Traditional Chinese medicine composition with efficacy of preventing and treating hyperplasia of mammary glands and preparation method of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition and a preparation method and application thereof, in particular to a traditional Chinese medicine composition for preventing and treating hyperplasia of mammary glands and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition for preventing and treating hyperplasia of mammary glands is at least prepared from the following raw materials: radix fici simplicissimae, black beans and tangerine seeds. Wherein the components comprise 10-40g of radix fici simplicissimae, 10-40g of black beans and 1-5g of tangerine seeds. The beverage can also contain 1-5 g of rose, 1-5 g of jasmine flower and 0.5-3 g of momordica grosvenori. The radix fici simplicissimae, the black beans, the tangerine seeds, the roses, the jasmine flowers and the siraitia grosvenorii are combined for use, the composition is used for preventing and treating hyperplasia of mammary glands, the medicine property is mild, the curative effect is exact, and toxic and side effects The composition can be used for preparing medicines or health foods for preventing and treating hyperplasia of mammary

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition, its preparation method, and its application, specifically to a traditional Chinese medicine composition for preventing and treating breast hyperplasia, its preparation method, and its application, belonging to the field of traditional Chinese medicine technology. Background Technology

[0002] Breast hyperplasia is a benign breast disease caused by abnormalities in the normal development and regression of the breast. Essentially, it is a disorder of the normal breast structure due to incomplete proliferation and involution of the breast tissue and stroma. This disease commonly affects women aged 30-50 and is the most common benign breast disease. 70%-80% of women have varying degrees of breast hyperplasia. While typical breast hyperplasia does not pose a direct and significant threat to health, the breast tenderness and lumps can cause negative emotions such as tension, anxiety, and irritability. Although the chance of breast hyperplasia becoming cancerous is small, medical research indicates a certain correlation between breast hyperplasia and cancer.

[0003] Currently, the main Western medicine treatments used in clinical practice are hormone drugs, estrogen antagonists, and vitamins. However, these drugs often have adverse reactions, require long treatment periods, and can gradually lead to drug resistance, placing a significant burden on the lives and finances of ordinary patients. In Traditional Chinese Medicine (TCM), breast hyperplasia falls under the category of "breast lumps," which is considered closely related to the liver, spleen, kidneys, the Chong and Ren meridians, and emotional factors. Common syndromes include liver qi stagnation, phlegm and blood stasis, and Chong and Ren meridian imbalance. Commonly used TCM formulas include Xiaoyao Wan, Yimucao granules, and Ruxiankang capsules, but these formulas are complex and have certain side effects. Furthermore, contemporary doctors often do not recognize early-stage breast hyperplasia as a disease, leaving patients without the necessary attention and awareness, feeling confused, and unable to use medication correctly. Therefore, there is a need to find a green, safe, low-side-effect, simple-to-formulate, and effective TCM combination to expand the application of TCM in the preparation of drugs for the prevention and treatment of breast hyperplasia. Summary of the Invention

[0004] The first objective of this invention is to provide a traditional Chinese medicine composition that has the effect of preventing and treating breast hyperplasia.

[0005] The objective of this invention is achieved through the following technical solution:

[0006] A traditional Chinese medicine composition for preventing and treating breast hyperplasia is prepared from at least the following raw materials: five-finger peach, black bean, and orange seed.

[0007] The ingredients include 10-40g of five-finger peach, 10-40g of black beans, and 1-5g of orange seeds.

[0008] Furthermore, the traditional Chinese medicine composition also contains rose, jasmine, and monk fruit.

[0009] Furthermore, the aforementioned traditional Chinese medicine composition is prepared from the following raw materials: 10-40g of five-finger peach, 10-40g of black beans, 1-5g of tangerine seeds, 1-5g of rose petals, 1-5g of jasmine flowers, and 0.5-3g of monk fruit.

