External traditional Chinese medicine preparation for treating skin allergy and preparation method thereof

Abstract

The invention discloses an external traditional Chinese medicine preparation for treating skin allergy and a preparation method thereof, relates to the technical field of traditional Chinese medicine preparations, and aims at solving the problems that an existing preparation takes effect slowly, only treats skin without nourishing, and is high in irritation and poor in stability. The preparation is prepared from 200-250 g of purslane, 150-200 g of artemisia apiacea, 150-200 g of golden cypress, 100-150 g of liquorice, 80-120 g of radix ophiopogonis, 80-100 g of radix polygonati officinalis and auxiliary materials, wherein the auxiliary materials comprise a matrix, an emulsifier and the like. The preparation method comprises the steps of medicinal material pretreatment, ethanol reflux extraction, 70% ethanol and ultrasonic assistance, water extraction, extract merging, oil phase / water phase preparation, emulsification homogenization and cooling adjustment, and finally the cream with the particle size smaller than or equal to 5 microns and the pH of 6.0-7.0 is obtained. The double effects of antiallergic and skin repair are achieved, the symptom improvement rate is 42.3%-47.2% after the traditional Chinese medicine is taken for 3 days, the recurrence rate is 1.7%-8.3% after the traditional Chinese medicine is stopped for 1 month, the adverse reaction rate is 0%-3.3%, and the traditional Chinese medicine is stable after being stored for 12 months at room temperature, is suitable for multiple skin types and can be clinically and domestically used.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a topical traditional Chinese medicine preparation for treating skin allergies and its preparation method. Background Technology

[0002] Skin allergies are a common allergic skin disease in clinical practice, mainly caused by histamine release and immune factor disorders. Symptoms include erythema, itching, papules, and desquamation. Long-term, recurrent attacks can easily lead to damage to the skin barrier (decreased stratum corneum moisture content and loss of ceramides). Current treatment methods are mainly divided into two categories: Western medicine preparations: mainly glucocorticoids (such as desonide cream) and antihistamines. Although they can quickly suppress inflammation, long-term use can easily cause side effects such as skin atrophy, pigmentation, and telangiectasia. Moreover, they can only relieve symptoms and cannot repair the damaged skin barrier. The relapse rate after stopping the medication is as high as 40%-60%.

[0003] Traditional Chinese medicine preparations, which are mostly based on "clearing heat and relieving itching", such as purslane alone for external use and phellodendron bark lotion, have relatively high safety. However, they have problems such as insufficient targeted formulation (such as focusing only on anti-inflammation and neglecting moisturizing and repair), poor synergy of effective ingredients (limited effect of single medicinal materials), and low dosage form stability (such as decoctions easily staining clothes and powders being unevenly absorbed), making it difficult to meet the integrated clinical needs of "treatment + maintenance".

[0004] Purslane, artemisia annua, and phellodendron bark are classic Chinese medicine herbs for treating skin allergies. Purslane contains polysaccharides and flavonoids, which can inhibit the release of histamine from mast cells and reduce allergic inflammation. Artemisia annua contains artemisinin, which can downregulate pro-inflammatory factors such as IL-4 and TNF-α, thus regulating immune disorders. Phellodendron bark contains berberine and berberine, which can inhibit Staphylococcus aureus and Pseudomonas aeruginosa, preventing secondary infections caused by allergies. However, current technology has not reported any synergistic combinations of these herbs with "skin care herbs" (such as licorice, ophiopogon japonicus, and polygonatum odoratum), nor has it clarified the pharmacological synergistic mechanisms among the herbs, making it difficult to balance the efficacy and safety of the preparation.

[0005] Based on this, this application proposes a topical Chinese medicine preparation with a dual-effect synergistic effect of "clearing heat and anti-allergy + moisturizing and repairing". By optimizing the combination of medicinal materials and the preparation process, it solves the problems of existing preparations that "only treat without nourishing, have large side effects and high recurrence rate". Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine preparation for external treatment of skin allergies and its preparation method, so as to solve the problems of existing preparations that "only treat but do not nourish, have large side effects, and have a high recurrence rate".

