A traditional Chinese medicine composition and traditional Chinese medicine breast patch suitable for preventing female breast hyperplasia and dissipating breast nodules

Abstract

The application discloses a traditional Chinese medicine composition suitable for preventing female breast hyperplasia and dissipating breast nodules and a traditional Chinese medicine breast patch, and belongs to the technical field of external preparations of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from Chinese herbal medicines of the blood-activating and stasis-dissolving type, the liver-soothing and qi-regulating type, the heat-clearing and swelling-dissolving type and the deficiency-tonifying and regulating type, such as Bupleurum, Radix Curcumae, etc., and is prepared into small-molecule extracts below 3kDa after composite fermentation of Lactobacillus plantarum and Bacillus subtilis and composite enzymolysis of cellulase, etc.; the traditional Chinese medicine breast patch is prepared into a paste from the composition, transdermal adjuvants, humectants and the like, and is coated on a base of a composite breathable non-woven fabric of bamboo fiber, wormwood fiber and viscose fiber. The application has scientific formula, treats both symptoms and root causes, has good transdermal absorption effect of small-molecule extracts, is comfortable and non-irritating in patching, can quickly relieve breast distending pain and dissipate breast nodules, can also strengthen body resistance and reduce the recurrence rate, is safe and reliable, is suitable for female patients with various benign breast diseases, is especially suitable for patients intolerable to oral administration, and is easy to be industrially produced.

Description

Technical Field

[0001] This invention relates to the field of external application of traditional Chinese medicine, specifically to a traditional Chinese medicine composition and a traditional Chinese medicine breast patch suitable for preventing breast hyperplasia and dissipating breast nodules in women. Background Technology

[0002] Breast hyperplasia and breast nodules are common benign breast diseases in women. Their onset is often related to factors such as endocrine disorders, liver qi stagnation, qi and blood stasis, and phlegm and blood stasis. Due to high work pressure, irregular schedules, and frequent emotional fluctuations, the incidence of these diseases is increasing year by year and affecting younger women. Breast hyperplasia often manifests as breast swelling and stabbing pain, which worsens before menstruation and improves after menstruation. Breast nodules present as palpable round or oval lumps in the breast; some nodules are accompanied by tenderness. If left untreated for a long time, they can not only affect a woman's quality of life, but some benign nodules also have the potential risk of malignant transformation.

[0003] Currently, treatment methods for breast hyperplasia and breast nodules mainly include oral Western medicine, oral Chinese medicine, and physical therapy. Oral Western medicine primarily focuses on regulating endocrine function and relieving pain. Although it has a rapid onset of action, it has significant side effects, and long-term use can easily affect gastrointestinal function and hormone levels. Oral Chinese medicine focuses on soothing the liver and regulating qi, promoting blood circulation and dispersing nodules. It has a mild effect and few side effects, but it has problems such as long treatment cycles, low absorption and utilization rate of effective drug components, and difficulty in tolerance for some patients due to weak spleen and stomach. Physical therapy, such as massage and hot compresses, can only relieve symptoms and cannot fundamentally dissipate nodules.

[0004] Traditional Chinese medicine (TCM) external preparations, acting directly on the affected area, avoid the first-pass effect of the gastrointestinal tract and the metabolic burden on the liver, and are convenient to use, making them an important development direction for the treatment of breast diseases. While there are many types of existing TCM breast patches and other external products, they generally suffer from the following problems: First, the raw materials of TCM often use simple water or alcohol extraction processes, resulting in insufficient extraction of effective components. Large molecules have difficulty penetrating the stratum corneum, leading to poor transdermal absorption and slow efficacy. Second, the formulations lack rationality, focusing primarily on promoting blood circulation and resolving stagnation, neglecting the combination of soothing the liver and regulating qi with tonifying and regulating deficiency, thus treating the symptoms but not the root cause, resulting in a high recurrence rate. Third, the patch substrate has poor breathability, and prolonged application can easily lead to skin stuffiness, redness, itching, and even allergies; the patch is also prone to falling off and has poor adhesion. Fourth, some products contain chemical preservatives and fragrances, increasing the risk of skin irritation.

[0005] Based on this, the development of a traditional Chinese medicine composition and herbal breast patch with a scientific formula, sufficient extraction of effective ingredients, good transdermal absorption, comfortable and non-irritating application, and the ability to fundamentally prevent breast hyperplasia and dissipate breast nodules has significant clinical application value and market prospects. Summary of the Invention

[0006] To address the problems of poor absorption of active ingredients, unscientific formulation, poor application comfort, and easy skin adverse reactions in existing topical Chinese medicine preparations for breast diseases, this invention provides a Chinese medicine composition and a Chinese medicine breast patch suitable for preventing breast hyperplasia and dissipating breast nodules in women. This Chinese medicine composition is based on classical Chinese medicine theory, scientifically combining four types of Chinese herbs: those that invigorate blood circulation and dissipate nodules, those that soothe the liver and regulate qi, those that clear heat and reduce swelling, and those that tonify and regulate deficiency. It is combined with modern extraction processes of compound bacterial fermentation and compound enzymatic hydrolysis to obtain small-molecule effective extracts with good transdermal absorption. The Chinese medicine breast patch uses this composition as its core, compounded with transdermal absorption aids and moisturizers, and paired with a highly breathable composite non-woven fabric base. It is comfortable and non-irritating to apply, quickly relieving breast swelling and pain symptoms, and fundamentally regulating the body to achieve both preventive and therapeutic effects. It is also safe and reliable, and unlikely to cause adverse skin reactions.

[0007] To achieve the above objectives, the present invention is implemented through the following technical solution:

[0008] A traditional Chinese medicine composition suitable for preventing breast hyperplasia and dissipating breast nodules in women is obtained by extraction and refining of raw materials for promoting blood circulation and dissipating nodules, raw materials for soothing the liver and regulating qi, raw materials for clearing heat and reducing swelling, and raw materials for tonifying deficiency and regulating the body. All raw materials are natural Chinese herbal medicines. The effective components of the traditional Chinese medicine composition are small molecule extracts with a value of less than 3kDa obtained by fermentation of each raw material by compound bacteria and compound enzymatic hydrolysis. The compound bacteria are a combination of Lactobacillus plantarum and Bacillus subtilis, and the compound enzymes are a combination of cellulase, pectinase and papain.

[0009] The raw materials of the traditional Chinese medicine composition, by weight, consist of the following components: 8-15 parts Bupleurum, 10-18 parts Curcuma longa, 6-12 parts Angelica sinensis, 8-15 parts Paeonia lactiflora, 10-20 parts Taraxacum mongolicum, 6-10 parts Prunella vulgaris, 5-9 parts Fritillaria thunbergii, 8-12 parts Trichosanthes kirilowii, 6-10 parts Astragalus membranaceus, 5-8 parts Codonopsis pilosula, 3-6 parts Atractylodes macrocephala, 4-7 parts Poria cocos, and 2-5 parts Glycyrrhiza uralensis.

[0010] Preferably, the optimal proportion of raw materials in the traditional Chinese medicine composition, by mass parts, is: 12 parts Bupleurum, 15 parts Curcuma longa, 9 parts Angelica sinensis, 12 parts Paeonia lactiflora, 15 parts Taraxacum mongolicum, 8 parts Prunella vulgaris, 7 parts Fritillaria thunbergii, 10 parts Trichosanthes kirilowii, 8 parts Astragalus membranaceus, 6 parts Codonopsis pilosula, 5 parts Atractylodes macrocephala, 6 parts Poria cocos, and 3 parts Glycyrrhiza uralensis.