[0010] Furthermore, the aforementioned traditional Chinese medicine composition is prepared from the following raw materials: 10-30g of five-finger peach, 10-30g of black beans, 3-5g of tangerine seeds, 3-5g of rose petals, 3-5g of jasmine flowers, and 1-3g of monk fruit.

[0011] Furthermore, the aforementioned traditional Chinese medicine composition is prepared from the following raw materials: 15-20g of five-finger peach, 15-20g of black beans, 3-5g of tangerine seeds, 3-5g of rose petals, 3-5g of jasmine flowers, and 1-3g of monk fruit.

[0012] Furthermore, in the aforementioned traditional Chinese medicine composition, the mass ratio of five-finger peach to black beans is 1:1.

[0013] Furthermore, in the aforementioned traditional Chinese medicine composition, the mass ratio of five-finger peach or black bean, orange seed, rose, and jasmine is 15-20:3:3:3.

[0014] Most preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 20g of five-finger peach, 20g of black beans, 3g of orange seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

[0015] A second object of the present invention is to provide a method for preparing the composition.

[0016] In some embodiments, the composition of the present invention may be a composition obtained by directly mixing the above-mentioned active pharmaceutical ingredients; the composition may be made into food, health food or pharmaceutical by conventional processes.

[0017] In some embodiments, the composition of the present invention may also be an extract obtained by combining the raw materials and extracting them using conventional methods, or an effective fraction obtained by further refining and purifying the extract; or it may be a composition formed by combining extracts obtained by extracting each raw material separately using conventional methods, or effective fractions obtained by further refining and purifying the extracts. The conventional extraction methods include maceration extraction, decoction extraction, reflux extraction, percolation extraction, and ultrasonic extraction; the extraction solvents include water and 20-95% ethanol solution; the refining and purification processes include alcohol precipitation, extraction, silica gel column separation, and macroporous resin column separation.

[0018] In some embodiments, the compositions of the present invention can be prepared into conventional oral dosage forms according to conventional pharmaceutical processes, such as decoctions, teas, pills (drop pills, honey pills, water pills, paste pills, wax pills, concentrated pills), powders, wines, syrups, extracts, elixirs, cakes, tablets, blister packs, oral liquids, granules, capsules, sustained-release formulations, nano-formulations, etc.

[0019] In some implementation schemes, conventional excipients in the pharmaceutical industry may be added, including: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices. Fillers include: starch, pregelatinized starch, lactose, mannitol, chitosan, microcrystalline cellulose, sucrose, etc.; disintegrants include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, croscarmellose, low-substituted hydroxypropyl cellulose, croscarmellose sodium, etc.; lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silica, etc.; suspending agents include: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include: starch paste, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.

[0020] A third object of the present invention is to provide the use of the composition or its formulation in the preparation of foods, health foods or medicines for the prevention and treatment of breast hyperplasia.

[0021] Technical effects of the present invention:

[0022] This invention combines five-finger peach, black bean, orange seed, rose, jasmine, and monk fruit to prevent and treat breast hyperplasia. The formula is mild in nature, effective, and has no toxic side effects. Moreover, all the ingredients in this formula are medicinal and edible herbs. Therefore, this formula can be used not only as a medicine but also as a food, especially a health food.

[0023] Five-finger fig (Ficus hirta) is the principal ingredient in this formula. It is the root of the Ficus hirta plant (Moraceae family), and is sweet and neutral in nature. It enters the spleen, lung, and liver meridians, and has the effects of strengthening the spleen and lungs, promoting qi circulation and eliminating dampness, and relaxing muscles and tendons. It is suitable for spleen deficiency edema, poor appetite and weakness, pulmonary tuberculosis cough, night sweats, leukorrhea, postpartum agalactia, rheumatic pain, edema, ascites due to cirrhosis, hepatitis, and traumatic injuries. Modern clinical and pharmacological studies have found that five-finger fig has antibacterial, immune-enhancing, expectorant, hypoxia-ischemia tolerance, antioxidant, liver-protective, anti-inflammatory and analgesic, and smooth muscle relaxant effects.

