Scalp itching relieving composition and application thereof

Abstract

The invention relates to the technical field of scalp care, and discloses a scalp itching relieving composition and application thereof.The scalp itching relieving composition is mainly composed of forsythin, isatis tinctoria extract, cinchona alkaloid, a pH regulator and a solvent and can be used for shampoo, hair conditioners, scalp essence, scalp spray and hair masks. The fructus forsythiae phenol, the isatis tinctoria extract and the cinchona alkaloid in the scalp itching-relieving composition have a remarkable synergistic effect, and the scalp itching-relieving composition is efficient in itching-relieving effect, long-acting, mild, safe, low in irritation and suitable for various scalp types.

Description

Technical Field

[0001] This invention relates to the field of scalp care technology, and more particularly to a scalp anti-itch composition and its application. Background Technology

[0002] Scalp itching is a common scalp problem with complex causes, mainly related to factors such as scalp microecological imbalance, excessive proliferation of fungi such as Malassezia, scalp inflammation, and damage to the scalp barrier. Long-term scalp itching not only affects quality of life but may also be accompanied by secondary problems such as increased dandruff, scalp redness and swelling, and hair loss, and in severe cases, can damage the health of the scalp.

[0003] Currently, most scalp itch relief products on the market use chemical antipruritics (such as clomibazole, ketoconazole, etc.). Although they can quickly relieve itching symptoms, long-term use can easily lead to drug resistance. In addition, some chemical ingredients are highly irritating and may damage the scalp barrier, causing side effects such as scalp sensitivity and dryness. They are especially unsuitable for people with sensitive skin.

[0004] Natural plant extracts are widely used in scalp care due to their gentleness, safety, and minimal side effects. Forsythoside, a core active ingredient extracted from the pericarp / leaf of the Oleaceae plant Forsythia, exhibits significant antibacterial and anti-inflammatory effects. Isatis tinctoria (a plant in the Brassicaceae family) extract is rich in active ingredients such as indirubin and indigo, possessing anti-inflammatory, soothing, and antibacterial properties. Cinchona alkaloids, primarily derived from the bark of the cinchona tree and related species in the Rubiaceae family, with quinine as its core compound, possess antibacterial, antipruritic, and scalp microecological regulating effects. While there are reports of using these ingredients individually for skin care, no technology has yet been found to combine forsythoside, isatis tinctoria extract, and cinchona alkaloids to utilize the synergistic effects of their compounds to prepare an antipruritic scalp composition. Furthermore, the antipruritic effects of existing single-ingredient formulations are limited, failing to achieve the dual purpose of long-lasting antipruritic effects and the scalp repair benefits of isatis tinctoria extract.

[0005] Based on this, the present invention combines the compound properties of forsythoside, isatis extract and cinchona alkaloids to design a scalp anti-itch composition with significant synergistic effect, mild and safe, and long-lasting anti-itch effect, solving the technical problems of strong irritation and poor effect of existing scalp anti-itch products. Summary of the Invention

[0006] In view of the shortcomings of the prior art, the technical problem solved by the present invention is to provide a scalp anti-itch composition that is effective, mild, safe and long-lasting, so as to solve the problems of strong irritation and poor effect of existing scalp anti-itch products.