[0011] The formulation of the herbal composition of this invention follows the principles of traditional Chinese medicine: "soothing the liver and regulating qi, promoting blood circulation and resolving stagnation, clearing heat and reducing swelling, and strengthening the spleen and replenishing qi." The components work synergistically to treat both the symptoms and the root cause.

[0012] Liver-soothing and Qi-regulating herbs: Bupleurum soothes the liver and relieves depression, harmonizes the exterior and interior, while Curcuma invigorates blood, relieves pain, and promotes Qi circulation and relieves depression. The two herbs complement each other and serve as the principal herbs to soothe the stagnation of Qi in the liver meridian, thereby fundamentally improving the pathogenesis of Qi stagnation and blood stasis.

[0013] Blood-activating and nodule-dissolving drugs: Angelica sinensis nourishes and activates blood, regulates menstruation and relieves pain; Paeonia lactiflora clears heat and cools blood, disperses blood stasis and relieves pain; Fritillaria thunbergii clears heat and resolves phlegm, disperses nodules and eliminates carbuncles; Trichosanthes kirilowii clears heat and eliminates phlegm, promotes qi and disperses nodules. These four drugs are assistant drugs, which help the principal drug activate blood, disperse blood stasis, resolve phlegm and disperse nodules, and eliminate breast nodules.

[0014] Heat-clearing and swelling-reducing herbs: Dandelion clears heat and detoxifies, reduces swelling and dissipates nodules; Prunella vulgaris clears liver fire, dissipates nodules and reduces swelling. The two herbs are used as adjuvant herbs to clear heat stagnation in the liver meridian and relieve breast redness, swelling and pain.

[0015] For tonifying and regulating the body: Astragalus tonifies qi and raises yang, consolidates the exterior and generates fluids; Codonopsis pilosula tonifies the middle jiao and benefits qi, strengthens the spleen and benefits the lungs; Atractylodes macrocephala strengthens the spleen and benefits qi, dries dampness and promotes diuresis; Poria cocos promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind; Glycyrrhiza uralensis tonifies qi and strengthens the middle jiao, and harmonizes the other herbs. These four herbs are the guiding herbs, which strengthen the spleen and benefit qi, support the body's resistance and consolidate the foundation, prevent excessive dispersion of stagnation and damage to the body's vital energy, and at the same time harmonize the properties of all the herbs in the formula, so that the herbs can be used together without harming the spleen and stomach.

[0016] The mass ratio of *Lactobacillus plantarum* to *Bacillus subtilis* in the compound bacteria is (2-3):1, with *Lactobacillus plantarum* having a bacterial activity of 10-20 billion CFU / g and *Bacillus subtilis* having a bacterial activity of 8-15 billion CFU / g; the mass ratio of cellulase, pectinase, and papain in the compound enzyme is (1-2):(1-2):1, with cellulase having an enzyme activity of 300,000-500,000 U / g, pectinase having an enzyme activity of 200,000-400,000 U / g, and papain having an enzyme activity of 100,000-300,000 U / g.

[0017] Lactobacillus plantarum can decompose large molecules such as polysaccharides and proteins in traditional Chinese medicine to produce small peptides, organic acids and other active ingredients. Bacillus subtilis can secrete a variety of enzymes to enhance the fermentation effect. The synergistic fermentation of the two can improve the dissolution rate of active ingredients and reduce the irritation of traditional Chinese medicine. Cellulase can decompose cellulose in plant cell walls, pectinase can decompose pectin and papain can decompose proteins. The complex enzymatic hydrolysis can further break down the cell wall structure of traditional Chinese medicine, release intracellular active ingredients, degrade large molecules into small molecules and significantly improve transdermal absorption efficiency.

[0018] The preparation method of the traditional Chinese medicine composition includes the following steps:

[0019] S1: Remove impurities from each Chinese herbal medicine raw material, dry it, and then pulverize it into 80-120 mesh powder. Mix it evenly to obtain a mixed powder of Chinese herbal medicine.

[0020] S2: Add 8 to 15 times the mass of purified water to the mixed Chinese medicine powder, add 0.8% to 2.0% of the mass of compound bacteria to the mixed Chinese medicine powder, and ferment aerobically for 20 to 26 hours at 36℃ to 42℃ and pH 6.0 to 6.8. After sterilization, cool to room temperature to obtain the fermented product.

[0021] S3: Add 0.5% to 1.5% by weight of compound enzyme of traditional Chinese medicine mixture powder to the fermentation product, and enzymatically hydrolyze for 3 to 5 hours at 48℃ to 56℃ and pH 5.5 to 6.5. After enzyme inactivation treatment, cool to room temperature to obtain the enzymatic hydrolysate.

[0022] S4: The enzymatic hydrolysate is filtered using a 3kDa ultrafiltration membrane. The filtrate with a concentration below 3kDa is collected, concentrated under reduced pressure, and spray-dried to obtain the traditional Chinese medicine composition powder.

[0023] In step S2, the sterilization temperature is 85℃~95℃ and the sterilization time is 20min~30min; in step S3, the enzyme inactivation temperature is 85℃~95℃ and the enzyme inactivation time is 20min~30min; in step S4, the spray drying inlet air temperature is 65℃~75℃ and the outlet air temperature is 35℃~45℃.

[0024] The present invention also provides a traditional Chinese medicine breast patch suitable for preventing breast hyperplasia and dissipating breast nodules in women, comprising a patch base and a traditional Chinese medicine ointment attached to the patch base, wherein the traditional Chinese medicine ointment is composed of the above-mentioned traditional Chinese medicine composition, transdermal absorption aid, moisturizer, thickener and purified water.

[0025] The herbal ointment, by weight, comprises the following components: 5-10 parts of herbal composition powder, 2-5 parts of transdermal absorption aid, 3-8 parts of moisturizer, 0.3-0.8 parts of thickener, and 60-80 parts of purified water; the transdermal absorption aid is a mixture of azone and menthol in a mass ratio of (1-3):1, the moisturizer is a mixture of glycerin, propylene glycol, and sodium hyaluronate in a mass ratio of (5-8):(3-5):1, and the thickener is a mixture of xanthan gum and carbomer in a mass ratio of (2-4):1.

[0026] Azone can significantly reduce the barrier function of the stratum corneum of the skin and promote the transdermal absorption of small molecule effective ingredients of traditional Chinese medicine. Menthol can not only enhance the transdermal effect, but also bring a cooling sensation and relieve breast tenderness. Glycerin, propylene glycol and sodium hyaluronate work synergistically to maintain the moisture of the ointment, while moisturizing the skin and reducing the irritation of the ointment to the skin. Xanthan gum and carbomer are combined to give the ointment good viscosity and adhesion, making it less likely to fall off, and the texture of the ointment is delicate and comfortable to apply.

[0027] The application substrate is a composite breathable nonwoven fabric, which is made of bamboo fiber, mugwort fiber and viscose fiber interlaced and bonded together. The fiber mass ratio is bamboo fiber: mugwort fiber: viscose fiber = (10~16):(5~9):(2~4). The fiber diameter is 2μm~4μm. The air permeability of the application substrate is 500mm / s~700mm / s, and the water vapor transmission is above 8000g / (m²·24h).

[0028] Bamboo fiber has good breathability, moisture absorption and antibacterial properties, while mugwort fiber is warm in nature and can warm the meridians, dispel cold and relieve pain. When combined with viscose fiber, the patch base has the characteristics of high breathability, high moisture absorption, antibacterial and gentle conditioning. Long-term application will not cause skin stuffiness or redness, and the medicinal effect of mugwort fiber can help relieve breast discomfort.

