External use traditional Chinese medicine formula for mastalgia and preparation method thereof

Abstract

The application discloses a kind of external use traditional Chinese medicine formula for mastalgia and preparation method, belong to traditional Chinese medicine compound preparation field.This formula is composed of Raphanus sativus L., perilla seed, white mustard seed, Evodia rutaecarpa, cyperus rotundus and bupleurum.The subcritical fluid extraction method is used to extract mixed seed oil from Raphanus sativus L., perilla seed and white mustard seed, and then alcohol reflux extraction is used to obtain alcohol extraction infusion from cyperus rotundus, bupleurum and Evodia rutaecarpa.The mixed seed oil is made into microemulsion with surfactant and cosurfactant, and then the alcohol extraction infusion is mixed with gel matrix.Finally, the microemulsion is mixed with gel matrix to be homogeneous, defoamed, and microemulsion gel is prepared.The traditional Chinese medicine extract is prepared into microemulsion gel in the application, which combines high transdermal absorption rate of microemulsion and good spreadability of gel, has the effects of soothing liver and regulating qi, warming meridians and dispelling cold, resolving phlegm and resolving mass, can effectively relieve mastalgia, and the preparation method is stable and reliable with little skin irritation.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compound preparations, and in particular to a topical traditional Chinese medicine formula and preparation method for mastalgia. Background Technology

[0002] Mastalgia is the most common clinical symptom of mammary hyperplasia, mainly characterized by cyclical swelling or stabbing pain in the breasts of women of childbearing age, which can severely impact their quality of life. Modern medicine believes that its pathogenesis is mainly related to an imbalance in the ratio of estrogen to progesterone caused by dysfunction of the hypothalamus-pituitary-ovarian axis. High estrogen levels cause edema and hyperplasia of breast tissue, which compresses nerve endings and triggers pain.

[0003] Currently, hormone-modulating drugs are commonly used in clinical treatment, but long-term use often leads to side effects such as menstrual disorders and liver damage, and has a high recurrence rate. Traditional Chinese medicine classifies mastalgia under the category of "mastopathy." Modern TCM theory holds that the core pathogenesis of mastalgia lies in liver qi stagnation, qi and blood stasis, combined with phlegm and dampness obstruction. Although TCM has rich experience in treatment, oral administration suffers from the first-pass effect in the liver, resulting in low bioavailability; traditional topical preparations also have problems such as poor transdermal absorption, insufficient stability, and high skin irritation.

[0004] Traditional Chinese medicine has accumulated rich experience in treating mastalgia. Internal treatments often focus on soothing the liver, regulating qi, and promoting blood circulation to remove blood stasis. However, oral administration requires absorption through the gastrointestinal tract and the first-pass effect of the liver, limiting bioavailability. External treatments, as a traditional and distinctive therapy in traditional Chinese medicine, directly target the lesions in the breast, offering unique advantages such as reaching the affected area and rapid onset of action. This makes them particularly suitable for diseases like mastalgia, where local symptoms are prominent. Summary of the Invention

[0005] The main objective of this invention is to provide a topical traditional Chinese medicine formula and preparation method for mastalgia, which can effectively solve the problems mentioned in the background art.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A topical Chinese medicine formula for mastalgia consists of the following raw materials in parts by weight: 0.5-1.5 parts radish seed, 0.5-1.5 parts perilla seed, 0.5-1.5 parts white mustard seed, 0.5-1.5 parts evodia fruit, 0.5-1.5 parts cyperus rhizome, and 0.5-1.5 parts bupleurum root.