[0007] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: A topical traditional Chinese medicine preparation for treating skin allergies is made from the following raw materials by weight: 200-250g of purslane, 150-200g of artemisia annua, 150-200g of phellodendron bark, 100-150g of licorice, and the balance of excipients; the excipients include a matrix, emulsifier, preservative, pH adjuster, and humectant; the matrix is ​​a mixture of 80-100g of petrolatum, 50-60g of lanolin, 40-50g of glyceryl stearate, and 30-40g of liquid paraffin; the emulsifier is 10-15g of Tween-80; the preservative is 1-2g of ethylparaben; the pH adjuster is 1-2g of triethanolamine; and the humectant is 50-60g of glycerin.

[0008] Synergistic anti-allergy effects: The "histamine inhibition" of purslane and the "immunomodulation" of artemisia complement each other. Purslane quickly relieves acute itching and erythema (effective within 30 minutes), while artemisia regulates immune disorders from the source (reducing the recurrence rate). The synergy of the two increases the rate of sustained improvement of allergy symptoms by 40%. At the same time, the "anti-inflammatory adjuvant" of phellodendron bark can enhance the anti-inflammatory effect of the former two. In vitro experiments have confirmed that the inhibition rate of TNF-α by the combination of the three (82.3%) is significantly higher than that of the single herbs (purslane 51.2%, artemisia 48.5%, phellodendron bark 45.7%).

[0009] Synergistic Antibacterial-Repair Effect: The "antibacterial effect" of Phellodendron bark creates conditions for skin barrier repair—avoiding secondary damage to the barrier caused by infection; the "repair effect" of licorice promotes the proliferation of skin fibroblasts (proliferation rate +35%) on the basis of antibacterial properties. The synergistic effect of the two shortens the skin barrier repair time from 14 days in traditional preparations to 7 days; if Ophiopogon japonicus / Polygonatum odoratum is added, their polysaccharide components can synergistically increase the moisture content of the stratum corneum (from 35% to 50%), avoiding skin dryness after allergy treatment.

[0010] Synergistic toxicity reduction: The "harmonizing properties of other herbs" of licorice can neutralize the bitter and cold irritation of phellodendron bark. In vitro skin irritation tests showed that the formulation containing licorice (irritation score 0.8) was significantly lower than the formulation without licorice (irritation score 2.3). At the same time, the neutral properties of ophiopogon japonicus and polygonatum odoratum can balance the slightly cold nature of purslane and artemisia annua, expanding the range of skin types suitable for the formulation (no irritation to neutral and combination skin). Further options include 80-120g of Ophiopogon japonicus.

[0011] Further options also include 80-100g of Polygonatum odoratum.

[0012] In a further embodiment, the weight ratio of purslane, artemisia annua, phellodendron bark, and licorice is 5:4:4:3.

[0013] In a further embodiment, the preparation contains purslane polysaccharide ≥5.0mg / g, artemisinin ≥0.2mg / g, berberine ≥0.3mg / g, and glycyrrhizic acid ≥1.0mg / g.

[0014] In a further embodiment, the formulation is a cream with a uniform texture, a pH value of 6.0-7.0, and a particle size ≤5μm.

[0015] In a further embodiment, the preparation contains ≥2.0 mg / g of Ophiopogon japonicus polysaccharide.

[0016] In a further embodiment, the preparation contains ≥1.8 mg / g of Polygonatum odoratum polysaccharide.

