Traditional Chinese medicine composition for treating breast nodules as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating breast nodules and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 6-10 parts of flos carthami, 5-9 parts of herba ephedrae, 4-8 parts of semen sinapis, 4-8 parts of processed rhizoma arisaematis, 8-12 parts of baked ginger, 5-9 parts of rhizoma pinellinae praeparata, 3-7 parts of cortex cinnamomi, 5-9 parts of radix aconiti lateralis praeparata slices, 0.5-0.6 part of musk and 3-4 parts of gamboge. The whole formula is reasonable in compatibility, and is mainly used for treating mammary gland caking caused by yang deficiency, nutrient blood insufficiency and congealing cold and dampness stagnation. The whole prescription is scientific in compatibility, all the medicines are mutually coordinated, and the traditional Chinese medicine can effectively restore yang, dispel cold, activate blood, diminish swelling, reduce phlegm, resolve masses and treat both symptoms and root causes.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine compositions, and in particular relates to a Chinese medicine composition for treating breast nodules, and a preparation method and application thereof. Background Art

[0002] Breast nodules usually appear as lumps in the breast, which may sometimes be accompanied by symptoms such as breast pain and nipple discharge. The cause of breast nodules is still unclear. It may be caused by infection or damage to the breast, or endocrine hormone level disorders, gene mutations, environmental factors, etc., which cause cancerous or non-cancerous growth of cells in the breast, and then nodular symptoms appear. Among them, the symptoms of non-lactation mastitis are lumps and pain, and the condition is prone to recurrence, which can cause inflammatory breast nodules. After treatment, the symptoms of mastitis disappear, but lumps may remain in the area where mastitis occurs. Non-lactation mastitis includes plasma cell mastitis and granulomatous mastitis. Plasma cell mastitis is a chronic, non-bacterial breast inflammation based on duct dilatation and plasma cell infiltration lesions. In the acute stage of the lesion, broad-spectrum antibiotics combined with metronidazole are generally used to control the inflammatory response, and adverse reactions to drugs are prone to occur during medication. Granulomatous mastitis is a benign granulomatous lesion limited to the mammary lobules. It is mainly treated with steroid hormones. However, steroid hormones are prone to cause hypercorticism syndrome (glucose intolerance, obesity, osteoporosis and osteonecrosis, etc.), aggravate infection, and induce or aggravate gastric and duodenal ulcers.

[0003] In recent years, in the treatment of breast nodules and breast lumps caused by chronic mastitis (i.e. plasma cell mastitis and granulomatous mastitis), there are various related studies and treatment methods for the application of traditional Chinese medicine, and good treatment effects have been achieved in clinical applications. In the treatment of breast lumps with traditional Chinese medicine, external treatment is an important treatment method, which includes acupoint injection, drug application, acupuncture therapy, massage, acupoint thread embedding and other Chinese medicine application treatments. Among them, Chinese medicine plasters are convenient and quick to use, directly act on the affected area, improve symptoms, and promote nodule absorption. They have definite clinical efficacy and are more worthy of promotion. Summary of the invention

[0004] In view of this, the object of the present invention is to provide a Chinese medicine composition that can effectively treat breast nodules.

[0005] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0006] A traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6-10 parts of safflower, 5-9 parts of ephedra, 4-8 parts of mustard, 4-8 parts of processed arisaema, 8-12 parts of roasted ginger, 5-9 parts of French pinellia, 3-7 parts of cinnamon bark, 5-9 parts of aconite root, 0.5-0.6 parts of musk and 3-4 parts of garcinia.

[0007] Preferably, the raw materials are included in parts by weight: 7-9 parts of safflower, 6-8 parts of ephedra, 5-7 parts of mustard, 5-7 parts of processed arisaema, 9-11 parts of roasted ginger, 6-8 parts of pinellia, 4-6 parts of cinnamon, 6-8 parts of aconite root, 0.54-0.58 parts of musk, and 3.2-3.5 parts of garcinia.

