Traditional Chinese medicine composition for treating hyperplasia of mammary glands as well as preparation and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating hyperplasia of mammary glands as well as a preparation and application thereof, and relates to the field of medicines. The traditional Chinese medicine composition for treating hyperplasia of mammary glands is prepared from the following raw material medicines in parts by weight: 13 to 18 parts of radix linderae, 4 to 6 parts of fructus amomi, 8 to 12 parts of rhizoma cyperi, 8 to 12 parts of radix aucklandiae, 8 to 12 parts of liquorice root, 13 to 18 parts of rhizoma corydalis, 13 to 18 parts of radix scrophulariae, 18 to 23 parts of oyster, 4 to 6 parts of spica prunellae, 8 to 12 parts of bulbus fritillariae thunbergii, 18 to 23 parts of herba taraxaci, 13 to 18 parts of loofah sponge, 13 to 18 parts of rhizoma zingiberis recens, 18 to 23 parts of semen citri reticulatae and 13 to 18 parts of paederia scandens. The traditional Chinese medicine composition can be prepared into decoction or granules. In the traditional Chinese medicine composition, the combined spicebush root and the nutgrass galingale rhizome are combined as monarch drugs; corydalis tuber is used as a ministerial drug; costustoot, fructus amomi, loofah sponge, tangerine seed, radix scrophulariae, oyster, selfheal, dandelion and thunberg fritillary bulb are combined as adjuvant drugs; the ginger and the liquorice are used as assistants and guides; the medicines are matched and supplement each other to jointly achieve the effects of promoting qi circulation and soothing liver, promoting blood circulation to remove blood stasis and eliminating stagnation and relieving pain, so that qi circulation and blood circulation are smooth, depression is dispersed and pain is relieved, and the traditional Chinese medicine has a good curative effect on treating hyperplasia of mammary glands.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating mammary hyperplasia, and a preparation and application thereof. Background Art

[0002] Hyperplasia of the breast (HMG) is a non-inflammatory, non-neoplastic condition characterized by varying degrees of proliferation and inadequate degeneration of the breast parenchyma and stroma, leading to a structural disorder of the breast. Hyperplasia of the breast is also known as mastopathy, fibroadenosis, fibrocystic mastopathy, mastalgia, fibrocystic changes, benign mammary dysplasia, or sclerosing adenosis. Hyperplasia of the breast accounts for over 75% of all breast diseases. Its onset is closely related to endocrine disorders, with primary manifestations including breast pain, lumps, and mood disorders. While most lesions are benign, approximately 2%-4% may become cancerous, necessitating clinical attention and effective treatment.

[0003] Western medicine treatment often uses hormone regulators such as tamoxifen, but it has side effects such as gastrointestinal reactions and menstrual disorders, and the recurrence rate after discontinuation of the drug is as high as 40%.

[0004] Although existing Chinese medicine formulas can soothe the liver and regulate qi, soften and disperse nodules, the cure rate is often not high. Therefore, it is of great significance to develop a Chinese medicine composition for treating breast hyperplasia that can cure the above diseases. Summary of the Invention

[0005] The present invention provides a traditional Chinese medicine preparation for treating mammary gland hyperplasia and application thereof. The traditional Chinese medicine composition of the present invention has a good effect of treating mammary gland hyperplasia when various medicines are matched.

[0006] The technical solution of the present invention is achieved as follows: A traditional Chinese medicine composition for treating breast hyperplasia comprises the following raw materials in parts by weight: 13-18 parts of Linderae scutellariae, 4-6 parts of Amomum villosum, 8-12 parts of Cyperus rotundus, 8-12 parts of Aucklandia lappa, 8-12 parts of Licorice root, 13-18 parts of Corydalis yanhusuo, 13-18 parts of Scrophularia ningpoensis, 18-23 parts of Oyster, 4-6 parts of Prunella vulgaris, 8-12 parts of Fritillaria thunbergii, 18-23 parts of Taraxacum officinale, 13-18 parts of Luffa fructus, 13-18 parts of Zingiber officinale, 18-23 parts of Citrus aurantium, and 13-18 parts of Caulis dahuricae. The traditional Chinese medicine composition of the present invention comprises the following raw materials in parts by weight: 13-18 parts of Linderae scutellariae, 4-6 parts of Prunella vulgaris, 8-12 parts of Fritillaria thunbergii, 18-23 parts of Taraxacum officinale, 13-18 parts of Luffa fructus, 13-18 parts of Zingiber officinale, 18-23 parts of Citrus aurantium, and 13-18 parts of Caulis dahuricae. The various raw materials in the composition are well matched to promote qi and soothe the liver, activate blood circulation and remove blood stasis, and dissipate stagnation and relieve pain, thereby promoting qi and blood circulation, relieving stagnation and relieving pain, and having a good therapeutic effect for treating breast hyperplasia.