[0017] A method for preparing a traditional Chinese medicine preparation for external use in treating skin allergies includes the following steps: S1: Pretreatment of medicinal materials: Take 200-250g of purslane, 150-200g of artemisia annua, 150-200g of phellodendron bark, and 100-150g of licorice. Remove impurities, wash and cut into sections, dry at a constant temperature of 60℃, grind into 80-100 mesh coarse powder, and mix evenly. Cutting the herbs into segments (2-3cm) avoids clumping during extraction due to excessively fine pieces (affecting solvent penetration), or the active ingredients being trapped within fibers and difficult to dissolve due to excessive coarseness. The particle size design of 80-100 mesh coarse powder increases the contact area between the herbs and the extraction solvent (2-3 times more contact area compared to 20-40 mesh coarse powder), while preventing fine powder (>120 mesh) from clogging the filter cloth during filtration, thus balancing extraction efficiency and subsequent filtration smoothness. Cleaning and washing remove dirt and impurities from the surface of medicinal materials (such as withered leaves on purslane and moldy parts on the bark of Phellodendron amurense), preventing impurities from affecting the accuracy of active ingredient detection; constant temperature drying at 60℃ (rather than high temperature drying) prevents the destruction of heat-sensitive components (such as artemisinin, which is easily decomposed above 70℃), ensuring that the content of active ingredients in different batches of medicinal materials fluctuates by ≤3%; uniform mixing avoids local enrichment of medicinal materials (such as concentrated artemisia annua leading to uneven artemisinin content), ensuring that the component ratio of each coarse powder is consistent with the formula design. The fiber structure of Ophiopogon japonicus and Polygonatum odoratum is relatively tough. After being cut into sections, they can be dried and pulverized at the same time as other medicinal materials such as Portulaca oleracea and Artemisia annua. There is no need to adjust the pretreatment parameters (such as the pulverization mesh size and drying temperature) separately, which simplifies the process steps, reduces equipment investment, and ensures the uniformity of the mixing between the maintenance medicine and the core medicinal material, avoiding insufficient local maintenance components in the preparation. S2: Ethanol reflux extraction: The mixed coarse powder was put into an extraction tank, 8 times the amount of 70% ethanol was added, and the mixture was heated to 70-75℃ under reflux. Ultrasonic extraction was performed at 300W power and 40kHz frequency for 1.5 hours each time, for a total of 2 extractions. The two extracts were combined and filtered through a 100-mesh filter cloth. The filtrate was concentrated under reduced pressure at a vacuum of -0.08 to -0.09MPa and a temperature of 50-55℃ until no alcohol odor was detected, to obtain an alcohol extract. The relative density of the alcohol extract measured at 60℃ was 1.20-1.25. 70% ethanol is the optimal concentration—it efficiently dissolves artemisinin (lipid-soluble, with a solubility 1.8 times that of 50% ethanol) and glycyrrhizic acid (semi-polar, with a dissolution rate of 92% in 70% ethanol), while avoiding the destruction of artemisinin by high-concentration ethanol (such as 90%) (decomposition rate ≤2%, far lower than 8% in 90% ethanol). It also reduces the premature dissolution of water-soluble components such as purslane polysaccharides (avoiding component overlap during subsequent water extraction and improving the purity of the extract). Eight times the amount of solvent ensures thorough saturation of the medicinal material, and two extractions result in a total extraction rate of over 90% for lipid-soluble components (compared to only 65%-70% in a single extraction). 300W, 40kHz ultrasonic energy can destroy the cell walls of medicinal materials (such as the lignified epidermis of Artemisia annua and the cork layer of Phellodendron chinense), expanding the release channels of active ingredients. Compared with traditional reflux extraction without ultrasound, the extraction time is shortened from 2.5 hours / time to 1.5 hours / time, and energy consumption is reduced by 30%. At the same time, ultrasound can reduce the amount of ethanol used (reducing solvent consumption by half compared to no ultrasound), thus reducing the energy consumption and time cost of subsequent concentration. A vacuum of -0.08 to -0.09 MPa and low-temperature concentration at 50-55℃ can lower the boiling point of ethanol (from 78℃ to 45-50℃), preventing artemisinin and glycyrrhizic acid from decomposing at high temperatures (decomposition rate ≤1%, far lower than the 10% of concentration at normal pressure); concentrating the extract to a relative density of 1.20-1.25 (60℃) avoids both excessive thinness leading to stratification when mixed with water extract and excessive thickness leading to dissolution difficulties, ensuring the homogeneity of the total extract; S3: Water extraction: Take the residue after ethanol extraction, add 6 times the amount of purified water, heat to boiling, and extract for 1 hour while maintaining a gentle boil; filter the extract through a 100-mesh filter cloth, and concentrate under reduced pressure at a vacuum of -0.08~-0.09MPa and a temperature of 50-55℃ to obtain a water extract with a relative density of 1.15-1.20 measured at 60℃; Even after ethanol extraction, the residue still contains a large amount of water-soluble components (such as purslane polysaccharides and licorice polysaccharides, accounting for 40%-50% of the total content of the medicinal materials). Six times the amount of purified water can fully wet the residue, and boiling it gently for 1 hour (polysaccharide components are easily dissolved at high temperatures, and dissolution equilibrium can be reached within 1 hour) can achieve an extraction rate of over 85% for water-soluble components. Compared with directly discarding the residue, this method can improve the utilization rate of raw materials and reduce the cost of medicinal materials (saving 10%-15% of the amount of medicinal materials used per 1000g of preparation). Both Ophiopogon japonicus polysaccharide and Polygonatum odoratum polysaccharide are water-soluble components. Under the conditions of 6 times the amount of water and simmering for 1 hour, the dissolution rate reaches 88% and 85% respectively (far higher than 70% with 5 times the amount of water). Moreover, they are completely compatible with the extraction conditions of Portulaca oleracea polysaccharide and Glycyrrhiza uralensis polysaccharide. There is no need to adjust the water extraction parameters (such as water volume and time) separately, which ensures that the core active ingredients of the health care medicine are fully integrated into the water extract, laying the foundation for the moisturizing and repairing function of subsequent preparations. The relative density of the water-extracted extract is controlled at 1.15-1.20 (60℃), which is close to the density of the alcohol-extracted extract (1.20-1.25). When mixed, it can quickly form a homogeneous system (avoiding stratification caused by density difference). At the same time, the viscosity of the extract at this density is moderate (500-800 mPa・s at 25℃). After adding the aqueous phase, it can be evenly dispersed and will not cause particle agglomeration during emulsification due to excessive viscosity.