[0008] Preferably, the raw materials are included in parts by weight: 8 parts of safflower, 7 parts of ephedra, 6 parts of mustard, 6 parts of processed arisaema, 10 parts of roasted ginger, 7 parts of French pinellia, 5 parts of cinnamon, 7 parts of aconite root, 0.56 parts of musk, and 3.4 parts of garcinia.

[0009] Another object of the present invention is to provide a method for preparing the traditional Chinese medicine composition, comprising weighing a formula amount of traditional Chinese medicine raw materials, mixing safflower, ephedra, mustard, processed arisaema, roasted ginger, French pinellia, cinnamon bark, and aconite root, and then crushing them into fine powder, crushing garcinia alone into garcinia flour, and mixing the crushed fine powder with musk and garcinia flour to obtain a powder.

[0010] Preferably, the particle size of the fine powder is 100-150 mesh, and the particle size of the gamboge flour is 120 mesh.

[0011] Another object of the present invention is to provide the use of the traditional Chinese medicine composition in the preparation of a drug for treating mastitis.

[0012] Preferably, the breast nodules include the plasma cell breast mass stage and the granulomatous mastitis mass stage.

[0013] Another object of the present invention is to provide a medicine for treating breast nodules, wherein the above-mentioned Chinese medicine composition is one of the effective ingredients or the only effective ingredient of the medicine.

[0014] Preferably, the drug comprises a pharmaceutically acceptable carrier or excipient and is prepared as an external dosage form.

[0015] Preferably, the auxiliary material is vaseline, and the external dosage form is an ointment.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] The invention provides a Chinese medicine composition, wherein the main medicine is the Chinese Pinellia ternata, which can dry dampness and resolve phlegm, eliminate lumps and resolve knots; the ministerial medicines are the mustard seeds and processed arisaema, which can reduce swelling, resolve knots and relieve pain; the auxiliary medicines are the ephedra, roasted ginger, aconite root and cinnamon, which can dispel cold and relieve pain, warm the meridians and dredge the vessels; the auxiliary medicines are the safflower, which can promote blood circulation and relieve menstruation, remove blood stasis and relieve pain, the garcinia, which can reduce swelling and attack toxins, remove rot and hemorrhoids, stop bleeding and relieve itching, and the musk, which can reduce swelling and relieve pain, promote blood circulation and relieve menstruation, and have a pungent and warm effect, are all the guiding medicines. The whole prescription has reasonable compatibility, and is mainly used to treat breast agglomeration caused by deficiency of yang in the body, deficiency of nutrient blood, and stagnation of cold and dampness. The whole prescription is scientifically compatible, and the various medicines are coordinated with each other, which can effectively restore yang and dispel cold, promote blood circulation and reduce swelling, resolve phlegm and resolve knots, and treat both the symptoms and the root causes. DETAILED DESCRIPTION

[0018] The present invention provides a Chinese medicine composition, comprising the following raw materials in parts by weight: 6-10 parts of safflower, 5-9 parts of ephedra, 4-8 parts of mustard, 4-8 parts of processed arisaema, 8-12 parts of roasted ginger, 5-9 parts of French pinellia, 3-7 parts of cinnamon, 5-9 parts of light aconite root, 0.5-0.6 parts of musk, and 3-4 parts of garcinia. Preferably, the following raw materials are included in parts by weight: 7-9 parts of safflower, 6-8 parts of ephedra, 5-7 parts of mustard, 5-7 parts of processed arisaema, 9-11 parts of roasted ginger, 6-8 parts of French pinellia, 4-6 parts of cinnamon, 6-8 parts of light aconite root, 0.54-0.58 parts of musk, and 3.2-3.5 parts of garcinia. More preferably, the raw materials include the following parts by weight: 8 parts of safflower, 7 parts of ephedra, 6 parts of mustard, 6 parts of processed arisaema, 10 parts of roasted ginger, 7 parts of French pinellia, 5 parts of cinnamon bark, 7 parts of light aconite root, 0.56 parts of musk, and 3.4 parts of garcinia. The raw materials described in the present invention are all commercially available products well known to those skilled in the art.

