Traditional Chinese medicine compound for treating acne-type acute mastitis as well as preparation method and application of traditional Chinese medicine compound

Abstract

The invention belongs to the technical field of research, development and utilization of traditional Chinese medicines, and relates to a traditional Chinese medicine compound for treating acne-type acute mastitis as well as a preparation method and application of the traditional Chinese medicine compound. Comprising the following raw materials: 10-15 parts of radix bupleuri, 15-25 parts of bulbus fritillariae thunbergii, 25-35 parts of radix salviae miltiorrhizae, 5-10 parts of radix paeoniae rubra, 25-35 parts of caulis spatholobi, 5-10 parts of pericarpium citri reticulatae, 25-35 parts of dandelion, 15-20 parts of selfheal, 10-15 parts of radix ranunculi ternati, 5-10 parts of honey-fried licorice root, 5-10 parts of ligusticum wallichii, 5-10 parts of angelica sinensis, 25-35 parts of radix paeoniae alba, 15-25 parts of honeysuckle, 5-10 parts of radix angelicae, 25-35 parts of astragalus membranaceus, 5-10 parts of platycodon grandiflorum, 5-10 parts of spina gleditsiae, 10-20 parts of codonopsis pilosula, 10-20 parts of poria cocos and 10-15 parts of rhizoma atractylodis , 15-20 parts of polygonum cuspidatum, 25-35 parts of raw hawthorn and 15-20 parts of oldenlandia diffusa. The traditional Chinese medicine composition has a good clinical curative effect on acne-type acute mastitis.

Description

Technical Field

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

[0002] Acne mastitis (first proposed in Practical Chinese Medicine Surgery edited by Gu Bohua in 1985) is a chronic suppurative benign disease of the breast, which is more common in non-lactating and non-pregnant women, and occasionally in male breasts. In the early stage, intermittent and spontaneous nipple discharge is common, and the breast mass develops rapidly, which may appear red, swollen, hot and painful and rapidly expand, and then suppurate and rupture, often forming a fistula connected to the nipple hole, and the pus contains acne-like substances. The course of the disease is protracted and recurrent, which can last for months or even years. This disease is equivalent to granulomatous mastitis and plasma cell mastitis in Western medicine. Granulomatous mastitis takes the breast lobule as the lesion center, and macrophages and neutrophil infiltration can be seen. Histological sections often show non-caseating granulomatous inflammation and lobular necrosis. The pathological characteristics of plasma cell mastitis are mainly mammary duct dilatation, periductal inflammation, accumulation of a large amount of lipid secretions in the duct, and plasma cell infiltration in the surrounding tissue.

[0003] Patients with comedonal mastitis often have nipple depression or deformity. In addition, emotional distress or trauma, diet and other stimulations lead to blood stasis, which aggregates into lumps. Long-term depression turns into heat, and the heat causes the flesh to rot and become pus, which then ulcerates and forms fistulas. Modern medicine believes that due to factors such as breast trauma, nipple inversion or immune dysfunction, a large number of shed epithelial cells and lipid secretions accumulate in the mammary ducts, leading to duct expansion. These aggregates decompose to produce chemical substances that stimulate the duct wall and cause inflammatory cell infiltration. As the lesion expands, lumps are formed, and lipid-like substances are contained in the pus after ulceration.

[0004] In recent years, due to the gradual increase of women's mental stress, the accelerated pace of life, the increase of risk factors such as smoking, drinking, obesity, etc., the number of patients with acne mastitis at home and abroad has increased year by year. Western medicine often advocates hormone, antibiotic, anti-tuberculosis treatment or surgical resection. Due to the rapid onset of this disease and the large range of lesions, which can sometimes affect the entire breast, antibiotics and other treatments are lingering and difficult to cure, with poor results and many adverse reactions. Most patients currently use surgical resection for treatment, but breast deformation is easy to occur after surgery. Large ones even need to undergo simple mastectomy to remove the entire breast glandular tissue, which has a serious impact on women's self-confidence and affects their psychological and physical health. Most patients find it difficult to accept. Chinese medicine can help patients relieve pain during the treatment process, and help patients retain breast glandular tissue to the greatest extent, maintain the breast shape on the basis of reducing inflammation and reducing lumps, protect the breast, reduce trauma, reduce damage to breast tissue, and avoid the harm caused by surgical treatment.

