External traditional Chinese medicine spray for treating skin diseases

Abstract

The invention discloses a traditional Chinese medicine external spray for treating skin diseases, and belongs to the technical field of traditional Chinese medicines. The spray is prepared from thirteen raw material medicines in specific parts by weight, such as spina gleditsiae, nidus vespae, catechu and scutellaria baicalensis, through three-dimensional complementary formula compatibility of'detoxification, antibiosis and repair ', core effective components are extracted through a constant-temperature dynamic water extraction method according to the ratio of the weight of the medicinal materials to the volume of water for extraction of 1: 8; the preparation method comprises the following steps: flocculation and clarification of chitosan, stabilization treatment of dipotassium glycyrrhizinate, pH adjustment, construction of a composite solvent system, terminal sterile filtration and other optimization processes in sequence. The spray provided by the invention has the comprehensive effects of removing necrotic tissue and promoting granulation, killing parasites to relieve itching, diminishing swelling and expelling toxin, and clearing heat and promoting diuresis, is suitable for treating various skin diseases such as eczema, folliculitis, tinea pedis and the like, and is scientific in formula, advanced in process, high in product purity, good in stability, good in transdermal absorbability, remarkable in curative effect and safe and convenient to use.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a topical spray of traditional Chinese medicine for treating skin diseases. Background Technology

[0002] Skin diseases are a common group of diseases that occur on the skin, mucous membranes and skin appendages. The causes are complex, including bacterial, fungal, and viral infections, as well as various internal and external factors such as allergies and endocrine disorders. These diseases, such as eczema, folliculitis, and athlete's foot, not only cause uncomfortable symptoms such as itching, pain, and redness, which seriously affect the patient's quality of life, but also have the characteristics of prolonged course and recurrence, making them a challenge in clinical diagnosis and treatment.

[0003] Currently, topical medications for treating skin diseases mainly fall into two categories: Western medicine and traditional Chinese medicine. Western medicine preparations often use hormones, antibiotics, or antifungal ingredients, which can quickly control surface symptoms, but long-term use can easily lead to side effects such as skin atrophy, pigmentation, drug resistance, and dysbiosis. Moreover, they are not easy to fundamentally regulate the body's condition, resulting in a high recurrence rate. On the other hand, traditional Chinese medicine topical preparations, while focusing on overall conditioning and having fewer side effects, generally suffer from problems such as unclear formulation mechanisms, crude extraction processes for effective ingredients, high levels of impurities, and poor stability, which affect their stable efficacy and widespread clinical application.

[0004] Therefore, developing a topical Chinese medicine preparation that can achieve both rapid onset of action and long-term conditioning, possess both antibacterial and anti-inflammatory properties as well as tissue repair functions, and has a refined preparation process and stable and controllable quality is of great significance for meeting the clinical needs for safe, efficient, and comprehensive treatment of skin diseases, and is also an important direction for the current modernization research and development of Chinese medicine. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine external spray for treating skin diseases, so as to solve the problems mentioned in the background art.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: a traditional Chinese medicine external spray for treating skin diseases, comprising the following raw materials by weight: 30-100 parts of Gleditsia sinensis thorns, 30-100 parts of bee honeycomb, 20-50 parts of catechu, 20-50 parts of Scutellaria baicalensis, 10-15 parts of Ligusticum chuanxiong, 10-15 parts of Taraxacum mongolicum, 10-15 parts of Kochia scoparia, 10-15 parts of Angelica sinensis, 10-15 parts of Astragalus membranaceus, 10-15 parts of Portulaca oleracea, 10-15 parts of Centella asiatica, 10-15 parts of Arctium lappa, and 10-15 parts of Clematis chinensis. After the raw material is prepared in the form of traditional Chinese medicine decoction pieces, it is extracted twice using a constant temperature dynamic water extraction method with a ratio of 1:8 between the weight of the medicinal material and the volume of extraction water. The first reflux extraction temperature is controlled at 90-100℃ for 2-3 hours, and the second reflux extraction temperature is controlled at 85-95℃ for 1-2 hours. The filtrates are combined, clarified, impurity removed, sterilized, and finely filtered to obtain the spray mother liquor.

