External medicament for treating breast diseases and preparation method thereof

Abstract

The invention relates to an external medicament for treating breast diseases and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine preparations. In order to solve the problems of single target spot and poor curative effect in the prior art, the invention provides an external medicament for treating breast diseases, which is mainly prepared from the following raw materials in parts by weight: 13-18 parts of semen momordicae; 25-35 parts of tangerine seeds; 24 to 32 parts of radix isatidis; 26 to 32 parts of mint; 45 to 53 parts of dandelion; 18 to 24 parts of tribulus terrestris; 1-5 parts of borneol; and an auxiliary material: rapeseed oil. Semen momordicae, semen citri reticulatae, radix isatidis, herba menthae, herba taraxaci and tribulus terrestris are micronized and processed into traditional Chinese medicine powder, borneol is mixed, the mixture is added into rapeseed oil to be soaked, and the required external medicine is obtained. The traditional Chinese medicine composition has the effects of eliminating pathological nodules and clearing heat toxin causes, has the synergistic effect of removing stasis and detoxifying, and realizes better functions of removing stasis, inhibiting hyperplasia of mammary glands, resisting inflammation and activating blood.

Description

Technical Field

[0001] The invention relates to an external-use medicament for treating breast diseases and a preparation method thereof, belonging to the technical field of traditional Chinese medicine preparations. Background Art

[0002] Breast disease is a common disease and a major threat to women's physical and mental health. It includes mastitis, breast hyperplasia, breast nodules, etc. If not treated in time, lesions will occur, especially breast hyperplasia, the risk of malignant transformation is several times higher than that of normal women. The different types of breast hyperplasia and their clinical manifestations are mainly liver depression and qi stagnation, depression, and irritability.

[0003] Currently, the treatment of breast diseases is primarily based on Western medicine. Treatments such as tamoxifen, thyroid hormone preparations, enzymes, and sex hormones are effective in relieving pain and reducing lumps. However, these treatments are associated with significant side effects, particularly sex hormones, which can further disrupt the body's hormonal balance and increase the risk of cancer. Therefore, their use should be minimized or avoided. Traditional Chinese medicine (TCM) is also available, including Xiaoyaosan, Xiaojinwan, Rupixiao, and Rukuaixiao. These are taken orally to treat lesions, but they also carry the same adverse effects as oral medications. Their overall composition is limited, resulting in limited efficacy, limited to anti-inflammatory effects and inability to achieve multi-targeted treatment. Topical TCM patches also suffer from low transdermal efficiency, making multi-targeted treatment infeasible and resulting in poor efficacy. Summary of the Invention

[0004] In response to the problems existing in the above-mentioned prior art, the present invention provides an external-use medicament for treating breast diseases and a preparation method thereof, and solves the problem of how to effectively treat or prevent breast diseases while having the effects of inhibiting breast hyperplasia, relieving inflammation and dispersing nodules.

[0005] One of the purposes of the present invention is achieved through the following technical solution: a topical medicament for treating breast diseases, wherein the topical medicament is mainly made of the following raw materials in parts by weight:

[0006] Momordica cochinchinensis: 13-18; Tangerine seed: 25-35; Isatis root: 24-32; Mint: 26-32; Dandelion: 45-53; Tribulus terrestris: 18-24; Borneol: 1-5; Auxiliary material: rapeseed oil.