[0007] Furthermore, the traditional Chinese medicine composition for treating breast hyperplasia comprises the following raw materials in parts by weight: 15 parts of Linderae scutellariae, 5 parts of Amomum villosum, 10 parts of Cyperus rotundus, 10 parts of Aucklandia lappa, 10 parts of Licorice root, 15 parts of Corydalis yanhusuo, 15 parts of Scrophularia ningpoensis, 20 parts of Oyster, 5 parts of Prunella vulgaris, 10 parts of Fritillaria thunbergii, 20 parts of Taraxacum mongolicum, 15 parts of Luffa cylindrica, 15 parts of Ginger, 20 parts of Citrus aurantium, and 15 parts of Caulis dahuricae. This composition has a better therapeutic effect in treating breast hyperplasia.

[0008] A traditional Chinese medicine preparation for treating breast hyperplasia is prepared from any one of the traditional Chinese medicine compositions of the present invention.

[0009] Furthermore, a Chinese medicine decoction for treating breast hyperplasia is prepared from any of the Chinese medicine compositions of the present invention. The decoction is prepared by decocting the ingredients in water according to the formula of the present invention.

[0010] Furthermore, a Chinese medicine granule for treating breast hyperplasia is prepared from any one of the Chinese medicine compositions of the present invention.

[0011] Furthermore, a Chinese medicine granule for treating breast hyperplasia, the preparation method of the granule comprises the following steps: taking each medicinal material, decocting and extracting with water, concentrating under reduced pressure at 55-65°C to 1.30-1.40, obtaining a clear paste, adding auxiliary materials, the mass ratio of the clear paste to the auxiliary materials being 1:1-2, granulating through an 80-120 mesh sieve, granulating, and sterilizing to obtain granules.

[0012] Furthermore, the auxiliary material is sucrose.

[0013] Use of any one of the Chinese medicine compositions of the present invention in preparing a medicine for treating breast hyperplasia.

[0014] Compared with the prior art, the present invention has the following beneficial effects: In the Chinese medicine composition of the present invention, Linderae spicate, dispersing, warming, and promoting circulation, soothes the liver, promotes qi circulation, and relieves pain, while Cyperus rotundus soothes the liver, regulates qi, and relieves pain. The two are combined as the main medicine; Corydalis yanhusuo promotes qi circulation, activates blood circulation, regulates menstruation, and relieves pain, and is the ministerial medicine. Costus root and Amomum villosum promote qi circulation, relieve pain, and relieve swelling; Luffa scoparia and Citrus aurantium promote menstruation, activate collaterals, and disperse stagnation; Scrophularia ningpoensis clears heat and nourishes yin, cools blood, and disperses stagnation; Oyster softens and disperses stagnation; Prunella vulgaris clears the liver, purges fire, disperses stagnation, and reduces swelling; Taraxacum mongolicum reduces swelling and disperses stagnation; Fritillaria thunbergii clears heat and resolves phlegm. The nine medicines are used together to clear phlegm, resolve stasis, and dissipate stagnation, and are all adjuvants. Ginger is pungent, dispersing, warming, and promoting circulation, while Licorice relieves urgency and relieves pain, and also coordinates the other medicines, serving as adjuvants. The various medicines in the Chinese medicine composition of the present invention are matched to work together to promote qi circulation, soothe the liver, promote blood circulation, and resolve stasis, and relieve pain, promoting qi circulation and blood circulation, relieving depression and pain, and having a good therapeutic effect in treating breast hyperplasia. DETAILED DESCRIPTION

[0015] In order to better understand the technical content of the present invention, specific examples are provided below to further illustrate the present invention. Unless otherwise specified, the experimental methods used in the examples of the present invention are all conventional methods; Unless otherwise specified, the materials and reagents used in the examples of the present invention can be obtained from commercial sources. The raw materials used in the embodiments of the present invention are all commercially available Chinese medicinal materials.

