A traditional Chinese medicine compound for treating acne-causing mastitis, and its preparation method and application

Abstract

The present invention belongs to the technical field of research, development and utilization of traditional Chinese medicine, and relates to a traditional Chinese medicine compound for treating acne-causing mastitis, a preparation method and application thereof, which comprises the following raw materials in parts by weight: 10-15 parts of bupleurum, 15-25 parts of thunbergii, 25-35 parts of salvia miltiorrhiza, 5-10 parts of red peony root, 25-35 parts of millettia reticulata, 5-10 parts of dried tangerine peel, 25-35 parts of dandelion, 15-20 parts of selfheal, 10- 15 parts, 5-10 parts of roasted liquorice root, 5-10 parts of chuanxiong, 5-10 parts of angelica, 25-35 parts of white peony root, 15-25 parts of honeysuckle, 5-10 parts of angelica dahurica, 25-35 parts of astragalus, 5-10 parts of platycodon, 5-10 parts of licorice root, 10-20 parts of codonopsis pilosula, 10-20 parts of poria, 10-15 parts of atractylodes macrocephala, 15-20 parts of knotweed, 25-35 parts of raw hawthorn, and 15-20 parts of oldenlandia diffusa. It has good clinical efficacy in treating comedonal mastitis.

Description

Technical Field

[0001] The invention belongs to the technical field of research, development and utilization of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine compound for treating comedonal mastitis, and a preparation method and application thereof. Background Art

[0002] Comedonal mastitis (first described in the 1985 edition of Practical Traditional Chinese Medicine Surgery, edited by Gu Bohua) is a benign, chronic, suppurative disease of the breast, most common in non-lactating and non-pregnant women, and occasionally in men. In the early stages, intermittent, spontaneous nipple discharge is common, followed by a rapidly developing breast lump that may become red, swollen, hot, and painful, and rapidly enlarge. It then suppurates and ruptures, often forming a fistula connecting to the nipple orifice. The pus contains comedone-like material. The course of the disease is protracted, with recurrent episodes that can last for months or even years. This disease is equivalent to granulomatous mastitis and plasma cell mastitis in Western medicine. Granulomatous mastitis centers on the mammary lobules, with infiltration of macrophages and neutrophils. Histological sections often demonstrate non-caseating granulomatous inflammation and lobular necrosis. Plasma cell mastitis is characterized by ductal dilatation, periductal inflammation, accumulation of lipid secretions within the ducts, and plasma cell infiltration of the surrounding tissues.

[0003] Patients with comedonal mastitis often experience inverted or deformed nipples. Combined with emotional distress, trauma, or dietary irritation, this can lead to stagnant Qi and blood, which can then form lumps. This stagnation can then transform into heat, which in turn leads to rotting flesh and pus, which can then ulcerate and form fistulas. Modern medicine believes that breast trauma, inverted nipples, or immune dysfunction can lead to the accumulation of desquamated epithelial cells and lipid secretions within the mammary ducts, causing ductal dilatation. These aggregates then decompose to produce chemicals that irritate the duct walls, triggering inflammatory cell infiltration. As the lesion expands, a lump forms, and the pus contains lipid-like substances.

[0004] In recent years, the number of patients with comedonal mastitis has been increasing annually both domestically and internationally due to increasing stress, accelerated lifestyles, and increased risk factors such as smoking, alcohol consumption, and obesity. Western medicine often advocates for treatment with hormone therapy, antibiotics, anti-tuberculosis therapy, or surgical resection. Due to the rapid onset of the disease and the large lesions, which can sometimes affect the entire breast, antibiotics and other treatments are lingering, ineffective, and have numerous adverse reactions. Most patients currently resort to surgical resection, but this surgery can easily cause breast deformation. In severe cases, mastectomy may even be necessary, involving the removal of the entire breast tissue. This can severely impact women's self-esteem and affect their psychological and physical health, making it difficult for most patients to accept. Traditional Chinese medicine, however, can help alleviate pain during treatment and preserve breast tissue to the greatest extent possible. While reducing inflammation and swelling, it can also maintain breast appearance, protect the breast, minimize trauma, and reduce damage to breast tissue, thus avoiding the harmful effects of surgery.

[0005] The prior art discloses a traditional Chinese medicine preparation for treating comedonal mastitis, comprising 1-3 parts by weight of coptis chinensis, 1-5 parts by weight of citronella seeds, 1-5 parts by weight of stir-fried gardenia, and 1-10 parts by weight of scutellaria baicalensis as main ingredients, along with pharmaceutical excipients. However, the preparation method of this traditional Chinese medicine preparation is relatively complex, making it difficult to meet the treatment needs of comedonal mastitis. Summary of the Invention

[0006] The purpose of the present invention is to provide a traditional Chinese medicine compound for treating comedonal mastitis, a preparation method and application thereof, so as to solve the problems that Western medicine is difficult to cure and surgery affects the appearance and the physiology and psychology of the patient, and the compound has good clinical efficacy and a high cure rate.

