Traditional Chinese medicine composition, preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition and a preparation method and application thereof; active ingredients of the traditional Chinese medicine composition include rose, bergamot, cydonia, poria cocos, Chinese yam, gordon euryale seed, coix seed, sea buckthorn, malt, chicken gizzard, angelica, longan, medlar, donkey-hide gelatin, mulberry, kelp, oyster, dandelion, dried tangerine or orange peel, platycladus, yellow mustard seed, peach kernel, saffron, radix astragali, American ginseng, raw sun-dried ginseng, dendrobium officinale, lily, ganoderma lucidum, jujube and mint; the traditional Chinese medicine composition is formed by the principle of monarch, minister, assistant and guide, forms a traditional Chinese medicine prescription of specific active ingredients, forms a herbal ointment that treats in all directions, has a remarkable curative effect on breast nodules, and has a good taste, is portable, and meets the long-term treatment requirements.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to traditional Chinese medicine compositions, their preparation methods, and uses. Background Technology

[0002] Breast nodules generally refer to lumps or nodules found in the breast during imaging or physical examination. It is a symptom, not an independent disease, and is a typical manifestation of breast hyperplasia. Clinically, breast hyperplasia is often defined as a syndrome characterized by breast pain, increased breast tension, localized thickening of the breast, and nodules with or without nipple discharge. Its pathogenesis is not yet clear, but may involve menstruation, marital and reproductive factors, diet, as well as genetic, endocrine, and environmental factors. Among all breast diseases, breast hyperplasia has a relatively high incidence rate, and this trend is gradually increasing. This disease affects women's physical and mental health, and with prolonged illness, benign breast nodules have a risk of further malignant transformation. Benign breast nodules are an important step in the progression of breast hyperplasia to breast cancer. Modern medicine believes that the multi-stage development of breast cancer is a continuous, banded process from benign breast disease to carcinoma in situ, and finally to invasive breast cancer. Breast cancer has the highest incidence rate among female malignant tumors. Therefore, in order to further advance the prevention and treatment of breast cancer, it is essential to focus on the prevention and treatment of breast nodules.

[0003] Currently, Western medicine treatment for breast nodules mainly relies on vitamins, hormones, or surgery, with unsatisfactory results. Vitamin therapy has unsatisfactory clinical effects, hormone therapy may cause menstrual disorders or even amenorrhea, and surgery leaves scars affecting appearance. Furthermore, benign breast nodules are often multiple and recurrent after surgery, requiring multiple and repeated surgeries, causing physical damage and significant psychological impact on patients. In traditional Chinese medicine, breast nodules are often classified under the category of "breast lumps," with their core pathogenesis summarized by physicians throughout history as "liver qi stagnation, spleen dysfunction, and phlegm and blood stasis." Treatment for benign breast nodules often involves using strong, rapid, and forceful Chinese herbal medicines to promote qi circulation, resolve phlegm, and break up blood stasis, which can be detrimental to the body's overall health and is not suitable for long-term use. Summary of the Invention

[0004] Therefore, it is necessary to provide a traditional Chinese medicine composition that integrates multiple functions such as resolving phlegm and dissipating nodules, soothing and nourishing the liver, promoting blood circulation and removing blood stasis, strengthening the spleen and removing dampness, and replenishing qi and blood, so as to provide a comprehensive treatment plan for treating both the symptoms and root causes of breast nodules and hyperplasia, as well as combining regulation and tonification.

[0005] In a first aspect, this application provides a traditional Chinese medicine composition, the active ingredients of which include rose, Buddha's hand, citron, poria, yam, fox nut, coix seed, sea buckthorn, malt, chicken gizzard lining, angelica, longan, wolfberry, donkey-hide gelatin, mulberry, kelp, oyster, dandelion, tangerine peel, platycodon, yellow mustard seed, peach kernel, saffron, astragalus, American ginseng, sun-dried ginseng, dendrobium officinale, lily, ganoderma, jujube, and peppermint.

[0006] In some embodiments, the active ingredients of the traditional Chinese medicine composition, by weight, include 20-40 parts of rose petals, 20-40 parts of bergamot, 1-30 parts of citron, 5-15 parts of poria cocos, 5-15 parts of yam, 5-15 parts of fox nut, 5-15 parts of coix seed, 10-20 parts of sea buckthorn, 10-30 parts of malt, 5-30 parts of chicken gizzard lining, 5-15 parts of angelica sinensis, 5-30 parts of longan, 10-35 parts of wolfberry, 20-40 parts of donkey-hide gelatin, and 2 parts of mulberry. 0-40 parts, kelp 10-20 parts, oyster 10-40 parts, dandelion 10-30 parts, dried tangerine peel 10-30 parts, platycodon 5-15 parts, yellow mustard seed 1-30 parts, peach kernel 1-30 parts, saffron 0.01-30 parts, astragalus 20-40 parts, American ginseng 10-30 parts, sun-dried ginseng 1-30 parts, dendrobium officinale 10-20 parts, lily 20-40 parts, ganoderma lucidum 10-30 parts, jujube 1-10 parts, and mint 5-20 parts.

[0007] In some embodiments, the active ingredients of the traditional Chinese medicine composition, by weight, include 20-40 parts of rose petals, 20-40 parts of bergamot, 1-30 parts of citron, 5-15 parts of poria cocos, 5-15 parts of yam, 5-15 parts of fox nut, 5-15 parts of coix seed, 10-20 parts of sea buckthorn, 10-30 parts of malt, 5-20 parts of chicken gizzard lining, 5-15 parts of angelica sinensis, 10-30 parts of longan, 10-30 parts of wolfberry, 20-40 parts of donkey-hide gelatin, and 2 parts of mulberry. 0-40 parts, kelp 10-20 parts, oyster 20-40 parts, dandelion 10-30 parts, dried tangerine peel 10-30 parts, platycodon 5-15 parts, yellow mustard seed 1-30 parts, peach kernel 1-30 parts, saffron 0.01-30 parts, astragalus 20-40 parts, American ginseng 10-30 parts, sun-dried ginseng 5-30 parts, dendrobium officinale 10-20 parts, lily 20-40 parts, ganoderma lucidum 10-30 parts, jujube 1-10 parts, and mint 5-20 parts.

[0008] In some embodiments, donkey-hide gelatin is donkey-hide gelatin pearls, peach kernels are roasted peach kernels, and coix seed is coix seed (fried).

[0009] In some embodiments, the components of the traditional Chinese medicine composition further include excipients;

[0010] Optionally, the excipients are selected from one or more of isomaltooligosaccharide, honey, succinate, and maltodextrin;

[0011] Further optionally, the amount of the excipient added is 500-1500 parts.

[0012] Secondly, this application also provides a method for preparing a traditional Chinese medicine composition, comprising the following steps:

[0013] The first active ingredient is mixed with the first portion of water and soaked, then filtered to obtain a solid.

[0014] Boil the oysters with the second portion of water to obtain oyster broth;

[0015] The oyster extract, the solids, and the third portion of water are mixed, boiled, filtered, and the filtrate is collected and concentrated to form a concentrate.

[0016] The second active ingredient is added to the concentrate, mixed, and then concentrated to form a paste to prepare the traditional Chinese medicine composition.

[0017] The first active ingredients include rose, bergamot, citron, poria cocos, yam, fox nut, coix seed, sea buckthorn, malt, chicken gizzard lining, kelp, dandelion, tangerine peel, platycodon root, yellow mustard seed, peach kernel, astragalus, American ginseng, sun-dried ginseng, dendrobium officinale, lily, ganoderma lucidum, angelica, longan, wolfberry, mulberry, jujube, and mint;

[0018] The second active ingredient includes saffron and donkey-hide gelatin;

[0019] Optionally, the second active ingredient may also include excipients.

[0020] In some embodiments, the mass ratio of the first active ingredient to the first portion of water is 1:(8-12); and / or, the soaking time is at least 6 hours; and / or, the concentration conditions include: concentrating at 60°C-70°C until the relative density of the filtrate is 1.10-1.20.

[0021] In some embodiments, the step of mixing the oyster extract, the solids, and the third portion of water for boiling and filtering includes:

[0022] The solids were mixed with a portion of water at a mass ratio of 1:(8-12), brought to a boil over high heat, then simmered over low heat for 2-3 hours. The mixture was filtered, and the first filtrate was collected.

[0023] Mix the filter residue with some water at a mass ratio of 1:(6-8), simmer over low heat for 1.5-2 hours, filter, and collect the second filtrate;

[0024] Mix the filter residue with the remaining water at a mass ratio of 1:(4-6), boil for 1-1.5 hours, filter, and collect the third filtrate;

[0025] Combine the first filtrate, the second filtrate, and the third filtrate.

[0026] In some embodiments, the donkey-hide gelatin includes donkey-hide gelatin beads, which are formed by placing donkey-hide gelatin blocks in talcum powder and / or clam powder and scalding them until they form beads; and / or, the peach kernels are blanched peach kernels formed by blanching; and / or, the coix seeds are roasted coix seeds formed by charring.

[0027] Thirdly, this application also provides the use of traditional Chinese medicine compositions prepared by the methods provided in the first or second aspects in the preparation of medicaments for treating breast nodules.

[0028] Fourthly, this application also provides a medicament for treating breast nodules, the components of which include a traditional Chinese medicine composition prepared by the method of the traditional Chinese medicine composition provided in the first aspect or the method of the traditional Chinese medicine composition provided in the second aspect.