[0016] Example 1 A traditional Chinese medicine composition for treating breast hyperplasia is prepared from the following raw materials in parts by weight: 15 parts of Linderae scutellariae, 5 parts of Amomum villosum, 10 parts of Cyperus rotundus, 10 parts of Aucklandia lappa, 10 parts of Licorice root, 15 parts of Corydalis yanhusuo, 15 parts of Scrophularia ningpoensis, 20 parts of Oyster, 5 parts of Prunella vulgaris, 10 parts of Fritillaria thunbergii, 20 parts of Taraxacum mongolicum, 15 parts of Luffa sponge, 15 parts of Ginger, 20 parts of Citrus aurantium, and 15 parts of Caulis Aconiti Lateralis Preparata.

[0017] The decoction was prepared by decocting the ingredients in water according to the formula of this embodiment. The amount of Chinese medicinal materials for one dose (200 g in total) was as follows: Linderae 15g, Amomum villosum 5g, Cyperus rotundus 10g, Aucklandia 10g, Licorice root 10g, Corydalis 15g, Scrophularia 15g, Oyster 20g, Prunella vulgaris 5g, Fritillaria thunbergii 10g, Taraxacum mongolicum 20g, Luffa 15g, Ginger 15g, Citrus aurantium 20g, Cistanche deserticola 15g.

[0018] Comparative Example 1 Based on Example 1, Linderae serratae var. aconiti lobatae was replaced by Aconitum carmichaelii.

[0019] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of aconite root (Baifu Pian), 5 parts of Amomum villosum, 25 parts of Cyperus rotundus, 10 parts of costus root, 10 parts of liquorice, 15 parts of Corydalis yanhusuo, 15 parts of Scrophularia ningpoensis, 20 parts of oyster, 5 parts of Prunella vulgaris, 10 parts of Fritillaria thunbergii, 20 parts of dandelion, 15 parts of luffa, 15 parts of ginger, 20 parts of citrus seeds, and 15 parts of Ceratonia suffruticosa.

[0020] According to the formula of this comparative example, decoction is prepared by decoction, and the amount of Chinese medicinal materials for one dose is as follows: Aconite (white aconite root) 15g, Amomum villosum 5g, Cyperus rotundus 25g, Aucklandia 10g, Licorice root 10g, Corydalis 15g, Scrophularia 15g, Oyster 20g, Prunella vulgaris 5g, Fritillaria thunbergii 10g, Taraxacum mongolicum 20g, Luffa loofah 15g, Ginger 15g, Citrus aurantium 20g, Cistanche deserticola 15g.

[0021] Comparative Example 2 Based on Example 1, Cyperus rotundus was replaced by Fructus Aurantii Immaturus.

[0022] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of Linderae striata, 5 parts of Amomum villosum, 10 parts of Citrus aurantium, 10 parts of Aucklandia lappa, 10 parts of Licorice root, 15 parts of Corydalis yanhusuo, 15 parts of Scrophularia ningpoensis, 20 parts of Oyster, 5 parts of Prunella vulgaris, 10 parts of Fritillaria thunbergii, 20 parts of Taraxacum mongolicum, 15 parts of Luffa sponge, 15 parts of Ginger, 20 parts of Citrus aurantium, and 15 parts of Caulis dahuricae.

[0023] According to the formula of this comparative example, decoction is prepared by decoction, and the amount of Chinese medicinal materials for one dose is as follows: Linderae 15g, Amomum villosum 5g, Citrus aurantium 10g, costus root 10g, liquorice 10g, Corydalis 15g, Scrophularia 15g, oyster 20g, Prunella vulgaris 5g, Fritillaria thunbergii 10g, dandelion 20g, Luffa 15g, ginger 15g, citrus seed 20g, Cistanche deserticola 15g.

[0024] Comparative Example 3 Based on Example 1, Corydalis yanhusuo was replaced by Leonurus japonicus.

[0025] A traditional Chinese medicine composition for treating breast hyperplasia is prepared from the following raw materials in parts by weight: 15 parts of Linderae scutellariae, 5 parts of Amomum villosum, 10 parts of Cyperus rotundus, 10 parts of Aucklandia lappa, 10 parts of Licorice root, 15 parts of Leonurus japonicus, 15 parts of Scrophularia ningpoensis, 20 parts of Oyster, 5 parts of Prunella vulgaris, 10 parts of Fritillaria thunbergii, 20 parts of Taraxacum mongolicum, 15 parts of Luffa sponge, 15 parts of Ginger, 20 parts of Citrus aurantium, and 15 parts of Caulis Aconiti Lateralis Preparata.

