An anti-inflammatory and antipruritic traditional Chinese medicine compound external preparation

Abstract

The application discloses an anti-inflammatory and antipruritic traditional Chinese medicine compound external preparation, which is composed of a traditional Chinese medicine extract and an external base, wherein the traditional Chinese medicine extract is prepared by reflux extraction of at least one of Bai Lan, Sanqi, Bai Xianpi, Ku Shen, Difuzi, Jixuecao and Bohe with 50-80% ethanol water solution at 35-65 DEG C, and then concentrated at 45-60 DEG C under reduced pressure to relative density of 1.05-1.25; the amount of the external base is at least 1.5-2.5 times of the total amount of Bai Lan, Sanqi and Bohe alcohol extracts; the preparation can be prepared into a spray, a gel, a cream or an ointment, and has the effects of anti-inflammation, antipruritus, detumescence, mosquito repellence, skin repair and pigment fading, and is used for treating insect bite dermatitis and skin discomfort after scratching.

Description

Technical Field

[0001] This invention belongs to the technical field of topical compound preparations of traditional Chinese medicine, and relates to an anti-inflammatory and antipruritic topical compound preparation of traditional Chinese medicine. Background Technology

[0002] Mosquito and midge bites are common skin irritation problems in summer and autumn. After a bite, local symptoms often include erythema, papules, wheals, itching, burning sensation, and varying degrees of swelling. Some people are more sensitive to midge bites, exhibiting dense distribution, intense itching, prolonged reaction, and recurring attacks. Scratching can easily lead to epidermal damage, secondary infection, prolonged inflammation, and pigmentation. In severe cases, it can even leave marks or scar-like changes.

[0003] In existing technologies, products targeting mosquito bites are mostly based on repellents, cooling and antipruritic agents, or single topical analgesics and antipruritic ingredients. While they can alleviate discomfort after a bite to some extent, they typically suffer from limited effectiveness, short duration of action, and insufficient control over inflammation and secondary infections. Some repellent products are primarily used for pre-bite protection and offer limited improvement for existing insect bite dermatitis. While some antipruritic products can relieve itching, they lack comprehensive intervention for redness, swelling, inflammatory reactions, skin damage from scratching, and pigmentation. Meanwhile, some existing topical Chinese medicine preparations, although possessing certain anti-inflammatory and antipruritic effects, often suffer from overly generalized ingredient combinations, unclear process parameters, significant loss of active ingredients during extraction or concentration, and insufficient dosage form compatibility, making it difficult to balance onset speed, stability, and user experience.

[0004] In summary, this invention addresses the following shortcomings of existing topical products for mosquito and midge bites: First, some products only have a simple repellent effect and cannot effectively relieve itching, redness, and inflammation after bites; second, some antipruritic products have a short onset of action, lack long-lasting relief, and are insufficient in improving insect bite dermatitis, skin damage after scratching, and secondary infections; third, existing topical Chinese medicine preparations often lack a design to retain volatile and low- to medium-polarity active ingredients, resulting in low utilization of effective components; fourth, some preparations have a single dosage form, making it difficult to simultaneously address multiple usage scenarios such as rapid onset of action, sustained relief, and skin repair.

[0005] Therefore, there is an urgent need for a traditional Chinese medicine compound topical preparation that can simultaneously address local skin inflammation, itching, and swelling, and is suitable for relieving discomfort caused by insect bite dermatitis and scratching. At the same time, it can preserve the core active ingredients through appropriate alcohol extraction and temperature control processes, so as to improve the comprehensive intervention capability for skin problems before and after mosquito and midge bites.

[0006] The information disclosed in this background section is intended only to enhance the understanding of the overall background of the invention and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0007] To address the shortcomings of existing technologies, this invention provides a topical compound traditional Chinese medicine preparation for anti-inflammatory and antipruritic purposes. The preparation involves screening, pulverizing, alcohol extraction, and temperature-controlled concentration of traditional Chinese medicine raw materials to retain the core active ingredients and then formulating them into sprays, gels, creams, or ointments for relieving skin itching, redness, inflammation, and discomfort after scratching.

[0008] To achieve the above objectives, the present invention adopts the following technical solution:

[0009] An anti-inflammatory and antipruritic compound topical preparation of traditional Chinese medicine, by weight, includes a traditional Chinese medicine extract and a topical matrix; wherein the traditional Chinese medicine extract is obtained by alcohol extraction of at least one of Magnolia officinalis, Sedum aizoon, Dictamnus dasycarpus, Sophora flavescens, Kochia scoparia, Centella asiatica, and Mentha haplocalyx.