[0029] The preparation method of the above-mentioned traditional Chinese medicine breast patch includes the following steps:

[0030] S1: Add the thickener to purified water according to the mass fraction, and stir at 50℃~60℃ until completely dissolved to obtain a gel matrix;

[0031] S2: Add the moisturizer and transdermal absorption aid to the gel matrix, stir and mix evenly at 45℃~55℃, cool down to 35℃~40℃, add the traditional Chinese medicine composition powder, and continue stirring until completely dispersed to obtain the traditional Chinese medicine ointment;

[0032] S3: The herbal ointment is evenly applied to the application surface of the patch base with a coating thickness of 0.2mm to 0.4mm. After cooling and shaping, cutting and packaging, the herbal patch is obtained.

[0033] The beneficial effects of this invention are as follows:

[0034] This invention features a scientifically formulated traditional Chinese medicine composition based on classic TCM theories. It combines four types of herbs in a synergistic manner, integrating liver-soothing and qi-regulating, blood-activating and stagnation-dispersing, heat-clearing and swelling-reducing, and deficiency-tonifying and conditioning effects. It addresses both the symptoms and the root cause, quickly relieving breast swelling and pain and dissipating breast nodules. It also strengthens the spleen and replenishes qi, supporting the body's vital energy and consolidating its foundation, fundamentally regulating the body's state, reducing the recurrence rate of breast hyperplasia and nodules, and achieving both preventive and therapeutic effects.

[0035] This invention employs a modern extraction process combining compound bacterial fermentation and compound enzymatic hydrolysis to transform the effective components of traditional Chinese medicine into small molecule extracts below 3kDa. This breaks down the barrier of the skin's stratum corneum, significantly improving transdermal absorption and allowing the medicine to exert its effects more quickly. At the same time, the fermentation and enzymatic hydrolysis processes can reduce the irritation of traditional Chinese medicine and improve the safety of the product.

[0036] The herbal patch of this invention has a reasonable formula. The compound transdermal absorption aid can further promote the skin penetration of the active ingredients, the moisturizer makes the patch moist and delicate, the thickener ensures the adhesion of the patch and makes it not easy to fall off. It contains no chemical preservatives, fragrances or other irritating ingredients, and is gentle and non-irritating to the skin.

[0037] The patch base of this invention is a highly breathable composite non-woven fabric that combines the advantages of bamboo fiber, mugwort fiber and viscose fiber. It has excellent breathability and moisture absorption, antibacterial properties and a gentle meridian conditioning effect. It does not cause discomfort such as stuffiness, redness, swelling or itching even after long-term application, and the application is highly comfortable.

[0038] This invention provides a convenient herbal breast patch that can be applied directly to the affected area of ​​the breast. The active ingredients reach the lesion directly, avoiding the first-pass effect of the gastrointestinal tract and the metabolic burden on the liver. It is suitable for women with various types of breast hyperplasia and breast nodules, and is especially suitable for patients with weak spleen and stomach who cannot tolerate oral medications. Moreover, the preparation process is simple and easy to industrialize. Detailed Implementation

[0039] The present invention will be described in detail below with reference to specific embodiments. The illustrative embodiments and descriptions of the present invention are used to explain the present invention, but are not intended to limit the present invention.

[0040] In a first aspect, the present invention provides a traditional Chinese medicine composition suitable for preventing breast hyperplasia and dissipating breast nodules in women. It is obtained by extraction and refining of raw materials for promoting blood circulation and dissipating nodules, raw materials for soothing the liver and regulating qi, raw materials for clearing heat and reducing swelling, and raw materials for tonifying deficiency and regulating the body. All raw materials are natural Chinese herbal medicines. The effective components of the traditional Chinese medicine composition are small molecule extracts with a value of less than 3kDa obtained by fermentation of each raw material by compound bacteria and compound enzymatic hydrolysis. The compound bacteria are a combination of Lactobacillus plantarum and Bacillus subtilis, and the compound enzymes are a combination of cellulase, pectinase and papain.

[0041] This invention categorizes natural Chinese herbal medicines into four main types based on their efficacy: those for promoting blood circulation and resolving stagnation, those for soothing the liver and regulating qi, those for clearing heat and reducing swelling, and those for tonifying and regulating deficiency. Using traditional Chinese medicine's syndrome differentiation and treatment as its core, it achieves a synergistic effect of soothing the liver and regulating qi, promoting blood circulation and resolving stagnation, clearing heat and reducing swelling, and tonifying and regulating deficiency, thus addressing breast problems at their root cause. Simultaneously, it employs a compound of Lactobacillus plantarum and Bacillus subtilis for fermentation, decomposing macromolecular substances in the herbal medicines to produce small-molecule active ingredients. These are then enzymatically hydrolyzed using a compound of cellulase, pectinase, and papain to break down the plant cell wall structure, releasing intracellular active ingredients. Finally, ultrafiltration yields a small-molecule extract below 3kDa, ensuring the transdermal absorption of the active ingredients.

[0042] This invention achieves a synergistic combination of multiple effects of traditional Chinese medicine compositions, addressing both the symptoms and the root cause. It can specifically alleviate the clinical symptoms of breast hyperplasia and nodules, while also strengthening the body's resistance and regulating its overall condition, reducing the risk of recurrence. The combined process of compound bacterial fermentation and compound enzymatic hydrolysis significantly improves the dissolution rate and molecular size of the effective components of traditional Chinese medicine. Extracts with a molecular weight below 3kDa can easily penetrate the stratum corneum of the skin, solving the technical problem of poor absorption of effective components in traditional topical Chinese medicine. All raw materials are natural Chinese herbs, with no chemical additives, ensuring high safety and a wide range of applicable populations.

[0043] In some embodiments, the raw materials of the traditional Chinese medicine composition, by weight, consist of the following components: 8-15 parts Bupleurum, 10-18 parts Curcuma longa, 6-12 parts Angelica sinensis, 8-15 parts Paeonia lactiflora, 10-20 parts Taraxacum mongolicum, 6-10 parts Prunella vulgaris, 5-9 parts Fritillaria thunbergii, 8-12 parts Trichosanthes kirilowii, 6-10 parts Astragalus membranaceus, 5-8 parts Codonopsis pilosula, 3-6 parts Atractylodes macrocephala, 4-7 parts Poria cocos, and 2-5 parts Glycyrrhiza uralensis.

[0044] It should be noted that this invention uses Bupleurum and Curcuma as the core ingredients to soothe the liver and regulate Qi; Angelica sinensis, Paeonia lactiflora, Fritillaria thunbergii, and Trichosanthes kirilowii to invigorate blood and dissipate nodules; Taraxacum mongolicum and Prunella vulgaris to clear heat and reduce swelling; and Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, and Glycyrrhiza uralensis to tonify and regulate. Each ingredient is formulated in a specific ratio to balance the efficacy of each component, avoiding imbalances caused by an excessively high proportion of any single component, while maximizing the synergistic effect between the components. Limiting the specific ingredient ratio range of the herbal composition makes the formula feasible and reproducible, facilitating industrial production. The precise ratio makes the synergistic effects of soothing the liver, invigorating blood, clearing heat, and tonifying more pronounced, resulting in a more stable conditioning effect on breast hyperplasia and nodules, effectively relieving breast pain and gradually dissipating breast nodules. The set range of ingredient proportions balances raw material costs and conditioning effects, demonstrating good industrial application value.

[0045] In some embodiments, the optimal proportion of raw materials in the traditional Chinese medicine composition by mass is: 12 parts Bupleurum, 15 parts Curcuma longa, 9 parts Angelica sinensis, 12 parts Paeonia lactiflora, 15 parts Taraxacum mongolicum, 8 parts Prunella vulgaris, 7 parts Fritillaria thunbergii, 10 parts Trichosanthes kirilowii, 8 parts Astragalus membranaceus, 6 parts Codonopsis pilosula, 5 parts Atractylodes macrocephala, 6 parts Poria cocos and 3 parts Glycyrrhiza uralensis.