[0007] In order to achieve the above object, the technical solution of the present invention is:

[0008] In a first aspect, the present invention provides a traditional Chinese medicine compound for treating comedonal mastitis, comprising the following raw materials in parts by weight:

[0009] 10-15 parts of bupleurum, 15-25 parts of thunbergii bulbs, 25-35 parts of salvia miltiorrhiza, 5-10 parts of red peony root, 25-35 parts of millettia spatholobi, 5-10 parts of dried tangerine peel, 25-35 parts of dandelion, 15-20 parts of selfheal, 10-15 parts of cat's claw, 5-10 parts of preparatory liquorice, 5-10 parts of chuanxiong, 5-10 parts of angelica, 25-35 parts of white peony root, 15-25 parts of honeysuckle, 5-10 parts of angelica dahurica, 25-35 parts of astragalus, 5-10 parts of platycodon, 5-10 parts of honeysuckle spines, 10-20 parts of codonopsis pilosula, 10-20 parts of poria, 10-15 parts of atractylodes macrocephala, 15-20 parts of knotweed, 25-35 parts of raw hawthorn, and 15-20 parts of oldenlandia diffusa.

[0010] In some other embodiments, the following raw materials are included in parts by weight:

[0011] 10-12 parts of bupleurum, 15-20 parts of thunbergii bulbs, 25-30 parts of salvia miltiorrhiza, 8-10 parts of red peony root, 25-30 parts of millettia spatholobi, 8-10 parts of dried tangerine peel, 25-30 parts of dandelion, 18-20 parts of selfheal, 10-13 parts of cat's claw, 5-8 parts of preparatory liquorice, 8-10 parts of chuanxiong, 8-10 parts of angelica, 25-30 parts of white peony root, 15-20 parts of honeysuckle, 8-10 parts of angelica dahurica, 25-30 parts of astragalus, 8-10 parts of platycodon, 8-10 parts of honeysuckle spines, 10-16 parts of codonopsis pilosula, 10-16 parts of poria, 10-14 parts of atractylodes macrocephala, 16-18 parts of polygonum cuspidatum, 25-30 parts of raw hawthorn, and 15-18 parts of oldenlandia diffusa.

[0012] In some other embodiments, the following raw materials are included in parts by weight:

[0013] 12 parts of bupleurum, 20 parts of fritillaria thunbergii, 30 parts of salvia miltiorrhiza, 9 parts of red peony root, 30 parts of millettia spatholobi, 9 parts of dried tangerine peel, 30 parts of dandelion, 18 parts of selfheal, 12 parts of cat's claw, 6 parts of preparatory liquorice, 9 parts of ligusticum, 9 parts of angelica, 9 parts of angelica, 30 parts of white peony root, 20 parts of honeysuckle, 9 parts of angelica dahurica, 30 parts of astragalus, 9 parts of platycodon, 9 parts of gleditsia spinosa, 15 parts of codonopsis pilosula, 15 parts of poria, 12 parts of atractylodes macrocephala, 18 parts of polygonum cuspidatum, 30 parts of raw hawthorn, and 18 parts of oldenlandia diffusa.

[0014] In some other embodiments, the Chinese herbal compound for treating comedonal mastitis is in the form of tablets, decoctions, and granules.

[0015] Although the disease has an acute onset, it progresses slowly. Traditional Chinese Medicine believes that the disease is closely related to the liver, spleen, and stomach. The pathogenesis can be summarized as being mostly caused by emotional depression or excessive worry. Anger damages the liver, worry damages the spleen, "Qi moves and water moves too", "the spleen and earth are weak, the clear is difficult to rise, the turbid is difficult to descend, and it stays in the middle and stagnates in the diaphragm, and becomes stagnant and turns into phlegm". Therefore, damage to the liver and spleen leads to abnormal water transportation and transformation, and the internal generation of dampness and turbidity gathers into phlegm. In addition, Qi stagnates and blood stasis occurs, and the milk meridians are blocked. The stagnant Qi and phlegm coagulate and the blood stasis forms lumps over time, which turn into fire over time. The heat causes the flesh to rot and turn into pus. In addition, patients with weak constitutions or those in the late stages of the disease have weak vital energy due to the long course of the disease, which is equivalent to low immune function in modern medicine. At this time, the discharge of pus and recovery of the condition require the help of drugs to help the pus out.

[0016] In view of this, the present invention is based on the understanding of the etiology and pathogenesis of comedonal mastitis by various schools of traditional Chinese medicine and proposes a traditional Chinese medicine compound for treating the disease from a holistic perspective. In the present invention, bupleurum root, astragalus root, and codonopsis root are used as the main ingredients. Bupleurum root can relieve liver qi and depression, open the breast orifices, and clear away heat and reduce fever. Astragalus root and codonopsis root have the effects of replenishing qi and strengthening the body, and can be used to regulate physical constitution and enhance the body's immunity. They can also strengthen the spleen to promote water metabolism. Astragalus root is a traditional Chinese medicine for treating mastitis. The three herbs in the formula are all the main ingredients, and they work together to soothe the liver and strengthen the spleen.