[0007] A method for preparing a topical traditional Chinese medicine for mastalgia, characterized by comprising the following steps: S1: Weigh out radish seeds, perilla seeds, and white mustard seeds according to the weight parts, and extract them using subcritical fluid extraction method. The extraction temperature is controlled at 10-60℃ to obtain mixed seed oil. S2: Weigh out Cyperus rotundus, Bupleurum chinense and Evodia rutaecarpa according to the weight parts, add 40-95% ethanol solution, heat and reflux to extract 1-3 times, 1-3 hours each time, filter, combine the filtrates, concentrate under reduced pressure to obtain ethanol extract. S3: Mix the mixed seed oil obtained in step S1 with the surfactant and co-surfactant evenly to form the oil phase. Add water to the oil phase under stirring to form a microemulsion. Swell the gel matrix in water and mix it with the alcohol extract obtained in step S2. Adjust the pH value to 5.5-7.5 to form a microemulsion gel.

[0008] Preferably, the extraction solvent used in the subcritical fluid extraction method in step S1 is selected from one or more of liquefied butane, liquefied propane or liquefied dimethyl ether; the extraction pressure is controlled at 0.2-1.0 MPa and the extraction time is 1-4 hours.

[0009] Preferably, the surfactant in step S3 is one of polyoxyethylene hydrogenated castor oil and polysorbate 80; the co-surfactant is one of propylene glycol and glycerin; and the gel matrix is ​​selected from one of carbomer 940, sodium carboxymethyl cellulose, and polyvinyl alcohol.

[0010] Preferably, step S3 specifically includes the following steps: A1: Mix the mixed seed oil obtained in step S1 with surfactant and co-surfactant at 10-40℃ to form an oil phase; add water to the oil phase while stirring to form a uniform and transparent microemulsion. A2: Swell the gel matrix in water, mix it with the alcohol extract obtained in step S2, stir evenly, and adjust the pH value to 5.5-7.5 to form a gel matrix; A3: Mix the microemulsion obtained in step A1 with the gel matrix obtained in step A2 evenly, add azone, and after homogenization and defoaming treatment, a topical microemulsion gel for mastalgia is obtained.

[0011] Preferably, the weight ratio of the mixed seed oil, surfactant and co-surfactant in step A1 is 1:(2-8):(1-4).

[0012] Preferably, the amount of azone added in step A3 is 0.5-2% of the total weight of the microemulsion gel.

[0013] Preferably, in step A3, the homogenization speed is 3000-10000 r / min, the homogenization time is 5-15 minutes, and the degassing is performed using vacuum degassing with a vacuum degree of -0.06 to -0.09 MPa and a degassing time of 10-20 minutes.

[0014] The application of the topical traditional Chinese medicine formula for mastalgia prepared according to any one of claims 1-8 in the treatment of mastalgia.

[0015] Compared with the prior art, the present invention has the following beneficial effects: 1. This invention utilizes subcritical fluid extraction technology to obtain a mixed seed oil from radish seeds, perilla seeds, and white mustard seeds. The mixed seed oil, along with surfactants and co-surfactants, forms a microemulsion system through spontaneous emulsification or low-energy emulsification. This system exhibits a composite structure where nanodroplets are trapped within a three-dimensional polymer network. The surfactants and co-surfactants present in the microemulsion interface film possess certain interfacial activity and fluidity. When in contact with the skin, they may insert into the highly ordered lipid bilayer between stratum corneum cells, interfering with the lipid arrangement and reducing the density of the stratum corneum as a transdermal barrier to some extent. Furthermore, the hydrophilic groups in the gel matrix and co-surfactants can hydrate the stratum corneum, causing keratinocytes to absorb water and swell, making the microstructure of the stratum corneum relatively loose. This provides more pathways for drug molecule diffusion, improving the transdermal absorption rate and bioavailability of the drug.

