Preparation method and application of traditional Chinese medicine composition

Abstract

The present invention provides a preparation method and application of a Chinese medicine composition, and belongs to the technical field of Chinese medicine compositions. The present invention provides corresponding extraction methods according to different Chinese medicines, promotes the dissolution of effective components, and after mixing the extracts of various Chinese medicines, the effective components extracted from various medicines interact with each other, thereby improving the therapeutic effect of the Chinese medicine composition. The Chinese medicine composition obtained by the present invention can effectively treat thyroid nodules and mastitis. The present invention mainly treats heat and detoxification, blood stasis, stagnation, liver and depression, and has a definite therapeutic effect without side effects.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions, and in particular relates to a preparation method and application of the traditional Chinese medicine composition. Background Art

[0002] Plasma cell mastitis is a chronic, non-bacterial breast inflammation based on duct dilatation and plasma cell infiltration. In the acute phase of the disease, broad-spectrum antibiotics combined with metronidazole are generally used to control the inflammatory response. Adverse reactions to drugs are prone to occur during medication.

[0003] Thyroid nodules belong to the category of "goiter" in traditional Chinese medicine. After the abnormal proliferation of thyroid cells, lumps are formed in the thyroid tissue. They can move up and down with the thyroid gland during swallowing, and the incidence rate is extremely high. At present, Western medicine mainly adopts hormone suppression therapy or surgical treatment to treat thyroid nodules. The recurrence rate after treatment is high and the treatment effect is not ideal.

[0004] Traditional Chinese medicine theory emphasizes that the human body is an organic whole, and the various organs, meridians, qi and blood are interconnected and influence each other. Chinese medicine treatment is not just aimed at a certain local symptom, but focuses on the regulation of the whole body. Clinically, the use of Chinese medicine for treatment helps to fundamentally solve the root cause of the disease and reduce the recurrence of the disease. At the same time, Chinese medicine has few side effects and definite efficacy in treating diseases. Therefore, the use of Chinese medicine to treat mastitis and thyroid nodules has great clinical value and potential demand. Summary of the invention

[0005] In view of this, the object of the present invention is to provide a method for preparing a Chinese medicine composition, and the obtained Chinese medicine composition can effectively treat mastitis and thyroid nodules.

[0006] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0007] A method for preparing a traditional Chinese medicine composition, wherein the traditional Chinese medicine composition comprises, by weight: 150-180 parts of nectarine nest, 130-160 parts of sophora flavescens, 130-160 parts of barbata scabra, 130-160 parts of tribulus truncatum, 130-160 parts of antler frost, 130-160 parts of pulsatilla, 70-90 parts of bitter liquorice, 70-90 parts of liquorice, 70-90 parts of bupleurum, 50-80 parts of green peel, and 1-3 parts of musk;

[0008] The preparation method of the Chinese medicine composition comprises the following steps:

[0009] Weigh each medicinal material in proportion; mix Scutellaria barbata and Psoralea corylifolia to obtain mixture 1, mix mixture 1 with ethanol with a mass fraction of 50-70%, and then perform reflux extraction to obtain extract 1; mix Nymphaeaceae, Sophora flavescens, Licorice root and Citrus aurantium to obtain mixture 2, mix mixture 2 with anhydrous ethanol and perform ultrasonic extraction to obtain extract 2; mix antler frost, Pulsatilla striata, Glycyrrhiza uralensis and Radix Bupleuri to obtain mixture 3, soak mixture 3 in water and then filter, collect water filtrate, add 70-80% methanol to the filter residue and perform ultrasonic extraction, collect alcohol filtrate after filtering, and mix the water filtrate and the alcohol filtrate to obtain extract 3; freeze musk and then crush it, mix the musk powder with ethanol with a mass fraction of 70-80%, and then perform microwave extraction to obtain extract 4; mix extract 1, extract 2, extract 3 and extract 4, and then reduce pressure and concentrate them into a paste to obtain a traditional Chinese medicine composition.

[0010] Preferably, the mixture 1 is mixed with 50-70% by mass ethanol at a solid-liquid ratio of 1 g:16-25 mL, the temperature of the reflux extraction is 40-60° C., and the time of the reflux extraction is 40-70 min.

[0011] Preferably, the mixture 2 is mixed with anhydrous ethanol at a solid-liquid ratio of 1 g:10-20 mL, the temperature of the ultrasonic extraction is 20-35° C., the power of the ultrasonic extraction is 150-200 W, and the time of the ultrasonic extraction is 20-40 min.

[0012] Preferably, the mixture 3 is mixed with water at a solid-liquid ratio of 1 g: 5-8 mL, and the soaking time is 1-2 h; the filter residue is mixed with methanol with a mass fraction of 70-80% at a solid-liquid ratio of 1 g: 8-15 mL, the temperature of the ultrasonic extraction is 30-45° C., the power of the ultrasonic extraction is 150-200 W, and the time of the ultrasonic extraction is 20-40 min.

[0013] Preferably, the musk is frozen at -80°C for 12 to 20 hours, the musk powder is mixed with 70 to 80% ethanol by mass at a solid-liquid ratio of 1 g:5 to 10 mL, the microwave extraction power is 200 to 400 W, and the microwave extraction time is 50 to 70 seconds.

[0014] Preferably, the temperature of the reduced pressure concentration is 50 to 65° C., and the pressure is -0.05 to -0.07 MPa.

[0015] Preferably, the paste is dried and then crushed to obtain medicinal powder, and the medicinal powder is prepared into water pills.

[0016] Preferably, the medicinal powder is mixed with vaseline to prepare an external preparation.

[0017] Another object of the present invention is to provide an application of the traditional Chinese medicine composition obtained by the preparation method in the preparation of a medicine for treating thyroid nodules.

[0018] Another object of the present invention is to provide the use of the traditional Chinese medicine composition obtained by the preparation method in the preparation of a drug for treating mastitis, wherein the mastitis is plasma cell mastitis.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] The invention provides a method for preparing a Chinese medicine composition, provides corresponding extraction methods according to different Chinese medicines, promotes the dissolution of effective components, and after mixing the extracts of various Chinese medicines, the effective components extracted from various medicines interact with each other, thereby improving the therapeutic effect of the Chinese medicine composition. The Chinese medicine composition obtained by the invention can effectively treat thyroid nodules and mastitis. The invention mainly treats heat and detoxification, dissipates blood stasis, disperses stagnation, relieves liver depression, and has a definite therapeutic effect without side effects. DETAILED DESCRIPTION

[0021] The invention provides a method for preparing a traditional Chinese medicine composition. In the invention, the traditional Chinese medicine composition comprises, by weight, 150-180 parts of nectarine nest, 130-160 parts of sophora flavescens, 130-160 parts of Scutellaria barbata, 130-160 parts of Trillium, 130-160 parts of antler frost, 130-160 parts of Pulsatilla scabra, 70-90 parts of bitter liquorice, 70-90 parts of liquorice, 70-90 parts of bupleurum, 50-80 parts of green peel and 1-3 parts of musk. Preferred ingredients include: 160-170 parts of honey beehive, 140-150 parts of Sophora flavescens, 140-150 parts of Scutellaria barbata, 140-150 parts of Tripterygium wilfordii, 140-150 parts of Deer Horn Powder, 140-150 parts of Pulsatilla chinensis, 75-85 parts of Glycyrrhiza uralensis, 75-85 parts of Licorice, 75-85 parts of Bupleurum, 60-70 parts of Citrus aurantium, and 1.5-2.5 parts of Musk. The present invention has no particular limitation on the specific sources of the above raw materials, and conventional commercial products in the art can be used.