[0017] Hawthorn, red peony root, salvia miltiorrhiza, Spatholobus suberectus, honeysuckle, dandelion, honeysuckle thorn, Hedyotis diffusa, cat's claw, and Angelica dahurica serve as assistant herbs. Hawthorn clears turbidity and lowers lipids while also assisting the main herbs in strengthening the spleen. Red peony root, salvia miltiorrhiza, and Spatholobus suberectus promote blood circulation and resolve blood stasis, thus reducing swelling. Red peony root and white peony root both enter the liver meridian, cooling blood and clearing the liver. Honeysuckle, dandelion, and Hedyotis diffusa clear heat and detoxify, while dandelion, honeysuckle thorn, and Angelica dahurica together reduce swelling and discharge pus. Cat's claw and Fritillaria thunbergii resolve phlegm and resolve stagnation.

[0018] Angelica sinensis, Chuanxiong rhizome, white peony root, white atractylodes macrocephala, Poria cocos, dried tangerine peel, knotweed, and prunella vulgaris serve as adjuvants. Tangerine peel regulates qi and strengthens the spleen, effectively relieving qi stagnation in the spleen. Bupleurum chinense is effective in promoting qi stagnation in the liver. Chuanxiong rhizome, a "blood qi medicine," can circulate qi throughout the body. The combination of these three herbs can promote qi circulation and relieve qi stagnation. "When qi flows, blood flows." Qi is yang, and blood is yin. Only when qi and blood are in harmony, and yin and yang are balanced, can blood circulate normally. Lumps dissipate when qi and blood flow smoothly. Combined with the blood-activating herbs in the auxiliary herbs, they can achieve the effect of harmonizing qi and blood. Knotweed and prunella vulgaris assist Bupleurum chinense in clearing liver fire. Knotweed can also resolve phlegm and disperse blood stasis, while prunella vulgaris can also disperse nodules and reduce swelling. They simultaneously assist in treating excessive warming and tonic effects of the main and auxiliary herbs, achieving a tonic with a dissolving effect.

[0019] Atractylodes macrocephala and Poria cocos strengthen the spleen and replenish Qi, enhancing the spleen and stomach's transport and transformation functions. Together with the main and auxiliary herbs, they support the production of Qi and blood. Angelica sinensis and white peony root nourish the blood and activate blood circulation. Platycodon grandiflorum and licorice are guiding herbs. Platycodon grandiflorum is light in texture, bitter in taste, and neutral in nature, known as the "boat and navigator," carrying the medicinal properties of other herbs upward. Platycodon grandiflorum can also dissipate phlegm and pus, while licorice harmonizes the various herbs in this prescription and tonifies the spleen and replenishes Qi. Together, these herbs clear heat and detoxify, activate blood circulation and remove blood stasis, reduce swelling and resolve stagnation, and support vital Qi. Modern pharmacological research and analysis have shown that the multiple Chinese herbs in this prescription have the ability to suppress inflammation, contributing to its anti-inflammatory and anti-infective properties.

[0020] About some single herbs:

[0021] Astragalus membranaceus, with a slightly warm nature and sweet flavor, enters the lung and spleen meridians. It has the effects of tonifying qi and raising yang, strengthening the defense system and strengthening the exterior, expelling toxins and draining pus, astringing sores and promoting tissue regeneration, and relieving stagnation and numbness. In this prescription, Angelica dahurica and Gleditsia chinensis leverage the benefits of Astragalus membranaceus to tonify qi and raise yang, expelling toxins and draining pus, enhancing its pus-draining properties and preventing qi deficiency and pathogenic factors from entrapping it. The Shennong's Herbal Classic mentions Astragalus membranaceus as "effective for treating carbuncles, chronic sores, draining pus, and relieving pain." Modern research indicates that Astragalus membranaceus contains numerous active ingredients that can inhibit the release of inflammatory factors. Astragalus membranaceus, an inflammatory disease, may be a candidate for its anti-inflammatory properties.

[0022] Bupleurum root, with a slightly cold nature and a pungent and bitter flavor, enters the liver, gallbladder, and lung meridians, relieving liver qi stagnation, dispersing heat, and reducing fever. The Compendium of Materia Medica mentions that bupleurum root can "calm the liver, gallbladder, triple burner, and envelope fire," soothing the liver and promoting bile secretion, clearing heat in these two meridians. Modern pharmacological research has shown that many of its chemical components have both anti-inflammatory and immune-boosting properties, and that extracted components such as saikosaponins have neuroprotective and neurotrophic properties, thereby exerting antidepressant effects.

[0023] Dandelion, with its cold nature, bitter and sweet flavors, enters the liver and stomach meridians, and has the effects of clearing heat and detoxifying, reducing swelling and dispersing stagnation, and promoting diuresis and relieving stranguria. The "New Compendium of Materia Medica" records that dandelion can "relieve swelling and eliminate tuberculosis." Dandelion contains sesquiterpenes, saponins, phenolic compounds, and flavonoids, all of which have therapeutic effects on inflammatory damage and have protective effects on the body.

[0024] Honeysuckle is cold in nature, sweet in flavor, and enters the lung, heart, and stomach meridians. It clears heat, detoxifies, and dispels wind-heat. The Jingyue Complete Works states, "It can dissipate poisons that haven't yet taken shape, and can break up established poisons." Later generations hailed it as a key herb for reducing swelling, dispelling toxins, and treating sores. Modern research has shown that honeysuckle contains compounds such as flavonoids, organic acids, triterpenoid saponins, and iridoids, all of which have significant antibacterial properties.