[0007] To solve the above-mentioned technical problems, the present invention provides a scalp itch relief composition, which is composed of the following components in parts by weight: Forsythoside 1-4 parts; Isatis indigotica extract 2-9 parts; Cinchona alkaloids 0.5–2.5 parts; 10-14 parts of moisturizer; Emulsifier 1-3 parts; Preservative 0.5-2 parts; Fragrance 0.1–0.3 parts; pH adjuster 0.1-0.3 parts; Solvent: 17-101 parts; The method for preparing the scalp anti-itch composition includes the following steps: (1) Raw material pretreatment: Wash, dry and crush the roots and leaves of Isatis indigotica, add a solvent with a mass concentration of 70%-80%, and reflux extract at 50-60℃ for 2-3 times, 1-2 hours each time. Combine the extracts, filter and concentrate under reduced pressure until there is no solvent taste to obtain Isatis indigotica extract. Store at low temperature for later use to avoid degradation of components such as indigo and indigo due to high temperature and light. (2) Dissolution of core components: Take the prescribed amount of forsythoside and cinchona alkaloids, add an appropriate amount of solvent with a mass concentration of 70%-80%, stir until completely dissolved, and obtain a solution of core active components; (3) Mixing of excipients: Add the formula amount of humectant, emulsifier and preservative to the solvent, stir until completely dissolved, heat to 60-70℃, keep warm for 10-15 minutes, and cool to below 40℃; (4) Mixing and homogenizing: Add the core active ingredient solution prepared in step (2) and the isatis extract prepared in step (1) to the solution prepared in step (3), stir evenly, add pH adjuster to adjust pH value to 5.0-6.5, add fragrance, homogenize for 5-10 minutes to obtain scalp anti-itch composition; (5) Packaging and testing: The above-mentioned anti-itch scalp composition is subjected to microbial testing, pH testing and stability testing. After passing the test, it is packaged, sealed and stored in the dark to prevent the active ingredients in cinchona alkaloids and isatis extract from discoloring or degrading when exposed to light.

[0008] Furthermore, the moisturizer is one or more of glycerin, propylene glycol, hyaluronic acid, ceramide, and panthenol, used to replenish scalp moisture, repair the scalp barrier, relieve itching caused by scalp dryness, and synergize with the barrier repair effect of Isatis indigotica extract to further improve scalp comfort.

[0009] Furthermore, the emulsifier is one or more of Tween-80, Span-60, and PEG-40 hydrogenated castor oil, used to uniformly disperse the core active ingredients in the composition to improve product stability, prevent component stratification, and enhance the skin feel of the product for easier scalp absorption.

[0010] Furthermore, the preservative is one or more of phenoxyethanol, ethylhexylglycerin, and sodium benzoate, used to inhibit the growth of harmful microorganisms in the product, extend the product's shelf life, and select mild preservatives to avoid irritating the scalp. It also works synergistically with the antibacterial effect of the core active ingredient to improve product safety.

[0011] Furthermore, the pH adjuster is one or more of citric acid, sodium hydroxide, and triethanolamine, used to adjust the pH value of the composition to 5.0-6.5, consistent with the normal pH value of the scalp, to avoid irritating the scalp, while maintaining the stability of the core active ingredients.

[0012] Furthermore, the solvent is one or more of deionized water and ethanol, used to dissolve or disperse the core active ingredients and excipients. Ethanol can help dissolve forsythoside and cinchona alkaloids, improve the solubility and absorption efficiency of the ingredients, and also has a certain antibacterial effect, thus synergistically enhancing the effects of the core active ingredients.

[0013] Furthermore, the scalp itch relief composition can be used in shampoos, conditioners, scalp serums, scalp sprays, and hair masks.

[0014] Compared with existing technologies, the present invention has the following advantages: 1. Significant synergistic effect, highly effective and long-lasting antipruritic effect: By utilizing the complementary properties of forsythoside, isatis extract and cinchona alkaloids, a synergistic effect of antibacterial, anti-inflammatory and antipruritic effects is achieved. It can not only quickly relieve scalp itching symptoms, but also regulate the scalp microecology and repair the scalp barrier from the root, and prevent itching from recurring. Experimental verification shows that after using the composition of this invention, the scalp itching relief rate can reach more than 90%, and the antipruritic effect lasts for more than 48 hours. 2. Gentle and safe with low irritation: The core active ingredients are all alkaloids from natural sources or natural plant extracts, avoiding the use of strong chemical antipruritic agents. The pH value is consistent with the normal pH value of the scalp, making it suitable for all types of scalp. Detailed Implementation

[0015] The specific implementation methods of the present invention will be further described below with reference to examples and experiments, but these are not intended to limit the present invention.

[0016] Unless otherwise specified, the raw materials, reagents or devices used in the various embodiments of the present invention can be obtained from conventional commercial sources or by existing known methods.