[0005] The prior art discloses a Chinese medicine preparation for treating acne-causing mastitis, which is prepared from 1-3 parts by weight of coptis root, 1-5 parts by weight of cyanidin seeds, 1-5 parts by weight of stir-fried gardenia, and 1-10 parts by weight of scutellaria as main ingredients and supplemented with pharmaceutical excipients. However, the preparation method of the Chinese medicine preparation is relatively complicated and it is difficult to meet the treatment needs of acne-causing mastitis. Summary of the invention

[0006] The invention aims to provide a Chinese medicinal 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 patients, 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 Chinese medicinal compound for treating comedonal mastitis, comprising the following raw materials 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 tangerine peel, 25-35 parts of dandelion, 15-20 parts of selfheal, 10-15 parts of cat's claw, 5-10 parts of 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 gleditsia spinosa, 10-20 parts of codonopsis pilosula, 10-20 parts of tuckahoe, 10-15 parts of atractylodes macrocephala, 15-20 parts of polygonum cuspidatum, 25-35 parts of raw hawthorn, and 15-20 parts of oldenlandia diffusa.

[0010] In some other embodiments, the following raw materials are included 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 orange peel, 25-30 parts of dandelion, 18-20 parts of selfheal, 10-13 parts of cat's claw, 5-8 parts of roasted 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, 25-30 parts of astragalus, 8-10 parts of platycodon, 8-10 parts of gleditsia spinosa, 10-16 parts of codonopsis pilosula, 10-16 parts of tuckahoe, 10-14 parts of atractylodes, 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 by weight:

[0013] 12 parts of bupleurum, 20 parts of thunbergii bulbs, 30 parts of salvia miltiorrhiza, 9 parts of red peony root, 30 parts of millettia spatholobi, 9 parts of dried orange peel, 30 parts of dandelion, 18 parts of selfheal, 12 parts of cat's claw, 6 parts of preparatory liquorice, 9 parts of ligusticum chuanxiong, 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 tuckahoe, 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 hurts the liver, worry hurts the spleen, "Qi moves and water also moves", "Spleen and earth are weak, the clear is difficult to rise, the turbid is difficult to descend, it stays in the middle and stagnates in the diaphragm, and becomes phlegm due to congestion". Therefore, damage to the liver and spleen leads to abnormal water transportation and transformation, endogenous dampness and turbidity gather into phlegm, and in addition, Qi stagnation and blood stasis, blocked milk channels, Qi stagnation and phlegm coagulate blood stasis for a long time and form lumps, which turn into fire for a long time, and heat and flesh rot into pus. Moreover, patients with weak constitution or in the late stage 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 medicine to help the pus go out.

[0016] In view of this, the present invention is based on the understanding of the etiology and pathogenesis of acne mastitis by various schools of traditional Chinese medicine, and proposes a Chinese medicine compound for treating the disease from an overall concept. In the present invention, bupleurum, astragalus and codonopsis are the main drugs, bupleurum can relieve liver and depression, open the breast orifices, and can also clear away heat and reduce fever, astragalus and codonopsis have the effect of replenishing qi and strengthening the body, can be used to regulate physical constitution, enhance the body's immunity, and can also strengthen the spleen to promote water transportation, and astragalus is a commonly used holy medicine for sores in ancient and modern times. The three medicines in the prescription are all the main drugs, and they work together to relieve liver and strengthen the spleen.

[0017] Hawthorn, red peony root, salvia miltiorrhiza, Millettia reticulata, honeysuckle, dandelion, honeysuckle thorn, white flower oldenlandia diffusa, cat's claw, and angelica dahurica are the assistant drugs. Hawthorn can clear turbidity and reduce lipids while helping the main drug to strengthen the spleen. Red peony root, salvia miltiorrhiza, and Millettia reticulata can promote blood circulation and remove blood stasis to reduce swelling. At the same time, red peony root and white peony root enter the liver meridian together to cool blood and clear the liver. Honeysuckle, dandelion, and white flower oldenlandia diffusa can clear away heat and detoxify, and dandelion, honeysuckle thorn, and angelica dahurica can reduce swelling and discharge pus when used together. Cat's claw and Fritillaria thunbergii can resolve phlegm and disperse nodules.