[0025] Salvia miltiorrhiza (Danshen) is slightly cold in nature and bitter in flavor. It enters the liver and heart meridians and has the effects of promoting blood circulation, removing blood stasis, cooling blood, eliminating carbuncles, and relieving pain. The "Compendium of Materia Medica" Mengsheng mentions that Danshen "produces new blood and removes bad blood," "breaks up accumulated masses and hard masses," and "dissipates goiters, tumors, and ulcers, draining pus and promoting flesh." Danshen's main components are water-soluble salvianolic acids and fat-soluble salvianolic ketones, which can protect the cardiovascular system and inhibit the expression of inflammatory factors.

[0026] Chuanxiong rhizome is warm in nature and pungent in flavor. It enters the liver, gallbladder, and pericardium meridians, promoting blood circulation and qi, dispelling wind and relieving pain. It primarily treats qi and blood stagnation, breaking up stagnant blood, and nourishing new blood. The "New Compendium of Materia Medica" states, "Liangxiong rhizome specializes in nourishing blood... activating the blood circulation... breaking up stagnant blood, and promoting the regeneration of postpartum blood..." Chuanxiong volatile oil is one of the active ingredients extracted from the rhizome. Z-ligustilide, ligustilide A, and neocnidione in this oil exhibit anti-inflammatory properties. Ligustrazine, a characteristic alkaloid of Chuanxiong rhizome, has anti-thrombotic and blood-clotting properties, and also has protective effects against brain and myocardial damage.

[0027] Millettia reticulata (Spatholobi cactus) is warm in nature, bitter and sweet in flavor, and enters the liver and kidney meridians. It has the effects of promoting blood circulation, tonifying blood, regulating menstruation and relieving pain, and relaxing tendons and collaterals. The "Supplement to Compendium of Materia Medica" records that Millettia reticulata can "cures a myriad of ailments, produces blood, harmonizes blood, tonifies blood,... and promotes the flow of tendons and collaterals." Pharmacological studies have shown that the active ingredients in Millettia reticulata are primarily small and medium-polar compounds, primarily flavonoids, which have been shown to improve hematopoiesis, and have anti-thrombotic and anti-inflammatory effects.

[0028] Fritillaria thunbergii, with its cold nature and bitter flavor, enters the lung and heart meridians, detoxifying, dispersing stagnation, and eliminating carbuncles, clearing heat, resolving phlegm, and relieving cough. The "Compendium of Materia Medica" states that it "is very effective in reducing phlegm and qi, relieving depression, and relieving pain... It kills all kinds of insects and treats throat paralysis, scrofula, breast abscesses, back abscesses, and all other carbuncle and swelling conditions." Studies have found that the fritillaryin extracted from Fritillaria thunbergii can inhibit inflammatory responses and alleviate tissue pathological damage through extracellular signaling, regulating the P13K / AKT pathway and the kinase (ERK1 / 2) pathway, achieving anti-inflammatory effects.

[0029] Cat's Claw, a herb with a warm nature and a pungent and sweet flavor, enters the liver and lung meridians and possesses potent detoxifying, swelling-reducing, phlegm-resolving, and stagnation-dispersing properties. Discovered in the 1950s in Xinyang, Henan Province, it is known for its stagnation-dispersing properties. It contains polysaccharides, organic acids, and flavonoids, which have been shown to have hepatoprotective, anti-inflammatory, and antibacterial properties.

[0030] Raw hawthorn is slightly warm in nature, sour and sweet in taste, and enters the spleen, stomach, and liver meridians, with the effects of clearing turbidity and reducing lipids. This disease is caused by the accumulation of large amounts of lipid substances in the mammary ducts, which stimulates the infiltration of inflammatory cells. Hawthorn's ability to clear turbidity and reduce lipids can be used to remove residual lipid substances in the ducts. Furthermore, the Compendium of Materia Medica states that hawthorn can "remove stagnant blood and treat sores," promoting the healing of ulcers. Modern studies have also shown that large doses of hawthorn can achieve the effect of promoting lactation. Pharmacological studies have shown that hawthorn total flavonoids, as one of the hawthorn extracts, can promote lipid metabolism while reducing fatty acid synthesis.

[0031] In a second aspect, the present invention provides a method for preparing a traditional Chinese medicine compound for treating comedonal mastitis, comprising the following steps:

[0032] (1) mixing the raw materials in the Chinese herbal compound for treating comedonal mastitis described in the first aspect, soaking the mixture in water, boiling the mixture for the first time, and filtering the mixture to obtain a first decoction and medicinal residues;

[0033] (2) After adding water to the medicinal residue, decoct it for the second time, filter it, and obtain the second decoction. Combine the two decoctions to obtain the final product.

[0034] In some other embodiments, in step (1), the amount of water added is 3-5 times the total weight of the raw materials;

[0035] The soaking time is 30-60min;

[0036] The first decoction is to boil the mixture, then control the temperature to 80-90° C. and decoct for 30-45 minutes.