[0029] Compared with traditional technologies, the technical effects of the present application's technical solution include:

[0030] This application provides a traditional Chinese medicine composition that targets the complex pathogenesis of breast nodules, characterized by "liver stagnation and spleen deficiency as the root cause, phlegm and blood stasis as the symptoms, and prolonged illness inevitably leading to deficiency as the root cause." It utilizes the active ingredients of rose, bergamot, citron, poria, yam, fox nut, coix seed, sea buckthorn, malt, chicken gizzard lining, angelica, longan, wolfberry, donkey-hide gelatin, mulberry, kelp, oyster shell, dandelion, tangerine peel, platycodon, yellow mustard seed, peach kernel, saffron, astragalus, American ginseng, sun-dried ginseng, dendrobium officinale, lily, ganoderma, jujube, and peppermint, formulated according to the principles of monarch, minister, assistant, and guide in traditional Chinese medicine. This herbal paste offers comprehensive treatment by soothing the liver and relieving stagnation to address the root cause, strengthening the spleen and resolving phlegm, promoting blood circulation and dispersing nodules to address the symptoms, and tonifying qi and nourishing blood to strengthen the root cause. It exhibits significant efficacy in treating breast nodules. Compared to traditional Chinese medicine formulas for treating breast nodules, which, while powerful and rapid, often deplete the body's vital energy and are not suitable for long-term use, and suffer from poor taste, difficulty in adherence, and inconvenience in carrying, the Chinese medicine composition proposed in this application is palatable, easy to take and carry, and easy to adhere to. While achieving both tonification and regulation and treating both the root cause and symptoms of breast nodules and hyperplasia, it can effectively improve patient treatment compliance and thus enhance clinical efficacy. Detailed Implementation

[0031] To facilitate understanding of the present invention, preferred embodiments are provided below to provide a more complete description of the invention. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to enable a thorough and complete understanding of the disclosure of the present invention.

[0032] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this invention pertains. The terms used in the description of the present invention herein are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the related listed items.

[0033] The term "strong fire" in traditional Chinese medicine refers to a large and urgent fire when decocting medicine, and its temperature range belongs to the conventional knowledge in this field.

[0034] The term "gentle fire" in traditional Chinese medicine refers to a small and slow fire when boiling medicine, and its temperature range belongs to the conventional knowledge in this field.

[0035] The term "gentle fire rock sugar" means rock sugar decocted with gentle fire, which is used in plaster prescriptions to reconcile the properties of medicine, correct the taste, and assist in forming the plaster.

[0036] Traditional Chinese medicine believes that the main factor of breast nodules is stagnation of liver qi, which causes qi stagnation and blood stasis as the disease progresses, and condenses into lumps locally. Modern medicine believes that breast hyperplasia is a disease of abnormal hyperplasia of breast epithelium caused by endocrine disorders, which is related to the lesions of breast lobules and tissue ducts. Traditional Chinese medicine calls it "breast mass". In "Xin De Ji of Surgical Diseases": A nodule in the breast, shaped like a pill or an egg, not painful, not having fever or chills, the skin color unchanged, and the nodule growing and subsiding with emotions. This is called breast mass. It describes the clinical characteristics of breast pain in breast hyperplasia and the close relationship between breast masses and emotional changes, and believes that this disease "is mainly caused by the stagnation of liver qi" and advocates using Xiaoyao Powder to soothe the liver and relieve depression for treatment. However, using Xiaoyao Powder alone to treat breast hyperplasia has obvious drawbacks and limitations: (1) Xiaoyao Powder is generally ineffective in dissipating nodules. Clinically, it is common that after patients take Xiaoyao Powder, their emotions improve and breast distending pain is relieved, but the size of the nodules detected by ultrasound during reexamination shows no obvious change; (2) Xiaoyao Powder is likely to damage liver yin. Bupleurum in Xiaoyao Powder is the main medicine for soothing the liver, and its nature is light, clear, and ascending and dispersing. The course of breast hyperplasia nodules is lingering, and long-term medication is required for conditioning. If Bupleurum is used for a long time, its ascending and dispersing nature is likely to damage liver yin, especially for patients with insufficient yin blood (such as those with scanty menstrual flow, dry mouth, and scanty tongue coating), which can lead to endogenous virtual fire and adverse reactions such as restlessness and insomnia; (3) Xiaoyao Powder has weak blood-activating and stasis-removing power. Breast nodules are often accompanied by blood stasis, manifested as stabbing pain, hard masses, and purplish dark tongue. Although there is Angelica sinensis in Xiaoyao Powder to nourish blood and promote blood circulation, the power of promoting blood circulation is mild. For patients with obvious blood stasis, the power of removing stasis is insufficient, and it is difficult to effectively soften and disperse the nodules; (4) Xiaoyao Powder has weak phlegm-resolving power. Although there are Poria cocos and Atractylodes macrocephala in Xiaoyao Powder to strengthen the spleen and promote diuresis, from the pathogenesis of "spleen deficiency generating phlegm", it can only "prevent the generation of phlegm" and is difficult to directly resolve phlegm and disperse the condensed "phlegm turbidity". (5) Xiaoyao Powder has insufficient power to supplement qi and blood.

[0037] Breast nodules have a long course and are difficult to cure, which will inevitably consume the body's qi and blood, leading to deficiency of vital energy. Patients often show signs of qi and blood deficiency such as pale complexion, fatigue, reduced menstrual flow, pale tongue and thin pulse. Although Xiaoyao San contains poria and atractylodes macrocephala to invigorate qi and strengthen the spleen, and angelica and white peony to nourish blood, its tonifying power is mild and focuses on "regulation" rather than "tonification". For the qi and blood deficiency caused by long-term illness, Xiaoyao San cannot provide enough "support" to strengthen the body, which makes the body unable to transport the medicinal power and unable to expel the pathogens, affecting the overall efficacy. Because the root of the "deficiency" has not been corrected, the nodules are prone to relapse after stopping the medication, and patients are also unable to achieve a fundamental improvement in their constitution. (6) Xiaoyao San is a powder, and the word "powder" means to disperse. Although it can dissipate nodules, it is inconvenient to take and has a poor taste, making it difficult for patients to persist for a long time.

[0038] Based on this, this application aims to provide a comprehensive treatment plan for breast nodules and hyperplasia by scientifically combining traditional Chinese medicine prescriptions. This plan integrates multiple effects such as resolving phlegm and dissipating nodules, soothing and nourishing the liver, promoting blood circulation and removing blood stasis, strengthening the spleen and removing dampness, and replenishing qi and blood.

[0039] In a first aspect, this application provides a traditional Chinese medicine composition, the active ingredients of which include rose, Buddha's hand, citron, poria, yam, fox nut, coix seed, sea buckthorn, malt, chicken gizzard lining, angelica, longan, wolfberry, donkey-hide gelatin, mulberry, kelp, oyster, dandelion, tangerine peel, platycodon, yellow mustard seed, peach kernel, saffron, astragalus, American ginseng, sun-dried ginseng, dendrobium officinale, lily, ganoderma, jujube, and peppermint.

[0040] Based on the principle of monarch, minister, assistant, and envoy compatibility in traditional Chinese medicine theory, in this application, rose, fingered citron, and citron fruit are used as the monarch drugs, jointly undertaking the functions of soothing the liver and relieving depression, and regulating qi movement. Among them, rose is sweet, slightly bitter, and warm in nature, with fragrant qi promoting qi movement, relieving depression and regulating blood circulation, specifically treating breast distending pain and emotional depression caused by liver qi stagnation. Its nature is gentle, soothing the liver without depleting yin, being the top of the monarch drugs; fingered citron is pungent, bitter, sour, and warm in nature, good at soothing the liver and regulating qi, and regulating the middle-jiao and resolving phlegm. It can relieve liver depression and regulate the spleen and stomach, fitting the pathogenesis of "liver qi invading the stomach"; citron fruit is pungent, bitter, sour, and warm in nature, soothing the liver and regulating qi, promoting the function of the middle-jiao and resolving phlegm, synergistically enhancing the power of soothing the liver with fingered citron. Twelve herbs including poria cocos, Chinese yam, gordon euryale seed, coix seed (fried), seabuckthorn, malt, chicken's gizzard-membrane, angelica sinensis, longan, wolfberry fruit, donkey-hide gelatin, and mulberry are used as the minister drugs. Among them, poria cocos, Chinese yam, gordon euryale seed, coix seed (fried), seabuckthorn, malt, and chicken's gizzard-membrane jointly undertake the functions of strengthening the spleen and promoting diuresis, resolving phlegm and dissipating accumulation; angelica sinensis, longan, wolfberry fruit, donkey-hide gelatin, and mulberry jointly undertake the functions of nourishing blood and regulating menstruation, moistening the liver body; among them, poria cocos strengthens the spleen and promotes diuresis, calming the mind and tranquilizing the spirit, being the core drug for strengthening the spleen; Chinese yam tonifies the spleen, lungs, and kidneys evenly, tonifying qi and yin, and protecting the middle-jiao; gordon euryale seed strengthens the spleen and consolidates the kidney, removing dampness and stopping leukorrhea, enhancing the function of "fixing and astringing"; coix seed (fried) strengthens the spleen and promotes diuresis, clearing heat and expelling pus, assisting in clearing the source of phlegm-dampness generation; malt soothes the liver and promotes qi movement, strengthening the spleen and promoting appetite. Its function of "promoting digestion and dissipating accumulation" can be analogized to "dissipating masses", embodying "dissipating accumulation" in "dissipating masses"; chicken's gizzard-membrane is a powerful drug for promoting digestion, strengthening the spleen and dissipating accumulation, removing stasis and dissipating masses, being the key drug for "assisting dissipation with digestion"; seabuckthorn strengthens the spleen and promotes digestion, activating blood circulation and removing stasis. It can not only strengthen the transportation of the middle-jiao to prevent the generation of phlegm-dampness, but also directly assist in activating blood circulation and dissipating masses. Compared with fresh ginger which is pungent, warm, and dispersing, and易耗气伤阴 after long-term use, seabuckthorn combines strengthening the spleen and promoting digestion with activating blood circulation and removing stasis, fitting the need for long-term regulation and treatment of breast hyperplasia nodules; angelica sinensis nourishes blood and promotes blood circulation, regulating menstruation and relieving pain. Its nature is "active", making the nourished blood without leaving stasis; longan tonifies the heart and spleen, benefits qi and blood, nourishing the heart and calming the spirit. Its nature is warm and moist, helping angelica sinensis nourish blood; wolfberry fruit nourishes the liver and kidney, benefits essence and improves eyesight, filling the lower-jiao essence and blood; donkey-hide gelatin is a drug of animal origin, nourishing yin and blood, moistening dryness and stopping bleeding. Its nature is "static", with a weaker greasy nature than rehmannia glutinosa and a stronger blood-nourishing power, and having the function of moistening dryness, balancing the warm and dry properties of the whole formula, making the nourished blood not disturbing the stomach, and being more suitable for long-term use; mulberry nourishes yin and blood, promoting the production of body fluid and moistening dryness, synergistically nourishing the liver and kidney with wolfberry fruit. This application further adds a fifth active ingredient, enabling the newly generated blood to quickly perfusion the meridians and directly reach the affected area, being more conducive to the elimination and treatment of breast nodules.