[0019] In the present invention, the Pinellia ternata is pungent in taste and warm in nature, and enters the spleen, stomach and lung meridians. It has the effects of drying dampness and resolving phlegm, relieving adverse reactions and stopping vomiting, and eliminating lumps and dispersing nodules. It can resolve phlegm and dispersing nodules, reduce swelling and relieve pain when used externally. As the main drug, it plays a leading role in the prescription for treating symptoms.

[0020] In the present invention, the mustard tastes pungent, is warm in nature, enters the lung meridian, has the effects of warming the lung, resolving phlegm and promoting qi, dispersing stagnation and dredging collaterals to relieve pain, can disperse the cold phlegm "inside the skin and outside the membrane", and can be used externally to warm and transform the cold phlegm, reduce swelling and relieve pain; the processed aranemia tastes bitter and pungent, is warm in nature, enters the lung, liver and spleen meridians, dries dampness and resolves phlegm, dispels wind and stops spasm, disperses stagnation and reduces swelling, and can be used externally to reduce swelling, dispersing stagnation and relieve pain; the mustard and processed aranemia are coordinated and compatible in dispersing stagnation and dredging collaterals, reducing swelling and relieving pain, and are the ministerial drugs of the formula, and assist the Chinese pinellia tuber in playing the effects of eliminating lumps, dispersing stagnation, reducing swelling and relieving pain, thereby effectively relieving breast lumps and pain symptoms.

[0021] In the present invention, the ephedra is flat in nature and pungent in taste, can induce sweating and dispel cold, promote lung function and relieve asthma, promote diuresis and reduce swelling, can be used externally to clear the pores, spread to the skin and fur, dispel cold and relieve pain; the roasted ginger is pungent and bitter in taste and hot in nature, enters the blood of the Taiyin meridian of the foot, stays but does not move, dries the cold and dampness of the spleen and stomach, removes the cold and fullness of the navel and abdomen, warms the heart qi, warms the liver meridian, warms the middle and relieves pain; the light aconite is a processed product of aconite, has a pungent and hot taste, enters the heart, kidney, liver and spleen meridians, warms and dispels cold evil and dredges the meridians, can warm and promote the yang qi of the whole body, and the qi flows when the blood flows. The external use of the pinellia warms and transforms the cold phlegm, reduces swelling and dispels the knot, and the aconite has a Hot and dry, it can open the twelve meridians and is the most important medicine for restoring yang, removing cold and dampness from the internal organs. Aconite is used in conjunction with Pinellia, and the two are used together to strengthen the function of warming yang, resolving phlegm and reducing swelling, achieving twice the result with half the effort; the cinnamon is pungent and sweet in taste, fragrant and penetrating, can penetrate the whole body, warm the meridians, dispel cold and relieve pain; the ephedra, roasted ginger, light aconite and cinnamon are coordinated in dispelling cold, warming the meridians and relieving pain, assisting the main medicine and the minister medicine to exert the effect of relieving pain, and with the effect of dispelling cold of the prescription, it is the adjuvant of the prescription, which helps to relieve breast pain and reduce lumps.

