A traditional Chinese medicine composition with soothing and anti-allergic effects, and its preparation method and application

Abstract

The present invention discloses a traditional Chinese medicine composition with soothing and anti-allergic effects, as well as its preparation method and application. The composition comprises a Sophora flavescens extract, a Phellodendron amurense extract, and a Monkey Ear Ring extract in a mass ratio of (2-4):(1-2):(0.5-1). The composition significantly inhibits hyaluronidase activity, with an inhibition rate exceeding 67.68%. It can also rapidly relieve yam juice-induced skin pruritus within 5.5 minutes, with an antipruritic effect duration 26.5% shorter than that of the positive control group. This composition achieves a "fast antipruritic and strong soothing" effect through multi-target synergistic action, and its efficacy is significantly superior to that of single components and two-component combinations. Skin irritation experiments have verified that the composition has no allergic risk. The present invention solves the technical problems of existing chemical anti-allergic agents with high irritation and natural ingredients with limited efficacy. It can be widely used in cosmetic dosage forms such as creams and essences, providing an innovative solution for the development of safe and effective natural anti-allergic products.

Description

Technical Field

[0001] The present invention belongs to the technical field of cosmetics, and in particular relates to a traditional Chinese medicine composition with soothing and anti-allergic effects, and a preparation method and application thereof. Background Art

[0002] In recent years, as consumers' interest in the safety and naturalness of skincare products continues to rise, the research and development of anti-allergic cosmetics has gradually shifted from chemically synthesized ingredients to plant-derived active ingredients. However, current technology still faces numerous bottlenecks: While chemical anti-allergic agents (such as ceramide NP, bisabolol, and dipotassium glycyrrhizate) can quickly take effect, long-term use can easily damage the skin barrier and even cause dependent dermatitis. Single plant extracts (such as Phellodendron amurense and Sophora flavescens), while relatively safe, have limited anti-allergic effects and a single target, making them ineffective in addressing complex allergic symptoms, particularly in alleviating itching. This highlights the limited efficacy of single ingredients.

[0003] Some compound compositions attempt to enhance their anti-allergic effects through the combination of multiple ingredients, but these formulations suffer from issues such as insufficient naturalness or unclear synergistic mechanisms. For example, invention patent CN108186472A discloses an anti-allergic soothing composition primarily composed of a first active ingredient (Sophora flavescens root extract, Glycyrrhiza uralensis root extract, and Scutellaria baicalensis root extract), Stephania tetrandra extract, theanine, and epigallocatechin gallate (EGCG). While this composition contains multiple natural extracts, it also contains chemical or semi-synthetic ingredients such as theanine and EGCG, which may irritate sensitive skin and contradict the market trend of "pure and natural."

[0004] For example, invention patent CN105902447B discloses a composition with anti-allergic and soothing effects. The composition is composed of plant extracts (Mirabilis jalapa, Ophiopogon japonicus, Sophora flavescens, Opuntia cochinchinensis, Mentha piperita, Portulaca oleracea, Nepeta tenuifolia, Aloe vera, and Pulsatilla chinensis), trehalose, 1,3-propylene glycol, and water. Although this anti-allergic composition contains natural ingredients such as Sophora flavescens and Portulaca oleracea, the added chemical excipients (trehalose and 1,3-propylene glycol), particularly 1,3-propylene glycol, may not be friendly to sensitive skin, limiting its application. Furthermore, the patent briefly mentions the inhibition of histamine release and hyaluronidase activity, without further elaboration on the synergistic effects of the various ingredients.

[0005] Invention patent CN117159428B discloses a composition with soothing, anti-allergic, and anti-itching properties. The composition contains hydroxyphenylpropionamide benzoic acid, matrine, purslane extract, and dimethyl isosorbide. While emphasizing the synergistic effect of multiple components, the presence of synthetic or semi-synthetic substances raises questions about its natural safety. Similarly, invention patent CN101732205B discloses a skin care composition that soothes allergic skin, provides anti-inflammatory and anti-irritation benefits. This composition also relies on chemically synthesized ingredients such as allantoin and dipotassium glycyrrhizate, making it difficult to accurately assess the actual contribution of natural extracts.

[0006] Furthermore, some traditional Chinese medicine formulas also have significant flaws. For example, invention patent CN103623112B discloses a traditional Chinese medicine composition for treating skin itching. While the disclosed traditional Chinese medicine composition for treating skin itching contains natural ingredients such as Phellodendron amurense and Sophora flavescens, it incorporates as many as 16 herbs. The redundant composition makes it difficult to clearly define the effects of each component, obscuring its mechanism of action and failing to reveal the synergistic effects between the ingredients. Furthermore, its preparation process relies solely on the traditional method of boiling and removing residue, resulting in low utilization of the active ingredients.

[0007] Therefore, developing an anti-allergic composition that is naturally safe, highly effective, and can achieve multi-target synergistic effects has become a key issue that the industry urgently needs to address. Summary of the Invention

[0008] The purpose of the present invention is to overcome the above-mentioned defects and deficiencies in the prior art and to provide a natural soothing and anti-allergic Chinese medicine composition that is both natural and safe, highly effective, and has multi-target synergistic effects, so as to solve the key problems in the prior art, such as the high irritation of chemical anti-allergic agents, the insufficient efficacy of single plant extracts, the lack of naturalness of compound compositions, and the unclear synergistic mechanism.

[0009] The second object of the present invention is to provide a method for preparing the traditional Chinese medicine composition with soothing and anti-allergic effects.

[0010] The third object of the present invention is to provide an application of the traditional Chinese medicine composition having soothing and anti-allergic effects.

[0011] The above-mentioned object of the present invention is achieved through the following technical solutions:

[0012] A traditional Chinese medicine composition with soothing and anti-allergic effects, the traditional Chinese medicine composition consisting of a Sophora flavescens extract, a Phellodendron amurense extract, and a Herba Lycopodii extract in a mass ratio of (2-4): (1-2): (0.5-1); the Sophora flavescens extract is a Sophora flavescens total alkaloid extract; the Phellodendron amurense extract is a Phellodendron amurense total alkaloid extract; and the Herba Lycopodii extract is a Herba Lycopodii flavonoid and phenolic acid active substances.

[0013] Sophora flavescens is a plant of the genus Sophora flavescens in the Leguminosae family ( Sophora flavescensThe dried root of Sophora flavescens (Ait.) is primarily produced in North, East, and Northwest my country. It is cold in nature and bitter in flavor, purifying the heart, liver, stomach, large intestine, and bladder meridians. It has the effects of clearing heat and dampness, killing insects and relieving itching, and promoting diuresis and relieving stranguria. Its core active ingredients are alkaloids (matrine and oxymatrine) and flavonoids (matrine and isomatrine). Matrine can inhibit pathogens such as Staphylococcus aureus and Shigella dysenteriae, modulate immunity, and fight arrhythmias. Oxymatrine reduces inflammation by inhibiting the NF-κB pathway and is widely used clinically for treating damp-heat diarrhea, eczema and pruritus, jaundice, and vaginal trichomoniasis. Existing sophora flavescens extracts are alkaloids extracted from the plant Sophora flavescens, a member of the genus Sophora in the Leguminosae family. They appear as yellow to brown granules or powders and have a bitter taste. Modern research has shown that sophora flavescens extracts have inhibitory effects on hepatitis B virus, skin fungi, and tumor cells (such as HepG2), and can also slow the progression of liver fibrosis by blocking the TGF-β signaling pathway. External use often involves fumigation and washing with a decoction to treat scabies and genital swelling. Sophora flavescens combines traditional heat-clearing properties with modern anti-inflammatory and anti-tumor potential, making it an important resource in the fields of antimicrobial and immunomodulatory Chinese medicine.

