Soothing plant composition for inhibiting histamine release, preparation method, application and product

Abstract

The present invention provides a soothing botanical composition that inhibits histamine release, as well as a preparation method, application, and product, relating to the field of cosmetics technology. The botanical composition is composed of gentiana macrophylla, asafoetida, and small white apricot, with the mass ratio of gentiana macrophylla, asafoetida, and small white apricot being 1-5:1-5:3-9. By optimizing the ratio and preparation method of the two ingredients, the resulting composition exhibits synergistic effects in soothing, anti-allergic, and anti-inflammatory effects. By inhibiting histamine release and TRPV1 activation, the product significantly improves its soothing, anti-allergic, and anti-inflammatory effects.

Description

Technical Field

[0001] The present invention relates to the technical field of cosmetics, and in particular to a soothing plant composition for inhibiting histamine release, a preparation method, an application, and a product. Background Art

[0002] Sensitive skin refers specifically to a highly reactive state of the skin under physiological or pathological conditions, mainly occurring on the face. Clinically, the skin is prone to subjective symptoms such as burning, stinging, itching, and tightness when stimulated by physical, chemical, mental, and other factors, with or without objective signs such as erythema, scaling, and capillary dilation.

[0003] Common allergies are generally Type I allergic reactions, mediated by the release of chemical transmitters such as histamine from mast cell degranulation. This stimulates vasodilation, increases vascular permeability, promotes bronchial smooth muscle contraction, and enhances terminal nerve induction, leading to excessive biological stress responses. Therefore, the clinical treatment of Type I allergic diseases primarily involves antihistamines and antiallergic drugs that inhibit mast cell degranulation. The pathogenesis of sensitive skin is roughly as follows: when harmful external substances, such as high temperature, ultraviolet rays, physical and chemical effects and other adverse factors are transmitted to the skin's nociceptors, stimulating and inducing TRP family effects, such as TRPV1, after TRPV1 is activated, it triggers the influx of calcium ions, generates action potentials, and the electrical signals transmit the sensation of heat and pain along the nerves to the brain, causing the skin to produce symptoms such as itching, burning, and tingling; in addition, TRPV1 and various external inducing factors can also stimulate the skin's keratinocytes and mast cells to secrete inflammatory factors, such as IL-1, PEG2, IL-8, TNF-α, NK1, etc., initiating an inflammatory chain reaction, leading to dilation of skin capillaries, increased permeability, smooth muscle contraction, etc., resulting in adverse skin reactions such as redness, inflammation, and itching.

[0004] Histamine, a biogenic amine produced by the decarboxylation of histidine, is normally stored in the cytoplasmic granules of skin mast cells, acting as an immune defense signal and participating in pathogen clearance and tissue repair. Physiologically, histamine maintains the homeostasis of the skin microenvironment by regulating microvascular tone and immune cell chemotaxis. However, when mast cells undergo excessive degranulation in response to external stimuli (such as physical friction, allergens, or neuropeptides), the released histamine is converted into a pro-inflammatory mediator. By binding to H1 receptors in the dermis, it triggers capillary endothelial cell contraction and plasma extravasation, leading to erythema and edema. Simultaneously, it activates HRH1 receptors on epidermal C-fiber terminals, triggering itch signaling and perpetuating a vicious cycle of itch, scratching, and inflammation. Inhibiting mast cell degranulation can directly reduce abnormal histamine release, thereby blocking its dual pathological effects on vascular permeability and neurosensitivity. Long-term, lowering histamine levels can also attenuate histamine's transcriptional repression of keratinocyte differentiation-related proteins (such as FLG and IVL), thereby repairing the skin barrier network damaged by repeated histamine storms.

[0005] TRPV1 (transient receptor potential vanilloid 1) is a non-selective cation channel protein that is mainly expressed in keratinocytes in the skin and is responsible for sensing heat, acid and chemical stimuli (such as capsaicin). Under physiological conditions, TRPV1 regulates calcium ions (Ca 2+ ) transmembrane flow participates in the dynamic balance of the epidermal barrier. When overstimulated, TRPV1 channels open abnormally, triggering Ca 2+ Large amounts of influx lead to an imbalance in the homeostasis of keratinocytes, such as Ca 2+ Overload activates the NF-κB signaling pathway, leading to overexpression of pro-inflammatory factors such as IL-6, IL-8, and TNF-α, inducing erythema and burning sensation; abnormal Ca 2+ Fluctuations interfere with the synthesis of tight junction proteins (such as claudin-1) and filaggrin, weakening the epidermal physical barrier and water retention capacity; mitochondrial Ca 2+ Accumulation leads to the outbreak of reactive oxygen species (ROS), accelerating lipid peroxidation and cell apoptosis, and forming a chronic sensitive microenvironment. Inhibiting TRPV1 receptor activation can accurately block Ca 2+ Dependent pathological processes: by stabilizing Ca2+ in keratinocytes 2 + concentration to reduce the release of pro-inflammatory factors and restore the expression of barrier-related proteins, thereby alleviating the immediate burning reaction and repairing the epidermal dysfunction caused by excessive activation of TRPV1.

[0006] Chinese patent application CN115414286A discloses a skin-soothing cosmetic composition containing Phaeodactylum tricornutum extract, citrus fruit extract, hydroxyphenylpropionamidobenzoic acid, and Portulaca oleracea extract as active ingredients; the composition inhibits TRPV1 effects, histamine release, and the expression of inflammatory factors, thereby achieving a skin-soothing effect. Chinese patent CN101612243A relates to the use of a natural plant Zanthoxylum bungeanum extract in the preparation of drugs, cosmetics, and health foods that inhibit histamine release. The application method involves applying the natural plant Zanthoxylum bungeanum extract to drugs, cosmetics, and health foods that inhibit histamine release.

[0007] Based on this, it is of great significance to develop a composition with new components that can inhibit histamine release and TRPV1 activation to achieve soothing, anti-allergic / anti-inflammatory effects and meet the needs of users with sensitive skin or suffering from allergies. Summary of the Invention

[0008] To address these issues, the present invention provides a botanical composition that synergistically inhibits histamine release, a preparation method, and its use in soothing, anti-allergic / anti-inflammatory cosmetics. The composition, comprising Gentiana macrophylla, Ferula odorata, and Prunus amygdalus dulcis, is formulated through an optimized ratio and preparation method. The resulting composition can inhibit histamine release and TRPV1 activation, achieving soothing, anti-allergic / anti-inflammatory effects and is widely applicable in the cosmetics field.

[0009] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0010] In a first aspect, the present invention provides a soothing plant composition for inhibiting histamine release, the raw materials of which are composed of Gentiana macrophylla, Ferula odoratum and Prunus amygdalus subspecies, and the mass ratio of Gentiana macrophylla, Ferula odoratum and Prunus amygdalus subspecies is 1-5:1-5:3-9.

[0011] Preferably, the mass ratio of Gentiana macrophylla, Ferula odorata and Prunus amygdalus subspecies is 1-3:1-3:4-9.