[0037] In some other embodiments, in step (2), the amount of water added is 3-5 times the total weight of the medicinal residue;

[0038] The second decoction is to boil the mixture, then control the temperature to 80-90° C. and decoct for 20-45 minutes.

[0039] In a third aspect, the present invention provides use of the traditional Chinese medicine compound for treating comedonal mastitis according to the first aspect in preparing a medicament for treating comedonal mastitis.

[0040] In some other embodiments, the comedonal mastitis is an acute or chronic inflammation of the breast during the non-lactation or non-pregnancy period, characterized by non-cyclical mastalgia, nipple discharge, areola or breast lumps, fistulas, and breast abscesses.

[0041] In some other embodiments, the comedonal mastitis includes granulomatous mastitis and plasma cell mastitis.

[0042] Beneficial effects of the present invention:

[0043] (1) The present invention provides an effective Chinese herbal compound for the clinical treatment of acne-causing mastitis. Guided by the holistic concept, it achieves the effects of promoting blood circulation, removing blood stasis, reducing swelling and dispersing nodules, while not forgetting to strengthen the body's resistance, regulate the body constitution, and enhance the body's resistance. While clearing away heat and detoxifying, it also takes into account the protection of the spleen and stomach in the middle jiao, and takes into account the three major principles of Chinese medicine surgery for treating diseases: "eliminating, supporting, and replenishing".

[0044] (2) The Chinese herbs in this prescription, such as Chuanxiong, Millettia reticulata, and Danshen, have analgesic effects and can help patients relieve pain during treatment and improve their quality of life. Furthermore, most breasts treated with this prescription are non-traumatic, with minimal changes in breast texture and morphology, thus avoiding the drawbacks of surgery and the adverse reactions of antibiotics and other treatments, resulting in higher patient acceptance. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The accompanying drawings, which constitute a part of the present invention, are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute improper limitations on the present invention.

[0046] Figure 1 The figures are before and after treatment of one of the 14 cases of comedonal mastitis in the clinical trial of the present invention, wherein A is the breast effect picture of the comedonal mastitis before treatment, B is the breast effect picture of the comedonal mastitis 3 months after treatment, and C is the breast effect picture of the comedonal mastitis after complete cure;

[0047] Figure 2 for Figure 1 The corresponding ultrasound renderings of the breast before and after treatment of comedonal mastitis, where A is the ultrasound rendering of the breast before treatment, B is the ultrasound rendering of the breast 3 months after treatment, and C is the ultrasound rendering of the breast after complete cure. DETAILED DESCRIPTION

[0048] Those skilled in the art will appreciate that the following examples are intended to illustrate the present invention only and should not be construed as limiting the scope of the invention. Unless otherwise specified, the examples were performed under conventional conditions or manufacturer's recommended conditions. Components used without manufacturer's indication are commercially available conventional products.

[0049] Example 1

[0050] A traditional Chinese medicine compound for treating comedonal mastitis, comprising the following raw materials in parts by weight:

[0051] 12 parts of bupleurum, 20 parts of fritillaria thunbergii, 30 parts of salvia miltiorrhiza, 9 parts of red peony root, 30 parts of millettia spatholobi, 9 parts of dried tangerine peel, 30 parts of dandelion, 18 parts of selfheal, 12 parts of cat's claw, 6 parts of preparatory liquorice, 9 parts of ligusticum, 9 parts of angelica, 9 parts of angelica, 30 parts of white peony root, 20 parts of honeysuckle, 9 parts of angelica dahurica, 30 parts of astragalus, 9 parts of platycodon, 9 parts of gleditsia spinosa, 15 parts of codonopsis pilosula, 15 parts of poria, 12 parts of atractylodes macrocephala, 18 parts of polygonum cuspidatum, 30 parts of raw hawthorn, and 18 parts of oldenlandia diffusa.

[0052] The preparation method is as follows:

[0053] Mix the above Chinese medicines, add water (the amount of water added is 3 times the weight of the Chinese medicines), soak for 30 minutes, then boil over medium heat, simmer over low heat (80-90°C) for 30-45 minutes, and filter to obtain the first decoction and medicinal residue; add water (the amount of water added is 3 times the weight of the medicinal residue), boil, and continue to cook for 30-45 minutes, combine the two decoctions to obtain a total of about 400 ml.

[0054] Example 2

[0055] Different from Example 1, the Chinese medicinal compound for treating comedonal mastitis comprises the following raw materials in parts by weight:

[0056] 10 parts of Bupleurum, 15 parts of Fritillaria thunbergii, 25 parts of Salvia miltiorrhiza, 8 parts of Red Peony Root, 25 parts of Millettia Spatholobi, 8 parts of Tangerine Peel, 25 parts of Taraxacum Herba, 18 parts of Prunella Vulgaris, 10 parts of Cat's Claw, 5 parts of Preparing Licorice, 8 parts of Chuanxiong, 8 parts of Angelica Sinensis, 25 parts of White Peony Root, 15 parts of Honeysuckle, 8 parts of Angelica Dahurica, 25 parts of Astragalus, 8 parts of Platycodon, 8 parts of Gleditsia Spina, 10 parts of Codonopsis pilosula, 10 parts of Poria, 10 parts of Atractylodes macrocephala, 16 parts of Polygonum cuspidatum, 25 parts of Raw Crataegus, and 15 parts of Hedyotis diffusa.