[0022] In the present invention, Psoralea corylifolia tastes sweet and slightly pungent, is cool in nature, and returns to the liver and spleen meridians, has the effects of clearing away heat and toxic substances, resolving phlegm and dispersing stagnation, and is used for carbuncle, scrofula, phlegm nucleus, and snake and insect bites. It is good at clearing away heat and toxic substances, reducing swelling and relieving pain, and is used for furuncle, external carbuncle, and throat paralysis. Scutellaria barbata tastes pungent and bitter, is cold in nature, and returns to the lung, liver, and kidney meridians. Scutellaria barbata is pungent and can be dispersed, bitter and cold, and can clear away heat and toxic substances, and can stop bleeding, and can also promote diuresis and reduce swelling, and has the effects of clearing away heat and toxic substances, removing blood stasis and promoting diuresis, and is used for furuncle, sore throat, pain from falls, edema, jaundice, and snake and insect bites. Psoralea corylifolia and Scutellaria barbata are used together, clearing away heat and toxic substances, removing blood stasis and dispersing stagnation, and are monarch drugs in total, and play a leading role in the prescription for the disease.

[0023] In the present invention, the honeycomb is sweet in taste and flat in nature, and it enters the liver, stomach and kidney meridians. It has the effects of dispelling wind, attacking toxicity, killing insects, relieving pain and anti-allergy, and is mainly used for dispelling wind and relieving pain, attacking toxicity and dispersing stagnation, killing insects and relieving itching. The green peel is bitter and pungent in taste, warm in nature, and enters the liver, gallbladder and stomach meridians. The green peel is bitter and descending, and the pungent and warm movement is scattered. It is good at soothing the liver and breaking qi, treating liver depression and flank pain, breast diseases, and abdominal pain caused by cold hernia, and is good at dispersing stagnation and eliminating stagnation, treating abdominal pain caused by accumulation of lumps, long-term malaria and abdominal pain caused by food accumulation. Bupleurum is bitter and pungent in taste, slightly cold in nature, and enters the liver, gallbladder and lung meridians. Bupleurum is bitter, pungent and dispersing, and its aromatic and soothing nature rises. It can clear slightly cold energy, and it can both dispel the evil qi of the gallbladder meridian and resolve fever, and dispel the qi of liver and gallbladder meridian stagnation and relieve liver depression, and also lift the qi of liver and gallbladder clear yang and lift the sunken qi, and has the effects of dispersing fever, soothing liver depression, and lifting yang qi. The three herbs of Naphalocrocis, Citrus aurantium and Bupleurum are used together as the ministerial herbs in the prescription to assist the monarch herbs in exerting their effects and make the whole prescription have the functions of attacking toxins, dispersing nodules, soothing the liver and relieving depression.

[0024] In the present invention, Radix Sophorae flavescentis is bitter in taste, cold in nature, and enters the lung and stomach meridians. It is good at clearing away heart, lung and stomach fire and detoxifying, reducing swelling and relieving sore throat, and is used for fire toxicity accumulation, milk moth throat paralysis, gingival swelling and pain, and mouth and tongue sores. Pulsatilla chinensis is the dried root of the Ranunculaceae plant Pulsatilla chinensis, bitter in taste, cold in nature, enters the stomach and large intestine meridians, has the effects of clearing away heat and detoxifying, cooling blood and stopping dysentery, and is mainly used to treat heat toxic blood dysentery and vaginal itching and leucorrhea. Glycyrrhiza uralensis is the root of the leguminous plant Sophora alopecuroides, bitter in taste, cold in nature, and has the effects of clearing away heat and detoxifying. It can be used to treat dysentery, eczema, toothache, and cough. Deer antler frost is salty and astringent, warm in nature, enters the liver and kidney meridians, has the effects of warming the kidney and assisting yang, astringing and stopping bleeding, and is commonly used for spleen and kidney yang deficiency, excessive leucorrhea, enuresis and frequent urination, metrorrhagia and bleeding, and sores that do not astringe. Sophora flavescens, Pulsatilla scabra, Licorice root and Deer antler powder are used together as adjuvants in the prescription to enhance the heat-clearing and detoxifying effects of the main herb, while also having the effects of warming the kidney and assisting yang, and relieving Chong and Ren disorders.

[0025] In the present invention, licorice is sweet, flat in nature, and enters the heart, lung, spleen, and kidney meridians. Licorice is sweet, nourishing, moistening, and slow, and is relatively cool in nature. It is roasted and flat and warm, and has the functions of invigorating qi and tonifying the middle, removing phlegm and relieving cough, detoxifying, relieving pain, and alleviating the properties of the medicine. It is mainly used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, coughing with sputum, abdominal and limb cramps and pain, carbuncle, sore, and relieves drug toxicity and potency. Musk is pungent, warm in nature, and enters the heart and spleen meridians. Musk is pungent, dispersing, warming, and aromatic, and is good at opening and closing the orifices. It is a good medicine for opening and refreshing the mind, and it is suitable for treating closed syndromes and coma regardless of cold and heat, and it is also suitable for promoting blood circulation and dredging menstruation, relieving pain, and treating blood stasis and blocking syndrome regardless of new and long. It takes its merit of promoting blood circulation and dredging menstruation, and is also commonly used for sores, dead fetuses, and retained placenta. Musk and licorice are coordinated and compatible as the adjuvant drugs of the prescription, which can further enhance the warming and blood-dispersing effects of the prescription, and can also lead the drugs into the interior, harmonize the medicinal properties, help the main and auxiliary drugs to exert their effects, and reduce drug stimulation.

[0026] The whole prescription of the present invention has reasonable compatibility and is mainly used for clearing away heat and detoxifying, removing blood stasis, dispersing stagnation, soothing the liver and relieving depression.

