutes in an ice bath at 0-4℃ and a rotation speed of 6000-10000 rpm; c) In step S2, the specific method of differential centrifugation is as follows: centrifuge at 200-400×g centrifugal force for 5-15 min, centrifuge at 1800-2200×g centrifugal force for 15-25 min, and centrifuge at 8000-12000×g centrifugal force for 25-35 min in sequence; d) In step S2, ultrafiltration concentration is performed using a 100-300 kDa ultrafiltration membrane; e) In step S3, purification is performed by size exclusion chromatography or gradient ultracentrifugation. The gradient ultracentrifugation conditions are: centrifugation at 90,000-110,000 × g for 60-80 min.

[0014] Experimental studies have shown that the above-mentioned optimized process parameters can stably prepare 30-150nm nano-vesicle extracts of Alpinia buergeriana. Low-temperature ice bath, gradient centrifugation, and precise ratio of protective solution with specific ultrafiltration membrane and purification conditions can completely preserve the activity of flavonoids and sesquiterpene lactones, avoid vesicle damage and activity degradation, ensure uniform vesicle particle size and good biocompatibility, and ensure the basis for the deep anti-inflammatory and repairing effects of the composition.

[0015] Preferably, the composition further comprises the following components in parts by weight: 1-4 parts of microecological regulating component, 3-10 parts of moisturizer, 0.2-0.6 parts of preservative and 0.02-0.2 parts of pH adjuster.

[0016] Preferably, the microecological regulating component includes oligo-α-glucan, which can selectively promote the proliferation of beneficial bacteria on the scalp, inhibit the colonization of harmful bacteria, and maintain the stability of the scalp microecology; the moisturizer includes at least one of glycerin, methyl propylene glycol, and trehalose; the preservative includes benzyl alcohol and / or caprylyl glycol; and the pH adjuster includes triethanolamine and / or citric acid.

[0017] Preferably, the preservative is benzyl alcohol and octyl glycol, and the mass ratio of benzyl alcohol to octyl glycol is (2.5-3.5):1.

[0018] Secondly, the present invention provides a method for preparing the aforementioned anti-inflammatory and soothing scalp composition, comprising the following steps: 1) Mix the moisturizer, microecological regulating components, purslane extract, asiaticoside, β-glucan and water at 35-40℃ to obtain material I; 2) Cool material I to 10-25℃, add almond and chamomile extract and mix to obtain material II; 3) Add preservatives to material II and adjust the pH to 5-6 with a pH adjuster. Filter to sterilize and vacuum degas to obtain the scalp anti-inflammatory and soothing composition.

[0019] Thirdly, the present invention provides the application of the aforementioned anti-inflammatory and soothing scalp composition in the preparation of scalp care products.

[0020] Fourthly, the present invention provides a scalp care product comprising the aforementioned anti-inflammatory and soothing scalp composition.

[0021] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) Based on the multiple pathogenesis mechanisms of sensitive scalp inflammation, barrier damage, and microecological imbalance, this invention specifically combines four functional components. Each component performs its own function and works together to form a complete scalp repair and conditioning system, achieving a synergistic effect. The overall formula efficacy is significantly better than the sum of the effects of each individual component. Among them, Alpinia serratifolia plant-derived extracellular vesicle extract, as the core targeted anti-inflammatory component, can accurately act on the scalp inflammation site and inhibit inflammation activation from the source; Portulaca oleracea extract can effectively clear and inhibit the release of scalp inflammatory mediators, block the spread of inflammation, and relieve scalp inflammatory reactions; Hydroxyasiaticoside focuses on repairing the scalp keratin barrier, repairing the damaged scalp keratin structure, and enhancing the scalp's own protective ability; β-glucan can bidirectionally regulate the scalp skin immune function, improve the scalp immune disorder, and at the same time, it is combined with oligo-α-glucan to precisely regulate the scalp microecology, nourish the beneficial bacteria of the scalp, inhibit the reproduction of harmful bacteria, and fundamentally improve the problem of scalp microecological imbalance.