[0007] Preferably, the active pharmaceutical ingredient comprises: The weight ratio of soapberry thorns to exposed beehives is 1:(1.2-1.5); The weight ratio of catechu to scutellaria baicalensis was (0.8-1):1.

[0008] By adopting the above technical solutions, the optimal synergistic ratio between the core drug pairs was established. The combination of Gleditsia sinensis thorns and bee honeycomb enhanced the effects of reducing swelling, detoxifying, killing parasites, and relieving itching. The combination of catechu and Scutellaria baicalensis took into account the effects of astringing sores, promoting tissue regeneration, clearing heat, and drying dampness, making the basic efficacy of the whole formula more prominent.

[0009] Preferably, the constant temperature dynamic water extraction method uses a circulating heat exchange system to maintain the stability of the extraction temperature, with a temperature fluctuation range of no more than ±2℃, to avoid local overheating of the liquid.

[0010] By adopting the above technical solution, uniform and stable heat exchange is ensured during the extraction process, effectively preventing the degradation and inactivation of heat-sensitive active ingredients due to local high temperature, thereby significantly improving the extraction rate and stability of the target active ingredients.

[0011] Preferably, the clarification step includes: firstly filtering the combined filtrate using a 0.45μm pore size microporous membrane, then adding 2.5-3.5% by weight of chitosan flocculant by volume of the filtrate, stirring, and then refrigerating and standing at 2-8℃ for 8-12 hours to obtain a transparent filtrate free of visible impurities.

[0012] By adopting the above technical solution, the synergistic effect of membrane filtration and bioflocculation effectively removes colloids, suspended particles and some macromolecular impurities from the drug solution, providing a highly clarified intermediate for subsequent deep processing and ensuring the physical stability of the product.

[0013] Preferably, after the clarification step and before fine filtration, the filtrate is brought to 40-45°C and dipotassium glycyrrhizate (0.1%-0.3% by weight of the total mother liquor of the spray) is added to the filtrate as a stabilizer to prevent the polyphenols and saponins from undergoing oxidation and discoloration during storage.

[0014] By adopting the above technical solution, the introduction of dipotassium glycyrrhizate not only effectively delays the deterioration of easily oxidized components as a stabilizer and maintains the long-term stability of the drug solution color, but also exerts its own anti-inflammatory and anti-allergic properties, producing a beneficial synergy with the prescription drug efficacy.

[0015] Preferably, the sterilization is high-pressure instantaneous sterilization at 115-121℃ for 15-30 minutes; the fine filtration is terminal aseptic filtration using a 0.1μm microporous membrane.

[0016] By adopting the above technical solution, the advantages of thermal sterilization and physical sterilization are combined. While thoroughly killing microorganisms, any potential microbial residues and tiny particles are removed, ensuring the sterility level of the final product and the safety of medication.

[0017] Preferably, the active pharmaceutical ingredient is classified by function, and the proportion of its components to the total weight of the active pharmaceutical ingredient is as follows: Detoxifying herbs: Gleditsia sinensis thorns, Kochia scoparia fruit, and dandelion account for 30-40% of the total; Antibacterial drugs: Propolis, Scutellaria baicalensis, and catechu account for 30-35% of the total; Repair-related drugs: Angelica sinensis, Astragalus membranaceus, and Centella asiatica account for 25-35% of the total.

[0018] By adopting the above technical solutions, the three-dimensional complementary mechanism of "detoxification-antibacterial-repair" was clarified from a pharmacological perspective, which made the formulation scientifically quantified and the proportions of each functional module coordinated, thus forming a complete treatment system for the pathological cycle of skin diseases.

[0019] Preferably, the pH value of the spray mother liquor is adjusted and controlled within the range of 5.5-6.8, and a composite sustained-release system is adopted: glycerol-propylene glycol is used as the solvent system with a volume fraction ratio of 3:2, which enhances the permeability of the drug solution.

[0020] By adopting the above technical solutions, the product's pH value is made similar to that of a healthy skin membrane, reducing irritation to damaged skin. At the same time, the optimized solvent system significantly enhances the transdermal penetration ability of active ingredients and prolongs the drug's residence time at the site of action, thereby improving bioavailability and duration of efficacy.