[0016] 2. This invention constructs a microemulsion gel system by dispersing microemulsions within a polymeric gel matrix. Nanoparticles are trapped within the three-dimensional polymeric network structure, effectively inhibiting droplet collision, aggregation, and Ostwald ripening, thus improving the physical stability of the formulation. Simultaneously, subcritical fluid extraction technology is performed under low temperature and low pressure conditions, preserving the effective components in the seed oil. The alcohol extract is concentrated under reduced pressure and then uniformly mixed with the gel matrix. The pH value is adjusted to near the physiological range of the skin. The resulting formulation has a uniform appearance, without stratification, demulsification, or drug precipitation. It exhibits minimal changes in pH and viscosity and demonstrates good long-term storage stability. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the preparation process of the topical traditional Chinese medicine formula for mastalgia of the present invention. Detailed Implementation

[0018] The endpoints and any values ​​of the ranges disclosed in this invention are not limited to the precise range thresholds, and these range thresholds should be understood to include values ​​close to these range thresholds. For numerical ranges, the endpoint values ​​of the various ranges, the endpoint values ​​of the various ranges and individual point values, and individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed in this invention.

[0019] The following describes in detail, with reference to the accompanying drawings, an external Chinese medicine formula and preparation method for mastalgia provided in the embodiments of this specification.

[0020] like Figure 1 As shown, a topical traditional Chinese medicine formula and preparation method for mastalgia are described, and the specific preparation steps are as follows.

[0021] Example 1 A method for preparing a topical traditional Chinese medicine formula for mastalgia, the specific steps of which are as follows: S1: First, weigh the following raw materials in parts by weight: 1.0 part of radish seed, 1.0 part of perilla seed, 1.0 part of white mustard seed, 1.0 part of evodia fruit, 1.0 part of cyperus rhizome, and 1.0 part of bupleurum root.

[0022] Radish seeds, perilla seeds, and white mustard seeds were cleaned, dried, and pulverized through a 20-mesh sieve before being placed into a subcritical extraction tank. Liquefied butane was used as the extraction solvent at a material-to-liquid ratio of 1:10 (kg / L), and static extraction was performed for 2 hours at an extraction temperature of 40℃ and an extraction pressure of 0.6 MPa. After extraction, the solvent was removed by vacuum evaporation, and the mixed seed oil was recovered.

[0023] S2: After cleaning, drying, and pulverizing Evodia rutaecarpa, Cyperus rotundus, and Bupleurum chinense, the powder is passed through a 10-mesh sieve and placed in a multi-functional extraction vessel. Eight times the volume of 70% ethanol aqueous solution is added, and the mixture is heated under reflux for two extractions: the first extraction lasts 2 hours, and the second extraction lasts 1.5 hours. The two extracts are combined and filtered through a 200-mesh filter cloth. The filtrate is concentrated under reduced pressure at 55℃ and a vacuum of -0.08MPa to recover the ethanol, and further concentrated to obtain an alcohol extract with a relative density of 1.20 at 60℃.

[0024] S3: Take 1.0 part of the mixed seed oil obtained in step S1, mix it with 5.0 parts of polyoxyethylene hydrogenated castor oil as a surfactant and 2.5 parts of propylene glycol as a co-surfactant, and stir at 300 rpm for 30 minutes at 25°C until homogeneous as the oil phase. While stirring continuously, slowly add 15.0 parts of deionized water to the oil phase and continue stirring for 30 minutes to form a homogeneous and transparent oil-in-water microemulsion.

[0025] Take 0.8 parts of Carbomer 940 as the gel matrix, sprinkle it evenly on the surface of 40.0 parts of deionized water, and let it stand overnight to swell and form a gel matrix. Disperse 3.0 parts of the alcohol extract obtained in step S2 with a small amount of glycerol, then add it to the above gel matrix and stir until homogeneous. Adjust the pH to 6.5 with triethanolamine to form a transparent gel from the carbomer.

[0026] The prepared microemulsion was slowly added to the prepared gel matrix under stirring, and the mixture was stirred until homogeneous. Azone, at 1.0% of the total weight of the microemulsion gel, was added as a penetration enhancer. The mixture was transferred to a high-speed homogenizer and homogenized at 6000 rpm for 10 minutes. Then it was transferred to a vacuum degassing machine and degassed at a vacuum of -0.08 MPa for 15 minutes to obtain a topical microemulsion gel for mastalgia.