[0041] Furthermore, based on the aforementioned principal and assistant herbs, kelp, oyster shell, dandelion, tangerine peel, platycodon root, yellow mustard seed, peach kernel, saffron, astragalus, American ginseng, sun-dried ginseng, dendrobium officinale, lily bulb, and ganoderma lucidum are used as adjuvant herbs in the herbal combination to address the secondary concurrent symptom of "phlegm and blood stasis," thereby achieving the effects of resolving phlegm and dissipating nodules, and promoting blood circulation and removing blood stasis. The six herbs—kelp, oyster shell, dandelion, tangerine peel, platycodon root, and yellow mustard seed—work together to resolve phlegm, soften hardened masses, reduce swelling, and dissipate nodules. Among them, kelp, salty and cold in nature, softens hardness, resolves phlegm and dissipates nodules, serving as the main medicine for dissipating nodules; oyster shell, salty, astringent and slightly cold in nature, softens hardness and dissipates nodules, and has a calming and sedative effect, working synergistically with kelp to enhance its softening power; dandelion, clearing heat and detoxifying, reducing swelling and dissipating nodules, can both work synergistically to dissipate mastitis and balance the warming and drying properties of the formula with its bitter and cold nature; tangerine peel, regulating qi and strengthening the spleen, drying dampness and resolving phlegm, allowing qi to flow smoothly and phlegm to dissipate, embodying the idea of ​​"treating phlegm by first treating qi"; platycodon root, promoting lung function and relieving sore throat, eliminating phlegm and pus, and carrying the medicine upwards, guiding the power of the other medicines directly to the chest and breast meridians; yellow mustard seed, pungent and warm in nature, has a strong effect in eliminating old and stubborn phlegm under the skin and membranes, forming a "cold and warm stimulating, opposite and complementary" effect with the salty and cold kelp and oyster shell, enhancing the attacking power. Peach kernel and saffron work together to promote blood circulation, remove blood stasis, and dissipate nodules. Among them, roasted peach kernels invigorate blood circulation, remove blood stasis, and moisten the intestines to relieve constipation, making them a key medicine for invigorating blood circulation and removing blood stasis; saffron invigorates blood circulation, removes blood stasis, cools the blood and detoxifies, relieves depression and calms the mind, its blood-invigorating power is strong and its nature is cold, which can balance the warm and dryness in the formula. Astragalus, American ginseng, sun-dried ginseng, Dendrobium officinale, lily bulb and Ganoderma lucidum work together to tonify qi and nourish yin, and strengthen the body's resistance. Among them, astragalus tonifies qi and raises yang, benefits the defensive qi and strengthens the exterior, making it a key medicine for tonifying qi, and it works synergistically with ginseng to enhance the qi-tonifying power; American ginseng tonifies qi and nourishes yin, clears heat and generates fluids, making it a mild tonic to prevent excessive dryness from warm tonics; sun-dried ginseng greatly tonifies the original qi, tonifies the spleen and lungs, generates fluids and calms the mind, making it the chief medicine for strengthening the body's resistance and restoring its foundation; Dendrobium officinale benefits the stomach and generates fluids, nourishes yin and clears heat, and protects the function of the middle jiao; lily bulb nourishes yin and moistens the lungs, clears the heart and calms the mind. Its yin-nourishing power can work synergistically with American ginseng and dendrobium to nourish yin fluids, and its calming effect can work with Ganoderma lucidum to relieve irritability and insomnia caused by liver stagnation and fire. It assists the principal herb in soothing the liver and relieving depression, achieving "harmony between body and mind". Ganoderma lucidum replenishes qi and calms the mind, and is effective in addressing anxiety and insomnia caused by prolonged illness and depletion of spirit, achieving harmony between body and mind.

[0042] Furthermore, based on the aforementioned principal, assistant, and adjuvant herbs, jujube and mint are added. Jujube, along with sea buckthorn (an assistant herb) and mint, along with platycodon (an adjuvant herb), together form guiding herbs, harmonizing the effects of the other herbs and directing them to their respective meridians. Jujube, in particular, tonifies the middle energizer, replenishes qi, nourishes blood, calms the mind, and moderates the properties of other herbs, thus harmonizing their effects. It also avoids the "Eighteen Incompatibilities" (kelp and seaweed are incompatible with licorice), ensuring safety for long-term use. Furthermore, jujube synergizes with sea buckthorn (an assistant herb) to better achieve the effects of tonifying the middle energizer, replenishing qi, and harmonizing the other herbs. Mint, being light and dispersing, soothes the liver, clears heat, and resolves stagnant heat, addressing the potential for prolonged liver stagnation to transform into heat. Simultaneously, mint synergizes with platycodon to carry the herbs upwards, further resolving the potential for prolonged liver stagnation to transform into heat.

[0043] This application presents a traditional Chinese medicine composition formulated through the combination of principal, assistant, adjuvant, and guide herbs. This composition has the effect of soothing the liver and relieving depression, retaining the function of soothing the liver and relieving depression while avoiding the depletion of qi and yin caused by prolonged use. At the same time, it strengthens the spleen and resolves phlegm, and has the direct ability to eliminate existing "phlegm nodules". It includes the effects of resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, and tonifying qi and supporting the body's resistance. It is also supplemented by harmonizing other herbs and guiding herbs to achieve multiple effects such as tonifying qi, promoting blood circulation, resolving phlegm, and regulating qi. Thus, it forms a comprehensive and multi-target treatment plan for breast nodules, with excellent efficacy for breast nodules and meets the needs of long-term treatment.

[0044] In some embodiments, the active ingredients of the traditional Chinese medicine composition, by weight, include 20-40 parts of rose petals, 20-40 parts of bergamot, 1-30 parts of citron, 5-15 parts of poria cocos, 5-15 parts of yam, 5-15 parts of fox nut, 5-15 parts of coix seed, 10-20 parts of sea buckthorn, 10-30 parts of malt, 5-30 parts of chicken gizzard lining, 5-15 parts of angelica sinensis, 5-30 parts of longan, 10-35 parts of wolfberry, 20-40 parts of donkey-hide gelatin, and 20 parts of mulberry. -40 parts, kelp 10-20 parts, oyster 10-40 parts, dandelion 10-30 parts, dried tangerine peel 10-30 parts, platycodon 5-15 parts, yellow mustard seed 1-30 parts, peach kernel 1-30 parts, saffron 0.01-30 parts, astragalus 20-40 parts, American ginseng 10-30 parts, sun-dried ginseng 1-30 parts, dendrobium officinale 10-20 parts, lily 20-40 parts, ganoderma lucidum 10-30 parts, jujube 1-10 parts, and mint 5-20 parts.

[0045] In some embodiments, the active ingredients of the traditional Chinese medicine composition, by weight, include 20-40 parts of rose petals, 20-40 parts of bergamot, 1-30 parts of citron, 5-15 parts of poria cocos, 5-15 parts of yam, 5-15 parts of fox nut, 5-15 parts of coix seed, 10-20 parts of sea buckthorn, 10-30 parts of malt, 5-20 parts of chicken gizzard lining, 5-15 parts of angelica sinensis, 10-30 parts of longan, 10-30 parts of wolfberry, 20-40 parts of donkey-hide gelatin, and 20 parts of mulberry. -40 parts, kelp 10-20 parts, oyster 20-40 parts, dandelion 10-30 parts, dried tangerine peel 10-30 parts, platycodon 5-15 parts, yellow mustard seed 1-30 parts, peach kernel 1-30 parts, saffron 0.01-30 parts, astragalus 20-40 parts, American ginseng 10-30 parts, sun-dried ginseng 5-30 parts, dendrobium officinale 10-20 parts, lily 20-40 parts, ganoderma lucidum 10-30 parts, jujube 1-10 parts, and mint 5-20 parts.

