Traditional Chinese medicine effective part composition for treating hyperplasia of mammary glands, traditional Chinese medicine preparation and application

Abstract

The invention relates to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine effective part composition for treating hyperplasia of mammary glands, a traditional Chinese medicine preparation and application. Comprising the following components in parts by weight: 10-25 parts of a centipede rhizome total saponin extract, 10-25 parts of a cucurbit rhizome total terpene extract, 10-25 parts of a star-flower root total terpene extract, 5-10 parts of a radix paeoniae alba total terpene extract, 5-15 parts of a platycodon grandiflorum total flavone extract, 5-10 parts of a paederia scandens total terpene extract, 5-10 parts of a gentiana apiata total flavone extract, 5-10 parts of a bighead atractylodes rhizome total terpene extract and 5-10 parts of a fructus aurantii total flavone extract. 5-10 parts of a common cnidium fruit total coumarin extract; the traditional Chinese medicine preparation comprises the composition and auxiliary materials. The invention also discloses application of the composition in preparation of medicines for treating hyperplasia of mammary glands and breast nodules. The traditional Chinese medicine composition directly acts on a focus part according to a treatment principle of activating blood, soothing the liver, removing stasis and regulating endocrine, and is used for treating hyperplasia of mammary glands and breast nodules in a multi-way synergistic manner.

Description

Technical Field

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

[0002] Mammary gland hyperplasia refers to hyperplasia of mammary gland epithelium and fibrous tissue, and is characterized by degenerative lesions of mammary gland tissue ducts and lobules and progressive growth of connective tissue. It is a hyperplastic lesion that is neither inflammatory nor tumorous, with the main clinical manifestations of breast lumps and pain. The causes of its onset include endocrine disorders, especially the imbalance between estrogen and progesterone, living habits and psychological factors. At the same time, prolactin is also related to the occurrence and development of mammary gland hyperplasia; some specific genes are also expressed to varying degrees in mammary gland hyperplasia, ultimately leading to a series of pathological changes such as the formation of breast fibrous tissue hyperplasia, fibrocystic hyperplasia and fibroadenoma. In big cities in China, about 50% - 70% of female patients have varying degrees of mammary gland hyperplasia, mostly occurring in women aged 25 - 45.

[0003] Clinical treatment methods for mammary gland hyperplasia include oral administration of hormonal drugs, acupuncture and massage, and surgical resection, etc. Although there is a certain therapeutic effect, there are some problems. For example, for the oral hormonal drug tamoxifen, while the curative effect is significant, it is often accompanied by side effects such as hot flashes, menstrual disorders and elevated triglycerides. Surgical resection cannot cure endocrine disorders and is prone to recurrence after surgery.

[0004] Traditional Chinese medicine believes that qi stagnation is the root cause of the onset of mammary gland nodules and hyperplasia. Qi stagnation will directly affect the occurrence and change of mammary gland diseases. "Women take the liver as the congenital foundation". In the theory of meridians, the jueyin meridian of foot runs along the chest and flanks and surrounds the nipples. Liver qi stagnation and liver failure to store blood lead to the production of local pathological products in the breast, including phlegm coagulation, stasis, etc. Epidemiological investigations also show that patients with qi depression are more likely to suffer from mammary gland diseases.

[0005] Traditional Chinese medicine has unique advantages and potential in the treatment of breast nodules and hyperplasia. Currently, the existing proprietary Chinese medicines for the treatment of breast hyperplasia are mainly Rupisanjie Capsules, Runhe Sanjie Tablets, Ruijiling Capsules, or Danzhi Xiaoyao Pills. The patent with the publication number CN109394933A discloses a traditional Chinese medicine oral preparation composition and its preparation method for the treatment of breast hyperplasia and breast nodules. The raw materials include musk, dragon's blood, toad, calomel, frankincense, myrrh, colostrum, medicated leaven, chicken gizzard-membrane, fritillary bulb, pangolin scales, and notoginseng. It treats breast hyperplasia and nodules by soothing the liver and regulating qi, activating blood circulation to dredge collaterals, and dissipating stasis and nodules; the patent with the publication number CN118059202A discloses a traditional Chinese medicine oral preparation composition for the treatment of breast nodules, which consists of the following raw materials: 10 parts of stir-fried turtle shell with vinegar, 10 parts of bolbostemma paniculatum, 5 parts of tangerine leaves, 6 parts of green tangerine peel, 8 parts of cyperus rotundus, 8 parts of rhizoma corydalis, 5 parts of myrrh, 6 parts of pseudobulbus cremastrae seu pleiones, 5 parts of ground beetle, 6 parts of zedoary, 5 parts of semiaquilegia adoxoides, 8 parts of astragalus membranaceus, 6 parts of angelica sinensis, 6 parts of cuscuta chinensis, and 6 parts of morinda officinalis. It mainly treats breast nodules by soothing the liver and regulating qi, promoting blood circulation to remove stasis; although the traditional Chinese medicine oral preparations of the above inventions can relieve the condition of breast hyperplasia, they have large side effects of oral medications, such as endocrine disorders, gastrointestinal irritation, and increased metabolic pressure on the liver and kidneys; the patent with the publication number CN119326855A discloses a traditional Chinese medicine patch for the treatment of breast nodules, which consists of the following raw materials: 70 parts of safflower, 70 parts of typha angustifolia, 55 parts of millettia reticulata, 50 parts of angelica sinensis, 50 parts of weeping forsythia, 42 parts of earthworm, 42 parts of gastrodia elata, 35 parts of notoginseng, 35 parts of cassia twig, 26 parts of thunberg fritillary bulb, 22 parts of frankincense, 22 parts of chicken gizzard-membrane, 12 parts of atractylodes lancea, 15 parts of platycodon grandiflorum, 8 parts of zedoary, 8 parts of semiaquilegia adoxoides, 6 parts of bupleurum chinense, and 6 parts of salvia miltiorrhiza; the traditional Chinese medicine patch of this patent has complex components and difficult quality control, and there is a risk of skin irritation. Some patients may have local adverse reactions such as rash and swelling if the application time is too long or for those with allergic constitutions, and the effect of the crude traditional Chinese medicine extract in treating breast hyperplasia and nodules is limited.

[0006] Therefore, it is necessary to research and develop new traditional Chinese medicine effective ingredient compositions for the treatment of breast hyperplasia to eliminate the drawbacks of existing drugs. Summary of the Invention

[0007] The purpose of the present invention is to provide a traditional Chinese medicine effective part composition, a traditional Chinese medicine preparation, and an application for the treatment of breast hyperplasia. Through the synergistic effect of multiple traditional Chinese medicine effective parts, with the treatment principle of "activating blood circulation - soothing the liver - dissipating nodules - regulating endocrine", it directly acts on the lesion site and treats breast hyperplasia and breast nodules through multi-pathway synergy, mainly manifested in significantly reducing the diameter and height of the nipple and the levels of E2, LH, and FSH in the serum, significantly increasing the PROG level, improving the conditions of breast hyperplasia and endocrine hormone disorders, and promoting breast health.

[0008] The embodiments of the present invention are achieved through the following technical solutions:

[0009] The invention provides a traditional Chinese medicine effective part composition for treating breast hyperplasia. The composition comprises, by weight, 10-25 parts of a total saponin extract of Scolopendra chinensis, 10-25 parts of a total terpene extract of Cucurbitacin rutaecarpa, 10-25 parts of a total terpene extract of Herba Cnidium monnieri, 5-10 parts of a total terpene extract of Paeonia lactiflora, 5-15 parts of a total flavonoid extract of Platycodon grandiflorum, 5-10 parts of a total terpene extract of Herba Coptidis, 5-10 parts of a total flavonoid extract of Herba Atractylodes macrocephalae, 5-10 parts of a total flavonoid extract of Fructus Aurantii Immaturus and 5-10 parts of a total coumarin extract of Fructus Cnidium monnieri.