[0021] In addition, the present invention also provides a method for preparing the above-mentioned traditional Chinese medicine external spray for treating skin diseases, comprising the following steps: S1. Weigh each raw material according to the formula ratio, prepare it into Chinese herbal medicine slices, and pulverize it into 150-300 mesh powder; S2. Using a constant temperature dynamic water extraction method, the herbs are extracted twice by a ratio of 1:8 (weight of herbs to volume of extraction water). The first extraction is carried out at 90-100°C for 2-3 hours, and the second extraction is carried out at 85-95°C for 1-2 hours. The filtrates from the two extractions are then combined. S3. Add 2.5-3.5% (by weight of filtrate volume) of chitosan flocculant to the combined filtrate, stir for 5 minutes, and refrigerate for 8-12 hours. S4. After the filtrate has been refrigerated and allowed to stand, it will be clarified, impurities removed, sterilized and finely filtered in sequence. S5. Add dipotassium glycyrrhizate as a stabilizer, and aseptically fill the product at a temperature below 45°C to obtain the spray product.

[0022] By adopting the above technical solution, a complete, stable and industrially scalable preparation process is provided. This process maximizes the extraction and retention of effective ingredients, and through multi-stage purification and stabilization treatment, a high-purity, high-stability and easy-to-use topical spray product is finally obtained.

[0023] Preferably, the stirring in step S3 is a homogenization process performed using a low-speed magnetic stirrer, with a stirring speed of 100-300 rpm and a time of 5-10 minutes.

[0024] By adopting the above technical solution, the gentle and uniform stirring method avoids the destruction of the formed flocs due to excessive shear force, ensuring that chitosan and impurities are in full contact and form larger and denser flocs, thereby greatly improving the efficiency and effect of subsequent sedimentation and filtration.

[0025] Compared with the prior art, the beneficial effects of the present invention are: This invention achieves multi-target, systemic treatment of skin diseases through a three-dimensional complementary formulation of "detoxification-antibacterial-repair". Each raw material works synergistically according to specific functional modules and precise proportions, which can not only quickly relieve superficial symptoms such as itching and redness, but also deeply eliminate pathogens and resolve dampness and toxins, and simultaneously promote the repair and regeneration of damaged tissues. This breaks through the limitations of traditional topical preparations that have a single therapeutic effect and only treat the symptoms without addressing the root cause, and significantly reduces the recurrence rate of the disease.

[0026] This invention utilizes an optimized integrated preparation process of "constant temperature dynamic water extraction - chitosan flocculation clarification - stabilizer protection" to maximize the extraction and retention of active ingredients while effectively removing impurities, ensuring high purity, high stability, and excellent transdermal absorption of the product. The spray solution prepared by this process is clear, stable, and easy to store, and its pH value is close to the physiological environment of the skin. The solvent system can effectively enhance drug penetration, allowing the efficacy to be fully exerted. It also has the significant advantages of being convenient to use, gentle, and non-irritating. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the preparation process of the traditional Chinese medicine external spray of the present invention; Figure 2 This is a schematic diagram of the isothermal dual reflux extraction system of the present invention. Detailed Implementation

[0028] To further explain the technical solution of the present invention, a detailed description is provided below through specific embodiments.

[0029] Please see Figure 1 and Figure 2 This invention provides a traditional Chinese medicine external spray for treating skin diseases, which is composed of the following raw materials by weight: 30-100 parts of Gleditsia sinensis thorns, 30-100 parts of bee honeycomb, 20-50 parts of catechu, 20-50 parts of Scutellaria baicalensis, 10-15 parts of Ligusticum chuanxiong, 10-15 parts of Taraxacum mongolicum, 10-15 parts of Kochia scoparia, 10-15 parts of Angelica sinensis, 10-15 parts of Astragalus membranaceus, 10-15 parts of Portulaca oleracea, 10-15 parts of Centella asiatica, 10-15 parts of Arctium lappa, and 10-15 parts of Clematis chinensis. After the raw material is prepared in the form of traditional Chinese medicine decoction pieces, it is extracted twice using a constant temperature dynamic water extraction method with a ratio of 1:8 between the weight of the medicinal material and the volume of extraction water. The first reflux extraction temperature is controlled at 90-100℃ for 2-3 hours, and the second reflux extraction temperature is controlled at 85-95℃ for 1-2 hours. The filtrates are combined, clarified, impurities removed, sterilized, and finely filtered to obtain the spray mother liquor.