[0046] In some preferred embodiments, the active ingredients of the traditional Chinese medicine composition, by weight, include 28-32 parts of rose petals, 28-32 parts of Buddha's hand citron, 1-30 parts of citron, 8-12 parts of Poria cocos, 8-12 parts of yam, 8-12 parts of Euryale ferox, 8-12 parts of coix seed, 12-18 parts of sea buckthorn, 18-30 parts of malt, 8-20 parts of chicken gizzard lining, 8-12 parts of angelica sinensis, 18-30 parts of longan, 15-30 parts of wolfberry, 28-32 parts of donkey-hide gelatin, and 2 parts of mulberry. 8-32 parts, kelp 12-18 parts, oyster 28-32 parts, dandelion 18-22 parts, dried tangerine peel 18-30 parts, platycodon 8-12 parts, yellow mustard seed 5-30 parts, peach kernel 1-30 parts, saffron 0.05-30 parts, astragalus 28-32 parts, American ginseng 15-30 parts, sun-dried ginseng 8-30 parts, dendrobium officinale 12-18 parts, lily 28-32 parts, ganoderma lucidum 18-22 parts, jujube 1-8 parts, and mint 10-20 parts.

[0047] In some embodiments, the components of the traditional Chinese medicine composition further include excipients. Exemplary excipients include excipients and / or flavoring agents, such as one or more of isomaltooligosaccharide, honey, sorbitol, and maltodextrin. Isomaltooligosaccharide is preferred as an excipient and flavoring agent for the paste, improving the taste while also possessing the modern function of prebiotic regulation of gut microbiota.

[0048] In some embodiments, the amount of excipients added is 500-1500 parts by weight of the traditional Chinese medicine composition, more preferably 800-1200 parts. For example, the amount of isomaltooligosaccharide added is 500-1500 parts.

[0049] Breast nodules are tangible pathogenic factors formed over time by phlegm and blood stasis, falling under the category of "excessive manifestation." This application combines liver-soothing and stagnation-relieving modules with phlegm-resolving and nodule-dispersing modules. It uses salty and cold herbs to directly dissolve phlegm nodules, and pungent and warm herbs to attack stubborn phlegm, constructing a "three-dimensional attack system" for breast nodules. This system addresses the technical problem of traditional Chinese medicine preparations for breast nodules lacking the powerful ability to directly disperse existing "phlegm and blood stasis" nodules, achieving both "treating the root cause and the symptoms." For existing nodules, it directly softens and disperses nodules, invigorates blood circulation, and removes blood stasis, resulting in significant shrinkage or disappearance of nodules. In some preferred formulations, active ingredients such as phlegm-resolving, nodule-dispersing, blood-activating, stasis-removing, qi-tonifying, and blood-nourishing ingredients are also added, better resolving the difficult syndrome of phlegm and blood stasis in breast nodules that cannot be resolved by general spleen-strengthening and dampness-draining drugs.

[0050] Secondly, this application also provides a method for preparing a traditional Chinese medicine composition, comprising the following steps:

[0051] S1. The first active ingredient is mixed with the first portion of water and soaked, then filtered to obtain a solid.

[0052] S2. Boil the oysters with the second portion of water to obtain oyster broth.

[0053] S3. Mix the oyster feed liquid, solids and the third part of water, boil and filter, collect the filtrate and concentrate it to form a concentrate.

[0054] S4. Add the second active ingredient to the concentrate, mix and collect the paste to prepare a traditional Chinese medicine composition.

[0055] The first active ingredients include rose, Buddha's hand, citron, poria cocos, yam, fox nut, coix seed, sea buckthorn, malt, chicken gizzard lining, kelp, dandelion, tangerine peel, platycodon root, yellow mustard seed, peach kernel, astragalus, American ginseng, sun-dried ginseng, dendrobium officinale, lily, ganoderma lucidum, angelica, longan, wolfberry, mulberry, jujube, and peppermint; the second active ingredients include saffron and donkey-hide gelatin.

[0056] In some embodiments, the second active ingredient further includes excipients.

[0057] In some embodiments, in step S1, the mass ratio of the first active ingredient to the first portion of water is 1:(8-12).

[0058] In some embodiments, in step S1, the soaking time is a "slow soaking and long soaking" of at least 6 hours. This process is designed to allow plant cells to fully absorb water and swell, creating the necessary conditions for the efficient dissolution of active ingredients during decoction; more preferably, it is 6 to 9 hours.

[0059] In some embodiments, the preparation process of oyster feed liquid in step S2 includes:

[0060] Place the raw oysters in a pot and simmer for 4 hours. Add water in the second part, enough to cover the oysters by about 2cm. Cover and bring to a boil over high heat, then reduce to a simmer (about 95℃) to prevent the temperature from dropping and reducing the medicinal effect. This allows the effective components for softening and dispersing nodules to be fully extracted. Keep the contents of the pot, i.e., the oyster liquid.

[0061] In some embodiments, step S3, the process of mixing the oyster broth, solids, and the third portion of water for boiling and filtering includes a "three-boiling and three-filtering" process, specifically including:

[0062] S31. First decoction: Mix the solids with part of the water in the third part at a mass ratio of 1:(8-12), bring to a boil over high heat, then simmer over low heat (about 95°C) for 2-3 hours, filter, and collect the first filtrate.

[0063] This stage aims to dissolve most of the water-soluble components and filter out the first batch of medicinal juice, which is dark in color and strong in taste, and is called the "essence".

[0064] S32. Mix the filter residue with part of the water in the third part at a mass ratio of 1:(6-8), simmer over low heat (about 95°C) for 1.5-2 hours, filter, and collect the second filtrate.

[0065] S33. Mix the filter residue with the remaining water in the third part of the water at a mass ratio of 1:(4-6), simmer over low heat (about 95°C) for 1-1.5 hours, filter, and collect the third filtrate.

[0066] Combine the first, second, and third filtrates and filter them together.

[0067] As a non-limiting example, the filtration adopts a two-step method of "primary filtration + fine filtration". The primary filtration uses a filter cloth with a mesh size of 120 or higher, and the fine filtration uses a precision filter with a pore size of 4μm to remove fine burnt debris and insoluble particles, making the paste delicate, smooth to drink, and retaining the large molecular effective ingredients.

[0068] In some embodiments, the concentration process employs reduced pressure concentration or open-air slow concentration at atmospheric pressure, specifically: the combined filtrate is transferred to a concentration vessel for low-temperature reduced pressure concentration or open-air slow concentration at atmospheric pressure; wherein the concentration temperature is 60℃-70℃.

[0069] In some embodiments, the concentration process requires continuous stirring to prevent scorching, concentrating the extract to a thick paste with a relative density of approximately 1.10-1.20 (50℃-60℃). Controlling the concentration process is a key indicator for the quality control of medicinal pastes, ensuring the stability of each batch of product.

[0070] In some embodiments, step S4, the step of adding the second active ingredient, includes:

[0071] First, add saffron extract and stir well. Heat over a low flame. Then add the excipients (isomaltooligosaccharide) and pre-treated donkey-hide gelatin. This process is called "secret preparation." Continue to stir slowly in the same direction with a copper spatula. This is called "refining the paste" to make the ingredients blend together. As the paste becomes thicker, it will slowly fall like satin when scooped up with a stirring stick, forming a "hanging flag." Alternatively, a small amount can be dropped into cold water. If it solidifies and does not disperse, forming a "drop of water forming a bead," the paste is ready. At this point, the paste will be glossy and amber in color.

[0072] In some embodiments, adhering to the ancient adage that "insufficient processing yields poor efficacy, while excessive processing results in the loss of medicinal properties," certain medicinal materials undergo a secret pre-processing method. The pre-processed donkey-hide gelatin is formed into donkey-hide gelatin beads. These beads, unlike donkey-hide gelatin used directly in medicine, possess the characteristics of flavor correction, deodorization, and easy melting. Specifically, donkey-hide gelatin blocks are placed in talcum powder and / or clam powder and heated until they form beads. Peach kernels are processed by scalding, which has the effect of reducing toxicity and enhancing efficacy. Job's tears are processed by roasting; raw Job's tears are cold in nature, while roasted Job's tears are milder and suitable for long-term conditioning. This application's pre-processing of certain medicinal materials aims to stimulate or transform their medicinal properties, laying the foundation for subsequent extraction.

[0073] As a non-limiting example, this application specifies the strict geographical origin of some medicinal materials, such as Astragalus membranaceus from Mongolia, Angelica sinensis from Minxian County, Gansu, and Poria cocos from Yunnan and other traditional producing areas. This application clearly defines the traditional producing areas of key medicinal materials. The authenticity of medicinal materials directly affects the content of effective components and efficacy, making the technical solution more certain and reproducible.

[0074] While traditional Chinese medicine preparations for treating breast nodules have certain therapeutic effects, their poor taste, difficulty in adhering to treatment regimens, and inconvenience in carrying them prevent patients from completing the full course of treatment, thus affecting the efficacy. This application utilizes a specific preparation process to produce a paste with a pleasant taste, making it easily acceptable to patients and ensuring the efficacy of the medicine.

[0075] Thirdly, this application also provides the use of traditional Chinese medicine compositions prepared by the methods provided in the first or second aspects in the preparation of medicaments for treating breast nodules.