[0010] In a preferred embodiment, the herbal extract is prepared from a mixture of alcoholic extracts of Magnolia officinalis, Sedum aizoon, Dictamnus dasycarpus, Sophora flavescens, Kochia scoparia, Centella asiatica, and Mentha haplocalyx, with the following proportions by weight: Magnolia officinalis 5-20 parts, Sedum aizoon 5-20 parts, Dictamnus dasycarpus 8-20 parts, Sophora flavescens 6-18 parts, Kochia scoparia 5-15 parts, Centella asiatica 5-15 parts, and Mentha haplocalyx 3-10 parts.

[0011] In a preferred embodiment, the topical preparation is any one of a spray, ointment, cream, or gel.

[0012] In a preferred embodiment, the topical matrix is ​​any one of a spray matrix, a gel matrix, a cream matrix, or an ointment matrix, and the amount of the topical matrix, by weight, is at least 1.5 to 2.5 times the total amount of the alcohol extracts of Magnolia officinalis, Sedum aizoon, and Mentha haplocalyx.

[0013] In a preferred embodiment, the topical matrix includes one or more of petrolatum, beeswax, paraffin, carbomer 940, triethanolamine, glycerin, propylene glycol, Tween 80, and purified water, to suit the molding requirements of different dosage forms and the skin experience.

[0014] This invention also provides a method for preparing the aforementioned anti-inflammatory and antipruritic traditional Chinese medicine compound for external use, comprising the following steps:

[0015] 1) After cleaning, screening, and removing impurities, the raw materials are crushed to 20-60 mesh and placed in a cleaned and disinfected sealed container for later use;

[0016] 2) Add an ethanol aqueous solution with a volume fraction of 50% to 80% to the pulverized raw material and extract at 35 to 65°C for 1 to 4 hours;

[0017] 3) The extract was obtained by filtration and concentrated under reduced pressure at 45-60℃ to a concentrate with a relative density of 1.05-1.25;

[0018] 4) Mix the concentrated liquid with the external application matrix to obtain the traditional Chinese medicine compound external application preparation.

[0019] In a preferred embodiment, the raw material is pulverized to 30-50 mesh to balance extraction efficiency and retention of active ingredients.

[0020] In a preferred embodiment, the alcohol extraction step is a reflux extraction, and the reflux temperature is 45-60°C, and the extraction is performed 1-3 times.

[0021] In a preferred embodiment, the depressurization concentration is carried out at 50–55°C to retain the volatile aromatic components in magnolia and the volatile components in peppermint, thereby maintaining the soothing, odor-masking, and cooling antipruritic effects of the formulation.

[0022] The present invention further provides the use of traditional Chinese medicine compound external preparations in the preparation of external preparations for local anti-inflammatory, antipruritic, and anti-swelling effects on the skin, and / or for insect bite dermatitis, relief of skin discomfort after scratching, lightening of pigmentation and scar repair.

[0023] Compared with existing technologies, this invention extracts raw materials such as Magnolia officinalis, Sedum aizoon, and Mentha haplocalyx with ethanol, and combines them with traditional Chinese medicine components such as Dictamnus dasycarpus, Sophora flavescens, Kochia scoparia, and Centella asiatica to construct a compound system that combines volatile active ingredients with low- to medium-polarity functional components. This results in a synergistic and enhanced effect in anti-inflammatory, antibacterial, antipruritic, anti-swelling, repairing, and repellent properties. The specific beneficial effects are reflected in the following aspects:

[0024] 1) The alcohol extraction system promotes the efficient extraction and stable retention of various types of active ingredients.

[0025] This invention employs a 50%–80% ethanol-water solution for extraction, which effectively dissolves both volatile aromatic components and low- to medium-polarity active substances simultaneously. Specifically, linalool, acetates, and other aromatic volatile components from Magnolia officinalis are fully released; flavonoids, triterpenoids, and alkaloids from Panax notoginseng are effectively extracted; and menthol and other cooling active components from peppermint are retained. Furthermore, by controlling the extraction temperature and vacuum concentration conditions, the loss of volatile components is effectively reduced, thereby forming a stable active ingredient system in the formulation and improving the overall efficacy and storage stability of the product.