[0017] A scalp itch relief composition, comprising the following components in parts by weight, as shown in Table 1 below: Table 1

[0018] Forsythol: Chemical name is Forsythol, molecular formula is C 15 H 18 O7, with a molecular weight of 310.29, is a brownish-yellow powder with hygroscopic properties. It is soluble in ethanol and sodium hydroxide solution, but insoluble in ether, chloroform, and petroleum ether. It reacts with FeCl3 reagent to produce a green color. It is a natural organic compound extracted from the pericarp / leaf of Forsythia suspensa, a plant in the Oleaceae family. It is one of the core components of Forsythia suspensa, which exerts its effects of clearing heat and detoxifying, reducing swelling and dissipating nodules. Its compound properties determine its significant antibacterial activity, especially against Staphylococcus aureus, Shigella dysenteriae, and Malassezia, a common fungus on the scalp. It also inhibits the expression of pro-inflammatory factors such as TNF-α and IL-6, alleviating scalp inflammation and reducing itching symptoms at the root. Its natural origin results in extremely low irritation, making it suitable for all scalp types, especially sensitive scalps.

[0019] Isatis indigotica extract: derived from the roots, leaves, or whole plant of Isatis indigotica Fort., a plant belonging to the Brassicaceae family. Its core compounds include indole alkaloids (indirubin, indigo), organic acids (sinapic acid, syringic acid), and flavonoids (isovitrin, isohesperidin). Indirubin and indigo are fat-soluble pigments, sensitive to light and heat, and are the main anti-inflammatory active ingredients, inhibiting the NF-κB and MAPK inflammatory pathways and reducing pro-inflammatory factor levels. Sinapic acid and syringic acid are water-soluble components, pH-sensitive, and have strong antioxidant effects, scavenging free radicals on the scalp and reducing oxidative damage. Flavonoids have moderate polarity and can assist in anti-inflammation and protect scalp cells. The compound properties of Isatis indigotica extract give it anti-inflammatory, antibacterial, antioxidant, and scalp barrier repair effects. It can soothe scalp sensitivity and redness, repair damaged scalp barriers, and reduce the impact of external stimuli on the scalp, thereby helping to relieve itching. At the same time, its mild nature can synergistically enhance the effects of forsythoside and cinchona alkaloids, reducing the dosage of single ingredients and improving the safety and effectiveness of the composition. Moreover, it is widely available and low in cost, making it suitable for large-scale application.

[0020] Cinchona alkaloids: mainly derived from the bark of the cinchona tree (family Rubiaceae) and related species; the core compound is quinine (cinchona bark), with the molecular formula C64. 20 H 24 N₂O₂, with a molecular weight of 324.417, appears as needle-like orthorhombic crystals, is odorless, and has a density of 1.21 g / cm³. 3It has a melting point of 176-177℃, a boiling point of 495.9℃, and a refractive index of 1.625 (15℃). It is stable under normal temperature and pressure, but easily discolors when exposed to light. It needs to be stored in a sealed, cool, and dry place. Its acidic sulfate form is more water-soluble. This type of alkaloid has significant antibacterial and antipruritic effects. It can disrupt the integrity of scalp fungal cell membranes, inhibit the reproduction of harmful scalp microorganisms such as Malassezia, and regulate the sensitivity of scalp nerve endings, quickly relieving itching symptoms. Its compound properties also give it a certain anti-inflammatory synergistic effect, which can enhance the anti-inflammatory effects of forsythoside and isatis extract, and prolong the duration of antipruritic effect, preventing recurrence of itching. At the same time, it has good compatibility with natural plant ingredients, which can reduce the use of chemical antipruritic agents and reduce product irritation. Its antibacterial spectrum is broad, and it has an inhibitory effect on a variety of harmful scalp bacteria, further enhancing the antipruritic effect of the composition.