[0057] The preparation method is the same as that in Example 1.

[0058] Example 3

[0059] Different from Example 1, the Chinese medicinal compound for treating comedonal mastitis comprises the following raw materials in parts by weight:

[0060] 15 parts of bupleurum, 25 parts of fritillaria thunbergii, 35 parts of salvia miltiorrhiza, 10 parts of red peony root, 35 parts of millettia spatholobi, 10 parts of dried tangerine peel, 35 parts of dandelion, 20 parts of selfheal, 15 parts of cat's claw, 10 parts of preparatory liquorice, 10 parts of ligusticum, 10 parts of chuanxiong, 10 parts of angelica, 35 parts of white peony root, 25 parts of honeysuckle, 10 parts of angelica dahurica, 35 parts of astragalus, 10 parts of platycodon, 10 parts of gleditsia spinosa, 20 parts of codonopsis pilosula, 20 parts of poria, 15 parts of atractylodes macrocephala, 20 parts of polygonum cuspidatum, 35 parts of raw hawthorn, and 20 parts of oldenlandia diffusa.

[0061] The preparation method is the same as that in Example 1.

[0062] Example 4

[0063] Different from Example 1, the Chinese medicinal compound for treating comedonal mastitis comprises the following raw materials in parts by weight:

[0064] 10 parts of Bupleurum, 15 parts of Fritillaria thunbergii, 25 parts of Salvia miltiorrhiza, 5 parts of Red Peony Root, 25 parts of Millettia Spatholobi, 5 parts of Tangerine Peel, 25 parts of Taraxacum Herba, 15 parts of Prunella Vulgaris, 10 parts of Cat's Claw, 5 parts of Preparing Licorice Root, 5 parts of Chuanxiong, 5 parts of Angelica Sinensis, 25 parts of White Peony Root, 15 parts of Honeysuckle, 5 parts of Angelica Dahurica, 25 parts of Astragalus, 5 parts of Platycodon, 5 parts of Gleditsia Spina, 10 parts of Codonopsis pilosula, 10 parts of Poria, 10 parts of Atractylodes macrocephala, 15 parts of Polygonum cuspidatum, 25 parts of Raw Crataegus, and 15 parts of Hedyotis diffusa.

[0065] The preparation method is the same as that in Example 1.

[0066] It should be noted that embodiment 1 is the most preferred embodiment of the present invention, which can achieve the effects of promoting blood circulation and removing blood stasis, reducing swelling and dispersing stagnation, while not forgetting to strengthen the body's resistance and replenishing deficiency, conditioning the body constitution, and enhancing the body's resistance. While clearing away heat and detoxifying, it also takes into account the spleen and stomach of the middle jiao, and takes into account the three major principles of "eliminating, supporting, and replenishing" in traditional Chinese medicine surgery for treating diseases. The Chinese medicines such as Chuanxiong, Millettia reticulata, and Salvia miltiorrhiza in this prescription have analgesic effects, can help patients alleviate the pain caused by pain during the treatment process, and improve the quality of life of patients. And after adopting this prescription for treatment, most breasts are non-traumatic, and the breast texture and morphological changes are small, avoiding the drawbacks caused by surgery, avoiding the adverse reactions of treatments such as antibiotics, and patient acceptance is higher.

[0067] The clinical effect of the Chinese medicinal compound for treating comedonal mastitis of the present invention is illustrated by clinical trial examples.

[0068] Clinical Data: Fourteen patients with comedonal mastitis, aged 29 to 47 years, admitted to the Department of Breast and Thyroid Surgery at Shandong Provincial Hospital of Traditional Chinese Medicine between June 2023 and February 2025, were selected for this study. Patients with both granulomatous and plasma cell mastitis were included. Basic clinical information is shown in Table 1.

[0069] Table 1 Clinical data

[0070]

[0071] Study subjects:

[0072] Diagnostic criteria: Refer to the "Expert Consensus on the Diagnosis and Treatment of Non-lactational Mastitis" and "Traditional Chinese Medicine Surgery". Non-lactational and non-pregnant women have lumps in the areola or breast, or symptoms such as nipple discharge and nipple retraction. Nipple lumps can subsequently form abscesses, which can form fistulas or ulcers after rupture, and discharge light yellow fluids.

[0073] Exclusion criteria:

[0074] (1) Patients with mastitis during pregnancy and lactation

[0075] (2) Patients with autoimmune diseases, breast cancer, and other breast diseases

[0076] (3) Patients who have recently received hormone therapy

[0077] (4) Those who suffer from mental illness, take psychotropic drugs, and are unable to cooperate with treatment

[0078] (5) Patients with heart, liver, and kidney dysfunction

[0079] Directions:

[0080] Divide the combined 400ml decoction into two equal portions and take it warm, once in the morning and once in the evening. It is recommended to take it about half an hour after a meal.