[0027] Example 2 A method for preparing a topical traditional Chinese medicine formula for mastalgia, the specific steps of which are as follows: S1: Weigh the following raw materials in parts by weight: 1.2 parts radish seed, 0.8 parts perilla seed, 1.0 part white mustard seed, 1.2 parts evodia fruit, 0.8 parts cyperus rhizome, and 1.0 part bupleurum root.

[0028] Radish seeds, perilla seeds, and white mustard seeds were cleaned, dried, and pulverized through a 20-mesh sieve before being placed into a subcritical extraction tank. Liquefied propane was used as the extraction solvent, with a material-to-liquid ratio of 1:8. Extraction was carried out at 25°C and 0.8 MPa using a dynamic circulation extraction method for 3 hours. After extraction, the pressure was slowly released, and the mixture was vaporized to obtain the mixed seed oil.

[0029] S2: Clean and dry Evodia rutaecarpa, Cyperus rotundus, and Bupleurum chinense, then pulverize them into coarse powder. Add 10 times the volume of 85% ethanol aqueous solution, and extract by reflux three times, 1.5 hours each time. Combine the three extracts and filter through a 300-mesh filter cloth. Concentrate the filtrate under reduced pressure at 50℃ and a vacuum of -0.09MPa, recover the ethanol, and continue concentrating to obtain an alcohol extract with a relative density of 1.25 at 60℃.

[0030] S3: Take 1.0 part of the mixed seed oil obtained in step S1, and mix it with 6.0 parts of polysorbate 80 as a surfactant and 3.0 parts of glycerol as a co-surfactant. Stir at 400 rpm for 20 minutes at 30°C until homogeneous to obtain the oil phase. While stirring continuously, slowly add 18.0 parts of deionized water to the oil phase and continue stirring until the system becomes transparent to obtain a microemulsion.

[0031] Take 1.5 parts of sodium carboxymethyl cellulose as the gel matrix and slowly sprinkle it into 35.0 parts of hot deionized water while stirring. Continue stirring until completely dissolved, and cool to form a gel matrix. Add 3.5 parts of the alcohol extract obtained in step S2 to the above gel matrix and stir evenly. Adjust the pH to 7.0 with citric acid or sodium hydroxide solution.

[0032] The prepared microemulsion was added to the gel matrix under stirring and mixed thoroughly. Azone, at a weight of 1.5% of the total microemulsion gelling agent, was added. The mixture was transferred to a high-speed homogenizer and homogenized at 8000 rpm for 8 minutes. Then, it was transferred to a vacuum degassing machine and degassed under a vacuum of -0.09 MPa for 12 minutes to obtain the final product.

[0033] Example 3 A method for preparing a topical traditional Chinese medicine formula for mastalgia, the specific steps of which are as follows: S1: Weigh the following raw materials in parts by weight: 0.8 parts radish seed, 1.2 parts perilla seed, 1.0 part white mustard seed, 0.8 parts evodia fruit, 1.2 parts cyperus rhizome, and 1.0 part bupleurum root.

[0034] Radish seeds, perilla seeds, and white mustard seeds were cleaned, dried, and pulverized. Using liquefied dimethyl ether as the extraction solvent, at a material-to-liquid ratio of 1:12 (kg / L), static extraction combined with intermittent stirring was performed for 4 hours at an extraction temperature of 15℃ and an extraction pressure of 0.4 MPa. After extraction, the solvent was recovered at low temperature to obtain mixed seed oil.

[0035] S2: After cleaning, drying, and slicing Evodia rutaecarpa, Cyperus rotundus, and Bupleurum chinense, add 6 times the volume (by weight) of 60% ethanol aqueous solution and extract twice by heating and reflux. The first extraction lasts for 3 hours, and the second extraction lasts for 2 hours. Combine the two extracts and filter using a plate and frame filter press. Concentrate the filtrate under reduced pressure at 65℃ and a vacuum of -0.06MPa to recover the ethanol, and continue concentrating to obtain an alcohol extract with a relative density of 1.15 at 60℃.