[0018] S4: Combining extracts: Mix the alcohol extract and the water extract, stir well to obtain the total extract; Artemisinin and glycyrrhizic acid (lipid-soluble) in the alcohol extract and purslane polysaccharide and glycyrrhizic acid polysaccharide (water-soluble) in the water extract form a stable system after being stirred evenly. The components can promote each other. Purslane polysaccharide can enhance the anti-inflammatory effect of artemisinin (in vitro experiments show that the inhibition rate of TNF-α after the two are mixed increases from 48% to 65% of artemisinin alone). Glycyrrhizic acid can synergistically enhance the skin barrier repair ability with glycyrrhizic acid polysaccharide (the proliferation rate of fibroblasts increases from 25% to 35% of glycyrrhizic acid alone), achieving a synergistic therapeutic effect of "1+1>2". Pre-combining the extracts (instead of adding them separately to the aqueous phase) can reduce one material transfer step and lower the risk of contamination from the extracts coming into contact with air and equipment (microbial contamination rate ≤0.5%, far lower than 3% when added in stages); at the same time, the homogeneity of the total extract can avoid excessive local components during subsequent aqueous phase preparation (such as artemisinin concentration leading to oil phase enrichment during emulsification), ensuring the homogeneity of the formulation components. The total extract can be directly sampled and tested for all core active ingredients (purslane polysaccharide, artemisinin, berberine, and glycyrrhizic acid), eliminating the need to separately test alcohol extract and water extract, thus simplifying the testing process (reducing testing time from 4 hours to 2 hours). At the same time, the fixed component ratio of the total extract ensures that the efficacy fluctuation of different batches of preparations is ≤5%, improving product reliability. S5: Oil phase preparation: Take 80-100g of petrolatum, 50-60g of lanolin, 40-50g of glyceryl stearate, and 30-40g of liquid paraffin, put them into the oil phase pot, heat to 75-80℃, stir until completely melted, and keep warm for later use. Vaseline (80-100g) provides basic occlusive properties (reducing skin moisture loss), lanolin (50-60g) enhances skin permeability (increasing the absorption rate of active ingredients by 15%), glyceryl stearate (40-50g) acts as an oil-phase emulsifier (aiding subsequent aqueous-phase emulsification and preventing layering), and liquid paraffin (30-40g) adjusts the viscosity of the cream (making the cream smooth and avoiding the greasy feeling caused by excessive Vaseline). The oil phase of this formula has a viscosity of 1500-2000 mPa・s at 25°C, which is neither too thin (easily dripping) nor too thick (difficult to spread) when applied, achieving a skin feel score of 4.8 / 5 (far higher than the 3.2 score of a single Vaseline base). 75-80℃ is the optimal melting temperature for the oil phase components (petrolatum melts at 38-45℃, lanolin at 36-42℃; 75-80℃ ensures complete melting of all components without oxidation or deterioration due to high temperatures). Simultaneously, this temperature coincides with the subsequent aqueous phase temperature (75-80℃), preventing increased interfacial tension during emulsification due to temperature differences (reducing emulsion particle aggregation; the proportion of particles ≤5μm reaches 98%, far exceeding the 85% at a 5℃ temperature difference). The selected base ingredients (petrolatum, lanolin, glyceryl stearate, and liquid paraffin) are all low-irritant excipients listed in the Chinese Pharmacopoeia, with a skin irritation score of ≤0.5 / 5 (far lower than the 1.5 score of mineral oil-containing bases). At the same time, lanolin can form a breathable film (rather than a sealed film) on the skin surface, avoiding skin discomfort caused by sweat accumulation, and is suitable for the long-term use needs of sensitive and dry skin. S6: Aqueous phase preparation: Take 50-60g of glycerol, 1-2g of ethylparaben, and 150-200g of purified water, put them into an aqueous phase pot, heat to 75-80℃, and stir until ethylparaben is completely dissolved; add the total extract obtained in step S4 to the aqueous phase, stir until the extract is completely dispersed, and keep warm for later use. Heating at 75-80℃ allows ethylparaben (preservative) to completely dissolve (solubility increases from 0.2 g / L at 25℃ to 1.5 g / L), preventing undissolved ethylparaben particles from causing localized preservative failure in the formulation (microbial limit compliance rate reaches 100%, far lower than the 90% for dissolution at room temperature); glycerin (humectant) has reduced viscosity at this temperature (from 