[0022] (2) This invention uses a 30-150nm plant-derived extracellular vesicle structure to carry the core active ingredient. This vesicle has a natural phospholipid bilayer structure, which is highly homologous to the cell membrane structure of human scalp skin, and has extremely strong skin penetration and biocompatibility. Compared with the drawbacks of conventional water-soluble and lipid-soluble active raw materials that can only act on the surface of the scalp and are difficult to penetrate to the dermal inflammatory sites, the Alpinia buergeriana nanovesicle extract of this invention can quickly penetrate the scalp stratum corneum barrier, accurately target the deep inflammatory lesions of the scalp, and efficiently deliver the core active ingredient to the target site.

[0023] (3) The formula of this invention is mild and non-irritating, with a scalp tolerance rate of 100%. It has no adverse reactions such as redness, stinging, increased itching, or allergies. It is not only suitable for daily care of healthy scalps, but also for sensitive scalps, damaged scalps, inflamed scalps, and other fragile scalp conditions.

[0024] (4) This invention optimizes the molecular structure of the core active ingredients through three technologies: nano-process modification, low-temperature preparation technology, and multi-component compound protection system. Stability tests have confirmed that the composition of this invention retains ≥89% of the active ingredients within a 24-month shelf life under normal storage conditions. Compared with conventional plant extract formulations, the stability is greatly improved, effectively solving the industry problem of poor long-term efficacy of natural active ingredients and serious efficacy decay within the shelf life of the product. Attached Figure Description

[0025] Figure 1 Transmission electron microscopy (TEM) image of the nanovesicle extract of Alpinia buergeriana prepared in Example 1 (scale bar = 100 nm). Figure 2 The particle size distribution of the nanovesicle extract of Alpinia buergeriana prepared in Example 1 (average particle size = 82 nm). Figure 3 Zeta potential distribution of the nanovesicle extract of Alpinia buergeriana prepared in Example 1 (average value = -19.6 mV). Detailed Implementation

[0026] To better illustrate the objectives, technical solutions, and advantages of this invention, the invention will be further described below with reference to specific embodiments. Those skilled in the art should understand that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0027] Unless otherwise specified, all raw materials used in the following examples and comparative examples are commercially available general-purpose materials.

[0028] The purslane extract was purchased from Shanxi Shuohang Biotechnology Co., Ltd., catalog number SHSW-0325-001; asiaticoside was purchased from Shanxi Tiangu Biotechnology Co., Ltd., catalog number TGSW-1022-254; β-glucan was purchased from Shanghai Maclean Biochemical Technology Co., Ltd., catalog number G810699; oligo-α-glucan was purchased from Guangzhou Jinbaolai Biotechnology Co., Ltd., catalog number Kesince A-GO; benzyl alcohol was purchased from Guangzhou Zhongye Chemical Co., Ltd., catalog number 012; caprylyl glycol was purchased from Guangzhou Sinoco Biotechnology Co., Ltd., catalog number 2022; glycerol was purchased from Guangzhou Gongying Chemical Co., Ltd.; trehalose was purchased from Shanxi Ruifeng Peptide Biotechnology Co., Ltd.; methyl propylene glycol was purchased from Guangzhou Xuxiang Chemical Co., Ltd.; triethanolamine was purchased from Shandong Honghe Chemical Co., Ltd.; sodium chloride was purchased from Hunan Kelun Pharmaceutical Co., Ltd., catalog number DA25100805; and ascorbic acid was purchased from Beijing Bailingwei Technology Co., Ltd., catalog number 231406.

[0029] Examples 1-6 Examples 1-6 provide a scalp anti-inflammatory and soothing composition, the formulation of which is shown in Table 1 (total parts by weight: 100 parts).