[0036] S3: Take 1.0 part of the mixed seed oil obtained in step S1, mix it with 4.0 parts of polyoxyethylene hydrogenated castor oil as a surfactant and 2.0 parts of propylene glycol as a co-surfactant, and stir and mix evenly at 20°C to form the oil phase. While stirring, slowly add 12.0 parts of deionized water to the oil phase and stir to form a uniform and transparent microemulsion.

[0037] Take 2.0 parts of polyvinyl alcohol as the gel matrix, add it to 30.0 parts of deionized water, let it swell, and then heat it in a water bath at 85°C until completely dissolved. Cool it to room temperature to form a gel matrix. Mix 2.8 parts of the alcohol extract obtained in step S2 with the above gel matrix and stir evenly. Adjust the pH value to 6.0 with triethanolamine.

[0038] The prepared microemulsion and gel matrix were stirred and mixed evenly in a mixer. Azone was added at 0.8% of the total weight of the microemulsion gel. The mixture was then passed through a microfluidic homogenizer and homogenized twice at 10,000 rpm for 5 minutes each time. Finally, the mixture was degassed under a vacuum of -0.07 MPa for 20 minutes to obtain the topical microemulsion gel for mastalgia.

[0039] Comparative Example 1 In step S3, 10.0 parts of stearic acid, 3.0 parts of cetyl alcohol, 5.0 parts of liquid paraffin, 2.0 parts of white petrolatum, and 1.0 part of the mixed seed oil obtained in step S1 are mixed and heated to 75°C to form the oil phase. 1.0 part of triethanolamine, 5.0 parts of glycerol, and 0.1 parts of ethylparaben are added to 40.0 parts of purified water and heated to 75°C to form the aqueous phase. 3.0 parts of the alcohol extract obtained in step S2 are dispersed in the aqueous phase.

[0040] Under constant temperature of 75°C, the aqueous phase is slowly poured into the oil phase while stirring in the same direction. After the addition is complete, continue stirring until emulsification is complete. Maintain the stirring speed and allow the system to cool naturally to room temperature. Once solidified, a conventional cream is obtained. The remaining steps are the same as in Example 1.

[0041] Comparative Example 2 In step S1, radish seeds, perilla seeds, and white mustard seeds are cleaned and dried, then fed into a screw oil press for pressing. During the pressing process, the material temperature rises to approximately 80-100℃. The pressed crude oil is collected, allowed to settle, and filtered to obtain mixed seed oil. The remaining steps are the same as in Example 1.

[0042] Comparative Example 3 The mixed seed oil obtained in step S1 was simply mixed with polyoxyethylene hydrogenated castor oil and propylene glycol to obtain an oil phase mixture. 0.8 parts of carbomer 940 were evenly sprinkled on the surface of deionized water and allowed to swell overnight. 3.0 parts of the alcohol extract obtained in step S2 were dispersed by grinding with a small amount of glycerol and added to the above gel matrix, then stirred until homogeneous. The pH was adjusted to 6.5 with triethanolamine. The above oil phase mixture was then directly added to the prepared gel matrix under stirring, and stirred until homogeneous. 1.0% azone was added, and the mixture was homogenized at 6000 rpm for 10 minutes, followed by vacuum degassing for 15 minutes to obtain the microemulsion gel. The remaining steps were the same as in Example 1.

[0043] The external Chinese medicines for mastalgia prepared in Examples 1-3 and Comparative Examples 1-3 were subjected to the following performance tests, and the results are shown in Tables 1-2: 1. Stability test Take 10g of each test sample and place it in a graduated centrifuge tube. Centrifuge at 4000 rpm for 30 minutes. Observe whether the samples show stratification, demulsification, precipitation, or drug separation after centrifugation. Record the stability of each group of samples.