945 mPa·s at 25℃ to 100 mPa·s at 75℃), allowing it to mix quickly and evenly with purified water, ensuring uniform moisturizing effect in subsequent formulations (stratum corneum moisture content fluctuation ≤3%). A water phase temperature of 75-80℃ can reduce the viscosity of the total extract (from 800 mPa·s at 25℃ to 200 mPa·s at 75℃), allowing the extract to be rapidly dispersed into tiny particles (particle size ≤10μm), thus avoiding excessive concentration of active ingredients in the formulation due to extract agglomeration (such as increased irritation due to concentration of berberine); at the same time, high temperature can promote the dissolution of active ingredients (such as glycyrrhizic acid) in the aqueous phase, ensuring that the components are evenly distributed in the emulsion during subsequent emulsification; Maintaining the temperature at 75-80℃ can prevent ethylparaben from crystallizing due to cooling (it easily crystallizes at 25℃, leading to uneven preservative effect). At the same time, it can prevent polysaccharide components (such as purslane polysaccharides) in the total extract from agglomerating due to cooling, ensuring the uniformity of the aqueous phase and subsequent oil phase mixing, and reducing the risk of emulsification failure (the emulsification success rate reaches 99%, far lower than the 90% when cooled to 60℃). S7: Emulsification and homogenization: While stirring at 300-500 rpm, slowly add the aqueous phase to the oil phase pot and continue stirring for 10-15 minutes to form a pre-emulsion; transfer the pre-emulsion to a homogenizer and homogenize it for 5-8 minutes at a pressure of 20-25 MPa. The optimal stirring speed is 00-500 rpm. Below 300 rpm, the aqueous phase is easily unevenly dispersed (forming large droplets with a diameter > 50 μm), while above 500 rpm, air is easily entrained (forming bubbles, which leads to voids in the formulation). At this speed, the initial emulsion droplets formed have a uniform diameter (10-20 μm), which lays the foundation for subsequent homogenization and avoids particle size fluctuations after homogenization due to uneven initial emulsion. Homogenization for 5-8 minutes ensures a concentrated particle size distribution (span ≤ 0.3, much higher than 0.8 after 3 minutes), reducing the risk of particle sedimentation. At the same time, high-pressure homogenization can enhance the interfacial bonding between the oil and water phases (interfacial tension decreases from 25 mN / m before homogenization to 15 mN / m), allowing the formulation to remain stratified for 12 months at room temperature (unhomogenized formulations show stratification after 3 months), thus extending the product's shelf life. S8: Cooling and Adjustment: Transfer the homogenized emulsion to a mixing tank and slowly cool it at a rate of 5-10℃ / hour. When the temperature drops to 45-50℃, add 1-2g of triethanolamine to adjust the pH to 6.0-7.0. Continue stirring until room temperature is reached. A cooling rate of 5-10℃ / hour (rather than rapid cooling) allows crystals in the emulsion to form slowly (like crystals in petrolatum), avoiding uneven internal stress in the cream due to excessively rapid crystal growth (shrinkage rate ≤2%, much higher than the 8% of rapid cooling), ensuring a delicate texture and no cracking of the cream, while also preventing active ingredients (such as artemisinin) from crystallizing due to sudden temperature changes (precipitation rate ≤0.5%). 45-50℃ is the optimal reaction temperature for triethanolamine—at this temperature, triethanolamine (alkaline) reacts fully with trace amounts of acidic components in the aqueous phase (such as the carboxyl group of glycyrrhizic acid), adjusting the pH to 6.0-7.0 (the physiological pH range of the skin). This avoids the burning sensation on the skin caused by excessively high pH (>7.5) (irritation score drops from 1.2 to 0.3), or the tightness on the skin caused by excessively low pH (<5.5). At the same time, this pH range can inhibit the growth of microorganisms (e.g., the reproduction rate of bacteria at pH 6.0-7.0 is 1 / 5 of that at pH 5.0), thus assisting preservatives in enhancing their antibacterial effects. Stirring to room temperature (25-30℃) stabilizes the viscosity of the cream at 3000-5000 mPa・s (the optimal viscosity for use, which is easy to spread and does not drip when applied), while ensuring that all ingredients are completely stable (e.g., the emulsification effect of glyceryl stearate is optimal at room temperature). The final cream is free of layering and bubbles, with an active ingredient content fluctuation of ≤2%, meeting the quality standards for external creams in the Chinese Pharmacopoeia, and can be directly filled and packaged.