[0012] Further preferably, the mass ratio of the gentiana macrophylla, asafoetida and small white apricot is 1-2:1.5-2.5:4-8.

[0013] In a second aspect, the present invention provides a method for preparing the above-mentioned plant composition, comprising the following steps:

[0014] Step 1: mixing Gentiana macrophylla, Ferula odorata and Prunus amygdalus dulcis with water, and extracting with water to obtain a water extract;

[0015] Step 2: The aqueous extract obtained in step 1 is filtered through a filter membrane and concentrated to obtain a concentrate;

[0016] Step 3: The concentrate obtained in step 2 is extracted with alcohol, separated, concentrated, and the molecular weight cutoff is 850-1500 or less, and dried to obtain a plant composition.

[0017] Preferably, in step 1, the mass of the water is 10-30 times the total mass of Gentiana macrophylla, Ferula odoratum and Apricot odoratum. Further preferably, in step 1, the mass of the water is 15-25 times the total mass of Gentiana macrophylla, Ferula odoratum and Apricot odoratum.

[0018] Preferably, in step 1, the water extraction temperature is 85-95°C, and the extraction time is 0.5-1.5 hours. Further preferably, in step 1, the water extraction temperature is 90-95°C, and the extraction time is 0.5-1.0 hours.

[0019] Preferably, in step 1, the water extraction is performed 1-3 times.

[0020] Preferably, in step 2, the pore size of the filter membrane is 0.05-0.4 μm; further preferably, in step 2, the pore size of the filter membrane is 0.05-0.1 μm.

[0021] Preferably, in step 2, the mass of the concentrate is 0.1-1 times the total mass of Gentiana macrophylla, Ferula odoratum and Apricot odoratum in step 1. Further preferably, in step 2, the mass of the concentrate is 0.5-1 times the total mass of Gentiana macrophylla, Ferula odoratum and Apricot odoratum in step 1.

[0022] Preferably, in step 3, the alcohol used in the alcohol extraction is ethanol solution.

[0023] Preferably, in step 3, the alcohol extraction is as follows: the concentrate obtained in step 2 is mixed with an ethanol solution so that the alcohol content of the mixture is greater than or equal to 35°.

[0024] Further preferably, in step 3, the alcohol extraction is: mixing the concentrate obtained in step 2 with an ethanol solution so that the alcohol content of the mixture is greater than or equal to 50°.

[0025] Preferably, in step 3, the temperature of the alcohol extraction is 0-10°C and the time is 3-8 hours. Further preferably, in step 3, the temperature of the alcohol extraction is 0-14°C and the time is 4-6 hours.

[0026] Preferably, in step 3, the molecular cut-off is a portion with a molecular weight cut-off of less than 1000.

[0027] In a third aspect, the present invention provides a cosmetic component comprising the above-mentioned plant composition and excipients accepted in the cosmetics field.

[0028] Preferably, the excipient accepted in the cosmetics field is selected from at least one of water, butylene glycol, 1,3-propylene glycol, 1,2-hexanediol and p-hydroxyacetophenone.

[0029] More preferably, the water is hot spring water.

[0030] In a fourth aspect, the present invention provides the use of the above-mentioned plant composition or cosmetic component in the preparation of soothing, anti-allergic / anti-inflammatory cosmetics.

[0031] Preferably, the cosmetic has the effect of inhibiting the release of histamine.

[0032] Preferably, the cosmetic has the effect of inhibiting TRPV1 activation.

[0033] Compared with the prior art, the present invention has the following beneficial effects:

[0034] This invention provides a novel botanical composition composed of Gentiana macrophylla, Ferula odorata, and Prunus amygdalus dulcis. By optimizing the ratio and preparation method of these three ingredients, the resulting composition exhibits synergistic effects in soothing, anti-allergic, and anti-inflammatory effects. By inhibiting histamine and TRPV1 release, it significantly enhances the product's soothing, anti-allergic, and anti-inflammatory effects. DETAILED DESCRIPTION

[0035] In order to make the technical means, creative features, purpose and effect of the present invention easy to understand, the present invention is further illustrated below in conjunction with specific embodiment, but the following embodiment is only a preferred embodiment of the present invention, not all. Based on the embodiment in the embodiment, other embodiments obtained by those skilled in the art without making creative work all fall within the protection scope of the present invention. It is worth noting that the raw materials used in the present invention are all common commercial products, and their source is not specifically limited. The technology and scientific terms used in the embodiment have the meaning commonly understood by those of ordinary skill in the art to which the present invention belongs.

[0036] Example 1

[0037] A soothing plant composition for inhibiting histamine release comprises 10g of gentiana macrophylla, 10g of asafoetida and 80g of small white apricot.

[0038] The preparation method is as follows:

[0039] Step 1. Weigh 10g of Gentiana macrophylla, 10g of Ferula odoratum and 80g of Apricot chinensis, add 1500g of water and extract at 95℃ for 1h, filter through gauze and remove the residue;

[0040] Step 2. The filtrate was filtered through a 0.05 μm ultrafiltration membrane until clarified, and concentrated to 50 g using a reverse osmosis membrane;

[0041] Step 3. Add ethanol to adjust the alcohol content to 50°; let it settle at 0°C for 4 hours, filter it through a 0.05 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove the alcohol, remove the molecules with a molecular weight below 1000, and dry it to obtain 20 g of the plant composition;

[0042] Step 4. Take 2 g of the plant composition, add 2 g of 1,2-hexanediol and 5 g of 1,3-propylene glycol, add water to 100 g, stir until dissolved, and sterilize to obtain the plant combination liquid that synergistically inhibits histamine release.

[0043] Example 2

[0044] A soothing botanical composition for inhibiting histamine release comprises 10g of gentiana macrophylla, 15g of asafoetida and 75g of small white apricot.

[0045] The preparation method is as follows:

[0046] Step 1. Weigh 10g of Gentiana macrophylla, 15g of Ferula odoratum and 75g of Apricot chinensis, add 2000g of water and extract at 95℃ for 1h, filter through gauze and remove the residue;

[0047] Step 2. The filtrate was filtered through a 0.1 μm ultrafiltration membrane until clarified, and concentrated to 75 g using a reverse osmosis membrane;

[0048] Step 3. Add ethanol to adjust the alcohol content to 60°; let it settle at 4°C for 5 hours, filter it with a 0.1 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove alcohol, remove molecules with a molecular weight below 1000, and dry it to obtain 23 g of the plant composition;

[0049] Step 4. Take 10g of the plant composition, add 0.5g of 1,2-hexanediol, 0.5g of p-hydroxyacetophenone and 5g of butanediol, add hot spring water to 100g, stir until dissolved, and sterilize to obtain a plant combination liquid that synergistically inhibits histamine release.

[0050] Example 3

[0051] A soothing plant composition for inhibiting histamine release comprises 20g of gentiana macrophylla, 30g of asafoetida and 50g of small white apricot as raw materials.

