A traditional Chinese medicine composition for treating thyroid diseases and breast diseases and its preparation method

Abstract

The present invention discloses a traditional Chinese medicine composition for treating thyroid diseases and breast diseases and a preparation method thereof, belonging to the technical field of traditional Chinese medicine. The raw materials by weight include: 9-25 parts of Pseudostellaria heterophylla, 3-10 parts of Bupleurum chinense, 6-10 parts of Epimedium brevicornu, 6-12 parts of Atractylodes macrocephala, 6-10 parts of Cyperus rotundus, 3-10 parts of Curcuma aromatica, 6-10 parts of Cistanche deserticola, 3-10 parts of Citrus reticulata Blanco, 3-9 parts of Pinellia ternata, 15-30 parts of Ranunculus ternatus Thunb., 0.03-1 part of Trionyx sinensis, 1-3 parts of Crocus sativus, 1-3 parts of Hirudo nipponia Whitman, 10-15 parts of Taraxacum mongolicum Hand.-Mazz., 10-15 parts of Lonicera japonica Thunb., 3-9 parts of Cremastra appendiculata (D. Don) Makino, 6-10 parts of Poria cum Radix Pini, 4-9 parts of Euonymus alatus, 2-10 parts of Glycyrrhiza uralensis Fisch.; the combination of various herbs treats both the symptoms and root causes, and together they have the effects of supplementing qi and strengthening the root, dissipating nodules and dredging collaterals, resolving phlegm and dissipating stasis, and can effectively improve the size of thyroid nodules in patients with thyroid nodules complicated with mammary gland hyperplasia of qi stagnation and phlegm obstruction syndrome, relieve breast pain, stabilize thyroid function, and have no side effects and are safe.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating thyroid diseases and breast diseases and a preparation method thereof. Background Art

[0002] A thyroid nodule refers to a nodular mass with abnormal single or multiple tissue structures in the thyroid gland caused by various factors. The mass moves up and down with the swallowing movement. In the early stage of the disease course, most patients have no obvious abnormal sensations and can be detected by palpation, physical examination and imaging examination. The nature of the nodule is diverse and can widely exist in the disease courses of various thyroid diseases, with the majority being benign nodules. Breast hyperplasia is a disease mainly characterized by hyperplasia and degenerative changes of breast tissue. The etiology is highly correlated with endocrine dysfunction. Patients often show breast pain and nodules or masses with unclear boundaries. In the initial stage of the disease course, breast symptoms fluctuate with the menstrual cycle and emotions. Both thyroid nodules and breast hyperplasia are endocrine diseases with a high incidence among young and middle-aged women, and the pathological bases of the two diseases are very similar, so they often occur simultaneously.

[0003] At present, the western medicine treatment for thyroid nodules combined with breast hyperplasia mainly includes hormone therapy and surgical operation. Although hormonal drugs can correct the disordered hormone levels in the body, they have the disadvantages of large drug adverse reactions and easy recurrence after drug withdrawal; although surgical operation can completely remove the lesions, the surgical trauma is large, seriously affecting the beauty of the patient. In recent years, although surgical means have developed towards minimally invasive directions, there are still problems such as inaccurate curative effects and many postoperative complications.

[0004] Thyroid nodules and breast hyperplasia are advantageous diseases for traditional Chinese medicine treatment. Traditional Chinese medicine believes that breast hyperplasia and thyroid nodules belong to the categories of "breast mass" and "goiter" respectively. Through clinical practice, it is found that the disease courses of the two diseases have a certain correlation. The disease locations of the two diseases are mostly in the three viscera of the liver, spleen and kidney and the thoroughfare and conception vessels. The main syndrome elements are qi stagnation, phlegm coagulation and blood stasis. Affected by the seven emotions, the liver loses its dredging function, stagnates and fails to transform, invades the spleen horizontally, resulting in the disorder of transportation and transformation, the failure of body fluids to be distributed, and the accumulation of phlegm. The combination of phlegm and qi binds and obstructs the mammary collaterals and the front of the neck, respectively developing into "breast mass" and "goiter". Emotional discomfort is the common cause of the two diseases, and the mutual binding of phlegm and stasis is the common pathogenesis of the two diseases. There are common laws in the syndrome differentiation and treatment of the two diseases in traditional Chinese medicine, which conform to the treatment principle of "treating different diseases with the same method" in traditional Chinese medicine. Summary of the Invention

[0005] In order to overcome the deficiencies of the prior art, one of the purposes of the present invention is to provide a traditional Chinese medicine composition for treating thyroid diseases and breast diseases. The traditional Chinese medicine composition has the effects of promoting blood circulation to remove blood stasis, softening hardness and dissipating nodules, and soothing the liver and relieving depression, and can treat diseases such as thyroid nodules and breast hyperplasia caused by emotional discomfort and the mutual binding of phlegm and stasis.

[0006] The second object of the present invention is to provide a method for preparing a Chinese medicine composition for treating thyroid disease and breast disease. The method has simple steps and the operator can quickly get started.

[0007] One of the purposes of the present invention is achieved by the following technical solution:

[0008] A Chinese medicine composition for treating thyroid disease and breast disease, characterized in that the raw materials in parts by weight include: 9-25 parts of Pseudostellariae Radix, 3-10 parts of Bupleurum Root, 6-10 parts of Epimedium, 6-12 parts of Atractylodes Macrocephala, 6-10 parts of Cyperus Root, 3-10 parts of Curcuma Radix, 6-10 parts of Cistanche Deserticola, 3-10 parts of Tangerine Peel, 3-9 parts of Pinellia, 15-30 parts of Cat's Claw, 0.03-1 part of Carapace of Turtle, 1-3 parts of Saffron, 1-3 parts of Leech, 10-15 parts of Taraxacum, 10-15 parts of Honeysuckle, 3-9 parts of Trillium, 6-10 parts of Poria, 4-9 parts of Euphorbia obesa, and 2-10 parts of Licorice.

[0009] Furthermore, the raw materials in parts by weight include: 17 parts of Pseudostellariae Radix, 6 parts of Bupleurum chinense, 8 parts of Epimedium, 9 parts of Atractylodes macrocephala, 8 parts of Cyperus rotundus, 6 parts of Curcuma aromatica, 8 parts of Cistanche deserticola, 6 parts of Citrus reticulata, 6 parts of Pinellia ternata, 22 parts of Cat's Claw, 0.6 parts of Carapace of Turtle, 2 parts of Saffron, 2 parts of Leech, 13 parts of Taraxacum, 13 parts of Honeysuckle, 6 parts of Trillium, 8 parts of Poria, 7 parts of Psoralea corylifolia, and 6 parts of Licorice.