[0030] Among the raw materials: the weight ratio of soapberry thorns to bee honeycomb is 1:(1.2-1.5); the weight ratio of catechu to scutellaria is (0.8-1):1.

[0031] Among them, the constant temperature dynamic water extraction method uses a circulating heat exchange system to maintain the stability of the extraction temperature, with a temperature fluctuation range of no more than ±2℃, to avoid local overheating of the liquid.

[0032] The clarification step includes: the combined filtrate is first filtered through a 0.45μm pore size microporous membrane, then 2.5-3.5% of chitosan flocculant by mass of the filtrate volume is added, and after stirring, it is refrigerated at 2-8℃ and allowed to stand for 8-12 hours to obtain a transparent filtrate free of visible impurities.

[0033] After the clarification step and before fine filtration, the filtrate is kept at 40-45°C and then dipotassium glycyrrhizate (0.1%-0.3% of the total weight of the spray mother liquor) is added as a stabilizer to prevent the polyphenols and saponins from undergoing oxidation and discoloration during storage.

[0034] The sterilization process involves high-pressure instantaneous sterilization at 115-121℃ for 15-30 minutes; the fine filtration process involves terminal aseptic filtration using a 0.1μm microporous membrane.

[0035] The active pharmaceutical ingredient (API) is categorized by function, and the proportion of its components to the total weight of the API is as follows: Detoxifying herbs: Gleditsia sinensis thorns, Kochia scoparia fruit, and dandelion account for 30-40% of the total; Antibacterial drugs: Propolis, Scutellaria baicalensis, and catechu account for 30-35% of the total; Repair-related drugs: Angelica sinensis, Astragalus membranaceus, and Centella asiatica account for 25-35% of the total.

[0036] The pH value of the spray mother liquor is adjusted and controlled within the range of 5.5-6.8, and a composite sustained-release system is adopted: glycerol-propylene glycol is used as the solvent system with a volume fraction ratio of 3:2, which enhances the permeability of the drug solution.

[0037] In addition, the present invention also provides a method for preparing the above-mentioned traditional Chinese medicine external spray for treating skin diseases, comprising the following steps: S1. Weigh each raw material according to the formula ratio, prepare it into Chinese herbal medicine slices, and pulverize it into 150-300 mesh powder; S2. Using a constant temperature dynamic water extraction method, the herbs are extracted twice by a ratio of 1:8 (weight of herbs to volume of extraction water). The first extraction is carried out at 90-100°C for 2-3 hours, and the second extraction is carried out at 85-95°C for 1-2 hours. The filtrates from the two extractions are then combined. S3. Add 2.5-3.5% (by weight of filtrate volume) of chitosan flocculant to the combined filtrate, stir for 5 minutes, and refrigerate for 8-12 hours. S4. After the filtrate has been refrigerated and allowed to stand, it will be clarified, impurities removed, sterilized and finely filtered in sequence. S5. Add dipotassium glycyrrhizate as a stabilizer, and aseptically fill the product at a temperature below 45°C to obtain the spray product.

[0038] In step S3, the stirring is a homogenization process performed using a low-speed magnetic stirrer at a speed of 100-300 rpm for 5-10 minutes.

[0039] Example 1: Preparation of a Traditional Chinese Medicine External Spray: This embodiment provides a traditional Chinese medicine external spray for treating skin diseases, the composition of which (by weight) is as follows: 60 parts of Gleditsia sinensis thorns, 80 parts of bee honeycomb, 35 parts of catechu, 35 parts of Scutellaria baicalensis, 12 parts of Ligusticum chuanxiong, 12 parts of Taraxacum mongolicum, 13 parts of Kochia scoparia, 12 parts of Angelica sinensis, 12 parts of Astragalus membranaceus, 12 parts of Portulaca oleracea, 12 parts of Centella asiatica, 12 parts of Arctium lappa, and 12 parts of Clematis chinensis.

[0040] Its preparation method includes the following steps: 1. Pretreatment: Weigh each raw material according to the above formula, prepare them into standard Chinese herbal medicine slices, and pulverize them into 300-mesh fine powder using an ultra-micro pulverizer for later use.