[0022] In the present invention, the safflower is pungent in taste and warm in nature, and enters the heart and liver meridians, can promote blood circulation and menstruation, remove blood stasis and relieve pain, and can be used for all blood stasis syndromes, and is a commonly used important medicine in gynecology and surgery, and can eliminate blood stasis by itself, and can promote blood circulation and relieve breast pain; the musk is pungent and warm in nature, and enters the heart and spleen meridians. Musk is pungent, dispersing, warming and unblocking, and has a fragrant aroma, which is good at opening and unblocking the orifices and is a good medicine for opening and refreshing the mind, and is suitable for treating closed syndromes and coma regardless of cold or heat, and is also a good product for promoting blood circulation, unblocking menstruation and relieving pain, and can treat blood stasis syndrome regardless of new or long-term, and can be taken Its blood-activating and menstruation-regulating effects can be used for sores, dead fetuses and retained placenta; the garcinia is sour and astringent in taste and cool in nature, and has the effects of reducing swelling, attacking toxins, removing rot and healing sores, stopping bleeding and killing insects, and is commonly used for carbuncle, swelling and toxins, ulcers, eczema, tumors, stubborn ringworms, swelling and pain from falls, bleeding sores and burns; the safflower, musk and garcinia can remove blood stasis and relieve pain, activate blood circulation and menstruation, reduce swelling and relieve pain, and the three are coordinated and compatible as the guiding drugs of the prescription, which strengthen the menstruation-regulating and analgesic effects of the whole prescription, and strengthen the functions of the whole prescription in reducing swelling, attacking toxins, removing rot and healing sores.

[0023] The whole prescription of the invention has reasonable compatibility, and is mainly used for curing yang and dispelling cold, promoting blood circulation and reducing swelling, resolving phlegm and dispersing stagnation, and is mainly used for treating agglomerations caused by yang deficiency, insufficient nutrient blood, cold stagnation and dampness stagnation, and can effectively relieve breast lumps and pain symptoms.

[0024] The present invention also provides a preparation method of the traditional Chinese medicine composition, comprising the following steps: weighing a formula amount of traditional Chinese medicine raw materials, mixing safflower, ephedra, mustard, processed arisaema, roasted ginger, French pinellia, cinnamon bark, and aconite root, and then crushing them into fine powder, crushing garcinia alone into garcinia flour, and mixing the crushed fine powder with musk and garcinia flour to obtain a powder.

[0025] In the present invention, the particle size of the fine powder is 100-150 mesh, preferably 120-130 mesh; the particle size of the gamboge flour is 120 mesh.

[0026] The present invention also provides the use of the Chinese medicine composition in preparing a drug for treating breast nodules. The breast nodules of the present invention include plasma cell breast nodules and granulomatous mastitis nodules.

[0027] The present invention also provides a medicine for treating breast nodules, wherein the above-mentioned Chinese medicine composition is one of the effective ingredients or the only effective ingredient of the medicine. The medicine of the present invention comprises a pharmaceutically acceptable carrier or excipient and is prepared into an external dosage form.

[0028] In the present invention, the auxiliary material is vaseline, the external dosage form is an ointment, and the powder is mixed with vaseline to prepare the ointment, and the powder and vaseline are mixed in a mass ratio of 1:4. The ointment can be further processed into an external-use Babu ointment.

[0029] The medicine for treating breast nodules provided by the present invention can be used for inflammatory and non-inflammatory lumps and nodules of the Yang deficiency and cold coagulation type, and can preferably be used for plasma cell mastitis in the Yang deficiency and cold coagulation stage or granulomatous mastitis in the Yang deficiency and cold coagulation stage. The medicine is applied externally to the breast mass once a day, each application lasting 10-12 hours, 14 days as a course of treatment, and 1-3 courses of treatment are used.

[0030] The prescription of the present invention has pungent and hot properties and is contraindicated for patients with all kinds of heat and toxic congestion such as the red and swollen stage and the suppurative stage of breast nodules.

[0031] The Chinese medicinal materials in the specific embodiments of the present invention are all provided by the pharmacy of the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine.

[0032] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0033] Example 1

[0034] A traditional Chinese medicine composition comprises the following raw materials in parts by weight: 8 parts of safflower, 7 parts of ephedra, 6 parts of mustard, 6 parts of processed arisaema, 10 parts of roasted ginger, 7 parts of French pinellia, 5 parts of cinnamon bark, 7 parts of aconite root, 0.56 parts of musk and 3.4 parts of garcinia.