[0052] The preparation method is as follows:

[0053] Step 1. Weigh 20 g of Gentiana macrophylla, 30 g of Ferula odoratum, and 50 g of Prunus amygdalus subspecies, add 2500 g of water, extract at 95°C for 1 h, filter through gauze, and set aside the residue to obtain filtrate 1;

[0054] Step 2. Add 2500 g of water to the residue and extract at 95°C for 1 h. Filter through gauze to remove the residue to obtain filtrate 2.

[0055] Step 3. Combine filtrates 1 and 2 and filter through a 0.1 μm ultrafiltration membrane until clarified, and concentrate to 100 g using a reverse osmosis membrane;

[0056] Step 4. Add ethanol to adjust the alcohol content to 70°; let it settle at 4°C for 6 hours, filter it with a 0.1 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove alcohol, remove molecules with a molecular weight below 1000, and dry it to obtain 28 g of the plant composition;

[0057] Step 5. Take 20g of the plant composition, add 0.5g of 1,2-hexanediol, 0.5g of p-hydroxyacetophenone and 5g of butanediol, add hot spring water to 100g, stir until dissolved, and sterilize to obtain a plant combination liquid that synergistically inhibits histamine release.

[0058] Example 4

[0059] A soothing botanical composition for inhibiting histamine release comprises 10g of gentiana macrophylla, 15g of asafoetida and 75g of small white apricot.

[0060] The preparation method is as follows:

[0061] Step 1. Weigh 10g of Gentiana macrophylla, 15g of Ferula odoratum and 75g of Apricot chinensis, add 2000g of water and extract at 95℃ for 1h, filter through gauze and remove the residue;

[0062] Step 2. The filtrate was filtered through a 0.1 μm ultrafiltration membrane until clarified, and concentrated to 75 g using a reverse osmosis membrane;

[0063] Step 3. Add ethanol to adjust the alcohol content to 60°; let it settle at 4°C for 5 hours, filter it with a 0.1 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove alcohol, remove molecules with a molecular weight below 1000, and dry it to obtain 23 g of the plant composition;

[0064] Step 4. Take 10 g of the plant composition, add 0.5 g of 1,2-hexanediol, 0.5 g of p-hydroxyacetophenone and 5 g of butanediol, add deionized water to 100 g, stir until dissolved, and sterilize to obtain a plant combination liquid that synergistically inhibits histamine release.

[0065] Example 5

[0066] A soothing botanical composition for inhibiting histamine release comprises 10g of gentiana macrophylla, 15g of asafoetida and 75g of small white apricot.

[0067] The preparation method is as follows (compared with Example 2, the alcohol content during alcohol precipitation in step 3 is inconsistent):

[0068] Step 1. Weigh 10g of Gentiana macrophylla, 15g of Ferula odoratum and 75g of Apricot chinensis, add 2000g of water and extract at 95℃ for 1h, filter through gauze and remove the residue;

[0069] Step 2. The filtrate was filtered through a 0.1 μm ultrafiltration membrane until clarified, and concentrated to 75 g using a reverse osmosis membrane;

[0070] Step 3. Add ethanol to adjust the alcohol content to 30°; let it settle at 4°C for 5 hours, filter it with a 0.1 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove alcohol, remove molecules with a molecular weight below 1000, and dry it to obtain 17 g of the plant composition;

[0071] Step 4. Take 10g of the plant composition, add 0.5g of 1,2-hexanediol, 0.5g of p-hydroxyacetophenone and 5g of butanediol, add hot spring water to 100g, stir until dissolved, and sterilize to obtain a plant combination liquid that synergistically inhibits histamine release.

[0072] Example 6

[0073] A soothing botanical composition for inhibiting histamine release comprises 10g of gentiana macrophylla, 15g of asafoetida and 75g of small white apricot.

[0074] The preparation method is as follows (compared with Example 2, the pore size of the ultrafiltration membrane in step 2 is inconsistent):

[0075] Step 1. Weigh 10g of Gentiana macrophylla, 15g of Ferula odoratum and 75g of Apricot chinensis, add 2000g of water and extract at 95℃ for 1h, filter through gauze and remove the residue;

[0076] Step 2. The filtrate was filtered through a 0.45 μm ultrafiltration membrane until clarified and concentrated to 75 g using a reverse osmosis membrane;

[0077] Step 3. Add ethanol to adjust the alcohol content to 60°; let it settle at 4°C for 5 hours, filter it through a 0.45 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove the alcohol, remove the molecules with a molecular weight below 1000, and dry it to obtain 26 g of the plant composition;

[0078] Step 4. Take 10g of the plant composition, add 0.5g of 1,2-hexanediol, 0.5g of p-hydroxyacetophenone and 5g of butanediol, add hot spring water to 100g, stir until dissolved, and sterilize to obtain a plant combination liquid that synergistically inhibits histamine release.

[0079] Example 7

[0080] A soothing botanical composition for inhibiting histamine release comprises 10g of gentiana macrophylla, 15g of asafoetida and 75g of small white apricot.

[0081] The preparation method is as follows (compared with Example 2, the molecular weight cutoff of step 3 is inconsistent):

[0082] Step 1. Weigh 10g of Gentiana macrophylla, 15g of Ferula odoratum and 75g of Apricot chinensis, add 2000g of water and extract at 95℃ for 1h, filter through gauze and remove the residue;

[0083] Step 2. The filtrate was filtered through a 0.1 μm ultrafiltration membrane until clarified, and concentrated to 75 g using a reverse osmosis membrane;

[0084] Step 3. Add ethanol to adjust the alcohol content to 60°; let it settle at 4°C for 5 hours, filter it with a 0.1 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove alcohol, remove molecules with a molecular weight below 800, and dry it to obtain 15 g of the plant composition;

[0085] Step 4. Take 10g of the plant composition, add 0.5g of 1,2-hexanediol, 0.5g of p-hydroxyacetophenone and 5g of butanediol, add hot spring water to 100g, stir until dissolved, and sterilize to obtain a plant combination liquid that synergistically inhibits histamine release.

[0086] Example 8

[0087] A soothing botanical composition for inhibiting histamine release comprises 10g of gentiana macrophylla, 15g of asafoetida and 75g of small white apricot.

[0088] The preparation method is as follows (compared with Example 2, the molecular weight cutoff of step 3 is inconsistent):

[0089] Step 1. Weigh 10g of Gentiana macrophylla, 15g of Ferula odoratum and 75g of Apricot chinensis, add 2000g of water and extract at 95℃ for 1h, filter through gauze and remove the residue;

[0090] Step 2. The filtrate was filtered through a 0.1 μm ultrafiltration membrane until clarified, and concentrated to 75 g using a reverse osmosis membrane;

[0091] Step 3. Add ethanol to adjust the alcohol content to 60°; let it settle at 4°C for 5 hours, filter it with a 0.1 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove alcohol, remove the molecules with a molecular weight below 2000, and dry it to obtain 29 g of the plant composition;

[0092] Step 4. Take 10g of the plant composition, add 0.5g of 1,2-hexanediol, 0.5g of p-hydroxyacetophenone and 5g of butanediol, add hot spring water to 100g, stir until dissolved, and sterilize to obtain a plant combination liquid that synergistically inhibits histamine release.