[0026] According to the formula of this comparative example, decoction is prepared by decoction, and the amount of Chinese medicinal materials for one dose is as follows: Linderae 15g, Amomum villosum 5g, Cyperus rotundus 10g, Aucklandia lappa 10g, Licorice root 10g, Leonurus japonicus 15g, Scrophularia ningpoensis 15g, Oyster 20g, Prunella vulgaris 5g, Fritillaria thunbergii 10g, Taraxacum mongolicum 20g, Luffa 15g, Ginger 15g, Citrus aurantium 20g, Cistanche deserticola 15g.

[0027] Comparative Example 4 Based on Example 1, the amount of each component was adjusted.

[0028] A traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of Linderae serrata, 5 parts of Amomum villosum, 15 parts of Cyperus rotundus, 15 parts of Aucklandia lappa, 15 parts of Glycyrrhiza uralensis, 15 parts of Corydalis yanhusuo, 15 parts of Scrophularia ningpoensis, 15 parts of Oyster, 5 parts of Prunella vulgaris, 15 parts of Fritillaria thunbergii, 15 parts of Taraxacum mongolicum, 15 parts of Luffa sponge, 15 parts of Ginger, 15 parts of Citrus aurantium, and 15 parts of Caulis Aconiti Lateralis Preparata.

[0029] According to the formula of this comparative example, decoction is prepared, and the amount of Chinese medicinal materials for one dose (a total of 200g) is as follows: Linderae 10g, Amomum villosum 5g, Cyperus rotundus 15g, Aucklandia 15g, Licorice root 15g, Corydalis 15g, Scrophularia 15g, Oyster 15g, Prunella vulgaris 5g, Fritillaria thunbergii 15g, Taraxacum mongolicum 15g, Luffa 15g, Ginger 15g, Citrus aurantium 15g, Cistanche deserticola 15g.

[0030] Test example 1 General Information A total of 200 patients with clinical diagnosis of breast hyperplasia, breast BI-RADS grade 4-6, aged 18-60 years, all female patients were selected and randomly divided into 40 groups, including study groups 1-5.

[0031] 2 Clinical manifestations 2.1 Non-inflammatory and non-neoplastic breast lesions; 2.2 Cyclic / non-cyclic breast pain; 2.3 Breast nodules or diffuse, step-wise thickening of the glands; 2.4 A small number of patients experience nipple discharge.

[0032] 3 Diagnostic methods 3.1 Patient history 3.2 Systematic breast examination 3.3 Ultrasound examination 3.4 Mammography 3.5 Breast MRI 3.6 Histopathological examination 4 Treatment methods Study groups 1-5 were administered the Chinese medicine compositions of Example 1 and Comparative Examples 1-4, respectively.

[0033] Usage: Decoction in water, one dose per day. Take 200ml of the decoction each time, decoct twice in a row, mix well, divide into two equal portions, and take 200ml each half an hour after meals in the morning and evening. 30 days constitutes one course of treatment, and 1-3 courses are recommended.

[0034] 5. Criteria for judging efficacy 5.1 Breast pain: No pain or tenderness was scored as 0 points; The patient felt slight pain and had slight pain when touched, which was scored as 2 points; Conscious pain, tenderness, aggravated before menstruation, and paroxysmal pain are scored as 4 points; The patient feels obvious pain, feels pain with slight touch, or cannot touch, and is continuous. If the pain is severe, it may radiate to the armpits, shoulders and back, affecting daily life. It is scored as 6 points.

[0035] 5.2 Breast lump size: Those without a mass were scored as 0 points; Mass ≤ 2 × 2 cm 2 Those who fail to meet the requirements will be scored as 2 points; Mass > 2 × 2 cm 2 , ≤5×5cm 2 Those with 4 points will be scored; Mass > 5 × 5 cm 2 Those who fail to pass the test will be scored as 6 points.

[0036] Percentage reduction of symptom score = (total score before treatment - total score after treatment) / total score before treatment × 100%.

[0037] Cure: symptom score reduction percentage ≥90%; Markedly effective: 70% ≤ symptom score reduction percentage < 90%; Effective: 30% ≤ symptom score reduction percentage < 70%; Ineffective: The percentage reduction of symptom score is <30%.