[0035] The preparation method comprises the following steps:

[0036] Weigh the raw materials in the formula, mix safflower, ephedra, mustard, processed arisaema, roasted ginger, French pinellia, cinnamon, and light aconite, and grind them into fine powder with a particle size of 120 mesh, grind garcinia alone into garcinia surface with a particle size of 120 mesh, mix the crushed fine powder with musk and garcinia surface to obtain a powder. Mix the powder with vaseline in a mass ratio of 1:4 to prepare an external Babu ointment.

[0037] Example 2

[0038] A traditional Chinese medicine composition comprises the following raw materials in parts by weight: 9 parts of safflower, 8 parts of ephedra, 5 parts of mustard, 7 parts of processed arisaema, 9 parts of roasted ginger, 7 parts of French pinellia, 4 parts of cinnamon bark, 6 parts of aconite root, 0.55 parts of musk and 3.3 parts of garcinia.

[0039] The preparation method is the same as Example 1.

[0040] Example 3

[0041] A traditional Chinese medicine composition comprises the following raw materials in parts by weight: 7 parts of safflower, 6 parts of ephedra, 7 parts of mustard, 5 parts of processed arisaema, 11 parts of roasted ginger, 9 parts of French pinellia, 6 parts of cinnamon bark, 9 parts of aconite root, 0.6 parts of musk and 3.6 parts of garcinia.

[0042] The preparation method is the same as Example 1.

[0043] Typical Cases

[0044] 1. Jiao, female, 26 years old, date of consultation: December 21, 2018, 1 child, 2 years postpartum, severe depression of both breasts, no breastfeeding, no onset during lactation, onset location: right breast, inner lower part, size 9*9cm, color Doppler ultrasound of Lan County Hospital of Traditional Chinese Medicine: right breast mastitis <20.3*26.8mm> right breast, inner lower part, redness and swelling, pathological diagnosis: plasma cell mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 5 weeks during the stiff mass period, and the stiff mass disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0045] 2. Gao, female, 27 years old, 1 child, 3 years postpartum, moderate depression of both breasts, no breastfeeding, no onset during lactation, onset during pregnancy, onset location on the outside of the right breast, size 6*7.5cm, with pinhole-sized ulcers, accompanied by inflammatory manifestations. On October 15, 2018, the Provincial People's Hospital pathological diagnosis: plasma cell mastitis. Intravenous drip antibiotic treatment for 10 days was not effective. In order to seek conservative treatment of traditional Chinese medicine, she was treated in our hospital on January 25, 2019. The external Babu ointment prepared by Example 1 of the present invention was used for 8 weeks during the stiff block period. The stiff block disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0046] 3. Yuan, female, 32 years old, consulted on February 19, 2018, 1 child, 4 years postpartum, no breast depression, plasma cell mastitis, married, regular menstruation, 1 son, first child at the time of onset, not breast-feeding, no onset during lactation, onset site on the upper inner side of the right breast, size 3.6*0.8 cm, skin edema, no orange peel sign, accompanied by inflammatory manifestations, redness and swelling on the inner side of the right breast, the redness and swelling range 3.6*0.8 cm, used the external Babu ointment prepared in Example 1 of the present invention for 4 weeks during the lump period, the lump disappeared and the patient recovered, and there was no adverse reaction during use.

[0047] 4. Shen, female, 32 years old, date of consultation: February 1, 2019, 1 child, 4.5 years postpartum, severe depression of both breasts, not breast-feeding, no onset during lactation or pregnancy, onset location: upper inside, upper outside, lower outside of left breast, hard lump, range 11.8*8.6CM, with orange peel sign, accompanied by inflammatory manifestations, redness and swelling of left breast. Pathological diagnosis of our hospital: granulomatous mastitis of left breast. The topical Babu ointment prepared in Example 1 of the present invention was used for 6 weeks during the hard lump period, and the patient recovered after the hard lump disappeared. During use, the patient had no adverse reactions.