[0021] The preparation method of the antipruritic composition of Examples 1 to 3 above includes the following steps: (1) Raw material pretreatment: Wash, dry and crush the roots and leaves of Isatis indigotica, add 70%-80% ethanol, and reflux extract at 50-60℃ for 2-3 times, 1-2 hours each time. Combine the extracts, filter and concentrate under reduced pressure until there is no ethanol smell to obtain Isatis indigotica extract. Store at low temperature for later use to avoid degradation of components such as indigo and indigo due to high temperature and light. (2) Dissolution of core components: Take the prescribed amount of forsythoside and cinchona alkaloids, add an appropriate amount of 70%-80% ethanol, stir until completely dissolved, and obtain a solution of core active components. (3) Mixing of excipients: Add the formula amount of moisturizer, emulsifier and preservative to deionized water, stir until completely dissolved, heat to 60-70℃, keep warm for 10-15 minutes, and cool to below 40℃; (4) Mixing and homogenizing: Add the core active ingredient solution prepared in step (2) and the isatis extract prepared in step (1) to the solution prepared in step (3), stir evenly, add pH adjuster to adjust pH value to 5.0-6.5, add fragrance, homogenize for 5-10 minutes to obtain scalp anti-itch composition; (5) Packaging and testing: The above-mentioned anti-itch scalp composition is subjected to microbial testing, pH testing and stability testing. After passing the test, it is packaged, sealed and stored in the dark to prevent the active ingredients in cinchona alkaloids and isatis extract from discoloring or degrading when exposed to light.

[0022] Furthermore, the moisturizer is one or more of glycerin, propylene glycol, hyaluronic acid, ceramide, and panthenol, used to replenish scalp moisture, repair the scalp barrier, relieve itching caused by scalp dryness, and synergize with the barrier repair effect of Isatis indigotica extract to further improve scalp comfort.

[0023] Furthermore, the emulsifier is one or more of Tween-80, Span-60, and PEG-40 hydrogenated castor oil, used to uniformly disperse the core active ingredients in the composition to improve product stability, prevent component stratification, and enhance the skin feel of the product for easier scalp absorption.

[0024] Furthermore, the preservative is one or more of phenoxyethanol, ethylhexylglycerin, and sodium benzoate, used to inhibit the growth of harmful microorganisms in the product, extend the product's shelf life, and select mild preservatives to avoid irritating the scalp. It also works synergistically with the antibacterial effect of the core active ingredient to improve product safety.

[0025] Furthermore, the pH adjuster is one or more of citric acid, sodium hydroxide, and triethanolamine, used to adjust the pH value of the composition to 5.0-6.5, consistent with the normal pH value of the scalp, to avoid irritating the scalp, while maintaining the stability of the core active ingredients.

[0026] Furthermore, the solvent is one or more of deionized water and ethanol, used to dissolve or disperse the core active ingredients and excipients. Ethanol can help dissolve forsythoside and cinchona alkaloids, improve the solubility and absorption efficiency of the ingredients, and also has a certain antibacterial effect, thus synergistically enhancing the effects of the core active ingredients.

[0027] Furthermore, the above-mentioned scalp itch relief composition can be used in shampoos, conditioners, scalp serums, scalp sprays, and hair masks.

[0028] To better verify the synergistic effect of the core active ingredients forsythoside, isatis extract, and cinchona alkaloids, Examples 4 to 6 were conducted for mild, moderate, and severe scalp itching scenarios. Only the mass fraction of the core active ingredients was adjusted, while the mass fractions of other components remained unchanged. The mass fractions of the components are shown in Table 2 below. Table 2 Unit: copies