[0046] It should be noted that this invention, through extensive experimentation, has determined the optimal ratio of each functional component. This achieves the best synergistic effect between the liver-soothing and qi-regulating effects of Bupleurum and Curcuma, the blood-activating and nodule-dispersing effects of Angelica sinensis and Paeonia lactiflora, the heat-clearing and swelling-reducing effects of Taraxacum mongolicum and Prunella vulgaris, and the tonifying and regulating effects of Astragalus membranaceus and Codonopsis pilosula. The effective concentrations of each component are matched to achieve a synergistic amplification of efficacy. The optimal ratio maximizes the therapeutic effect of the herbal composition, providing faster relief of discomfort such as breast tenderness and more efficient dissipation of breast nodules. While ensuring optimal therapeutic effects, it also achieves efficient utilization of each raw material, reducing waste and further controlling production costs. Furthermore, it provides a precise basis for raw material ratios for industrial production, ensuring the uniformity and stability of product quality.

[0047] In some embodiments, the mass ratio of *Lactobacillus plantarum* to *Bacillus subtilis* in the compound bacteria is (2-3):1, the activity of *Lactobacillus plantarum* is 10-20 billion CFU / g, and the activity of *Bacillus subtilis* is 8-15 billion CFU / g; the mass ratio of cellulase, pectinase, and papain in the compound enzyme is (1-2):(1-2):1, the activity of cellulase is 300,000-500,000 U / g, the activity of pectinase is 200,000-400,000 U / g, and the activity of papain is 100,000-300,000 U / g.

[0048] It should be noted that this invention specifies the exact ratio, activity level, and enzyme activity parameters of the compound bacteria and enzymes. *Lactobacillus plantarum* and *Bacillus subtilis* are compounded in a specific mass ratio, utilizing the characteristics of *Lactobacillus plantarum* in decomposing polysaccharides and proteins and the characteristics of *Bacillus subtilis* in secreting multiple enzymes and enhancing fermentation effects to achieve synergistic fermentation results. Cellulase, pectinase, and papain are compounded in a specific mass ratio to decompose cellulose, pectin, and protein in plant cell walls, respectively, comprehensively breaking down the cell wall structure. Specific activity levels and enzyme activity parameters ensure the rate and efficiency of fermentation and enzymatic hydrolysis reactions, avoiding insufficient or excessive activity leading to increased costs. The precise ratio of compound bacteria and enzymes makes fermentation and enzymatic hydrolysis reactions more efficient and complete, further improving the dissolution rate and miniaturization of effective components. Specific activity levels and enzyme activity parameters ensure the stability of the fermentation and enzymatic hydrolysis process, avoiding batch-to-batch variations and improving product quality consistency. While ensuring process effectiveness, the reasonable control of the amount of bacteria and enzymes used reduces raw material costs in the production process.

[0049] In some embodiments, the preparation method of the traditional Chinese medicine composition includes the following steps:

[0050] S1: Remove impurities from each Chinese herbal medicine raw material, dry it, and then pulverize it into 80-120 mesh powder. Mix it evenly to obtain a mixed powder of Chinese herbal medicine.

[0051] S2: Add 8 to 15 times the mass of purified water to the mixed Chinese medicine powder, add 0.8% to 2.0% of the mass of compound bacteria to the mixed Chinese medicine powder, and ferment aerobically for 20 to 26 hours at 36℃ to 42℃ and pH 6.0 to 6.8. After sterilization, cool to room temperature to obtain the fermented product.

[0052] S3: Add 0.5% to 1.5% by weight of compound enzyme of traditional Chinese medicine mixture powder to the fermentation product, and enzymatically hydrolyze for 3 to 5 hours at 48℃ to 56℃ and pH 5.5 to 6.5. After enzyme inactivation treatment, cool to room temperature to obtain the enzymatic hydrolysate.

[0053] S4: The enzymatic hydrolysate is filtered using a 3kDa ultrafiltration membrane. The filtrate with a concentration below 3kDa is collected, concentrated under reduced pressure, and spray-dried to obtain the traditional Chinese medicine composition powder.

[0054] It should be noted that this invention ensures uniform mixing by pulverizing and sieving raw materials, providing a good reaction basis for subsequent fermentation and enzymatic hydrolysis; controls the temperature, pH, and time of fermentation to provide the optimal growth and metabolic environment for the compound bacteria, ensuring the full progress of the fermentation reaction; sets the temperature, pH, and time of enzymatic hydrolysis to match the optimal catalytic conditions of the compound enzyme, improving the efficiency of enzymatic hydrolysis; and achieves the separation and drying of small molecule extracts through ultrafiltration and spray drying processes to obtain a traditional Chinese medicine composition powder that is easy to store and easy to compound.

[0055] Standardized preparation steps make the preparation process of traditional Chinese medicine compositions operable and repeatable, facilitating large-scale industrial production; precise control of fermentation and enzymatic hydrolysis reaction conditions ensures the full extraction and miniaturization of active ingredients, further enhancing the transdermal absorption and conditioning effects of the product; the application of ultrafiltration and spray drying processes enables the product to be formed into a powder form, with good stability, long shelf life, and easy to combine with other excipients to prepare traditional Chinese medicine patches.

[0056] In some embodiments, the sterilization temperature in step S2 is 85℃~95℃ and the sterilization time is 20min~30min; the enzyme inactivation temperature in step S3 is 85℃~95℃ and the enzyme inactivation time is 20min~30min; and the spray drying inlet air temperature in step S4 is 65℃~75℃ and the outlet air temperature is 35℃~45℃.

[0057] It should be noted that this invention specifies the exact temperature and time parameters for sterilization, enzyme inactivation, and spray drying during the preparation process. Sterilization and enzyme inactivation employ specific temperatures and times to thoroughly kill bacteria and inactivate enzymes while avoiding the destruction of the effective components of the traditional Chinese medicine due to excessively high temperatures or prolonged times. Spray drying is set with specific temperature parameters to ensure rapid drying of the extract into powder while preventing denaturation of the effective components due to high temperatures, thus preserving their biological activity. Precise sterilization and enzyme inactivation parameters, while ensuring aseptic requirements of the process, maximize the preservation of the effective components and biological activity of the traditional Chinese medicine composition, ensuring the product's conditioning effect. The specific spray drying temperature results in a uniform powder with good flowability, easy mixing with other excipients, and excellent powder solubility, leading to more uniform dispersion during subsequent preparation of the paste. This avoids the loss of effective components due to improper process parameters, improves raw material utilization, and reduces production costs.

[0058] Secondly, the present invention provides a traditional Chinese medicine breast patch suitable for preventing breast hyperplasia and dissipating breast nodules in women, comprising a patch base and a traditional Chinese medicine ointment attached to the patch base, wherein the traditional Chinese medicine ointment is composed of the above-mentioned traditional Chinese medicine composition, transdermal absorption aid, moisturizer, thickener and purified water.

[0059] It should be noted that this invention prepares a traditional Chinese medicine (TCM) composition into a TCM breast patch, which consists of two parts: a patch base and a TCM ointment. The TCM composition is compounded with transdermal absorption aids, moisturizers, and thickeners to form an ointment, which is then adhered to the patch base. Through application, it acts directly on the breast lesion, allowing the active ingredients to penetrate the skin and reach the lesion directly, avoiding the first-pass effect of the gastrointestinal tract and the metabolic burden on the liver, achieving localized targeted treatment. The dosage form design of the breast patch allows the active ingredients of the TCM to act directly on the lesion, resulting in strong targeting and a more direct and significant therapeutic effect, quickly relieving breast swelling and pain. The external dosage form avoids the gastrointestinal irritation of oral medications, making it suitable for breast disease patients with weak spleen and stomach who cannot tolerate oral medications, thus broadening the applicable population. It is convenient to use, requiring no decoction, and can be applied anytime, fitting the lifestyle of modern women and improving patient compliance.