[0027] The preparation method of the Chinese medicine composition of the present invention comprises the following steps:

[0028] Weigh each medicinal material in proportion; mix Scutellaria barbata and Psoralea corylifolia to obtain mixture 1, mix mixture 1 with ethanol with a mass fraction of 50-70%, and then perform reflux extraction to obtain extract 1; mix Nymphaeaceae, Sophora flavescens, Licorice root and Citrus aurantium to obtain mixture 2, mix mixture 2 with anhydrous ethanol and perform ultrasonic extraction to obtain extract 2; mix antler frost, Pulsatilla striata, Glycyrrhiza uralensis and Radix Bupleuri to obtain mixture 3, soak mixture 3 in water and then filter, collect water filtrate, add 70-80% methanol to the filter residue and perform ultrasonic extraction, collect alcohol filtrate after filtering, and mix the water filtrate and the alcohol filtrate to obtain extract 3; freeze musk and then crush it, mix the musk powder with ethanol with a mass fraction of 70-80%, and then perform microwave extraction to obtain extract 4; mix extract 1, extract 2, extract 3 and extract 4, and then reduce pressure and concentrate them into a paste to obtain a traditional Chinese medicine composition.

[0029] In the preparation method of the present invention, the mixture 1 is mixed with 50-70% ethanol by mass at a solid-liquid ratio of 1g:16-25mL, the temperature of the reflux extraction is 40-60°C, and the time of the reflux extraction is 40-70min. The solid-liquid ratio is preferably 1g:18-22mL, more preferably 1g:20mL; the temperature is preferably 45-55°C, more preferably 50°C; the time is preferably 50-60min, more preferably 55min. The mixture 1 is obtained by mixing Scutellaria barbata and Psoralea corylifolia and then crushing them through a 150-mesh sieve.

[0030] In the preparation method of the present invention, mixture 2 is mixed with anhydrous ethanol at a solid-liquid ratio of 1g:10-20mL, the temperature of the ultrasonic extraction is 20-35°C, the power of the ultrasonic extraction is 150-200W, and the time of the ultrasonic extraction is 20-40min. The solid-liquid ratio is preferably 1g:13-16mL, more preferably 1g:15mL; the temperature is preferably 25-30°C, more preferably 28°C; the power is preferably 160-180W, more preferably 170W; the time is preferably 25-35min, more preferably 30min. The mixture 2 is a mixture of beehive, Sophora flavescens, Licorice and Citrus aurantium, and then crushed through a 200-mesh sieve.

[0031] In the preparation method of the present invention, the mixture 3 is mixed with water at a solid-liquid ratio of 1g:5-8mL, and the soaking time is 1-2h; the filter residue is mixed with methanol with a mass fraction of 70-80% at a solid-liquid ratio of 1g:8-15mL, the temperature of the ultrasonic extraction is 30-45°C, the power of the ultrasonic extraction is 150-200W, and the time of the ultrasonic extraction is 20-40min. The mixture is preferably mixed with water at a solid-liquid ratio of 1g:6mL; the filter residue is preferably mixed with methanol at a solid-liquid ratio of 1g:10-12mL; the ultrasonic extraction temperature is preferably 35-40°C; the ultrasonic extraction power is preferably 170-180W; the ultrasonic extraction time is preferably 25-30min. The mixture 3 is a mixture of antler frost, whitehead, bitter liquorice and bupleurum, and then crushed through a 200-mesh sieve.

[0032] In the preparation method of the present invention, the musk is frozen at -80°C for 12 to 20 hours, preferably 16 to 18 hours; the musk powder is sieved through a 100 to 200 mesh sieve; the musk powder is mixed with 70 to 80% ethanol by mass at a solid-liquid ratio of 1 g: 5 to 10 mL, preferably 1 g: 6 to 8 mL; the power of the microwave extraction is 200 to 400 W, preferably 250 to 350 W; the microwave extraction time is 50 to 70 seconds. The microwave extraction of the present invention is preferably repeated 2 to 3 times, and the combined extract is extract 4.

[0033] In the present invention, the order of obtaining extract 1, extract 2, extract 3 and extract 4 is not particular, and the above four extracts are mixed and then concentrated under reduced pressure, and the temperature of the reduced pressure concentration is 50 to 65°C, and the pressure is -0.05 to -0.07MPa; preferably, the temperature is 55 to 60°C, and the preferred pressure is -0.06MPa. As an implementable method, the solution after the four extracts are mixed is concentrated under reduced pressure to an ointment with a relative density of 1.4 to 1.6 g / mL. The present invention can remove the organic solvent in the extract by reduced pressure concentration.

[0034] The present invention provides corresponding extraction methods according to different traditional Chinese medicines, promotes the dissolution of effective components, and after the traditional Chinese medicine extracts are mixed, the effective components extracted from the various medicines interact with each other, thereby improving the therapeutic effect of the traditional Chinese medicine composition.

[0035] The traditional Chinese medicine composition of the present invention is added with pharmaceutically acceptable adjuvants to prepare powders, pastes, decoctions, pills, capsules, tablets, granules and oral liquids.

[0036] The traditional Chinese medicine composition obtained in the present invention is dried and then crushed to obtain medicine powder, the drying temperature is 40-45° C., and the medicine powder is sieved through a 200-mesh sieve.

[0037] The Chinese medicine composition of the present invention can be prepared as water pills. As an practicable method, the preparation method of the water pills in the specific embodiment of the present invention comprises the following steps: putting part of the medicine powder into a coating machine, spraying purified water on the medicine powder, uniformly wetting the medicine powder with the help of mechanical rotation, forming fine particles, sprinkling the medicine powder so that the medicine powder adheres to the surface of the fine particles, spraying purified water again and repeating the above steps, screening with a 2.3mm aperture to obtain a pill mold for standby use; putting the pill mold into a coating machine, spraying purified water and medicine powder to make pellets, putting the pellets into a four-stage separator and sieving the pellets with 3.0mm, 3.5mm, 4.0mm and 4.4mm sieves to obtain pellets; putting the pellets into a coating machine, first wetting the pellets with purified water, rotating the pellets to make the surface of the pellets delicate, smooth and uniform in color, and taking them out for drying. The drying temperature is 45-60°C, and the pellets are dried to a moisture content of 6.0-8.5% to obtain dry pills. The dry pellets are poured into a four-stage separator and sieved with 3.0mm, 3.5mm, 4.0mm, and 4.4mm sieves. The sieved dry pellets are poured into the coating machine, 50-70kg per pot, and 0.2kg of purified water is added in portions, the pellets are turned and mixed in the coating machine, and the powder on the surface is ground off, until the surface of the pellets is round and bright, and the color is uniform. After cooling, water pills are obtained.

[0038] In the present invention, the external preparation is prepared by mixing the medicine powder with vaseline, and the medicine powder and vaseline are mixed in a mass ratio of 1:1 to 4.