[0038] 6 Treatment results Table 1 Comparison of efficacy among study groups

[0039] As can be seen from Table 1, the Chinese medicine composition of Example 1 of the present invention has a significant therapeutic effect on the treatment of breast hyperplasia (BI-RADS 4-6), with a cure rate of 87.5%, which is significantly higher than that of Comparative Examples 1-4.

[0040] Wherein, in Comparative Example 1, Linderae Radix is ​​replaced by Aconite Radix; In Comparative Example 2, Cyperus rotundus is replaced by Fructus Aurantii Immaturus, and the therapeutic effects of Comparative Examples 1-2 are significantly decreased, and especially the cure rate is relatively low. In Comparative Example 3, Corydalis yanhusuo is replaced by Leonurus japonicus on the basis of Example 1, and the therapeutic effect of Comparative Example 3 is also significantly decreased, and the cure rate is also significantly decreased. In Comparative Example 4, the dosage of each component is adjusted on the basis of Example 1, and the therapeutic effect of Comparative Example 4 is significantly decreased, and the cure rate is also not good enough. In summary, a certain amount of Linderae Radix, Cyperus rotundus, and Corydalis yanhusuo are added to the formula of the present invention to produce a significant effect on the therapeutic effect of treating cyclomastopathy, and the ratio of each raw material dosage of the present invention has a significant effect on the therapeutic effect.

[0041] Example 2 A traditional Chinese medicine composition for treating breast hyperplasia is prepared from the following raw materials in parts by weight: 18 parts of Linderae scutellariae, 4 parts of Amomum villosum, 8 parts of Cyperus rotundus, 12 parts of Aucklandia lappa, 10 parts of Glycyrrhiza uralensis, 18 parts of Corydalis yanhusuo, 13 parts of Scrophularia ningpoensis, 18 parts of Oyster, 6 parts of Prunella vulgaris, 8 parts of Fritillaria thunbergii, 23 parts of Taraxacum mongolicum, 13 parts of Luffa sponge, 18 parts of ginger, 18 parts of Citrus aurantium, and 13 parts of Caulis dahuricae.

[0042] The decoction was prepared by decoction according to the formula of this embodiment. The amount of Chinese medicinal materials for one dose was as follows: Linderae 18g, Amomum villosum 4g, Cyperus rotundus 8g, Aucklandia 12g, Licorice root 10g, Corydalis 18g, Scrophularia 13g, Oyster 18g, Prunella vulgaris 6g, Fritillaria thunbergii 8g, Taraxacum mongolicum 23g, Luffa 13g, Ginger 18g, Citrus aurantium 18g, Cistanche deserticola 13g.

[0043] The Chinese medicine composition in this embodiment is used to treat breast hyperplasia (the patient's breast BI-RADS grade is 4-6), and the clinical cure rate is 82.5%.

[0044] Example 3 A traditional Chinese medicine composition for treating breast hyperplasia is prepared from the following raw materials in parts by weight: 13 parts of Linderae scutellariae, 6 parts of Amomum villosum, 12 parts of Cyperus rotundus, 8 parts of Aucklandia lappa, 10 parts of Glycyrrhiza uralensis, 13 parts of Corydalis yanhusuo, 18 parts of Scrophularia ningpoensis, 23 parts of Oyster, 4 parts of Prunella vulgaris, 12 parts of Fritillaria thunbergii, 18 parts of Taraxacum mongolicum, 18 parts of Luffa sponge, 13 parts of ginger, 23 parts of Citrus aurantium, and 18 parts of Caulis dahuricae.

[0045] The decoction was prepared by decoction according to the formula of this embodiment. The amount of Chinese medicinal materials for one dose was as follows: Linderae 13g, Amomum villosum 6g, Cyperus rotundus 12g, Aucklandia lappa 8g, Licorice root 10g, Corydalis 13g, Scrophularia ningpoensis 18g, Oyster 23g, Prunella vulgaris 4g, Fritillaria thunbergii 12g, Taraxacum mongolicum 18g, Luffa 18g, Ginger 13g, Citrus aurantium 23g, Ceratonia suffruticosa 18g.

[0046] The Chinese medicine composition in this embodiment is used to treat breast hyperplasia (the patient's breast BI-RADS grade is 4-6), and the clinical cure rate is 80.0%.