[0010] Radix Pseudostellariae: Nature and flavor and meridians: sweet, slightly bitter, neutral. Enters the spleen and lung meridians. Functions and indications: replenishes qi and strengthens the spleen, produces body fluid and moistens the lungs. Used for spleen deficiency, fatigue, loss of appetite, weakness after illness, insufficient qi and yin, spontaneous sweating and thirst, and dry cough due to lung dryness.

[0011] Bupleurum: Nature and flavor and meridians: pungent, bitter, slightly cold. Enters the liver, gallbladder, and lung meridians. Functions and indications: dispels heat, relieves liver depression, and raises Yang Qi. Used for colds and fever, alternating cold and heat, chest and flank pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0012] Xianlingpi: Nature and flavor and meridians: pungent, sweet, warm. Enters the liver and kidney meridians. Functions and indications: tonifies kidney yang, strengthens tendons and bones, and removes rheumatism. Used for kidney yang deficiency, impotence and spermatorrhea, tendon and bone weakness, rheumatic arthralgia, numbness and cramps.

[0013] Atractylodes macrocephala: Nature and flavor and meridians: bitter, sweet, warm. Enters the spleen and stomach meridians. Functions and indications: Strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and stabilizes the fetus. Used for spleen deficiency, poor appetite, abdominal distension and diarrhea, phlegm and fluid, dizziness and palpitations, edema, spontaneous sweating, and restless fetuses.

[0014] Cyperus rotundus: Nature and flavor and meridians: pungent, slightly bitter, slightly sweet, neutral. It enters the liver, spleen, and triple burner meridians. Functions and indications: soothes the liver and relieves depression, regulates qi and relieves fullness, regulates menstruation and relieves pain. It is used for liver depression and qi stagnation, chest and flank pain, qi pain, breast pain, spleen and stomach qi stagnation, abdominal distension, fullness and pain, irregular menstruation, amenorrhea and dysmenorrhea.

[0015] Turmeric: Nature, flavor, and channels entered: Pungent, bitter, cold. It enters the liver, heart, and lung channels. Functions and indications: Promote blood circulation to relieve pain, promote qi movement to relieve depression, clear the heart and cool the blood, promote bile secretion and remove jaundice. It is used for stabbing pain in the chest and hypochondrium, angina pectoris, amenorrhea and dysmenorrhea, breast distension and pain, coma due to febrile disease, epilepsy and mania, hematemesis and epistaxis due to blood heat, jaundice with reddish urine.

[0016] Cistanche: Nature, flavor, and channels entered: Sweet, salty, warm. It enters the kidney and large intestine channels. Functions and indications: Tonify the kidney yang, benefit essence and blood, moisten the intestine and relieve constipation. It is used for insufficiency of kidney yang, deficiency of essence and blood, impotence and infertility, soreness and weakness of the waist and knees, weakness of muscles and bones, constipation due to intestinal dryness.

[0017] Tangerine Peel: Nature, flavor, and channels entered: Bitter, pungent, warm. It enters the lung and spleen channels. Functions and indications: Regulate qi and strengthen the spleen, dry dampness and resolve phlegm. It is used for abdominal distension and fullness, anorexia and vomiting and diarrhea, cough with profuse phlegm.

[0018] Pinellia: Nature, flavor, and channels entered: Pungent, warm; toxic. It enters the spleen, stomach, and lung channels. Functions and indications: Dry dampness and resolve phlegm, lower adverse qi and stop vomiting, dissipate binds and masses. It is used for damp phlegm and cold phlegm, cough with profuse phlegm, dizziness due to phlegm retention, wind phlegm dizziness, headache due to phlegm syncope, vomiting and nausea, chest and epigastric stuffiness, globus hystericus; externally for carbuncles and phlegm nodes.

[0019] Cat's Claw Herb: Nature, flavor, and channels entered: Sweet, pungent, warm. It enters the liver and lung channels. Functions and indications: Resolve phlegm and dissipate binds, detoxify and reduce swelling. It is used for scrofula and phlegm nodes, sores and boils, snake and insect bites.

[0020] Trionyx Sinensis Carapax: Nature, flavor, and channels entered: Pungent, warm. It enters the heart and spleen channels. Functions and indications: Resuscitate the consciousness, promote blood circulation and dredge the channels, reduce swelling and relieve pain. It is used for coma due to febrile disease, stroke with phlegm syncope, sudden syncope due to qi stagnation, syncope due to pestilence, amenorrhea, mass in the abdomen, dystocia and stillbirth, angina pectoris, sudden pain in the chest and abdomen, injury from falls and bumps, pain and numbness due to arthralgia, swelling and scrofula, sore throat.

[0021] Saffron: Nature, flavor, and channels entered: Sweet, flat. It enters the heart and liver channels. Functions and indications: Promote blood circulation and remove stasis, cool the blood and detoxify, relieve depression and calm the mind. It is used for amenorrhea and mass in the abdomen, stasis after childbirth, maculae due to warm toxin, melancholy and stuffiness, palpitation and mania.

[0022] Leech: Nature, flavor, and channels entered: Salty, bitter, flat; slightly toxic. It enters the liver channel. Functions and indications: Break blood and dredge the channels, remove stasis and dissolve masses. It is used for blood stasis amenorrhea, mass in the abdomen, hemiplegia due to stroke, injury from falls and bumps.

[0023] Dandelion: Nature, flavor, and channels entered: Bitter, sweet, cold. It enters the liver and stomach channels. Functions and indications: Clear heat and detoxify, reduce swelling and dissipate binds, promote diuresis and relieve stranguria. It is used for sores and boils, breast abscess, scrofula, redness of the eyes, sore throat, lung abscess, intestinal abscess, jaundice due to damp heat, stranguria with pain.

[0024] Honeysuckle Flower: Nature, flavor, and channels entered: Sweet, cold. It enters the lung, heart, and stomach channels. Functions and indications: Clear heat and detoxify, disperse wind-heat. It is used for sores and boils, sore throat, erysipelas, dysentery with heat toxin, common cold with wind-heat, fever due to warm disease.