[0039] The present invention also provides the use of the Chinese medicine composition obtained by the preparation method in preparing a drug for treating thyroid nodules. The drug for treating thyroid nodules in the present invention is an oral preparation or an external preparation, and the method of taking the drug includes taking only the oral preparation, or taking the oral preparation combined with applying the external preparation on the affected part.

[0040] The present invention also provides the use of the Chinese medicine composition obtained by the preparation method in preparing a drug for treating mastitis, wherein the mastitis is plasma cell mastitis. The drug for treating mastitis in the present invention is an internal preparation or an external preparation, and the method of taking the drug includes taking only the internal preparation, or taking the internal preparation combined with applying the external preparation on the affected part.

[0041] The coating machine used in the specific embodiment of the present invention is a stainless steel coating machine, model BQ-1000.

[0042] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0043] Example 1

[0044] A Chinese medicine composition, the raw materials of which are as follows: 1.62g of Nasturtium wilfordii, 1.46g of Sophora flavescens, 1.46g of Scutellaria barbata, 1.46g of Psoralea corylifolia, 1.46g of Pleurotus eryngii, 1.46g of Pleurotus eryngii, 1.46g of Pulsatilla scabra, 0.81g of Licorice root, 0.81g of Licorice root, 0.81g of Bupleurum root, 0.65g of Citrus aurantium, and 0.0194g of Musk.

[0045] The preparation method of the Chinese medicine composition is as follows:

[0046] Weigh each medicine according to the proportion;

[0047] Scutellaria barbata and Psoralea corylifolia were mixed and crushed through a 150-mesh sieve to obtain a mixture 1, the mixture 1 was mixed with 60% ethanol by mass at a solid-liquid ratio of 1 g:20 mL, and then refluxed for extraction at a reflux extraction temperature of 50° C. for an extraction time of 55 min to obtain an extract 1;

[0048] The mixture of honeysuckle, Sophora flavescens, Licorice and Citrus aurantium was mixed and crushed through a 200-mesh sieve to obtain a mixture 2. The mixture 2 was mixed with anhydrous ethanol at a solid-liquid ratio of 1 g:15 mL, and then subjected to ultrasonic extraction at an ultrasonic power of 170 W and an extraction time of 30 min to obtain an extract 2.

[0049] Deer antler frost, Pulsatilla scabra, Glycyrrhiza uralensis and Radix Bupleuri were mixed and crushed through a 200-mesh sieve to obtain a mixture 3, the mixture 3 was mixed with purified water at a solid-liquid ratio of 1 g: 6 mL, and the water extract filtrate was collected after soaking for 2 hours; the filter residue was mixed with 70% methanol at a solid-liquid ratio of 1 g: 10 mL, and ultrasonic extraction was performed at an ultrasonic power of 180 W and an extraction time of 30 min. After filtering, the alcohol extract filtrate was collected, and the water extract filtrate and the alcohol extract filtrate were mixed to obtain an extract 3;

[0050] Musk was frozen at -80°C for 18 hours and then crushed to pass through a 150-mesh sieve. Musk powder was mixed with 70% ethanol by mass at a solid-liquid ratio of 1 g:6 mL and then subjected to microwave extraction. The microwave power was 300 W and the extraction time was 60 s. The extraction was repeated 3 times, and the extracts from the 3 times were mixed to obtain extract 4.

[0051] After extract 1, extract 2, extract 3 and extract 4 are mixed, they are concentrated under reduced pressure at 55°C and -0.06MPa to form a paste with a relative density of 1.5g / mL. The paste is dried at 40°C and crushed through a 200-mesh sieve to obtain a traditional Chinese medicine composition.

[0052] Example 2

[0053] A Chinese medicine composition, the raw materials of which are as follows: 1.5g of Nymphaeaceae, 1.5g of Sophora flavescens, 1.6g of Scutellaria barbata, 1.6g of Psoralea corylifolia, 1.5g of Pleurotus eryngii, 1.5g of Pleurotus eryngii, 1.5g of Pulsatilla striata, 0.75g of Glycyrrhiza uralensis, 0.9g of Licorice root, 0.8g of Bupleurum chinense, 0.6g of Citrus aurantium and 0.016g of Musk.

[0054] The preparation method is the same as that of Example 1.

[0055] Example 3

[0056] A Chinese medicine composition, the raw material composition is as shown in Example 1.

[0057] The preparation method of the Chinese medicine composition is as follows:

[0058] Weigh each medicine according to the proportion;

[0059] Scutellaria barbata and Psoralea corylifolia were mixed and crushed through a 150-mesh sieve to obtain a mixture 1, the mixture 1 was mixed with 70% ethanol by mass at a solid-liquid ratio of 1 g:16 mL, and then refluxed for extraction at a reflux extraction temperature of 55° C. for an extraction time of 45 min to obtain an extract 1;

[0060] The mixture of honeysuckle, Sophora flavescens, Licorice and Citrus aurantium was mixed and crushed through a 200-mesh sieve to obtain a mixture 2. The mixture 2 was mixed with anhydrous ethanol at a solid-liquid ratio of 1 g:10 mL, and then subjected to ultrasonic extraction at an ultrasonic power of 200 W and an extraction time of 25 min to obtain an extract 2.

[0061] Deer antler frost, Pulsatilla scabra, Glycyrrhiza uralensis and Radix Bupleuri were mixed and crushed through a 200-mesh sieve to obtain a mixture 3, the mixture 3 was mixed with purified water at a solid-liquid ratio of 1 g: 8 mL, and the mixture was soaked for 2 hours and then the water filtrate was collected; the filter residue was mixed with 80% methanol at a solid-liquid ratio of 1 g: 10 mL, and then ultrasonically extracted at an ultrasonic power of 150 W and an extraction time of 40 min, and the alcohol filtrate was collected after filtration, and the water filtrate and the alcohol filtrate were mixed to obtain an extract 3;

[0062] Musk was frozen at -80°C for 18 hours and then crushed to pass through a 150-mesh sieve. Musk powder was mixed with 75% ethanol by mass at a solid-liquid ratio of 1 g:10 mL and then subjected to microwave extraction. The microwave power was 200 W and the extraction time was 70 seconds. The extraction was repeated twice, and the two extracts were mixed to obtain extract 4.

[0063] After extract 1, extract 2, extract 3 and extract 4 are mixed, they are concentrated under reduced pressure at 55°C and -0.06MPa to form a paste with a relative density of 1.5g / mL. The paste is dried at 40°C and crushed through a 200-mesh sieve to obtain a traditional Chinese medicine composition.