[0018] Angelica, Chuanxiong, White Peony, Atractylodes, Poria, Tangerine Peel, Polygonum Cuspidatum, and Prunella Vulgaris are adjuvants. Tangerine peel regulates qi and strengthens the spleen, and is good at relieving qi stagnation in the spleen. Bupleurum is good at relieving qi stagnation in the liver. Chuanxiong is "a qi medicine in the blood" and can circulate qi in the whole body. The combination of the three can promote qi to relieve qi stagnation. "When qi moves, blood moves." 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. When qi and blood move smoothly, the lumps disappear. They are used together with the blood-activating medicine in the ministerial medicine to achieve the effect of regulating qi and blood. Polygonum Cuspidatum and Prunella Vulgaris can help Bupleurum to clear liver fire. Polygonum Cuspidatum can also resolve phlegm and disperse blood stasis. Prunella Vulgaris can also disperse nodules and reduce swelling. At the same time, they can help treat the excessive warming and tonic power of the monarch and ministerial medicines, so that the tonic can also eliminate.

[0019] Atractylodes macrocephala and Poria cocos can strengthen the spleen and replenish qi, enhance the function of spleen and stomach transportation and transformation, and help qi and blood transformation together with the main and auxiliary drugs. Angelica sinensis and white peony root can nourish blood and activate blood circulation. Platycodon grandiflorum and licorice are the guiding drugs. Platycodon grandiflorum is light in weight, bitter in taste and flat in nature. It is called "the boat agent" and can carry the medicinal power of other drugs upward. Platycodon grandiflorum can remove phlegm and pus. Licorice plays the role of harmonizing various drugs and replenishing spleen and qi in this prescription. All the drugs are used together to play the effects of clearing away heat and detoxification, activating blood circulation and removing blood stasis, reducing swelling and dispersing nodules, and supporting positive energy. Moreover, the multi-flavor Chinese medicine in this prescription has the effect of inhibiting inflammation through modern pharmacological research and analysis, so that this prescription can play the role of anti-inflammatory and anti-infection.

[0020] About some single herbs:

[0021] Astragalus is slightly warm in nature, sweet in taste, and belongs to the lung and spleen meridians. It has the functions of replenishing qi and raising yang, strengthening the body's defense system, expelling toxins and pus, astringing sores and promoting tissue regeneration, and relieving stagnation and arthritis. In this prescription, Angelica dahurica and Gleditsia sinensis use the functions of Astragalus to replenish qi and raise yang, expel toxins and pus, and increase its function of expelling pus to prevent qi deficiency and evil from sinking. "Shennong's Herbal Classic" mentions that Astragalus "is used to treat carbuncle, long-term sores, discharge pus and relieve pain." Modern research shows that Astragalus has a large number of active ingredients and can inhibit the release of inflammatory factors. As an inflammatory disease, comedonal mastitis can play its anti-inflammatory role.

[0022] Bupleurum is slightly cold in nature, pungent and bitter in taste, and enters the liver, gallbladder, and lung meridians. It has the effects of soothing the liver and relieving depression, and dispersing and reducing fever. The Compendium of Materia Medica mentions that Bupleurum can "calm the liver, gallbladder, triple burner, and envelope phase fire", soothe the liver and gallbladder, and clear the fire of the two meridians. Modern pharmacological studies have shown that many chemical components in Bupleurum have both anti-inflammatory and immune-enhancing effects, and the extracted Bupleurum saponins and other components have the effects of protecting and nourishing nerves, thereby exerting an anti-depressant effect.

[0023] Dandelion is cold in nature, bitter and sweet in taste, and enters the liver and stomach meridians. It has the effects of clearing away heat and detoxifying, reducing swelling and dispersing nodules, and promoting dampness and relieving stranguria. The New Compendium of Materia Medica records that dandelion can "eliminate swelling and eliminate tuberculosis." Dandelion contains sesquiterpenes, saponins, phenolic compounds, flavonoids and other ingredients, which have good therapeutic effects on inflammatory injuries and have a protective effect on the body.