[0026] 2) Synergistic effect of repulsion-odor masking-sensory modulation

[0027] The aromatic volatile components released by magnolia and mint in this invention have a good odor masking effect, which can interfere with the carbon dioxide emitted by the human body and the volatile substances emitted by the skin to a certain extent, thereby reducing the probability of mosquitoes and midges approaching and achieving a repellent effect before they bite; at the same time, the unique floral scent of magnolia also has a certain emotional calming effect, which can relieve the irritability and discomfort caused by mosquito bites and improve the user experience.

[0028] 3) Synergistic mechanism of transdermal penetration enhancement and rapid itch relief

[0029] The menthol contained in peppermint in this invention has a natural transdermal absorption promoting effect, which can enhance the penetration of active ingredients in white peony and sedum into the deep layers of the skin; at the same time, combined with traditional Chinese medicine ingredients such as Kochia scoparia and Dictamnus dasycarpus that have antipruritic effects, it can produce a synergistic effect on the surface layer of the skin and superficial nerve endings, so as to achieve rapid inhibition of itching signals, thereby achieving a rapid onset of action and obvious antipruritic effect.

[0030] 4) Synergistic effect of multiple targets: anti-inflammatory, antibacterial, and anti-swelling

[0031] This invention achieves a synergistic effect in inflammation control through the combination of various traditional Chinese medicine ingredients: flavonoids and triterpenoids in Sedum aizoon have good anti-inflammatory, analgesic, and swelling-reducing effects; Sophora flavescens and Dictamnus dasycarpus have broad-spectrum antibacterial activity, inhibiting common pathogens such as Staphylococcus aureus, which helps reduce the risk of secondary infection after scratching; Centella asiatica promotes tissue repair and has anti-inflammatory effects; the synergistic effect of the above ingredients can effectively reduce local redness, swelling, inflammatory response, and pain after insect bites.

[0032] 5) Dual pathway regulation of anti-allergy and antipruritic effects

[0033] Insect bite dermatitis is often accompanied by local immune and allergic reactions. In this invention: Sophora flavescens and Kochia scoparia have anti-allergic effects and can regulate the release of local inflammatory mediators in the skin; Dictamnus dasycarpus and Mentha haplocalyx have antipruritic and soothing effects; through a multi-pathway mechanism of action, it effectively reduces the duration of itching and the probability of recurrence.

[0034] 6) Repair and anti-pigmentation effects

[0035] In this invention, ingredients such as Centella asiatica can promote skin barrier repair and collagen production, reducing the repair time of skin damage after scratching; at the same time, by inhibiting inflammatory response and improving local microcirculation, it helps to reduce the probability of pigmentation after insect bites, thereby improving the quality and appearance of skin recovery.

[0036] This invention utilizes a multi-level synergistic mechanism of "volatile repellency - transdermal promotion - anti-inflammatory and antibacterial - antipruritic and anti-allergic - tissue repair" to enable the formulation to function both before and after mosquito and midge bites. It can be used for repellency and protection before bites, as well as for rapid antipruritic, anti-inflammatory and swelling reduction and post-bite repair, thereby achieving comprehensive intervention for the entire process of insect bite dermatitis. Attached Figure Description

[0037] Figure 1 Images of the mild skin injury repair model in Experiment 5 (including wound healing rate, erythema resolution time, skin luster recovery, pigmentation score, histological repair, etc.). Detailed Implementation

[0038] The present invention will be further described below through specific embodiments. To make the inventive objectives, technical solutions, and beneficial technical effects of the present invention clearer, the present invention will be further described in detail below with reference to the embodiments. It should be understood that the embodiments described in this specification are merely for explaining the present invention and are not intended to limit the present invention.

[0039] Unless otherwise stated, all instruments and reagents used in the examples are commercially available or synthesized using conventional methods and can be used directly without further processing, and all instruments used in the examples are commercially available.

[0040] Example 1: Spray

[0041] Take 5 parts by weight of Magnolia officinalis, 5 parts of Sedum aizoon, 8 parts of Dictamnus dasycarpus root bark, 6 parts of Sophora flavescens root, 5 parts of Kochia scoparia fruit, 5 parts of Centella asiatica root, and 3 parts of Mentha haplocalyx.

[0042] After cleaning, screening, and removing impurities, the above raw materials are placed in a cleaned and sterilized sealed container for later use, and then pulverized to 20 mesh. A 50% (v / v) ethanol aqueous solution is added to the pulverized raw materials at a solid-liquid ratio of 1:8. The mixture is then refluxed at 35°C for 1 hour, extracted once, filtered, and the filtrates are combined and concentrated under reduced pressure at 45°C to obtain a concentrated solution with a relative density of 1.05.