[0064] Comparative Example 1

[0065] A Chinese medicine composition, which is different from Example 1 in that: the honey bee nest, Sophora flavescens, Scutellaria barbata, Tripterygium wilfordii, Psoralea corylifolia, Pulsatilla chinensis, Glycyrrhiza uralensis, Radix Glycyrrhizae, Radix Bupleuri and Pericarpium Cibotii are mixed and crushed into 100 mesh fine powder, and then sealed in a bag and sterilized in an electric constant temperature oven at 100°C for 1 hour. Musk is mixed with 75% ethanol by mass fraction at a material-liquid ratio of 1g:5mL and ground evenly, and then mixed evenly with the sterilized fine powder by an equal amount of rubbing method, and honey is refined and rolled, and the refining temperature of the honey is 60°C to make large honey pills.

[0066] Comparative Example 2

[0067] A Chinese medicine composition, which differs from Example 1 in that: after mixing Nymphaeaceae, Sophora flavescens, Scutellaria barbata, Psoralea corylifolia, Psoralea corylifolia, Pulsatilla scabra, Glycyrrhiza uralensis, Licorice root, Radix bupleuri, Pericarpium Cibotii and Musk, the mixture is crushed and passed through a 150-mesh sieve to obtain a mixture, the mixture is mixed with 60% ethanol by mass at a solid-liquid ratio of 1g:20mL, and then refluxed for extraction, the reflux extraction temperature is 50°C, the extraction time is 55min, and an extract is obtained, and the extract is concentrated under reduced pressure.

[0068] Comparative Example 3

[0069] A Chinese medicine composition, which differs from Example 1 in that: the mixture 3 is mixed with 70% methanol by mass at a solid-liquid ratio of 1g:10mL, and then ultrasonically extracted, the ultrasonic power is 180W, the extraction time is 30min, and the alcohol extraction filtrate is collected after filtration as extract 3.

[0070] Comparative Example 4

[0071] A Chinese medicine composition, which is different from Example 1 in that: the preparation method of the Chinese medicine composition is as follows:

[0072] Weigh each medicine according to the proportion;

[0073] Mix the honeycomb, Sophora flavescens, Scutellaria barbata, Tripterygium wilfordii, Psoralea corylifolia, Pulsatilla chinensis, Glycyrrhiza uralensis, Radix Glycyrrhizae, Radix Bupleuri and Pericarpium Cibotii and grind them through a 200-mesh sieve to obtain a mixture, mix the mixture with purified water at a solid-liquid ratio of 1 g:8 mL, soak for 2 h and collect the water filtrate; mix the filter residue with 80% methanol at a solid-liquid ratio of 1 g:10 mL and perform ultrasonic extraction at an ultrasonic power of 150 W for an extraction time of 40 min, collect the alcohol filtrate after filtering, and mix the water filtrate with the alcohol filtrate to obtain extract 1;

[0074] Musk was frozen at -80°C for 18 hours and then crushed to pass through a 150-mesh sieve. Musk powder was mixed with 70% ethanol by mass at a solid-liquid ratio of 1 g:6 mL and then subjected to microwave extraction. The microwave power was 300 W and the extraction time was 60 s. The extraction was repeated 3 times, and the extracts from the 3 times were mixed to obtain extract 4.

[0075] After the extract 1 and the extract 4 are mixed, they are concentrated under reduced pressure at 55°C and -0.06MPa to a paste with a relative density of 1.5g / mL. The paste is dried at 40°C and crushed through a 200-mesh sieve to obtain a traditional Chinese medicine composition.

[0076] Example 4

[0077] Effect of Chinese herbal medicine combination on thyroid nodules.

[0078] The Chinese medicine compositions in Examples 1 to 3 and Comparative Examples 2 to 4 were prepared into water pills.

[0079] The preparation method of water pills is as follows: put part of the powder into a coating machine, spray purified water on the powder, use mechanical rotation to evenly wet the powder and form fine particles, sprinkle the powder to make it adhere to the surface of the fine particles, spray purified water again and repeat the above steps, screen with a 2.3mm aperture to obtain a pill mold for use; put the pill mold into the coating machine, spray purified water and powder to make pellets, put the pellets into a four-stage separator and sieve them with 3.0mm, 3.5mm, 4.0mm and 4.4mm sieves to obtain pellets; put the pellets into the coating machine, first wet the pellets with purified water, rotate them to make the surface of the pellets delicate, smooth and uniform in color, and take them out for drying. The drying temperature is 50°C, and the moisture content of the pellets is 6.0-8.5% to obtain dry pills. The dry pills are poured into a four-stage separator and sieved with 3.0mm, 3.5mm, 4.0mm and 4.4mm sieves. Pour the screened dry pills into the coating machine, 60kg per pot, add 0.2kg of purified water in batches, turn the pills in the coating machine to mix evenly, and grind off the powder on the surface, until the surface of the pills is round and shiny with uniform color. After cooling, you will get water pills.

[0080] Patients with benign thyroid nodules were selected as the observation subjects, and patients with malignant tumors, pregnancy or lactation were excluded. Patients with benign thyroid nodules were randomly divided into 7 groups, 40 patients in each group, and there was no statistical difference in the basic data of patients between the groups (P>0.05).

[0081] Group 1: taking the water pills prepared from the Chinese medicine composition of Example 1;

[0082] Group 2: taking the water pills prepared from the Chinese medicine composition of Example 2;

[0083] Group 3: taking the water pills prepared from the Chinese medicine composition of Example 3;

[0084] Group 4: taking the honey pills prepared in Comparative Example 1;

[0085] Group 5: taking the water pills prepared from the Chinese medicine composition of Comparative Example 2;

[0086] Group 6: taking the water pills prepared from the Chinese medicine composition of Comparative Example 3;

[0087] Group 7: taking the water pills prepared from the Chinese medicine composition of Comparative Example 4.

[0088] Efficacy judgment criteria: Cured: the volume of thyroid nodules after treatment is reduced by ≥80% compared with before treatment; Markedly effective: the volume of thyroid nodules after treatment is reduced by 60-79% compared with before treatment; Effective: the volume of thyroid nodules after treatment is reduced by 30-50% compared with before treatment; Ineffective: the volume of thyroid nodules after treatment is reduced by <30% compared with before treatment.

[0089] Cure rate = number of cured cases / total number of cases*100%; total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases*100%

[0090] Dosage: 2 times a day, 6g each time, 30 days as a course of treatment. The efficacy will be calculated after 2 courses of treatment.

[0091] The results are shown in Table 1.

[0092] Table 1 The efficacy of Chinese medicine composition on thyroid nodules

[0093] Group Total number of cases (cases) Recovered (Example) Significantly effective (example) Valid (Example) Invalid (Example) Recovery rate (%) Total effective rate (%) Group 1 40 23 9 6 2 57.5 95 Group 2 40 20 6 10 4 50 90 Group 3 40 21 11 5 3 52.5 92.5 Group 4 40 9 5 14 12 22.5 70 Group 5 40 13 6 14 7 32.5 82.5 Group 6 40 15 8 11 6 37.5 85 Group 7 40 7 16 6 11 17.5 72.5

[0094] No adverse reactions occurred in patients after taking the Chinese medicine compositions of Examples 1 to 3 and Comparative Examples 1 to 4. According to the results in Table 1, the effect of the Chinese medicine composition obtained by the preparation method provided by the present invention on treating thyroid nodules is significantly improved.