[0030] Table 1. Formulation table (parts by weight) of the compositions described in Examples 1-6 The almond and chamomile extracts described in Examples 1-2 were prepared using the following method: (1) Raw material processing and homogenization: Take 500g of fresh Almond and Pistil, wash it with ultrapure water, soak it for 30 minutes, then soak it in 75% alcohol for 2 minutes for surface disinfection, and then wash it twice with sterile pure water. Cut the washed Almond and Pistil into small pieces of 1-2cm, put them into a homogenizer, add 300mL of protective solution (0.9% sodium chloride + 2% trehalose + 0.5% ascorbic acid), and homogenize it at 8000rpm for 5min under 4℃ ice bath conditions to obtain homogenate; (2) Differential centrifugation: The above homogenate was centrifuged at 300×g for 10 min and the supernatant was collected; the supernatant was centrifuged at 2000×g for 20 min and the supernatant was collected; the supernatant was centrifuged at 10000×g for 30 min and the final supernatant was collected. (3) Filtration and concentration: The final supernatant was filtered through a 0.22 mm filter membrane and then a Pellicon tangential flow filtration system was used. The system was equipped with a regenerated cellulose membrane pack with a molecular weight cutoff of 300 kDa. The injection pressure was controlled at 1.5 bar, the tangential flow rate was 400 mL / min, and the system temperature was ≤25℃. The supernatant was concentrated to 25 mL to obtain the concentrate. (4) Purification: The above concentrate was purified by size exclusion chromatography using an IZON qEV original column (70nm). Sterile PBS solution (pH=7.4) was used as the eluent. The fractions were collected according to the ultraviolet absorption peak (280nm). The fractions with a particle size of 30-150nm were combined to obtain the Alpinia buergeriana extract. (5) Low temperature storage: Store the above-mentioned almond and chamomile extract at -80℃ in a sealed container and thaw at 2-8℃ before use.

[0031] The almond and chamomile extracts described in Examples 3-4 were prepared using the following method: (1) Raw material processing and homogenization: Take 500g of fresh Almond and Pistil, wash it with ultrapure water, soak it for 30 minutes, then soak it in 75% alcohol for 2 minutes for surface disinfection, and then wash it twice with sterile pure water. Cut the washed Almond and Pistil into small pieces of 1-2cm, put them into a homogenizer, add 300mL of protective solution (0.5% sodium chloride + 3% trehalose + 0.1% ascorbic acid), and homogenize it at 6000rpm for 8min under 4℃ ice bath conditions to obtain homogenate; (2) Differential centrifugation: The above homogenate was centrifuged at 200×g for 15 min and the supernatant was collected; the supernatant was centrifuged at 1800×g for 25 min and the supernatant was collected; the supernatant was centrifuged at 8000×g for 35 min and the final supernatant was collected. (3) Filtration and concentration: The final supernatant was filtered through a 0.22 mm filter membrane and then a Pellicon tangential flow filtration system was used. The system was equipped with a regenerated cellulose membrane pack with a molecular weight cutoff of 100 kDa. The injection pressure was controlled at 1.2 bar, the tangential flow rate was 450 mL / min, and the system temperature was ≤25℃. The supernatant was concentrated to 25 mL to obtain the concentrate. (4) Purification: The above concentrate was purified by size exclusion chromatography using an IZON qEV original column (70nm). Sterile PBS solution (pH=7.4) was used as the eluent. The fractions were collected according to the ultraviolet absorption peak (280nm). The fractions with a particle size of 30-150nm were combined to obtain the Alpinia buergeriana extract. (5) Low temperature storage: Store the above-mentioned almond and chamomile extract at -80℃ in a sealed container and thaw at 2-8℃ before use.

[0032] The almond and chamomile extracts described in Examples 5-6 were prepared using the following method: (1) Raw material processing and homogenization: Take 500g of fresh Almond and Pistil, wash it with ultrapure water, soak it for 30 minutes, then soak it in 75% alcohol for 2 minutes for surface disinfection, then wash it twice with sterile pure water, cut the washed Almond and Pistil into small pieces of 1-2cm, put them into a homogenizer, add 300mL of protective solution (1.5% sodium chloride + 1% trehalose + 1% ascorbic acid), and homogenize it at 10000rpm for 3min under 4℃ ice bath conditions to obtain homogenate; (2) Differential centrifugation: The above homogenate was centrifuged at 400×g for 5 min and the supernatant was collected; the supernatant was centrifuged at 2200×g for 15 min and the supernatant was collected; the supernatant was centrifuged at 12000×g for 25 min and the final supernatant was collected. (3) Filtration and concentration: The final supernatant was filtered through a 0.22 mm filter membrane and then a Pellicon tangential flow filtration system was used. The system was equipped with a regenerated cellulose membrane pack with a molecular weight cutoff of 300 kDa. The injection pressure was controlled at 1.8 bar, the tangential flow rate was 350 mL / min, and the system temperature was ≤25℃. The supernatant was concentrated to 25 mL to obtain the concentrate. (4) Purification: The above concentrate was subjected to gradient ultracentrifugation (100000×g, 4℃, 70min), with sterile PBS solution (pH=7.4) as the elution solution. The fractions were collected according to the ultraviolet absorption peak (280nm), and the fractions with a particle size of 30-150nm were combined to obtain the Alpinia buergeriana extract. (5) Low temperature storage: Store the above-mentioned almond and chamomile extract at -80℃ in a sealed container and thaw at 2-8℃ before use.