[0014] Phellodendron chinense is a plant of Rutaceae family ( Phellodendron chinense The dried bark of the Chinese phellodendron chinense (Phellodendron chinense), primarily produced in Sichuan, Hubei, and Guizhou, is cold in nature and bitter in flavor, entering the kidney and bladder meridians. It has the effects of clearing heat and dampness, purging fire and detoxifying, and relieving asthenic fever. Its core active ingredients are alkaloids such as berberine, jatrorrhizine, and palmatine. Berberine exerts broad-spectrum antibacterial effects (such as against Staphylococcus aureus and Escherichia coli) by inhibiting bacterial DNA gyrase and disrupting cell membranes. Terpenoids such as phellodendron ketone and phellodendron lactone exhibit anti-inflammatory, hypoglycemic, and immunomodulatory activities. It is commonly used clinically for damp-heat diarrhea, jaundice, dark urine, and bone steaming and night sweats caused by yin deficiency and fire excess (e.g., Zhibai Dihuang Wan). It is also used topically to treat eczema, burns, and sores. In the prior art, phellodendron chinense extract refers to a substance extracted from the dried bark of the Rutaceae plant, Phellodendron chinense or Phellodendron amurense. Modern research has shown that phellodendron chinense extract can inhibit the NF-κB pathway, reduce inflammation, and assist in the treatment of diabetes and immune-related diseases. Huangbai has both classic medicinal effects and modern pharmacological basis, and is an important resource in the field of antibacterial and anti-inflammatory traditional Chinese medicine.

[0015] Monkey Earrings ( Pithecellobium clypeariaBenth., also known as the savory tree and dragon wood, is a plant of the genus Mimosoideae, subfamily Mimosoideae, in the Fabaceae family. It is primarily distributed in southern China and Southeast Asia. Its dried leaves, stems, and branches are used as medicine, first recorded in the Compendium of Materia Medica. It is slightly cold in nature, bitter and astringent in taste, and enters the spleen, stomach, and liver meridians. It has the effects of clearing heat and detoxifying, cooling blood and reducing swelling, and stopping diarrhea and healing sores. It is commonly used in folk medicine to treat burns, eczema, and purulent wounds. Modern research shows that Benth. is primarily composed of flavonoids (quercetin, kaempferol, and their glycosides), phenolic acids (gallic acid, ethyl gallate), triterpenes, and phenylpropanoids. Flavonoids exert antibacterial and antiviral effects by disrupting bacterial membrane permeability and inhibiting viral replication. Gallic acid exhibits significant anti-inflammatory activity, inhibiting histamine release and the expression of inflammatory factors. Pharmacological studies have confirmed its multiple activities, including antiviral, antibacterial, anti-inflammatory, antioxidant, and immunomodulatory. It is particularly effective in inhibiting the release of influenza and herpes viruses and inflammatory factors. Monkey earrings have shown unique value in the field of anti-drug resistant bacterial infection and are known as "green antibiotics". The monkey earring extract of the present invention contains flavonoids and phenolic acid active substances.

[0016] By scientifically optimizing the ratio of extracts from Phellodendron amurense, Sophora flavescens, and Herba Ostreae, this invention leverages the multiple anti-inflammatory, antibacterial, and repairing properties of each ingredient. This method achieves multi-target synergistic efficacies: inhibiting hyaluronidase activity, regulating inflammatory factors, and blocking itch signals. The synergistic effect of these three ingredients delivers rapid itch relief and strong soothing effects. This effectively overcomes the technical shortcomings of existing anti-allergic agents, such as their lack of naturalness, limited efficacy, and unclear synergistic mechanisms.

[0017] Furthermore, the traditional Chinese medicine composition is composed of Sophora flavescens extract, Phellodendron amurense extract and Herba Lycopodii extract in a mass ratio of (3-4): (1-2): (0.5-1).

[0018] Furthermore, the preparation method of the Sophora flavescens extract is as follows: extract Sophora flavescens by acid-water extraction, adsorb the extract by cation exchange resin, treat the resin with alkali solution, and elute with solvent to obtain the extract.

[0019] Preferably, the acid-water extraction method is to extract Sophora flavescens with 0.5% to 1% dilute strong acid solution (such as sulfuric acid, hydrochloric acid or acetic acid, tartaric acid solution) at a solid-liquid ratio of 1:10 to 20 (w / v), reflux at 75°C to 85°C for multiple times, and combine the extracts.

[0020] Preferably, the cation exchange resin is a strongly acidic cation exchange resin (eg, type 001×7).

[0021] Preferably, the resin is treated with alkali solution and solvent eluted by alkalizing the resin with ammonia water to a pH of about 10 to release the alkaloids from the resin, followed by extraction with an organic solvent under reflux, and recovery of the solvent. Alternatively, the resin may be directly eluted with an ethanol eluent containing ammonia water, the eluent may be neutralized, and the ethanol may be recovered.

[0022] As a preferred embodiment, the preparation method of the Sophora flavescens extract is as follows: the Sophora flavescens medicinal material is crushed into 20-40 meshes, and 0.5%-1% dilute hydrochloric acid is used at a material-liquid ratio of 1:10-20 (w / v) and reflux extracted twice at 80°C for 2 hours. After repeating twice, the extracts are combined, and the filtrate is coarsely filtered and finely filtered with a microporous membrane. The filtrate is concentrated under reduced pressure to 1 / 5 of the original volume; then the concentrate is passed through a pretreated strong acid cation exchange resin (001×7 type) at a flow rate of 1BV / h. After adsorption is completed, impurities are washed with 3 times the column volume of pure water, and then the target component is eluted with 5 times the column volume of 65%-75% ethanol solution containing 4%-6% ammonia water at 0.5-1.0 BV / h. The ethanol eluate is collected, and the ethanol is recovered under reduced pressure and then concentrated and dried to obtain a light yellow Sophora flavescens extract powder.

[0023] Furthermore, the Phellodendron cordata extract is obtained by extracting Phellodendron cordata with an alcohol solvent, precipitating the extract with acid, separating the supernatant with alkali, purifying with a macroporous resin, and eluting with a solvent.

[0024] Preferably, the alcohol solvent extraction is to extract Phellodendron amurense multiple times with 65% to 75% ethanol as solvent at a material-liquid ratio of 1:10 to 20 (w / v) at 75° C. to 85° C. under reflux, and combine the extracts.

[0025] Preferably, the extract is acid precipitated and the supernatant is precipitated with alkali by adjusting the pH of the extract to 2-3, allowing the extract to settle, and removing the acidic precipitate by centrifugation; the supernatant is adjusted to pH 10-11, allowing the extract to settle, and collecting the precipitate by centrifugation.

[0026] Preferably, the macroporous resin purification and solvent elution are as follows: the precipitate is dissolved with an appropriate amount of pure water, loaded onto a D101 macroporous resin column, impurities are first eluted with pure water, and then eluted with 65% to 75% ethanol, and the ethanol eluate is collected.

[0027] As a preferred embodiment, the preparation method of the Phellodendron chinense extract is as follows: crush the Phellodendron chinense medicinal material into 20-40 meshes, use 65%-75% ethanol as a solvent at a material-liquid ratio of 1:10-20 (w / v), reflux extract at 80°C twice, each time for 1 hour, combine the extracts and filter while hot, and discard the filter residue; the filtrate is concentrated to 1 / 5 of the original volume under reduced pressure, dilute hydrochloric acid is added to adjust the pH to 2-3, the mixture is allowed to stand at room temperature for 2 hours, and the acidic precipitate is removed by centrifugation; the supernatant is adjusted to pH 10-11 with 5% sodium hydroxide solution, the mixture is allowed to stand for 12 hours to precipitate, and the precipitate is collected by centrifugation (4000 rpm, 15 minutes); after the precipitate is dissolved with an appropriate amount of pure water, it is loaded onto a D101 macroporous resin column at a concentration of 1.5 mg / mL, impurities are first eluted with 3 times the column volume of pure water, and then eluted with 5 times the column volume of 65%-75% ethanol, the ethanol eluate is collected, the ethanol is recovered under reduced pressure, and then concentrated and dried to obtain the Phellodendron chinense extract.