[0044] Take 20g of each test sample, seal it in a vial, and place it in a 45℃ constant temperature incubator for 10 days. Take samples on day 0, day 5, and day 10 for observation. Observation indicators include: appearance, uniformity, pH value change, and viscosity change.

[0045] Take an appropriate amount of each test sample after 10 days of storage, spread it on a glass slide, cover it with a coverslip, and observe it under an optical microscope. Observe the distribution of drug particles, whether there is aggregation, and the precipitation of crystals, and take pictures for recording. Focus on comparing the differences in microstructure between the Example 1 group and Comparative Example 3.

[0046] 2. Skin irritation test Thirty SD rats were randomly divided into 6 groups of 5 rats each: Example 1, Example 2, Example 3, Comparative Example 1, Comparative Example 2, and Comparative Example 3. Twenty-four hours before the experiment, the hair on both sides of the spine on the back of each rat was removed using an electric shaver, covering an area of ​​approximately 3cm × 3cm, taking care to avoid skin damage. A self-controlled left-right method was used, with the left side representing the drug-treated side and the right side representing the untreated control side.

[0047] Approximately 0.5g of the test sample from each group was evenly applied to the shaved area on the left side of the corresponding rat, and then covered and secured with non-irritating medical tape and gauze. The right side was similarly covered but not treated. The drug was administered once daily for 7 consecutive days. Before each administration, the skin reaction at the administration site and control site, such as erythema and edema, was observed and recorded.

[0048] Table 1: Stability test results of Examples 1-3 and Comparative Examples 1-3 Table 2: Results of skin irritation tests in Examples 1-3 and Comparative Examples 1-3 As shown in Table 1, no layering, demulsification, or drug precipitation was observed in Examples 1-3 under centrifugation and high-temperature conditions. The appearance was uniform, and the pH and viscosity showed minimal changes, indicating that the microemulsion gel of this invention may possess good physical stability. Comparative Example 1, a conventional cream, exhibited surface water separation, bottom sedimentation, and hardening of the cream under centrifugation and high-temperature conditions, indicating that the physical stability of conventional creams is inferior to that of microemulsion gels. Comparative Example 2, using a pressing method to prepare seed oil, showed stability similar to the example groups, indicating that the extraction method of seed oil has less impact on formulation stability than dosage form factors, and the microemulsion gel system can still maintain good stability. Comparative Example 3, without microemulsion pretreatment, directly added the oil phase mixture to the gel matrix, resulting in surface oil floating, bottom sedimentation, and a significant increase in pH, indicating that the unmicroemulsified oil phase is difficult to disperse stably in the gel, lacking the stabilizing effect of the microemulsion structure on the dispersed phase.

[0049] Table 2 shows that the skin erythema and edema scores were low after continuous administration for 1-7 days in Examples 1, indicating that the microemulsion gel of the present invention may have good skin compatibility and low irritation. Comparative Example 1, a conventional cream, had a higher irritation score than the Example group, possibly due to the interference of fatty acid components in the cream matrix on the skin barrier. Comparative Example 2, using a pressing method to prepare seed oil, had a slightly higher irritation score than the Example group, possibly due to oxidation products generated during high-temperature extraction. Comparative Example 3, without microemulsion pretreatment, had a significantly higher irritation score than other groups, indicating that the oil phase was directly dispersed in the gel without emulsification, and the surfactants and seed oil existed in a non-uniform state with excessively high local concentrations, potentially causing strong skin irritation.

[0050] In summary, this invention constructs a delivery system with excellent physical stability by combining microemulsions with a gel matrix, while nonionic surfactants and a suitable pH environment ensure the skin compatibility of the formulation. The effective solubilization of the oil phase by the microemulsion structure and the anchoring effect of the gel network on the dispersed phase are likely the key reasons for its superior stability compared to conventional creams; while the oil phase without microemulsion lacks a stable interfacial film and uniform dispersion, resulting in significantly reduced stability and skin compatibility.