[0025] Chinese paris rhizome: Nature, flavor and meridian tropism: sweet, slightly pungent, cool. It acts on the liver and spleen meridians. Functions and indications: clearing heat and detoxifying, resolving phlegm and dissipating nodules. It is used for carbuncles, sores, scrofula, snake and insect bites, and masses in the hypochondrium and abdomen.

[0026] Poria cum Radix Pini: Nature, flavor and meridian tropism: sweet and bland, flat. It acts on the heart and liver meridians. Functions and indications: nourishing the heart and calming the mind, promoting diuresis to alleviate edema. It is used for palpitation, amnesia, and insomnia.

[0027] Winged euonymus twig: Nature, flavor and meridian tropism: bitter, pungent, cold; it acts on the liver meridian. Functions and indications: promoting blood circulation to dredge menstruation, detoxifying and detumescence, killing insects. It is used for amenorrhea, mass in the abdomen, postpartum stasis and abdominal pain, and abdominal pain due to worm accumulation.

[0028] The second object of the present invention is achieved by the following technical solution:

[0029] The present invention provides a method for manufacturing a traditional Chinese medicine composition for treating thyroid diseases and breast diseases, comprising the following steps:

[0030] S1. Take the following 19 raw medicinal materials of Pseudostellaria heterophylla, Bupleurum chinense, Epimedium brevicornu, Atractylodes macrocephala, Cyperus rotundus, Curcuma aromatica, Cistanche deserticola, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Trionyx sinensis, Crocus sativus, Hirudo, Taraxacum mongolicum, Lonicera japonica, Chinese paris rhizome, Poria cum Radix Pini, Winged euonymus twig, and Glycyrrhiza uralensis Fisch. After cleaning and selection, coarsely crush them respectively to obtain coarse medicinal material particles for standby;

[0031] S2. Take the coarse medicinal material particles of Pseudostellaria heterophylla, Bupleurum chinense, Epimedium brevicornu, Atractylodes macrocephala, Cistanche deserticola, Hirudo, and Poria cum Radix Pini obtained in step S1, soak them in cold water for 30 - 60 minutes to obtain the first medicinal liquid to be decocted for standby;

[0032] S3. First, bring the first medicinal liquid to be decocted obtained in step S2 to a boil over high heat, then change to slow fire and simmer for 40 - 60 minutes, stirring 2 - 3 times to obtain the decocted medicinal liquid; meanwhile, take the coarse medicinal material particles of Cyperus rotundus, Curcuma aromatica, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Crocus sativus, Taraxacum mongolicum, Lonicera japonica, Chinese paris rhizome, Winged euonymus twig, and Glycyrrhiza uralensis Fisch. obtained in step S1, soak them in cold water for 30 - 60 minutes to obtain the second medicinal liquid to be decocted;

[0033] S4. Put the second medicinal liquid to be decocted obtained in step S3 into the decocted medicinal liquid obtained in step S3 and decoct them together. After boiling, decoct for another 20 - 30 minutes, stirring 2 - 3 times to prepare the described traditional Chinese medicine composition for treating thyroid diseases and breast diseases.

[0034] Application of a traditional Chinese medicine composition for treating thyroid diseases and breast diseases in the preparation of drugs for treating thyroid diseases and breast diseases.

[0035] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0036] In the traditional Chinese medicine composition for treating thyroid diseases and breast diseases of the present invention, Pseudostellaria heterophylla, Bupleurum chinense, and Epimedium brevicornum are used as the monarch drugs. Pseudostellaria heterophylla replenishes qi and strengthens the spleen, Bupleurum chinense soothes the liver and relieves depression, and Epimedium brevicornum tonifies the kidney yang. The combination of the three regulates the liver, spleen, and kidney, achieving the effects of replenishing qi and consolidating the root, regulating qi and relieving fullness. Atractylodes macrocephala, Cyperus rotundus, Tulipa gesneriana, Cistanche deserticola, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Trionyx sinensis, Crocus sativus, and Hirudo nipponia are the ministerial drugs. Atractylodes macrocephala invigorates the spleen and replenishes qi, drying dampness and promoting diuresis; Cyperus rotundus resolves phlegm and dissipates nodules, detoxifying and reducing swelling; Tulipa gesneriana promotes blood circulation to relieve pain and regulates qi and relieves depression; Cistanche deserticola tonifies the kidney yang and nourishes essence and blood. The combination of the three with the monarch drugs enhances the function of coordinating the liver, spleen, and stomach, preventing the recurrence of phlegm and stasis aggregation; Citrus reticulata Blanco regulates qi and dredges collaterals, Pinellia ternata and Ranunculus ternatus resolve phlegm and dredge collaterals, Trionyx sinensis and Crocus sativus promote blood circulation and dredge collaterals, and the insect drug Hirudo nipponia with a strong power of running around is used for dredging the meridian with its effects of breaking blood and dredging menstruation, expelling stasis and eliminating mass. The combination of the above six can solve the existing phlegm and stasis; the combination of the monarch and ministerial drugs treats both the principal and secondary aspects of the disease. Taraxacum mongolicum, Lonicera japonica, Cremastra appendiculata, Poria cocos, Sparganium stoloniferum, and Euonymus alatus are the adjuvant drugs. Taraxacum mongolicum clears heat and detoxifies, reducing swelling and dissipating nodules; Lonicera japonica clears heat and detoxifies, dispersing wind-heat; Cremastra appendiculata clears heat and detoxifies, resolving phlegm and dissipating nodules; Poria cocos nourishes the heart and soothes the mind, promoting diuresis and reducing swelling; Sparganium stoloniferum breaks blood and promotes qi movement, reducing mass and relieving pain; Euonymus alatus breaks blood and dredges menstruation, detoxifying and reducing swelling. The above six are adjuvant drugs, which can promote the smooth flow of qi movement and assist the orderly rise and fall of the middle energizer. Glycyrrhiza uralensis is the guiding drug, which mainly harmonizes, soothes, and supplements, can detoxify all poisons, and plays the role of harmonizing various drugs. The combination of all drugs treats both the principal and secondary aspects of the disease, jointly achieving the effects of replenishing qi and consolidating the root, dissipating nodules and dredging collaterals, resolving phlegm and dispersing stasis.