[0095] Example 5

[0096] Effect of Chinese medicine composition on mastitis.

[0097] The Chinese medicine compositions in Examples 1 to 3 and Comparative Examples 2 to 4 were prepared into water pills. The preparation method of the water pills was the same as that in Example 4.

[0098] The Chinese medicine compositions in Examples 1 to 3 and Comparative Examples 2 to 4 were prepared as external preparations: the drug powder was mixed with vaseline in a mass ratio of 1:1 to obtain a paste.

[0099] Patients with pathological diagnosis of plasma cell mastitis were selected as the observation subjects, and patients with breast ulceration or other breast diseases were excluded. Patients with plasma cell mastitis were randomly divided into 7 groups, 45 patients in each group, and there was no statistical difference in the basic data of patients between the groups (P>0.05).

[0100] Group 1: taking the water pills prepared from the Chinese medicine composition of Example 1 and applying the ointment prepared from the Chinese medicine composition of Example 1 to the affected area;

[0101] Group 2: taking the water pills prepared from the Chinese medicine composition of Example 2 and applying the ointment prepared from the Chinese medicine composition of Example 2 to the affected area;

[0102] Group 3: taking the water pills prepared from the Chinese medicine composition of Example 3 and applying the ointment prepared from the Chinese medicine composition of Example 3 to the affected area;

[0103] Group 4: taking the honey pills prepared in Comparative Example 1;

[0104] Group 5: taking the water pills prepared from the Chinese medicine composition of Comparative Example 2, and applying the ointment prepared from the Chinese medicine composition of Comparative Example 2 to the affected area;

[0105] Group 6: taking the water pills prepared from the Chinese medicine composition of Comparative Example 3, and applying the ointment prepared from the Chinese medicine composition of Comparative Example 3 to the affected area;

[0106] Group 7: taking the water pills prepared from the Chinese medicine composition of Comparative Example 4, and applying the ointment prepared from the Chinese medicine composition of Comparative Example 4 on the affected area.

[0107] Efficacy judgment criteria: Cured: no breast abscess, no breast discharge, and no obvious pain after treatment; Effective: after treatment, breast abscess is reduced, breast discharge is reduced, and breast pain is relieved; Ineffective: after treatment, breast abscess does not shrink or increase, breast discharge is reduced, and breast pain is not relieved.

[0108] Cure rate = number of cured cases / total number of cases*100%; total effective rate = (number of cured cases + number of effective cases) / total number of cases*100%

[0109] Directions:

[0110] Group 1-3 and Group 5-7: Take water pills twice a day, 6g each time, and apply ointment twice a day, 6g each time. 2 months is a course of treatment;

[0111] Group 4: Take honey pills twice a day, 9g each time, 2 months as a course of treatment.

[0112] The therapeutic efficacy was statistically analyzed after 2 courses of treatment.

[0113] The results are shown in Table 2.

[0114] Table 2 The efficacy of Chinese medicine combination on mastitis

[0115] Group Total number of cases (cases) Recovered (Example) Valid (Example) Invalid (Example) Recovery rate (%) Total effective rate (%) Group 1 45 28 16 1 62.2 97.8 Group 2 45 24 18 3 53.3 93.3 Group 3 45 26 16 3 57.8 93.3 Group 4 45 16 19 10 35.6 77.8 Group 5 45 18 18 9 40 80 Group 6 45 20 17 8 44.4 82.2 Group 7 45 13 18 14 28.9 68.9

[0116] No adverse reactions occurred in patients after using the Chinese medicine compositions of Examples 1 to 3 and Comparative Examples 1 to 4. According to the results in Table 2, the Chinese medicine composition prepared by the present invention can effectively treat plasma cell mastitis with significant efficacy.

[0117] Typical cases of thyroid nodules

[0118] Case one: Zeng, male, 28 years old, first visit on May 12, 2009, because of sudden swelling of thyroid gland, hardening, dysphagia and pain, and radiation to the ear and temporal part of the diseased side, hospitalized. Patient often had throat discomfort 1 year ago, irritability and insomnia, but the pain was lighter, and the color Doppler ultrasound result showed: right thyroid gland probed and multiple thyroid nodules of 1.6cm-2cm of different sizes, with clear borders. Once went to provincial-level multiple hospitals for diagnosis and treatment, symptoms such as throat discomfort during medication were significantly alleviated, and easy recurrence was observed after drug withdrawal, and color Doppler ultrasound was checked once every 3 months, and nodules were not reduced, and gradually increased the weight of in the last half month. Pathological prompt: benign thyroid nodules. Belong to the scope of treatment of the present invention, after 2 courses of treatment of the Chinese medicine composition prepared by the embodiment of the present invention 2, thyroid swelling subsided, and symptoms such as throat discomfort were alleviated, and 2 courses of treatment were continued during the follow-up visit on August 23, 2009, and the patient's thyroid swelling and throat pain disappeared completely, and there was no recurrence after a follow-up visit one year later.

[0119] Case 2: Xi, female, 32 years old, first diagnosed on March 5, 2010. Three years ago, she found that her neck was thickened, but she did not receive any treatment. In the past year, her neck has become thicker, and she has difficulty breathing, hoarseness and difficulty swallowing. She touched the front of her neck and felt multiple nodules, about the size of egg yolk. She had been to a local hospital for treatment, but the diagnosis was unknown. She had taken "iodine sugar pills" for treatment, but the swelling in the front of her neck did not significantly reduce. She came to our hospital for treatment on March 5, 2011. Palpation of the front of the neck showed that 2 masses of about 5.0cm×4.0cm×4.0cm and 3.0cm×3.0cm×2.0cm could be touched on the left side: a mass of about 1.0cm×1.0cm×1.0cm could be touched on the right side, and the mass could move up and down with swallowing, with clear boundaries, moderately hard texture, good activity, and some nodules had a sense of fluctuation and tenderness. Ultrasound examination of the thyroid gland showed that the bilateral thyroid glands were significantly enlarged, with multiple nodules, a maximum diameter of 4.0cm, a minimum diameter of 1.0cm, and liquid dark areas in some nodules. Pathological prompt: thyroid nodules. After one course of treatment of the Chinese medicine composition prepared by the embodiment of the present invention 3, the goiter of the neck was better than before, and the nodules were reduced. After 2 months of consolidation medication, the enlargement and nodules disappeared, and the pain disappeared. Follow-up for 1 year without recurrence.