[0024] Black beans, the dried, mature seeds of the soybean plant (a legume), are also the principal ingredient in this formula. They are sweet and neutral in nature, and enter the spleen and kidney meridians. They are believed to benefit essence and improve eyesight, nourish blood and dispel wind, promote urination, invigorate blood circulation, and detoxify. The Compendium of Materia Medica states that "black beans have the effects of tonifying the kidneys and nourishing blood, detoxifying, invigorating blood circulation and removing blood stasis, darkening hair and improving eyesight, and prolonging life." Modern research also indicates that black beans can darken hair, tonify the kidneys and spleen, resist aging, lower cholesterol, improve myocardial blood flow, moisturize the skin, improve eyesight, and nourish blood.

[0025] In this formula, the orange seed is an assistant ingredient. It is the dried, mature seed of the citrus plant (Citrus reticulata) and its cultivated varieties, belonging to the Rutaceae family. It has a bitter taste and neutral properties, and enters the liver and kidney meridians. It is used to regulate qi, disperse stagnation, and relieve pain, and is commonly used for hernia pain, testicular swelling and pain, and mastitis. Modern research has found that the main chemical components of orange seeds include limonenes, fatty acids, proteins, and minerals (Ca, Fe, Zn, Cu, Pb), possessing anti-tumor, anti-inflammatory, analgesic, and antioxidant effects.

[0026] Rose petals are the dried flower buds of the rose plant (Rosa rugosa), belonging to the Rosaceae family. They are sweet and slightly bitter in taste, warm in nature, and enter the liver and spleen meridians. They have the functions of regulating qi and relieving depression, harmonizing blood, and relieving pain. They are used for liver and stomach qi pain, poor appetite and nausea, irregular menstruation, and injuries from falls. Rose petals are used as an adjuvant in prescriptions.

[0027] Jasmine flowers are also used as an adjuvant in this prescription. They are the flowers of the jasmine plant (Oleaceae family), and have a pungent, slightly sweet, and warm nature. They enter the spleen, stomach, and liver meridians and have the effects of regulating qi, relieving depression, dispelling foulness, and harmonizing the middle jiao. They are used to treat diarrhea, abdominal pain, conjunctivitis, and sores. The *New Compendium of Medicinal Herbs* states that jasmine flowers can soothe the liver, relieve depression, regulate qi, and stop pain.

[0028] Monk fruit is sweet and cool in nature, and enters the lung and large intestine meridians. It has the effects of moistening the lungs and relieving cough, promoting body fluid production and quenching thirst. It is suitable for coughs due to lung heat or dryness, whooping cough, and thirst due to summer heat. It also has the effect of moistening the intestines and promoting bowel movements. Monk fruit is one of the first batch of medicinal and edible materials approved by the state. Modern medicine has proven that monk fruit has significant effects on bronchitis, hypertension, and other diseases, and can also play a role in preventing and treating coronary heart disease, arteriosclerosis, and obesity. It has high nutritional value and has the effects of clearing heat and relieving summer heat, resolving phlegm and relieving cough, cooling blood and soothing bones, clearing the lungs and moistening the intestines, and promoting body fluid production and quenching thirst. It can treat acute and chronic bronchitis, pharyngitis, bronchial asthma, whooping cough, stomach heat, constipation, acute tonsillitis, etc., and is also suitable for diabetic patients. Monk fruit is used as an adjuvant in prescriptions.

[0029] Through long-term clinical observation and experimental research, the composition of the present invention has a significant effect on improving mild to moderate breast hyperplasia. Attached Figure Description

[0030] Figure 1 The component classification and quantity distribution diagram of composition 1 prepared in Example 1.