[0010] The present invention also provides a traditional Chinese medicine preparation for treating breast hyperplasia, comprising the above-mentioned traditional Chinese medicine effective part composition and pharmaceutically acceptable excipients; wherein the traditional Chinese medicine effective part composition accounts for 40-80% of the total weight of the preparation.

[0011] The preparation method of the above-mentioned Chinese medicine preparation comprises the following steps:

[0012] S1. Grind the above raw materials separately, pass through a 40-mesh sieve, and set aside;

[0013] S2. The above raw material extracts are combined and concentrated according to the ratio, and auxiliary materials are added to prepare a clinically applicable dosage form.

[0014] The present invention also provides an application of the above-mentioned effective part composition of traditional Chinese medicine in preparing medicine for treating breast hyperplasia and breast nodules.

[0015] The technical solutions of the embodiments of the present invention have at least the following advantages and beneficial effects:

[0016] The present invention, based on the known pharmacological effects of the seven Qinling medicines, proposes for the first time to compound different extracts of different Chinese medicinal materials for the treatment of breast nodules and breast hyperplasia. Specifically, the present invention uses the total saponin extract of Scolopendra subspinipes, the total terpene extract of Cucurbitacin rubra, the total terpene extract of Chafengqi, the total terpene extract of White Peony Root, the total flavonoid extract of Platycodon grandiflorum, the total terpene extract of Millettia repens, the total flavonoid extract of Herba Anemarrhenae, the total terpene extract of Atractylodes macrocephala, the total flavonoid extract of Fructus Aurantii Immaturus, and the total coumarin extract of Fructus Cnidium as effective parts for scientific proportioning. Through the synergistic enhancement of multiple components, the invention adopts the therapeutic principle of "activating blood circulation - soothing the liver - dispersing nodules - regulating endocrine", directly acts on the lesion site, is more conducive to absorption, and has a mild effect. It synergistically treats breast hyperplasia and breast nodules through multiple pathways, which is mainly manifested in significantly reducing the diameter and height of the nipple and the levels of E2, LH and FSH in serum, significantly increasing the level of PROG, improving breast hyperplasia and endocrine hormone disorders, and promoting breast health. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only illustrate certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0018] Figure 1 Schematic diagram showing the effect of the effective fraction composition of the traditional Chinese medicine of the present invention on the nipple height and nipple diameter of mammary hyperplasia model rats;

[0019] Figure 2 This is a schematic diagram showing the effect of the effective fraction composition of the traditional Chinese medicine of the present invention on the hormone levels in the serum of rats with mammary hyperplasia model;

[0020] Figure 3 This is a schematic diagram of the effects of the effective fraction composition of the traditional Chinese medicine of the present invention on the pathological morphology of mammary gland tissue in rats with mammary hyperplasia model. DETAILED DESCRIPTION

[0021] To make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention are described clearly and completely below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer are used. Where the manufacturer of the reagents or instruments is not specified, all are conventional products that can be purchased commercially.

[0022] The following is a detailed description of a composition of effective parts of traditional Chinese medicine, a traditional Chinese medicine preparation and an application for treating breast hyperplasia provided in an embodiment of the present invention.

[0023] A composition of effective parts of traditional Chinese medicine for treating breast hyperplasia comprises, by weight, 10-25 parts of total saponin extract of Scolopendra suber, 10-25 parts of total terpene extract of Cucurbitacin rubra, 10-25 parts of total terpene extract of Herba Cnidium, 5-10 parts of total terpene extract of Paeonia lactiflora, 5-15 parts of total flavonoids extract of Platycodon grandiflorum, 5-10 parts of total terpene extract of Cnidium monnieri, 5-10 parts of total flavonoids extract of Herba Atractylodes macrocephalae, 5-10 parts of total flavonoids extract of Fructus Aurantii Immaturus, and 5-10 parts of total coumarin extract of Fructus Cnidium monnieri.

[0024] Preferably, the composition comprises, by weight: 15-20 parts of total saponin extract of Scolopendra suber, 15-20 parts of total terpene extract of Cucurbitacin rubra, 15-20 parts of total terpene extract of Herba Chuifugae, 7-9 parts of total terpene extract of Paeonia lactiflora, 8-12 parts of total flavonoid extract of Platycodon grandiflorum, 6-8 parts of total terpene extract of Cnidium monnieri, 6-8 parts of total flavonoid extract of Herba Atractylodes macrocephala, 6-8 parts of total flavonoid extract of Fructus Aurantii Immaturus, and 6-8 parts of total coumarin extract of Fructus Cnidium monnieri.

[0025] Preferably, the composition comprises, by weight: 15 parts of total saponin extract of Scolopendra suber, 15 parts of total terpene extract of Cucurbitacin rubra, 15 parts of total terpene extract of Chaenomeles sinensis, 7 parts of total terpene extract of White Peony Root, 10 parts of total flavonoid extract of Platycodon grandiflorum, 7 parts of total terpene extract of Millettia repens, 7 parts of total flavonoid extract of Herba Polygoni Multiflori, 7 parts of total terpene extract of Atractylodes macrocephala, 7 parts of total flavonoid extract of Fructus Aurantii Immaturus, and 7 parts of total coumarin extract of Fructus Cnidium monnieri.

[0026] Preferably, the preparation method of the total saponin extract of Scolopendra subtilis is as follows: extracting Scolopendra subtilis with ethanol by heating and refluxing for multiple times to obtain extracts respectively, combining the extracts, filtering, concentrating the filtrate under reduced pressure, eluting the concentrate through a D101 macroporous resin, collecting the eluate, and concentrating; more specifically, adding 10-30 times the amount of 70%-80% ethanol to Scolopendra subtilis, heating and refluxing at 70-90° C. for multiple extractions, each for 1-2 hours, combining the extracts, filtering, concentrating the filtrate under reduced pressure, passing the concentrate through a D101 macroporous resin, first washing with 5BV of water, then washing with 4BV of 30% ethanol, and finally eluting with 6BV of 70% ethanol, collecting the 70% ethanol eluate, and concentrating to obtain the extract;

[0027] More specifically, the total saponin extract of Scolopendra suberectus includes Araloside A and at least one of Chikusetsusaponin IVa, Chikusetsu saponin Ib, and 28-Desglucosylchikusetsusaponin IV, and the content of total saponins in the extract is 30% to 78%, wherein the content of Araloside A is not less than 40% of the total saponins.

[0028] Preferably, the preparation methods of the total terpene extracts of Cucurbitacin and Atractylodes macrocephala are the same, both adopting the following manner: the raw materials (i.e., Cucurbitacin and Atractylodes macrocephala) are soaked and extracted separately, evaporated to dryness under reduced pressure, the extracts are dispersed with water and then extracted with an organic solvent, the extracts are collected and concentrated, the concentrates are separated with a silica gel column, eluted with a chloroform-methanol gradient, and recovered; more specifically, the raw materials (Cucurbitacin and Atractylodes macrocephala) are respectively soaked and extracted with 10-30 times the amount of 95% ethanol for 40-50 hours, evaporated to dryness under reduced pressure, the extracts are dispersed with water and extracted with petroleum ether, ethyl acetate, and n-butanol for multiple times, the extracts are collected and concentrated, the concentrates are separated with a silica gel column, and then eluted with a chloroform-methanol gradient, recovered, and concentrated to obtain the Cucurbitacin total terpene extract and the Atractylodes macrocephala total terpene extract;

[0029] More specifically, the total sesquiterpenoid extract of Ledebouriella seseloides includes one of 10α-H-furanoligularenone, 10β-H-furanoligularenone, S-Petasin, petasol, and 2-Hydroxplatyphyllide. The content of total sesquiterpenoids in the extract is not less than 30% to 78%. Among them, the content of 10α-H-furanoligularenone is not less than 25% of the total sesquiterpenoids, and the content of 10β-H-furanoligularenone is not less than 18% of the total sesquiterpenoids.