[0041] 2. Dynamic water extraction: Put the medicinal powder into a multi-functional extraction tank, add 8 times the amount of purified water (medicinal weight: water volume = 1:8), and soak for 40 minutes; turn on the circulating heat exchange system and perform two constant temperature dynamic reflux extractions; the temperature of the first extraction is controlled at 98±2℃, kept at a slight boil, and extracted for 3 hours; the temperature of the second extraction is controlled at 92±2℃ and extracted for 1.5 hours; during the extraction process, the circulating pump ensures that the temperature of the medicinal solution is uniform and there is no local overheating.

[0042] 3. Filtrate Combination: Collect the filtrates from the two extractions separately, and combine them into a temporary storage tank through a pipeline filter to obtain a combined filtrate with a total volume of approximately 8 times that of the medicinal materials.

[0043] 4. Membrane filtration and flocculation clarification: The combined filtrate is first filtered through a microporous membrane with a pore size of 0.45 μm to remove larger particulate impurities. Then, under stirring, chitosan flocculant at a mass of 3% of the filtrate volume is slowly added, and the mixture is stirred at 150 rpm for 5 minutes using a low-speed magnetic stirrer to ensure thorough mixing.

[0044] 5. Cold storage aging: Transfer the above filtrate to a cold storage at 2-8℃ and let it stand for 12 hours to allow the chitosan and impurities such as free proteins, tannins, and polysaccharides in the solution to fully flocculate and settle, and obtain the supernatant.

[0045] 6. Fine filtration: Take the supernatant after refrigeration, first pass it through a diatomaceous earth layer for coarse filtration, and then pass it through 0.45μm and 0.22μm microporous membranes for fine filtration until the filtrate is clear and transparent and free of any impurities visible to the naked eye.

[0046] 7. Stabilization treatment: Heat the filtrate (spray mother liquor) after fine filtration to 42°C, and add dipotassium glycyrrhizate at 0.2% of the total weight of the mother liquor while stirring at a uniform speed. Stir until completely dissolved. This step can effectively prevent the polyphenols and saponins in the medicine from oxidizing and discoloring during storage.

[0047] 8. pH adjustment and volume adjustment: Use a dilute citric acid solution to precisely adjust the pH of the mother liquor to 6.0; then, add a glycerol and propylene glycol mixed solvent with a volume ratio of 3:2 to make up to the final volume and stir evenly.

[0048] 9. Terminal sterilization and filling: The prepared drug solution is treated with a high-pressure instantaneous sterilization system at 115℃ for 30 minutes; after the drug solution cools down to below 45℃, it is filtered under aseptic conditions using a 0.1μm terminal sterile filter, and immediately filled into sterile spray bottles and sealed to obtain the product.

[0049] Example 2, Preparation of a Traditional Chinese Medicine External Spray: This embodiment provides another formulation of a traditional Chinese medicine external spray, the composition of which (by weight) is as follows: 30 parts of Gleditsia sinensis thorns, 30 parts of bee honeycomb, 20 parts of catechu, 20 parts of Scutellaria baicalensis, 10 parts of Ligusticum chuanxiong, 10 parts of dandelion, 10 parts of Kochia scoparia, 10 parts of Angelica sinensis, 10 parts of Astragalus membranaceus, 10 parts of Portulaca oleracea, 10 parts of Centella asiatica, 10 parts of Arctium lappa, and 10 parts of Clematis chinensis.

[0050] The preparation method is basically the same as that in Example 1, except that the amount of chitosan added in step 4 is 2.5% and the amount of dipotassium glycyrrhizate added in step 7 is 0.1%.

[0051] Example 3, Preparation of a Traditional Chinese Medicine External Spray: This embodiment provides another formulation of a traditional Chinese medicine external spray, the composition of which (by weight) is as follows: 100 parts of Gleditsia sinensis thorns, 100 parts of bee honeycomb, 50 parts of catechu, 50 parts of Scutellaria baicalensis, 15 parts of Ligusticum chuanxiong, 15 parts of dandelion, 15 parts of Kochia scoparia, 15 parts of Angelica sinensis, 15 parts of Astragalus membranaceus, 15 parts of Portulaca oleracea, 15 parts of Centella asiatica, 15 parts of Arctium lappa, and 15 parts of Clematis chinensis.