[0060] In some embodiments, the herbal ointment, by weight, comprises the following components: 5-10 parts of herbal composition powder, 2-5 parts of transdermal absorption aid, 3-8 parts of moisturizer, 0.3-0.8 parts of thickener, and 60-80 parts of purified water; the transdermal absorption aid is a mixture of azone and menthol in a mass ratio of (1-3):1, the moisturizer is a mixture of glycerin, propylene glycol, and sodium hyaluronate in a mass ratio of (5-8):(3-5):1, and the thickener is a mixture of xanthan gum and carbomer in a mass ratio of (2-4):1.

[0061] It should be noted that this invention specifies the exact raw material composition, mass fractions, and proportions of each excipient in the herbal ointment. The herbal powder is the core active ingredient. Azone and menthol, a transdermal absorption aid, reduce the barrier effect of the stratum corneum, promoting the transdermal absorption of the active ingredients. Menthol also provides a cooling sensation to relieve breast tenderness. Glycerin, propylene glycol, and sodium hyaluronate, a moisturizer, maintain the ointment's hydration, moisturize the skin, and reduce skin irritation. Xanthan gum and carbomer, a thickener, adjust the viscosity and adhesion of the ointment, ensuring it does not easily fall off. The specific proportions of each ingredient achieve an optimal balance between the ointment's efficacy, skin feel, and performance. The clearly defined ratio of raw materials in the ointment ensures its stability and performance, resulting in good adhesion and resistance to detachment. It provides a non-sticky feel and excellent skin comfort during application. The combined use of transdermal absorption enhancers further improves the transdermal absorption efficiency of the effective components of the traditional Chinese medicine, leading to faster conditioning effects. The addition of moisturizers makes the ointment gentle and non-irritating to the skin, preventing dryness, redness, or other discomfort even after prolonged application, thus enhancing comfort. All excipients are mild, cosmetic-grade raw materials with good compatibility with the traditional Chinese medicine composition, exhibiting no adverse reactions and high safety.

[0062] In some embodiments, the application substrate is a composite breathable nonwoven fabric, which is made of bamboo fiber, mugwort fiber and viscose fiber interlaced and bonded together. The fiber mass ratio is bamboo fiber: mugwort fiber: viscose fiber = (10~16):(5~9):(2~4), the fiber diameter is 2μm~4μm, the air permeability of the application substrate is 500mm / s~700mm / s, and the water vapor transmission is above 8000g / (m²·24h).

[0063] It should be noted that this invention specifies the raw material composition, ratio, fiber diameter, and breathability parameters of the patch substrate. A composite breathable nonwoven fabric is made by interweaving and bonding bamboo fiber, mugwort fiber, and viscose fiber in a specific mass ratio. Bamboo fiber provides excellent breathability, moisture absorption, and antibacterial properties; mugwort fiber warms the meridians, dispels cold, and relieves pain, helping to alleviate breast discomfort; viscose fiber enhances the softness and fit of the substrate. Controlling the fiber diameter within a specific range ensures the substrate's fineness and breathability; setting specific breathability parameters ensures unobstructed skin respiration and avoids stuffiness, redness, and swelling caused by prolonged application.

[0064] The composite breathable non-woven fabric base has excellent breathability and moisture absorption, and does not cause stuffiness, redness or other discomfort even after prolonged wear, resulting in high comfort and solving the technical problem of poor breathability of traditional nipple patch bases. The antibacterial properties of bamboo fiber make it difficult for bacteria to grow on the base, further improving the safety of the product. The warming and meridian-clearing effects of mugwort fiber work synergistically with the conditioning effects of traditional Chinese medicine ointment, further enhancing the conditioning effect on breast hyperplasia and nodules. The optimization of fiber diameter and ratio ensures high adhesion between the base and the skin, making it less likely to fall off, and suitable for use on the breast area.

[0065] Thirdly, the present invention provides a method for preparing a traditional Chinese medicine breast patch suitable for preventing breast hyperplasia and dissipating breast nodules in women, comprising the following steps:

[0066] S1: Add the thickener to purified water according to the mass fraction, and stir at 50℃~60℃ until completely dissolved to obtain a gel matrix;

[0067] S2: Add the moisturizer and transdermal absorption aid to the gel matrix, stir and mix evenly at 45℃~55℃, cool down to 35℃~40℃, add the traditional Chinese medicine composition powder, and continue stirring until completely dispersed to obtain the traditional Chinese medicine ointment;

[0068] S3: The herbal ointment is evenly applied to the application surface of the patch base with a coating thickness of 0.2mm to 0.4mm. After cooling and shaping, cutting and packaging, the herbal patch is obtained.

[0069] In practice, the thickener is first dissolved in purified water to form a gel matrix, ensuring its uniformity and stability. Then, a humectant and transdermal absorption aid are added and mixed thoroughly. After cooling, the powdered traditional Chinese medicine composition is added to prevent the active ingredients from being deactivated by high temperatures, thus preserving their bioactivity. Finally, the paste is evenly coated onto the application base, cooled and shaped, cut, and packaged to obtain the finished nipple patch. Temperature and operational control at each step ensure the adhesion between the paste and the base and the overall quality of the product. Standardized preparation steps make the production of traditional Chinese medicine nipple patches operable and repeatable, facilitating large-scale industrial production. Temperature control during preparation prevents the deactivation of the active ingredients in the traditional Chinese medicine, maximizing the preservation of the product's conditioning effects. Even coating and firm adhesion to the base after cooling and sizing ensure the product's performance. The cutting and packaging processes ensure uniform product specifications, facilitating storage, transportation, and sales, and demonstrating promising prospects for industrial application.

[0070] The present invention will be further described below with reference to several embodiments, but the present invention is not limited to these embodiments.

[0071] Example 1

[0072] A traditional Chinese medicine composition suitable for preventing breast hyperplasia and dissipating breast nodules in women, comprising the following raw materials by weight: 12 parts Bupleurum, 15 parts Curcuma longa, 9 parts Angelica sinensis, 12 parts Paeonia lactiflora, 15 parts Taraxacum mongolicum, 8 parts Prunella vulgaris, 7 parts Fritillaria thunbergii, 10 parts Trichosanthes kirilowii, 8 parts Astragalus membranaceus, 6 parts Codonopsis pilosula, 5 parts Atractylodes macrocephala, 6 parts Poria cocos, and 3 parts Glycyrrhiza uralensis.

[0073] The mass ratio of Lactobacillus plantarum to Bacillus subtilis in the compound bacteria is 2.5:1, with Lactobacillus plantarum having a bacterial activity of 15 billion CFU / g and Bacillus subtilis having a bacterial activity of 10 billion CFU / g. The mass ratio of cellulase, pectinase, and papain in the compound enzymes is 1.5:1.5:1, with cellulase having an enzyme activity of 400,000 U / g, pectinase having an enzyme activity of 300,000 U / g, and papain having an enzyme activity of 200,000 U / g.

[0074] Preparation method of traditional Chinese medicine composition:

[0075] S1: Remove impurities from each Chinese herbal medicine raw material, dry it, pulverize it into 100-mesh powder, and mix it evenly to obtain a mixed powder of Chinese herbal medicine;

[0076] S2: Add 12 times the mass of purified water to the mixed Chinese medicine powder, add 1.5% of the mass of compound bacteria to the mixed Chinese medicine powder, and ferment aerobically at 39℃ and pH 6.5 for 24 hours. After sterilization at 90℃ for 25 minutes, the mixture is cooled to room temperature to obtain the fermented product.