[0093] Example 9

[0094] A soothing repair cream for inhibiting histamine release, the formula of which is shown in Table 1, and the preparation process is as follows:

[0095] 1: Prepare Phase A1. Soak SEPIMAX ZEN (polyacrylate crosspolymer-6) in cold water and pre-disperse sodium hyaluronate with glycerin. Then add the ingredients in Phase A1 to the main beaker and stir until dissolved. Place the beaker in a water bath and heat at 85°C.

[0096] 2: Prepare phase A2. Disperse SEPINOV EMT-10 with butanediol, then add water. Heat and stir until evenly mixed. Then add phase A1 and stir evenly.

[0097] 3. Heat phase C slightly to dissolve and set aside. Heat phase B to dissolve and stir evenly. When the material temperature reaches above 85°C, emulsify. Heat the main beaker while stirring. Slowly pour phase B into the main beaker. Keep warm and stir for about 3 minutes. Then add phase C and homogenize at a speed of about 4500rpm for about 3 minutes. Finally, add phase D and stir at 150rpm to cool down.

[0098] The plant composition in phase D is the plant composition liquid obtained in step 4 of Example 2.

[0099] Table 1. Recipe

[0100]

[0101] Comparative Example 1

[0102] A soothing plant composition for inhibiting histamine release, comprising 100g of Gentiana macrophylla as a raw material.

[0103] The preparation method is as follows (compared with Example 2, the raw material is only Gentiana macrophylla):

[0104] Step 1. Weigh 100g of Gentiana macrophylla, add 2000g of water and extract at 95℃ for 1h, filter through gauze and remove the residue;

[0105] Step 2. The filtrate was filtered through a 0.1 μm ultrafiltration membrane until clarified, and concentrated to 75 g using a reverse osmosis membrane;

[0106] Step 3. Add ethanol to adjust the alcohol content to 60°; let it settle at 4°C for 5 hours, filter it with a 0.1 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove alcohol, remove the molecular weight below 1000, and dry it to obtain 16 g of Gentiana macrophylla extract;

[0107] Step 4. Take 10g of Gentiana macrophylla extract, add 0.5g of 1,2-hexanediol, 0.5g of p-hydroxyacetophenone and 5g of butanediol, add hot spring water to 100g, stir until dissolved, and sterilize to obtain Gentiana macrophylla extract.

[0108] Comparative Example 2

[0109] A soothing plant composition for inhibiting histamine release, the raw material of which is 100g of small white apricot.

[0110] The preparation method is as follows (compared with Example 2, the raw material is only small white apricot):

[0111] Step 1. Weigh 100g of small white apricot, add 2000g of water, extract at 95℃ for 1h, filter through gauze, and remove the residue;

[0112] Step 2. The filtrate was filtered through a 0.1 μm ultrafiltration membrane until clarified, and concentrated to 75 g using a reverse osmosis membrane;

[0113] Step 3. Add ethanol to adjust the alcohol content to 60°; let it settle at 4°C for 5 hours, filter it with a 0.1 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove alcohol, remove the molecules with a molecular weight below 1000, and dry it to obtain 25 g of Xiaobaixing extract;

[0114] Step 4. Take 10g of the plant composition, add 0.5g of 1,2-hexanediol, 0.5g of p-hydroxyacetophenone and 5g of butanediol, add hot spring water to 100g, stir until dissolved, and sterilize to obtain the small white apricot extract.

[0115] Comparative Example 3

[0116] A soothing plant composition for inhibiting histamine release comprises 100g of fragrant asafoetida as a raw material.

[0117] The preparation method is as follows (compared with Example 2, the raw material is only Ferula odorata):

[0118] Step 1. Weigh 100g of Ferula odorifera, add 2000g of water, extract at 95℃ for 1h, filter through gauze, and remove the residue;

[0119] Step 2. The filtrate was filtered through a 0.1 μm ultrafiltration membrane until clarified, and concentrated to 75 g using a reverse osmosis membrane;

[0120] Step 3. Add ethanol to adjust the alcohol content to 60°; let it settle at 4°C for 5 hours, filter it with a 0.1 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove alcohol, remove the molecules with a molecular weight below 1000, and dry it to obtain 12 g of Ferula odorata extract;

[0121] Step 4. Take 10g of the plant composition, add 0.5g of 1,2-hexanediol, 0.5g of p-hydroxyacetophenone and 5g of butanediol, add hot spring water to 100g, stir until dissolved, and sterilize to obtain the fragrant asafoetida extract.

[0122] Comparative Example 4

[0123] A soothing plant composition for inhibiting histamine release comprises 50g of gentiana macrophylla, 30g of asafoetida and 20g of small white apricot.

[0124] The preparation method is as follows (compared with Example 2, the mass ratio of the raw materials Gentiana macrophylla, Ferula odorata, and Apricot chinensis is 5:3:2):

[0125] Step 1. Weigh 50g of Gentiana macrophylla, 30g of Ferula odoratum and 20g of Apricot chinensis, add 2000g of water and extract at 95℃ for 1h, filter through gauze and remove the residue;

[0126] Step 2. The filtrate was filtered through a 0.1 μm ultrafiltration membrane until clarified, and concentrated to 75 g using a reverse osmosis membrane;

[0127] Step 3. Add ethanol to adjust the alcohol content to 60°; let it settle at 4°C for 5 hours, filter it with a 0.1 μm ultrafiltration membrane until it is clear; concentrate it under reduced pressure to remove alcohol, remove molecules with a molecular weight below 1000, and dry it to obtain 19 g of the plant composition;

[0128] Step 4. Take 10g of the plant composition, add 0.5g of 1,2-hexanediol, 0.5g of p-hydroxyacetophenone and 5g of butanediol, add hot spring water to 100g, stir until dissolved, and sterilize to obtain a plant combination liquid that synergistically inhibits histamine release.

[0129] Comparative Example 5

[0130] A soothing repair cream reference substance for inhibiting histamine release has a formula as shown in Table 2 and a production process as follows:

[0131] 1. Prepare Phase A1: Soak ZEN in cold water, pre-disperse sodium hyaluronate with glycerin, then add the ingredients in Phase A1 to the main beaker and start stirring. After stirring and dissolving evenly, place the beaker in a water bath and heat to keep warm. The water bath temperature is 85°C.

[0132] 2: Prepare phase A2: Disperse EMT-10 with butanediol, then add water, heat and stir until evenly mixed, then add phase A1 and stir evenly.

[0133] 3: Heat phase C slightly and dissolve it for later use. Heat phase B and dissolve it and stir evenly. Emulsify the material after the temperature reaches above 85°C. Heat the main beaker while stirring. Slowly pour phase B into the main beaker. Add phase C after keeping warm and stirring for about 3 minutes. Finally, homogenize at a speed of about 4500rpm for about 3 minutes, then stir at 150rpm to cool down.

[0134] Table 2. Recipe

[0135]

[0136] Test Example 1

[0137] Stimulation model based on the release of histamine from mast cells:

[0138] 1. Experimental Materials

[0139] P815 mast cells (Cell Bank, Chinese Academy of Sciences), CP48 / 80 (Sigma), hydrocortisone (GLPBIO), histamine ELISA kit (Cloud Clone), multifunctional microplate reader (Thermo Fisher), etc.