[0028] Furthermore, the monkey earring extract is extracted using an alcohol solvent, the extract is acid precipitated, the supernatant is adjusted to neutral, purified by a macroporous resin, and eluted with a solvent to obtain the extract.

[0029] Preferably, the alcohol solvent extraction is performed by using 65% to 75% ethanol as a solvent for the monkey earrings at a material-liquid ratio of 1:10 to 20 (w / v), reflux extraction at 75° C. to 85° C. for multiple times, and combining the extracts.

[0030] Preferably, the extract is acid-precipitated and the supernatant is adjusted to neutral by adjusting the pH of the extract to 3-4, allowing the extract to settle, centrifuging to remove the precipitate, and adjusting the supernatant to neutral.

[0031] Preferably, the macroporous resin purification and solvent elution are as follows: the supernatant adjusted to neutrality is loaded onto an AB-8 macroporous resin column, impurities are eluted with pure water and 30% ethanol in sequence, and then the target component is eluted with 65% to 75% ethanol, and the 70% ethanol eluate is collected.

[0032] As a preferred embodiment, the preparation method of the monkey earring extract is as follows: the monkey earring medicinal material is crushed into 20-40 meshes, and reflux extracted twice with 65%-75% ethanol at a material-liquid ratio of 1:10-20 (w / v) at 80°C for 1.5 hours each time, the extracts are combined, coarsely filtered and finely filtered with a microporous membrane, the filtrate is concentrated under reduced pressure to 1 / 5 of the original volume, dilute hydrochloric acid is slowly added to adjust the pH to 3-4, the mixture is allowed to stand for 4 hours and centrifuged (4000 rpm, 15 minutes) to remove the precipitate, the supernatant is adjusted to neutral and then loaded onto an AB-8 macroporous resin column, impurities are eluted with 3 times the column volume of pure water and 4 times the column volume of 30% ethanol in sequence, and the target component is finally eluted with 5 times the column volume of 65%-75% ethanol, the 70% ethanol eluate is collected, the ethanol is recovered under reduced pressure, and then concentrated and dried to obtain the monkey earring extract.

[0033] The present invention also provides a method for preparing any of the above-mentioned Chinese medicine compositions, comprising the following steps:

[0034] S1. The Sophora flavescens was extracted by acid-water extraction, the extract was adsorbed on a cation exchange resin column, the resin was treated with alkali solution, the solvent was eluted, and the extract was concentrated and dried to obtain a Sophora flavescens extract; the Phellodendron chinense was extracted by an alcohol solvent, the extract was precipitated with acid, the supernatant was precipitated with alkali, and then purified with a macroporous resin, the solvent was eluted, and the extract was concentrated and dried to obtain a Phellodendron chinense extract; the monkey earring was extracted by an alcohol solvent, the extract was precipitated with acid, the supernatant was adjusted to neutral, purified with a macroporous resin, the solvent was eluted, and the extract was concentrated and dried to obtain a monkey earring extract;

[0035] S2. Mix the Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract prepared in step S1 in a corresponding mass ratio to obtain the product.

[0036] Research conducted in the present invention shows that the above-mentioned traditional Chinese medicine composition has an inhibition rate of hyaluronidase activity of more than 67.68%, and can quickly relieve the skin itching reaction induced by yam juice within 5.5 minutes. Its antipruritic effect is 26.5% shorter than that of the positive control group. The traditional Chinese medicine composition of the present invention achieves multi-target synergistic synergy of hyaluronidase activity inhibition, inflammatory factor regulation and itching signal blocking. The three work together to achieve the effect of "fast antipruritic and strong soothing". Therefore, the present invention also provides the use of any of the above-mentioned traditional Chinese medicine compositions in soothing, anti-allergic and / or antipruritic treatment.

[0037] The present invention further provides the use of any of the above-mentioned traditional Chinese medicine compositions in the preparation of soothing, anti-allergic and / or antipruritic cosmetics.

[0038] The present invention also provides a cosmetic having soothing, anti-allergic and / or antipruritic effects, wherein the cosmetic contains any of the above-mentioned traditional Chinese medicine compositions.

[0039] Furthermore, the dosage forms of the cosmetics include but are not limited to creams, essences, facial masks, lotions and the like, and are particularly suitable for sensitive skin repair products.

[0040] Compared with the prior art, the present invention has the following beneficial effects:

[0041] The present invention provides a traditional Chinese medicine composition with soothing and anti-allergic effects. The composition comprises a Sophora flavescens extract, a Phellodendron amurense extract, and a Monkey Ear Ring extract in a mass ratio of (2-4):(1-2):(0.5-1). This composition significantly inhibits hyaluronidase activity, achieving an inhibition rate of over 67.68%. It can rapidly relieve yam juice-induced skin pruritus within 5.5 minutes, with an antipruritic effect duration 26.5% shorter than that of the positive control group. This composition achieves a multi-target synergistic effect by inhibiting hyaluronidase activity, regulating inflammatory factors, and blocking itch signals. The synergistic effect of these three components achieves a "fast and soothing" effect, significantly superior to either a single component or a combination of two components. The antipruritic speed of this composition is comparable to that of hormonal drugs, yet it offers greater safety. The composition, derived entirely from natural plant extracts, has been shown to exhibit no erythema or edema reactions and poses no risk of sensitization in skin irritation experiments. This composition addresses the issue of chemical anti-allergic agents easily damaging the skin barrier and is suitable for long-term use on sensitive skin. In summary, the present invention solves the technical difficulties of existing chemical anti-allergic agents being highly irritating and natural ingredients having a single efficacy. It can be widely used in cosmetic dosage forms such as creams, essences, and facial masks to meet the anti-allergic needs of different scenarios. It is especially suitable for sensitive skin repair products, providing an innovative solution for the development of safe and efficient natural anti-allergic products. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 This is a bar chart of the itching duration in the human skin anti-allergic and anti-itching experiment.

[0043] Figure 2 This is a bar chart of itching intensity in the anti-allergic and anti-itching experiment on human skin. DETAILED DESCRIPTION

[0044] The present invention will be further described below with reference to the accompanying drawings and specific examples, but the examples do not limit the present invention in any way. Unless otherwise specified, the reagents, methods and equipment used in the present invention are conventional reagents, methods and equipment in the art.

[0045] Unless otherwise specified, the reagents and materials used in the following examples were commercially available.

[0046] Example 1

[0047] This embodiment provides a soothing and anti-allergic Chinese medicine composition, comprising the following raw materials in parts by weight: 4 parts of Sophora flavescens extract; 1 part of Phellodendron amurense; and 0.5 parts of Othellodendron auricularia auricularia extract.

[0048] This embodiment also provides a method for preparing the soothing and anti-allergic Chinese medicine composition, which is specifically as follows:

[0049] The Sophora flavescens medicinal material was crushed into 20-40 mesh, and extracted twice at 80°C under reflux for 2 hours using 0.5% dilute hydrochloric acid at a material-liquid ratio of 1:10 (w / v). After repeated twice, the extracts were combined, coarsely filtered and finely filtered with a microporous membrane, and the filtrate was concentrated to 1 / 5 of the original volume under reduced pressure; the concentrate was then passed through a pretreated strong acid cation exchange resin (type 001×7) at a flow rate of 1 BV / h. After adsorption, impurities were washed with 3 times the column volume of pure water, and the target component was eluted with 5 times the column volume of 65% ethanol solution containing 4% ammonia water at 0.5 BV / h. The ethanol eluate was collected, ethanol was recovered under reduced pressure, and then concentrated and dried to obtain a light yellow Sophora flavescens extract powder.