[0077] S3: Add 1.0% by weight of compound enzyme of traditional Chinese medicine mixture powder to the fermentation product, and enzymatically hydrolyze for 4 hours at 52℃ and pH 6.0. After inactivating the enzyme at 90℃ for 25 minutes, the mixture is cooled to room temperature to obtain the enzymatic hydrolysate.

[0078] S4: The enzymatic hydrolysate is filtered using a 3kDa ultrafiltration membrane, and the filtrate below 3kDa is collected. It is then concentrated under reduced pressure to a relative density of 1.15–1.20 (60℃), and spray-dried under conditions of 70℃ air intake and 40℃ air outlet to obtain the traditional Chinese medicine composition powder.

[0079] A traditional Chinese medicine breast patch suitable for preventing breast hyperplasia and dissipating breast nodules in women, by weight, comprises the following components: 8 parts of the above-mentioned traditional Chinese medicine powder, 3 parts of transdermal absorption aid, 5 parts of moisturizer, 0.5 parts of thickener, and 70 parts of purified water; the transdermal absorption aid is a mixture of azone and menthol in a mass ratio of 2:1, the moisturizer is a mixture of glycerin, propylene glycol, and sodium hyaluronate in a mass ratio of 6:4:1, and the thickener is a mixture of xanthan gum and carbomer in a mass ratio of 3:1.

[0080] The base material for the patch is a composite breathable nonwoven fabric with a fiber mass ratio of bamboo fiber: artemisia fiber: viscose fiber = 13:7:3. The fiber diameter is 3μm, the air permeability is 600mm / s, and the water vapor transmission rate is 9000g / (m²·24h).

[0081] Preparation method of traditional Chinese medicine breast patch:

[0082] S1: Add the thickener to purified water according to the mass fraction, and stir at 55°C until completely dissolved to obtain a gel matrix;

[0083] S2: Add the moisturizer and transdermal absorption aid to the gel matrix, stir and mix evenly at 50°C, cool down to 38°C, add the traditional Chinese medicine composition powder, and continue stirring for 30 minutes until completely dispersed to obtain the traditional Chinese medicine ointment;

[0084] S3: The herbal ointment is evenly applied to the application surface of the patch base with a coating thickness of 0.3mm. After cooling and shaping at 25℃, it is cut into a shape suitable for breast application and sealed to obtain the herbal breast patch.

[0085] Example 2

[0086] A traditional Chinese medicine composition suitable for preventing breast hyperplasia and dissipating breast nodules in women, comprising the following raw materials by mass: 8 parts Bupleurum, 10 parts Curcuma longa, 6 parts Angelica sinensis, 8 parts Paeonia lactiflora, 10 parts Taraxacum mongolicum, 6 parts Prunella vulgaris, 5 parts Fritillaria thunbergii, 8 parts Trichosanthes kirilowii, 6 parts Astragalus membranaceus, 5 parts Codonopsis pilosula, 3 parts Atractylodes macrocephala, 4 parts Poria cocos, and 2 parts Glycyrrhiza uralensis.

[0087] The mass ratio of Lactobacillus plantarum to Bacillus subtilis in the compound bacteria is 2:1, with Lactobacillus plantarum having a bacterial activity of 10 billion CFU / g and Bacillus subtilis having a bacterial activity of 8 billion CFU / g. The mass ratio of cellulase, pectinase and papain in the compound enzymes is 1:1:1, with cellulase having an enzyme activity of 300,000 U / g, pectinase having an enzyme activity of 200,000 U / g, and papain having an enzyme activity of 100,000 U / g.

[0088] Preparation method of traditional Chinese medicine composition:

[0089] S1: Remove impurities from each Chinese herbal medicine raw material, dry it, and then pulverize it into 80-mesh powder. Mix it evenly to obtain a mixed powder of Chinese herbal medicine.

[0090] S2: Add 8 times the mass of purified water to the mixed Chinese medicine powder, add 0.8% of the mass of compound bacteria to the mixed Chinese medicine powder, and ferment aerobically at 36℃ and pH 6.0 for 20 hours. After sterilization at 85℃ for 20 minutes, the mixture is cooled to room temperature to obtain the fermented product.

[0091] S3: Add 0.5% by weight of compound enzyme of traditional Chinese medicine mixture powder to the fermentation product, and enzymatically hydrolyze for 3 hours at 48℃ and pH 5.5. After inactivating the enzyme at 85℃ for 20 minutes, the mixture is cooled to room temperature to obtain the enzymatic hydrolysate.

[0092] S4: The enzymatic hydrolysate is filtered using a 3kDa ultrafiltration membrane, and the filtrate below 3kDa is collected. It is then concentrated under reduced pressure to a relative density of 1.15–1.20 (60℃), and spray-dried under conditions of 65℃ air intake and 35℃ air outlet to obtain the traditional Chinese medicine composition powder.

[0093] A traditional Chinese medicine breast patch suitable for preventing breast hyperplasia and dissipating breast nodules in women, the traditional Chinese medicine ointment is composed of the following components by weight: 5 parts of the above-mentioned traditional Chinese medicine powder, 2 parts of transdermal absorption aid, 3 parts of moisturizer, 0.3 parts of thickener, and 60 parts of purified water; the transdermal absorption aid is a mixture of azone and menthol in a 1:1 mass ratio, the moisturizer is a mixture of glycerin, propylene glycol, and sodium hyaluronate in a 5:3:1 mass ratio, and the thickener is a mixture of xanthan gum and carbomer in a 2:1 mass ratio.

[0094] The base material for the patch is a composite breathable nonwoven fabric with a fiber mass ratio of bamboo fiber: artemisia fiber: viscose fiber = 10:5:2. The fiber diameter is 2μm, the air permeability is 500mm / s, and the water vapor transmission rate is 8000g / (m²·24h).

[0095] Preparation method of traditional Chinese medicine breast patch:

[0096] S1: Add the thickener to purified water according to the mass fraction, and stir at 50°C until completely dissolved to obtain a gel matrix;

[0097] S2: Add the moisturizer and transdermal absorption aid to the gel matrix, stir and mix evenly at 45°C, cool down to 35°C, add the traditional Chinese medicine composition powder, and continue stirring for 20 minutes until completely dispersed to obtain the traditional Chinese medicine ointment;

[0098] S3: The herbal ointment is evenly applied to the application surface of the patch base with a coating thickness of 0.2mm. After cooling and shaping at 25℃, it is cut, sealed and packaged to obtain the herbal patch.

[0099] Example 3

[0100] A traditional Chinese medicine composition suitable for preventing breast hyperplasia and dissipating breast nodules in women, comprising the following raw materials by mass: 15 parts Bupleurum, 18 parts Curcuma longa, 12 parts Angelica sinensis, 15 parts Paeonia lactiflora, 20 parts Taraxacum mongolicum, 10 parts Prunella vulgaris, 9 parts Fritillaria thunbergii, 12 parts Trichosanthes kirilowii, 10 parts Astragalus membranaceus, 8 parts Codonopsis pilosula, 6 parts Atractylodes macrocephala, 7 parts Poria cocos, and 5 parts Glycyrrhiza uralensis.

[0101] The mass ratio of Lactobacillus plantarum to Bacillus subtilis in the compound bacteria is 3:1, with Lactobacillus plantarum having a bacterial activity of 20 billion CFU / g and Bacillus subtilis having a bacterial activity of 15 billion CFU / g. The mass ratio of cellulase, pectinase, and papain in the compound enzymes is 2:2:1, with cellulase having an enzyme activity of 500,000 U / g, pectinase having an enzyme activity of 400,000 U / g, and papain having an enzyme activity of 300,000 U / g.