[0033] The preparation method of the compositions described in Examples 1-6 includes the following steps: (1) At 38℃ and 320rpm, the humectant, oligo-α-glucan, purslane extract, asiaticoside, β-glucan and water were mixed for 20min to obtain material I; (2) Cool material I to 20°C, add almond and chamomile extract at 150 rpm and mix for 15 min to obtain material II; (3) Add preservative at 25℃ and 200rpm and mix for 10min to obtain material III; (4) Adjust the pH to 5.5 with a pH adjuster, then filter through a 0.22 mm filter membrane for sterilization, vacuum degas for 10 min, fill into a light-proof container under sterile conditions, seal, and sterilize under ultraviolet light at a temperature ≤30℃ for 20 min to obtain the composition.

[0034] Comparative Examples 1-4 Comparative Examples 1-4 provide a composition, the formulation of which is shown in Table 2 (total parts by weight is 100 parts).

[0035] Table 2 Formulation table (parts by weight) of the compositions described in Comparative Examples 1-4 The preparation processes of the almond and chamomile extracts described in Comparative Examples 1-4 are the same as those in Example 1, and the compositions described are also the same as those in Example 1, with the only difference being the formulation.

[0036] Comparative Example 5 This comparative example provides a composition that differs from Example 1 only in that the almond and chamomile extract is prepared using a conventional alcohol extraction method, as detailed below: (1) Raw material pretreatment: Take 500g of fresh Almond Chrysanthemum, wash it with ultrapure water and drain the surface moisture. Place the washed Almond Chrysanthemum in a constant temperature drying oven at 45-50℃ and dry it. Take it out every 2 hours to cool and weigh it until the mass difference between two adjacent weighings is ≤0.2% to reach constant weight. The total drying time is about 12 hours. Take it out and cool it to room temperature, crush it with a pulverizer, pass it through a 40-mesh standard sieve, collect the powder under the sieve, and you will get dried Almond Chrysanthemum powder. Seal and store it for later use.

[0037] (2) Ethanol extraction: Weigh 100g of the above-mentioned dried powder of Alpinia serratifolia and Chrysanthemum morifolium, place it in a 2000mL round-bottom flask, add 800mL of 70% ethanol aqueous solution at a material-to-liquid ratio of 1:8 (g:ml), and soak at room temperature for 60min to fully saturate. Install the round-bottom flask in a reflux extraction apparatus (placed in a fume hood), heat to 80℃, and maintain stable reflux extraction for 2h. During the extraction process, perform magnetic stirring at a speed of 150r / min to ensure thorough extraction. After extraction, stop heating, cool to room temperature, let stand for 30min, and then use a Buchner funnel with qualitative filter paper (pore size 15-20μm) to perform vacuum filtration and collect the filtrate; (3) Secondary extraction: Transfer the filter residue from step (2) back to the round-bottom flask, add 800 mL of 70% ethanol aqueous solution, and perform a second extraction under the same conditions (reflux extraction at 80℃ for 2 h, stirring at 150 r / min). After extraction, cool to room temperature, let stand for 30 min, filter under reduced pressure using the same method, and collect the secondary filtrate; (4) Combining and Concentration: Combine the filtrates obtained in steps (2) and (3), place them in a rotary evaporator, set the water bath temperature to 50°C and the vacuum degree to -0.08MPa, concentrate under reduced pressure and recover ethanol until there is no alcohol taste, and obtain a brownish viscous paste, which is the conventional alcohol-extracted almond and chamomile extract. (5) Storage: Store the obtained extract in a sealed container in a refrigerator at 4°C away from light for later use.

[0038] Comparative Example 6 This comparative example provides a composition that differs from Example 1 only in that an equal amount of calendula extract is used instead of purslane extract.

[0039] Test Example 1: Verification of Anti-inflammatory Efficacy One hundred and twenty volunteers (aged 20-50 years) with scalp redness, itching, and other inflammatory problems were selected and randomly divided into 12 groups of 10 people each. Each group used the products from Examples 1-6 and Comparative Examples 1-6, respectively, three times a week for four consecutive weeks. The improvement rate of scalp redness and the inhibition rate of inflammatory factors IL-6 and TNF-α were measured after four weeks of use. The results are shown in Table 3.