[0048] 5. Meng, female, 37 years old, visited on July 23, 2019, 1 child, 2 years postpartum, after the child collided, a lump suddenly appeared on the outside and lower part of the right breast, the skin color did not change at the beginning, and it did not occur during lactation or pregnancy. The puncture pathology diagnosis of the Provincial People's Hospital was: right breast plasma cell mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 6 weeks during the stiff mass period, and the stiff mass disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0049] 6. Yan, female, 30 years old, 1 child, 2 years postpartum, mildly retracted breasts, breastfeeding, no onset during lactation or pregnancy, onset location is the right breast inner upper outer areola, skin edema, accompanied by inflammatory manifestations, right breast lump, redness and swelling of the upper part of the right breast. On February 2, 2020, the B-ultrasound of Shanxi Medical University Hospital indicated breast inflammation, and surgery was recommended. On February 10, 2020, the municipal maternal and child puncture showed: granuloma mastitis in the right breast, oral small gold tablets, and ultrasonic treatment were ineffective, the tumor increased, affecting the whole breast, accompanied by fever. On March 10, 2020, she was treated in our hospital, and the topical Babu ointment prepared in Example 1 of the present invention was used for 9 weeks during the stiff mass period. The stiff mass disappeared and the patient recovered. During the use, the patient had no adverse reactions.

[0050] 7. Ren, female, 27 years old, 1 child, 2 years postpartum, severe depression of both breasts, not breastfeeding, no onset during lactation or pregnancy, onset location is the outer lower areola of the right breast, with ulceration, accompanied by inflammatory manifestations, redness and swelling under the right breast, the range of redness and swelling is 5.7*2.8cm. In December 2019, Yangyong City People's Hospital, puncture, pus extraction, drainage, the wound did not heal, on March 12, 2020, the Provincial People's Hospital puncture pathology diagnosis: right breast plasma cell mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 2 weeks during the stiff mass period, and the stiff mass disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0051] 8. Zhang, female, 28 years old, visited on March 31, 2020, developed at 24 weeks of pregnancy, with the disease site being the upper and lower outer areola of the left breast, with 3 1-cent coin-sized ulcers, ulcers the size of a 1-cent coin, skin edema, accompanied by inflammatory manifestations, and the puncture pathology diagnosis of the outside hospital: granulomatous mastitis of the left breast. Continuous use of anti-inflammatory ointment for external use plus Chinese medicine pricking and cupping before delivery, the skin healed, and there were still stiff masses under the skin. Weaning was done one week after delivery. After 3 weeks of using the external Babu ointment prepared in Example 1 of the present invention, the lump disappeared and the patient was cured. During use, the patient had no adverse reactions.