[0076] In some embodiments, the medicament further includes pharmaceutically acceptable excipients. Exemplarily, pharmaceutically acceptable excipients include materials, compositions, or mediators, such as liquid or solid fillers, diluents, excipients, solvents, or encapsulating materials.

[0077] In some embodiments, the dosage form of the drug includes capsules, tablets, pills, powders, and granules. It is understood that in such dosage forms, the active compound is mixed with at least one conventional inert excipient (or carrier).

[0078] The drug provided in this application has significant therapeutic effects on breast nodules and breast hyperplasia. At the same time, it also has a significant relieving effect on nodules that are diagnosed as phlegm and blood stasis, liver qi stagnation, and imbalance of the Chong and Ren meridians.

[0079] Fourthly, this application also provides a medicament for treating breast nodules, the components of which include a traditional Chinese medicine composition prepared by the method described in the first aspect or the method described in the second aspect.

[0080] For experimental parameters not specified in the following specific embodiments, please refer to the guidelines given in this application document first, or refer to experimental manuals or other experimental methods known in the art, or refer to the experimental conditions recommended by the manufacturer.

[0081] The raw materials and reagents involved in the following specific embodiments can be obtained commercially or prepared by those skilled in the art using known methods.

[0082] In the embodiments of this application, Astragalus membranaceus is selected from Mongolia, Angelica sinensis is selected from Minxian County, Gansu Province, and Poria cocos is selected from Yunnan and other traditional producing areas.

[0083] Basic Example 1

[0084] This basic example provides a traditional Chinese medicine composition, the formula of which is basically the same as that of Example 1, except that an equal amount of ginger is used to replace sea buckthorn, while the other components and preparation methods are the same as those of Example 1.

[0085] A paste was prepared according to the above formula using the preparation method of Example 1. If no corresponding medicinal material is added during the preparation process, the preparation step of the medicinal material can be omitted. All other conditions are the same as in Example 1.

[0086] Basic Example 2

[0087] This basic example provides a traditional Chinese medicine composition, the formula of which is basically the same as that of Example 1. The difference is that sea buckthorn is not added, and coix seed (fried) is used to make up the mass fraction. The other ingredients and preparation methods are the same as those of Example 1.

[0088] Basic Example 3

[0089] This basic example provides a traditional Chinese medicine composition, the formula of which is basically the same as that of Example 1. The difference is that Coix seed (fried) is not added, and sea buckthorn is used to make up the mass fraction. The other ingredients and preparation methods are the same as those of Example 1.

[0090] The specific preparation steps of the traditional Chinese medicine compositions in Basic Examples 1-3 are as follows:

[0091] Material selection and processing: Donkey-hide gelatin is processed into donkey-hide gelatin beads (donkey-hide gelatin blocks are placed in talcum powder and heated until they form beads), peach kernels are blanched to form blanched peach kernels, and coix seeds are stir-fried to form coix seeds (stir-fried). The preparation is carried out in accordance with the pharmacopoeia method, and the remaining medicinal materials are selected from authentic local materials.

[0092] Cleaning and Soaking: Cleaning: Quickly rinse under running purified water to remove surface dust without compromising efficacy. Floral herbs are delicate and should not be scrubbed. Place rose petals in a container and gently rinse with water for 3-5 seconds. Prolonged rinsing will dilute the volatile medicinal properties, affecting the liver-soothing and qi-regulating effects, and significantly weakening the mood-soothing effect. Soaking: Mix rose petals, Buddha's hand, citron, poria cocos, yam, fox nut, coix seed (not added in basic example 3), sea buckthorn (ginger in basic example 1, not added in basic example 2), malt, chicken gizzard lining, kelp, dandelion, dried tangerine peel, platycodon root, yellow mustard seed, peach kernel, astragalus root, American ginseng, sun-dried ginseng, dendrobium officinale, lily bulb, ganoderma lucidum, angelica sinensis, longan, goji berries, mulberry, jujube, and mint. Add 10 times the total weight of the herbs to water and soak for 6 hours. Filter and set aside the dregs.

[0093] Decoction and Filtration: First decoction: Place raw oysters separately in a pot and decoct for 4 hours. The water level should be about 2 cm above the oysters. Cover and bring to a boil over high heat, then reduce to a simmer and maintain a temperature of 95°C to prevent the medicinal effect from being reduced. Decoction for 4 hours allows the effective components for softening and dispersing nodules to be fully extracted. Then, add the soaked dregs and use the "three-decoction, three-filtration" method. Specifically: First, add 10 times the amount of water and soak for 6 hours (soak the jujubes after splitting them open), bring to a boil over high heat, then simmer over low heat for 2 hours; Second, add 8 times the amount of water and simmer over low heat for 1.5 hours; Third, add 6 times the amount of water and simmer over low heat for 1 hour. Combine the three filtrates and filter them through a 120-mesh or finer filter to obtain the final filtrate.

[0094] Concentration and paste formation: After concentrating the filtrate to a relative density of 1.15 (55℃), add saffron first, then add isomaltooligosaccharide and donkey-hide gelatin beads in a specific order to ensure efficacy. Continue stirring until the paste is formed when it "hangs like a flag" or "drops form beads".

[0095] Example 1

[0096] This embodiment provides a traditional Chinese medicine composition, the formula of which is as follows:

[0097] 30g rose petals, 30g Buddha's hand citron, 5g citron, 10g Poria cocos, 10g yam, 10g fox nut, 10g roasted coix seed, 15g sea buckthorn, 20g malt, 10g chicken gizzard lining, 10g angelica sinensis, 20g longan, 20g wolfberry, 30g donkey-hide gelatin, 30g mulberry, 15g kelp, 30g oyster, 20g dandelion, 20g dried tangerine peel, 10g platycodon grandiflorus, 5g yellow mustard seed, 5g roasted peach kernel, 0.05g saffron, 30g astragalus, 15g American ginseng, 10g sun-dried ginseng, 15g dendrobium officinale, 30g lily bulb, 20g ganoderma lucidum, 5g jujube, 1000g isomaltooligosaccharide, and 10g peppermint.

[0098] A paste was prepared according to the above formula, and the specific preparation steps are as follows:

[0099] Material selection and processing: Donkey-hide gelatin is processed into donkey-hide gelatin beads (donkey-hide gelatin blocks are placed in talcum powder and heated until they form beads), peach kernels are blanched to form blanched peach kernels, and coix seeds are stir-fried to form coix seeds (stir-fried). The preparation is carried out in accordance with the pharmacopoeia method, and the remaining medicinal materials are selected from authentic local materials.

[0100] Cleaning and Soaking: Cleaning: Quickly rinse under running purified water to remove surface dust without compromising efficacy. Floral herbs are delicate and should not be scrubbed. Place rose petals in a container and gently rinse with water for 3-5 seconds; prolonged rinsing will dilute the volatile medicinal properties, affecting the liver-soothing and qi-regulating effects, and significantly weakening its mood-soothing efficacy. Soaking: Mix rose petals, Buddha's hand, citron, poria cocos, yam, fox nut, coix seed, sea buckthorn, malt, chicken gizzard lining, kelp, dandelion, dried tangerine peel, platycodon root, yellow mustard seed, peach kernel, astragalus, American ginseng, sun-dried ginseng, dendrobium officinale, lily bulb, ganoderma lucidum, angelica sinensis, longan, goji berries, mulberry, jujube, and mint. Add 10 times the total weight of the herbs to water and soak for 6 hours. Filter and set aside the dregs.

[0101] Decoction and Filtration: First decoction: Place raw oysters separately in a pot and decoct for 4 hours. The water level should be about 2 cm above the oysters. Cover and bring to a boil over high heat, then reduce to a simmer and maintain a temperature of 95°C to prevent the medicinal effect from being reduced. Decoction for 4 hours allows the effective components for softening and dispersing nodules to be fully extracted. Then, add the soaked dregs and use the "three-decoction, three-filtration" method. Specifically: First, add 10 times the amount of water and soak for 6 hours (soak the jujubes after splitting them open), bring to a boil over high heat, then simmer over low heat for 2 hours; Second, add 8 times the amount of water and simmer over low heat for 1.5 hours; Third, add 6 times the amount of water and simmer over low heat for 1 hour. Combine the three filtrates and filter them through a 120-mesh or finer filter to obtain the final filtrate.

[0102] Concentration and paste formation: After concentrating the filtrate to a relative density of 1.15 (55℃), add saffron first, then add isomaltooligosaccharide and donkey-hide gelatin beads in a specific order to ensure efficacy. Continue stirring until the paste is formed when it "hangs like a flag" or "drops form beads".

[0103] Example 2

[0104] This embodiment provides a traditional Chinese medicine composition, the formula of which is as follows:

[0105] 30g rose petals, 30g Buddha's hand citron, 5g citron, 10g Poria cocos, 10g yam, 10g fox nut, 10g roasted coix seed, 15g sea buckthorn, 20g malt, 20g chicken gizzard lining, 10g angelica sinensis, 20g longan, 20g wolfberry, 30g donkey-hide gelatin, 30g mulberry, 15g kelp, 30g oyster, 20g dandelion, 20g dried tangerine peel, 10g platycodon grandiflorus, 30g yellow mustard seed, 30g roasted peach kernel, 30g saffron, 30g astragalus, 15g American ginseng, 10g sun-dried ginseng, 15g dendrobium officinale, 30g lily bulb, 20g ganoderma lucidum, 5g jujube, 1000g isomaltooligosaccharide, and 10g peppermint.

[0106] A paste was prepared according to the above formula using the preparation method of Example 1.