[0007] Using Momordica cochinchinensis as the monarch drug, which mainly attacks breast nodules and inhibits breast hyperplasia, and exerts the effects of dissipating stasis and detoxifying. Using dandelion and isatis root as the minister drugs, they assist Momordica cochinchinensis to achieve the effects of enhancing anti-inflammatory and antibacterial, clearing heat and detoxifying, and eliminating the hot-toxic environment, so as to achieve the purpose of treating breast diseases. Utilizing the synergistic effect of Momordica cochinchinensis, dandelion and isatis root, it effectively breaks through the limitations of traditional oral medications. The present invention can exert its strong stasis-dissipating effect through external application, avoiding the risks of using oral medications. Since Momordica cochinchinensis contains saponin active ingredients such as momordin, application can more effectively promote local blood circulation, directly act on breast lesions, and inhibit fibrous tissue hyperplasia, thus effectively treating breast hyperplasia. At the same time, using tangerine seeds, tribulus terrestris and mint as adjuvant drugs, the tangerine seeds in the adjuvant drugs can regulate qi and dissipate stasis, dredge the qi stagnation in the liver meridian, and the tribulus terrestris can promote blood circulation and dispel wind, relieving local swelling; using borneol as the messenger drug, it can guide all the drugs to reach the lesions directly, enhance transdermal absorption, and have the effect of clearing heat and relieving pain. The present invention enables the active ingredients of various Chinese medicinal materials to act synergistically with each other through the traditional Chinese medicine theory of monarch, minister, adjuvant and messenger to achieve the purpose of multi-target treatment of breast diseases, effectively treating or preventing breast diseases, and having the effects of inhibiting breast hyperplasia, anti-inflammatory, dissipating stasis and promoting blood circulation.

[0008] More specifically, on the one hand, through the synergistic effect of Momordica cochinchinensis, dandelion and isatis root, it can not only eliminate pathological breast nodules (dissipate stasis), but also clear the hot-toxic disease, with multiple effects of synergistically dissipating stasis and detoxifying; by utilizing the synergistic effect between the warm nature of Momordica cochinchinensis and the cold nature of dandelion and isatis root, it prevents the advantages of warm-dryness promoting heat and balances cold and heat, which is more beneficial to the treatment of breast diseases; and the combination of tangerine seeds and tribulus terrestris synergistically regulates qi and promotes blood circulation, jointly improving the state of qi stagnation and blood stasis, promoting breast microcirculation, and effectively improving breast tissue, achieving the advantages of inhibiting breast hyperplasia and dissipating stasis (eliminating breast nodules). Through the combination of dandelion, isatis root, tangerine seeds and tribulus terrestris, it can also form the effects of "detoxifying - dissipating stasis - dredging collaterals", with a trinity treatment target, better achieving the effects of eliminating breast nodules, inhibiting breast hyperplasia and promoting blood circulation. The monarch drug Momordica cochinchinensis synergistically with dandelion and isatis root can target the "hot-toxic" pathology of breast inflammatory lesions, inhibit pathogenic microorganisms, and have a better anti-inflammatory effect; while tangerine seeds and tribulus terrestris regulate the qi stagnation and blood stasis in the liver meridian, improve the hormone disorder and microcirculation disorder related to breast hyperplasia, and more effectively inhibit breast hyperplasia.

[0009] On the other hand, Momordica cochinchinensis in combination with Taraxacum mongolicum can effectively inhibit common pathogens of mastitis such as Staphylococcus aureus and Escherichia coli. By adding Isatis indigotica to assist Taraxacum mongolicum and Momordica cochinchinensis, it can better clear the deep heat toxin in the mammary gland, prevent the spread of inflammation, neutralize bacterial endotoxins, and block the vicious cycle of "redness - exudation - necrosis" of mastitis; activate local immune cells in the mammary gland (such as NK cells), enhance the anti - infection ability, and effectively enhance the anti - inflammatory ability. Moreover, in combination with Mentha haplocalyx and Borneolum syntheticum, by Mentha haplocalyx dilating pores and relaxing the stratum corneum, and by stimulating cold - sensitive receptors, it can relieve the inflammatory fever and burning pain of the mammary gland and reduce the release of neurotransmitters related to mammary gland pain (such as substance P). By Borneolum syntheticum destroying the lipid structure of the stratum corneum, it can effectively promote drug penetration, with the advantages of enhancing transdermal absorption and synergistic effect, enhancing the absorption of active ingredients such as Momordica cochinchinensis, Taraxacum mongolicum, and Isatis indigotica, enhancing the local penetration of active ingredients such as momordicoside and taraxacum polysaccharide in the compatibility, enabling the active ingredients to directly reach the deep tissues of the mammary gland, improving the local curative effect, and more effectively achieving the effects of inhibiting mammary gland hyperplasia, dissipating nodules, and anti - inflammation. The external medicine preparation of the present invention can be directly coated, or can be made into patches such as mammary gland patches for direct application, without oral administration, without damaging the stomach and intestines and without the metabolic burden on the liver and kidneys; and through the way of application, using transdermal absorption therapy, the drug can directly act on the mammary gland tissue, with a high local concentration and less systemic exposure, which is more conducive to achieving the effects of treating or preventing mammary gland diseases, inhibiting mammary gland hyperplasia, anti - inflammation, dissipating nodules, and promoting blood circulation.