[0120] Case 3: Zhou, female, 46 years old, first diagnosed on December 11, 2011, neck mass has been for many years, recently the volume gradually increased, and dysphagia, hoarseness and other compression symptoms were admitted to the hospital. Physical examination found that the thyroid gland was significantly enlarged, and the performance touched most nodules, and there was no significant change in thyroid function. Thyroidectomy was performed, and the specimen was sent for pathological examination: the surface and section of the enlarged thyroid gland had nodules of different sizes and numbers, with clear boundaries and no capsule. Under the microscope, the thyroid follicles were of different sizes, with highly expanded follicles full of colloid, small follicles without colloid, and interstitial fibrosis. It was diagnosed as benign thyroid nodules. After 1 course of treatment with the Chinese medicine composition prepared by Example 1 of the present invention, the neck mass was reduced to the size of soybeans, and the symptoms such as dysphagia and hoarseness were alleviated. After continuing to use the medicine for 2 months, the mass disappeared completely, and there was no recurrence in 1 year of follow-up.

[0121] Case 4: Xu, male, 52 years old, first diagnosed on March 23, 2012. The patient had no obvious cause 1 year ago, and the right thyroid gland was enlarged, accompanied by symptoms such as nausea, vomiting, dizziness, headache, thirst, etc. When he examined himself, he found that multiple nodules could be touched in the neck and the laryngeal depression moved downward. The routine thyroid function test and external B-ultrasound in the local hospital were normal. Therefore, he came to the Affiliated Hospital of Inner Mongolia Medical University for treatment. During the diagnosis, the right thyroid gland of the head and neck was large and there was no pain when pressing. Ultrasound examination: It showed that there was a low echo nodule in the right thyroid gland, about 2.0cm×3.0cm in size, irregular in shape, uneven internal echo, and blood flow signals around the nodule, which was diagnosed as benign thyroid nodule. The doctor was directly asked to prescribe the Chinese medicine composition prepared by Example 1 of the present invention for him. After using it for 1 month, the self-reported symptoms were significantly alleviated, and the swelling was significantly reduced after examination. After using it for another course of treatment, the patient's symptoms disappeared without obvious discomfort. Follow-up for half a year without recurrence.

[0122] Case 5: Fu, female, 36 years old, was admitted to the hospital on March 6, 2013 due to neck swelling and discomfort, accompanied by mild dysphagia. The patient reported that the symptoms had lasted for about 3 months and had a tendency to worsen recently. There was no history of thyroid disease in the past, and there was no genetic history of related diseases in the family. Physical examination revealed that a lump of about 2cm×3cm in size could be touched on the right side of the patient's neck. The texture was hard, the surface was smooth, the boundaries were clear, and it moved up and down with swallowing. Ultrasound examination showed that the nodule had a regular morphology, clear boundaries, and no obvious malignant features. Fine needle puncture biopsy results confirmed that it was a benign thyroid nodule. After one course of treatment with the Chinese medicine composition prepared in Example 2 of the present invention, the swelling symptoms were alleviated. Continue to use one course of treatment, and follow up for half a year and the patient had no obvious discomfort.

[0123] Case 6: Zhang, female, 11 years old, first diagnosed on May 4, 2013. The patient found a lump in the front of the neck 2 months ago, which gradually increased in size without pain, redness, swelling or other discomfort. At the same time, hoarseness occurred, but there were no obvious symptoms such as dysphagia and dyspnea. The patient had visited a local hospital, and B-ultrasound examination showed that the thyroid was enlarged, but no further examination and treatment were performed. Recently, she came to our hospital again because of the increase in the lump in the front of the neck and the aggravation of hoarseness. Physical examination: A mass of about 4cm×5cm can be seen in the front of the neck, with a hard texture and a smooth surface; the thyroid gland can be touched, with a hard texture and no tenderness; the carotid artery pulsation is normal; the cervical lymph nodes are not touched and enlarged. Laboratory examination: Thyroid ultrasound examination showed diffuse enlargement of both lobes, and a low echo area was seen in the left lobe, and the nodule size was about 2.0cm×1.5cm. Diagnosis: Thyroid nodules with diffuse hyperplasia. After two courses of treatment with the Chinese medicine composition prepared in Example 1 of the present invention, the swelling disappeared, the symptoms disappeared, and the patient had no obvious discomfort during a six-month follow-up.

[0124] Case 7: Ye, male, 60 years old, first diagnosed on June 12, 2014. During a physical examination one year ago, thyroid nodules were found in the patient. The largest one was about 22×12mm. There was no tenderness, distending pain, hoarseness, dyspnea and other discomforts. He did not pay attention to it and did not receive special treatment. A thyroid ultrasound examination one month ago showed multiple thyroid nodules, which were larger than before. He had a history of hypertension and coronary heart disease, and occasionally had dizziness, chest tightness, and palpitations. Physical examination in hospital: bilateral thyroid glands were enlarged to grade I, and each nodule was about 2×2cm, hard, non-tender, and could move up and down with swallowing. Thyroid color Doppler ultrasound: thyroid section morphology is abnormal, the two sides of the lobes are enlarged asymmetrically, the outline is regular, the surface is smooth, the internal echo is uneven, and multiple nodules of different sizes can be seen therein, with clear boundaries, the largest nodule of the left lobe is about 25×14mm, and the largest nodule of the right lobe is about 22×12mm. The echoes in each nodule are different, and the strengths are different. Most of them are liquid-solid mixed echoes, and no capsule echoes are seen. Diagnosed as asymmetric enlargement of the two sides of the thyroid lobe, multiple nodules inside. After treating 3 months with the Chinese medicine composition prepared by the embodiment of the present invention 2, the patient has consciously shrunk his thyroid enlargement significantly, and the nodules of the patient who followed up a case by regular visits to 1 year disappeared without obvious discomfort.

[0125] Case 8: Zhi, female, 29 years old. The patient began to experience clinical symptoms of tremor, anxiety, insomnia and menorrhagia 2 months ago, and came to the Affiliated Hospital of Inner Mongolia Medical University for the first visit on August 14, 2015. The endocrinologist examined the patient and found that the patient had no symptoms of thyroid toxicity. Thyroid function results showed that TSH was within the normal reference range. Thyroid ultrasound results showed that the maximum diameter of the nodule in the left lower lobe was 2.4 cm. Thyroid imaging results showed that there was a hyperfunctioning hot nodule in the left thyroid gland. The patient denied local compressive symptoms of thyroid nodules and a family history of thyroid malignant tumors. Thyroid examination: There was no obvious enlargement of the thyroid gland, and a nodule could be touched in the left lower lobe, which was about 1.5 cm in size, solid, and tough in texture, and could move with swallowing. Imaging examination: Thyroid ultrasound results showed that the thyroid gland was slightly enlarged, and the nodule in the left lower lobe of the thyroid gland was 2.6×2.7×2.6 cm in size, mainly solid, with equal echoes, and abundant internal blood flow. Diagnosed as thyroid nodule. After being treated with the Chinese medicine composition prepared in Example 1 of the present invention for 2 months, the patient's spirit improved, all subjective symptoms were eliminated, and there was no recurrence during the 1-year follow-up.