[0030] The total sesquiterpenoid extract of Atractylodes macrocephala includes one of 3β-acetoxyatractylone and Atractylenolide-1, 2-Atractylenolide, and Atractylenolide III. The content of total sesquiterpenoids in the extract is not less than 28% to 41%. Among them, the content of 3β-acetoxyatractylone is not less than 33% of the total sesquiterpenoids.

[0031] Preferably, the preparation methods of the total flavonoid extracts of Platycodon grandiflorum, Swertia nervosa, and Aurantii Fructus Immaturus are the same, and all are as follows: The raw materials are extracted by heating under reflux with ethanol, the extraction solutions are combined, filtered, the filtrate is concentrated under reduced pressure, the concentrated solution is eluted through AB-8 type resin, the ethanol eluate is collected and concentrated; More specifically, the raw materials are extracted by heating under reflux with 10-30 times the amount of 70%-80% ethanol at 70-80°C for multiple times, 2-3 hours each time; the extraction solutions are combined, filtered, the filtrate is concentrated under reduced pressure, the concentrated solution passes through AB-8 type resin, elution conditions: first remove impurities with distilled water, and then elute with 70% ethanol at a flow rate of 1.0-2.0 BV / h, collect the 70% ethanol eluate and concentrate to obtain the total flavonoid extracts of Platycodon grandiflorum, Swertia nervosa, and Aurantii Fructus Immaturus.

[0032] More specifically, the total flavonoid extract of Platycodon grandiflorum includes at least one of 5,7-Dihydroxy-4'-methoxyflavone, lonicerin, rhoifolin, luteolin 7-O-β-D-glucopyranosid, and apigenin7-O-β-D-gluglucopyranoside. The content of total flavonoids in the extract is not less than 26% to 65%. Among them, the content of 5,7-Dihydroxy-4'-methoxyflavon is not less than 30% of the total flavonoids.

[0033] The total flavonoid extract of **Zhulingcao** includes 3',4',5,7-Tetrahydroxy-6-C-glucopyranosylflavone and 6-C-Glucosylapigenin. The content of total flavonoids in the extract is not less than 35% - 60%, and the content of 3',4',5,7-Tetrahydroxy-6-C-glucopyranosylflavone is not less than 20% of the total flavonoids.

[0034] The total flavonoid extract of **Fructus Aurantii** includes Hesperidin, Nobiletin, Neohesperidin, 5-demethylnobiletin, 5,6,7,8-Tetramethoxy-2-(4-methoxyphenyl)-4-benzopyrone, etc. The content of total flavonoids in the extract is not less than 35% - 71%, and the content of Hesperidin is not less than 30% of the total flavonoids, and Nobiletin is not less than 26% of the total flavonoids.

[0035] Preferably, the preparation methods of the total terpenoids extracts of **Chuifengqi** and **Radix Paeoniae Alba** are the same, and they are all carried out in the following way: ultrasonic-assisted extraction. The raw materials are extracted by ultrasonic-assisted extraction with 60% - 70% ethanol solution, the extraction solutions are combined and centrifuged, ethanol is removed by reduced pressure concentration, degreasing and decoloring are carried out by extracting with the same volume of petroleum ether for multiple times, and extraction is carried out with the same volume of saturated n-butanol for multiple times, and the extraction solutions are combined and concentrated. More specifically, the raw materials are extracted by ultrasonic-assisted extraction with 10 - 30 times the amount of 60% - 70% ethanol solution for 30 - 60 min. After multiple extractions, the extraction solutions are combined and centrifuged (2000 - 4000 rpm, 10 - 30 min), ethanol is removed by reduced pressure concentration at 50 - 70 °C, degreasing and decoloring are carried out by extracting with the same volume of petroleum ether for multiple times, and extraction is carried out with the same volume of saturated n-butanol for multiple times, and the extraction solutions are combined and concentrated to obtain the total terpenoids extracts of **Chuifengqi** and **Radix Paeoniae Alba**.

[0036] More specifically, the total terpenoids extract of **Chuifengqi** includes at least one of 3beta-Hydroxyurs-12-en-28-oic acid, Nigaichigoside F1, 2α,19α-Dihydroxyursolic acid, and (2alpha,3beta)-2,3-Dihydroxy-olean-12-en-28-oic acid. The content of total terpenoids in the extract is not less than 20% - 35%, and the content of 3beta-Hydroxyurs-12-en-28-oic acid is not less than 23% of the total terpenoids.

[0037] The total paeony glycosides extract comprises at least one of 3beta-Hydroxy-20(29)-lupaene-28-oic acid, 23-Hydroxybetulinic acid, (3beta,4alpha)-3,23-Dihydroxyolean-12-en-28-oic acid, and Oleanic acid. The content of total terpenoids in the extract is not less than 20% - 35%, and the content of 3beta-Hydroxy-20(29)-lupaene-28-oic acid is not less than 30% of the total terpenoids.

[0038] Preferably, the preparation method of the total paederia scandens terpenoids extract is as follows: reflux extraction with methanol for multiple times, combine the extraction solutions, concentrate under reduced pressure, add water to prepare a solution, pass through HPD-100 macroporous resin, and collect and concentrate the ethanol eluate; more specifically, heat and reflux the raw materials with 5 - 10 times the amount of methanol for multiple times, each time for 1.5 - 2.5 h, combine the extraction solutions, concentrate under reduced pressure, add water to prepare a solution, pass through HPD-100 macroporous resin, elute with water to remove impurities, then elute with 90% ethanol solution, collect and concentrate the ethanol eluate to obtain the total paederia scandens terpenoids extract.

[0039] More specifically, the total paederia scandens terpenoids extract comprises at least one of Methylpaederosidate, Paederoside, and Paederosidic acid. The content of total terpenoids in the extract is not less than 26% - 38%, and the content of Methylpaederosidate is not less than 10% of the total terpenoids.

[0040] Preferably, the preparation method of the total osthole coumarins extract of cnidium monnieri is as follows: adopt the supercritical CO2 extraction method, and the extraction conditions are: the pressure of the extraction kettle is 35 - 45 MPa, the temperature is 35 - 45 °C, the pressures of the separation kettle I and separation kettle II used for supercritical CO2 extraction are both 5 MPa, the temperature of separation kettle I is 45 °C, and the temperature of separation kettle II is 46 °C.

[0041] More specifically, the total coumarin extract of Cnidium monnieri includes at least one of 7-Methoxy-8-(3-methyl-2-butenyl)-2H-1-benzopyran-2-one, 4-Methoxy-7H-furo[3,2-g]chromen-7-one, 7-Methoxy-4-methylcoumarin, 5,8-Dimethoxy-6,7-furanocoumarin, 2-Acetyl-7-methoxybenzofuran, and Imperatorin. The total coumarin content in the extract is not less than 25% to 39%, and the content of 7-Methoxy-8-(3-methyl-2-butenyl)-2H-1-benzopyran-2-one is not less than 20% of the total coumarin.

[0042] In addition, it should be noted that the multiple relationship between the above-mentioned raw materials and solvents (such as ethanol and methanol) is by weight ratio, and the unit is g / g.