[0031] Figure 2 The component classification and content distribution diagram of composition 1 prepared in Example 1. Detailed Implementation

[0032] Example 1 Preparation of Composition 1

[0033] Ingredients: 20g of five-finger peach, 20g of black beans, 3g of orange seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

[0034] Preparation method: Weigh all raw materials according to the proportions, mix them, add 500mL of pure water, boil, then simmer for 40 minutes. Pour out and filter. Add another 400mL of pure water to the residue, boil, then simmer for 30 minutes. Pour out and filter. Add another 400mL of pure water to the residue, boil, then simmer for 30 minutes. Pour out and filter. Mix the filtrates from the three processes thoroughly, and concentrate to 500mL using a rotary evaporator.

[0035] Dosage and administration: Drink a total of 500ml twice a day.

[0036] Example 2 Preparation of Composition 2

[0037] Ingredients: 40g of five-finger peach, 40g of black beans, 1g of orange seed, 1g of rose petals, 1g of jasmine petals, and 0.5g of monk fruit.

[0038] The preparation method is the same as in Example 1.

[0039] Dosage and administration: Drink a total of 500ml twice a day.

[0040] Example 3 Preparation of Composition 3

[0041] Ingredients: 10g of five-finger peach, 10g of black beans, 5g of orange seeds, 5g of rose petals, 5g of jasmine flowers, and 3g of monk fruit.

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

[0043] Dosage and administration: Drink a total of 500ml twice a day.

[0044] Example 4 Preparation of Composition 4

[0045] Ingredients: 10g of five-finger peach, 10g of black beans, 3g of orange seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

[0046] The preparation method is the same as in Example 1.

[0047] Dosage and administration: Drink a total of 500ml twice a day.

[0048] Example 5: Preparation of Composition 5

[0049] Ingredients: 30g of five-finger peach, 30g of black beans, 3g of orange seeds, 3g of rose petals, 3g of jasmine flowers, and 3g of monk fruit.

[0050] The preparation method is the same as in Example 1.

[0051] Dosage and administration: Drink a total of 500ml twice a day.

[0052] Example 6: Compositions prepared by different methods:

[0053] (1) Mix the raw materials first and then decoct (composition 1)

[0054] Ingredients: 20g of five-finger peach, 20g of black beans, 3g of tangerine seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

[0055] Preparation method: Weigh all raw materials according to the proportions, mix them, add 500mL of pure water, boil until boiling, then simmer for 40 minutes. Pour out and filter. Add another 400mL of pure water to the residue, boil until boiling, then simmer for 30 minutes. Pour out and filter. Add another 400mL of pure water to the residue, boil until boiling, then simmer for 30 minutes. Pour out and filter. Mix the filtrates from the three processes thoroughly, and concentrate by rotary evaporation.

[0056] (2) The raw materials are mixed first and then sonicated (composition 6)

[0057] Ingredients: 20g of five-finger peach, 20g of black beans, 3g of tangerine seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

[0058] Preparation method: Weigh each raw material according to the proportion, mix them, add 10-8-8 times the amount of 100℃ double distilled water and extract by ultrasonic extraction three times, 40 minutes each time, concentrate and dry at -80℃.

[0059] (3) The raw materials are first decocted separately and then mixed together (composition 7).

[0060] Ingredients: 20g of five-finger peach, 20g of black beans, 3g of tangerine seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

[0061] Preparation method: Weigh each raw material according to the specified proportions, add 500mL of pure water to each, boil, then simmer for 40 minutes. Pour out and filter. Add another 400mL of pure water to the residue, boil, then simmer for 30 minutes. Pour out and filter. Add another 400mL of pure water to the residue, boil, then simmer for 30 minutes. Pour out and filter. Mix the filtrates from the three boilings thoroughly, then concentrate using a rotary evaporator.

[0062] Experiment Example 1: Chemical Composition Study

[0063] The chemical composition of composition 1 prepared in Example 1 was analyzed using UPLC-Q-TOF / MS. The distribution of component categories is shown in the figure. Figure 1 The composition classification and content distribution are shown in the figure. Figure 2 .