[0010] In the above - mentioned external medicine preparation for treating mammary gland diseases, preferably, the weight ratio of Momordica cochinchinensis, Taraxacum mongolicum, and Isatis indigotica is 1.0:3.0 - 3.3:2.0 - 2.1. By reasonably controlling the above weight ratio, it can better achieve the dynamic balance of cold and warm medicinal properties. With the warm - natured Momordica cochinchinensis as the core, and in combination with the cold - natured Taraxacum mongolicum and Isatis indigotica, it forms a balanced state where the warm - natured medicine disperses without generating excessive heat, and the cold - natured medicine clears heat without damaging yang qi, better achieving the effects of dissipating nodules and anti - inflammation, avoiding qi and blood stasis (aggravating nodules) caused by solely using the above - mentioned cold - natured medicinal materials and avoiding exacerbating the inflammatory reaction (such as redness, swelling, heat, and pain) caused by solely using warm - dry medicinal materials.

[0011] In the above-mentioned external medicament for treating breast diseases, preferably, the weight ratio of Momordica cochinchinensis seeds: semen citri reticulatae: Tribulus terrestris is 1: 1.8-2.2: 1.2-1.5. By reasonably controlling the dosage compatibility of the monarch drug with semen citri reticulatae and Tribulus terrestris, multi-target treatment of inhibiting breast hyperplasia, anti-inflammation and regulating immune function can be better achieved, which can directly act on the core pathogenesis of "intermingled phlegm, stasis, heat and toxin" in breast hyperplasia and nodule formation, inhibit abnormal deposition of collagen in breast tissue, reduce induration, relieve inflammatory swelling, redness and pain of the breast by inhibiting inflammatory factors such as TNF-α and IL-6, effectively reduce the overexpression of estrogen receptor (ER) in combination with semen citri reticulatae, inhibit hyperplasia of breast duct epithelium; increase blood oxygen supply, promote excretion of metabolic wastes; inhibit TGF-β1 signaling pathway, reduce the formation of breast fibroadenoma; and synergistically with Tribulus terrestris to effectively inhibit the excessive immune response in chronic breast inflammation, reduce mast cell degranulation, relieve breast eczema-like lesions, reduce blood viscosity, overall improve immune function, and have the effect of anti-inflammation.

[0012] In the above-mentioned external medicament for treating breast diseases, preferably, the total weight of peppermint and borneol is 32-36. It can more effectively enhance the local penetration of active ingredients in the compatibility, reach the deep part of the breast directly, have better curative effect on breast diseases, and achieve the effects of quickly inhibiting breast hyperplasia and anti-inflammation.

[0013] In the above-mentioned external medicament for treating breast diseases, preferably, the isatis root is replaced with honeysuckle; the peppermint is replaced with forsythia. Replacing with honeysuckle also has the effect of anti-inflammation and has the characteristic of better transdermal property; while replacing with forsythia has a better effect of dissipating stasis.

[0014] In the above-mentioned external medicament for treating breast diseases, preferably, the external medicament is adsorbed with pharmaceutically acceptable materials to make a breast patch. Here, the pharmaceutically acceptable materials can be commonly used sterile dressings. Specific operation: When in use, directly apply the external medicament (drug) on the adsorption layer of the sterile dressing to make the corresponding breast patch, and then stick it on the corresponding acupoints.