[0107] Example 3

[0108] This embodiment provides a traditional Chinese medicine composition, the formula of which is as follows:

[0109] 30g rose petals, 30g Buddha's hand citron, 30g citron, 10g Poria cocos, 10g yam, 10g fox nut, 10g roasted coix seed, 15g sea buckthorn, 30g malt, 10g chicken gizzard lining, 10g angelica sinensis, 20g longan, 20g wolfberry, 30g donkey-hide gelatin, 30g mulberry, 15g kelp, 30g oyster, 20g dandelion, 30g dried tangerine peel, 10g platycodon grandiflorus, 5g yellow mustard seed, 5g roasted peach kernel, 0.05g saffron, 30g astragalus, 15g American ginseng, 10g sun-dried ginseng, 15g dendrobium officinale, 30g lily bulb, 20g ganoderma lucidum, 5g jujube, 1000g isomaltooligosaccharide, 20g peppermint.

[0110] A paste was prepared according to the above formula using the preparation method of Example 1.

[0111] Example 4

[0112] This embodiment provides a traditional Chinese medicine composition, the formula of which is as follows:

[0113] 30g rose petals, 30g Buddha's hand citron, 5g citron, 10g Poria cocos, 10g yam, 10g fox nut, 10g roasted coix seed, 15g sea buckthorn, 20g malt, 10g chicken gizzard lining, 10g angelica sinensis, 30g longan, 30g wolfberry, 30g donkey-hide gelatin, 30g mulberry, 15g kelp, 30g oyster, 20g dandelion, 20g dried tangerine peel, 10g platycodon grandiflorus, 5g yellow mustard seed, 5g roasted peach kernel, 0.05g saffron, 30g astragalus, 30g American ginseng, 30g sun-dried ginseng, 15g dendrobium officinale, 30g lily bulb, 20g ganoderma lucidum, 5g jujube, 1000g isomaltooligosaccharide, and 10g peppermint.

[0114] A paste was prepared according to the above formula using the preparation method of Example 1.

[0115] Example 5

[0116] This embodiment provides a traditional Chinese medicine composition, the formula of which is as follows:

[0117] 30g rose petals, 30g Buddha's hand citron, 5g citron, 10g Poria cocos, 10g yam, 10g Euryale ferox, 10g coix seed (fried), 15g sea buckthorn, 20g malt, 30g chicken gizzard lining, 10g Angelica sinensis, 5g longan, 35g wolfberry, 30g donkey-hide gelatin, 30g mulberry, 15g kelp, 10g oyster, 20g dandelion, 20g dried tangerine peel, 10g platycodon grandiflorus, 5g yellow mustard seed, 5g roasted peach kernel, 0.05g saffron, 30g astragalus, 24g American ginseng, 1g sun-dried ginseng, 15g Dendrobium officinale, 30g lily bulb, 20g Ganoderma lucidum, 5g jujube, 1000g isomaltooligosaccharide, and 10g peppermint.

[0118] The efficacy of the traditional Chinese medicine composition prepared in this application for treating breast nodules was verified, and the clinical data are as follows:

[0119] Ninety patients aged 32-52 years with symptoms of breast pain and breast nodules were selected. The duration of their illness ranged from 1 to 5 years. The patients' clinical manifestations included pain, hyperplasia, and nodules.

[0120] Patients were randomly divided into 9 groups: 8 experimental groups and 1 control group, with 10 patients in each group. The control group was treated with Xiaoyao San (15g Bupleurum, 15g Angelica sinensis, 15g Paeonia lactiflora, 15g Atractylodes macrocephala, 15g Poria cocos, 15g Zingiber officinale, 6g Mentha haplocalyx and 6g Glycyrrhiza uralensis).

[0121] Efficacy assessment criteria: Referring to the relevant recommendations in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and the "Expert Consensus on the Clinical Diagnosis and Treatment of Breast Hyperplasia with Integrated Traditional Chinese and Western Medicine", and combined with the clinical characteristics of breast hyperplasia nodules, a four-level efficacy assessment standard was formulated, as shown in Table 1.

[0122] Table 1: Criteria for Judging Therapeutic Effect

[0123]

[0124] Based on the above-mentioned efficacy evaluation criteria, the clinical treatment results are shown in Table 2:

[0125] Table 2: Clinical Treatment Results

[0126]

[0127] According to the treatment statistics in Table 2, compared with the basic cases 1-3, the traditional Chinese medicine composition and Xiaoyao San group provided in Examples 1-5 have obvious therapeutic effects on breast nodules, and the efficacy of Examples 1-4 is more significant, while the efficacy of the basic case 5 is significantly reduced.

[0128] This application also provides some clinical treatment experience:

[0129] (3) Clinical treatment experience of basic cases 1-3:

[0130] Case 1: Ms. Wu, 41 years old, from Lanshan District, Linyi, Shandong Province, is a corporate manager. She presented with breast tenderness and nodules for 2 years. She reported significant premenstrual breast tenderness, and the nodules were of medium consistency upon palpation. Her tongue was pale red with a white, greasy coating, and her pulse was wiry and slippery.

[0131] Breast ultrasound examination (before treatment): Heterogeneous echogenicity of both breast tissue layers. A hypoechoic nodule measuring approximately 9.1mm × 6.3mm was visible in the upper outer quadrant of the left breast, with clear borders and no obvious blood flow signal. The tongue was pale red with a white, greasy coating, and the pulse was wiry and slippery.

[0132] Take the paste prepared according to the basic formula in Example 1, once in the morning and once in the evening, 15 ml each time, mixed with 100 ml to 200 ml of warm water and taken orally.

[0133] A follow-up examination after 3 months of treatment showed that the patient reported a slight reduction in swelling and pain, but the nodule had only shrunk to a limited extent. Breast ultrasound showed that the nodule in the upper outer quadrant of the left breast had shrunk to 8.2mm × 5.8mm (a reduction of 9.9% in length and 7.9% in thickness). The patient's tongue was pale red with a thin white coating, and the pulse was wiry and weak.

[0134] Case 2: Ms. Zhou, 35 years old, from Rencheng District, Jining, Shandong Province, is a civil servant. She sought medical attention after a breast nodule was discovered during a physical examination. She occasionally experiences premenstrual breast tenderness but has no other significant discomfort. She requested conservative treatment.

[0135] Breast ultrasound examination (before treatment): The echogenicity of both breast tissue layers was uneven. A hypoechoic nodule measuring approximately 7.8mm × 5.2mm was visible in the upper outer quadrant of the left breast, with clear borders and a BI-RADS grade of 3. No definite nodule was seen in the right breast. The tongue was pale red with a thin white coating, and the pulse was wiry.

[0136] Take the paste prepared according to the formula in Example 2, once in the morning and once in the evening, 15 ml each time, mixed with 100 ml to 200 ml of warm water and taken orally.

[0137] A follow-up examination after 3 months of treatment showed that the patient reported reduced breast tenderness, but the nodules showed no significant change. Breast ultrasound revealed that the nodule in the upper outer quadrant of the left breast had shrunk to 7.3mm × 5.0mm (length reduced by 6.4%, thickness reduced by 3.8%), with no significant change. The tongue was pale red with a thin white coating, and the pulse was slightly wiry.

[0138] Case 3: Ms. Zheng, 37 years old, from Dezhou City, Shandong Province, is a teacher. She sought medical attention after a physical examination revealed breast nodules. She reported mild premenstrual breast tenderness, but no other discomfort.

[0139] Breast ultrasound examination (before treatment): The echogenicity of both breast tissue layers was uneven. A hypoechoic nodule measuring approximately 6.5mm × 4.8mm with clear borders was visible in the upper outer quadrant of the left breast. No definite nodule was seen in the right breast. The tongue was pale red with a thin white coating, and the pulse was wiry.

[0140] Take the paste prepared according to the basic formula in Example 3, once in the morning and once in the evening, 15 ml each time, mixed with 100 ml to 200 ml of warm water and taken orally.

[0141] A follow-up examination after 3 months of treatment showed that the patient reported a slight reduction in swelling and pain. Breast ultrasound showed that the nodule in the upper outer quadrant of the left breast had shrunk to 6.2mm × 4.7mm (length reduced by 4.6%, thickness reduced by 2.1%), with essentially no change. The tongue was pale red with a thin white coating, and the pulse was slightly wiry.

[0142] (1) Clinical treatment experience of Examples 1-5:

[0143] Case 4: Ms. Li, 38 years old, from Laoshan District, Qingdao, Shandong Province, is an office worker. She sought medical attention due to recurrent breast tenderness for more than two years. She usually experiences high work pressure and is prone to irritability. Her breast tenderness is more pronounced before menstruation and lessens after menstruation. She has taken traditional Chinese medicine such as Xiaoyao Wan and Rupixiao, but the symptoms recur from time to time, and the nodules have not shrunk significantly.

[0144] Breast ultrasound examination (before treatment): Bilateral breast hyperplasia with heterogeneous echogenicity of the glandular layer. A hypoechoic nodule measuring approximately 8.2mm × 5.1mm was visible in the upper outer quadrant of the left breast, with clear borders, regular shape, and no obvious blood flow signal within it, BI-RADS grade 3. Multiple scattered small nodules were visible in the right breast, the largest being approximately 5.6mm × 4.3mm, and were isoechoic.

[0145] Take the ointment prepared according to the formula in Example 1, once in the morning and once in the evening, 15 ml each time, mixed with 100 ml to 200 ml of warm water and taken orally.