[0024] Honeysuckle is cold in nature and sweet in taste. It enters the lung, heart and stomach meridians and has the functions of clearing away heat, detoxifying and dispersing wind-heat. The Complete Works of Jingyue says that "it can dissipate the poison that has not yet formed, and it can break the poison that has already formed." Later generations called it an important medicine for reducing swelling, dispersing poison and curing sores. Modern research has shown that compounds such as flavonoids, organic acids, triterpenoid saponins and cycloterpenoids can be extracted from honeysuckle, which can play a significant antibacterial role.

[0025] Salvia miltiorrhiza is slightly cold in nature and bitter in taste. It enters the liver and heart meridians and has the effects of promoting blood circulation and removing blood stasis, cooling blood and eliminating carbuncle, dredging menstruation and relieving pain. The "Compendium of Materia Medica" mentions that Salvia miltiorrhiza "generates new blood, removes bad blood", "breaks up accumulation and hard masses", "disperses galls, tumors, and ulcers, discharges pus and regenerates flesh". The main components of Salvia miltiorrhiza 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 is warm in nature and pungent in taste. It enters the liver, gallbladder and pericardium meridians. It has the effects of promoting blood circulation and qi, dispelling wind and relieving pain. It is mainly used to treat qi stagnation and blood stagnation, breaking up old blood and nourishing new blood. "New Compilation of Materia Medica" says "Chuanxiong is good at nourishing blood...promoting blood circulation...breaking up old blood, removing old blood and giving birth to new blood after childbirth..." Chuanxiong volatile oil is one of the effective ingredients extracted from Chuanxiong. Z-ligustilide, ligustilide A and neo-cnidium monnieri in Chuanxiong volatile oil have anti-inflammatory effects. Ligustrazine is a characteristic alkaloid of Chuanxiong, which has anti-thrombotic and blood coagulation effects, and also has a certain protective effect on brain and myocardial damage.

[0027] Millettia reticulata is warm in nature, bitter and sweet in taste, and enters the liver and kidney meridians. It has the effects of promoting blood circulation, replenishing blood, regulating menstruation and relieving pain, and relaxing tendons and activating collaterals. The "Supplement to Compendium of Materia Medica" records that Millettia reticulata can "cure all diseases, produce blood, harmonize blood, replenish blood, break blood... and promote the circulation of tendons and collaterals." Pharmacological studies have shown that the active ingredients of Millettia reticulata are mostly small and medium polar compounds, mainly flavonoid compounds, which have the effects of improving hematopoietic function, anti-thrombosis, and anti-inflammatory.

[0028] Fritillaria thunbergii is cold in nature, bitter in taste, and enters the lung and heart meridians. It has the functions of detoxifying, dispersing stagnation, eliminating carbuncle, clearing heat, resolving phlegm and relieving cough. The "Compendium of Materia Medica" says that it "can reduce phlegm and qi, relieve depression, relieve pain... kill all kinds of insects and treat throat paralysis, scrofula, breast carbuncle, back abscess, and all kinds of carbuncle swelling and poison". Studies have found that the Fritillaria thunbergii extracted from Fritillaria thunbergii can inhibit inflammatory response, relieve tissue pathological damage through extracellular signal regulation of P13K / AKT pathway and kinase (ERK1 / 2) pathway, and achieve anti-inflammatory effect.

[0029] Cat's Claw is warm in nature, pungent and sweet in taste, and enters the liver and lung meridians. It has strong power to detoxify, reduce swelling, resolve phlegm and disperse knots. Cat's Claw is a newly discovered Chinese medicine in Xinyang, Henan Province in the 1950s. It is good at dispersing knots. Cat's Claw contains polysaccharides, organic acids, flavonoids and other substances, which have pharmacological effects such as protecting the liver, anti-inflammatory, and inhibiting bacteria.

[0030] Raw hawthorn is slightly warm in nature, sour and sweet in taste, and enters the spleen, stomach, and liver meridians. It has the effect of clearing turbidity and reducing lipids. This disease is caused by the accumulation of a large amount of lipid substances in the mammary ducts, which stimulates the infiltration of inflammatory cells. The effect of hawthorn in clearing turbidity and reducing lipids is used to remove the residual lipid substances in the ducts. It is also recorded in the Compendium of Materia Medica that hawthorn can "remove stagnant blood, treat sores", and promote the healing of ulcers. Modern studies have also shown that the use of hawthorn in large doses can achieve the effect of milk recovery. Pharmacological studies have shown that hawthorn total flavonoids, as one of the extracts of hawthorn, can promote lipid metabolism and reduce the synthesis of fatty acids.