[0037] Pharmacodynamic experiments show that the traditional Chinese medicine composition for treating thyroid diseases and breast diseases of the present invention can effectively improve the size of thyroid nodules in patients with thyroid nodules complicated with mammary gland hyperplasia and qi stagnation and phlegm obstruction syndrome, relieve breast pain, stabilize thyroid function, and has no side effects, showing good therapeutic effects on patients with thyroid nodules complicated with mammary gland hyperplasia and qi stagnation and phlegm obstruction syndrome, and has clinical application value. Specific embodiments

[0038] Next, in combination with specific embodiments, the present invention will be further described. It should be noted that on the premise of no conflict, the following described embodiments or various technical features can be arbitrarily combined to form new embodiments.

[0039] Embodiment 1

[0040] The raw materials of a traditional Chinese medicine composition for treating thyroid diseases and breast diseases provided in this embodiment include, by weight: 17 parts of Pseudostellaria heterophylla, 6 parts of Bupleurum chinense, 8 parts of Epimedium brevicornum, 9 parts of Atractylodes macrocephala, 8 parts of Cyperus rotundus, 6 parts of Tulipa gesneriana, 8 parts of Cistanche deserticola, 6 parts of Citrus reticulata Blanco, 6 parts of Pinellia ternata, 22 parts of Ranunculus ternatus, 0.6 part of Trionyx sinensis, 2 parts of Crocus sativus, 2 parts of Hirudo nipponia, 13 parts of Taraxacum mongolicum, 13 parts of Lonicera japonica, 6 parts of Cremastra appendiculata, 8 parts of Poria cocos, 7 parts of Euonymus alatus, and 6 parts of Glycyrrhiza uralensis.

[0041] The preparation method of the traditional Chinese medicine composition for treating thyroid and breast diseases provided in this embodiment includes the following steps:

[0042] S1. Take the following 19 raw medicinal materials of Radix Pseudostellariae, Radix Bupleuri, Herba Epimedii, Rhizoma Atractylodis Macrocephalae, Rhizoma Cyperi, Radix Curcumae, Herba Cistanches, Pericarpium Citri Reticulatae, Rhizoma Pinelliae, Herba Ranunculi Ternati, Carapax Trionycis, Crocus sativus, Hirudo, Herba Taraxaci, Flos Lonicerae, Rhizoma Cremastrae Seu Pleiones, Poria, Ramulus Euonymi, and Radix Glycyrrhizae in the formula amount, perform net selection, and coarsely crush them separately to obtain coarse medicinal material particles for standby;

[0043] S2. Take the coarse medicinal material particles of Radix Pseudostellariae, Radix Bupleuri, Herba Epimedii, Rhizoma Atractylodis Macrocephalae, Herba Cistanches, Hirudo, and Poria obtained in step S1, soak them in cold water for 30 - 60 min to obtain the first medicinal liquid to be decocted for standby;

[0044] S3. First, bring the first medicinal liquid to be decocted obtained in step S2 to a boil over high heat, then change to slow fire and simmer for 40 - 60 min, stirring 2 - 3 times to obtain the decocted medicinal liquid; At the same time, take the coarse medicinal material particles of Rhizoma Cyperi, Radix Curcumae, Pericarpium Citri Reticulatae, Rhizoma Pinelliae, Herba Ranunculi Ternati, Crocus sativus, Herba Taraxaci, Flos Lonicerae, Rhizoma Cremastrae Seu Pleiones, Ramulus Euonymi, and Radix Glycyrrhizae obtained in step S1, soak them in cold water for 30 - 60 min to obtain the second medicinal liquid to be decocted;

[0045] S4. Put the second medicinal liquid to be decocted obtained in step S3 into the decocted medicinal liquid obtained in step S3 and decoct them together. After boiling, decoct for another 20 - 30 min, stirring 2 - 3 times to prepare the described traditional Chinese medicine composition for treating thyroid diseases and breast diseases.

[0046] Example 2

[0047] The raw materials of the traditional Chinese medicine composition for treating thyroid diseases and breast diseases provided in this example include, by weight: 9 parts of Radix Pseudostellariae, 10 parts of Radix Bupleuri, 10 parts of Herba Epimedii, 6 parts of Rhizoma Atractylodis Macrocephalae, 10 parts of Rhizoma Cyperi, 3 parts of Radix Curcumae, 6 parts of Herba Cistanches, 3 parts of Pericarpium Citri Reticulatae, 9 parts of Rhizoma Pinelliae, 15 parts of Herba Ranunculi Ternati, 1 part of Carapax Trionycis, 1 part of Crocus sativus, 3 parts of Hirudo, 15 parts of Herba Taraxaci, 10 parts of Flos Lonicerae, 9 parts of Rhizoma Cremastrae Seu Pleiones, 10 parts of Poria, 4 parts of Ramulus Euonymi, and 2 parts of Radix Glycyrrhizae.

[0048] The preparation method of the traditional Chinese medicine composition for treating thyroid and breast diseases provided in this example includes the following steps:

[0049] S1. Take the following 19 raw medicinal materials of Radix Pseudostellariae, Radix Bupleuri, Herba Epimedii, Rhizoma Atractylodis Macrocephalae, Rhizoma Cyperi, Radix Curcumae, Herba Cistanches, Pericarpium Citri Reticulatae, Rhizoma Pinelliae, Herba Ranunculi Ternati, Carapax Trionycis, Crocus sativus, Hirudo, Herba Taraxaci, Flos Lonicerae, Rhizoma Cremastrae Seu Pleiones, Poria, Ramulus Euonymi, and Radix Glycyrrhizae in the formula amount, perform net selection, and coarsely crush them separately to obtain coarse medicinal material particles for standby;

[0050] S2. Take the coarse medicinal material particles of Radix Pseudostellariae, Radix Bupleuri, Herba Epimedii, Rhizoma Atractylodis Macrocephalae, Herba Cistanches, Hirudo, and Poria obtained in step S1, soak them in cold water for 30 - 60 min to obtain the first medicinal liquid to be decocted for standby;

[0051] S3. First, bring the first medicinal agent to be decocted obtained in step S2 to a boil over high heat, then switch to slow simmering over low heat for 40 - 60 minutes, stirring 2 - 3 times to obtain a decocted medicinal liquid; meanwhile, take the coarse granules of the medicinal materials of Cyperus rotundus, Curcuma aromatica, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Crocus sativus, Taraxacum mongolicum Hand.-Mazz., Lonicera japonica Thunb., Pseudobulbus Cremastrae seu Pleiones, Euonymus alatus, and Glycyrrhiza uralensis Fisch. obtained in step S1, soak them in cold water for 30 - 60 minutes to obtain a second medicinal agent to be decocted;

[0052] S4. Put the second medicinal agent to be decocted obtained in step S3 into the decocted medicinal liquid obtained in step S3 and decoct them together. After boiling, continue to decoct for 20 - 30 minutes, stirring 2 - 3 times to prepare the described traditional Chinese medicine composition for treating thyroid diseases and breast diseases.