[0102] Preparation method of traditional Chinese medicine composition:

[0103] S1: Remove impurities from each Chinese herbal medicine raw material, dry it, and then pulverize it into 120-mesh powder. Mix it evenly to obtain a mixed powder of Chinese herbal medicine.

[0104] S2: Add 15 times the mass of purified water to the mixed Chinese medicine powder, add 2.0% of the mass of compound bacteria to the mixed Chinese medicine powder, and ferment aerobically at 42℃ and pH 6.8 for 26 hours. After sterilization at 95℃ for 30 minutes, the mixture is cooled to room temperature to obtain the fermented product.

[0105] S3: Add 1.5% by weight of compound enzyme of traditional Chinese medicine mixture powder to the fermentation product, and enzymatically hydrolyze for 5 hours at 56℃ and pH 6.5. After inactivating the enzyme at 95℃ for 30 minutes, the mixture is cooled to room temperature to obtain the enzymatic hydrolysate.

[0106] S4: The enzymatic hydrolysate was filtered using a 3kDa ultrafiltration membrane, and the filtrate below 3kDa was collected. The filtrate was concentrated under reduced pressure to a relative density of 1.15–1.20 (60℃), and then spray-dried under conditions of 75℃ air intake and 45℃ air outlet to obtain the traditional Chinese medicine composition powder.

[0107] A traditional Chinese medicine breast patch suitable for preventing breast hyperplasia and dissipating breast nodules in women, by weight, comprises the following components: 10 parts of the above-mentioned traditional Chinese medicine powder, 5 parts of transdermal absorption aid, 8 parts of moisturizer, 0.8 parts of thickener, and 80 parts of purified water; the transdermal absorption aid is a mixture of azone and menthol in a mass ratio of 3:1, the moisturizer is a mixture of glycerin, propylene glycol, and sodium hyaluronate in a mass ratio of 8:5:1, and the thickener is a mixture of xanthan gum and carbomer in a mass ratio of 4:1.

[0108] The base material for the patch is a composite breathable nonwoven fabric with a fiber mass ratio of bamboo fiber: artemisia fiber: viscose fiber = 16:9:4. The fiber diameter is 4μm, the air permeability is 700mm / s, and the water vapor transmission rate is 9500g / (m²·24h).

[0109] Preparation method of traditional Chinese medicine breast patch:

[0110] S1: Add the thickener to purified water according to the mass fraction, and stir at 60°C until completely dissolved to obtain a gel matrix;

[0111] S2: Add the moisturizer and transdermal absorption aid to the gel matrix, stir and mix evenly at 55°C, cool down to 40°C, add the traditional Chinese medicine composition powder, and continue stirring for 40 minutes until completely dispersed to obtain the traditional Chinese medicine ointment;

[0112] S3: The herbal ointment is evenly applied to the application surface of the patch base with a coating thickness of 0.4mm. After cooling and shaping at 25℃, it is cut, sealed and packaged to obtain the herbal patch.

[0113] Comparative Example 1

[0114] The traditional Chinese medicine composition was prepared using a traditional water extraction process. Specifically, the mixed powder of traditional Chinese medicine from Example 1 was taken, 12 times the mass of purified water was added, and the mixture was decocted twice, 1.5 hours each time. The decoctions were combined, filtered, concentrated and dried to obtain the extract. The remaining steps were the same as in Example 1 to prepare the traditional Chinese medicine breast patch.

[0115] Comparative Example 2

[0116] The traditional Chinese medicine composition does not involve a compound bacterial fermentation step; instead, it undergoes direct compound enzymatic hydrolysis. The remaining steps are the same as in Example 1, and the traditional Chinese medicine breast patch is prepared.

[0117] Comparative Example 3

[0118] The traditional Chinese medicine composition does not involve a compound enzymatic hydrolysis step, but only undergoes compound bacterial fermentation. The remaining steps are the same as in Example 1 to prepare the traditional Chinese medicine breast patch.

[0119] Comparative Example 4

[0120] The base for applying the herbal breast patch is ordinary non-woven fabric, and the remaining steps are the same as in Example 1.

[0121] Comparative Example 5

[0122] The herbal ointment contains no transdermal absorption aids, and the remaining steps are the same as in Example 1 to prepare the herbal breast patch.

[0123] Performance testing

[0124] Skin irritation test

[0125] Thirty healthy female subjects were randomly divided into 5 groups of 6 each. The herbal breast patches described in Examples 1-3 and Comparative Examples 4 and 5 were applied to the outer skin of the breast for 8 hours each time, for a total of 7 days. Skin condition was observed. Results showed that subjects in Examples 1-3 experienced no adverse reactions such as redness, itching, rash, or stinging, and their comfort scores (out of 10) were all above 8.5. In Comparative Example 4, 3 subjects experienced skin stuffiness and slight redness, with a comfort score of 6.2. In Comparative Example 5, no adverse skin reactions were observed, but the patch had poor transdermal penetration, resulting in a sticky feeling at the application site, and a comfort score of 7.8.

[0126] In vitro transdermal absorption test

[0127] Using a pigskin transdermal diffusion test device, the herbal ointments of Examples 1-3 and Comparative Examples 1-3 were placed on the surface of pigskin. The receiving solution was phosphate buffer (pH 7.4). The mixture was stirred at a constant temperature of 37°C, and samples were taken at 2h, 4h, 8h, and 12h to determine the content of active ingredients (saikosaponin, turmeric, and ferulic acid) in the receiving solution and calculate the cumulative transdermal absorption rate. The results showed that the cumulative transdermal absorption rate of Examples 1-3 at 12h was all above 65%, with Example 1 reaching 72.3%. Comparative Example 1 (water extraction process) was only 28.5%, Comparative Example 2 (no fermentation) was 45.2%, and Comparative Example 3 (no enzymatic hydrolysis) was 42.8%, indicating that the compound microbial fermentation + compound enzymatic hydrolysis process of the present invention can significantly improve the transdermal absorption efficiency of active ingredients.

[0128] Clinical efficacy test

[0129] One hundred and eighty female patients with breast hyperplasia and breast nodules (aged 25-45 years, nodule diameter 0.5-2 cm, all diagnosed as benign by breast ultrasound) were randomly divided into six groups of 30 patients each. Each group used the herbal breast patches described in Examples 1-3 and Comparative Examples 1-3, respectively. The patches were applied once daily for 8 hours to the nodule area, for three consecutive menstrual cycles (each cycle constituting one course of treatment). Efficacy evaluation criteria:

[0130] Cure: The symptoms of breast tenderness have completely disappeared, and the breast nodules have completely disappeared as confirmed by ultrasound.

[0131] Significant effect: Breast tenderness symptoms are significantly relieved, and the diameter of breast nodules is reduced by ≥50%;

[0132] Effective: Breast tenderness symptoms are relieved, and the diameter of breast nodules shrinks by 20% to 50%;

[0133] Ineffective: No relief of breast tenderness symptoms, no change or increase in the diameter of breast nodules.

[0134] The clinical results are shown in the table below:

[0135] The results show that the total effective rate of the herbal breast patches of Examples 1-3 of this invention for breast hyperplasia with breast nodules is over 90%, with Example 1 reaching 96.7%, significantly better than Comparative Examples 1-3. Furthermore, all effective patients experienced significant relief of breast pain after one course of treatment, indicating that the herbal breast patches of this invention have rapid onset and significant efficacy. Simultaneously, no significant adverse skin reactions or systemic discomfort were observed in any patients during use, indicating high product safety.