[0043] In the effective part composition of traditional Chinese medicine described in the present invention, the effects of each raw material component are as follows:

[0044] Centipede Seven is the root bark and stem bark of Aralia chinensis L. of the Araliaceae family. It is bitter, pungent, and has a neutral nature. The root bark, stem bark, leaves, flowers, etc. can all be used as medicine, and it has the effects of analgesia and anti-inflammatory, expelling wind and promoting qi movement, removing dampness and activating blood circulation.

[0045] Gourd Seven is the root and rhizome of Ligularia hodgsonii Hook. of the Compositae family. It is sweet and pungent, and has a warm nature. It has the effects of regulating qi and activating blood circulation, relieving pain, relieving cough and resolving phlegm, and is used for traumatic injuries, overexertion injuries, low back and leg pain, cough and asthma, whooping cough, and hemoptysis due to lung abscess.

[0046] Chasing Wind Seven is the dried whole herb of Geum aleppicum Jacq. of the Rosaceae family. It is sweet and slightly bitter, and has a cool nature. It has the effects of replenishing qi and strengthening the spleen, nourishing blood and yin, moistening the lungs and resolving phlegm, and is used for qi and blood deficiency, consumptive cough, and leukorrhea due to spleen deficiency.

[0047] White Peony Root is the dried root of Paeonia lactiflora Pall. of the Ranunculaceae family. It is bitter, sour, and has a slightly cold nature. It has the effects of nourishing blood and regulating menstruation, astringing yin and stopping sweating, soothing the liver and relieving pain, and suppressing liver yang, and is used for sallow complexion due to blood deficiency, irregular menstruation, spontaneous sweating, night sweating, hypochondriac pain, abdominal pain, limb cramps, headache and dizziness.

[0048] Platycodon Root is the dried root of Platycodon grandiflorum (Jacq.) A. DC. of the Campanulaceae family. It is bitter, pungent, and has a neutral nature. It has the effects of dispersing the lung qi, relieving sore throat, resolving phlegm, and discharging pus, and is used for cough with profuse phlegm, chest tightness and discomfort, sore throat and hoarse voice, and lung abscess with expectoration of pus.

[0049] The root or whole herb of Paederia foetida L., a plant of the genus Paederia in the Rubiaceae family, is sweet, slightly bitter, and has a neutral nature. It has the effects of expelling wind and dampness, promoting digestion and resolving food stagnation, relieving cough, and alleviating pain. It is used for rheumatic pain in the muscles and bones, traumatic injuries, and traumatic pain.

[0050] The whole herb of Gentiana acaulis L., a plant of the genus Gentiana in the Gentianaceae family, is bitter and has a neutral nature. It has the effects of regulating menstruation and promoting blood circulation, clearing heat and improving eyesight, and promoting urination. It is used for irregular menstruation, dysmenorrhea, dizziness, insomnia, difficult urination, stranguria, metrorrhagia and leukorrhagia, leucorrhea, dysentery, and abdominal pain.

[0051] The dried rhizome of Atractylodes macrocephala Koidz., a plant of the Compositae family, is bitter, sweet, and has a warm nature. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and preventing miscarriage. It is used for poor appetite due to spleen deficiency, abdominal distension and diarrhea, dizziness and palpitation due to phlegm retention, edema, spontaneous sweating, and threatened abortion.

[0052] The dried immature fruit of Citrus aurantium L. and its cultivated varieties, plants of the Rutaceae family, is bitter, pungent, sour, and has a slightly cold nature. It has the effects of regulating qi and widening the middle-jiao, promoting qi movement and relieving distension. It is used for qi stagnation in the chest and hypochondrium, fullness and pain, indigestion, retention of phlegm-fluid, and visceral ptosis.

[0053] The dried ripe fruit of Cnidium monnieri (L.) Cuss., a plant of the Umbelliferae family, is pungent, bitter, and has a warm nature. It has the effects of drying dampness, expelling wind, killing insects and relieving itching, and warming the kidney and strengthening yang. It is used for itching of the vulva and leukorrhea, eczema and pruritus, damp arthralgia and low back pain, impotence due to kidney deficiency, and infertility due to cold uterus.

[0054] Based on the known pharmacological effects of the seven herbs in the Qinling Mountains, for the treatment of breast nodules and breast hyperplasia, the present invention first proposes to compound different extracts of different Chinese medicinal materials. Specifically, it is embodied in: scientifically proportioning the total saponin extract of Scolopendra subspinipes mutilans, the total terpene extract of Calanthe discolor, the total terpene extract of Clematis apiifolia, the total terpene extract of Paeonia lactiflora, the total flavonoid extract of Platycodon grandiflorum, the total terpene extract of Paederia foetida, the total flavonoid extract of Gentiana acaulis, the total terpene extract of Atractylodes macrocephala, the total flavonoid extract of Citrus aurantium, and the total coumarin extract of Cnidium monnieri as the effective parts. Through the synergistic effect of multiple components, with the treatment principle of "activating blood circulation - soothing the liver - dissipating nodules - regulating endocrine", it directly acts on the lesion site, is more conducive to absorption, and has a mild effect. It treats breast hyperplasia and breast nodules through multi-channel synergistic treatment, mainly manifested in significantly reducing the diameter and height of the nipple and the levels of E2, LH, and FSH in the serum, significantly increasing the PROG level, improving the conditions of breast hyperplasia and endocrine hormone disorders, and promoting breast health.

[0055] The present invention also provides a traditional Chinese medicine preparation for treating breast hyperplasia, including the above-mentioned traditional Chinese medicine effective part composition and pharmaceutically acceptable excipients; wherein the traditional Chinese medicine effective part composition accounts for 40 - 80% of the total weight of the preparation.

[0056] Preferably, the excipients include one or more of solvents, solubilizers, cosolvents, and transdermal absorption promoters; more specifically, the solvent can be water, ethanol, glycerol, etc.; the solubilizer can be polysorbate-80, polyoxyethylene hydrogenated castor oil, poloxamer, etc.; the cosolvent can be sodium benzoate, citric acid, nicotinamide, etc.; the transdermal absorption promoter can be menthol, oleic acid, borneol, etc.

[0057] Preferably, the dosage form of the above traditional Chinese medicine preparation is any one of ointment, liniment, patch, lotion, solution, powder, spray.

[0058] The preparation method of the above traditional Chinese medicine preparation includes the following steps:

[0059] S1. Crush the above raw materials respectively, pass through a 40-mesh sieve, and set aside;

[0060] S2. Combine, concentrate the extracts of the above raw materials according to the ratio, and add excipients to make a dosage form suitable for clinical use.

[0061] The present invention also provides an application of the above traditional Chinese medicine effective part composition in the preparation of drugs for treating mammary gland hyperplasia and mammary gland nodules.

[0062] Example 1

[0063] This example provides a traditional Chinese medicine effective part composition for treating mammary gland hyperplasia, which includes, by weight: 25 parts of total saponins extract of Centipeda minima, 25 parts of total terpenoids extract of Ligularia virgaurea, 25 parts of total terpenoids extract of Ligularia fischeri, 10 parts of total terpenoids extract of Paeonia lactiflora, 15 parts of total flavonoids extract of Platycodon grandiflorum, 10 parts of total terpenoids extract of Paederia scandens, 10 parts of total flavonoids extract of Swertia nervosa, 10 parts of total terpenoids extract of Atractylodes macrocephala, 10 parts of total flavonoids extract of Aurantii Fructus Immaturus, 10 parts of total coumarins extract of Cnidium monnieri.