[0043] Take 20 parts of the above concentrated liquid and mix it evenly with 30 parts of the spray matrix. The spray matrix consists of 24 parts of purified water, 5 parts of propylene glycol, and 1 part of Tween 80. After stirring evenly, fill the container to obtain an anti-inflammatory and antipruritic compound spray of traditional Chinese medicine.

[0044] Example 2: Gel

[0045] By weight, take 12 parts of Magnolia officinalis, 12 parts of Sedum aizoon, 14 parts of Dictamnus dasycarpus, 12 parts of Sophora flavescens, 10 parts of Kochia scoparia, 10 parts of Centella asiatica, and 6 parts of Mentha haplocalyx.

[0046] After cleaning, screening, and removing impurities, the above raw materials are placed in a cleaned and sterilized sealed container for later use, and then pulverized to 40 mesh. A 65% (v / v) ethanol aqueous solution is added to the pulverized raw materials at a solid-liquid ratio of 1:10, and the mixture is refluxed at 50°C for 2.5 hours. The extraction is repeated twice, filtered, and the filtrates are combined and concentrated under reduced pressure at 52°C to obtain a concentrated solution with a relative density of 1.15.

[0047] Take 30 parts of the above concentrated solution and mix it evenly with 60 parts of the gel matrix. The gel matrix is ​​composed of 0.8 parts of carbomer 940, 0.5 parts of triethanolamine, 5 parts of glycerin, 8 parts of propylene glycol, and 45.7 parts of purified water. First, disperse carbomer 940 in purified water, then add glycerin, propylene glycol and triethanolamine in sequence to adjust it into a gel. Then add the concentrated solution, stir evenly, defoam, and fill into the container to obtain an anti-inflammatory and antipruritic traditional Chinese medicine compound gel.

[0048] Example 3: Cream

[0049] By weight, take 20 parts of Magnolia officinalis, 20 parts of Sedum aizoon, 20 parts of Dictamnus dasycarpus, 18 parts of Sophora flavescens, 15 parts of Kochia scoparia, 15 parts of Centella asiatica, and 10 parts of Mentha haplocalyx.

[0050] After cleaning, screening, and removing impurities, the above raw materials are placed in a cleaned and sterilized sealed container for later use, and then pulverized to 60 mesh. An 80% (v / v) ethanol aqueous solution is added to the pulverized raw materials at a solid-liquid ratio of 1:12. The mixture is then refluxed at 65°C for 4 hours, extracted three times, filtered, and the filtrates are combined and concentrated under reduced pressure at 60°C to obtain a concentrated solution with a relative density of 1.25.

[0051] Take 30 parts of the above concentrated liquid and mix it evenly with 75 parts of the cream base. The cream base consists of 20 parts of petrolatum, 8 parts of beeswax, 10 parts of paraffin, 5 parts of glycerin, 2 parts of Tween 80, and 30 parts of purified water. First, heat and melt the oil phase component, then emulsify the water phase component with the oil phase. After cooling to below 40°C, add the concentrated liquid, homogenize, and fill into the container to obtain an anti-inflammatory and antipruritic traditional Chinese medicine compound cream.

[0052] Example 4: Ointment

[0053] By weight, take 15 parts of Magnolia officinalis, 15 parts of Sedum aizoon, 16 parts of Dictamnus dasycarpus, 15 parts of Sophora flavescens, 12 parts of Kochia scoparia, 12 parts of Centella asiatica, and 8 parts of Mentha haplocalyx.

[0054] After cleaning, screening, and removing impurities, the above raw materials are placed in a cleaned and sterilized sealed container for later use, and then pulverized to 30 mesh. A 70% (v / v) ethanol aqueous solution is added to the pulverized raw materials at a solid-liquid ratio of 1:10. The mixture is then refluxed at 55°C for 3 hours, extracted once, filtered, and the filtrates are combined and concentrated under reduced pressure at 55°C to obtain a concentrated solution with a relative density of 1.20.

[0055] Take 25 parts of the above concentrated liquid and mix it evenly with 50 parts of the ointment base. The ointment base consists of 35 parts of petrolatum, 5 parts of beeswax, 8 parts of paraffin wax, and 2 parts of propylene glycol. After heating and melting the petrolatum, beeswax, and paraffin wax, cool it to a suitable temperature, then add propylene glycol and the concentrated liquid, stir evenly, and fill into the container to obtain an anti-inflammatory and antipruritic compound ointment.