[0064] The results showed that in composition 1 prepared in Example 1, the amounts of flavonoids, terpenoids, and phenylpropanoids accounted for 20.06%, 16.62%, and 14.33% of the total number of components, respectively, and the sum of the three components accounted for more than 50%. Figure 1 ).

[0065] Terpenes, flavonoids, organic acids and their derivatives accounted for 26.81%, 23.25%, and 19.19% of the total content, respectively, with the sum of these three components accounting for over 65%. Figure 2 ).

[0066] Clinical efficacy study of Experiment Example 2

[0067] Eighty participants were enrolled (statistical data are shown in Table 1). Based on the Western medicine diagnostic criteria of the "Expert Consensus on the Diagnosis and Treatment of Breast Hyperplasia" and the TCM diagnostic criteria for mastopathy in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine," and confirmed by imaging examinations, all were diagnosed with breast hyperplasia. Simultaneously, patients with syndromes of liver qi stagnation, phlegm-blood stasis, and imbalance of the Chong and Ren meridians were screened according to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines."

[0068] Exclusion criteria: 1) Pregnant or lactating women; 2) Concurrent mastitis; 3) Concurrent malignant tumors; 4) Mental illness; 5) Liver or kidney failure; 6) Severe external breast infection; 7) Hypersensitivity to the study drug or related components.

[0069] Experimental groups: control group (including patients with three types: liver qi stagnation, phlegm and blood stasis, and imbalance of the Chong and Ren meridians, with a ratio of 7:6:7), experimental group 1 (liver qi stagnation group), experimental group 2 (phlegm and blood stasis group), and experimental group 3 (imbalance of the Chong and Ren meridians group), with 20 people in each group.

[0070] Experimental Methods: Sixty participants in experimental groups 1, 2, and 3 simultaneously took the composition prepared in Example 1, 500 ml twice daily for three consecutive months. The control group of 20 participants did not receive any medication. Demographic data and disease-related indicators are shown in Table 1. Results after three months of observation are shown in Tables 2-4.

[0071] Table 1. Demographic data and disease-related indicators

[0072] Control group (n=20) Experimental group (n=60) age 38.6±1.28 39.65±2.23 Course of disease 1.19±0.22 1.23±0.56 Simple lobular hyperplasia (example) 14 42 Maximum diameter of the mass (mm) 7.47±0.91 7.42±1.34 catheter diameter (mm) <![CDATA[3 . 82±0.71]]> 3.99±0.54 Gland thickness (mm) 15.14±2.10 15.61±2.47

[0073] Table 2 Comparison of main symptoms between the experimental group and the control group.

[0074]

[0075] Note: Experimental group 1 was the liver qi stagnation group, experimental group 2 was the phlegm and blood stasis group, and experimental group 3 was the Chong and Ren meridian imbalance group.

[0076] Note: 1. Breast pain: No pain symptoms - 0 points; No spontaneous pain, but pain upon touching the breast - 2 points; Intermittent spontaneous pain - 4 points; Continuous spontaneous pain that does not affect daily life - 6 points; Continuous spontaneous pain, accompanied by pain in the armpit, shoulder and back, which has a certain impact on daily life - 8 points.

[0077] 2. Breast lump:

[0078] Size: No breast lump -0 points; maximum diameter of breast lump not exceeding 2cm -2 points; maximum diameter of breast lump in the range of 2-5cm -4 points; maximum diameter of breast lump exceeding 5cm -6 points.

[0079] Scope: No breast lump - 0 points; Lump in 1-2 quadrants of the breast - 2 points; Lump in 3-4 quadrants of the breast - 4 points. Hardness: No breast lump - 0 points; Soft breast lump, similar to normal glandular tissue - 2 points; Firm breast lump, similar to the tip of the nose - 4 points; Hard breast lump, similar to the forehead - 6 points.

[0080] 3. Nipple discharge: No discharge symptoms -0 points; a small amount of discharge can be seen when the nipple is squeezed -2 ​​points; obvious discharge when the nipple is squeezed -4 points; spontaneous nipple discharge -6 points.