[0146] After three months of treatment, a follow-up examination revealed that the patient reported a significant reduction in breast tenderness and a substantial relief from premenstrual discomfort. Breast ultrasound showed improved bilateral breast hyperplasia and more uniform glandular echogenicity. The nodule in the upper outer quadrant of the left breast shrank to 5.4mm × 3.1mm (a 34.1% reduction in length and 39.2% in thickness), with clear borders and enhanced echogenicity. Most of the scattered small nodules in the right breast disappeared, with the largest measuring approximately 3.2mm × 2.8mm.

[0147] Case 5: Ms. Zhang, 45 years old, from Lixia District, Jinan, Shandong Province, is a self-employed individual. She had breast nodules for 5 years, and in the past year, she experienced significant, localized sharp pain in her breasts; the lumps were hard to the touch. She had a history of fibrocystic breast disease and had previously taken various traditional Chinese medicines with little effect.

[0148] Breast ultrasound examination (before treatment): The echogenicity of both breast tissue layers was disordered. An irregular hypoechoic nodule, approximately 13.5mm × 8.2mm in size, was visible in the upper outer quadrant of the left breast. The nodule had indistinct borders, heterogeneous internal echoes, scattered hyperechoic calcifications, and linear blood flow signals within it. BI-RADS classification was 4a. Two adjacent nodules, fused together in the upper inner quadrant of the right breast, were visible, forming a lobulated shape. They totaled approximately 10.2mm × 7.5mm, exhibiting hypoechoic characteristics and abundant blood flow signals. The tongue was purplish-dark with petechiae on the edges; the sublingual veins were tortuous, and the pulse was choppy.

[0149] Take the ointment prepared according to the formula in Example 2, once in the morning and once in the evening, 15 ml each time, mixed with 100 ml to 200 ml of warm water and taken orally.

[0150] A follow-up examination after 3 months of treatment revealed that the patient reported a significant reduction in breast pain and softening of the lumps. Breast ultrasound showed that the nodule in the upper outer quadrant of the left breast had shrunk to 10.8mm × 6.5mm (a 20.0% reduction in length and 20.7% in thickness), with clearer borders, no increase in internal calcifications, and significantly reduced blood flow signal. The fused nodule in the right breast separated into two independent nodules, measuring 6.5mm × 5.0mm and 5.2mm × 4.1mm respectively, with increased echogenicity. The purplish-dark color of the tongue improved, and the petechiae faded.

[0151] Case 6: Ms. Chen, 35 years old, from Huangdao District, Qingdao, Shandong Province, works in the financial industry. Due to high work pressure and long-term depression, she has experienced recurrent breast tenderness for 3 years. The tenderness begins a week before each menstrual period and lasts until the end of menstruation, severely affecting her sleep and work. She has previously taken Xiaoyao Wan and Jiawei Xiaoyao Wan, but the effects were not lasting.

[0152] Breast ultrasound examination (before treatment): Both breast tissues showed thickening of the glandular layer with heterogeneous echogenicity, exhibiting a leopard-spot pattern. An oval hypoechoic nodule measuring approximately 2.2mm × 1.9mm was visible in the upper outer quadrant of the left breast, with clear borders and no obvious blood flow signal, BI-RADS grade 3. Two small cysts, approximately 4.2mm × 3.5mm each, were visible in the right breast. The patient's tongue was pale red with a thin white coating, and her pulse was wiry.

[0153] Take the ointment prepared according to the formula in Example 3, once in the morning and once in the evening, 15 ml each time, mixed with 100 ml to 200 ml of warm water and taken orally.

[0154] A follow-up examination after 3 months of treatment revealed significant improvement in the patient's mood and sleep quality. She experienced no breast tenderness before menstruation, only mild discomfort. Breast ultrasound showed thickening of the mammary gland layer in both breasts, with uneven echogenicity and a leopard-spot appearance. BI-RADS classification: 2. The nodule in the upper outer quadrant of the left breast had disappeared, and the small cyst in the right breast had been absorbed and disappeared. The tongue and pulse appeared normal.

[0155] Case 7: Ms. Sun, 37 years old, from Kuiwen District, Weifang, Shandong Province, is a middle school teacher. Due to long-term work pressure and family troubles, she suffered from depression and anxiety, experiencing breast tenderness accompanied by chest tightness and rib distension for over a year. Her menstrual cycle was irregular, with severe premenstrual breast tenderness affecting her daily life. She had previously taken traditional Chinese medicine and Western painkillers, but with limited effectiveness.

[0156] Breast ultrasound examination (before treatment): Diffuse thickening of the breast tissue in both breasts, with heterogeneous echogenicity. Multiple hypoechoic nodules of varying sizes were visible in the upper outer quadrant and lower inner quadrant of the left breast, the largest being approximately 9.2mm × 6.5mm in size, located in the upper outer quadrant, with clear borders and no obvious blood flow signal. Scattered patchy hypoechoic areas were visible in the right breast, without definite nodules. The patient's tongue was pale red with a thin yellow coating, and her pulse was wiry and rapid.

[0157] Take the ointment prepared according to the formula in Example 3, once in the morning and once in the evening, 15 ml each time, mixed with 100 ml to 200 ml of warm water and taken orally.

[0158] A follow-up examination after 3 months of treatment revealed that the patient reported stable emotions, disappearance of chest tightness and rib distension, and a return to normal menstrual cycles, with only slight breast tenderness before menstruation. Breast ultrasound showed that the largest nodule in the left breast had shrunk to 5.9mm × 4.4mm (a 35.9% reduction in length and 32.3% in thickness), and most of the other smaller nodules had disappeared. The right breast showed more uniform echogenicity than before. The tongue appeared normal, and the pulse was slightly wiry but not rapid.

[0159] Case 8: Ms. Liu, 49 years old, from Laishan District, Yantai, Shandong Province, is nearing menopause. She has had breast nodules for 2 years and has experienced menstrual irregularities, shortened cycles, and reduced menstrual flow for the past six months. The relationship between breast tenderness and menstrual cycle is unclear. She also experiences menopausal symptoms such as lower back and knee pain, dizziness, tinnitus, hot flashes, and sweating.

[0160] Breast ultrasound examination (before treatment): Bilateral breast tissue atrophy, increased echogenicity, and ductal dilation. A hypoechoic nodule measuring approximately 10.5mm × 7.2mm was visible in the upper inner quadrant of the left breast, with clear borders and punctate blood flow signals, BI-RADS grade 3. A cystic-solid nodule measuring approximately 7.2mm × 5.5mm was visible in the upper outer quadrant of the right breast. The tongue was pale red with little coating, and the pulse was thready and rapid.

[0161] Take the ointment prepared according to the formula in Example 4, once in the morning and once in the evening, 15 ml each time, mixed with 100 ml to 200 ml of warm water and taken orally.

[0162] A follow-up examination after 3 months of treatment revealed significant improvement in the patient's lower back and knee pain, dizziness, and tinnitus; reduced hot flashes and sweating; a more regular menstrual cycle; and near-complete disappearance of breast tenderness. Breast ultrasound showed that the nodule in the upper inner quadrant of the left breast had shrunk to 8.1mm × 5.8mm (a 22.9% reduction in length and a 19.4% reduction in thickness), with decreased blood flow signal. The cystic component of the solid-cystic nodule in the right breast had been absorbed, shrinking to 5.8mm × 4.6mm.

[0163] Case 9: Ms. Wu, 52 years old, from Huancui District, Weihai, Shandong Province, has been menopausal for one year. She sought medical attention after a physical examination revealed breast nodules. She reported postmenopausal breast tenderness and discomfort, accompanied by hot flashes, sweating, irritability, insomnia, and lower back and knee weakness. She has a history of uterine fibroids.

[0164] Breast ultrasound examination (before treatment): Bilateral breast tissue atrophy, increased echogenicity, and widespread dilation of mammary ducts. An oval isoechoic nodule measuring approximately 12.8mm × 8.5mm was visible in the upper outer quadrant of the left breast, with clear borders and a small amount of blood flow signal, BI-RADS grade 3. A hypoechoic nodule measuring approximately 6.5mm × 4.8mm was visible in the upper inner quadrant of the right breast. The tongue was red with little coating, and the pulse was thready, rapid, and weak.

[0165] Take the ointment prepared according to the formula in Example 4, once in the morning and once in the evening, 15 ml each time, mixed with 100 ml to 200 ml of warm water and taken orally.

[0166] A follow-up examination after 3 months of treatment revealed significant improvement in the patient's symptoms of hot flashes, sweating, irritability, and insomnia; the disappearance of breast tenderness; and an overall improvement in mental state. Breast ultrasound showed that the nodule in the upper outer quadrant of the left breast had shrunk to 9.6mm × 6.5mm (a 25.0% reduction in length and 23.5% in thickness), with increased echogenicity, clearer borders, and absent blood flow signals. The nodule in the upper inner quadrant of the right breast had shrunk to 4.8mm × 3.7mm. Improvement in mammary duct dilation was also observed.

[0167] Case 10: Ms. Zhao, 51 years old, from Zhangdian District, Zibo City, Shandong Province, is retired. She had a breast nodule for 8 years, and the nodule had been continuously enlarging in the past 2 years. A needle biopsy was recommended, but she refused due to fear and requested traditional Chinese medicine treatment. She reported sharp pain in her breast radiating to her armpit, and the lump was hard like rubber.