[0052] 9. Meng, female, 34 years old, consultation date May 28, 2019, 1 child, 8 years postpartum, right breast retraction, breastfeeding, no onset during lactation or pregnancy, onset location right breast inner upper areola, mass range 6.7*3.8cm, external hospital puncture pathological diagnosis: right breast plasma cell mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 5 weeks during the stiff mass period, and the stiff mass disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0053] 10. Mi, female, 31 years old, consultation time May 2021, 1 child, 4 years postpartum, sunken breasts, no breastfeeding, no onset during lactation or pregnancy, onset location right breast, size 5.7*2.4cm, ulceration, ulcer diameter 3mm, skin edema, accompanied by inflammatory manifestations, redness and swelling around the entire areola of the right breast, external hospital puncture pathology diagnosis: right breast granulomatous mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 6 weeks during the stiff mass period, and the stiff mass disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0054] 11. Yang, female, 38 years old, date of consultation: February 18, 2021, 1 child, 3 years postpartum, severe depression of left breast, no breastfeeding, no onset during lactation or pregnancy, first onset in August 2020, cured by surgery in an external hospital, relapsed in December 2020, onset in left breast, ulceration, skin edema, high fever, cough, fatigue, vomiting after eating, poor systemic symptoms, external hospital puncture pathology diagnosis: left breast plasma cell mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 8 weeks during the stiff mass period, and the stiff mass disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0055] 12. Liu, female, 34 years old, date of consultation: July 27, 2021, 1 child, 5 years postpartum, no depression in both breasts, no breastfeeding, no onset during lactation or pregnancy, onset location: right breast areola, with ulceration, ulcer size 2 cm, accompanied by inflammatory manifestations, external hospital puncture pathology diagnosis: right breast plasma cell mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 3 weeks during the stiff mass period, and the stiff mass disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0056] 13. Li, female, 30 years old, date of consultation: December 8, 2022, 1 child, 4 years postpartum, no depression in both breasts, breastfeeding, no onset during lactation or pregnancy, onset location: right breast outer upper areola, 9-10 o'clock 0.4*0.3cm, 0.9*0.5cm, with ulceration, skin edema, accompanied by inflammatory manifestations, redness and swelling on the outer side of the right breast areola, puncture pathology diagnosis of our hospital: right breast plasma cell mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 3 weeks during the stiff mass period, and the stiff mass disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0057] 14. Yang, female, 32 years old, date of consultation: December 14, 2021, 1 child, 5 years postpartum, right breast slightly sunken, not breast-feeding, no onset during pregnancy, onset location on the outer side of the right breast, upper areola, size 4*1.4cm, with ulceration, ulcer size 1mm, external hospital puncture pathology diagnosis: right breast granulomatous mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 4 weeks during the stiff mass period, and the stiff mass disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0058] 15. Guo, female, 32 years old, date of consultation: December 21, 2021, 1 child, 5 years postpartum, not breast-feeding, no onset during lactation or pregnancy, first onset in mid-December 2020, 4 years postpartum, cured by external hospital treatment. This time, there was a lump on the right breast, accompanied by inflammatory manifestations, and the right breast was red and swollen. The puncture pathology of this hospital diagnosed: right breast granulomatous mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 2 weeks during the stiff mass period. The stiff mass disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0059] 16. Zheng, female, 39 years old, date of consultation: October 2, 2022, 2 children, 3.5 years postpartum, right breast slightly sunken, breastfeeding, no onset during lactation or pregnancy, first onset on August 30, 2021, 7-8 months of lactation, cured after treatment in an external hospital. The location of the onset this time is the upper inner part of the right breast, the size is 12*11cm, there is ulceration, the size of the ulcer is 0.2cm, the skin is edematous, accompanied by inflammatory manifestations, and the upper inner part of the right breast is red and swollen. The puncture pathology diagnosis of the Provincial People's Hospital: granulomatous mastitis of the right breast. The topical Babu ointment prepared in Example 1 of the present invention was used for 3 weeks during the stiff mass period. The stiff mass disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0060] 17. Zhang, female, 43 years old, consultation date June 15, 2022, 2 children, 2.5 years postpartum, breastfeeding, no onset during lactation or pregnancy, onset location on the outside of both breasts, size: left 3.7*1.3cm, right 2.8*1.1cm. On June 16, 2022, puncture pathology diagnosis: bilateral plasma cell mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 5 weeks during the lumps stage, and the lumps disappeared and the patient recovered. During use, the patient had no adverse reactions.

[0061] 18. Guo, female, 28 years old, 1 child, 3 years postpartum, breastfeeding, no onset during lactation or pregnancy, a sudden lump in the left breast in mid-October 2022, the location of the disease is the left areola, the size is 10*7cm, there is ulceration, the ulcer is 0.5mm, accompanied by inflammation, redness and swelling on the inside and outside of the left breast. The puncture pathology diagnosis result of the People's Hospital on October 28, 2022: granulomatous mastitis of the left breast. In order to seek conservative treatment of traditional Chinese medicine, she was treated in our hospital on November 20, 2022. The external use Babu ointment prepared in Example 1 of the present invention was used for 5 weeks during the stiff mass period. The stiff mass disappeared and the patient recovered. During the use, the patient had no adverse reactions.