[0019] In a further embodiment, step S1 also includes 80-120g of Ophiopogon japonicus and / or 80-100g of Polygonatum odoratum, which are pre-treated together with other medicinal materials.

[0020] The present invention has the following beneficial effects: With comprehensive and synergistic effects, the formula achieves the dual goals of "treatment + repair": The formulation is based on purslane, artemisia annua, phellodendron bark, and licorice. Through the synergistic effect of multiple mechanisms such as "histamine inhibition + immune regulation + antibacterial and anti-infection + barrier repair", it can quickly relieve skin allergy, itching, and erythema symptoms within 3 days of use (improvement rate 42.3%-47.2%). The recurrence rate after 1 month of discontinuation is only 1.7%-8.3%, which is far lower than that of commercially available Western medicines (30%). The optional addition of ophiopogon japonicus and polygonatum odoratum further increases the moisture content of the stratum corneum (reaching 45.2%-56.3%), solving the problem of skin dryness caused by the "only treatment without nourishment" of traditional formulations, and upgrading from symptomatic treatment to root cause repair.

[0021] High safety and broad compatibility, overcoming the limitations of use on sensitive skin: Relying on the "harmonizing" properties of licorice to neutralize the bitter and cold irritation of phellodendron bark, combined with the neutral properties of ophiopogon japonicus and polygonatum odoratum, the formulation has a stable pH of 6.0-7.0 (matching the physiological pH of the skin), with an adverse reaction rate of only 0%-3.3% and no hormone-related side effects; Homogenization to a particle size ≤5μm during the preparation process improves skin compatibility, and the microbial limits meet pharmacopoeia standards, making it suitable for various skin types such as sensitive skin, dry skin, and combination skin, especially suitable for children, pregnant women, and people with hormone intolerance, thus expanding the scope of application. Attached Figure Description

[0022] Figure 1 This is a flowchart for the preparation of traditional Chinese medicine formulations. Detailed Implementation

[0023] The principles and features of the present invention are described below with reference to the accompanying drawings. The examples given are only for explaining the present invention and are not intended to limit the scope of the present invention.

[0024] 1. Formulation Design (Examples 1-4 and Comparative Examples 1-5)

[0025] 2. Clinical validation protocol Inclusion criteria: Patients diagnosed with acute contact dermatitis (meeting the diagnostic criteria of "Chinese Clinical Dermatology"), aged 18-65 years, with an allergy symptom score ≥6 (scoring criteria are shown in Table 1), who have not used anti-allergy drugs / preparations in the past week, and who have no severe liver or kidney dysfunction; Sample size: 60 patients were included in each group, for a total of 540 patients. There were no statistically significant differences in gender, age, and disease duration among the groups (P>0.05). Instructions for use: After cleaning the affected area, apply a thin layer of the corresponding preparation twice daily for 14 consecutive days. Evaluation indicators: Symptom scoring: Before medication, at 3 days of medication, at 7 days of medication, and at 14 days of medication, itching, erythema, papules, and desquamation were scored (Table 1). The symptom improvement rate was calculated as (pre-medication score - post-medication score) / pre-medication score × 100%. Overall effective rate: (Number of cured cases (improvement rate ≥ 90%) + (Number of cases with significant improvement (60% ≤ improvement rate < 90%) + (Number of cases with effective results (30% ≤ improvement rate < 60%)) / Total number of cases × 100%; Incidence of adverse reactions: Record adverse reactions such as skin redness, stinging, and burning sensation during medication; Skin barrier indicators: After 14 days of medication, the stratum corneum moisture content (Corneometer CM825) and transepidermal water loss (TEWL, Tewameter™ 300) were measured. Relapse rate: The number of cases with symptom relapse (symptom score ≥3) was counted one month after stopping the medication.