[0053] Example 3

[0054] The raw materials of the traditional Chinese medicine composition for treating thyroid diseases and breast diseases provided in this example include, by weight: 25 parts of Pseudostellaria heterophylla, 3 parts of Bupleurum chinense DC., 6 parts of Epimedium brevicornu Maxim., 12 parts of Atractylodes macrocephala Koidz., 6 parts of Cyperus rotundus, 10 parts of Curcuma aromatica, 10 parts of Cistanche deserticola Ma, 10 parts of Citrus reticulata Blanco, 3 parts of Pinellia ternata, 15 parts of Ranunculus ternatus, 0.03 parts of Amyda sinensis (Wiegmann), 3 parts of Crocus sativus, 1 part of Whitmania pigra Whitman, 1 part of Taraxacum mongolicum Hand.-Mazz., 15 parts of Lonicera japonica Thunb., 9 parts of Pseudobulbus Cremastrae seu Pleiones, 10 parts of Poria cum Radix Pini, 4 parts of Euonymus alatus, and 10 parts of Glycyrrhiza uralensis Fisch.

[0055] The preparation method of the traditional Chinese medicine composition for treating thyroid and breast diseases provided in this example includes the following steps:

[0056] S1. Take the formula amount of 19 raw medicinal materials including Pseudostellaria heterophylla, Bupleurum chinense DC., Epimedium brevicornu Maxim., Atractylodes macrocephala Koidz., Cyperus rotundus, Curcuma aromatica, Cistanche deserticola Ma, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Amyda sinensis (Wiegmann), Crocus sativus, Whitmania pigra Whitman, Taraxacum mongolicum Hand.-Mazz., Lonicera japonica Thunb., Pseudobulbus Cremastrae seu Pleiones, Poria cum Radix Pini, Euonymus alatus, and Glycyrrhiza uralensis Fisch., perform cleaning and selection, and respectively coarsely crush them to obtain coarse granules of the medicinal materials for standby;

[0057] S2. Take the coarse granules of the medicinal materials of Pseudostellaria heterophylla, Bupleurum chinense DC., Epimedium brevicornu Maxim., Atractylodes macrocephala Koidz., Cistanche deserticola Ma, Whitmania pigra Whitman, and Poria cum Radix Pini obtained in step S1, soak them in cold water for 30 - 60 minutes to obtain a first medicinal agent to be decocted for standby;

[0058] S3. First, bring the first medicinal agent to be decocted obtained in step S2 to a boil over high heat, then switch to slow simmering over low heat for 40 - 60 minutes, stirring 2 - 3 times to obtain a decocted medicinal liquid; meanwhile, take the coarse granules of the medicinal materials of Cyperus rotundus, Curcuma aromatica, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Crocus sativus, Taraxacum mongolicum Hand.-Mazz., Lonicera japonica Thunb., Pseudobulbus Cremastrae seu Pleiones, Euonymus alatus, and Glycyrrhiza uralensis Fisch. obtained in step S1, soak them in cold water for 30 - 60 minutes to obtain a second medicinal agent to be decocted;

[0059] S4. Put the second medicinal agent to be decocted obtained in step S3 into the decocted medicinal liquid obtained in step S3 and decoct them together. After boiling, continue to decoct for 20 - 30 minutes, stirring 2 - 3 times to prepare the described traditional Chinese medicine composition for treating thyroid diseases and breast diseases.

[0060] Example 4

[0061] The traditional Chinese medicine composition for treating thyroid diseases and breast diseases provided in this example comprises raw materials in parts by weight: 21 parts of Pseudostellaria heterophylla, 8 parts of Bupleurum chinense, 7 parts of Epimedium brevicornu, 10 parts of Atractylodes macrocephala, 9 parts of Cyperus rotundus, 4 parts of Curcuma aromatica, 7 parts of Cistanche deserticola, 8 parts of Citrus reticulata Blanco, 5 parts of Pinellia ternata, 19 parts of Ranunculus ternatus, 0.75 part of Amyda sinensis, 1.5 parts of Crocus sativus, 2.5 parts of Whitmania pigra, 14 parts of Taraxacum mongolicum, 11 parts of Lonicera japonica, 7 parts of Cremastra appendiculata, 9 parts of Poria, 6 parts of Euonymus alatus, 6 parts of Glycyrrhiza uralensis.

[0062] The preparation method of the traditional Chinese medicine composition for treating thyroid and breast diseases provided in this example comprises the following steps:

[0063] S1. Take 19 raw material herbs including Pseudostellaria heterophylla, Bupleurum chinense, Epimedium brevicornu, Atractylodes macrocephala, Cyperus rotundus, Curcuma aromatica, Cistanche deserticola, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Amyda sinensis, Crocus sativus, Whitmania pigra, Taraxacum mongolicum, Lonicera japonica, Cremastra appendiculata, Poria, Euonymus alatus, and Glycyrrhiza uralensis in the formulated amounts, perform cleaning and selection, and respectively coarsely crush them to obtain coarse medicinal granules, and set aside;

[0064] S2. Soak the coarse medicinal granules of Pseudostellaria heterophylla, Bupleurum chinense, Epimedium brevicornu, Atractylodes macrocephala, Cistanche deserticola, Whitmania pigra, and Poria obtained in step S1 in cold water for 30 - 60 min to obtain the first medicinal liquid to be decocted, and set aside;

[0065] S3. First, bring the first medicinal liquid to be decocted obtained in step S2 to a boil over high heat, then change to low heat and slowly decoct for 40 - 60 min, stirring 2 - 3 times to obtain the decocted medicinal liquid; meanwhile, soak the coarse medicinal granules of Cyperus rotundus, Curcuma aromatica, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Crocus sativus, Taraxacum mongolicum, Lonicera japonica, Cremastra appendiculata, Euonymus alatus, and Glycyrrhiza uralensis obtained in step S1 in cold water for 30 - 60 min to obtain the second medicinal liquid to be decocted;

[0066] S4. Put the second medicinal liquid to be decocted obtained in step S3 into the decocted medicinal liquid obtained in step S3 and decoct them together. After boiling, continue to decoct for 20 - 30 min, stirring 2 - 3 times to prepare the traditional Chinese medicine composition for treating thyroid diseases and breast diseases.