[0081] Table 3 Comparison of secondary symptoms between the experimental group and the control group

[0082]

[0083] Note: Experimental group 1 was the liver qi stagnation group, experimental group 2 was the phlegm and blood stasis group, and experimental group 3 was the Chong and Ren meridian imbalance group.

[0084] Table 4 Comparison of breast imaging parameters between the experimental group and the control group

[0085] control group Experimental group 1 Experimental group 2 Experimental group 3 Maximum diameter of the mass (mm) 7.34±1.10 5.84±0.74* 7.02±1.01 5.22±0.89** catheter diameter (mm) 3.97±0.47 2.65±0.49* 3.22±0.57 2.34±0.69* Gland thickness (mm) 15.68±1.68 12.11±2.85* 13.33±1.23 11.03±2.36**

[0086] Note: Compared with the control group, *P<0.05, **P<0.01

[0087] The results showed that at baseline (before administration), there were no significant differences in the levels of primary symptoms, secondary symptoms, and imaging indicators between the experimental and control groups. After administration, all indicators in the experimental group improved. Among the primary symptoms, the number of patients with breast pain ≥2 points in experimental groups 1-3 was significantly lower than that in the control group, and the number of patients with breast lumps ≥4 points in the experimental group was significantly lower than that in the control group. Among the secondary symptoms, the number of patients with chest tightness, rib distension, lower back and knee weakness, depression and irritability, and menstrual abnormalities in experimental groups 1 and 3 was significantly lower than that in the control group. The maximum diameter of the lumps, duct diameter, and glandular thickness in experimental groups 1 and 3 were significantly smaller than those in the control group. This indicates that the composition has a significant ameliorative effect on patients with breast hyperplasia of the liver qi stagnation type and the Chong and Ren meridian imbalance type, especially the Chong and Ren meridian imbalance type.

[0088] Experimental Example 3: Animal Experiment Study

[0089] 1. Experimental Methods:

[0090] Sample preparation:

[0091] Sample 1: 20g of *Ficus hirta* (five-finger peach) and 3g of *Citrus reticulata* (orange seed). Add 500mL of pure water, bring to a boil, then simmer for 40 minutes. Pour out and filter. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Pour out and filter. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Pour out and filter. Mix the three filtrates thoroughly and concentrate using a rotary evaporator to obtain an extract.

[0092] Sample 2: 20g of *Ficus hirta* (five-finger peach), 20g of black beans, and 3g of orange seeds. Add 500mL of pure water, bring to a boil, then simmer for 40 minutes. Pour out and filter. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Pour out and filter. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Pour out and filter. Mix the three filtrates thoroughly and concentrate using a rotary evaporator to obtain an extract.

[0093] Sample 3: 20g of *Ficus hirta* (five-finger peach), 20g of black beans, 3g of orange seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of *Siraitia grosvenorii* (monk fruit). Add 500mL of pure water, bring to a boil, then simmer for 40 minutes. Pour out and filter. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Pour out and filter. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Pour out and filter. Mix the three filtrates thoroughly, then concentrate using a rotary evaporator to obtain an extract.

[0094] Sample 4: 20g of *Ficus hirta* (five-finger peach), 20g of black beans, 3g of tangerine seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of *Siraitia grosvenorii* (monk fruit). Add 500mL of pure water to each herb, bring to a boil, then simmer for 40 minutes. Filter the decoction. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Filter the decoction again. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Filter the decoction again. Mix the filtrates from each herb thoroughly, then concentrate the extract using a rotary evaporator.

[0095] Sample 5: 15g of *Ficus hirta* (five-finger peach), 15g of black beans, 3g of orange seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of *Siraitia grosvenorii* (monk fruit). Add 500mL of pure water, bring to a boil, then simmer for 40 minutes. Pour out and filter. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Pour out and filter. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Pour out and filter. Mix the three filtrates thoroughly, then concentrate by rotary evaporation to obtain an extract.