[0026] Table 1. Scoring criteria for skin allergy symptoms (0-3 points for each item, 0-12 points in total)

[0027] (II) Experimental Results 1. Symptom improvement rate and overall effective rate Table 2 Comparison of symptom improvement rate and total effective rate in each group (n=60)

[0028] in conclusion: The symptom improvement rate and total effective rate of Examples 1-4 were significantly higher than those of Comparative Examples 1-4 (P<0.05), proving that purslane, artemisia annua, phellodendron bark, and licorice are the core essential medicinal materials, and none of them can be omitted; The improvement and cure rates of Examples 2-4 (including maintenance medicine) were better than those of Example 1 (without maintenance medicine), especially Example 4 (Ophiopogon japonicus + Polygonatum odoratum) had the best effect, proving that maintenance medicine can enhance the therapeutic effect; Example 4 and Comparative Example 5 (Western medicine) had similar overall effective rates and cure rates, but Example 4 had better safety and recurrence rates (see below). 2. Incidence of adverse reactions Table 3 Comparison of adverse reaction rates among groups (n=60)

[0029] in conclusion: The adverse reaction rates of Examples 1-4 were significantly lower than those of Comparative Examples 1-4 (P<0.05), demonstrating the "harmonizing and detoxifying" effect of licorice. The adverse reaction rate of Examples 2-4 (containing Ophiopogon japonicus / Polygonatum odoratum) was lower than that of Example 1, and Example 4 had no adverse reactions, proving that the maintenance medicine can further reduce irritation; The adverse reaction rates of Examples 1-4 were all lower than those of Comparative Example 5 (Western medicine), proving that the formulation of this application is safer and suitable for sensitive skin; 3. Skin barrier indicators and recurrence rate Table 4 Comparison of skin barrier indices and recurrence rates among different groups (n=60)

[0030] in conclusion: Examples 1-4 showed higher stratum corneum moisture content and lower TEWL (more intact skin barrier), with a significantly lower recurrence rate than comparative examples 1-5 (P<0.05), demonstrating that the formulation of this application can repair the skin barrier and reduce the risk of recurrence. The skin barrier indicators and recurrence rate of Examples 2-4 (containing Ophiopogon japonicus / Polygonatum odoratum) were better than those of Example 1, with Example 4 showing the best effect, proving that the maintenance medicine can enhance the skin barrier repair ability.

[0031] (III) Quality Control Verification The formulation applied for must meet the following quality standards to ensure batch stability: Appearance: Light yellow to brownish-yellow cream, uniform texture, no layering or graininess, pH 6.0-7.0, particle size ≤5μm; Content of active ingredients (HPLC detection): Purslane polysaccharide ≥5.0mg / g, artemisinin ≥0.2mg / g, berberine ≥0.3mg / g, glycyrrhizic acid ≥1.0mg / g; Microbial limits: Bacterial count ≤100 CFU / g, mold and yeast count ≤10 CFU / g, Staphylococcus aureus and Pseudomonas aeruginosa must not be detected; Stability: Accelerated test (40℃±2℃, RH75%±5%) for 6 months and long-term test (25℃±2℃, RH60%±10%) for 12 months, no significant changes were observed in the formulation properties, active ingredient content, and microbial limits (content fluctuation ≤5%).

[0032] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine preparation for external use in treating skin allergies, made from the following raw materials in the indicated weight proportions: 200-250g of purslane, 150-200g of artemisia annua, 150-200g of phellodendron bark, 100-150g of licorice root, and the remainder being excipients; wherein the excipients include a matrix, emulsifier, preservative, pH adjuster, and humectant, wherein the matrix is ​​a mixture of 80-100g of petrolatum, 50-60g of lanolin, 40-50g of glyceryl stearate, and 30-40g of liquid paraffin, the emulsifier is 10-15g of Tween-80, the preservative is 1-2g of ethylparaben, the pH adjuster is 1-2g of triethanolamine, and the humectant is 50-60g of glycerin.

2. The traditional Chinese medicine preparation for external treatment of skin allergies according to claim 1, characterized in that, It also includes 80-120g of Ophiopogon japonicus.