[0056] Example 5: Spray

[0057] Take 5 parts by weight of Magnolia officinalis, 5 parts of Sedum aizoon, 8 parts of Dictamnus dasycarpus root bark, 6 parts of Sophora flavescens root, 5 parts of Kochia scoparia fruit, 5 parts of Centella asiatica root, and 3 parts of Mentha haplocalyx.

[0058] After cleaning, screening, and removing impurities, the above raw materials are placed in a cleaned and sterilized sealed container for later use, and then pulverized to 20 mesh. A 50% (v / v) ethanol aqueous solution is added to the pulverized raw materials at a solid-liquid ratio of 1:8, and the mixture is refluxed at 35°C for 1 hour. The extraction is repeated once, and after filtration, the mixture is concentrated under reduced pressure at 45°C to obtain a concentrated solution with a relative density of 1.05.

[0059] Take 20 parts of the above concentrated liquid and mix it with 80 parts of the spray matrix, which consists of 70 parts of purified water, 8 parts of propylene glycol, 1 part of Tween 80 and 1 part of glycerin. After stirring evenly, filter and fill the mixture to obtain the spray.

[0060] Example 6: Spray

[0061] By weight, take 12 parts of Magnolia officinalis, 12 parts of Sedum aizoon, 14 parts of Dictamnus dasycarpus, 12 parts of Sophora flavescens, 10 parts of Kochia scoparia, 10 parts of Centella asiatica, and 6 parts of Mentha haplocalyx.

[0062] After cleaning, screening, and removing impurities, the above raw materials are placed in a cleaned and sterilized sealed container for later use, and then pulverized to 40 mesh. A 65% (v / v) ethanol aqueous solution is added to the pulverized raw materials at a solid-liquid ratio of 1:10, and the mixture is refluxed at 50°C for 2.5 hours, extracted twice. After filtration, the solution is concentrated under reduced pressure at 52°C to obtain a concentrated solution with a relative density of 1.15.

[0063] Take 25 parts of the above concentrated solution and mix it with 75 parts of the spray matrix, which consists of 63 parts of purified water, 8 parts of propylene glycol, 2 parts of Tween 80 and 2 parts of glycerin. After stirring evenly, filter and fill the mixture to obtain the spray.

[0064] Example 7: Spray

[0065] By weight, take 20 parts of Magnolia officinalis, 20 parts of Sedum aizoon, 20 parts of Dictamnus dasycarpus, 18 parts of Sophora flavescens, 15 parts of Kochia scoparia, 15 parts of Centella asiatica, and 10 parts of Mentha haplocalyx.

[0066] After cleaning, screening, and removing impurities, the above raw materials are placed in a cleaned and sterilized sealed container for later use, and then pulverized to 60 mesh. An 80% (v / v) ethanol aqueous solution is added to the pulverized raw materials at a solid-liquid ratio of 1:12, and the mixture is refluxed at 65°C for 4 hours. The extraction is repeated 3 times. After filtration, the mixture is concentrated under reduced pressure at 60°C to obtain a concentrated solution with a relative density of 1.25.

[0067] Take 30 parts of the above concentrated liquid and mix it with 70 parts of the spray matrix. The spray matrix consists of 58 parts of purified water, 8 parts of propylene glycol, 2 parts of Tween 80, and 2 parts of glycerin. After stirring evenly, filter and fill the mixture to obtain the spray.

[0068] Example 8: Magnolia-Sedum-Mentha-Penicillin Extract Spray

[0069] Take 12 parts by weight of Magnolia officinalis, 12 parts of Sedum aizoon, and 6 parts of Mentha haplocalyx.

[0070] After cleaning, screening, and removing impurities, the above raw materials are placed in a cleaned and sterilized sealed container for later use, and then pulverized to 40 mesh. A 65% (v / v) ethanol aqueous solution is added to the pulverized raw materials at a solid-liquid ratio of 1:10, and the mixture is refluxed at 50°C for 2.5 hours. The extraction is repeated twice, and the filtrates are combined after filtration. The filtrates are then concentrated under reduced pressure at 52°C to obtain a concentrated solution with a relative density of 1.15.