[0140] The preparation method of the samples to be tested in the cell experiment is shown in Table 3:

[0141] Table 3. Sample preparation methods for cell experiments

[0142]

[0143] Experimental Methods 2.1 Cell Culture

[0144] P815 cells were cultured in RPMI-1640 complete medium (RPMI-1640 medium, 10% FBS, 1% double antibody) in a 37°C, 5% CO2 cell culture incubator. P815 cells grew semi-adherently to a cell density of 80%-90%. After subculturing and conventional culture for 2-3 days, cells in the logarithmic growth phase were collected for testing.

[0145] 2.2 Cytotoxicity test

[0146] Take the P815 cell suspension in the logarithmic phase and growing well, and inoculate it into a 96-well plate containing RPMI-1640 complete medium, with 1×10 cells per well. 4 After 24 h of culture, samples of different concentrations were added. After 24 h of sample action, CCK-8 working solution was added and the cells were placed in a 37°C incubator for 1.5 h. The absorbance at 450 nm was detected by a microplate reader.

[0147] Cell viability (%) = OD value of sample group / OD value of blank control group × 100%.

[0148] 2.3 Histamine release assay

[0149] The P815 cell suspension in the logarithmic phase and growing well was taken and inoculated into a 24-well plate containing RPMI-1640 complete medium, with 5×10 cells per well. 5 After 24 hours of culture, samples at different concentrations were added. After incubation for 30 minutes at 37°C and 5% CO₂, C48 / 80 compound (final concentration 50 μg / mL) was added and stimulated for 15 minutes at 37°C and 5% CO₂. Treatment was terminated by placing the cells on ice for 10 minutes. The supernatant was collected and centrifuged at 4°C and 10,000 rpm for 5 minutes. The supernatant was used as the test sample. Histamine release from cells was measured according to the histamine ELISA kit instructions. Histamine levels were calculated using a histamine standard curve. Experimental groupings are shown in Table 4.

[0150] Inhibition rate (%) = ((negative control group - blank control group) - (sample group - blank control group)) / (negative control group - blank control group) * 100%.

[0151] Table 4. Grouping table for histamine release assay

[0152]

[0153] 2.4 Calculation of Combination Index (CI)

[0154] The Combination Index (CI) is a method for evaluating drug combinations, proposed by Chou and Talalay in 1984. This method, based on the dose-response curve, compares the actual effect of a combination with its theoretical effect to determine whether the combination exhibits synergistic, additive, or antagonistic effects. A CI value less than 0.9 indicates a synergistic effect; smaller values ​​indicate a stronger synergistic effect; a CI value between 0.9 and 1.1 indicates an additive effect; and a CI value greater than 1.1 indicates an antagonistic effect; larger values ​​indicate a stronger antagonistic effect.

[0155] The calculated inhibition rate was analyzed using CompuSyn software to obtain the CI value.

[0156] 2.5 Statistical analysis

[0157] The data of the experimental results were expressed as mean ± standard deviation (x ± s). The differences between the groups were tested by ANOVA, and pairwise comparisons were performed by Dunnett's multiple comparison test. The significance level was α = 0.05.

[0158] Experimental Results 3.1 Cytotoxicity Test Results

[0159] The results of the cytotoxicity test on P815 cells of the cell experimental samples prepared in Examples 1 to 8 and Comparative Examples 1 to 4 are shown in Tables 5 and 6.

[0160] Table 5. Results of P815 cytotoxicity tests in Examples 1-8

[0161]

[0162] Table 6. Cytotoxicity test results of Comparative Examples 1-4 on P815 cells

[0163]

[0164] As shown in Tables 5 and 6, the test samples had no cytotoxicity within the test range after cytotoxicity testing, and concentrations of 0.01%, 0.1%, and 1% were selected for subsequent histamine release detection experiments.

[0165] 3.2 Histamine release test results

[0166] The results of the effects of the cell experimental samples prepared in Examples 1 to 8 and Comparative Examples 1 to 4 on the histamine release of P815 cells are shown in Tables 7 to 19.

[0167] Table 7. Effect of Example 1 on histamine release in P815 cells

[0168]

[0169] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0170] Example 1 can significantly inhibit histamine release induced by C48 / 80 at concentrations of 0.1-1% (**p<0.01 vs. negative control); the inhibition rates are 8.53% and 45.47%, respectively.

[0171] Table 8. Effect of Example 2 on histamine release in P815 cells

[0172]

[0173] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0174] Example 2 can significantly inhibit the histamine release induced by C48 / 80 at a concentration of 1% (**p<0.01 vs. negative control); the inhibition rate is: 49.06%.

[0175] Table 9. Effect of Example 3 on histamine release in P815 cells

[0176]

[0177] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0178] Example 3 at a concentration of 1% can significantly inhibit the histamine release induced by C48 / 80 (**p<0.01 vs. negative control); the inhibition rate is: 44.27%.

[0179] Table 10. Effect of Example 4 on histamine release in P815 cells

[0180]

[0181] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0182] Example 4 at a concentration of 1% can significantly inhibit the histamine release induced by C48 / 80 (**p<0.01 vs. negative control); the inhibition rate is: 45.46%.

[0183] Table 11. Effect of Example 5 on histamine release in P815 cells

[0184]

[0185] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0186] Example 5 at a concentration of 1% can significantly inhibit the histamine release induced by C48 / 80 (**p<0.01 vs. negative control); the inhibition rate is: 34.80%.

[0187] Table 12. Effect of Example 6 on histamine release in P815 cells

[0188]

[0189] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0190] Example 6 can significantly inhibit the histamine release induced by C48 / 80 at a concentration of 1% (**p<0.01 vs. negative control); the inhibition rate is: 33.61%.

[0191] Table 13. Effect of Example 7 on histamine release in P815 cells

[0192]

[0193] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0194] Example 7 at a concentration of 1% can significantly inhibit the histamine release induced by C48 / 80 (**p<0.01 vs. negative control); the inhibition rate is: 33.06%.

[0195] Table 14. Effect of Example 8 on histamine release in P815 cells

[0196]

[0197] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0198] Example 8 at a concentration of 1% can significantly inhibit the histamine release induced by C48 / 80 (**p<0.01 vs negative control); the inhibition rate is: 34.32%.

[0199] Table 15. Effect of Comparative Example 1 on histamine release in P815 cells

[0200]

[0201] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0202] Comparative Example 1 at a concentration of 1% can significantly inhibit the histamine release induced by C48 / 80 (**p<0.01 vs negative control); the inhibition rate is 29.73%.

[0203] Table 16. Effect of Comparative Example 2 on histamine release in P815 cells

[0204]

[0205] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0206] Comparative Example 2 can significantly inhibit the histamine release induced by C48 / 80 at concentrations of 0.75-1% (**p<0.01 vs negative control); the inhibition rates are 24.95% and 32.19%, respectively.