[0168] Breast ultrasound examination (before treatment): Atrophy of the mammary gland layers in both breasts, with increased echogenicity. A large hypoechoic nodule, approximately 16.8mm × 11.2mm in size, was visible in the lower outer quadrant of the left breast. It was irregularly shaped, lobulated, with heterogeneous internal echoes and scattered hyperechoic calcifications. Blood flow signal was abundant, RI=0.72, BI-RADS classification 4a. Multiple hypoechoic nodules were visible in the right breast, the largest being located in the upper inner quadrant, approximately 9.5mm × 6.8mm in size. The tongue was purplish-dark with ecchymosis, and the pulse was deep and hesitant.

[0169] Take the ointment prepared according to the formula in Example 5, once in the morning and once in the evening, 15 ml each time, mixed with 100 ml to 200 ml of warm water and taken orally.

[0170] Reexamination after 3 months of taking the medicine: Breast ultrasound showed that the nodule in the lower outer quadrant of the left breast shrank to 14.2 mm × 9.5 mm (the length shrank by 15.5% and the thickness shrank by 15.2%). Its shape became more regular than before, the lobulation sign was not obvious, the blood flow signal decreased, and the RI dropped to 0.65. The largest nodule in the right breast shrank to 7.8 mm × 5.9 mm. The patient reported that the stabbing pain had basically disappeared and the mass felt softer to the touch. The tongue ecchymosis had lightened.

[0171] Case 11: Patient Ms. Sun, 48 years old, from Taishan District, Tai'an, Shandong, a retired worker. She visited the doctor due to breast distending pain accompanied by fatigue and insomnia. She reported having breast distending pain and discomfort, hot flashes and sweating, and lack of energy before and after menopause. The tongue was pale red with little coating, and the pulse was thready and rapid.

[0172] Breast ultrasound examination (before treatment): The glandular layers of both breasts were atrophied and the echo was enhanced. An isoechoic nodule was visible in the upper outer quadrant of the left breast, with a size of about 8.2 mm × 6.0 mm, clear boundaries, and no obvious blood flow signal inside. No definite nodule was seen in the right breast. The tongue was pale red with little coating, and the pulse was thready and rapid.

[0173] Take the paste prepared with the formula of Example 5, once in the morning and once in the evening, 15 ml each time, and stir well with 100 - 200 ml of warm water before taking.

[0174] Reexamination after 3 months of taking the medicine: The patient reported improved energy, better sleep, reduced hot flashes and sweating, and alleviated breast distending pain. Breast ultrasound showed that the nodule in the upper outer quadrant of the left breast shrank to 6.7 mm × 5.0 mm (the length shrank by 18.3% and the thickness shrank by 16.7%), with clear boundaries. The tongue image became moist, and the pulse condition was gentle.

[0175] From the above clinical treatment experience and results, through the compatibility principle of monarch, minister, assistant, and envoy in this application, a synergistic effect is formed among the active ingredients, which can significantly reduce the size of breast nodules, and some breast nodules disappear. At the same time, it can also relieve symptoms of blood stasis, regulate emotions, improve sleep and other symptoms. From the perspective of traditional Chinese medicine theory, the core pathogenesis of breast nodules is closely related to "spleen deficiency generating phlegm, qi stagnation and blood stasis, disharmony of thoroughfare and conception vessels, and qi and blood deficiency". Therefore, the traditional Chinese medicine composition of this application does not simply have the effect of dissipating nodules, but also has multiple effects such as coordinating spleen strengthening, phlegm resolving, blood activating, stasis removing, menstruation regulating, and blood nourishing. It takes both the root and the branch into consideration, soothes the liver and relieves depression, improves the constitution, and is better, more stable, and not prone to recurrence than simply using medicines for softening and resolving hard masses. At the same time, through a specific process, the traditional Chinese medicine composition is made into a paste, which can be better accepted by patients, and can be taken stably and for a long time to ensure the medicinal effect.

[0176] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope recorded in this specification.

[0177] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A traditional Chinese medicine composition, characterized in that, The active ingredients of the traditional Chinese medicine composition include rose, Buddha's hand, citron, poria, yam, fox nut, coix seed, sea buckthorn, malt, chicken gizzard lining, angelica, longan, wolfberry, donkey-hide gelatin, mulberry, kelp, oyster, dandelion, tangerine peel, platycodon, yellow mustard seed, peach kernel, saffron, astragalus, American ginseng, sun-dried ginseng, dendrobium officinale, lily, ganoderma, jujube, and peppermint.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The active ingredients of the traditional Chinese medicine composition, by weight, include 20-40 parts of rose petals, 20-40 parts of bergamot, 1-30 parts of citron, 5-15 parts of poria cocos, 5-15 parts of yam, 5-15 parts of fox nut, 5-15 parts of coix seed, 10-20 parts of sea buckthorn, 10-30 parts of malt, 5-30 parts of chicken gizzard lining, 5-15 parts of angelica sinensis, 5-30 parts of longan, 10-35 parts of wolfberry, 20-40 parts of donkey-hide gelatin, and 20-40 parts of mulberry. 10-20 parts of kelp, 10-40 parts of oyster, 10-30 parts of dandelion, 10-30 parts of dried tangerine peel, 5-15 parts of platycodon, 1-30 parts of yellow mustard seed, 1-30 parts of peach kernel, 0.01-30 parts of saffron, 20-40 parts of astragalus, 10-30 parts of American ginseng, 1-30 parts of sun-dried ginseng, 10-20 parts of dendrobium officinale, 20-40 parts of lily bulb, 10-30 parts of ganoderma lucidum, 1-10 parts of jujube, and 5-20 parts of mint.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The active ingredients of the traditional Chinese medicine composition, by weight, include 20-40 parts of rose petals, 20-40 parts of bergamot, 1-30 parts of citron, 5-15 parts of poria cocos, 5-15 parts of yam, 5-15 parts of fox nut, 5-15 parts of coix seed, 10-20 parts of sea buckthorn, 10-30 parts of malt, 5-20 parts of chicken gizzard lining, 5-15 parts of angelica sinensis, 10-30 parts of longan, 10-30 parts of wolfberry, 20-40 parts of donkey-hide gelatin, and 20-40 parts of mulberry. 10-20 parts of kelp, 20-40 parts of oyster, 10-30 parts of dandelion, 10-30 parts of dried tangerine peel, 5-15 parts of platycodon, 1-30 parts of yellow mustard seed, 1-30 parts of peach kernel, 0.01-30 parts of saffron, 20-40 parts of astragalus, 10-30 parts of American ginseng, 5-30 parts of sun-dried ginseng, 10-20 parts of dendrobium officinale, 20-40 parts of lily bulb, 10-30 parts of ganoderma lucidum, 1-10 parts of jujube, and 5-20 parts of mint.

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, The components of the traditional Chinese medicine composition also include excipients; Optionally, the excipients are selected from one or more of isomaltooligosaccharide, honey, succinate, and maltodextrin; Further optionally, the amount of the excipient added is 500-1500 parts.

5. A method for preparing a traditional Chinese medicine composition, characterized in that, Includes the following steps: The first active ingredient is mixed with the first portion of water and soaked, then filtered to obtain a solid. Boil the oysters with the second portion of water to obtain oyster broth; The oyster extract, the solids, and the third portion of water are mixed, boiled, filtered, and the filtrate is collected and concentrated to form a concentrate. The second active ingredient is added to the concentrate, mixed, and then concentrated to form a paste to prepare the traditional Chinese medicine composition. The first active ingredients include rose, bergamot, citron, poria cocos, yam, fox nut, coix seed, sea buckthorn, malt, chicken gizzard lining, kelp, dandelion, tangerine peel, platycodon root, yellow mustard seed, peach kernel, astragalus, American ginseng, sun-dried ginseng, dendrobium officinale, lily, ganoderma lucidum, angelica, longan, wolfberry, mulberry, jujube, and mint; The second active ingredient includes saffron and donkey-hide gelatin; Optionally, the second active ingredient may also include excipients.

6. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, The mass ratio of the first active ingredient to the first portion of water is 1:(8-12); and / or, the soaking time is at least 6 hours; and / or, the concentration conditions include: concentrating at 60°C-70°C until the relative density of the filtrate is 1.10-1.

20.

7. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, The steps of mixing the oyster extract, the solids, and the third portion of water for boiling and filtering include: The solids were mixed with a portion of water at a mass ratio of 1:(8-12), brought to a boil over high heat, then simmered over low heat for 2-3 hours. The mixture was filtered, and the first filtrate was collected. Mix the filter residue with some water at a mass ratio of 1:(6-8), simmer over low heat for 1.5-2 hours, filter, and collect the second filtrate; Mix the filter residue with the remaining water at a mass ratio of 1:(4-6), boil for 1-1.5 hours, filter, and collect the third filtrate; Combine the first filtrate, the second filtrate, and the third filtrate.

8. The method for preparing the traditional Chinese medicine composition according to any one of claims 5 to 7, characterized in that, The donkey-hide gelatin includes donkey-hide gelatin beads, which are formed by placing donkey-hide gelatin blocks in talcum powder and / or clam powder and scalding them until they form beads; and / or, the peach kernels are blanched peach kernels formed by blanching; and / or, the coix seeds are roasted coix seeds formed by charring.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 5 to 8 in the preparation of a medicament for treating breast nodules.

10. A drug for treating breast nodules, characterized in that, The drug comprises the traditional Chinese medicine composition according to any one of claims 1 to 4 or the traditional Chinese medicine composition prepared by the preparation method of the traditional Chinese medicine composition according to any one of claims 5 to 8.

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