[0096] Animal experiments: ICR mice were used, with 10 mice in each group.

[0097] Grouping:

[0098] Group A: Blank control

[0099] Group B: Model Group

[0100] Group C: Modeling + Sample 1 (2.5g / kg)

[0101] Group D: Modeling + Sample 2 (3.5g / kg)

[0102] Group E: Modeling + Sample 3 (6.5g / kg)

[0103] Group F: Modeling + Sample 4 (6.5g / kg)

[0104] Group G: Modeling + Sample 5 (6.5g / kg)

[0105] Mice in group BF were intraperitoneally injected with estradiol benzoate at a dose of 0.5 mg / kg once daily for 25 days, followed by intraperitoneal injection of progesterone at a dose of 4 mg / kg once daily for 5 days. Simultaneously, mice in group CF were administered the corresponding drug via gavage daily. The drug was obtained by diluting the extracts from samples 1-5 with water. Groups A and B were administered an equal volume of physiological saline via gavage, while groups C, D, E, F, and G were administered the drug via gavage at a dose of 0.2 mL per 20 g body weight, resulting in doses of 2.5 g / kg, 3.5 g / kg, 6.5 g / kg, 6.5 g / kg, and 6.5 g / kg for groups C, D, E, F, and G, respectively. Administered the drug via gavage once daily for 30 consecutive days.

[0106] The diameter of the second pair of nipples in all mice was measured with calipers before and after drug administration, and the average diameter of the two nipples was recorded as the nipple diameter of that mouse. Blood was collected from the eyeballs, and the levels of estradiol (E2) and progesterone (Pg) were determined by ELISA.

[0107] 2. Experimental results: The results are shown in Tables 5-6.

[0108] Table 5 Comparison of breast diameter before and after treatment

[0109] Breast diameter before treatment (mm) Post-treatment breast diameter (mm) Group A 0.424±0.056 0.413±0.084 Group B 0.412±0.074 <![CDATA[0.579±0.136 # ]]> Group C 0.421±0.074 0.533±0.108 Group D 0.412±0.051 0.495±0.128* Group E 0.413±0.087 0.446±0.174* Group F 0.421±0.077 0.570±0.168 Group G 0.418±0.064 0.467±0.152*

[0110] Note: After treatment, compared with the blank control group, # P < 0.05; compared with the model group, *P < 0.05

[0111] Table 6 Comparison of E2 and Pg levels in each group after treatment.

[0112] E2 (pg / ml) <![CDATA[Pg( ng / ml)]]> Group A 122.01±10.74 1.004±0.045 Group B <![CDATA[158.47±24.32 ## ]]> <![CDATA[0.736±0.064 # ]]> Group C 144.24±18.78* 0.744±0.077 Group D 134.56±17.95** 0.882±0.054* Group E 128.71±14.52** 1.041±0.073* Group F 150.77±18.42 0.798±0.086 Group G 131.78±16.21** 0.974±0.084*

[0113] Note: Compared with the blank control group, # P < 0.05, ## P < 0.01; compared with the model group, *P < 0.05, **P < 0.01

[0114] The results showed that after treatment, compared with the control group, the mammary diameter of mice in the model group was significantly increased, while samples 2, 3, and 5 significantly reduced the mammary diameter (P < 0.05). Compared with the control group, the E2 level of mice in the model group was significantly increased, and the Pg level was significantly decreased. Samples 1, 2, 3, and 5 significantly reduced the E2 level, while samples 2, 3, and 5 significantly increased the Pg level. Overall, the results indicated that sample 3 had the best effect.

[0115] Example 7 Decoction

[0116] Formula: 20g of five-finger peach, 20g of black beans, 3g of tangerine seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

[0117] Preparation: Weigh all raw materials according to the proportions, mix them, add 500mL of pure water, bring to a boil, then simmer for 40 minutes. Pour out and filter. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Pour out and filter. Add another 400mL of pure water to the residue, bring to a boil, then simmer for 30 minutes. Pour out and filter. Mix the filtrates from the three processes thoroughly, and concentrate by rotary evaporation.