[0051] In the description of this specification, the reference to terms such as "embodiment," "various embodiments," etc., indicates that a specific feature, structure, material, or characteristic described in connection with that embodiment or preparation example is included in at least one embodiment of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments.

[0052] The above are merely preferred embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A topical traditional Chinese medicine formula for mastalgia, characterized in that, It is composed of the following raw materials in parts by weight: 0.5-1.5 parts of radish seed, 0.5-1.5 parts of perilla seed, 0.5-1.5 parts of white mustard seed, 0.5-1.5 parts of evodia fruit, 0.5-1.5 parts of cyperus rhizome, and 0.5-1.5 parts of bupleurum root.

2. A method for preparing a topical traditional Chinese medicine for mastalgia, characterized in that, Includes the following steps: S1: Weigh out radish seeds, perilla seeds, and white mustard seeds according to the weight parts, and extract them using subcritical fluid extraction method. The extraction temperature is controlled at 10-60℃ to obtain mixed seed oil. S2: Weigh out Cyperus rotundus, Bupleurum chinense and Evodia rutaecarpa according to the weight parts, add 40-95% ethanol solution, heat and reflux to extract 1-3 times, 1-3 hours each time, filter, combine the filtrates, concentrate under reduced pressure to obtain ethanol extract. S3: Mix the mixed seed oil obtained in step S1 with the surfactant and co-surfactant evenly to form the oil phase. Add water to the oil phase under stirring to form a microemulsion. Swell the gel matrix in water and mix it with the alcohol extract obtained in step S2. Adjust the pH value to 5.5-7.5 to form a microemulsion gel.

3. The method for preparing a topical traditional Chinese medicine for mastalgia according to claim 2, characterized in that, In step S1, the subcritical fluid extraction method uses an extraction solvent selected from one or more of liquefied butane, liquefied propane, or liquefied dimethyl ether; the extraction pressure is controlled at 0.2-1.0 MPa, and the extraction time is 1-4 hours.

4. A method for preparing a topical traditional Chinese medicine for mastalgia according to claim 2, characterized in that, The surfactant in step S3 is one of polyoxyethylene hydrogenated castor oil and polysorbate 80; the co-surfactant is one of propylene glycol and glycerin; and the gel matrix is ​​one of carbomer 940, sodium carboxymethyl cellulose, and polyvinyl alcohol.

5. A method for preparing a topical traditional Chinese medicine for mastalgia according to claim 2, characterized in that, Step S3 specifically includes the following steps: A1: Mix the mixed seed oil obtained in step S1 with surfactant and co-surfactant at 10-40℃ to form an oil phase; add water to the oil phase while stirring to form a uniform and transparent microemulsion. A2: Swell the gel matrix in water, mix it with the alcohol extract obtained in step S2, stir evenly, and adjust the pH value to 5.5-7.5 to form a gel matrix; A3: Mix the microemulsion obtained in step A1 with the gel matrix obtained in step A2 evenly, add azone, and after homogenization and defoaming treatment, a topical microemulsion gel for mastalgia is obtained.

6. A method for preparing a topical traditional Chinese medicine for mastalgia according to claim 5, characterized in that, The mass ratio of the mixed seed oil, surfactant and co-surfactant in step A1 is 1:(2-8):(1-4).

7. A method for preparing a topical traditional Chinese medicine for mastalgia according to claim 5, characterized in that, In step A3, the amount of azone added is 0.5-2% of the total weight of the microemulsion gel.

8. A method for preparing a topical traditional Chinese medicine for mastalgia according to claim 5, characterized in that, In step A3, the homogenization speed is 3000-10000 r / min, the homogenization time is 5-15 minutes, and the degassing is performed by vacuum degassing with a vacuum degree of -0.06 to -0.09 MPa and a degassing time of 10-20 minutes.

9. The application of the topical traditional Chinese medicine formula for mastalgia prepared according to any one of claims 1-8 in the treatment of mastalgia.

Images