[0015] The second object of the present invention is achieved by the following technical solution. A method for preparing an external medicament for treating breast diseases, the method comprising the following steps:

[0016] A. Weigh the following raw materials in parts by weight and carry out micronization treatment to process them into traditional Chinese medicine powders:

[0017] Momordica cochinchinensis seeds: 13-18; semen citri reticulatae: 25-35; isatis root: 26-32; peppermint: 26-32; dandelion: 45-53; Tribulus terrestris: 18-24;

[0018] B. Then, mix 1 - 5 parts by weight of borneol with the traditional Chinese medicine powder, and then add it to rapeseed oil for soaking. After the soaking is completed, the required external medicine is obtained.

[0019] After the selected traditional Chinese medicines are micronized, the active ingredients in each traditional Chinese medicine can be effectively leached under the soaking of rapeseed oil. The traditional Chinese medicine powder and rapeseed oil are mixed together to form a corresponding viscous external medicine. Soaking with rapeseed oil can dissolve fat-soluble components. More importantly, it is used to extract fat-soluble components in traditional Chinese medicines (such as momordic acid and cucurbitacin in the monarch drug Momordica cochinchinensis, taraxasterol, lupeol, and isatisindigotica ketone in the ministerial drugs, etc.) and volatile oils (such as semen citri reticulatae, mint, and borneol), etc. Fat-soluble active substances. Among the active ingredients, cucurbitacin has anti-inflammatory and anti-tumor effects, momordic acid can promote blood circulation, taraxasterol and lupeol can anti-inflammatory and inhibit breast hyperplasia, and isatisindigotica ketone has antibacterial and anti-inflammatory effects. Using rapeseed oil also has the advantage of good skin affinity. Rapeseed oil contains oleic acid (about 60%) and linoleic acid, has good permeability, low irritation, and low cost. When in use, the obtained external medicine can also be adsorbed by a pharmaceutically acceptable material to obtain the required breast patch. Making it into a breast patch and directly applying it does not require oral administration, does not harm the stomach and intestines, and has no burden on liver and kidney metabolism; and through the way of application and transdermal absorption treatment, the drug can directly reach the breast tissue, with a high local concentration and less systemic exposure, which is more conducive to the treatment of breast diseases and achieves the effects of inhibiting breast hyperplasia, anti-inflammatory, and dissipating stasis. The overall production process is simple, can maximize the medicinal properties of traditional Chinese medicines, and is beneficial to practical application. The external medicine is adsorbed by a pharmaceutically acceptable material to obtain a breast patch. As a further preference, the dosage (weight) of the rapeseed oil is preferably 1.5 - 2.0 times the total weight of the added traditional Chinese medicine raw materials.

[0020] In the above method for preparing the external medicine for treating breast diseases, as a preference, the particle size of the traditional Chinese medicine powder in step A is ≤ 10 μm. Making the micronized traditional Chinese medicine powder reach the micron level is more conducive to the leaching of effective active ingredients when it is soaked in rapeseed oil. Through the combined action of the active ingredients in the medicinal liquid, it can better inhibit breast hyperplasia, anti-inflammatory, dissipate stasis, and promote blood circulation, achieving the effect of multi-target treatment of breast diseases. As a further preference, the particle size of the traditional Chinese medicine powder is 2 μm - 5 μm.

[0021] In the above method for preparing the external medicine for treating breast diseases, as a preference, the soaking time in step B is 25 days - 40 days. It can more fully leach the active ingredients in each traditional Chinese medicine and better ensure the therapeutic effect of the medicinal liquid on breast diseases. As an even further preference, the soaking is carried out at a temperature of 25°C - 30°C.