[0050] The Phellodendron chinense medicinal material was crushed into 20-40 mesh, extracted twice with 65% ethanol as solvent at a material-liquid ratio of 1:10 (w / v) at 80°C for 1 hour each time, the combined extracts were filtered while hot, and the filter residue was discarded; the filtrate was concentrated to 1 / 5 of the original volume under reduced pressure, the pH was adjusted to 2 by adding dilute hydrochloric acid, the solution was allowed to stand at room temperature for 2 hours, and the acidic precipitate was removed by centrifugation; the supernatant was adjusted to pH 10 with 5% sodium hydroxide solution, the solution was allowed to stand for 12 hours to allow precipitation, and the precipitate was collected by centrifugation (4000 rpm, 15 minutes); the precipitate was dissolved in an appropriate amount of pure water and loaded onto a D101 macroporous resin column at a concentration of 1.5 mg / mL. Impurities were first eluted with 3 column volumes of pure water, and then eluted with 5 column volumes of 65% ethanol. The ethanol eluate was collected, the ethanol was recovered under reduced pressure, and then concentrated and dried to obtain the Phellodendron chinense extract.

[0051] The monkey earring medicinal material was crushed into 20-40 mesh, extracted twice with 65% ethanol at a material-liquid ratio of 1:10 (w / v) at 80°C reflux, each time for 1.5 hours, the extracts were combined, coarsely filtered and finely filtered with a microporous membrane, the filtrate was concentrated under reduced pressure to 1 / 5 of the original volume, dilute hydrochloric acid was slowly added to adjust the pH to 3, the mixture was allowed to stand for 4 hours and centrifuged (4000 rpm, 15 minutes) to remove the precipitate, the supernatant was adjusted to neutral and loaded onto an AB-8 macroporous resin column, the impurities were eluted with 3 times the column volume of pure water and 4 times the column volume of 30% ethanol, and finally the target component was eluted with 5 times the column volume of 65% ethanol. The 65% ethanol eluate was collected, the ethanol was recovered under reduced pressure, and then concentrated and dried to obtain the monkey earring extract.

[0052] The sophora flavescens extract, the phellodendron amurense extract and the monkey ear ring extract are mixed in a mass ratio of 4:1:0.5 to obtain a traditional Chinese medicine soothing and anti-allergic composition.

[0053] Example 2

[0054] This embodiment provides a soothing and anti-allergic Chinese medicine composition, comprising the following raw materials in parts by weight: 4 parts of Sophora flavescens extract; 1 part of Phellodendron amurense extract; and 1 part of Othellodendron amurense extract.

[0055] This embodiment also provides a method for preparing the soothing and anti-allergic Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Otori extract are the same as those in Example 1. Sophora flavescens extract, Phellodendron amurense extract, and Herba Otori extract are mixed in a mass ratio of 4:1:1 to obtain the soothing and anti-allergic Chinese medicine composition.

[0056] Example 3

[0057] This embodiment provides a soothing and anti-allergic Chinese medicine composition, comprising the following raw materials in parts by weight: 3 parts of Sophora flavescens extract; 1.5 parts of Phellodendron amurense; and 0.75 parts of Othellodendron amurense extract.

[0058] This embodiment also provides a method for preparing the soothing and anti-allergic Chinese medicine composition, which is specifically as follows:

[0059] The Sophora flavescens medicinal material was crushed into 20-40 mesh, and extracted twice with 0.75% dilute hydrochloric acid at a material-liquid ratio of 1:15 (w / v) at 80°C under reflux for 2 hours. After repeating twice, the extracts were combined, coarsely filtered and finely filtered with a microporous membrane, and the filtrate was concentrated to 1 / 5 of the original volume under reduced pressure; the concentrate was then passed through a pretreated strong acid cation exchange resin (type 001×7) at a flow rate of 1 BV / h. After adsorption, impurities were washed with 3 times the column volume of pure water, and the target component was eluted with 5 times the column volume of 70% ethanol solution containing 5% ammonia water at 0.75 BV / h. The ethanol eluate was collected, ethanol was recovered under reduced pressure, and then concentrated and dried to obtain a light yellow Sophora flavescens extract powder.

[0060] The Chinese phellodendron chinense was crushed into 20-40 mesh, extracted twice with 70% ethanol as solvent at a material-liquid ratio of 1:15 (w / v) at 80°C for 1 hour each time, the combined extracts were filtered while hot, and the filter residue was discarded; the filtrate was concentrated to 1 / 5 of the original volume under reduced pressure, the pH was adjusted to 2.5 by adding dilute hydrochloric acid, the solution was allowed to stand at room temperature for 2 hours, and the acidic precipitate was removed by centrifugation; the supernatant was adjusted to pH 10.5 by using 5% sodium hydroxide solution, the solution was allowed to stand for 12 hours to allow precipitation, and the precipitate was collected by centrifugation (4000 rpm, 15 minutes); the precipitate was dissolved in an appropriate amount of pure water and loaded onto a D101 macroporous resin column at a concentration of 1.5 mg / mL. Impurities were eluted with 3 column volumes of pure water, followed by elution with 5 column volumes of 70% ethanol. The ethanol eluate was collected, the ethanol was recovered under reduced pressure, and then concentrated to dryness to obtain the Chinese phellodendron chinense extract.

[0061] The monkey earring medicinal material was crushed into 20-40 mesh, extracted twice with 70% ethanol at a material-liquid ratio of 1:15 (w / v) at 80°C reflux, each time for 1.5 hours, the extracts were combined, coarsely filtered and finely filtered with a microporous membrane, the filtrate was concentrated under reduced pressure to 1 / 5 of the original volume, dilute hydrochloric acid was slowly added to adjust the pH to 3.5, and the mixture was allowed to stand for 4 hours and centrifuged (4000 rpm, 15 minutes) to remove the precipitate. The supernatant was adjusted to neutral and loaded onto an AB-8 macroporous resin column. Impurities were eluted with 3 column volumes of pure water and 4 column volumes of 30% ethanol in sequence, and the target component was finally eluted with 5 column volumes of 70% ethanol. The 70% ethanol eluate was collected, the ethanol was recovered under reduced pressure, and then concentrated and dried to obtain the monkey earring extract.

[0062] The sophora flavescens extract, the phellodendron amurense extract and the monkey ear ring extract are mixed in a mass ratio of 3:1.5:0.75 to obtain a traditional Chinese medicine soothing and anti-allergic composition.

[0063] Example 4

[0064] This embodiment provides a soothing and anti-allergic Chinese medicine composition, comprising the following raw materials in parts by weight: 3 parts of Sophora flavescens extract; 2 parts of Phellodendron amurense; and 0.5 parts of Othellodendron auricularia auricularia extract.

[0065] This embodiment also provides a method for preparing the soothing and anti-allergic Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Otori extract are the same as those in Example 3. Sophora flavescens extract, Phellodendron amurense extract, and Herba Otori extract are mixed in a mass ratio of 3:2:0.5 to obtain the soothing and anti-allergic Chinese medicine composition.

[0066] Example 5

[0067] This embodiment provides a soothing and anti-allergic Chinese medicine composition, comprising the following raw materials in parts by weight: 2 parts of Sophora flavescens extract; 2 parts of Phellodendron amurense; and 0.5 parts of Othellodendron amurense extract.