[0064] This example also provides a spray, which includes the above traditional Chinese medicine effective part composition and borneol; its preparation method is as follows:

[0065] (1) Dry and crush each raw material drug, pass through a 40-mesh sieve, and set aside;

[0066] (2) Add 20 times the mass of 70% ethanol to each gram of Centipeda minima, heat under reflux at 80 °C for 3 times, 2 hours each time, combine the extraction solutions, filter, concentrate the filtrate under reduced pressure, pass the concentrated solution through D101 macroporous resin, first wash with 5BV of water, then wash with 4BV of 30% ethanol, and finally elute with 6BV of 70% ethanol, collect the 70% ethanol eluate, and concentrate to obtain the total saponins extract of Centipeda minima;

[0067] (3) After soaking and extracting 1 gram of *Paris vietnamensis* (Takht.) H. Li and *Atractylodes macrocephala* Koidz. separately with 20 times the mass of 95% ethanol for 48 hours, evaporating to dryness under reduced pressure, dispersing the extract in water, then extracting 3 times with petroleum ether, ethyl acetate, and n-butanol respectively, collecting the extraction solutions for concentration respectively, separating the concentrated solutions with a silica gel column, eluting with a chloroform-methanol gradient, collecting the eluate, and concentrating it to obtain the total terpene extracts of *Paris vietnamensis* (Takht.) H. Li and *Atractylodes macrocephala* Koidz.

[0068] (4) After heating and refluxing 1 gram of *Platycodon grandiflorus* (Jacq.) A. DC., *Swertia nervosa* (G. Don) Wall. ex C. B. Clarke, and *Poncirus trifoliata* (L.) Raf. separately with 20 times the mass of 70% ethanol at 75 °C for 3 times, each time for 2.5 hours; combining the extraction solutions, filtering, concentrating the filtrate under reduced pressure, eluting the concentrated solution through AB-8 type resin, elution conditions: first removing impurities with distilled water, then eluting with 70% ethanol at a flow rate of 1.0 BV / h, collecting the 70% ethanol eluate, and concentrating it to obtain the total flavonoid extracts of *Platycodon grandiflorus* (Jacq.) A. DC., *Swertia nervosa* (G. Don) Wall. ex C. B. Clarke, and *Poncirus trifoliata* (L.) Raf.;

[0069] (5) After ultrasonically assisting the extraction of 1 gram of *Lysimachia barystachys* Bunge and *Paeonia lactiflora* Pall. separately with 15 times the mass of 70% ethanol solution for 30 minutes, extracting 2 times and then combining the extraction solutions and centrifuging (3000 rpm, 10 minutes), concentrating under reduced pressure at 60 °C to remove ethanol, extracting with an equal volume of petroleum ether 2 times for defatting and decoloring, extracting with an equal volume of saturated n-butanol 2 times and then collecting the extraction solution and concentrating it to obtain the total terpene extracts of *Lysimachia barystachys* Bunge and *Paeonia lactiflora* Pall.;

[0070] (6) After heating and refluxing 1 gram of *Paederia scandens* (Lour.) Merr. with 8 times the mass of methanol for 2 times, each time for 2 hours, combining the extraction solutions, concentrating under reduced pressure, adding water to prepare a solution, passing through HPD-100 type macroporous resin, eluting with water to remove impurities, then eluting with 90% ethanol solution, collecting the ethanol eluate, and concentrating it to obtain the total terpene extract of *Paederia scandens* (Lour.) Merr.;

[0071] (7) The total coumarin extract of *Cnidium monnieri* (L.) Cuss. is prepared by supercritical CO₂ extraction method, and the extraction conditions are: the pressure of the extraction kettle is 40 MPa, the temperature is 40 °C, the pressures of the first and second separation kettles are both 5 MPa, the temperature of the first separation kettle is 45 °C, the temperature of the second separation kettle is 46 °C, and the rest of the operations are the same as the prior art;

[0072] (8) Mix the extracts obtained in the above steps (2) to (7) evenly in proportion, add borneol and stir to dissolve it, let it stand and filter, and divide the filtrate into clean and sterilized spray containers to prepare a spray.

[0073] Example 2

[0074] The difference between this embodiment and embodiment 1 is that the effective part composition of traditional Chinese medicine for treating breast hyperplasia includes, by weight, 10 parts of total saponin extract of Scolopendra subspinipes, 10 parts of total terpene extract of Cucurbitacin rubra, 10 parts of total terpene extract of Herba Chuifugae, 5 parts of total terpene extract of Paeonia lactiflora, 5 parts of total flavonoid extract of Platycodon grandiflorum, 5 parts of total terpene extract of Cnidium monnieri, 5 parts of total flavonoid extract of Herba Chuifugae, 5 parts of total terpene extract of Atractylodes macrocephala, 5 parts of total flavonoid extract of Fructus Aurantii Immaturus, and 5 parts of total coumarin extract of Fructus Cnidium monnieri.

[0075] Example 3

[0076] The difference between this embodiment and Example 1 is that the effective part composition of traditional Chinese medicine for treating breast hyperplasia includes, by weight, 15 parts of total saponin extract of Scolopendra subspinipes, 15 parts of total terpene extract of Cucurbitacin rubra, 15 parts of total terpene extract of Herba Epimedii, 7 parts of total terpene extract of Paeonia lactiflora, 10 parts of total flavonoid extract of Platycodon grandiflorum, 7 parts of total terpene extract of Cnidium monnieri, 7 parts of total flavonoid extract of Herba Atractylodes macrocephala, 7 parts of total flavonoid extract of Fructus Aurantii Immaturus, and 7 parts of total coumarin extract of Fructus Cnidium monnieri.

[0077] Example 4

[0078] The difference between this embodiment and embodiment 3 is that the effective part composition of traditional Chinese medicine for treating breast hyperplasia comprises, by weight, 7 parts of hesperidin, 15 parts of 10α-H-furanoligularenone and 10β-H-furanoligularenone, 7 parts of 3β-acetoxyatractylone, 15 parts of 3beta-Hydroxyurs-12-en-28-oic acid, 7 parts of methylpaederosidate, 7 parts of 3beta-Hydroxy-20(29)-lupaene-28-oic acid, 15 parts of araloside A, 10 parts of 5,7-Dihydroxy-4'-methoxyflavone, 7-methoxy-8-(3-methyl-2-butenyl)-2H-1-benzopyran-2-one, and 10 parts of 4-hydroxy-2-amino-3-thiazolinone. 7 parts of PEG-100, 7 parts of 3',4',5,7-Tetrahydroxy-6-C-glucopyranosylflavone, and 7 parts of PEG-100 are mixed uniformly according to the proportions. Borneol is added and stirred to dissolve. The mixture is allowed to stand and filtered. The filtrate is dispensed into clean and sterilized spray containers to prepare a spray.

[0079] Example 5

[0080] The difference between this example and Example 3 lies in that the dosage form of the traditional Chinese medicine preparation is a patch. In step (8), after mixing each extract evenly according to the proportion, honey is added and concentrated to a thick paste. After cooling, 8 g of the paste is taken from each portion and evenly coated on the empty waterproof film sticker, thus obtaining the traditional Chinese medicine patch.

[0081] Example 6

[0082] The difference between this example and Example 3 lies in that the dosage form of the traditional Chinese medicine preparation is an ointment. In step (8), after mixing each extract evenly according to the proportion, 8 parts of vaseline, 8 parts of stearyl alcohol, 8 parts of lanolin, and 12 parts of stearic acid are added, and they are put into a reaction kettle to be heated and dissolved, and then stirred at high speed and mixed evenly until an emulsified state is achieved, and then filled to obtain the traditional Chinese medicine ointment.