[0207] Table 17. Effect of Comparative Example 3 on histamine release in P815 cells

[0208]

[0209] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0210] Comparative Example 3 at a concentration of 1% can significantly inhibit the histamine release induced by C48 / 80 (**p<0.01 vs negative control); the inhibition rate is: 30.85%.

[0211] Table 18. Effect of Comparative Example 4 on histamine release in P815 cells

[0212]

[0213] Note: ## p<0.01 vs blank control, **p<0.01 vs negative control.

[0214] Comparative Example 4 at a concentration of 1% can significantly inhibit the histamine release induced by C48 / 80 (**p<0.01 vs negative control); the inhibition rate is: 35.25%.

[0215] Table 19. Inhibitory effect and CI value of each sample on histamine release induced by C48 / 80 in P815 cells

[0216]

[0217] As shown in Table 19, the extract of Gentiana macrophylla, the extract of Ferula odoratum and the extract of Apricot kernel, as well as the combination of the three, all significantly inhibited the release of histamine from P815 cells induced by C48 / 80 at a concentration of 1%. The samples with a combination of Gentiana macrophylla accounting for 10-20%, Ferula odoratum accounting for 10-30%, and Apricot kernel accounting for 50-80% had a synergistic effect on the release of histamine from P815 cells induced by C48 / 80, with a CI value between 0.2 and 0.9, while the comparative example 4 with a combination of Gentiana macrophylla accounting for 50%, Ferula odoratum accounting for 30%, and Apricot kernel accounting for 20% had no synergistic effect. Among them, the CI values ​​of Examples 1 to 4 were lower than those of Examples 5 to 8, and the CI values ​​were between 0.2 and 0.5, indicating that the compositions prepared under the specific processes of Examples 1 to 4 of the present invention have a stronger synergistic effect on inhibiting histamine.

[0218] Test Example 2

[0219] Soothing test based on capsaicin stimulation model of human keratinocytes:

[0220] 1. Experimental Materials

[0221] Human keratinocytes HACAT (Institute of Cell Biology, Chinese Academy of Sciences), capsaicin (GLPBIO), capsaicin (GLPBIO), Fluo-4AM (Thermo Fisher), D-hank's buffer (BioSharp), multi-function microplate reader (Thermo Fisher), etc. The sample preparation method is shown in Table 3.

[0222] 2. Experimental Methods

[0223] 2.1 Cell culture

[0224] HaCaT keratinocytes were cultured in DMEM complete medium (DMEM high glucose medium, 10% FBS, 1% double antibody) in a 37°C, 5% CO2 cell culture incubator. HaCaT cells were grown adherently. When the cell density reached 70-80%, the cells were digested with trypsin to remove them from the culture flask. The cells were passaged at a ratio of 1:3 and cultured for 2-3 days before the cells in the logarithmic growth phase were collected for testing.

[0225] 2.2 Cytotoxicity test

[0226] A HaCaT cell suspension in the logarithmic phase with good growth was taken and inoculated into a 96-well plate containing DMEM complete medium, with 8×10 cells per well. 3After culturing for 24 h, samples of different concentrations were added and cultured for another 24 h. The cells were washed twice with PBS and 100 μL of CCK-8 working solution (CCK-8 reagent: DMEM complete medium = 1:10) was added to each well. The cells were incubated in a cell culture incubator at 37°C and 5% CO2 for 2 h. The absorbance was measured at 450 nm using a microplate reader.

[0227] Cell viability (%) = OD value of sample group / OD value of blank control group × 100%.

[0228] 2.3 Calcium influx detection

[0229] A HaCaT cell suspension in the logarithmic phase with good growth was taken and inoculated into a black well 96-well plate with 8×10 cells per well. 3 After 24 hours of incubation, cells were incubated with 1 μM Fluo-4 AM for 30 minutes in a 37°C, 5% CO2 incubator. After three washes with D-hank's solution, cells were added with various sample concentrations and 5 μM capsaicin. After incubation for 30 minutes in a 37°C, 5% CO2 incubator, fluorescence intensity was measured using a fluorescence microplate reader at an EX / EM ratio of 485 / 525 nm to determine the F0 value. Cells were then stimulated with 10 μM capsaicin (CAP), and fluorescence intensity was measured using a fluorescence microplate reader at an EX / EM ratio of 485 / 525 nm to determine the F1 value. The experimental groupings are shown in Table 20.

[0230] Inhibition rate (%) = ((negative control group F1-negative control group F0)-(each group F1-each group F0)) / (negative control group F1-negative control group F0) × 100%.

[0231] Table 20. Grouping table for calcium influx detection experiment

[0232]

[0233] 2.4 Calculation of Combination Index (CI)

[0234] The Combination Index (CI) is a method for evaluating drug combinations, proposed by Chou and Talalay in 1984. This method, based on the dose-response curve, compares the actual effect of a combination with the theoretical effect to determine whether the combination exhibits synergistic, additive, or antagonistic effects. A CI value less than 0.9 indicates a synergistic effect; smaller values ​​indicate a stronger synergistic effect; a CI value between 0.9 and 1.1 indicates an additive effect; and a CI value greater than 1.1 indicates an antagonistic effect; larger values ​​indicate a stronger antagonistic effect.

[0235] The calculated inhibition rate was analyzed using CompuSyn software to obtain the CI value.

[0236] 2.5 Statistical analysis

[0237] The data of the experimental results were expressed as mean ± standard deviation (x ± s). The differences between the groups were tested by ANOVA, and pairwise comparisons were performed by Dunnett's multiple comparison test. The significance level was α = 0.05.

[0238] 3. Experimental Results

[0239] 3.1 Cytotoxicity assay

[0240] The results of the cytotoxicity test on HaCaT cells of the cell experimental samples prepared in Examples 1 to 8 and Comparative Examples 1 to 4 are shown in Tables 21 and 22.

[0241] Table 21. Results of HaCaT cytotoxicity tests in Examples 1-8

[0242]

[0243] Table 22. Comparative Examples 1-4 HaCaT cytotoxicity test results

[0244]

[0245] As shown in Tables 21 and 22, the test samples had no cytotoxicity within the test range after cytotoxicity testing, and concentrations of 0.01%, 0.1%, and 1% were selected for subsequent calcium ion influx detection experiments.

[0246] 3.2 Calcium influx detection

[0247] Table 23. Effect of Example 1 on calcium influx in the TRPV1 pathway

[0248]

[0249] Note: **p<0.01 vs negative control.

[0250] Example 1 can significantly inhibit the calcium influx of HaCaT cells induced by capsaicin at a concentration of 1% (**p<0.01 vs. negative control); the inhibition rate is: 28.56%.

[0251] Table 24. Effect of Example 2 on calcium influx in the TRPV1 pathway

[0252]

[0253] Note: **p<0.01 vs negative control.

[0254] Example 2 can significantly inhibit the calcium influx of HaCaT cells induced by capsaicin at a concentration of 1% (**p<0.01 vs. negative control); the inhibition rate is: 34.50%.

[0255] Table 25. Effect of Example 3 on calcium influx in the TRPV1 pathway

[0256]

[0257] Note: **p<0.01 vs negative control.