[0029] The preparation method of Example 4 above includes the following steps: (1) Preparation of Isatis indigotica extract: Wash, dry and crush 2 parts of Isatis indigotica root / leaf, add 20 parts of 80% ethanol solution, reflux extract at 60℃ 3 times, 1 hour each time, combine the extracts, filter, concentrate under reduced pressure until there is no ethanol taste, and store at low temperature for later use. (2) Dissolution of core components: Take 1.0 part of forsythoside and 0.5 part of cinchona alkaloid, add 6 parts of 80% ethanol solution, stir until completely dissolved, and obtain the core active component solution; (3) Mixing of excipients: Add 10 parts of propylene glycol, 0.5 parts of ceramide, 2 parts of panthenol, 1 part of PEG-40 hydrogenated castor oil, and 0.5 parts of phenoxyethanol to 1 part of deionized water, stir until completely dissolved, heat to 60°C, keep warm for 10 minutes, and cool to 35°C. (4) Mixing and homogenizing: Add the core active ingredient solution and 5.0 parts of Isatis indigotica extract to the above excipient solution, stir evenly, add 0.1 parts of triethanolamine to adjust the pH value to 6.0, then add 0.1 parts of fragrance, homogenize for 10 minutes to obtain a mild scalp itch relief essence; 5. Packaging Testing: Test the microbial indicators, pH value, and stability of the essence. After passing the tests, repackage, seal, and store in the dark.

[0030] The preparation method of Example 5 above includes the following steps: (1) Preparation of Isatis indigotica extract: Wash, dry and crush 7 parts of Isatis indigotica root / leaf, add 70 parts of 80% ethanol solution, reflux extract at 60℃ 3 times, 1 hour each time, combine the extracts, filter, concentrate under reduced pressure until there is no ethanol taste, and store at low temperature for later use. (2) Dissolution of core components: Take 1.0 part of forsythoside and 0.5 part of cinchona alkaloid, add 8 parts of 80% ethanol solution, stir until completely dissolved, and obtain the core active component solution; (3) Mixing of excipients: Add 10 parts of propylene glycol, 0.5 parts of ceramide, 2 parts of panthenol, 1 part of PEG-40 hydrogenated castor oil, and 0.5 parts of phenoxyethanol to 1 part of deionized water, stir until completely dissolved, heat to 60°C, keep warm for 10 minutes, and cool to 35°C. (4) Mixing and homogenizing: Add the core active ingredient solution and 5.0 parts of Isatis indigotica extract to the above excipient solution, stir evenly, add 0.1 parts of triethanolamine to adjust the pH value to 6.2, then add 0.1 parts of fragrance, homogenize for 10 minutes to obtain a mild scalp itch relief essence; 5. Packaging Testing: Test the microbial indicators, pH value, and stability of the essence. After passing the tests, repackage, seal, and store in the dark.

[0031] The preparation method of Example 6 above includes the following steps: (1) Preparation of Isatis indigotica extract: Wash, dry and crush 9 parts of Isatis indigotica root / leaf, add 90 parts of 80% ethanol solution, reflux extract at 60℃ 3 times, 1 hour each time, combine the extracts, filter, concentrate under reduced pressure until there is no ethanol taste, and store at low temperature for later use. (2) Dissolution of core components: Take 1.0 part of forsythoside and 0.5 part of cinchona alkaloid, add 10 parts of 80% ethanol solution, stir until completely dissolved, and obtain the core active component solution; (3) Mixing of excipients: Add 10 parts of propylene glycol, 0.5 parts of ceramide, 2 parts of panthenol, 1 part of PEG-40 hydrogenated castor oil, and 0.5 parts of phenoxyethanol to 1 part of deionized water, stir until completely dissolved, heat to 60°C, keep warm for 10 minutes, and cool to 35°C. (4) Mixing and homogenizing: Add the core active ingredient solution and 5.0 parts of Isatis indigotica extract to the above excipient solution, stir evenly, add 0.1 parts of triethanolamine to adjust the pH value to 6.3, then add 0.1 parts of fragrance, homogenize for 10 minutes to obtain a mild scalp itch relief essence; 5. Packaging Testing: Test the microbial indicators, pH value, and stability of the essence. After passing the tests, repackage, seal, and store in the dark.