[0081] Results: All 14 patients were cured. The lumps disappeared, the skin color returned to normal, the related complications such as lower limb erythema disappeared, and there were no obvious abnormalities in ultrasound examination. There were no obvious adverse reactions after taking this Chinese medicine compound. The healing time is shown in Table 2.

[0082] Table 2 Healing time

[0083] Within 6 months 6-9 months 9-12 months quantity 0 4 10 Proportion 0％ 28.6％ 71.4％

[0084] Figure 1 The present invention is a clinical trial of 14 cases of breast treatment of comedonal mastitis before and after the effect diagram, wherein A is the breast effect diagram of comedonal mastitis before treatment, B is the breast effect diagram of comedonal mastitis 3 months after treatment, C is the breast effect diagram of comedonal mastitis after complete cure. Figure 2 for Figure 1 The corresponding ultrasound effect diagrams of the breast before and after treatment of comedonal mastitis, where A is the ultrasound effect diagram of the breast before treatment, B is the ultrasound effect diagram of the breast 3 months after treatment, and C is the ultrasound effect diagram of the breast after complete cure. Figure 1 or Figure 2 It can be seen that after taking this Chinese medicine compound, the therapeutic effect of acne-causing mastitis is more significant.

[0085] Typical medical cases

[0086] Typical Medical Case 1

[0087] Han, a 32-year-old female, had been weaned for two and a half years. Nine months prior, she developed redness and swelling above her left nipple due to stress and anxiety. Untreated, she developed pain two months later and received intravenous and oral cephalosporin for one month at a local hospital, with limited success. She presented to our outpatient clinic. Physical examination revealed a firm, tender, red, and slightly warm lump above her left nipple, approximately 6 x 4 cm in diameter. Ultrasound examination revealed a fluid-filled dark area above the left nipple, suggesting the possibility of an abscess.

[0088] After taking this prescription for one month, a biopsy at our outpatient clinic revealed granulomatous mastitis. A week later, an ulcer developed over the red and swollen area. Three months after the ulcer, a physical examination at our outpatient clinic revealed the ulcer had healed, the skin had a pale reddish color, and the swelling had shrunk. A palpable mass measuring approximately 3 x 2 cm was palpable. Two months after taking this prescription, no obvious lump was found, the skin color returned to normal, and ultrasound revealed a small, fluid-filled dark area. The medication was discontinued after two weeks of continued use. Follow-up has not revealed any recurrence to date.

[0089] Typical Medical Case 2

[0090] Zhang, female, 37 years old, weaned for 5 years. One year ago, due to mental stress and high pressure, a lump appeared in the left breast, the skin temperature was slightly high, and the lump was painful. She was injected with cephalosporin and levofloxacin in the local hospital, but the effect was poor. She came to our hospital for treatment one month later. Physical examination: a lump was felt above the left breast, extending to the upper outer quadrant, with a hard texture and unclear boundaries, about 8*8cm in size, red skin color, painful, and an ulcer visible at 4 o'clock.

[0091] After taking this prescription for one month, the breast lump softened. A biopsy was performed at this hospital, and the results showed granulomatous mastitis. After four months of continued medication, a physical examination revealed that the left breast lump had significantly shrunk, with a palpable mass measuring approximately 5 x 4 cm. Ultrasound revealed a patchy, viscous, dark area within the lump. After three months of continued medication, a follow-up visit to this hospital revealed that the lump had shrunk to approximately 2 x 2 cm. After two months of continued medication, no palpable lump was found. A light red scar formed at the ulcer site, while the skin color elsewhere had returned to normal. Color Doppler ultrasound revealed no significant abnormalities. Follow-up revealed no recurrence.

[0092] Typical Medical Case 3

[0093] A 38-year-old female patient, surnamed Ji, had been weaned for two years when, one year prior, she suddenly developed a firm, unprovoked lump in her right breast, reportedly covering most of her right breast. A biopsy at a local hospital revealed granulomatous mastitis. A month of cephalexin injections was ineffective, and she presented to our outpatient clinic after the lump ruptured. Physical examination revealed multiple, contiguous, and poorly defined lumps in her right breast, extending to the superior, lateral, and superior medial areas. The lump was large, red, and tender. Ultrasound examination revealed an inflammatory mass in the right breast with fluid flowing within it.

[0094] After taking this prescription for 3 months, a physical examination showed that the right breast lump was still connected, slightly soft, dark red, and warm, and about to rupture. After 2 weeks of continued treatment, the right breast ulcerated on the outer side. After rupturing, a physical examination was conducted after 2 months of continued treatment: the right breast lump had shrunk. Ultrasound showed three interconnected hypoechoic areas, and fluid flow was visible under pressure. After 3 months of continued treatment, a secondary ulcer developed on the outer side of the right breast. Physical examination showed that the right breast lump had significantly shrunk, with a 1cm*1.5cm lump palpated on the outer side and a 3cm*1cm lump palpated on the inner side. After 3 months of continued treatment, physical examination showed that no obvious lump was palpated in the right breast, the wound had healed, and ultrasound showed no obvious abnormalities. After 1 week of continued treatment, the drug was discontinued. Follow-up showed no recurrence.