[0022] In summary, compared with the prior art, the present invention has the following advantages:

[0023] 1. By synergistically using Momordica cochinchinensis, Taraxacum mongolicum, and Isatis indigotica, it can not only eliminate pathological nodules (eliminate breast nodules), but also clear the pathogenic factors of heat toxin, with the effect of synergistically dissipating nodules and detoxifying. Through the combination of Taraxacum mongolicum, Isatis indigotica, Citrus reticulatae nucula, and Tribulus terrestris, it can form the effects of clearing toxins - dissipating nodules - dredging collaterals, with a three - in - one multi - target therapeutic effect, achieving better effects of dissipating nodules, inhibiting breast hyperplasia, anti - inflammation, and promoting blood circulation. And Citrus reticulatae nucula and Tribulus terrestris can regulate qi stagnation and blood stasis in the liver meridian, improve hormone disorders and microcirculation disorders related to breast hyperplasia, and further achieve the effects of promoting blood circulation and inhibiting breast hyperplasia.

[0024] 2. Momordica cochinchinensis synergistically with Taraxacum mongolicum can effectively inhibit common pathogens of mastitis such as Staphylococcus aureus and Escherichia coli. And by adding Isatis indigotica to assist Taraxacum mongolicum and Momordica cochinchinensis, it can better clear the deep - seated heat toxin in the breast, prevent the spread of inflammation, neutralize bacterial endotoxins, block the vicious cycle of "redness - exudation - necrosis" of mastitis, enhance the anti - infection ability, and effectively achieve the anti - inflammatory effect.

[0025] 3. After micronization treatment in the present invention, the Chinese herbal medicine powder reaches the micron level, which is more conducive to the leaching of active ingredients when soaking in rapeseed oil, enabling the active ingredients in the medicinal liquid to act together, and better inhibiting breast hyperplasia, anti - inflammation, dissipating nodules, and promoting blood circulation. Detailed implementation mode

[0026] The following are specific examples to further specifically illustrate the technical solutions of the present invention, but the present invention is not limited to these examples.

[0027] Example 1

[0028] The external medicine for treating breast diseases is mainly made from raw materials with the following weights:

[0029] Momordica cochinchinensis: 15 g; Citrus reticulatae nucula: 30 g; Isatis indigotica: 30 g; Borneol: 3 g; Mentha haplocalyx: 30 g; Taraxacum mongolicum: 50 g; Tribulus terrestris: 20 g; Rapeseed oil: 267 g.

[0030] The preparation method of the above - mentioned external medicine for treating breast diseases is as follows:

[0031] Ultra - fine pulverization: Weigh according to the raw materials of the above - mentioned Chinese herbal medicines. Mix Momordica cochinchinensis, Citrus reticulatae nucula, Isatis indigotica, Taraxacum mongolicum, Mentha haplocalyx, and Tribulus terrestris respectively, and use a jet mill to pulverize them to obtain Chinese herbal medicine powders respectively, so that the particle size of the Chinese herbal medicine powders ≤ 10 μm;

[0032] Final mixing and packaging: Then add 3 g of borneol powder of the above weight to the traditional Chinese medicine powder, and use a V-type mixer to mix for 30 minutes until evenly mixed; then add 267 g of rapeseed oil and soak at room temperature (25 °C) so that the rapeseed oil covers the traditional Chinese medicine powder, and carry out the soaking treatment for 30 days to obtain the required external medicine. It can be directly used for application; or when in use, apply the external medicine to the adsorption layer of a sterile dressing to make a breast patch for direct application.

[0033] Example 2

[0034] The external medicine for treating breast diseases is mainly made from the following raw materials in parts by weight:

[0035] Momordica cochinchinensis: 13 g; Citrus reticulata nucifera: 25 g; Isatis indigotica: 26 g; Borneol: 4 g; Mentha haplocalyx: 26 g; Taraxacum mongolicum: 45 g; Tribulus terrestris: 18 g; Excipient: 280 g of rapeseed oil.

[0036] The specific production method of the above external medicine for treating breast diseases is the same as that of Example 1 and will not be elaborated here.