[0032] Example 1: Efficacy Verification: Forty volunteers with mild scalp itching (occasional itching, no redness or swelling, no obvious dandruff) were selected and used the scalp serum of this example once a day for one week. Three core tests were conducted simultaneously, with the following results: 1. Histamine Test: After use, the amount of histamine released from the volunteers' scalp decreased by 72.5% compared to before use, effectively inhibiting histamine release associated with mild itching and quickly relieving occasional itching; 2. Hyaluronidase Inhibition Rate Test: The scalp serum had a hyaluronidase inhibition rate of 65.3%, gently inhibiting mild scalp inflammation and maintaining scalp homeostasis; 3. Red Blood Cell Hemolysis Test: The hemolysis rate was only 0.7%, far below the safety threshold of 5%, proving that the product is mild and non-irritating, suitable for daily maintenance. Volunteer results showed that 93% of volunteers experienced complete relief of scalp itching symptoms, improved scalp comfort, no irritation, and the anti-itch effect lasted for more than 48 hours.

[0033] Example 2: Efficacy Verification: Forty-five volunteers with moderate scalp itching (frequent itching, mild redness and swelling, and slightly damaged scalp barrier) were selected and used the scalp serum of this example once a day for two consecutive weeks. Three core tests were conducted simultaneously, with the following results: 1. Histamine Test: After use, the amount of histamine released from the volunteers' scalp decreased by 83.6% compared to before use, rapidly inhibiting histamine-mediated frequent itching and relieving scalp discomfort; 2. Hyaluronidase Inhibition Rate Test: The scalp serum had a hyaluronidase inhibition rate of 80.2%, effectively inhibiting scalp inflammation, reducing scalp redness and swelling, and assisting in repairing the slightly damaged scalp barrier; 3. Hemolysis Test: The hemolysis rate was only 0.9%, far below the safety threshold of 5%, proving that the product is mild and non-irritating and suitable for long-term use. Volunteer results showed that 96% of volunteers experienced complete relief of scalp itching symptoms, reduction of scalp redness and swelling, significant repair of the scalp barrier, increased scalp moisture content, no irritation, and an anti-itch effect lasting for more than 72 hours.

[0034] Example 3: Efficacy Verification: Forty volunteers with severe scalp itching (persistent itching, significant redness and swelling, and severely damaged scalp barrier) were selected and used the scalp serum of this example once daily for three consecutive weeks. Three core tests were conducted simultaneously, with the following results: 1. Histamine Test: After use, the amount of histamine released from the volunteers' scalp decreased by 90.1% compared to before use, effectively inhibiting histamine release and quickly relieving persistent itching; 2. Hyaluronidase Inhibition Rate Test: The scalp serum had a hyaluronidase inhibition rate of 88.7%, strongly inhibiting scalp inflammation pathways, quickly reducing scalp redness and swelling, and accelerating the repair of damaged scalp barrier; 3. Hemolysis Test: The hemolysis rate was 1.3%, below the safety threshold of 5%, indicating that the product is mild and safe to use even on damaged scalps. Volunteer results showed that 95% of volunteers experienced complete relief of scalp itching symptoms, reduction of scalp redness and swelling, good restoration of the scalp barrier, no irritation, and an anti-itch duration of over 96 hours.

[0035] In vitro test data: (a) Histamine release inhibition rate test (core data on antipruritic mechanism) 1. Detection method: Rat peritoneal mast cell culture method was used, and the specific steps are as follows: (1) Rat peritoneal mast cells were isolated and cultured, and the cell concentration was adjusted to 1×10⁻⁶. 6 100 μL / mL was inoculated into 96-well plates; (2) Add 10 μL of each test sample and control sample to each well and incubate for 30 min (25℃). (3) Add 40 μL of histamine release inducer (Compound 48 / 80) at a concentration of 1 μg / mL and continue incubation for 15 min; (4) Centrifuge (3000 r / min, 10 min), take the supernatant, and use an ELISA kit to detect histamine content, following the instructions of the kit; (5) Calculate the histamine release inhibition rate: Histamine release inhibition rate (%) = (histamine content in blank control group - histamine content in sample group) / histamine content in blank control group × 100%.

[0036] 2. Testing instruments and reagents: Microplate reader (model: Thermo Multiskan FC), centrifuge (model: Eppendorf 5810R), rat histamine ELISA kit (brand: R&D Systems, catalog number: EH3HIS), Compound48 / 80 (purity ≥98%), physiological saline, etc.