[0047] Example 4 A traditional Chinese medicine granule for treating breast hyperplasia is prepared from the following raw materials in parts by weight: 15 parts of Linderae scutellariae, 5 parts of Amomum villosum, 10 parts of Cyperus rotundus, 10 parts of Aucklandia lappa, 10 parts of Licorice root, 15 parts of Corydalis yanhusuo, 15 parts of Scrophularia ningpoensis, 20 parts of Oyster, 5 parts of Prunella vulgaris, 10 parts of Fritillaria thunbergii, 20 parts of Taraxacum mongolicum, 15 parts of Luffa fructus, 15 parts of ginger, 20 parts of Citrus aurantium, and 15 parts of Caulis dahuricae.

[0048] The granule preparation method comprises the following steps: extracting the Chinese medicinal materials Linderae radix, Amomum villosum, Cyperus rotundus, Aucklandia lappa, Glycyrrhiza uralensis, Corydalis yanhusuo, Scrophularia ningpoensis, Oyster, Prunella vulgaris, Fritillaria thunbergii, Taraxacum mongolicum, Luffa scoparia, ginger, Citrus aurantium, and Caulis dasyphyllae by decocting in water, concentrating under reduced pressure to 1.30-1.40 (60°C) to obtain a clear paste, adding an auxiliary material (sucrose) at a mass ratio of 1:1, granulating through a 100-mesh sieve, shaping the granules, and sterilizing to obtain the granules. The Chinese medicinal granules in this embodiment have been used to treat breast hyperplasia and have shown good clinical efficacy.

[0049] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention.

Claims

1. A Chinese medicine composition for treating breast hyperplasia, characterized in that: The invention comprises the following raw materials in parts by weight: 13-18 parts of Linderae serrata, 4-6 parts of Amomum villosum, 8-12 parts of Cyperus rotundus, 8-12 parts of Aucklandia lappa, 8-12 parts of Licorice root, 13-18 parts of Corydalis yanhusuo, 13-18 parts of Scrophularia ningpoensis, 18-23 parts of Oyster, 4-6 parts of Prunella vulgaris, 8-12 parts of Fritillaria thunbergii, 18-23 parts of Taraxacum mongolicum, 13-18 parts of Luffa sponge, 13-18 parts of Ginger, 18-23 parts of Citrus aurantium, and 13-18 parts of Ceratonia suffruticosa.

2. A Chinese medicine composition for treating breast hyperplasia according to claim 1, characterized in that, The invention comprises the following raw materials in parts by weight: 15 parts of Linderae scutellariae, 5 parts of Amomum villosum, 10 parts of Cyperus rotundus, 10 parts of Aucklandia lappa, 10 parts of Licorice root, 15 parts of Corydalis yanhusuo, 15 parts of Scrophularia ningpoensis, 20 parts of Oyster, 5 parts of Prunella vulgaris, 10 parts of Fritillaria thunbergii, 20 parts of Taraxacum mongolicum, 15 parts of Luffa sponge, 15 parts of Ginger, 20 parts of Citrus aurantium, and 15 parts of Cistanche deserticola.

3. A Chinese medicine preparation for treating breast hyperplasia, characterized in that: Prepared from the Chinese medicine composition according to any one of claims 1 to 2.

4. A Chinese medicinal decoction for treating breast hyperplasia, characterized in that: Prepared from the Chinese medicine composition according to any one of claims 1 to 2.

5. A Chinese medicine granule for treating breast hyperplasia, characterized in that: Prepared from the Chinese medicine composition according to any one of claims 1 to 2.

6. A Chinese medicine granule for treating breast hyperplasia according to claim 5, characterized in that: The preparation method of the granules comprises the following steps: taking various medicinal materials, decocting in water for extraction, concentrating under reduced pressure at 55-65° C. to 1.30-1.40 to obtain a clear paste, adding auxiliary materials with a mass ratio of the clear paste to the auxiliary materials being 1:1-2, sieving and granulating, shaping the particles, and sterilizing to obtain the granules.

7. A Chinese medicine granule for treating breast hyperplasia according to claim 6, characterized in that: The auxiliary material is sucrose.

8. A Chinese medicinal granule for treating breast hyperplasia according to claim 6, characterized in that: The sieving is through an 80-120 mesh sieve.

9. Use of the Chinese medicine composition according to any one of claims 1 to 2 in the preparation of a medicament for treating breast hyperplasia.

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