[0258] Example 3 can significantly inhibit the calcium influx of HaCaT cells induced by capsaicin at a concentration of 1% (**p<0.01 vs. negative control); the inhibition rate is: 30.34%.

[0259] Table 26. Effect of Example 4 on TRPV1 Pathway Calcium Influx

[0260]

[0261] Note: **p<0.01 vs negative control.

[0262] Example 4 can significantly inhibit calcium influx in HaCaT cells induced by capsaicin at a concentration of 1% (**p<0.01 vs. negative control); the inhibition rate is: 30.77%.

[0263] Table 27. Effect of Example 5 on TRPV1 Pathway Calcium Influx

[0264]

[0265] Note: **p<0.01 vs negative control.

[0266] Example 5 can significantly inhibit the calcium influx of HaCaT cells induced by capsaicin at a concentration of 1% (**p<0.01 vs. negative control); the inhibition rate is: 24.53%.

[0267] Table 28. Effect of Example 6 on TRPV1 Pathway Calcium Influx

[0268]

[0269] Note: **p<0.01 vs negative control.

[0270] Example 6 can significantly inhibit the calcium influx of HaCaT cells induced by capsaicin at a concentration of 1% (**p<0.01 vs. negative control); the inhibition rate is: 25.45%.

[0271] Table 29. Effect of Example 7 on TRPV1 Pathway Calcium Influx

[0272]

[0273] Note: **p<0.01 vs negative control.

[0274] Example 7 can significantly inhibit the calcium influx of HaCaT cells induced by capsaicin at a concentration of 1% (**p<0.01 vs. negative control); the inhibition rate is: 24.67%.

[0275] Table 30. Effect of Example 8 on TRPV1 Pathway Calcium Influx

[0276]

[0277] Note: **p<0.01 vs negative control.

[0278] Example 8 can significantly inhibit the calcium influx of HaCaT cells induced by capsaicin at a concentration of 1% (**p<0.01 vs. negative control); the inhibition rate is: 25.28%.

[0279] Table 31. Effect of Comparative Example 1 on TRPV1 Pathway Calcium Influx

[0280]

[0281] Note: **p<0.01 vs negative control.

[0282] Comparative Example 1 at a concentration of 1% can significantly inhibit the calcium influx of HaCaT cells induced by capsaicin (**p<0.01 vs negative control); the inhibition rate is: 18.91%.

[0283] Table 32. Effect of Comparative Example 2 on TRPV1 Pathway Calcium Influx

[0284]

[0285] Note: **p<0.01 vs negative control.

[0286] Comparative Example 2 can significantly inhibit calcium influx in HaCaT cells induced by capsaicin at concentrations of 0.75-1% (**p<0.01 vs negative control); the inhibition rates are 15.59% and 21.05%, respectively.

[0287] Table 33. Effect of Comparative Example 3 on TRPV1 Pathway Calcium Influx

[0288]

[0289] Note: **p<0.01 vs negative control.

[0290] Comparative Example 3, at a concentration of 1%, significantly inhibited capsaicin-induced calcium influx in HaCaT cells (**p<0.01 vs. negative control); the inhibition rate was 20.99%.

[0291] Table 34. Effect of Comparative Example 4 on TRPV1 Pathway Calcium Ion Influx

[0292]

[0293] Note: **p<0.01 vs negative control.

[0294] Comparative Example 4, at a concentration of 1%, significantly inhibited capsaicin-induced calcium influx in HaCaT cells (**p<0.01 vs. negative control); the inhibition rate was 24.52%.

[0295] Table 35. Inhibition rate and CI value of each sample on capsaicin-induced calcium influx through TRPV1 pathway

[0296] The results are shown in Table 35. The extracts of Gentiana macrophylla, Ferula odoratum and Apricot kernel extract and their combination at a concentration of 1% all significantly inhibited the calcium influx of HaCaT cells caused by capsaicin through activation of the TRPV1 pathway; and the combination of samples with a Gentiana macrophylla ratio of 10-20%, Ferula odoratum of 10-30% and Apricot kernel accounted for 50-80% had a synergistic effect on the inhibition of the TRPV1 pathway, with a CI value between 0.3-0.9, while the comparative example 4 with a combination of Gentiana macrophylla ratio of 50%, Ferula odoratum of 30% and Apricot kernel accounted for 20% had no synergistic effect; among them, the CI values ​​of Examples 1 to 4 were lower than those of Examples 5 to 8, and the CI values ​​were between 0.3-0.6, indicating that the compositions prepared under the specific processes of Examples 1 to 4 of the present invention have a very strong synergistic effect on inhibiting the TRPV1 pathway; in addition, compared with Example 2, the inhibitory effect of Example 4 prepared with deionized water on the TRPV1 pathway was reduced.

[0297] Test Example 3

[0298] Cosmetic efficacy evaluation test based on human body:

[0299] 1. Sample information

[0300] Table 36. Sample information

[0301]

[0302] 2. Test Method

[0303] After cleansing your face every morning and evening, take an appropriate amount of Soothing Repair Cream and apply it evenly on your facial skin. Use your fingertips to pat your face to aid absorption.

[0304] 2.1 Subjects

[0305] 2.1.1 Target population: no less than 60 people, with no less than 30 people in the control group and no less than 30 people in the test group. Grouping should be done using a random table.

[0306] 2.1.2 Inclusion Criteria

[0307] 1) Healthy women aged 18-60, East Asian skin type;

[0308] 2) The skin is sensitive;

[0309] 3) Informed consent and the ability to use the product and complete the corresponding tests as required by the researcher.

[0310] 2.1.3 Exclusion criteria

[0311] 1) Pregnant or breastfeeding women;

[0312] 2) Those with severe systemic diseases and currently taking medication for systemic diseases;

[0313] 3) The tested area has undergone skin treatment, cosmetic or other tests that may affect the results;

[0314] 4) People with allergic diseases or those who are allergic to cosmetics;

[0315] 5) Participated in other clinical trials currently or before the start of this study.

[0316] 2.1.4 Shedding standards

[0317] 1) The respondent was lost to follow-up or voluntarily requested to withdraw;

[0318] 2) Poor compliance, failure to use samples on time and in the correct amount, and failure to make return visits as required;

[0319] 3) Using other cosmetics similar to the test samples during the research process;

[0320] 4) New diseases that directly affect the evaluation of clinical status, including skin diseases, appear during the study period;

[0321] 5) Subjects who became pregnant during the study;

[0322] 6) Those who experience serious adverse reactions (SAEs) during the entire study period.

[0323] 2.2 Instruments

[0324] Facial imaging system (Canfield, VISIA, USA); transepidermal water loss rate tester (Vapometer, Delfin, Finland); skin color tester (NR110, 3nh, China).

[0325] 2.3 Test indicators

[0326] 2.3.1 Facial red zone scoring

[0327] The facial redness score is an important indicator for measuring the soothing effect of cosmetics. A higher facial redness score indicates more severe redness. If the facial redness score decreases significantly after using a product compared to before use, the product is considered to have soothing properties.