[0037] Example 3

[0038] The external medicine for treating breast diseases is mainly made from the following raw materials in parts by weight:

[0039] Momordica cochinchinensis: 18 g; Citrus reticulata nucifera: 35 g; Isatis indigotica: 32 g; Borneol: 5 g; Mentha haplocalyx: 32 g; Taraxacum mongolicum: 53 g; Tribulus terrestris: 24 g; Excipient: 275 g of rapeseed oil.

[0040] The specific production method of the above external medicine for treating breast diseases is the same as that of Example 1 and will not be elaborated here.

[0041] Example 4

[0042] The external medicine for treating breast diseases is mainly made from the following raw materials in parts by weight:

[0043] Momordica cochinchinensis: 18 g; Citrus reticulata nucifera: 35 g; Isatis indigotica: 32 g; Borneol: 5 g; Mentha haplocalyx: 32 g; Taraxacum mongolicum: 53 g; Tribulus terrestris: 24 g; Excipient: 270 g of rapeseed oil.

[0044] The specific production method of the above external medicine for treating breast diseases is the same as that of Example 1 and will not be elaborated here.

[0045] Example 5

[0046] The external medicine for treating breast diseases is mainly made from the following raw materials in parts by weight:

[0047] Momordica cochinchinensis: 15 g; Orange seeds: 27 g; Isatis root: 30 g; Borneol: 5 g; Mint: 28 g; Dandelion: 45 g; Tribulus terrestris: 22.5 g; Excipient: Appropriate amount of rapeseed oil.

[0048] The specific preparation method of the above external medicine for treating breast diseases is the same as that in Example 1 and will not be repeated here.

[0049] Example 6

[0050] The external medicine for treating breast diseases is mainly prepared from the following raw materials in parts by weight:

[0051] Momordica cochinchinensis: 15 g; Orange seeds: 30 g; Isatis root: 31.5 g; Borneol: 4 g; Mint: 28 g; Dandelion: 48 g; Tribulus terrestris: 21 g; Excipient: 270 g of rapeseed oil.

[0052] The specific preparation method of the above external medicine for treating breast diseases is the same as that in Example 1 and will not be repeated here.

[0053] Example 7

[0054] The external medicine for treating breast diseases is mainly prepared from the following raw materials in weight:

[0055] Momordica cochinchinensis: 15 g; Orange seeds: 30 g; Honeysuckle: 28 g; Borneol: 3 g; Forsythia: 30 g; Dandelion: 50 g; Tribulus terrestris: 24 g; Rapeseed oil: 267 g.

[0056] The specific preparation method of the above external medicine for treating breast diseases is the same as that in Example 1 and will not be repeated here.

[0057] Randomly select the external medicine obtained in the above corresponding examples or make breast patches when in use. When in use, apply the external medicine (paste) or breast patch on the affected area and apply it for 2 hours every day.

[0058] In order to better verify the therapeutic effect of the external medicine or breast patch of the present invention, 50 cases of acute mastitis (initial stage) during lactation were selected.

[0059] Main symptoms: Obvious swelling and redness appear on the affected breast, the skin temperature rises, there is severe pain when touching, accompanied by hard lumps (milk accumulation or inflammation area); the discharge of milk is abnormal, and some patients have blocked milk ducts.

[0060] External application plan:

[0061] 1. After cleaning the patient's breast and avoiding the nipple, select the external medicine obtained in Example 1 and apply it externally on the affected area of the breast, fix the dressing, and change the dressing 2 times a day.

[0062] Effect: 40 cases were markedly effective, 6 cases were effective, and the total effective rate was 92%.

[0063] 2. After 24 hours of medication: The pain is relieved and the area of local swelling and redness is reduced.

[0064] 3. After 48 hours of medication: The body temperature returns to normal, the induration softens, and the milk flow is unobstructed;

[0065] 4. After 7 days of medication: The symptoms are completely relieved.

[0066] 100 patients with breast hyperplastic nodules of BI-RADS category 3 were selected. The main symptoms were diffuse pain in both breasts, and there was also pain limited to the nodule area; it was aggravated before menstruation and relieved after menstruation; a mass could be felt, with a medium hardness texture, relatively clear boundaries, and good mobility (no adhesion); there was a sense of tightness in the breast discomfort.