3. The traditional Chinese medicine preparation for external treatment of skin allergies according to claim 1, characterized in that, It also includes 80-100g of Solomon's Seal.

4. The traditional Chinese medicine preparation for external treatment of skin allergies according to claim 1, characterized in that, The weight ratio of purslane, artemisia annua, phellodendron bark, and licorice is 5:4:4:

3.

5. The traditional Chinese medicine preparation for external treatment of skin allergies according to claim 1, characterized in that, The preparation contains purslane polysaccharide ≥5.0mg / g, artemisinin ≥0.2mg / g, berberine ≥0.3mg / g, and glycyrrhizic acid ≥1.0mg / g.

6. The traditional Chinese medicine preparation for external treatment of skin allergies according to claim 1, characterized in that, The formulation is an ointment with a uniform texture, a pH value of 6.0-7.0, and a particle size ≤5μm.

7. The traditional Chinese medicine preparation for external treatment of skin allergies according to claim 1, characterized in that, The preparation contains ≥2.0 mg / g of Ophiopogon japonicus polysaccharide.

8. The traditional Chinese medicine preparation for external treatment of skin allergies according to claim 1, characterized in that, The preparation contains ≥1.8 mg / g of Polygonatum odoratum polysaccharide.

9. A method for preparing a traditional Chinese medicine preparation for external use in treating skin allergies according to any one of claims 1-8, characterized in that, Includes the following steps: Step S1: Pre-treatment of medicinal materials: Take 200-250g of purslane, 150-200g of artemisia annua, 150-200g of phellodendron bark, and 100-150g of licorice. Remove impurities, wash and cut into sections, dry at a constant temperature of 60℃, grind into 80-100 mesh coarse powder, and mix evenly. Step S2: Ethanol reflux extraction: The mixed coarse powder is put into an extraction tank, 8 times the amount of 70% ethanol is added, and the mixture is heated to 70-75℃ under reflux. Ultrasonic extraction is performed at 300W power and 40kHz frequency for 1.5 hours each time, for a total of 2 extractions. The two extracts are combined and filtered through a 100-mesh filter cloth. The filtrate is concentrated under reduced pressure at a vacuum of -0.08 to -0.09MPa and a temperature of 50-55℃ until no alcohol odor is detected, to obtain an alcohol extract. The relative density of the alcohol extract measured at 60℃ is 1.20-1.

25. Step S3: Water extraction: Take the residue after ethanol extraction, add 6 times the amount of purified water, heat to boiling, and extract for 1 hour while maintaining a gentle boil; filter the extract through a 100-mesh filter cloth, and concentrate under reduced pressure at a vacuum of -0.08~-0.09MPa and a temperature of 50-55℃ to obtain a water extract with a relative density of 1.15-1.20 measured at 60℃; Step S4: Combining extracts: Mix the alcohol extract and the water extract, stir well to obtain the total extract; Step S5: Oil phase preparation: Take 80-100g of petrolatum, 50-60g of lanolin, 40-50g of glyceryl stearate, and 30-40g of liquid paraffin, put them into the oil phase pot, heat to 75-80℃, stir until completely melted, and keep warm for later use. Step S6: Aqueous phase preparation: Take 50-60g of glycerol, 1-2g of ethylparaben, and 150-200g of purified water, put them into an aqueous phase pot, heat to 75-80℃, and stir until ethylparaben is completely dissolved; add the total extract obtained in step S4 to the aqueous phase, stir until the extract is completely dispersed, and keep warm for later use. Step S7: Emulsification and homogenization: While stirring at 300-500 rpm, slowly add the aqueous phase to the oil phase pot and continue stirring for 10-15 minutes to form a pre-emulsion; transfer the pre-emulsion to a homogenizer and homogenize it at 20-25 MPa pressure for 5-8 minutes. Step S8: Cooling and Adjustment: Transfer the homogenized emulsion to a mixing tank and slowly cool it at a rate of 5-10℃ / hour. When the temperature drops to 45-50℃, add 1-2g of triethanolamine to adjust the pH to 6.0-7.

0. Continue stirring until room temperature is reached.

10. The method for preparing the traditional Chinese medicine preparation for external treatment of skin allergies according to claim 1, characterized in that, Step S1 also includes 80-120g of Ophiopogon japonicus and / or 80-100g of Polygonatum odoratum, which are pre-treated together with other medicinal materials.

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