[0037] 3. The test results are shown in Table 3 below: Table 3

[0038] 4. Results Analysis: The histamine release inhibition rates of Examples 4-6 were significantly higher than those of the single-component control group (P<0.05). Furthermore, the inhibition rate gradually increased with the increase of the content of the core active ingredients forsythoside, isatis extract and cinchona alkaloids, indicating that the synergistic effect of the three ingredients can significantly inhibit histamine release, with a clear antipruritic mechanism, which is superior to that of a single component.

[0039] (II) Hyaluronidase inhibition rate test (core data on anti-inflammatory and barrier repair) 1. Detection method: The in vitro inhibition assay of hyaluronidase (colorimetric method) was used. The specific steps are as follows: (1) Prepare 0.1 mol / L acetate-sodium acetate buffer (pH=5.5), 0.1% sodium hyaluronate solution, and hyaluronidase solution (concentration 100 U / mL). (2) Add 50 μL of buffer and 20 μL of each test sample / control sample to a 96-well plate and incubate for 10 min (25℃). (3) Add 20 μL of hyaluronidase solution and continue incubation for 20 min (37℃); (4) Add 100 μL of sodium hyaluronate solution, incubate for 30 min (37℃), add 100 μL of alkaline copper reagent, boil in water for 10 min, and cool to room temperature; (5) Add 50 μL of Folin-phenol reagent, incubate for 20 min, and measure the absorbance (OD value) at 650 nm using an ELISA reader. (6) Calculate the hyaluronidase inhibition rate: Inhibition rate (%) = (OD value of blank control group - OD value of sample group) / (OD value of blank control group - OD value of blank reagent group) × 100%.

[0040] 2. Testing instruments and reagents: Microplate reader (model: Thermo Multiskan FC), constant temperature water bath (model: HH-S26S), hyaluronidase (1000U / g), sodium hyaluronate (purity ≥98%), Folin-phenol reagent, alkaline copper reagent, etc.

[0041] 3. The test results are shown in Table 4 below: Table 4

[0042] 4. Results Analysis: The hyaluronidase inhibition rates of Examples 4 to 6 were significantly higher than those of the single-component control group (P<0.05). The higher the content of forsythoside, isatis extract, and cinchona alkaloids, the higher the inhibition rate, indicating that the synergistic effect of the three can effectively inhibit scalp inflammation, reduce hyaluronic acid degradation, assist in repairing the scalp barrier, and have a synergistic antipruritic effect.

[0043] (III) Red blood cell hemolysis test (core safety data) 1. Detection method: Rabbit red blood cell hemolysis test was used. The specific steps are as follows: (1) Take venous blood from healthy rabbits, add anticoagulant (sodium citrate), centrifuge (2000r / min, 5min), discard the supernatant, wash the red blood cells 3 times with physiological saline, and prepare a 5% red blood cell suspension; (2) Add 100 μL of 5% red blood cell suspension to a 96-well plate, and add 10 μL of each test sample / control sample respectively, and incubate for 60 min (37℃). (3) Centrifuge (3000r / min, 10min), take the supernatant, and measure the absorbance (OD value) at 540nm wavelength using an ELISA reader. (4) Positive hemolysis group: 10 μL of distilled water was added (complete hemolysis); negative control group: 10 μL of normal saline was added (no hemolysis); (5) Calculate the hemolysis rate: Hemolysis rate (%) = (OD value of sample group - OD value of negative control group) / (OD value of positive hemolysis group - OD value of negative control group) × 100%; Safety threshold: Hemolysis rate < 5% is considered to have no obvious irritation.

[0044] 2. Testing instruments and reagents: microplate reader (model: Thermo Multiskan FC), centrifuge (model: Eppendorf 5810R), venous blood from healthy rabbits, sodium citrate, physiological saline, distilled water, etc.

[0045] 3. The test results are shown in Table 5: Table 5

[0046] 4. Results Analysis: The hemolysis rates of Examples 4 to 6 were all far below the safety threshold of 5%, and significantly lower than those of some commercially available chemical antipruritic essences (positive control group), indicating that the scalp antipruritic composition of the present invention is mild and non-irritating.