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

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

[0033] (2) After adding water to the medicinal residue, decoct it for a second time, filter it, and obtain the second decoction liquid. Combine the two decoction liquids 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 residues;

[0038] The second decoction is after boiling, the temperature is controlled at 80-90° C., and the decoction is performed for 20-45 minutes.

[0039] In a third aspect, the present invention provides use of the Chinese medicinal 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 clinical treatment of acne-causing mastitis, which is guided by the holistic concept, namely, it achieves the effects of promoting blood circulation and 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 Salvia miltiorrhiza, have analgesic effects, which can help patients relieve pain during treatment and improve their quality of life. In addition, most breasts are non-traumatic after treatment with this prescription, and the texture and shape of the breasts change little, avoiding the disadvantages of surgery and the adverse reactions of antibiotics and other treatments, which is more acceptable to patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The accompanying drawings in the specification, 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 figure is a breast effect diagram of one of the 14 cases in the clinical trial of the present invention before and after the treatment of acne-prone mastitis, wherein A is a breast effect diagram of acne-prone mastitis before treatment, B is a breast effect diagram of acne-prone mastitis after 3 months of treatment, and C is a breast effect diagram of acne-prone mastitis after complete cure;

[0047] Figure 2 for Figure 1 The corresponding ultrasound renderings of the breast before and after treatment of comedonal mastitis, wherein 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 only used to illustrate the present invention and should not be considered to limit the scope of the present invention. Specific conditions are not specified in the examples, and the conventional conditions or conditions recommended by the manufacturer are used. The components used without indicating the manufacturer are all conventional products available on the market.

[0049] Example 1

[0050] A Chinese medicinal compound for treating acne-causing mastitis, comprising the following raw materials by weight:

[0051] 12 parts of bupleurum, 20 parts of thunbergii bulbs, 30 parts of salvia miltiorrhiza, 9 parts of red peony root, 30 parts of millettia spatholobi, 9 parts of dried orange peel, 30 parts of dandelion, 18 parts of selfheal, 12 parts of cat's claw, 6 parts of preparatory liquorice, 9 parts of ligusticum chuanxiong, 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 tuckahoe, 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 thereof 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 residue; add water (the amount of water added is 3 times the weight of the residue), boil, and continue to cook for 30-45 minutes, combine the two decoctions, a total of about 400 ml.

[0054] Example 2

[0055] Different from Example 1, the Chinese medicinal compound for treating acne-causing mastitis comprises the following raw materials 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 dried orange peel, 25 parts of dandelion, 18 parts of selfheal, 10 parts of cat's claw, 5 parts of preparatory liquorice, 8 parts of ligusticum chuanxiong, 8 parts of angelica, 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 spinosa, 10 parts of codonopsis pilosula, 10 parts of tuckahoe, 10 parts of atractylodes macrocephala, 16 parts of polygonum cuspidatum, 25 parts of raw hawthorn, and 15 parts of oldenlandia 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 acne-causing mastitis comprises the following raw materials 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 orange peel, 35 parts of dandelion, 20 parts of selfheal, 15 parts of cat's claw, 10 parts of preparatory liquorice, 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 tuckahoe, 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 acne-causing mastitis comprises the following raw materials 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 dried orange peel, 25 parts of dandelion, 15 parts of selfheal, 10 parts of cat's claw, 5 parts of preparatory liquorice, 5 parts of chuanxiong, 5 parts of angelica, 25 parts of white peony root, 15 parts of honeysuckle, 5 parts of angelica, 25 parts of astragalus, 5 parts of platycodon, 5 parts of gleditsia spinosa, 10 parts of codonopsis pilosula, 10 parts of tuckahoe, 10 parts of atractylodes macrocephala, 15 parts of polygonum cuspidatum, 25 parts of raw hawthorn, and 15 parts of oldenlandia diffusa.