[0071] Take 25 parts of the above concentrated liquid and mix it with 50 parts of the spray matrix, wherein the spray matrix consists of 42 parts of purified water, 6 parts of propylene glycol, 1 part of Tween 80 and 1 part of glycerin, so that the amount of the external matrix is ​​twice the total amount of the alcohol extract. After stirring evenly, filter and fill to obtain the spray of white chrysanthemum, sedum and menthol extract.

[0072] Comparative Example 1: Comparative Example with White Orchid Removed

[0073] Prepared according to the process of Example 2, but without adding white chrysanthemum. All other raw materials, extraction conditions, concentration conditions and gel matrix are the same as in Example 2.

[0074] Comparative Example 2: Comparative Example with Mint Removed

[0075] Prepared according to the process of Example 2, but without adding peppermint. All other raw materials, extraction conditions, concentration conditions and gel matrix are the same as in Example 2.

[0076] Comparative Example 3: Comparative examples using water extraction instead of alcohol extraction

[0077] Prepared according to the raw material ratio of Example 2, but replacing the ethanol aqueous solution with purified water, keeping other conditions the same, extracted at 50°C for 2.5 hours, filtered and concentrated into a concentrated solution, and then made into a gel according to Example 2.

[0078] Comparative Example 4: Comparative Example of High Temperature and Normal Pressure Concentration

[0079] Prepared according to the raw material ratio and alcohol extraction conditions of Example 3, but the extract was concentrated by heating at atmospheric pressure above 70°C until the same relative density of 1.25 was achieved, and then prepared into an ointment according to Example 3.

[0080] The performance of Examples 1-8 and Comparative Examples 1-4 was verified as follows: 1. In vitro antibacterial experiment; 2. Anti-inflammatory and anti-swelling effects of the formulation; 3. Antipruritic effect; 4. Repellency experiment; 5. Skin repair / pigmentation improvement experiment; 6. Repeatability and stability verification.

[0081] Among them, the in vitro antibacterial experiments were selected from (blank matrix group, Examples 1-4, Example 8, and Comparative Examples 1-4).

[0082] Repulsion experiments were conducted using (Example 8, Example 1, Example 2, Comparative Example 1, Comparative Example 2, and blank matrix group).

[0083] Repair and fading of pigmentation experiments (Examples 2, 3, 4, and 8);

[0084] To ensure repeatability and stability, three batches of parallel samples were prepared for Examples 1, 2, and 3, and Examples 5, 6, and 7 were used as replicate batches.

[0085] In addition, all embodiments, comparative examples, and blank matrix groups were selected for antipruritic, anti-inflammatory, and anti-swelling effects.

[0086] I. In vitro antibacterial experiment: Using the paper disc diffusion method, Staphylococcus aureus was selected as the bacterial strain to verify the inhibitory effect of the preparation on Staphylococcus aureus. The diameter of the inhibition zone, the minimum inhibitory concentration, and the colony count reduction rate were examined. The results are as follows:

[0087] Group Diameter of the inhibition zone (mm) Minimum inhibitory concentration (MIC) (mg / mL) Colony count decrease rate (%) Blank matrix group 0.0±0.0 >8.00 0.0±0.0 Example 1 12.6±0.5 1.28 57.8±2.6 Example 2 16.8±0.7 0.76 72.4±3.1 Example 3 17.5±0.6 0.72 74.1±2.9 Example 4 15.7±0.6 0.93 67.3±2.7 Example 8 14.9±0.5 1.05 62.8±2.5 Comparative Example 1 11.8±0.4 1.52 51.6±2.8 Comparative Example 2 9.4±0.4 1.95 40.9±2.3 Comparative Example 3 8.2±0.3 2.30 34.8±2.1 Comparative Example 4 10.2±0.4 1.74 46.5±2.4

[0088] The example group showed a more significant antibacterial effect than the blank matrix group and the comparative group. The complete compound group was superior to the groups without magnolia, without peppermint and water extract, indicating that the alcohol extraction process and the synergistic effect of the components play a key role in the antibacterial effect.