[0083] Experimental Example 1 - Determination of the Content of the Effective Parts of Traditional Chinese Medicine

[0084] The effective part extracts prepared by the preparation method of Example 1 were separated and purified by techniques such as silica gel column chromatography, sephadex gel chromatography, semi-preparative liquid chromatography, column chromatography, and thin layer chromatography, and their structures were analyzed by techniques such as 1H-NMR, 1D / 2D-NMR, 13C-NMR (DEPT), MS, and IR. It was measured that:

[0085] The total saponin content in the total saponin extract of Polygonatum cathcartii is 45%, and the content of Araloside A accounts for 60% of the total saponin;

[0086] The total terpenoids in the total terpenoid extract of Ligularia sibirica var. przewalskii account for 50% of the Ligularia sibirica var. przewalskii extract. Among them, the content of 10α-H-furanoligularenone accounts for 35% of the total terpenoids, and the content of 10β-H-furanoligularenone accounts for 30% of the total terpenoids;

[0087] The total terpenoid content in the total terpenoid extract of Gentiana apiata is 30%, and the content of 3beta-Hydroxyurs-12-en-28-oicacid accounts for 40% of the total terpenoids;

[0088] The total terpenoid content in the total terpenoid extract of Paeonia lactiflora is 35%, and the content of 3beta-Hydroxy-20(29)-lupaene-28-oic acid accounts for 40% of the total terpenoids;

[0089] The total flavonoid content in the total flavonoid extract of Platycodon grandiflorum is 65%, and the content of 5,7-Dihydroxy-4'-methoxyflavon accounts for 40% of the total flavonoids;

[0090] The total terpenoid content in the total terpenoid extract of Paederia scandens is 40%, and the content of Methylpaederosidate accounts for 30% of the total terpenoids;

[0091] The total flavonoid content in the total flavonoid extract of **Zhulingcao** is 70%, and the content of 3',4',5,7-Tetrahydroxy-6-C-glucopyranosylflavone accounts for 30% of the total flavonoid;

[0092] The total terpene content in the total terpene extract of **Atractylodis Macrocephalae Rhizoma** is 50%, and the content of 3β-acetoxyatractylone accounts for 40% of the total terpene;

[0093] The total flavonoid content in the total flavonoid extract of **Fructus Aurantii** is 80%, and the content of Hesperidin accounts for 40% of the total flavonoid, and the content of Nobiletin accounts for 30% of the total flavonoid;

[0094] The total coumarin content in the total coumarin extract of **Cnidii Fructus** is 50%, and the content of 7-Methoxy-8-(3-methyl-2-butenyl)-2H-1-benzopyran-2-one accounts for 30% of the total coumarin.

[0095] Experimental Example 2 - Therapeutic Effect of the Effective Part Composition of Traditional Chinese Medicine of the Present Invention on Rats with Mammary Hyperplasia Model

[0096] Model establishment: Sixty female SD rats weighing 180 - 220 g were adaptively fed for one week and randomly divided into 6 experimental groups, with 10 rats in each group, namely the blank group, the model group, the high, medium, and low dose groups of Example 3 (hereinafter referred to as the high dose group, the medium dose group, and the low dose group), and the positive group (using a mammary gland patch).

[0097] From the 8th day, except for the blank group, the rats in the other groups were established with a mammary hyperplasia model. The specific method is as follows: Estradiol benzoate was continuously intramuscularly injected into the hind legs at a dose of 0.5 mg / kg / d for 25 days; from the 26th day, progesterone was used and continuously intramuscularly injected into the hind legs at a dose of 5 mg / kg / d for 5 days.

[0098] After conversion according to the body surface area ratio of humans and rats, the drugs in each administration group (i.e., the high dose group, the medium dose group, and the low dose group) were sprayed on the second and third pairs of mammary glands of the rats and fixed with medical paper tape, and replaced daily for 30 consecutive days. Among them, the low dose group was administered 0.015 mL each time, the medium dose group was administered 0.03 mL each time, and the high dose group was administered 0.06 mL each time; the model group and the blank control group were not given special treatment.

[0099] Test method: The body weight of the rats and the diameter and height of the second group (i.e., the second and third pairs) of nipples of the rats were measured once a week, and the average value was taken. The test results are shown in Table 1.

[0100] Table 1 - Body Weights of Rats in Each Group Before and After Administration

[0101] Group Body weight after modeling (g) Body weight after drug administration (g) Blank group 238.46±11.01 252.01±12.36 Model group <![CDATA[216.92±5.14 ## > 220.32±9.79 Positive group 218.09±5.76 235.94±14.21 Low-dose group 218.851±10.87 232.78±24.15 Medium-dose group 217.67±9.12 <![CDATA[240.10±11.69 * > High-dose group 220.32±13.21 <![CDATA[241.46±17.88 ** >

[0102] It should be noted that: # indicates a significant difference compared with the blank group (P < 0.05), ## indicates a highly significant difference compared with the blank group (P < 0.01), * indicates a significant difference compared with the model group (P < 0.05), and ** indicates a highly significant difference compared with the model group (P < 0.01).

[0103] As can be seen from the results in Table 1: Before administration, the body weights of the rats in the blank group increased naturally, while those in the model group, positive group, low-dose group, medium-dose group, and high-dose group decreased compared with the blank group, indicating that the body weights of the rats decreased under the stimulation of sex hormones. After administration, compared with the model group, the body weights of the medium-dose group and high-dose group increased significantly (P < 0.05), indicating that the medium-dose group and high-dose group can improve the weight loss under estrogen stimulation.

[0104] In addition, the nipple height and nipple diameter of the rats in each experimental group are as Figure 1 shown. As can be seen from Figure 1 , compared with the blank group, the left and right nipple diameters and heights of the rats in the model group increased significantly (P < 0.01), indicating that after being affected by estrogen, the endocrine of the rats was abnormal and the nipples were swollen and enlarged. Compared with the model group, the nipple diameters of the rats in the positive group, medium-dose group, and high-dose group decreased significantly (P < 0.05), and the left and right nipple heights of the rats in the high-dose group and medium-dose group of Example 5 decreased significantly (P < 0.01). The left and right nipple heights of the rats in the positive group and low-dose group decreased, but there was no significant difference, indicating that the effective part composition of traditional Chinese medicine of the present invention can reduce the abnormal nipple diameter and nipple height, improve the condition of breast nodules, and promote breast health.

[0105] Experimental Example 3 - Effect of the effective part composition of traditional Chinese medicine of the present invention on the hormone levels in the serum of rats with mammary gland hyperplasia

[0106] Test method: At the end of the experimental period, after fasting overnight, the rats were anesthetized by intraperitoneal injection of 10% chloral hydrate. Blood samples were obtained through the abdominal aorta, and the serum was separated by centrifugation (centrifuged at 3000 rpm for 10 min at 4°C and stored at -80°C for hormone determination). The expression levels of estradiol (E2), progesterone (P), luteinizing hormone (LH), and follicle-stimulating hormone (FSH) in the serum of rats with mammary gland hyperplasia were determined by ELISA method.

[0107] The test results are as Figure 2 shown. As can be seen from Figure 2 :

[0108] (1) Compared with the blank group, the level of E2 in the model group was significantly increased (P<0.05); compared with the model group, the levels of E2 in the positive group, high-dose group, medium-dose group, and low-dose group were significantly decreased (P<0.05); (2) compared with the blank group, the level of P in the model group was significantly decreased (P<0.05); compared with the model group, the levels of P in the positive control group and high-dose group increased; (3) the level of LH in the model group was significantly increased compared with the blank group (P<0.05); compared with the model group, the level of LH in the high-dose group was significantly decreased (P<0.05); (4) compared with the blank group, the level of FSH in the model group was significantly increased (P<0.05), and compared with the model group, the levels of FSH in the high-dose group, medium-dose group, and low-dose group were significantly decreased (P<0.05); it shows that the effective fraction composition of traditional Chinese medicine of the present invention can reduce the content of estradiol in the serum of mice with mammary gland hyperplasia model, increase the content of progesterone, regulate the endocrine situation, reduce the stimulation of estrogen on mammary gland tissue, and improve mammary gland nodules.