[0118] Dosage and administration: The total daily intake is 450ml, twice a day (as a tea substitute).

[0119] Example 8 Granules

[0120] Formula: 20g of five-finger peach, 20g of black beans, 3g of tangerine seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

[0121] Preparation method: Weigh each raw material according to the proportion, reflux extract twice with 10-8 times the amount of 95% ethanol aqueous solution, 1 hour each time, combine the extracts, concentrate under reduced pressure to obtain dry paste, add suitable conventional excipients (excipients, flavoring agents, etc.), make into granules, and package according to the dosage to obtain granules.

[0122] Example 9: Capsules

[0123] Formula: 20g of five-finger peach, 20g of black beans, 3g of tangerine seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

[0124] Preparation method: Weigh each raw material according to the proportion, decoct twice with 10-8 times the amount of water, one hour each time, combine the decoctions, concentrate under reduced pressure to obtain a dry paste, add suitable conventional excipients (excipients, flavoring agents, etc.), make into granules, and package into capsules according to the dosage to obtain capsules.

[0125] Example 10 Oral Liquid

[0126] Formula: 20g of five-finger peach, 20g of black beans, 3g of tangerine seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

[0127] Preparation method: Weigh each raw material according to the proportion, decoct and extract three times with 10-8-8 times the amount of water, one hour each time, combine the three extracts, concentrate under reduced pressure to obtain a concentrated solution of the corresponding concentration, add suitable conventional excipients (flavoring agents, antibacterial agents, etc.), and package into containers of a certain specification according to the dosage to obtain the mixture (oral liquid) or tincture.

[0128] Example 11 Tablets

[0129] Formula: 20g of five-finger peach, 20g of black beans, 3g of tangerine seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

[0130] Preparation method: Weigh each raw material according to the proportion, extract twice with 10-8 times the amount of 70% ethanol aqueous solution using ultrasound, 40 minutes each time, combine the extracts, concentrate under reduced pressure to obtain a concentrated solution of the corresponding concentration, add suitable conventional excipients, make soft material, compress and package to obtain tablets.

Claims

1. A traditional Chinese medicine composition, characterized in that, It is prepared from at least the following raw materials: five-finger peach, black beans, and orange seeds.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, Five-finger peach 10-40g, black beans 10-40g, orange seeds 1-5g.

3. The traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, It also contains rose petals, jasmine petals, and monk fruit.

4. The traditional Chinese medicine composition as described in claim 3, characterized in that, Five-finger peach 10-40g, black beans 10-40g, orange seeds 1-5g, rose petals 1-5g, jasmine petals 1-5g, monk fruit 0.5-3g.

5. The traditional Chinese medicine composition as described in claim 3, characterized in that, Five-finger peach 10-30g, black beans 10-30g, orange seeds 3-5g, rose petals 3-5g, jasmine petals 3-5g, monk fruit 1-3g.

6. The traditional Chinese medicine composition according to claim 3, characterized in that, Five-finger peach 15-20g, black beans 15-20g, orange seeds 3-5g, rose petals 3-5g, jasmine petals 3-5g, monk fruit 1-3g.

7. The traditional Chinese medicine composition according to claim 3, characterized in that, 20g of five-finger peach, 20g of black beans, 3g of orange seeds, 3g of rose petals, 3g of jasmine flowers, and 1g of monk fruit.

8. The traditional Chinese medicine composition according to any one of claims 1-7, characterized in that, The mass ratio of five-finger peach to black beans is 1:

1.

9. A pharmaceutical composition comprising the traditional Chinese medicine composition according to any one of claims 1-8.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-8 or the pharmaceutical composition according to claim 9 in the preparation of food, medicine or health food for the prevention and treatment of breast hyperplasia.

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