[0089] II. A carrageenan-induced plantar edema model was used to verify the anti-inflammatory and anti-edema effects of the formulation. The plantar edema rate and edema inhibition rate at 4 h were examined. The results are as follows:

[0090] Group Foot edema rate (%) Swelling inhibition rate (%) Blank matrix group 41.8±2.2 0.0±0.0 Example 1 28.4±1.6 32.1±2.4 Example 5 28.7±1.7 31.4±2.1 Example 2 19.6±1.3 53.1±2.7 Example 6 19.8±1.2 52.7±2.5 Example 3 17.8±1.1 57.4±2.8 Example 7 18.1±1.0 56.8±2.6 Example 4 22.5±1.4 46.1±2.3 Example 8 25.1±1.5 39.9±2.2 Comparative Example 1 30.3±1.8 27.5±2.0 Comparative Example 2 33.6±1.9 19.6±1.9 Comparative Example 3 39.1±2.0 6.5±1.1 Comparative Example 4 31.2±1.7 25.4±2.0

[0091] III. The antipruritic effect was verified using a capsaicin-induced pruritus model. The latency period of the first scratch, the number of scratches within a specified time, and the duration of scratching were observed. The results are as follows:

[0092] Group Incubation period (s) of the first scratch Number of scratches in 30 minutes Scratching duration (s) Blank matrix group 94±9 28.7±2.4 624±35 Example 1 136±11 19.1±1.8 438±29 Example 5 138±10 18.7±1.7 431±27 Example 2 168±12 14.0±1.2 325±21 Example 6 170±11 13.8±1.1 319±20 Example 3 182±13 12.2±1.0 296±18 Example 7 180±12 12.5±1.1 301±19 Example 4 156±10 16.1±1.4 364±24 Example 8 149±10 17.0±1.5 387±25 Comparative Example 1 124±9 21.4±2.0 472±31 Comparative Example 2 115±8 23.6±2.1 501±34 Comparative Example 3 103±8 25.8±2.2 536±36 Comparative Example 4 121±9 22.1±1.9 486±30

[0093] IV. Using mosquito repellent cage experiments, the number of times mosquitoes landed or bitten per unit time was recorded to verify the repellency effect. The results are as follows:

[0094] Group Number of times the plane lands within 10 minutes. Avoidance rate (%) Blank matrix group 18.4±1.2 0.0±0.0 Example 1 6.7±0.6 63.6±3.1 Example 2 7.6±0.7 58.7±2.8 Example 8 4.1±0.5 77.7±3.4 Comparative Example 1 10.6±0.8 42.3±2.5

[0095] V. Mild skin injury repair model: The wound healing rate, erythema resolution time, skin luster recovery, pigmentation score, and histological repair were observed. The results are as follows:

[0096] Group Wound healing rate on day 7 (%) Time for erythema to fade (days) Day 14 pigmentation score Histological repair score Example 2 72.4±3.0 5.1±0.4 1.6±0.2 3.5±0.3 Example 3 80.6±2.7 4.3±0.3 1.2±0.1 4.2±0.2 Example 4 76.8±2.8 4.6±0.3 1.3±0.1 3.9±0.2 Example 8 68.2±3.1 5.4±0.4 1.8±0.2 3.1±0.3

[0097] VI. The repeatability of the procedure was verified through appearance, pH, viscosity / sprayability, content consistency, low temperature, room temperature, and accelerated stability. The results are as follows:

[0098] 6.1 Repeatability Validation

[0099] Group Appearance pH Viscosity / Ejection Content consistency (RSD, %) Example 1 / 5 (Spray Type) Clear and uniform, without layering 6.15±0.03 The spray is uniform, 0.94±0.02 g / 10 sprays. 1.8 Example 2 / 6 (Gel type) Uniform, transparent gel, free of bubbles 6.47±0.04 Viscosity 19,050 ± 220 mPa·s 1.6 Example 3 / 7 (Cream Type) White and uniform, smooth and without any grainy texture. 6.88±0.05 Consistency 1.62 ± 0.05 cm 1.5

[0100] 6.2 Stability verification (storage for 3 months)

[0101] Group 4℃ low temperature Normal temperature (25℃) Acceleration (40℃ / 75%RH) Example 1 / 5 No change in appearance; content retention rate 98.1%. No change in appearance; content retention rate 96.4%. No stratification; content retention rate 92.3%. Example 2 / 6 No change in appearance; content retention rate 97.7%. No change in appearance; content retention rate 95.9%. No water separation, content retention rate of 91.1%. Example 3 / 7 No change in appearance; content retention rate 97.4%. No change in appearance; content retention rate 95.6%. Oil-free water separation, with a content retention rate of 90.4%.