[0109] Experimental Example 4 - Effect of the Effective Fraction Composition of Traditional Chinese Medicine of the Present Invention on the Pathological Morphology of Mammary Gland Tissue in Rats with Mammary Gland Hyperplasia

[0110] Test method: (1) Sampling: After the rats were bled, they were placed on an ice box. With the second pair of nipples of the rats as the center, the nipples and the surrounding 1 cm of skin and the glands under the skin were cut off. The right mammary gland of the rats was put into a specimen bag and immediately frozen in liquid nitrogen, and then stored in a -80°C refrigerator for later use. The left mammary gland of the rats was fixed with 4% paraformaldehyde for histopathological examination and immunohistochemical staining. (2) Hematoxylin-eosin (HE) staining: The tissue specimens were immersed in 4% paraformaldehyde solution for 48 hours. Subsequently, the mammary gland tissue blocks went through a series of processes, including dehydration, clearing, wax impregnation, embedding, sectioning, and drying to produce paraffin sections. After dewaxing with xylene, dehydration with gradient alcohol, and HE staining, and then applying a sealing method, the staining results were obtained, as Figure 3 shown.

[0111] It can be seen from Figure 3 that: Through HE staining observation, the pathological morphological examination of the normal control group showed no hyperplastic lesions and no dilation of mammary gland ducts. The mammary gland tissue of the model group rats was histologically abnormal, including significant hyperplastic lesions, dilation of mammary gland ducts, and a significant increase in the number of alveolar cells. Compared with the model group, the degree of mammary gland hyperplasia in the positive group was significantly reduced, and the number of alveolar cells was significantly reduced. The mammary glands in the high-dose group, medium-dose group, and low-dose group recovered well, and the mammary gland volume and the number of alveoli decreased to varying degrees, indicating that the effective fraction composition of traditional Chinese medicine of the present invention can reduce the number of alveoli, reduce the secretion of mammary gland ducts, significantly improve mammary gland nodules, and promote mammary gland health.

[0112] Experimental Example 5 - Clinical Therapeutic Effect Test of the Effective Fraction Composition of Traditional Chinese Medicine of the Present Invention on Mammary Gland Hyperplasia Test sample: The spray prepared in Example 1 4;

[0113] Test method: 140 patients with different degrees of mammary gland hyperplasia from February 2021 to December 2024 were selected. The specific manifestations were single or multiple masses in one or both breasts, often accompanied by periodic breast pain, and even showing states such as mental tension, irritability, etc. The age distribution was 25 - 55 years old. They were randomly divided into 4 groups, and each group used the corresponding test sample (the spray prepared in Examples 1 - 4). After use, it was wrapped with plastic wrap for 2 hours and then wiped off. The effect was observed after 30 days, and the results are shown in Table 2; at the same time, the treatment effect was judged according to the following criteria, and the treatment effective rate (%) was calculated. The specific criteria for judging the curative effect were as follows:

[0114] Marked effect: All or main symptoms were significantly eliminated, pain and discomfort disappeared significantly, but there were still slight symptoms, and most of the normal life was restored;

[0115] Effective: Symptoms and signs improved, pain and discomfort were relieved, but there were still slight symptoms, and part of the normal life was restored;

[0116] Ineffective: Symptoms and signs had no obvious improvement or worsened.

[0117] Table 2 - Treatment effect

[0118]

[0119]

[0120] It can be seen from the results in Table 2 that the treatment effective rate of the sprays prepared in Examples 1 - 4 of the present invention is 87.5% - 97.4%, indicating that the effective part composition of traditional Chinese medicine of the present invention has a better treatment effect on mammary gland hyperplasia.

[0121] Clinical typical case data:

[0122] 1. Ms. Shu, 43 years old. Clinical diagnosis opinion: Bilateral breast hypoechoic nodules. The breast tissue structure was slightly disordered, and multiple hypoechoic bands were seen inside. There were several hypoechoic nodules in both breasts, with clear boundaries and regular shapes. The largest nodule in the left breast was about 7.4 mm x 5.4 mm, located at the 3 o'clock direction; the largest nodule in the right breast was about 5.8 mm x 3.4 mm, located at the 10 o'clock direction, and no obvious blood flow signal was shown by CDFI. Another hypoechoic nodule with a size of about 3.8 mm x 4.0 mm was seen at the 3 o'clock direction of the right breast, with clear boundaries, local edges angled, aspect ratio greater than 1, and no obvious blood flow signal was seen by CDFI. Several hypoechoic nodules were seen in both axillae, with clear demarcation of cortex and medulla. The largest nodule in the left axilla was about 7 mm x 4 mm; the largest nodule in the right axilla was about 18 mm x 8 mm, and dot - strip - like blood flow signal was visible inside by CDFI.

[0123] Treatment: Administer the spray prepared in Example 1 of the present invention. On the day of conditioning, spray it repeatedly twice at one time, once a day, and continuously treat for 15 days.

[0124] Diagnostic results: The bilateral breast glandular structures are slightly disordered, with multiple strip-shaped hypoechoic areas seen inside. CDFI: No obvious abnormal blood flow signal is seen inside. Several hypoechoic nodules are seen in the right breast, with clear boundaries, regular shapes, smooth edges. The larger one is 7mm x 4mm, located at the 3 o'clock position. CDFI: No obvious blood flow signal is seen inside. Several hypoechoic nodules are seen in the left breast, with clear boundaries, regular shapes, smooth edges. The larger one is 6mm x 3mm, located at the 3 o'clock position. CDFI: No obvious blood flow signal is seen inside. No obvious abnormal lymph node images in terms of morphology and echo are seen in bilateral axillae.

[0125] 2. Ms. Yage, 34 years old. Diagnostic opinion: Hypoechoic nodules in the left breast and widened ducts (BIRADS: 4a category), bilateral hypoechoic nodules in the breast (BIRADS: 2 category). The bilateral breast echoes are enhanced and thickened. Localized thickening of the gland can be seen, with unclear boundaries. A small number of smaller distributed duct echoes can be seen. A hypoechoic nodule can be seen at the 9 o'clock position in the right breast, with a size of 7.6 x 4.1mm and clear boundaries. A hypoechoic nodule can be seen at the 11 o'clock position, with a size of 5.7 x 3.6mm and clear boundaries. A cystic nodule can be seen at the 3 o'clock direction, with a size of 5.1 x 2.1mm. Several hypoechoic nodules can be seen in the gland of the left breast. The larger one is located at the 3 o'clock position, with a size of approximately 5.8 x 2.8mm and clear boundaries. A hypoechoic area can be seen at the 9 o'clock direction in the left breast, with a range of 4.8 x 3.1mm, irregular shape, unclear boundaries, and slightly widened distal ducts. No enlarged lymph node echoes are detected in bilateral axillae.

[0126] Treatment: Administer the spray prepared in Example 2 of the present invention. Spray it repeatedly twice at one time, once a day, and continuously treat for 5 months.