[0067] S4. Put the medicinal liquid to be decocted obtained in step S3 into the decocted medicinal liquid obtained in step S3 and decoct them together. After boiling, continue to decoct for 20 - 30 min, stirring 2 - 3 times to prepare the traditional Chinese medicine composition for treating thyroid diseases and breast diseases.

[0068] Example 5

[0069] The traditional Chinese medicine composition for treating thyroid diseases and breast diseases provided by this embodiment comprises the following raw materials in parts by weight: 13 parts of Pseudostellaria heterophylla, 4 parts of Bupleurum chinense, 9 parts of Epimedium brevicornu, 8 parts of Atractylodes macrocephala, 7 parts of Cyperus rotundus, 8 parts of Curcuma aromatica, 9 parts of Cistanche deserticola, 4 parts of Citrus reticulata Blanco, 7 parts of Pinellia ternata, 26 parts of Ranunculus ternatus, 0.25 part of Trionyx sinensis, 2.5 parts of Crocus sativus, 1.5 parts of Hirudo, 12 parts of Taraxacum mongolicum Hand.-Mazz., 14 parts of Lonicera japonica Thunb., 5 parts of Cremastra appendiculata (D. Don) Makino, 9 parts of Poria cum Radix Pini, 6 parts of Euonymus alatus, and 8 parts of Glycyrrhiza uralensis Fisch.

[0070] The preparation method of the traditional Chinese medicine composition for treating thyroid and breast diseases provided by this embodiment comprises the following steps:

[0071] S1. Take 19 raw medicinal materials including Pseudostellaria heterophylla, Bupleurum chinense, Epimedium brevicornu, Atractylodes macrocephala, Cyperus rotundus, Curcuma aromatica, Cistanche deserticola, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Trionyx sinensis, Crocus sativus, Hirudo, Taraxacum mongolicum Hand.-Mazz., Lonicera japonica Thunb., Cremastra appendiculata (D. Don) Makino, Poria cum Radix Pini, and Euonymus alatus in the formula amount, conduct cleaning and selection, and respectively coarsely crush them to obtain coarse medicinal material particles for standby;

[0072] S2. Soak the coarse medicinal material particles of Pseudostellaria heterophylla, Bupleurum chinense, Epimedium brevicornu, Atractylodes macrocephala, Cistanche deserticola, Hirudo, and Poria cum Radix Pini obtained in step S1 in cold water for 30 - 60 min to obtain the first medicinal liquid to be decocted for standby;

[0073] S3. First, bring the first medicinal liquid to be decocted obtained in step S2 to a boil over high heat, then switch to low heat and slowly decoct for 40 - 60 min, stirring 2 - 3 times to obtain the decocted medicinal liquid; meanwhile, soak the coarse medicinal material particles of Cyperus rotundus, Curcuma aromatica, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Crocus sativus, Taraxacum mongolicum Hand.-Mazz., Lonicera japonica Thunb., Cremastra appendiculata (D. Don) Makino, Euonymus alatus, and Glycyrrhiza uralensis Fisch. obtained in step S1 in cold water for 30 - 60 min to obtain the second medicinal liquid to be decocted;

[0074] S4. Put the second medicinal liquid to be decocted obtained in step S3 into the decocted medicinal liquid obtained in step S3 and decoct them together. After boiling, decoct for another 20 - 30 min, stirring 2 - 3 times to prepare the traditional Chinese medicine composition for treating thyroid diseases and breast diseases.

[0075] Experimental Example

[0076] 1 General Information

[0077] A total of 76 female patients with thyroid nodules and breast hyperplasia admitted to the Guangdong Thyroid and Breast Medical Research Center from February 2021 to October 2023 were selected, and eligible patients were recruited as research subjects. The enrolled patients were randomly divided into 2 groups: 38 cases in the experimental group, aged 22-46 (33.2±4.5) years old; course of disease 4-16 (7.1±1.0) months; 8 cases of single nodules, 30 cases of multiple nodules; 28 cases of unilateral breast hyperplasia, 10 cases of bilateral breast hyperplasia. 38 cases in the control group, aged 21-45 (32.9±4.3) years old; course of disease 4-17 (7.2±0.9) months; 7 cases of single nodules, 33 cases of multiple nodules; 28 cases of unilateral breast hyperplasia, 10 cases of bilateral breast hyperplasia. There was no statistically significant difference in the age, course of disease and other general data between the two groups (all P>0.05).

[0078] Inclusion criteria: patients who met the requirements of the Western medicine diagnosis of thyroid nodules in "Surgery" and the requirements of breast hyperplasia in the "Expert Consensus on the Diagnosis and Treatment of Cystoma Hyperplasia"; patients who met the TCM diagnosis of thyroid nodules combined with qi stagnation and phlegm obstruction of breast hyperplasia in the "Guiding Principles for Clinical Research of New Chinese Medicines"; the patients were aged 20 to 50 years old, all had simple nodules, no abnormal thyroid function, a disease course of more than 3 months, had not been treated with hormone drugs in the past six months, and voluntarily signed the informed consent form.

[0079] Exclusion criteria: patients with malignant tumors, severe liver and kidney dysfunction, severe lesions of the nervous system, circulatory system, respiratory system, endocrine system and hematopoietic system, acute mastitis, breast tuberculosis, breast fibroadenoma, breast cancer and other breast diseases, Hashimoto's thyroiditis, hyperthyroidism, hypothyroidism, thyroid cancer and other thyroid diseases, pregnant and lactating women, allergic constitution and those who are allergic to the ingredients of this experiment are excluded.

[0080] 2 Diagnostic criteria

[0081] 2.1 Western medicine diagnostic criteria

[0082] Western medicine diagnosis refers to the provisions of "Surgery" on thyroid nodules and the "Expert Consensus on Diagnosis and Treatment of Fibrocystic ...

[0083] 2.2 TCM diagnostic criteria

[0084] The diagnostic standard of traditional Chinese medicine refers to the "Guiding Principles for Clinical Research of New Chinese Medicines", and the syndrome is differentiated as qi stagnation and phlegm obstruction: the main symptoms are fullness and pain in the neck, lumps and pain in the breasts, the symptoms change with the menstrual cycle, there is phlegm in the throat, and emotional distress; the secondary symptoms are distension and pain in the chest and flanks, the pain is not fixed, irritability, impatience, and loss of appetite; the tongue and pulse are red, the tongue coating is thin or thin yellow, slightly greasy, and the pulse is stringy and slippery.