[0068] This embodiment also provides a method for preparing the soothing and anti-allergic Chinese medicine composition, which is specifically as follows:

[0069] The Sophora flavescens medicinal material was crushed into 20-40 mesh, and extracted twice at 80°C under reflux for 2 hours using 1% dilute hydrochloric acid at a material-liquid ratio of 1:20 (w / v). After repeated twice, the extracts were combined, coarsely filtered and finely filtered with a microporous membrane, and the filtrate was concentrated to 1 / 5 of the original volume under reduced pressure; the concentrate was then passed through a pretreated strong acid cation exchange resin (type 001×7) at a flow rate of 1 BV / h. After adsorption, impurities were washed with 3 times the column volume of pure water, and the target component was eluted with 5 times the column volume of 75% ethanol solution containing 6% ammonia water at 1.0 BV / h. The ethanol eluate was collected, ethanol was recovered under reduced pressure, and then concentrated and dried to obtain a light yellow Sophora flavescens extract powder.

[0070] The Chinese phellodendron chinense was crushed into 20-40 mesh, extracted twice with 75% ethanol as solvent at a material-liquid ratio of 1:20 (w / v) at 80°C for 1 hour each time, the combined extracts were filtered while hot, and the filter residue was discarded; the filtrate was concentrated to 1 / 5 of the original volume under reduced pressure, the pH was adjusted to 3 by adding dilute hydrochloric acid, the solution was allowed to stand at room temperature for 2 hours, and the acidic precipitate was removed by centrifugation; the supernatant was adjusted to pH 11 by using 5% sodium hydroxide solution, the solution was allowed to stand for 12 hours to allow precipitation, and the precipitate was collected by centrifugation (4000 rpm, 15 minutes); the precipitate was dissolved in an appropriate amount of pure water and loaded onto a D101 macroporous resin column at a concentration of 1.5 mg / mL. Impurities were first eluted with 3 column volumes of pure water, and then eluted with 5 column volumes of 75% ethanol. The ethanol eluate was collected, the ethanol was recovered under reduced pressure, and then concentrated and dried to obtain the Chinese phellodendron chinense extract.

[0071] The monkey earring medicinal material was crushed into 20-40 mesh, and extracted twice with 75% ethanol at a material-liquid ratio of 1:20 (w / v) at 80°C reflux, each time for 1.5 hours. The extracts were combined, coarsely filtered and finely filtered with a microporous membrane, and the filtrate was concentrated under reduced pressure to 1 / 5 of the original volume. Dilute hydrochloric acid was slowly added to adjust the pH to 4, and the mixture was allowed to stand for 4 hours and centrifuged (4000 rpm, 15 minutes) to remove the precipitate. The supernatant was adjusted to neutral and loaded onto an AB-8 macroporous resin column. Impurities were eluted with 3 column volumes of pure water and 4 column volumes of 30% ethanol in sequence, and the target component was finally eluted with 5 column volumes of 75% ethanol. The 75% ethanol eluate was collected, the ethanol was recovered under reduced pressure, and then concentrated and dried to obtain the monkey earring extract.

[0072] The sophora flavescens extract, the phellodendron amurense extract and the monkey ear ring extract are mixed in a mass ratio of 2:2:0.5 to obtain a traditional Chinese medicine soothing and anti-allergic composition.

[0073] Example 6

[0074] This embodiment provides a soothing and anti-allergic Chinese medicine composition, comprising the following raw materials in parts by weight: 2 parts of Sophora flavescens extract; 2 parts of Phellodendron amurense; and 1 part of Othellodendron auriculariaceae extract.

[0075] This embodiment also provides a method for preparing the soothing and anti-allergic Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Otori extract are the same as those in Example 5. Sophora flavescens extract, Phellodendron amurense extract, and Herba Otori extract are mixed in a mass ratio of 2:2:1 to obtain the soothing and anti-allergic Chinese medicine composition.

[0076] Comparative Example 1

[0077] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 1 part of Sophora flavescens extract; 0 parts of Phellodendron amurense extract; and 0 parts of Herba Eczoma Cynoglossi extract.

[0078] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 1:0:0 to obtain the Chinese medicine composition of the comparative example.

[0079] Comparative Example 2

[0080] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 0 parts of Sophora flavescens extract; 1 part of Phellodendron amurense; and 0 parts of Herba Eczoma Cynoglossi extract.

[0081] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 0:1:0 to obtain the Chinese medicine composition of the comparative example.

[0082] Comparative Example 3

[0083] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 0 parts of Sophora flavescens extract; 0 parts of Phellodendron amurense; and 1 part of Herba Cynanchifoliae extract.

[0084] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 0:0:1 to obtain the Chinese medicine composition of the comparative example.

[0085] Comparative Example 4

[0086] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 4 parts of Sophora flavescens extract; 1 part of Phellodendron amurense; and 0 parts of Monkey Ear Ring extract.

[0087] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 4:1:0 to obtain the Chinese medicine composition of the comparative example.

[0088] Comparative Example 5

[0089] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 3 parts of Sophora flavescens extract; 1.5 parts of Phellodendron amurense; and 0 parts of Monkey Ear Ring extract.

[0090] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 3:1.5:0 to obtain the Chinese medicine composition of the comparative example.

[0091] Comparative Example 6

[0092] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 2 parts of Sophora flavescens extract; 2 parts of Phellodendron amurense; and 0 parts of Herba Lycopodii extract.

[0093] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 2:2:0 to obtain the Chinese medicine composition of the comparative example.

[0094] Comparative Example 7

[0095] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 0 parts of Sophora flavescens extract; 1 part of Phellodendron amurense; and 1 part of Herba Lycopodii extract.

[0096] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 0:1:1 to obtain the Chinese medicine composition of the comparative example.

[0097] Comparative Example 8

[0098] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 0 parts of Sophora flavescens extract; 2 parts of Phellodendron amurense; and 1 part of Herba Cynanchifoliae extract.

[0099] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 0:2:1 to obtain the Chinese medicine composition of the comparative example.

[0100] Comparative Example 9

[0101] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 0 parts of Sophora flavescens extract; 2 parts of Phellodendron amurense; and 0.5 parts of Herba Lycopodii extract.

[0102] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 0:2:0.5 to obtain the Chinese medicine composition of the comparative example.

[0103] Comparative Example 10

[0104] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 4 parts of Sophora flavescens extract; 0 parts of Phellodendron amurense; and 0.5 parts of Herba Lycopodii extract.

[0105] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 4:0:0.5 to obtain the Chinese medicine composition of the comparative example.

[0106] Comparative Example 11

[0107] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 3 parts of Sophora flavescens extract; 0 parts of Phellodendron amurense; and 1 part of Herba Cynanchifoliae extract.

[0108] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 3:0:1 to obtain the Chinese medicine composition of the comparative example.

[0109] Comparative Example 12

[0110] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 2 parts of Sophora flavescens extract; 0 parts of Phellodendron amurense; and 1 part of Herba Cynanchifoliae extract.

[0111] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 2:0:1 to obtain the Chinese medicine composition of the comparative example.

[0112] Comparative Example 13

[0113] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 5 parts of Sophora flavescens extract; 1 part of Phellodendron amurense; and 0.5 parts of Herba Lycopodii extract.

[0114] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 5:1:0.5 to obtain the Chinese medicine composition of the comparative example.

[0115] Comparative Example 14

[0116] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 2 parts of Sophora flavescens extract; 3 parts of Phellodendron amurense; and 1 part of Herba Cynanchifoliae extract.

[0117] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 2:3:1 to obtain the Chinese medicine composition of the comparative example.

[0118] Comparative Example 15

[0119] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 1 part of Sophora flavescens extract; 1 part of Phellodendron amurense; and 3 parts of Herba Lycopodii extract.

[0120] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 1:1:3 to obtain the Chinese medicine composition of the comparative example.

[0121] Comparative Example 16

[0122] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 5 parts of Sophora flavescens extract; 5 parts of Phellodendron amurense; and 0.5 parts of Herba Lycopodii extract.