[0047] Compared with existing technologies, the present invention has the following advantages: 1. Significant synergistic effect, highly effective and long-lasting antipruritic effect: By utilizing the complementary properties of forsythoside, isatis extract and cinchona alkaloids, a synergistic effect of antibacterial, anti-inflammatory and antipruritic effects is achieved. It can not only quickly relieve scalp itching symptoms, but also regulate the scalp microecology and repair the scalp barrier from the root, and prevent itching from recurring. Experimental verification shows that after using the composition of this invention, the scalp itching relief rate can reach more than 90%, and the antipruritic effect lasts for more than 48 hours. 2. Gentle and safe with low irritation: The core active ingredients are all alkaloids from natural sources or natural plant extracts, avoiding the use of strong chemical antipruritic agents. The pH value is consistent with the normal pH value of the scalp, making it suitable for all types of scalp.

[0048] The embodiments of the present invention have been described in detail above, but the present invention is not limited to the described embodiments. For those skilled in the art, various changes, modifications, substitutions, and variations to these embodiments without departing from the principles and spirit of the present invention still fall within the protection scope of the present invention.

Claims

1. A scalp anti-itch composition, characterized in that, Composed of the following components by mass: Forsythoside 1-4 parts; Isatis indigotica extract 2-9 parts; Cinchona alkaloids 0.5–2.5 parts; 10-14 parts of moisturizer; Emulsifier 1-3 parts; Preservative 0.5-2 parts; Fragrance 0.1–0.3 parts; pH adjuster 0.1-0.3 parts; Solvent: 17-101 parts; The method for preparing the scalp anti-itch composition includes the following steps: (1) Raw material pretreatment: Wash, dry and crush the roots and leaves of Isatis indigotica, add a solvent with a mass concentration of 70%-80%, and reflux extract at 50-60℃ for 2-3 times, 1-2 hours each time. Combine the extracts, filter and concentrate under reduced pressure until there is no solvent taste to obtain Isatis indigotica extract. Store at low temperature for later use to avoid degradation of components such as indigo and indigo due to high temperature and light. (2) Dissolution of core components: Take the prescribed amount of forsythoside and cinchona alkaloids, add an appropriate amount of solvent with a mass concentration of 70%-80%, stir until completely dissolved, and obtain a solution of core active components; (3) Mixing of excipients: Add the formula amount of humectant, emulsifier and preservative to the solvent, stir until completely dissolved, heat to 60-70℃, keep warm for 10-15 minutes, and cool to below 40℃; (4) Mixing and homogenizing: Add the core active ingredient solution prepared in step (2) and the isatis extract prepared in step (1) to the solution prepared in step (3), stir evenly, add pH adjuster to adjust pH value to 5.0-6.5, add fragrance, homogenize for 5-10 minutes to obtain scalp anti-itch composition; (5) Packaging and testing: The above-mentioned anti-itch scalp composition is subjected to microbial testing, pH testing and stability testing. After passing the test, it is packaged, sealed and stored in the dark to prevent the active ingredients in cinchona alkaloids and isatis extract from discoloring or degrading when exposed to light.

2. The scalp antipruritic composition according to claim 1, characterized in that, The moisturizer is one or more of glycerin, propylene glycol, hyaluronic acid, ceramide, and panthenol.

3. The scalp antipruritic composition according to claim 1, characterized in that, The emulsifier is one or more of Tween-80, Span-60, and PEG-40 hydrogenated castor oil.

4. The scalp antipruritic composition according to claim 1, characterized in that, The preservative is one or more of phenoxyethanol, ethylhexylglycerin, and sodium benzoate.

5. The scalp antipruritic composition according to claim 1, characterized in that, The pH adjuster is one or more of citric acid, sodium hydroxide, and triethanolamine.

6. The scalp antipruritic composition according to claim 1, characterized in that, The solvent is one or more of deionized water and ethanol.

7. The scalp antipruritic composition according to claim 1, characterized in that, Used in shampoos, conditioners, scalp serums, scalp sprays, and hair masks.

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