[0085] 3 Treatment options

[0086] 3.1 Treatment drugs and treatment methods

[0087] Control group: Given conventional Western medicine treatment: Oral administration of Tamoxifen Citrate Tablets (Hainan Hailing Chemical Pharmaceutical Co., Ltd., National Medicine Approval No. H46020268, specification: 10 mg / tablet), 10 mg each time, 2 times a day, continuously treated for 3 menstrual cycles; Levothyroxine Sodium Tablets (Shenzhen Zhonglian Pharmaceutical Co., Ltd., National Medicine Approval No. H20010522, specification: 50 μg / tablet) were taken orally on an empty stomach. The initial dosage was 12.5 μg per day. For those with no obvious adverse reactions, the dosage was adjusted to 25 μg per day after 1 week, and maintained for 3 months. Thyroid function was rechecked at the hospital every month.

[0088] Experimental group: A traditional Chinese medicine composition for treating thyroid diseases and breast diseases provided in Example 1 of the present invention. The patients were reviewed once every 4 weeks, and the medicine was appropriately modified according to syndrome differentiation. One dose was taken daily, decocted in water and taken warm in the morning and evening, and taken continuously for 3 months.

[0089] The curative effects of both groups were evaluated after 3 months of treatment.

[0090] 4 Curative effect evaluation criteria

[0091] 5 Curative effect indicators and safety indicators

[0092] 5.1 Curative effect indicators

[0093] ① Curative effect of thyroid nodules: Refer to the "Standardized Diagnosis and Treatment of Thyroid Nodules" to formulate the curative effect judgment criteria for thyroid nodules. Recovery: After treatment, the clinical symptoms of the patient completely disappeared, no mass was palpable, and B-ultrasound examination showed that the maximum diameter of the nodule was shortened by more than 80%; Marked effect: After treatment, the clinical symptoms of the patient were significantly relieved, and B-ultrasound examination showed that the maximum diameter of the nodule was shortened by 60% - 80%; Effective: After treatment, the clinical symptoms of the patient were improved to a certain extent, and B-ultrasound examination showed that the maximum diameter of the nodule was shortened by 30% - 60%; Ineffective: After treatment, the clinical symptoms of the patient were not improved at all, and B-ultrasound examination showed that the maximum diameter of the nodule was shortened by less than 30%. The total effective rate was recovery + marked effect + effective.

[0094] ② Breast symptom score: The integral criteria formulated in the "Expert Consensus on the Diagnosis and Treatment of Mammary Hyperplasia" were used to quantitatively score the breast pain, mass size, and mass texture of the patients before and after treatment. Breast pain: No breast pain was recorded as 6 points; breast with tenderness or pain on palpation but no spontaneous pain was recorded as 12 points; breast with spontaneous pain and persistent, not affecting daily life was recorded as 24 points; breast with persistent spontaneous pain, seriously affecting the patient's daily life was recorded as 30 points. Mass size: No breast mass was recorded as 0 points, the maximum diameter of the largest breast mass less than 2 cm was recorded as 3 points, the maximum diameter of the largest breast mass 2 - 5 cm was recorded as 6 points, and the maximum diameter of the largest breast mass more than 5 cm was recorded as 9 points. Mass texture: No breast mass was recorded as 0 points, breast with an elasticity score of 0 was recorded as 3 points, breast with an elasticity score of 1 was recorded as 6 points, breast with an elasticity score of 2 was recorded as 9 points, and breast with an elasticity score of 3 was recorded as 12 points.

[0095] ③ Size of thyroid nodules: The maximum diameter and volume of the nodules of the patients before and after treatment were measured using a color Doppler flow imaging instrument.

[0096] ④ Thyroid function: Fasting peripheral venous blood of the patients before and after treatment was taken, anticoagulated with heparin, centrifuged at 3500 r / min for 15 min, the supernatant was separated, and the levels of five thyroid function indicators (TSH, TT3, TT4, FT3, FT4) were detected by radioimmunoassay.

[0097] Note: The normal ranges of the five thyroid function indicators (TSH, TT3, TT4, FT3, FT4) are as follows:

[0098] TSH (thyroid stimulating hormone): 0.35 - 5.5 uIU / ml; TT3 (triiodothyronine): 0.8 - 2.0 nmol / L; TT4 (thyroxine): 60 - 180 nmol / L; FT3 (free triiodothyronine): 3.5 - 6.5 pmol / L; FT4 (free thyroxine): 10.5 - 24.5 pmol / L.

[0099] 5.2 Safety indicators

[0100] Record the occurrence of adverse reactions during the treatment of the two groups and whether there are changes in blood and urine routine, liver and kidney functions before and after treatment.

[0101] 6 Results

[0102] Table 1 Comparison of the curative effects of thyroid nodules after treatment in the two groups [cases (%)]

[0103] Group Number of cases Cured Markedly effective Effective Ineffective Total effective Experimental group 38 13(34.2) 19(50.0) 5(13.2) 1(2.6) 37(97.4) Control group 38 5(13.2) 14(36.8) 8(21.1) 11(28.9) 27(71.1)

[0104] After treatment, the total effective rate of thyroid nodules in the experimental group was significantly higher than that in the control group, and the difference between the two groups was statistically significant (P < 0.05), indicating that the traditional Chinese medicine composition for treating thyroid and breast diseases of the present invention has a significant curative effect on the thyroid nodule disease in patients with thyroid nodules complicated with mammary hyperplasia of qi stagnation and phlegm obstruction type.

[0105] Table 2 Comparison of breast symptom scores between the two groups before and after treatment ( points)

[0106]

[0107]

[0108] After treatment, the scores of breast pain, mass size, and mass texture in both groups were significantly lower than those before treatment (P < 0.05 for all), and the observation group was significantly lower than the control group (P < 0.05 for all), indicating that the traditional Chinese medicine composition for treating thyroid and breast diseases of the present invention has a significant curative effect on the mammary hyperplasia disease in patients with thyroid nodules complicated with mammary hyperplasia of qi stagnation and phlegm obstruction type.

[0109] Table 3 Comparison of thyroid nodule sizes between the two groups before and after treatment

[0110]

[0111] After treatment, the maximum diameter and volume of nodules in both groups were significantly reduced (P < 0.05 for all), and the observation group was significantly lower than the control group (P < 0.05), indicating that the traditional Chinese medicine composition for treating thyroid and breast diseases of the present invention can reduce the thyroid nodules in patients with thyroid nodules complicated with mammary hyperplasia of qi stagnation and phlegm obstruction type.