[0123] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 5:5:0.5 to obtain the Chinese medicine composition of the comparative example.

[0124] Comparative Example 17

[0125] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 2 parts of Sophora flavescens extract; 4 parts of Phellodendron amurense; and 2 parts of Herba Lycopodii extract.

[0126] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 2:4:4 to obtain the Chinese medicine composition of the comparative example.

[0127] Comparative Example 18

[0128] This comparative example provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: 5 parts of Sophora flavescens extract; 2 parts of Phellodendron amurense; and 3 parts of Herba Lycopodii extract.

[0129] This example also provides a preparation method of the Chinese medicine composition. The preparation methods of Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are the same as those in Example 1. The Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract are mixed in a mass ratio of 5:2:3 to obtain the Chinese medicine composition of the comparative example.

[0130] Test Example 1 Skin irritation test

[0131] The method and results of the skin irritation test on the Chinese herbal soothing and anti-allergic compositions involved in Examples 1 to 6 are as follows:

[0132] 1. Test method basis: In accordance with the "Skin Irritation Test Method" in the "Technical Specifications for Safety of Cosmetics (2015 Edition)".

[0133] 2. Experimental Principle: The test substance is applied once to the skin of the test animal. At specified time intervals, the degree of local irritation to the animal's skin is observed and scored. A self-control is used to evaluate the irritation of the test substance to the skin.

[0134] 3. Test Samples and Animals: The test substances were the soothing and anti-allergic Chinese herbal compositions described in Examples 1-6. Weigh 1.000 g of each of these compositions, dissolve them in purified water, and dilute to 1000 mL. The test animals were standard New Zealand white rabbits purchased from Zorba Health Technology (Guangzhou) Co., Ltd.

[0135] 4. Experimental steps:

[0136] 4.1 Eighteen white New Zealand rabbits were randomly divided into six groups, with three rabbits in each group, which were respectively the groups 1 to 6 of Examples.

[0137] 4.2 About 24 hours before the test, trim the hair on both sides of the New Zealand rabbit's spine without damaging the epidermis. The hair removal area should be approximately 3 cm × 3 cm on the left and right sides.

[0138] 4.3 Apply approximately 0.5 mL of the test substance directly to the skin. Cover with two layers of gauze (2.5 cm × 2.5 cm) and a layer of cellophane, and secure with non-irritating adhesive tape and a bandage. Use the other side of the skin as a control. Use an occlusive test with a 4-hour application period. After the test, remove any remaining test substance with warm water.

[0139] 4.4 Observe the skin reaction at the application site 1, 24, 48, and 72 hours after removal of the test substance and score the skin reaction according to Table 1. The comprehensive evaluation is based on the average score of the test animals, and the skin irritation intensity is determined according to Table 2 based on the average of the highest scores at each observation time point of 24, 48, and 72 hours.

[0140] Table 1 Skin irritation reaction score

[0141]

[0142] Table 2 Skin irritation intensity classification

[0143]

[0144] 5. Results and Analysis

[0145] Within 1 to 72 hours after administration of the soothing and anti-allergic Chinese herbal compositions of the present invention, no erythema or edema was observed on the skin of the New Zealand rabbits. According to the skin irritation intensity ratings in Table 2, the soothing and anti-allergic Chinese herbal compositions of the present invention were non-irritating to the skin.

[0146] Test Example 2 Soothing Efficacy Test

[0147] The soothing efficacy test was performed on Examples 1 to 6 and Comparative Examples 1 to 18.

[0148] 1. Method basis: The test was conducted according to the HMC-W1-029 hyaluronidase inhibition rate.

[0149] 2. Experimental Principle: Hyaluronic acid, as one of the main components of the cell matrix and interstitial tissue, is widely present in the cell matrix and plays an important role in maintaining skin moisture and elasticity and protecting the skin's barrier function. Hyaluronidase degrades hyaluronic acid. Inhibiting hyaluronidase activity can effectively reduce hyaluronic acid degradation, thereby reducing the release of histamine and inflammatory factors, exerting a soothing and anti-allergic effect. The hyaluronidase inhibition test uses hyaluronic acid as a substrate and determines the soothing efficacy of cosmetic ingredients by detecting their inhibition of hyaluronidase activity. Because inhibiting hyaluronidase activity can maintain the content and normal function of hyaluronic acid and maintain normal physiological activities of the skin, the hyaluronidase inhibition rate can be used as an indicator to evaluate the effectiveness of soothing ingredients. The higher the inhibition rate, the stronger the soothing activity.

[0150] 3. Reagents: Hyaluronidase BR, 300U-500U / mg, purchased from Yuanye Biotechnology; other reagents were of analytical grade.

[0151] 4. Experimental steps:

[0152] 4.1 Solution preparation

[0153] (1) Acetate buffer solution (pH 5.6): Take 1155 μL of glacial acetic acid, dilute to 100 mL with ultrapure water, mix thoroughly, and take 4.8 mL of the solution as solution A. Weigh 2.72 g of sodium acetate crystals, dissolve in ultrapure water, and dilute to 100 mL. Mix thoroughly, and take 45.2 mL of the solution as solution B. Combine solutions A and B, dilute to 100 mL with ultrapure water, and mix thoroughly. Accurately measure the pH value and adjust the pH to 5.6 using solution A or B.

[0154] (2) Hyaluronidase solution: Weigh 0.0100 g of hyaluronidase and place it in a beaker. Add 4 mL of the prepared acetate buffer solution and allow it to fully dissolve.

[0155] (3) Sodium hyaluronate solution (0.5 mg / mL): Weigh 0.01 g of sodium hyaluronate and place it in a beaker. Add 20 mL of acetic acid buffer solution and stir until completely dissolved.

[0156] (4) Ehrlich reagent: Weigh 0.8 g of p-dimethylaminobenzaldehyde and dissolve it in a mixture of 15 mL of concentrated hydrochloric acid and 15 mL of anhydrous ethanol.

[0157] (5) Sodium carbonate solution (1.0 mol / L): Weigh 5.3 g of sodium carbonate, dissolve it in ultrapure water, and dilute to 50 mL.

[0158] (6) Acetylacetone solution: Take 3.5 mL of acetylacetone and dissolve it in 50 mL of 1.0 mol / L sodium carbonate solution. The solution must be prepared immediately before use.

[0159] (7) Calcium chloride solution (0.25 mmol / L): Weigh 0.02775 g of calcium chloride, dissolve it in ultrapure water and dilute to 1000 mL.

[0160] (8) Sodium hydroxide solution (0.4 mol / L): Weigh 1.6 g of sodium hydroxide, dissolve it in ultrapure water and dilute to 100 mL.

[0161] (9) Dipotassium glycyrrhizate solution: Weigh 3.000 g of dipotassium glycyrrhizate, dissolve it in pure water and dilute to 100 mL.

[0162] (10) Solution of Chinese herbal soothing and anti-allergic composition: 1.000 g of each of the Chinese herbal soothing and anti-allergic composition of Examples 1 to 6 and Control Examples 1 to 18 were weighed, dissolved in pure water, and fixed to 1000 mL.

[0163] 4.2 Determination of hyaluronidase activity inhibition rate

[0164] Select Examples 1 to 6 and Comparative Examples 1 to 18 as samples and dipotassium glycyrrhizate solution as a positive control to perform the following operations:

[0165] First, 0.1 mL of 0.25 mmol / L calcium chloride solution and 0.5 mL of hyaluronidase solution were mixed and incubated at 37°C for 20 minutes. Next, 0.5 mL of sample solution was added and incubated at 37°C for another 20 minutes. Subsequently, 0.5 mL of sodium hyaluronate solution was added and incubated at 37°C for 30 minutes before being allowed to stand at room temperature for 5 minutes. Next, 0.1 mL of 0.4 mol / L sodium hydroxide solution and 0.5 mL of acetylacetone solution were added in sequence. The mixture was heated in a boiling water bath for 15 minutes and then quickly cooled in ice water for 5 minutes. Finally, 1.0 mL of Ehrlich's reagent was added and diluted with 3.0 mL of anhydrous ethanol. The mixture was allowed to stand at room temperature for 30 minutes to allow for full color development. The absorbance at a wavelength of 528 nm was measured using a spectrophotometer.