[0328] 2.3.2 Transepidermal water loss rate (TEWL)

[0329] Transepidermal Water Loss (TEWL) is an important indicator for measuring the effectiveness of cosmetics in repairing and rejuvenating skin. A higher TEWL value indicates faster water loss from the skin and a weaker skin barrier. If the TEWL value decreases significantly after using a product compared to before use, it indicates that the product has good repairing properties.

[0330] 2.3.3 Adverse skin reactions

[0331] According to the grading standards for adverse skin reactions in human trial tests specified in the 2015 edition of the "Technical Specifications for Safety of Cosmetics", when conducting follow-up visits with the subjects, it is necessary to carefully inquire, conduct thorough inspections, and record in detail any adverse reactions that the subjects experience during the use of the samples.

[0332] 2.4 Test Area

[0333] The test area for transepidermal water loss (TEWL) was the cheek, and the test area for facial redness scoring was the entire face.

[0334] 2.5 Test Environment

[0335] The subjects exposed their skin at the measurement site and equilibrated it in an environment of 20-22°C and 40-60% humidity for 20 minutes before skin testing.

[0336] 2.6 Testing Process

[0337] 1) On Day 0, participants signed an informed consent form and entered the screening phase. Participants who passed the screening phase were formally enrolled in the study. Participants cleansed their face and then remained in the test environment for 20 minutes to reach equilibrium. Skin parameters were then measured on the test area. The product was applied once in the lab, and 15 minutes later, skin parameters were measured again on the test area.

[0338] 2) On day 7, after the subjects cleaned their faces and equilibrated in the test environment for 20 minutes, skin parameters of the test area were measured;

[0339] 3) On day 28, the subjects cleaned their faces and allowed them to equilibrate in the test environment for 20 minutes before measuring the skin parameters of the test area.

[0340] 2.7 Adverse Reactions

[0341] If a subject experiences any adverse reaction during the test, they must immediately stop using the test sample and visit a physician at the research center for an examination. The physician will determine whether to discontinue use of the test sample based on the specific circumstances. Furthermore, any adverse reactions and other related events occurring during the test should be recorded in detail and reflected in the final report.

[0342] 2.8 Data Analysis

[0343] Calculate the mean and standard deviation of each parameter in each group at the same time point.

[0344] Calculate the change value and change rate of each parameter at each time point compared with before using the product.

[0345] SPSS 22.0 software was used for statistical analysis to assess whether there were significant differences in skin parameters at different time points after sample application compared to before application. If the data conformed to a normal distribution, a paired t-test was used with a significance level of α = 0.05. If the data were non-normally distributed or nonparametric, a two-sample rank sum test was used with a significance level of α = 0.05.

[0346] 4. Experimental Results

[0347] This trial recruited 62 female subjects with sensitive skin, all of East Asian descent. Testing was conducted between February 12, 2025, and March 12, 2025. The 62 subjects were randomly assigned to two groups: a control group of 31 participants with an average age of 38.58 ± 10.89 years; and a test group of 31 participants with an average age of 40.16 ± 10.24 years. All 62 subjects completed the testing. The results are as follows.

[0348] 3.1 Facial red zone scoring

[0349] The statistical results of facial red zone parameters during the test are shown in Table 37:

[0350] As can be seen from the table, compared with before use, the test group samples containing the plant composition can reduce the facial red area score at each time point; compared with the control group, the test group samples containing the plant composition have lower facial red area scores at each time point, indicating that the soothing repair cream prepared in Example 9 of the present invention has a soothing effect.

[0351] Table 37. Statistical results of facial red zone parameters

[0352]

[0353] Note: **p<0.01 vs before use in each group; ## p<0.01 vs the control group at each time point.

[0354] 3.2 Transepidermal water loss rate (TEWL)

[0355] The statistical results of transepidermal water loss rate (TEWL) during the test are shown in Table 38:

[0356] As can be seen from Table 38, compared with before use, the test group samples containing the plant composition can reduce the TEWL value at each time point; compared with the control group, the test group samples containing the plant composition have lower TEWL values ​​at each time point, indicating that the soothing repair cream prepared in Example 9 of the present invention has a repair effect.

[0357] Table 38. Statistical results of transepidermal water loss rate (TEWL)

[0358]

[0359] Note: **p<0.01 vs before use in each group; ## p<0.01 vs the control group at each time point.

[0360] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A soothing plant composition for inhibiting histamine release, characterized in that: The raw materials are composed of gentiana macrophylla, fragrant asafoetida and small white apricot, and the mass ratio of the gentiana macrophylla, fragrant asafoetida and small white apricot is 1-5:1-5:3-9; The preparation method of the soothing plant composition comprises the following steps: Step 1: mixing Gentiana macrophylla, Ferula odorata and Prunus amygdalus dulcis with water, and extracting with water to obtain a water extract; Step 2: The aqueous extract obtained in step 1 is filtered through a filter membrane and concentrated to obtain a concentrate; Step 3: The concentrate obtained in step 2 is extracted with alcohol, separated, concentrated, and the molecular weight cutoff is 850-1500 or less, and dried to obtain a plant composition.

2. The soothing plant composition according to claim 1, characterized in that The mass ratio of the gentiana macrophylla, asafoetida and small white apricot is 1-3:1-3:4-9.

3. The soothing plant composition according to claim 1, characterized in that In step 1, the mass of the water is 10-30 times the total mass of Gentiana macrophylla, Ferula odoratum and Apricot chinensis; the water extraction temperature is 85-95° C., the extraction time is 0.5-1.5 h; and the water extraction is repeated 1-3 times.

4. The soothing botanical composition according to claim 1, characterized in that In step 2, the pore size of the filter membrane is 0.05-0.4 μm; the mass of the concentrate is 0.1-1 times the total mass of Gentiana macrophylla, Ferula odorata and Apricot chinensis in step 1.

5. The soothing botanical composition according to claim 1, characterized in that In step 3, the alcohol used for the alcohol extraction is an ethanol solution; the alcohol extraction is as follows: the concentrate obtained in step 2 is mixed with the ethanol solution so that the alcohol content of the mixture is greater than or equal to 35°; the temperature of the alcohol extraction is 0-10°C and the time is 3-8h; in step 3, the molecular cutoff is the part with a molecular weight of less than 1000.

6. A cosmetic component, characterized in that The invention comprises the soothing plant composition according to any one of claims 1 to 5 and an excipient accepted in the cosmetics field; the excipient accepted in the cosmetics field is selected from at least one of water, butylene glycol, 1,3-propylene glycol, 1,2-hexanediol and p-hydroxyacetophenone.

7. The cosmetic component according to claim 6, characterized in that The water in the auxiliary material accepted in the cosmetics field is hot spring water.

8. Use of the soothing botanical composition according to any one of claims 1 to 5 or the cosmetic component according to any one of claims 6 to 7 in the preparation of soothing, anti-allergic / anti-inflammatory cosmetics.

9. The use according to claim 8, characterized in that The cosmetic has the effects of inhibiting the release of histamine and / or inhibiting the activation of TRPV1.

Images