[0040] Detection methods: A scalp redness detection instrument (Gushang hair follicle detector) was used to calculate the redness improvement rate. IL-6 and TNF-α levels were detected using an ELISA kit, and the inhibition rate was calculated according to the following formula.

[0041] (1) Redness improvement rate (%) = (Redness index before product use - Redness index after product use) / Redness index before product use × 100%; (2) IL-6 inhibition rate (%) = (IL-6 content before use - IL-6 content after use) ÷ IL-6 content before use × 100%; (3) TNF-α inhibition rate (%) = (TNF-α content before use − TNF-α content after use) ÷ TNF-α content before use × 100%.

[0042] Table 3 The above results indicate that the compounding of Alpinia serratifolia extract with Portulaca oleracea, asiaticoside, and β-glucan in a specific ratio in this invention significantly improved the redness reduction rate and inhibited the inflammatory factors compared to the control formulations, demonstrating outstanding overall anti-inflammatory and soothing effects. Comparative Example 5, which used conventional alcohol extraction to prepare Alpinia serratifolia extract, showed even worse efficacy, confirming that the nanovesicle process effectively preserves active ingredients, enhances transdermal absorption, and significantly improves the efficacy of the raw materials. Comparative Examples 1-4, while maintaining the total amount of active ingredients, retained only one or two of the four active ingredients, resulting in a significant decrease in the formula's repair and anti-inflammatory capabilities, demonstrating a significant synergistic effect among the four active ingredients. Furthermore, replacing the active ingredients in Example 6 resulted in a certain degree of attenuation in the anti-inflammatory and redness-soothing effects of the resulting composition, confirming that the specific active ingredients selected in this invention are the core foundation for achieving synergistic anti-inflammatory and skin redness-improving effects; only by using the component compounding system defined in this invention can the active ingredients better form a synergistic effect, thereby significantly improving the overall efficacy of the composition.

[0043] Test Example 2: Verification of the efficacy of scalp microecological regulation 120 volunteers (aged 20-45 years, with dandruff and itching problems) were randomly divided into 12 groups of 10 each. Each group used the products from Examples 1-6 and Comparative Examples 1-6 for 4 consecutive weeks. The inhibition rate of harmful bacteria (Malassezia), the improvement rate of dandruff, and the relief rate of itching were measured after 4 weeks of use. The results are shown in Table 4.

[0044] A 1cm sample of the subject's scalp was scraped using a sterile cotton swab. 2 The scales and secretions from the area were placed in an EP tube containing 1 mL of sterile physiological saline, vortexed for 1 min, and 100 µL of the suspension was spread onto a plate of Malassezia-specific culture medium (Leeming & Notman medium). The plate was incubated at 32 °C for 72 h, and the colony forming units (CFU) were counted.

[0045] (1) Harmful bacteria inhibition rate (%) = (Number of harmful bacteria before use - Number of harmful bacteria after use) / Number of harmful bacteria before use × 100%; (2) Dandruff improvement rate = (number of people whose dandruff improved effectively / total number of people in the group) × 100%; Judgment criteria: A reduction of ≥50% in the area and amount of dandruff compared to before use indicates effective improvement in dandruff, as determined by instrument detection; (3) Itching relief rate (%) = (Number of people whose itching was effectively relieved / Total number of people in this group) × 100%; Judgment criteria: A reduction of ≥50% in the degree of itching compared to before use indicates effective relief of itching, and is assessed by the volunteers themselves.

[0046] Table 4 The above results show that the composition prepared by the specific scheme of the present invention has a significantly higher inhibition rate against Malassezia, a higher dandruff improvement rate, and a higher itch relief rate than the comparative example. It can effectively inhibit harmful bacteria, improve the imbalance of scalp microecology, and solve the problems of inflammation, dandruff, and itching of sensitive scalp.

[0047] Test Example 3: Stability Verification of Active Ingredients Five portions of each of the products from Examples 1-2 and Comparative Examples 3-5 were individually packaged and stored at room temperature (25°C) for 24 months. Samples were taken at 0, 6, 12, and 24 months. The content of the core active ingredient (total flavonoids) in the Alpinia buergeriana extract was detected by high performance liquid chromatography, and the retention rate of the active ingredient was calculated. The results are shown in Table 5.