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

[0066] It should be noted that embodiment 1 is the best embodiment of the present invention, which can achieve the effects of promoting blood circulation and removing blood stasis, reducing swelling and dispersing nodules, while not forgetting to strengthen the body and replenish 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 the treatment of diseases by traditional Chinese medicine surgery. The Chinese medicines such as Chuanxiong, Millettia reticulata, and Salvia miltiorrhiza in this prescription have analgesic effects, which can help patients alleviate the pain caused by pain during the treatment process and improve the quality of life of patients. And most of the breasts after treatment with this prescription are non-traumatic, and the breast texture and morphological changes are small, avoiding the disadvantages caused by surgery, avoiding the adverse reactions of treatments such as antibiotics, and the patient acceptance is higher.

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

[0068] Clinical data: 14 patients with comedonal mastitis admitted to the Department of Breast and Thyroid Surgery of Shandong Provincial Hospital of Traditional Chinese Medicine from June 2023 to February 2025 were selected as the research subjects, aged 29 to 47 years old, including patients with granulomatous mastitis and plasma cell mastitis. The 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-lactation Mastitis" and "Chinese Medicine Surgery". Non-lactation and non-pregnant women have lumps in the areola or breast, or accompanied by symptoms such as nipple discharge and nipple retraction. Nipple lumps can secondary to the formation of abscesses, which can form fistulas or ulcers after rupture, and discharge light yellow fluids.

[0073] Exclusion criteria:

[0074] (1) Patients with mastitis during pregnancy or 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 psychiatric drugs, and are unable to cooperate with treatment

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

[0079] Directions:

[0080] Divide the combined 400ml decoction into two equal portions and take it once in the morning and evening, warm. 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 to 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 after treatment for 3 months, and C is the breast effect diagram of comedonal mastitis after complete cure. Figure 2 for Figure 1 The corresponding ultrasound effect pictures of the breast before and after the treatment of comedonal mastitis, where A is the ultrasound effect picture of the breast before the treatment, B is the ultrasound effect picture of the breast after 3 months of treatment, and C is the ultrasound effect picture of the breast after the 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, female, 32 years old, weaned for two and a half years. Nine months ago, due to stress, anxiety and tension, redness and swelling appeared above the left nipple. No treatment was given. Pain appeared two months later. She was injected and taken orally for one month at a local hospital with poor results. She came to our outpatient clinic and had a physical examination: a 6*4cm mass was palpated above the left nipple, which was hard, tender, red, and slightly warm. Ultrasound showed a dark area of ​​fluid above the left nipple, and abscess formation was considered.

[0088] After taking this prescription for one month, the patient underwent puncture at the outpatient clinic of our hospital, and the results showed granulomatous mastitis. After taking it for another week, ulcers appeared at the red and swollen area. After taking it for another 3 months, the patient underwent physical examination at the outpatient clinic: the ulcers healed, the skin color was light red, the mass shrank, and a mass of about 3*2cm could be palpated. After taking it for another 2 months, no obvious mass was found during physical examination, the skin color returned to normal, and a small amount of liquid dark area seemed to be seen on ultrasound. The patient continued to take it for two weeks before stopping the medication. No recurrence has been found so far during follow-up.

[0089] Typical medical case 2

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

[0091] After taking this prescription for 1 month, the breast lump became soft, and a pathological puncture was performed in this hospital, and the results showed granulomatous mastitis. After taking it for 4 months, the physical examination showed that the left breast lump was significantly reduced, and a lump of about 5*4cm could be palpated. Ultrasound showed that there was a flaky viscous dark area in the lump. After taking it for 3 months, the patient went to the outpatient clinic of this hospital for a follow-up visit. The physical examination found that the lump had shrunk to a range of about 2*2cm. After taking it for 2 months, no obvious lump was palpated, and there was a light red scar at the ulcer. The skin color of other parts returned to normal, and no obvious abnormality was found in the color Doppler ultrasound. No recurrence was found during follow-up.

[0092] Typical medical case 3

[0093] Ji, female, 38 years old, weaned for 2 years. One year ago, there was no obvious cause for a sudden lump in the right breast, which was hard and covered most of the right breast. She had a puncture at a local hospital, and the results showed granulomatous mastitis. She was injected with cephalosporin for 1 month, but the effect was poor. She was treated in our outpatient clinic after the ulceration. Physical examination: multiple lumps were palpated in the right breast, connected into one piece, with unclear boundaries, affecting the upper outer, outer and upper inner, with a large range, red skin, and obvious tenderness. Ultrasound showed an inflammatory mass in the right breast, with fluid flowing inside.