[0136] In summary, the traditional Chinese medicine composition and herbal breast patch of the present invention are scientifically formulated and technologically advanced, with good transdermal absorption, comfortable and non-irritating application, and can effectively prevent breast hyperplasia and dissipate breast nodules in women. The therapeutic effect is significant and safe, and it has good clinical application value and market prospects.

[0137] The technical solutions provided by the embodiments of the present invention have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of the embodiments of the present invention. The descriptions of the embodiments above are only for helping to understand the principles of the embodiments of the present invention. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the embodiments of the present invention. Therefore, the content of this specification should not be construed as a limitation of the present invention.

Claims

1. A traditional Chinese medicine composition suitable for preventing breast hyperplasia and dissipating breast nodules in women, characterized in that, The product is obtained through extraction and refining of raw materials for promoting blood circulation and dispersing nodules, soothing the liver and regulating qi, clearing heat and reducing swelling, and tonifying and regulating deficiency. All raw materials are natural Chinese herbal medicines. The effective components of the Chinese herbal medicine composition are small molecule extracts with a value of less than 3kDa obtained by fermentation of each raw material with compound bacteria and compound enzymatic hydrolysis. The compound bacteria are a combination of Lactobacillus plantarum and Bacillus subtilis, and the compound enzymes are a combination of cellulase, pectinase and papain.

2. The traditional Chinese medicine composition according to claim 1, suitable for preventing female breast hyperplasia and dissipating breast nodules, is characterized in that, The raw materials of the traditional Chinese medicine composition, by weight, consist of the following components: 8-15 parts Bupleurum, 10-18 parts Curcuma longa, 6-12 parts Angelica sinensis, 8-15 parts Paeonia lactiflora, 10-20 parts Taraxacum mongolicum, 6-10 parts Prunella vulgaris, 5-9 parts Fritillaria thunbergii, 8-12 parts Trichosanthes kirilowii, 6-10 parts Astragalus membranaceus, 5-8 parts Codonopsis pilosula, 3-6 parts Atractylodes macrocephala, 4-7 parts Poria cocos, and 2-5 parts Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition according to claim 2, suitable for preventing female breast hyperplasia and dissipating breast nodules, is characterized in that, The optimal proportions of raw materials in the traditional Chinese medicine composition, by mass, are: 12 parts Bupleurum, 15 parts Curcuma longa, 9 parts Angelica sinensis, 12 parts Paeonia lactiflora, 15 parts Taraxacum mongolicum, 8 parts Prunella vulgaris, 7 parts Fritillaria thunbergii, 10 parts Trichosanthes kirilowii, 8 parts Astragalus membranaceus, 6 parts Codonopsis pilosula, 5 parts Atractylodes macrocephala, 6 parts Poria cocos, and 3 parts Glycyrrhiza uralensis.

4. The traditional Chinese medicine composition according to claim 1, suitable for preventing female breast hyperplasia and dissipating breast nodules, is characterized in that, The mass ratio of *Lactobacillus plantarum* to *Bacillus subtilis* in the compound bacteria is (2-3):1, with *Lactobacillus plantarum* having a bacterial activity of 10-20 billion CFU / g and *Bacillus subtilis* having a bacterial activity of 8-15 billion CFU / g; the mass ratio of cellulase, pectinase, and papain in the compound enzyme is (1-2):(1-2):1, with cellulase having an enzyme activity of 300,000-500,000 U / g, pectinase having an enzyme activity of 200,000-400,000 U / g, and papain having an enzyme activity of 100,000-300,000 U / g.

5. The traditional Chinese medicine composition according to claim 1, suitable for preventing female breast hyperplasia and dissipating breast nodules, is characterized in that, The preparation method of the traditional Chinese medicine composition includes the following steps: S1: Remove impurities from each Chinese herbal medicine raw material, dry it, and then pulverize it into 80-120 mesh powder. Mix it evenly to obtain a mixed powder of Chinese herbal medicine. S2: Add 8 to 15 times the mass of purified water to the mixed Chinese medicine powder, add 0.8% to 2.0% of the mass of compound bacteria to the mixed Chinese medicine powder, and ferment aerobically for 20 to 26 hours at 36℃ to 42℃ and pH 6.0 to 6.

8. After sterilization, cool to room temperature to obtain the fermented product. S3: Add 0.5% to 1.5% by weight of compound enzyme of traditional Chinese medicine mixture powder to the fermentation product, and enzymatically hydrolyze for 3 to 5 hours at 48℃ to 56℃ and pH 5.5 to 6.

5. After enzyme inactivation treatment, cool to room temperature to obtain the enzymatic hydrolysate. S4: The enzymatic hydrolysate is filtered using a 3kDa ultrafiltration membrane. The filtrate with a concentration below 3kDa is collected, concentrated under reduced pressure, and spray-dried to obtain the traditional Chinese medicine composition powder.

6. The traditional Chinese medicine composition according to claim 5, suitable for preventing female breast hyperplasia and dissipating breast nodules, is characterized in that, In step S2, the sterilization temperature is 85℃~95℃ and the sterilization time is 20min~30min; in step S3, the enzyme inactivation temperature is 85℃~95℃ and the enzyme inactivation time is 20min~30min; in step S4, the spray drying inlet air temperature is 65℃~75℃ and the outlet air temperature is 35℃~45℃.

7. A traditional Chinese medicine breast patch suitable for preventing breast hyperplasia and dissipating breast nodules in women, characterized in that, It includes an application base and a traditional Chinese medicine ointment attached to the application base, wherein the traditional Chinese medicine ointment is composed of the traditional Chinese medicine composition according to any one of claims 1 to 6, a transdermal absorption aid, a moisturizer, a thickener and purified water.

8. The traditional Chinese medicine breast patch according to claim 7, suitable for preventing female breast hyperplasia and dissipating breast nodules, is characterized in that... The herbal ointment, by weight, comprises the following components: 5-10 parts of herbal composition powder, 2-5 parts of transdermal absorption aid, 3-8 parts of moisturizer, 0.3-0.8 parts of thickener, and 60-80 parts of purified water; the transdermal absorption aid is a mixture of azone and menthol in a mass ratio of (1-3):1, the moisturizer is a mixture of glycerin, propylene glycol, and sodium hyaluronate in a mass ratio of (5-8):(3-5):1, and the thickener is a mixture of xanthan gum and carbomer in a mass ratio of (2-4):

1.

9. The traditional Chinese medicine breast patch according to claim 7, suitable for preventing female breast hyperplasia and dissipating breast nodules, is characterized in that... The application substrate is a composite breathable nonwoven fabric, which is made of bamboo fiber, mugwort fiber and viscose fiber interlaced and bonded together. The fiber mass ratio is bamboo fiber: mugwort fiber: viscose fiber = (10~16):(5~9):(2~4). The fiber diameter is 2μm~4μm. The air permeability of the application substrate is 500mm / s~700mm / s, and the water vapor transmission is above 8000g / (m²·24h).

10. The method for preparing a traditional Chinese medicine breast patch suitable for preventing female breast hyperplasia and dissipating breast nodules according to any one of claims 7 to 9, characterized in that, Includes the following steps: S1: Add the thickener to purified water according to the mass fraction, and stir at 50℃~60℃ until completely dissolved to obtain a gel matrix; S2: Add the moisturizer and transdermal absorption aid to the gel matrix, stir and mix evenly at 45℃~55℃, cool down to 35℃~40℃, add the traditional Chinese medicine composition powder, and continue stirring until completely dispersed to obtain the traditional Chinese medicine ointment; S3: The herbal ointment is evenly applied to the application surface of the patch base with a coating thickness of 0.2mm to 0.4mm. After cooling and shaping, cutting and packaging, the herbal patch is obtained.

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