[0048] Retention rate of active ingredients (%) = (content of active ingredients after N months of storage / content of active ingredients after 0 months) × 100%.

[0049] Table 5 The above results indicate that the scalp anti-inflammatory and soothing composition containing *Alpinia buergeriana* extract of this invention exhibits a significantly higher retention rate of active ingredients than Comparative Example 5, which uses a conventional ethanol extraction process. This confirms that the nanovesicle extraction system employed in this invention effectively protects the active substances in the extract, significantly improves the stability of the finished product, and demonstrates performance superior to traditional ethanol extraction methods. Furthermore, after removing other functional components from the compound system in Comparative Examples 3-4, the activity retention rate of the composition decreased simultaneously, indicating that the auxiliary components synergistically stabilize the activity of *Alpinia buergeriana* extract, and a complete compound system is crucial for maintaining high activity retention.

[0050] Test Example 4: Mildness Test Thirty volunteers with sensitive skin (aged 18-45 years, all with scalp sensitivity and redness) were selected and randomly divided into three groups of 10 each. They used Examples 1-2 and Comparative Example 5 for 28 consecutive days, and the tolerance rate was calculated. The results are shown in Table 6.

[0051] Tolerance rate (%) = (Number of volunteers who had no adverse reactions after using the product / Total number of participants in this group) × 100%.

[0052] Table 6 The above results indicate that the scalp anti-inflammatory and soothing composition containing almond and chamomile extract provided by the present invention is mild and non-irritating, with a tolerance rate of 100%. This demonstrates that the formulation design and preparation process of the present invention can effectively reduce product irritation and is suitable for use on sensitive scalps.

[0053] Test Example 5: In vitro anti-inflammatory efficacy verification The RAW264.7 macrophage inflammation model was induced by LPS. The samples of Examples 1-2 and Comparative Examples 1-6 were diluted with culture medium to 100 μg / mL. The inhibition rate of nitric oxide (NO) release and the inhibition rate of IL-6 and TNF-α secretion were detected. Each group was set with 6 replicates and repeated 3 times. The results of the in vitro anti-inflammatory experiment are shown in Table 7.

[0054] Table 7 The above results demonstrate that the composition prepared by the specific method of this invention can significantly inhibit the secretion of inflammatory factors induced by LPS stimulation, verifying the anti-inflammatory mechanism of the composition at the cellular level. However, if only the traditional alcohol extraction process is used to prepare the almond and chamomile extract and it is combined with other ingredients, or if any functional active component is missing from the compound system, the composition's ability to block the release of inflammatory factors is significantly weakened. This further confirms that the specific preparation process and the complete component compound system of this invention are the dual keys to ensuring excellent anti-inflammatory activity.

[0055] Test Example 6: Characterization of Nanovesicle Structure The structure of the almond and chamomile extract obtained in Example 1 was characterized as follows: 1. Transmission electron microscopy (TEM): After the sample was negatively stained with phosphotungstic acid, it was observed under a transmission electron microscope. Clear and complete spherical / cup-shaped vesicle structures were visible, with a scale bar of 100 nm. There was no aggregation or damage. 2. Particle size and Zeta potential: Dynamic light scattering (DLS) was used to detect the average particle size, which was 30-150 nm, with the main peak concentrated at 82 nm. The PDL value was 0.16, and the Zeta potential was -15 to -25 mV, with an average value of -19.6 mV. The system was stable and homogeneous. 3. Composition analysis: Contains phosphatidylcholine (characteristic lipid), flavonoids, sesquiterpene lactones (characteristic active substances), plant heat shock proteins, and membrane transport proteins (characteristic marker proteins), which are consistent with the typical composition of plant-derived extracellular vesicles.

[0056] In summary, the scalp anti-inflammatory and soothing composition containing *Alpinia serratifolia* extract provided by this invention possesses excellent anti-inflammatory, redness-soothing, microecological regulation, and barrier repair effects, and is gentle, safe, and stable. By optimizing the nanovesicle preparation process of *Alpinia serratifolia* extract and combining it with purslane extract, asiaticoside, β-glucan, and oligo-α-glucan, a synergistic effect of rapid anti-inflammatory and long-lasting soothing and repairing is achieved, overcoming many shortcomings of existing scalp anti-inflammatory products.