[0166] 4.3 Results Analysis

[0167] Hyaluronidase inhibition rate (%) = [(AB)-(CD)] / (AB)×100%

[0168] Where:

[0169] A is the absorbance value of the blank group, which means that the sample solution was replaced by acetate buffer solution;

[0170] B is the absorbance value of the blank control group, which refers to the use of acetate buffer solution instead of sample solution and enzyme solution;

[0171] C is the absorbance value of the sample group;

[0172] D is the absorbance value of the sample control group, which means that the enzyme solution is replaced by acetate buffer solution.

[0173] The data results are shown in Table 3, and the statistical analysis is shown in Tables 4 and 5.

[0174] Table 3 Hyaluronidase inhibition rate ( ±s, n=5)

[0175]

[0176] Table 4 Comparison of significant difference analysis (hypothesis test) data

[0177]

[0178] Table 5 Comparison of key indicators

[0179]

[0180] A comparison of the overall data distribution shows that the inhibition rates of the Examples (TCM anti-allergic compositions) were outstanding, ranging from 67.68% to 69.79%, with a mean of 68.57% ± 1.03%. The standard deviation was small, demonstrating high stability. The inhibition rates of all samples were higher than those of the positive control (58.61%) and the comparative example group. The inhibition rate of the positive control group (dipotassium glycyrrhizate), serving as a reference standard for chemical soothing ingredients, was 58.61% ± 2.05%. The inhibition rates of the comparative example group ranged from 31.97% to 51.45%, with a mean of 41.82% ± 5.46%. The standard deviation was large, with significant fluctuations. Most samples had inhibition rates below 45%, with only comparative examples 13 to 18 approaching or slightly exceeding 50%, but these rates were still lower than those of the Examples and the positive control.

[0181] A significant difference analysis further validated the advantages of the TCM anti-allergic composition. In a t-test comparing the examples and the positive control, the mean difference between the two reached 9.96%, with a t-value of ≈8.23 (df=11, p<0.001), a highly significant difference. This indicates that the TCM anti-allergic composition significantly outperformed the positive control, a chemical soothing ingredient. A variance analysis between the examples and the comparative example groups revealed a between-group variance of 225.31, a within-group variance of 18.24, and an F-value of ≈12.35 (p<0.001), indicating a highly significant difference in means. The effect size analysis yielded a Cohen's d of 2.31 (a large effect size), demonstrating that the TCM anti-allergic composition not only had a significantly higher inhibition rate than the comparative example group, but also demonstrated a significant difference in actual efficacy.

[0182] Comparison of key indicators revealed that the traditional Chinese medicine anti-allergic composition demonstrated significant advantages across multiple core parameters. The sample size for the example was 6, with a mean inhibition rate of 68.57% ± 1.03%, a minimum of 67.68%, a maximum of 69.79%, and a median of 68.48%. This mean inhibition rate was 9.96% higher than the positive control (58.61% ± 2.05%) and 26.75% higher than the mean of the control group (41.82% ± 5.46%). In terms of data fluctuation, the standard deviation of the example was only 1.03%, demonstrating stability far exceeding the 5.46% of the control group. Specifically, the positive control, as a single chemical component reference standard, had a mean inhibition rate 16.79% higher than that of the control group. However, the traditional Chinese medicine composition, through the synergistic action of multiple components, achieved a further breakthrough in inhibition rate, with a more concentrated data distribution, demonstrating the scientific and reliable nature of the formulation design.

[0183] In summary, the efficacy advantages of traditional Chinese medicine anti-allergic compositions are clearly supported by experimental data. The mean inhibition rate (41.82%) of the comparative examples (Comparative Examples 1-18) was significantly lower than that of the examples (68.57%) due to their different formulations, a difference of 26.75%. This confirms that the specific combination of traditional Chinese medicine ingredients is the core factor in enhancing hyaluronidase inhibition. Compared with the positive control (dipotassium glycyrrhizate), the traditional Chinese medicine composition, through the synergistic effect of multiple ingredients, increased the mean inhibition rate by 9.96%, exceeding the upper limit of the efficacy of a single active chemical ingredient and demonstrating the unique advantages of traditional Chinese medicine compound formulations in terms of their mechanism of action.

[0184] Test Example 3: Human skin anti-allergic and anti-itching test

[0185] 1. Principle: The mechanism of yam juice inducing itching

[0186] The sensitizing effect of fresh yam (Dioscorea opposita) juice mainly depends on the calcium oxalate raphe and protease substances it contains. Its action pathways include two types. The first is physical stimulation. The calcium oxalate raphe penetrates the stratum corneum of the skin and directly activates transient receptor potential vanilloid 1 (TRPV1) and transient receptor potential ankyrin 1 (TRPA1), triggering the transmission of itching nerve signals (similar to the mechanism of mosquito bites). The second type is chemical stimulation. Yam proteases (such as dioscorin) can break down skin surface proteins, promote the release of histamine and substance P, and amplify the inflammatory response.

[0187] The sensitizing components of yam juice were used to induce local skin irritation (itching and erythema), simulating allergic symptoms. The experimental group was treated with the target anti-allergic composition. Comparisons with the blank, model, and positive control groups evaluated the composition's inhibitory effects on itching duration, intensity, and skin inflammation, thereby verifying its efficacy in inhibiting histamine release and alleviating itching and inflammation.

[0188] 2. Experimental Materials

[0189] Chinese yam juice (allergen): Prepared by squeezing fresh Chinese yam (Dioscorea opposita) juice and filtering through a 0.22 μm pore size filter membrane. Prepared immediately before use to ensure the stability of calcium oxalate raphide activity and protease activity.

[0190] Test sample: 1.000 g of the independently developed Chinese medicine soothing and anti-allergic composition (including Examples 1 to 6 and Comparative Examples 1 to 18) was accurately weighed and dissolved in distilled water to a volume of 1000 mL.

[0191] Positive control drug: Commercially available hydrocortisone butyrate cream (produced by Hunan Dino Pharmaceutical Co., Ltd.) was used;

[0192] Blank control: distilled water.

[0193] The experimental equipment includes basic instruments such as micropipettes (accuracy ±1μL), timers, 75% alcohol cotton pads, sterile cotton swabs and thermometers and hygrometers.

[0194] The subjects must meet the following conditions: healthy volunteers aged 18-45 years, with no skin damage and history of allergies / skin diseases, not pregnant or breastfeeding, and signed informed consent; exclusion criteria include those who have used antihistamines or immunosuppressants in the past two weeks, and those who are allergic to yam or positive control drugs.

[0195] 3. Experimental Procedure

[0196] Fifteen subjects who met the inclusion criteria were recruited. On the day of the experiment, subjects entered a constant temperature and humidity laboratory (25°C ± 1°C, 50% ± 5% humidity) and sat quietly for 15 minutes to acclimate to the environment. The experimenter then cleaned the skin on the flexor side of their forearms with a 75% alcohol pad. Four symmetrical, non-overlapping test areas (2 x 2 cm, at least 2 cm apart) were then marked to serve as the blank, model, test, and positive control groups. Reagents were precisely applied using a micropipette: 50 μl of normal saline was applied to the blank group, while 50 μl of yam juice was applied to the other three groups. Immediately afterwards, the test group area was evenly covered with a traditional Chinese medicine anti-allergic composition (50 μl / cm², patted until absorbed). Hydrocortisone butyrate cream was applied in the same manner to the positive control group, while the model group received no treatment. A crossover design was employed, with all subjects receiving the traditional Chinese medicine soothing and anti-allergic compositions of Examples 1-6 and Comparative Examples 1-18 at different time points (at least one day apart), and the efficacy of each treatment was recorded.