[0052] The preparation method is basically the same as that in Example 1, except that the amount of chitosan added in step 4 is 3.5% and the amount of dipotassium glycyrrhizate added in step 7 is 0.3%.

[0053] Example 4, Clinical efficacy observation trial: To verify the efficacy of the topical herbal spray of this invention, the following clinical trials were conducted: 1. Study Subjects: 120 patients admitted to the outpatient clinic between 2023 and 2024 were selected, with diseases including eczema, folliculitis, tinea pedis, and insect bite dermatitis. They were randomly divided into a treatment group and a control group, with 60 patients in each group. There were no significant differences between the two groups in terms of age, gender, disease duration, and disease severity, making them comparable.

[0054] 2. Treatment methods: The treatment group used the traditional Chinese medicine external spray prepared in Example 1 of this invention, applying it to the affected area 3-4 times daily. The control group used a commonly available brand of compound ketoconazole cream (for fungal infections) or mometasone furoate cream (for dermatitis and eczema), applying it twice daily. The treatment course for both groups was 2 weeks.

[0055] 3. Efficacy criteria: Complete recovery: The skin lesions have completely subsided, and symptoms such as itching have disappeared; Significant effect: Most skin lesions subsided, and symptoms improved markedly; Effective: Skin lesions have subsided and symptoms have been alleviated; Ineffective: Skin lesions and symptoms do not improve or worsen.

[0056] Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%.

[0057] 4. Treatment results:

[0058] The results showed that the total effective rate of the topical herbal spray of the present invention was significantly higher than that of the control group, and it exhibited the characteristics of rapid onset and stable effect in relieving itching, reducing redness and swelling, and promoting wound healing.

[0059] Typical case: Case 1: Mr. Zhang, male, 29 years old, developed athlete's foot (interdigital erosion and itching) due to poor breathability of his athletic shoes. After using the spray of this invention three times a day for three days, the itching basically disappeared and the eroded surface began to dry; after continuous use for one week, the affected skin returned to normal.

[0060] Case 2: Ms. Li, 35 years old, had folliculitis on her back (multiple red papules with tenderness). After using the spray of this invention four times a day for two days, the color of the papules darkened and the tenderness decreased; after one week, most of the papules disappeared, leaving only slight pigmentation.

[0061] Compared to Example 1, the extraction ratio was changed: To demonstrate the importance of the 1:8 extraction ratio, a comparative example was set up. Except for changing the extraction water ratio to 1:5 (insufficient water) and 1:12 (excessive water), the remaining steps and formulations were the same as in Example 1.

[0062] The results showed that the extraction ratio of 1:5 resulted in a low yield of extract and insufficient extraction of active ingredients; while the extraction ratio of 1:12 resulted in a high yield of extract, but contained too many impurities, making subsequent clarification difficult, and the product had a dark color and poor stability. This demonstrates that 1:8 is the optimal extraction ratio.

[0063] Comparative Example 2, omitting the stabilizer: No dipotassium glycyrrhizate was added during the preparation process, and the rest was the same as in Example 1. The resulting product and the product of Example 1 were placed in an accelerated testing chamber at 40°C for one month.

[0064] The results showed that the spray without stabilizer was significantly darker and turned brown, while the spray with stabilizer showed almost no change in color, proving that dipotassium glycyrrhizate is crucial for maintaining product stability.

[0065] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. 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 external spray for treating skin diseases, characterized in that, It consists of the following active pharmaceutical ingredients in parts by weight: 30-100 parts of Gleditsia sinensis thorns, 30-100 parts of bee honeycomb, 20-50 parts of catechu, 20-50 parts of Scutellaria baicalensis, 10-15 parts of Ligusticum chuanxiong, 10-15 parts of Taraxacum mongolicum, 10-15 parts of Kochia scoparia, 10-15 parts of Angelica sinensis, 10-15 parts of Astragalus membranaceus, 10-15 parts of Portulaca oleracea, 10-15 parts of Centella asiatica, 10-15 parts of Arctium lappa, and 10-15 parts of Clematis chinensis. After the raw material is prepared in the form of traditional Chinese medicine decoction pieces, it is extracted twice using a constant temperature dynamic water extraction method with a ratio of 1:8 between the weight of the medicinal material and the volume of extraction water. The first reflux extraction temperature is controlled at 90-100℃ for 2-3 hours, and the second reflux extraction temperature is controlled at 85-95℃ for 1-2 hours. The filtrates are combined, clarified, impurity removed, sterilized, and finely filtered to obtain the spray mother liquor.