[0057] Finally, it should be noted that the above embodiments are used to illustrate the technical solutions of the present invention and not to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A scalp anti-inflammatory and soothing composition, characterized in that, The composition comprises the following components in parts by weight: 0.1-2 parts of Alpinia serratifolia extract, 0.5-3 parts of Portulaca oleracea extract, 0.05-0.3 parts of asiaticoside, and 0.2-1 parts of β-glucan; The preparation method of the almond and chamomile extract includes the following steps: S1. Add Almond and Piper nigrum to a protective solution containing sodium chloride, trehalose and ascorbic acid and homogenize to obtain a homogenate. S2. Centrifuge the homogenate at a differential speed, collect the supernatant, filter to remove bacteria, and then concentrate by ultrafiltration to obtain the concentrate. S3. Purify the concentrate and collect the 30-150nm fraction to obtain the Almond and Vega extract.

2. The scalp anti-inflammatory and soothing composition as described in claim 1, characterized in that, The total weight of the purslane extract, asiaticoside, and β-glucan is 1-10 times the weight of the almond and chamomile extract.

3. The scalp anti-inflammatory and soothing composition as described in claim 2, characterized in that, The composition comprises the following components in parts by weight: 1-2 parts of Alpinia serratifolia extract, 1.5-2.5 parts of Portulaca oleracea extract, 0.15-0.25 parts of hydroxyascorbic acid and 0.5-0.8 parts of β-glucan.

4. The scalp anti-inflammatory and soothing composition as described in claim 1, characterized in that, The preparation method of the almond and chamomile extract includes at least one of the following a)-e): a) In step S1, the protective solution comprises the following components at the following mass concentrations: sodium chloride 0.5-1.5%, trehalose 1-3%, and ascorbic acid 0.1-1%; b) In step S1, the specific conditions for homogenization are: homogenizing for 3-8 minutes in an ice bath at 0-4℃ and a rotation speed of 6000-10000 rpm; c) In step S2, the specific method of differential centrifugation is as follows: centrifuge at 200-400×g centrifugal force for 5-15 min, centrifuge at 1800-2200×g centrifugal force for 15-25 min, and centrifuge at 8000-12000×g centrifugal force for 25-35 min in sequence; d) In step S2, ultrafiltration concentration is performed using a 100-300 kDa ultrafiltration membrane; e) In step S3, purification is performed by size exclusion chromatography or gradient ultracentrifugation. The gradient ultracentrifugation conditions are: centrifugation at 90,000-110,000 × g for 60-80 min.

5. The scalp anti-inflammatory and soothing composition as described in claim 1 or 2, characterized in that, The composition further includes the following components in parts by weight: 1-4 parts of microecological regulating component, 3-10 parts of moisturizer, 0.2-0.6 parts of preservative and 0.02-0.2 parts of pH adjuster.

6. The scalp anti-inflammatory and soothing composition as described in claim 5, characterized in that, The microecological regulating component includes oligo-α-glucan; the humectant includes at least one of glycerin, methyl propylene glycol and trehalose; the preservative includes benzyl alcohol and / or octyl glycol; and the pH adjuster includes triethanolamine and / or citric acid.

7. The scalp anti-inflammatory and soothing composition as described in claim 6, characterized in that, The preservatives are benzyl alcohol and octyl glycol, and the mass ratio of benzyl alcohol to octyl glycol is (2.5-3.5):

1.

8. A method for preparing the scalp anti-inflammatory and soothing composition according to any one of claims 5-7, characterized in that, Includes the following steps: 1) Mix the moisturizer, microecological regulating components, purslane extract, asiaticoside, β-glucan and water at 35-40℃ to obtain material I; 2) Cool material I to 10-25℃, add almond and chamomile extract and mix to obtain material II; 3) Add preservatives to material II and adjust the pH to 5-6 with a pH adjuster. Filter to sterilize and vacuum degas to obtain the scalp anti-inflammatory and soothing composition.

9. The use of the scalp anti-inflammatory and soothing composition according to any one of claims 1-7 in the preparation of scalp care products.

10. A scalp care product, characterized in that, The scalp care product includes the scalp anti-inflammatory and soothing composition as described in any one of claims 1-7.

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