[0197] All operations were performed by two qualified experimenters. After the intervention, a timed observation was started, and the subjects were asked to raise their hands immediately when they first felt itching. The time of the first report of itching and the intensity of the itching were recorded. After that, the experimenter asked the subjects about their itching feelings every 5 minutes and recorded the intensity of the itching. The timer was stopped when the subject's itching completely disappeared, and the duration of the itching was calculated. The visual analogue scale (VAS) was used to score the intensity of the itching, and the subjects verbally described the current itching sensation based on a score of 0-10. All data were entered into a spreadsheet in real time. After the experiment, a sterile cotton swab dipped in saline was used to remove residual reagents. All subjects were observed for 2 hours after the end of the experiment and received a telephone follow-up within 24 hours to confirm the absence of delayed allergic reactions.

[0198] 4. Evaluation Method

[0199] (1) Itch duration (minutes): The time interval from the first report of itching to the subject's confirmation that the itching sensation has completely disappeared.

[0200] (2) Itching intensity: After the allergen is applied, the time when the itching starts is counted, and the instant score is recorded every 5 minutes, and the area under the curve (AUC) is calculated.

[0201] (3) Scoring criteria: Use visual analog scale (0-10 points), record every 5 minutes.

[0202] 0 points: no itching;

[0203] 1-3 points: mild itching, not affecting concentration;

[0204] 4-7 points: moderate itching, tolerable but causing discomfort;

[0205] 8-10 points: Severe itching, unbearable and affecting normal activities.

[0206] Area under the curve (AUC) calculation:

[0207]

[0208] The total duration was the time from the first onset of itching to the complete disappearance of itching.

[0209] 5. Data Processing and Statistical Analysis

[0210] Relevant data and statistical analysis are detailed in Tables 6-10 and Figure 1 、 Figure 2 .

[0211] Table 6 Statistics of pruritus duration and pruritus intensity ( ±s, n=15)

[0212]

[0213] As shown in Table 6, the pruritus duration in the blank group was 0, and the AUC was 0, confirming the rationality of the baseline experimental design. The pruritus duration in the model group was 36.9 ± 1.66 minutes, and the AUC was 183.9115, indicating that yam juice successfully induced significant pruritus and inflammatory responses. The pruritus duration in the positive control group was 7.27 ± 0.76 minutes, and the AUC was 24.34055, demonstrating its significant anti-allergic and antipruritic effects.

[0214] The mean duration of pruritus in Example groups (1-6) was 5.34±0.12 minutes (range: 5.13-5.53 minutes), which was significantly lower than that in the positive control group. The mean AUC was 20.79±0.37 (range: 20.41-21.37), which was significantly better than that in the positive control group.

[0215] The duration of pruritus varied significantly among the comparative example groups (1-18). Some groups (e.g., comparative examples 11-18) were close to that of the positive control group, but most (e.g., comparative examples 1-10) were significantly worse than the example group (mean: 18.2±4.2 minutes). The mean AUC was 55.66±17.64, significantly higher than that of the example group.

[0216] Table 7 Comparative analysis of itching duration (minutes)

[0217]

[0218] Table 8 Comparative analysis of itch intensity AUC values

[0219]

[0220] Table 9 Verification of significance of differences between groups (Example group vs. positive control group)

[0221]

[0222] Table 10 Verification of significance of differences between groups (Example group vs. Comparative example group (combined analysis))

[0223]

[0224] The data and comparative analysis in Tables 6-10 show that the Example group exhibited significant anti-allergic and antipruritic advantages compared to the positive control group and the comparative example group. First, in terms of pruritus duration, the average pruritus duration in the Example group was 5.34±0.12 minutes, which was 26.5% shorter than the 7.27±0.76 minutes in the positive control group (p<0.01). This indicates that the Chinese herbal anti-allergic composition has a faster onset of action and can more quickly inhibit the transmission of itch signals. Second, in terms of pruritus intensity (AUC), the average AUC value in the Example group was 20.99±0.50, significantly lower than the 24.34 in the positive control group (a decrease of 13.8%, p<0.01), suggesting that it more effectively alleviates skin inflammatory responses by regulating histamine release or inhibiting inflammatory mediators (such as substance P). Further verification by independent sample t-test (α=0.05) showed that the inter-group differences of the two indicators were highly statistically significant (p<0.01), supporting that the efficacy of the Chinese medicine anti-allergic composition is better than that of the positive control drug (hydrocortisone butyrate cream).

[0225] In addition, compared with the comparative group, the advantages of the example group are more prominent. The average duration of itching in the comparative group was as long as 16.84±4.56 minutes, and the average AUC was 55.66±17.64, while the example group shortened it by 68.3% and reduced it by 62.6%, respectively. Although some formulas in the comparative group (such as comparative examples 11 to 18) showed certain therapeutic effects (such as the itching time of comparative example 18 was 9.47 minutes and the AUC was 30.71), they were still far inferior to the example group. The reason for this is that the formula of the example group has a synergistic effect by optimizing the ratio.

[0226] In summary, the experimental data combined with statistical analysis show that the Chinese herbal anti-allergic composition (example group) is not only significantly better than the hormone positive control drug in alleviating the skin itching and inflammatory response induced by yam juice, but also achieves synergistic enhancement through formula optimization, and has better therapeutic effect than the control group.

Claims

1. A Chinese medicine composition with soothing and anti-allergic effects, characterized in that: The traditional Chinese medicine composition is prepared from a Sophora flavescens extract, a Phellodendron amurense extract, and a Herba Lycopodii extract in a mass ratio of (2-4): (1-2): (0.5-1); the Sophora flavescens extract is a Sophora flavescens total alkaloid extract; the Phellodendron amurense extract is a Phellodendron amurense total alkaloid extract; and the Herba Lycopodii extract is a Herba Lycopodii flavonoid and phenolic acid extract. The preparation method of the traditional Chinese medicine composition comprises the following steps: S1. The Sophora flavescens was extracted by acid-water extraction, the extract was adsorbed on a cation exchange resin column, the resin was treated with alkali solution, the solvent was eluted, and the extract was concentrated and dried to obtain a Sophora flavescens extract; the Phellodendron chinense was extracted by an alcohol solvent, the extract was precipitated with acid, the supernatant was precipitated with alkali, and then purified with a macroporous resin, the solvent was eluted, and the extract was concentrated and dried to obtain a Phellodendron chinense extract; the monkey earring was extracted by an alcohol solvent, the extract was precipitated with acid, the supernatant was adjusted to neutral, purified with a macroporous resin, the solvent was eluted, and the extract was concentrated and dried to obtain a monkey earring extract; S2. Mix the Sophora flavescens extract, Phellodendron amurense extract, and Herba Lycopodii extract prepared in step S1 in a corresponding mass ratio to obtain the product.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from a sophora flavescens extract, a phellodendron amurense extract and a monkey earring extract in a mass ratio of (3-4): (1-2): (0.5-1).

3. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of soothing, anti-allergic and / or antipruritic cosmetics.

4. A cosmetic with soothing, anti-allergic and / or antipruritic effects, characterized in that: Contains the Chinese medicine composition according to claim 1 or 2.

5. The use according to claim 3 or the cosmetic according to claim 4, characterized in that: The dosage form of the cosmetic is cream, essence or facial mask.

6. The use according to claim 3 or the cosmetic according to claim 4, characterized in that: The dosage form of the cosmetic is an emulsion.

Images