[0102] The experimental results above show that the embodiments of the present invention exhibit superior effects compared to the blank matrix group and the corresponding comparative group in Staphylococcus aureus inhibition, carrageenan-induced inflammation model, capsaicin-induced pruritus model, mosquito repellency experiment, and skin repair and pigmentation improvement experiment. In particular, the embodiment employing an alcohol extraction process and controlling the extraction temperature, extraction time, and reduced-pressure concentration conditions better preserves the effective components in Magnolia officinalis, Sedum aizoon, and Mentha haplocalyx, while simultaneously forming a synergistic effect with components such as Dictamnus dasycarpus, Sophora flavescens, Kochia scoparia, and Centella asiatica, achieving comprehensive relief of skin discomfort after insect bites. Observations also indicate that timely application of this preparation after a bite usually results in swelling subsiding within 1-2 days, with some users experiencing significant swelling reduction within 3 hours; the specific onset time varies depending on individual constitution.

[0103] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A topical preparation of traditional Chinese medicine with anti-inflammatory and antipruritic properties, characterized in that, By weight, it includes Chinese herbal extracts and external matrix; The herbal extract is obtained by alcohol extraction from the following raw materials, including at least one of the following: Magnolia officinalis, Sedum aizoon, Dictamnus dasycarpus, Sophora flavescens, Kochia scoparia, Centella asiatica, and Mentha haplocalyx.

2. The traditional Chinese medicine compound external preparation according to claim 1, characterized in that, The herbal extract is prepared from a mixture of alcoholic extracts of Magnolia officinalis, Sedum aizoon, Dictamnus dasycarpus, Sophora flavescens, Kochia scoparia, Centella asiatica, and Mentha haplocalyx, and the proportions of each ingredient by weight are as follows: 5-20 parts of Magnolia officinalis, 5-20 parts of Sedum aizoon, 8-20 parts of Dictamnus dasycarpus root bark, 6-18 parts of Sophora flavescens root, 5-15 parts of Kochia scoparia fruit, 5-15 parts of Centella asiatica root, and 3-10 parts of Mentha haplocalyx.

3. The topical preparation of a traditional Chinese medicine compound for anti-inflammatory and antipruritic purposes according to claim 1, characterized in that, The topical preparation is any one of a spray, ointment, cream, or gel.

4. The traditional Chinese medicine compound external preparation according to claim 1, characterized in that, The topical matrix is ​​any one of a spray matrix, gel matrix, cream matrix, or ointment matrix, and the amount of the topical matrix, by weight, is at least 1.5 to 2.5 times the total amount of the alcohol extracts of Magnolia officinalis, Sedum aizoon, and Mentha haplocalyx.

5. The traditional Chinese medicine compound external preparation according to claim 4, characterized in that, The external matrix includes one or more of petrolatum, beeswax, paraffin, carbomer 940, triethanolamine, glycerin, propylene glycol, Tween 80, and purified water.

6. A method for preparing a topical compound traditional Chinese medicine preparation for anti-inflammatory and antipruritic purposes, comprising the following steps: 1) After cleaning, screening, and removing impurities, the raw materials are crushed to 20-60 mesh and placed in a cleaned and disinfected sealed container for later use; 2) Add an ethanol aqueous solution with a volume fraction of 50% to 80% to the pulverized raw material and extract at 35 to 65°C for 1 to 4 hours; 3) The extract was obtained by filtration and concentrated under reduced pressure at 45-60℃ to a concentrate with a relative density of 1.05-1.25; 4) Mix the concentrated liquid with the external application matrix to obtain the traditional Chinese medicine compound external application preparation.

7. The method for preparing an anti-inflammatory and antipruritic compound topical preparation of traditional Chinese medicine according to claim 6, characterized in that, The raw materials are pulverized to 30-50 mesh.

8. The method for preparing an anti-inflammatory and antipruritic compound topical preparation of traditional Chinese medicine according to claim 6, characterized in that, The alcohol extraction step is a reflux extraction, with a reflux temperature of 45–60°C, and the extraction is performed 1–3 times.

9. The method for preparing an anti-inflammatory and antipruritic compound topical preparation of traditional Chinese medicine according to claim 6, characterized in that, The vacuum concentration is carried out at 50–55°C to preserve the volatile aromatic components of magnolia and the volatile components of peppermint.

10. The use of the traditional Chinese medicine compound topical preparation according to any one of claims 1 to 5 in the preparation of a topical preparation for local anti-inflammatory, antipruritic, and anti-swelling effects on the skin, and / or for insect bite dermatitis, relief of skin discomfort after scratching, lightening of pigmentation and scar repair.

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