[0112] Table 4 Comparison of thyroid function indexes between the two groups before and after treatment

[0113]

[0114]

[0115] There were no statistically significant differences in the levels of TSH, TT3, TT4, FT3, and FT4 between the two groups before and after treatment (P > 0.05 for all), and there were also no statistically significant differences in the levels of TSH, TT3, TT4, FT3, and FT4 between the two groups after treatment (P > 0.05 for all), indicating that the traditional Chinese medicine composition for treating thyroid and breast diseases of the present invention has no obvious effect on thyroid function and is safe without side effects.

[0116] The results of this experiment showed that the total effective rate of the experimental group after treatment was significantly higher than that of the control group. The breast symptom scores (breast pain, mass size, mass texture) and the sizes of thyroid nodules (maximum nodule diameter, nodule volume) were significantly lower than those of the control group. There were no statistically significant differences in the levels of TSH, TT3, TT4, FT3, and FT4 before and after treatment and between the two groups after treatment. No obvious adverse reactions occurred during the treatment of the two groups.

[0117] In summary, the traditional Chinese medicine composition for treating thyroid diseases and breast diseases of the present invention can effectively improve the size of thyroid nodules in patients with thyroid nodules complicated with mammary gland hyperplasia of qi stagnation and phlegm obstruction syndrome, relieve breast pain, stabilize thyroid function, and is safe without side effects. It has a good therapeutic effect on patients with thyroid nodules complicated with mammary gland hyperplasia of qi stagnation and phlegm obstruction syndrome and has clinical application value.

[0118] The above embodiments are only the preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by those skilled in the art based on the present invention belong to the scope of protection required by the present invention.

Claims

1. A traditional Chinese medicine composition for treating thyroid nodules and breast hyperplasia of qi stagnation and phlegm obstruction syndrome type, characterized in that, By weight, it is composed of the following raw materials: 9-25 parts of Pseudostellaria heterophylla, 3-10 parts of Bupleurum chinense, 6-10 parts of Epimedium brevicornu, 6-12 parts of Atractylodes macrocephala, 6-10 parts of Cyperus rotundus, 3-10 parts of Curcuma aromatica, 6-10 parts of Cistanche deserticola, 3-10 parts of Citrus reticulata Blanco, 3-9 parts of Pinellia ternata, 15-30 parts of Ranunculus ternatus, 0.03-1 part of Trionyx sinensis, 1-3 parts of Crocus sativus, 1-3 parts of Hirudo nipponia, 10-15 parts of Taraxacum mongolicum, 10-15 parts of Lonicera japonica, 3-9 parts of Cremastra appendiculata, 6-10 parts of Poria cum Radix Pini, 4-9 parts of Euonymus alatus, 2-10 parts of Glycyrrhiza uralensis Fisch.

2. The traditional Chinese medicine composition for treating thyroid nodules combined with mammary gland hyperplasia of qi stagnation and phlegm obstruction syndrome type as claimed in claim 1, wherein By weight, it is composed of the following raw materials: 17 parts of Pseudostellaria heterophylla, 6 parts of Bupleurum chinense, 8 parts of Epimedium brevicornu, 9 parts of Atractylodes macrocephala, 8 parts of Cyperus rotundus, 6 parts of Curcuma aromatica, 8 parts of Cistanche deserticola, 6 parts of Citrus reticulata Blanco, 6 parts of Pinellia ternata, 22 parts of Ranunculus ternatus, 0.6 part of Trionyx sinensis, 2 parts of Crocus sativus, 2 parts of Hirudo nipponia, 13 parts of Taraxacum mongolicum, 13 parts of Lonicera japonica, 6 parts of Cremastra appendiculata, 8 parts of Poria cum Radix Pini, 7 parts of Euonymus alatus, 6 parts of Glycyrrhiza uralensis Fisch.

3. The preparation method of a traditional Chinese medicine composition for treating thyroid nodules with qi stagnation and phlegm obstruction syndrome type combined with mammary gland hyperplasia according to claim 1 or 2, characterized in that, It includes the following steps: S1. Take 19 raw material herbs including Pseudostellaria heterophylla, Bupleurum chinense, Epimedium brevicornu, Atractylodes macrocephala, Cyperus rotundus, Curcuma aromatica, Cistanche deserticola, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Trionyx sinensis, Crocus sativus, Hirudo nipponia, Taraxacum mongolicum, Lonicera japonica, Cremastra appendiculata, Poria cum Radix Pini, Euonymus alatus, and Glycyrrhiza uralensis Fisch. in the formula amount, carry out net selection, and respectively coarsely crush them to obtain coarse medicinal granules for standby; S2. Take the coarse medicinal granules of Pseudostellaria heterophylla, Bupleurum chinense, Epimedium brevicornu, Atractylodes macrocephala, Cistanche deserticola, Hirudo nipponia, and Poria cum Radix Pini obtained in step S1 and soak them in cold water for 30-60 min to obtain the first decoction agent for standby; S3. First bring the first decoction agent obtained in step S2 to a boil over high heat, then change to low heat and simmer for 40-60 min, stirring 2-3 times to obtain the decocted liquid; at the same time, take the coarse medicinal granules of Cyperus rotundus, Curcuma aromatica, Citrus reticulata Blanco, Pinellia ternata, Ranunculus ternatus, Crocus sativus, Taraxacum mongolicum, Lonicera japonica, Cremastra appendiculata, Euonymus alatus, and Glycyrrhiza uralensis Fisch. obtained in step S1 and soak them in cold water for 30-60 min to obtain the second decoction agent; S4. Put the second decoction agent obtained in step S3 into the decocted liquid obtained in step S3 and decoct them together. After boiling, decoct for another 20-30 min, stirring 2-3 times to prepare the described traditional Chinese medicine composition for treating thyroid nodules complicated with mammary gland hyperplasia of qi stagnation and phlegm obstruction syndrome.

4. Use of the traditional Chinese medicine composition for treating thyroid nodules complicated with mammary gland hyperplasia of qi stagnation and phlegm obstruction syndrome according to claim 1 or 2 in the preparation of a drug for treating thyroid nodules complicated with mammary gland hyperplasia of qi stagnation and phlegm obstruction syndrome.

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