[0067] External application plan:

[0068] 1. After cleaning the corresponding affected area of the patient, select the external medicine obtained in Example 1 and apply it externally on the corresponding body surface position of the breast nodule once a day for 6 hours each time. If there is an allergic reaction to the application, apply it for 2 hours.

[0069] Effect: 80 cases were markedly effective, 15 cases were effective, and the total effective rate was 95%.

[0070] 2. In the first menstrual cycle of medication: The distending pain was reduced by 50%.

[0071] 3. After 2 consecutive months of medication: The B-ultrasound reexamination showed that the nodules shrank and the pain basically disappeared.

[0072] 50 patients with chronic breast hyperplasia were selected. The main symptoms were persistent dull pain or stabbing pain in both breasts, which could radiate to the armpit or the shoulder and back; there were breast masses that could be felt as granular, cord-like or sheet-like thickened glands, with unclear boundaries and a tough texture. There was no adhesion to the skin and deep tissues, and it could be pushed and moved; there was a history of obvious distension and tightness in the breasts before menstruation.

[0073] External application plan:

[0074] 1. After cleaning the corresponding affected area of the patient, select the external medicine obtained in Example 1 and apply it externally on the affected area for 2 hours of application each day.

[0075] Effect: 35 cases were markedly effective, 5 cases were effective, and the total effective rate was 80%.

[0076] 2. After 2 weeks of medication: The sense of tightness in the breasts was reduced, the hard distension was reduced, and the softness felt increased. The tenderness was relieved.

[0077] 3. After 2 months of medication: The hard lump softened, the range shrank, and the pain frequency decreased.

[0078] 100 patients with breast hyperplastic nodules classified as BI-RADS 3 were selected. The main symptoms were: diffuse pain in both breasts, and pain limited to the nodule area; the pain was aggravated before menstruation and relieved after menstruation; a mass could be palpated, with medium hardness, relatively clear boundaries, and good mobility (no adhesion); there was a sense of tightness in the breasts.

[0079] External application plan:

[0080] 1. After cleaning the corresponding affected area of the patient, select the external medicine obtained in Example 1 and apply the dressing on the corresponding body surface position of the breast nodule once a day for 6 hours each time. For those with dressing allergies, apply for 2 hours.

[0081] Effect: 80 cases showed marked effect, 15 cases were effective, and the total effective rate was 95%.

[0082] 2. In the first menstrual cycle of taking the medicine: the distending pain was reduced by 50%.

[0083] 3. After 2 consecutive months of taking the medicine: B-ultrasound reexamination showed that the nodules shrank and the pain basically disappeared.

[0084] 50 patients with chronic breast hyperplasia were selected. The main symptoms were: persistent dull pain or stabbing pain in both breasts, which could radiate to the armpit or shoulder and back. There were breast masses that could be felt as granular, cord-like or sheet-like thickened glands, with unclear boundaries and tough texture. There was no adhesion to the skin and deep tissues, and it could be moved when pushed. There was a history of obvious distension and tightness in the breasts before menstruation.

[0085] External application plan:

[0086] 1. After cleaning the corresponding affected area of the patient, select the external medicine obtained in Example 1 and apply the dressing on the affected area for 2 hours each day.

[0087] Effect: 35 cases showed marked effect, 5 cases were effective, and the total effective rate was 80%.

[0088] 2. After 2 weeks of taking the medicine: the sense of tightness in the breasts was reduced, the hard distension was reduced, and the softness when touched increased. The tenderness was relieved.

[0089] 3. After 2 months of taking the medicine: the hard mass became soft, the range shrank, and the pain frequency decreased.

[0090] 50 patients with breast hyperplastic nodules classified as BI-RADS 3 were selected. The main symptoms were: diffuse pain in both breasts, and pain limited to the nodule area; the pain was aggravated before menstruation and relieved after menstruation; a mass could be palpated, with medium hardness, relatively clear boundaries, and good mobility.