[0062] 19. Song, female, 35 years old, consultation date September 10, 2023, plasma cell mastitis, 1 child, 4 years postpartum, severe left breast depression, onset location on the upper outer part of the left breast, mass range 6.8*4.5cm, ulceration, skin redness and swelling, accompanied by inflammatory manifestations, September 7, 2023, our hospital puncture pathological diagnosis result: left breast plasma cell mastitis. The topical Babu ointment prepared in Example 1 of the present invention was used for 3 weeks during the hard mass stage, and the hard mass disappeared and the patient recovered. During the use, the patient had no adverse reactions.

[0063] 20. Bi, female, 31 years old, visited on July 4, 2023, 4 years postpartum, with mild left nipple depression, no breastfeeding, the diseased area was on the outside of the left breast, accompanied by inflammatory manifestations. B-ultrasound showed a 3.3*1.8cm low-echo area at 2-3 points on the left breast, with irregular shape and unclear boundaries. Fine needle puncture on July 4, 2023: plasma cell mastitis in the left breast. The topical Babu ointment prepared in Example 1 of the present invention was used for 8 weeks during the hard mass period, and the hard mass has basically disappeared. During the use, the patient had no adverse reactions.

[0064] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The invention comprises the following raw materials in parts by weight: 6-10 parts of safflower, 5-9 parts of ephedra, 4-8 parts of mustard, 4-8 parts of processed arisaema, 8-12 parts of roasted ginger, 5-9 parts of French pinellia, 3-7 parts of cinnamon bark, 5-9 parts of aconite root, 0.5-0.6 parts of musk and 3-4 parts of garcinia.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 7-9 parts of safflower, 6-8 parts of ephedra, 5-7 parts of mustard, 5-7 parts of processed arisaema, 9-11 parts of roasted ginger, 6-8 parts of French pinellia, 4-6 parts of cinnamon bark, 6-8 parts of aconite root, 0.54-0.58 parts of musk and 3.2-3.5 parts of garcinia.

3. The Chinese medicine composition according to claim 1, characterized in that The invention comprises the following raw materials in parts by weight: 8 parts of safflower, 7 parts of ephedra, 6 parts of mustard seeds, 6 parts of processed arisaema, 10 parts of roasted ginger, 7 parts of French pinellia, 5 parts of cinnamon bark, 7 parts of aconite root, 0.56 parts of musk and 3.4 parts of garcinia.

4. The method for preparing the Chinese medicine composition according to claims 1-3, characterized in that: Weigh the formulated amount of Chinese medicinal raw materials, mix safflower, ephedra, mustard, processed arisaema, roasted ginger, French pinellia, cinnamon bark, and aconite root, and grind them into fine powder; grind garcinia alone into garcinia flour, and mix the ground fine powder with musk and garcinia flour.

5. The preparation method according to claim 4, characterized in that: The particle size of the fine powder is 100-150 meshes, and the particle size of the gamboge surface is 120 meshes.

6. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicine for treating breast nodules.

7. The use according to claim 6, characterized in that: The breast nodules include the plasma cell breast mass stage and the granulomatous mastitis mass stage.

8. A drug for treating breast nodules, characterized in that: The Chinese medicine composition described in any one of claims 1 to 3 is one of the active ingredients or the only active ingredient of the medicine.

9. The drug according to claim 8, characterized in that The medicine comprises a pharmaceutically acceptable carrier or excipient and is prepared into an external dosage form.

10. The drug according to claim 9, characterized in that The auxiliary material is vaseline, and the external dosage form is an ointment.