[0127] Diagnostic results: Bilateral breast hypoechoic nodules (BIRADS: category 3), left breast ductal dilatation (BIRADS: category 2), right breast cystic nodule (BIRADS: category 2). A hypoechoic nodule can be seen at the 12 o'clock position of the right breast, with a size of approximately 4.9 x 2.6 mm and clear boundaries. A cystic dark area can be detected below the nipple, with a size of approximately 4.9 x 2.3 mm. Another hypoechoic nodule can be seen at the 9 o'clock position, with a size of approximately 5.1 x 3.2 mm and clear boundaries. In the left breast, tortuous and dilated ductal echoes can be detected below the nipple, with a size of approximately 2.8 mm. Another hypoechoic nodule can be detected at the 3 o'clock position, the larger one being approximately 4.2 x 2.6 mm. The echoes of the remaining bilateral breasts are enhanced and thickened, with localized glandular thickening, unclear boundaries, and a small amount of smaller distributed ductal echoes. No obvious mass effect is seen within the gland, no obvious calcification is seen inside, and no obvious attenuation is seen behind the thickened gland. No obvious abnormal blood flow signals are seen in the bilateral breasts. No obvious enlarged lymph node echoes are seen in the bilateral axillae.

[0128] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention can have various changes and modifications. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine effective part composition for treating mammary gland hyperplasia, characterized in that, By weight parts, it includes 10 - 25 parts of total saponin extract of Centipeda minima (L.) A. Br. et Aschers., 10 - 25 parts of total terpene extract of Ligularia fischeri (Ledeb.) Turcz., 10 - 25 parts of total terpene extract of Clinopodium polycephalum (Vant.) C. Y. Wu et Hsuan, 5 - 10 parts of total terpene extract of Paeonia lactiflora Pall., 5 - 15 parts of total flavonoid extract of Platycodon grandiflorum (Jacq.) A. DC., 5 - 10 parts of total terpene extract of Paederia scandens (Lour.) Merr., 5 - 10 parts of total flavonoid extract of Swertia nervosa (G. Don) Wall., 5 - 10 parts of total terpene extract of Atractylodes macrocephala Koidz., 5 - 10 parts of total flavonoid extract of Aurantii Fructus Immaturus, 5 - 10 parts of total coumarin extract of Cnidium monnieri (L.) Cuss..

2. The effective part composition of traditional Chinese medicine for treating mammary gland hyperplasia according to claim 1, wherein By weight parts, it includes: 15 - 20 parts of total saponin extract of Centipeda minima (L.) A. Br. et Aschers., 15 - 20 parts of total terpene extract of Ligularia fischeri (Ledeb.) Turcz., 15 - 20 parts of total terpene extract of Clinopodium polycephalum (Vant.) C. Y. Wu et Hsuan, 7 - 9 parts of total terpene extract of Paeonia lactiflora Pall., 8 - 12 parts of total flavonoid extract of Platycodon grandiflorum (Jacq.) A. DC., 6 - 8 parts of total terpene extract of Paederia scandens (Lour.) Merr., 6 - 8 parts of total flavonoid extract of Swertia nervosa (G. Don) Wall., 6 - 8 parts of total terpene extract of Atractylodes macrocephala Koidz., 6 - 8 parts of total flavonoid extract of Aurantii Fructus Immaturus, 6 - 8 parts of total coumarin extract of Cnidium monnieri (L.) Cuss..

3. The effective part composition of traditional Chinese medicine for treating mammary gland hyperplasia according to claim 1 or 2, characterized in that, The preparation method of the total saponin extract of Centipeda minima (L.) A. Br. et Aschers. is as follows: Centipeda minima (L.) A. Br. et Aschers. is heated and refluxed with an organic solvent for multiple times to obtain extraction liquids respectively, the extraction liquids are combined, filtered, the filtrate is concentrated under reduced pressure, the concentrated liquid is eluted through macroporous resin, the eluate is collected, and concentrated to obtain the total saponin extract of Centipeda minima (L.) A. Br. et Aschers..

4. The effective part composition of traditional Chinese medicine for treating mammary gland hyperplasia according to claim 1 or 2, characterized in that, The preparation methods of the total terpene extracts of Ligularia fischeri (Ledeb.) Turcz. and Atractylodes macrocephala Koidz. are the same, and both adopt the following method: The raw materials of Ligularia fischeri (Ledeb.) Turcz. and Atractylodes macrocephala Koidz. are respectively soaked and extracted to obtain extracts, the extracts are evaporated to dryness under reduced pressure, dispersed with water and then extracted with an organic solvent to obtain extraction liquids; the extraction liquids are respectively collected and concentrated to obtain concentrated liquids; the concentrated liquids are separated by a silica gel column and gradient elution is carried out, and the total terpene extract of Ligularia fischeri (Ledeb.) Turcz. and the total terpene extract of Atractylodes macrocephala Koidz. can be respectively obtained by recovery.

5. The effective part composition of traditional Chinese medicine for treating mammary gland hyperplasia according to claim 1 or 2, characterized in that, The preparation methods of the total flavonoid extracts of Platycodon grandiflorum (Jacq.) A. DC., Swertia nervosa (G. Don) Wall. and Aurantii Fructus Immaturus are the same, and both adopt the following method: The raw materials of Platycodon grandiflorum (Jacq.) A. DC., Swertia nervosa (G. Don) Wall. and Aurantii Fructus Immaturus are heated and refluxed with an organic solvent for extraction to obtain an extraction liquid, the extraction liquids are combined, filtered, the filtrate is collected and concentrated under reduced pressure, the concentrated liquid is collected and eluted, the eluate is collected and concentrated, and the total flavonoid extracts of Platycodon grandiflorum (Jacq.) A. DC., Swertia nervosa (G. Don) Wall. and Aurantii Fructus Immaturus are obtained.

6. The effective part composition of traditional Chinese medicine for treating mammary gland hyperplasia according to claim 1 or 2, characterized in that, The preparation methods of the total terpene extracts of Clinopodium polycephalum (Vant.) C. Y. Wu et Hsuan and Paeonia lactiflora Pall. are the same, and both adopt the following method: Ultrasonic - assisted extraction is adopted, the raw materials of Clinopodium polycephalum (Vant.) C. Y. Wu et Hsuan and Paeonia lactiflora Pall. are ultrasonically assisted - extracted with an organic solvent to obtain an extraction liquid, the extraction liquids are combined and centrifuged, concentrated under reduced pressure, and extracted multiple times to obtain an extraction liquid, the extraction liquids are combined and concentrated, and the total terpene extracts of Clinopodium polycephalum (Vant.) C. Y. Wu et Hsuan and Paeonia lactiflora Pall. are obtained.

7. The effective part composition of traditional Chinese medicine for treating mammary gland hyperplasia according to claim 1 or 2, characterized in that, The preparation method of the total terpene extract of Paederia scandens (Lour.) Merr. is as follows: It is heated and refluxed with an organic solvent for multiple times to obtain an extraction liquid, the extraction liquids are combined, the extraction liquid is concentrated under reduced pressure and then dissolved in water to form a solution, passed through macroporous resin to obtain an eluate, the eluate is collected and concentrated, and the total terpene extract of Paederia scandens (Lour.) Merr. is obtained.

8. The effective part composition of traditional Chinese medicine for treating mammary gland hyperplasia according to claim 1 or 2, characterized in that, The preparation method of the total coumarin extract of Cnidium monnieri (L.) Cuss. is as follows: Supercritical CO2 extraction method is adopted for extraction, and the extraction conditions are: the pressure of the extraction kettle is 35 - 45 MPa, and the temperature is 35 - 45 °C.

9. A traditional Chinese medicine preparation for treating mammary gland hyperplasia, characterized in that, It includes the traditional Chinese medicine effective - part composition according to any one of claims 1 - 8 and pharmaceutically acceptable excipients; Among them, the traditional Chinese medicine effective - part composition accounts for 40 - 80% of the total weight of the preparation.

10. Use of the composition of the effective part of traditional Chinese medicine according to any one of claims 1 to 8 in the preparation of a medicament for treating mammary gland hyperplasia and mammary gland nodules.

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