[0091] External application plan:

[0092] 1. After cleaning the corresponding affected area of the patient, select the external medicine obtained in Example 3 and apply it externally on the corresponding body surface position of the breast nodule, once a day for 6 hours each time; for those with allergic reactions to the application, apply it for 2 hours.

[0093] Effect: 38 cases showed marked effect, 9 cases showed effective, and the total effective rate was 94%.

[0094] 2. In the first menstrual cycle of taking the medicine: the distending pain was reduced by 50%.

[0095] 3. After continuously taking the medicine for 2 months: the B-ultrasound reexamination showed that the nodules shrank and the pain basically disappeared.

[0096] Similarly, randomly select the external medicine obtained in Examples 2-7 or use the breast patch to treat the patient during use, and all can reach a comparable level, and can achieve excellent therapeutic effects in the treatment of mammary gland hyperplasia, breast nodules and anti-inflammation.

[0097] The specific embodiments described in the present invention are only illustrative of the spirit of the present invention. Those skilled in the art of the present invention can make various modifications or supplements to the described specific embodiments or use similar ways to replace them, but will not deviate from the spirit of the present invention or exceed the scope defined by the appended claims.

[0098] Although a detailed description of the present invention has been made and some specific embodiments have been cited, it is obvious that various changes or modifications can be made by those skilled in the art without departing from the spirit and scope of the present invention.

Claims

1. An external medicament for treating breast diseases, characterized in that, The external medicament is mainly prepared from the following raw materials in parts by weight: Momordica cochinchinensis: 13 - 18; Orange seeds: 25 - 35; Isatis root: 24 - 32; Mint: 26 - 32; Dandelion: 45 - 53; Tribulus terrestris: 18 - 24; Borneol: 1 - 5; Excipient: Rapeseed oil.

2. The external medicine for treating breast diseases according to claim 1, characterized in that, The weight ratio of Momordica cochinchinensis, dandelion and Isatis root is 1.0: 3.0 - 3.3: 2.0 - 2.

1.

3. The external medicine for treating breast diseases according to claim 1, characterized in that, The weight ratio of Momordica cochinchinensis: Orange seeds: Tribulus terrestris is 1: 1.8 - 2.2: 1.2 - 1.

5.

4. The external medicament for treating breast diseases according to claim 1 or 2 or 3, characterized in that, The total weight of mint and borneol is 32 - 36.

5. The external medicine for treating breast diseases according to claim 1 or 2 or 3, characterized in that, The Isatis root is replaced with honeysuckle; The Tribulus terrestris is replaced with Vaccaria segetalis.

6. The external medicament for treating breast diseases according to claim 1 or 2 or 3, characterized in that, The external medicament is adsorbed with pharmaceutically acceptable materials to make a breast patch.

7. A method for preparing an external medicament for treating breast diseases, characterized in that, The method comprises the following steps: A. Weigh the following raw materials in parts by weight and carry out micronization treatment to process them into traditional Chinese medicine powder: Momordica cochinchinensis: 13 - 18; Orange seeds: 25 - 35; Isatis root: 26 - 32; Mint: 26 - 32; Dandelion: 45 - 53; Tribulus terrestris: 18 - 24; B. Then mix 1 - 5 parts by weight of borneol with the traditional Chinese medicine powder, and add it to rapeseed oil for soaking. After the soaking is completed, the required external medicament is obtained.

8. The method for preparing the external medicament for treating breast diseases according to claim 7, characterized in that, In step A, the particle size of the traditional Chinese medicine powder ≤ 10 μm.

9. The method for preparing the external medicine for treating breast diseases according to claim 8, wherein, The particle size of the traditional Chinese medicine powder is 2 μm - 5 μm.

10. The method for preparing an external medicament for treating breast diseases according to claim 7 or 8 or 9, characterized in that, In step B, the soaking time is 25 days - 40 days.