2. The traditional Chinese medicine external spray for treating skin diseases according to claim 1, characterized in that, In the aforementioned active pharmaceutical ingredient: The weight ratio of soapberry thorns to exposed beehives is 1:(1.2-1.5); The weight ratio of catechu to scutellaria baicalensis was (0.8-1):

1.

3. The traditional Chinese medicine external spray for treating skin diseases according to claim 1, characterized in that: The constant temperature dynamic water extraction method uses a circulating heat exchange system to maintain the stability of the extraction temperature, with temperature fluctuations not exceeding ±2℃, thus avoiding local overheating of the liquid.

4. The traditional Chinese medicine external spray for treating skin diseases according to claim 1, characterized in that, The clarification step includes: firstly filtering the combined filtrate using a 0.45μm pore size microporous membrane, then adding 2.5-3.5% (by weight of the filtrate volume) of chitosan flocculant, stirring, and then refrigerating and standing at 2-8℃ for 8-12 hours to obtain a transparent filtrate free of visible impurities.

5. A traditional Chinese medicine external spray for treating skin diseases according to claim 4, characterized in that: After the clarification step and before fine filtration, the filtrate is brought to 40-45°C and dipotassium glycyrrhizate (0.1%-0.3% by weight of the spray mother liquor) is added as a stabilizer to prevent the polyphenols and saponins from undergoing oxidation and discoloration during storage.

6. A traditional Chinese medicine external spray for treating skin diseases according to claim 1, characterized in that: The sterilization is high-pressure instantaneous sterilization at 115-121℃ for 15-30 minutes; the fine filtration is terminal aseptic filtration using a 0.1μm microporous membrane.

7. A traditional Chinese medicine external spray for treating skin diseases according to claim 1, characterized in that, The active pharmaceutical ingredient (API) is classified by function, and the proportion of its components to the total weight of the API is as follows: Detoxifying herbs: Gleditsia sinensis thorns, Kochia scoparia fruit, and dandelion account for 30-40% of the total; Antibacterial drugs: Propolis, Scutellaria baicalensis, and catechu account for 30-35% of the total; Repair-related drugs: Angelica sinensis, Astragalus membranaceus, and Centella asiatica account for 25-35% of the total.

8. A traditional Chinese medicine external spray for treating skin diseases according to claim 1, characterized in that, The pH value of the spray mother liquor is adjusted and controlled within the range of 5.5-6.8, and a composite sustained-release system is adopted: glycerol-propylene glycol is used as the solvent system with a volume fraction ratio of 3:2, which enhances the permeability of the drug solution.

9. A method for preparing the traditional Chinese medicine external spray for treating skin diseases according to any one of claims 1-8, characterized in that, Includes the following steps: S1. Weigh each raw material according to the formula ratio, prepare it into Chinese herbal medicine slices, and pulverize it into 150-300 mesh powder; S2. Using a constant temperature dynamic water extraction method, the herbs are extracted twice by a ratio of 1:8 (weight of herbs to volume of extraction water). The first extraction is carried out at 90-100°C for 2-3 hours, and the second extraction is carried out at 85-95°C for 1-2 hours. The filtrates from the two extractions are then combined. S3. Add 2.5-3.5% (by weight of filtrate volume) of chitosan flocculant to the combined filtrate, stir for 5 minutes, and refrigerate for 8-12 hours. S4. After the filtrate has been refrigerated and allowed to stand, it will be clarified, impurities removed, sterilized and finely filtered in sequence. S5. Add dipotassium glycyrrhizate as a stabilizer, and aseptically fill the product at a temperature below 45°C to obtain the spray product.

10. The method for preparing the traditional Chinese medicine external spray for treating skin diseases according to claim 9, characterized in that: The stirring described in step S3 is a homogenization process performed using a low-speed magnetic stirrer at a speed of 100-300 rpm for 5-10 minutes.

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