[0094] After taking this prescription for 3 months, the patient had a physical examination: the right breast mass was still connected into a piece, slightly soft, dark red, with high skin temperature and about to rupture. After taking it for 2 weeks, the right breast ruptured on the outside. After taking it for 2 months, the patient had a physical examination: the right breast mass was palpable and shrunk. Ultrasound showed that the three low-echo areas were connected, and fluid flow could be seen under pressure. The patient continued to take it for 3 months, during which time a secondary ulcer occurred on the outside of the right breast. Physical examination: the right breast mass was significantly reduced, a 1cm*1.5cm mass was palpable on the outside, and a mass of about 3*1cm was palpable on the inside. After taking it for 3 months, the patient had a physical examination: no obvious mass was palpable on the right breast, the wound healed, and no obvious abnormality was found on ultrasound. The patient continued to take it for 1 week and then stopped taking the medicine. There was no recurrence during follow-up.

[0095] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicinal compound for treating comedonal mastitis, characterized in that: The following raw materials are included 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 tangerine peel, 25-35 parts of dandelion, 15-20 parts of selfheal, 10-15 parts of cat's claw, 5-10 parts of 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 gleditsia spinosa, 10-20 parts of codonopsis pilosula, 10-20 parts of tuckahoe, 10-15 parts of atractylodes macrocephala, 15-20 parts of polygonum cuspidatum, 25-35 parts of raw hawthorn, and 15-20 parts of oldenlandia diffusa.

2. The Chinese medicinal compound for treating acne-causing mastitis according to claim 1, characterized in that: The following raw materials are included 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 orange peel, 25-30 parts of dandelion, 18-20 parts of selfheal, 10-13 parts of cat's claw, 5-8 parts of roasted 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, 25-30 parts of astragalus, 8-10 parts of platycodon, 8-10 parts of gleditsia spinosa, 10-16 parts of codonopsis pilosula, 10-16 parts of tuckahoe, 10-14 parts of atractylodes, 16-18 parts of polygonum cuspidatum, 25-30 parts of raw hawthorn, and 15-18 parts of oldenlandia diffusa.

3. The Chinese medicinal compound for treating acne-causing mastitis according to claim 1, characterized in that: The following raw materials are included by weight: 12 parts of bupleurum, 20 parts of thunbergii bulbs, 30 parts of salvia miltiorrhiza, 9 parts of red peony root, 30 parts of millettia spatholobi, 9 parts of dried orange peel, 30 parts of dandelion, 18 parts of selfheal, 12 parts of cat's claw, 6 parts of preparatory liquorice, 9 parts of ligusticum chuanxiong, 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 tuckahoe, 12 parts of atractylodes macrocephala, 18 parts of polygonum cuspidatum, 30 parts of raw hawthorn, and 18 parts of oldenlandia diffusa.

4. The Chinese medicinal compound for treating comedonal mastitis according to claim 1, characterized in that: The medicament of the traditional Chinese medicine compound for treating comedonal mastitis is tablet, decoction and granule.

5. A method for preparing a Chinese medicinal compound for treating comedonal mastitis, characterized in that: The following steps are involved: (1) mixing the raw materials in the Chinese medicinal compound for treating acne-causing mastitis according to any one of claims 1 to 3, soaking the mixture in water, decocting the mixture for the first time, filtering the mixture, and obtaining a first decoction liquid and medicinal residues; (2) After adding water to the medicinal residue, decoct it for a second time, filter it, and obtain the second decoction liquid. Combine the two decoction liquids to obtain the final product.

6. The method for preparing the Chinese medicinal compound for treating comedonal mastitis according to claim 5, characterized in that: In step (1), the amount of water added is 3-5 times the total weight of the raw materials; the soaking time is 30-60 minutes; 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, characterized in that: In step (2), the amount of water added is 3-5 times the total weight of the medicinal residues; The second decoction is after boiling, the temperature is controlled at 80-90° C., and the decoction is performed for 20-45 minutes.

8. Use of the Chinese medicinal compound for treating comedonal mastitis according to any one of claims 1 to 4 in preparing a medicine for treating comedonal mastitis.

9. The use according to claim 8, 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.

10. The use according to claim 9, characterized in that: The comedonal mastitis includes granulomatous mastitis and plasma cell mastitis.

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