[0095] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. Use of a traditional Chinese medicine compound for treating comedonal mastitis in preparing a medicine for treating comedonal mastitis, characterized in that: The comedonal mastitis is an acute or chronic inflammation of the breast during the non-lactation or non-pregnancy period, characterized by non-cyclical mastalgia, nipple discharge, areola or breast lumps, fistulas and breast abscesses. The comedonal mastitis includes granulomatous mastitis and plasma cell mastitis; The traditional Chinese medicine compound for treating acne-causing mastitis comprises the following raw materials in parts by weight: 10-15 parts of bupleurum, 15-25 parts of thunbergii bulbs, 25-35 parts of salvia miltiorrhiza, 5-10 parts of red peony root, 25-35 parts of millettia spatholobi, 5-10 parts of dried tangerine peel, 25-35 parts of dandelion, 15-20 parts of selfheal, 10-15 parts of cat's claw, 5-10 parts of pre-roasted liquorice, 5-10 parts of chuanxiong, 5-10 parts of angelica, 25-35 parts of white peony root, 15-25 parts of honeysuckle, 5-10 parts of angelica, 25-35 parts of astragalus, 5-10 parts of platycodon, 5-10 parts of honeysuckle spines, 10-20 parts of codonopsis pilosula, 10-20 parts of poria, 10-15 parts of atractylodes macrocephala, 15-20 parts of knotweed, 25-35 parts of raw hawthorn, and 15-20 parts of oldenlandia diffusa; The preparation method of the traditional Chinese medicine compound for treating comedonal mastitis comprises the following steps: (1) Mixing the raw materials of the traditional Chinese medicine compound for treating acne-causing mastitis, soaking them in water, boiling them for the first time, and filtering them to obtain the first decoction liquid and medicinal residues; (2) After adding water to the medicinal residue, decoct it for the second time and filter it to obtain the second decoction. Combine the two decoctions to obtain the final product.

2. The use according to claim 1, characterized in that The traditional Chinese medicine compound for treating acne-causing mastitis comprises the following raw materials in parts by weight: 10-12 parts of bupleurum, 15-20 parts of thunbergii bulbs, 25-30 parts of salvia miltiorrhiza, 8-10 parts of red peony root, 25-30 parts of millettia spatholobi, 8-10 parts of dried tangerine peel, 25-30 parts of dandelion, 18-20 parts of selfheal, 10-13 parts of cat's claw, 5-8 parts of preparatory liquorice, 8-10 parts of chuanxiong, 8-10 parts of angelica, 25-30 parts of white peony root, 15-20 parts of honeysuckle, 8-10 parts of angelica dahurica, 25-30 parts of astragalus, 8-10 parts of platycodon, 8-10 parts of honeysuckle spines, 10-16 parts of codonopsis pilosula, 10-16 parts of poria, 10-14 parts of atractylodes macrocephala, 16-18 parts of polygonum cuspidatum, 25-30 parts of raw hawthorn, and 15-18 parts of oldenlandia diffusa.

3. The use according to claim 1, characterized in that The traditional Chinese medicine compound for treating acne-causing mastitis comprises the following raw materials in parts by weight: 12 parts of bupleurum, 20 parts of fritillaria thunbergii, 30 parts of salvia miltiorrhiza, 9 parts of red peony root, 30 parts of millettia spatholobi, 9 parts of dried tangerine peel, 30 parts of dandelion, 18 parts of selfheal, 12 parts of cat's claw, 6 parts of preparatory liquorice, 9 parts of ligusticum, 9 parts of angelica, 9 parts of angelica, 30 parts of white peony root, 20 parts of honeysuckle, 9 parts of angelica dahurica, 30 parts of astragalus, 9 parts of platycodon, 9 parts of gleditsia spinosa, 15 parts of codonopsis pilosula, 15 parts of poria, 12 parts of atractylodes macrocephala, 18 parts of polygonum cuspidatum, 30 parts of raw hawthorn, and 18 parts of oldenlandia diffusa.

4. The use according to claim 1, characterized in that The medicament of the traditional Chinese medicine compound for treating comedonal mastitis is in the form of tablets, decoction and granules.

5. A method for preparing a traditional Chinese medicine compound for treating comedonal mastitis, characterized in that: The preparation of the Chinese medicinal compound for treating comedonal mastitis according to any one of claims 1 to 4 comprises the following steps: (1) Mixing the raw materials of the traditional Chinese medicine compound for treating acne-causing mastitis, soaking them in water, boiling them for the first time, and filtering them to obtain the first decoction liquid and medicinal residues; (2) After adding water to the medicinal residue, decoct it for the second time and filter it to obtain the second decoction. Combine the two decoctions to obtain the final product.

6. The method for preparing the Chinese medicinal compound for treating comedonal mastitis according to claim 5, wherein: In step (1), the amount of water added is 3-5 times the total weight of the raw materials; the soaking time is 30-60min; The first decoction is to boil the mixture, then control the temperature to 80-90° C. and decoct for 30-45 minutes.

7. The method for preparing the Chinese medicinal compound for treating comedonal mastitis according to claim 5, wherein: In step (2), the amount of water added is 3-5 times the total weight of the medicinal residue; The second decoction is to boil the mixture, then control the temperature to 80-90° C. and decoct for 20-45 minutes.

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