[0126] Case 9: Chen, female, 48 years old. The patient accidentally discovered a lump in the anterior neck area 1 year ago, about the size of a thumb, and no diagnosis and treatment were performed. The neck mass gradually increased during the course of the disease, and was admitted to the hospital on May 24, 2016. Physical examination: soft neck, no resistance, no distension of the jugular vein, centered trachea, bulging skin in the anterior neck area, multiple masses can be touched in the bilateral thyroid glands, the largest of which is about 1.5cm×1.0cm, oval in shape, with unclear boundaries, medium in texture, no tenderness, moving up and down with swallowing, no vascular murmurs, and no enlargement of surrounding lymph nodes. Thyroid color Doppler ultrasound: solid space-occupying lesions in the left and right lobes of the thyroid gland, considering nodular goiter. The mass was reduced after 2 courses of treatment with the Chinese medicine composition prepared in Example 3 of the present invention. After 1 month of consolidation medication, there was no obvious discomfort.

[0127] Typical case of plasma cell mastitis

[0128] Case 1: Fan, female, 44 years old. The patient felt local breast pain and discomfort 1 month ago and was admitted to the Affiliated Hospital of Inner Mongolia Medical University on June 29, 2015. Physical examination: A lump can be touched under the areola of the breast, extending to a certain quadrant, with a nodular surface, unclear boundaries, and no adhesion to the chest wall. Nipple edema, orange skin, no fever and other systemic symptoms. The nipple has a powder sample, with an odor accompanied by nipple overflow, which is blood or watery, accompanied by lateral axillary lymphadenopathy. Ultrasound shows high and low echo areas, irregular shapes, unclear boundaries, and no capsule. Molybdenum target X-rays show a mass of flake-like masses with blurred edges. The puncture pathology results show microscopic plasma cell infiltration, and B lymphocytes and T lymphocytes can be seen in some parts, which are diagnosed as plasma cell mastitis. The breast pain symptoms are improved after 2 courses of the Chinese medicine composition prepared using Example 1 of the present invention, and the skin of the lump and prolactin levels return to normal. After another 2 courses of treatment, the symptoms completely disappeared and there was no recurrence during the 1-year follow-up.

[0129] Case 2: Yuan, female, 58 years old. Half a year ago, the patient found a right breast mass without obvious cause, local distension and pain, no chills and fever. She had been to a local hospital for right breast tumor puncture. The puncture pathology showed: fibrous collagen tissue hyperplasia with infiltration of lymphocytes, plasma cells and neutrophils in the interstitium, which met the indications of plasma cell mastitis. After symptomatic treatment such as cefuroxime anti-infection, lysine aspirin analgesia and fluid infusion, the effect was not good. For further treatment, she came to our outpatient clinic on July 7, 2016. Physical examination: a mass of about 4.0cm×3.0cm can be palpated above the right breast, with unclear boundaries, tough and hard texture, mild tenderness, acceptable local skin temperature, normal skin color, and enlarged lymph nodes can be palpated in the right axilla. No obvious abnormal signs were found in the left breast. Breast ultrasound: about 3.8cm×1.8cm low-echo mass is seen above the right breast, the internal echo is not uniform, the shape is not regular, the boundary is not clear, CDFI: no obvious blood flow signal is seen around and inside. Multiple expansion of peripheral ducts, nodular low echoes are seen inside. Tip: right breast low-echo mass (BI-RADS classification: Grade 4), right mastitis is possible, bilateral breast glandular hyperplasia. Diagnosis: right breast plasma cell mastitis. After 2 courses of Chinese medicine composition prepared by Example 1 of the present invention, the pain and distension of the right breast mass are significantly improved, and the size of the mass changes significantly. Continue to take 2 courses of treatment during the follow-up visit, the right breast mass disappears, and there is no other discomfort. Follow up a case for one year without recurrence.

[0130] Case 3: Zang, female, 40 years old, first visit on March 19, 2018. Chief complaint: 12 days after the incision and drainage of the left breast abscess, it recurred and worsened for 1 week. Current medical history: The patient still feels redness, swelling, heat and pain in the left breast, and the pain is mainly distending pain. There is yellow secretion flowing out from the incision and drainage. The tongue is red, the tongue coating is thick and yellow, and the pulse is rapid. Past history: A history of breast hyperplasia and polycystic ovary syndrome for many years. Physical examination: The patient is conscious, mentally OK, fat, well-developed, normal skin color, a few acne on the face, more body hair, and black acanthosis. Breast examination: There is a lump in the upper outer quadrant of the left breast, which is hard and red and swollen. There is an incision on the upper and lower left breasts, and yellow secretions flow out; there is a lump on the right breast, which is medium in quality, and there is no obvious redness, swelling, heat and pain. There are no enlarged lymph nodes under the two armpits. Auxiliary examination of breast and bilateral axillary lymph nodes by color Doppler ultrasound showed: bilateral breast hyperplasia, low echo nodules in the left breast, low-anechoic area in the left breast, and no obvious enlarged lymph nodes in the bilateral axillary lymph nodes. Routine blood test on March 19: elevated leukocytes. Diagnosis: plasma cell mastitis. After one course of treatment with the Chinese medicine composition prepared in Example 2 of the present invention, breast examination showed that there was a lump in the upper quadrant of the left breast, which was slightly softer than before, and the redness and swelling were reduced. There was an incision on the upper and lower left breast, and the secretion at the incision was significantly reduced compared with before. After two courses of consolidation, the patient reported that the incision on the left breast had closed, no secretions were seen, the redness, swelling, heat and pain in the breast subsided, and no ulcers or fistulas appeared again, and the disease was cured.

[0131] Case 4: Wan, female, 28 years old, first diagnosed on August 31, 2019. Chief complaint: Breast pain accompanied by discharge for more than one month. Current medical history: The patient had stinging after touching both breasts without obvious cause one month ago, accompanied by redness and swelling of the skin around the breasts, increased skin temperature, and a small amount of red discharge from the nipples, without fever or other discomfort. She went to a local clinic for a breast ultrasound examination, which showed: lobular hyperplasia of both breasts; BI-RADS level 2 cystic nodules of both breasts; local duct dilatation of both breasts (about 0.47cm at the wider part of the right breast and about 0.36cm at the wider part of the left breast). Plasma cell mastitis was diagnosed and surgical treatment was recommended, but the patient refused. Western medicine anti-infection treatment was temporarily given for one week. After taking the medicine, the patient felt that the pain in both breasts had not improved significantly, and there was still discharge after squeezing the breasts. A second visit was made at the suggestion of family members. At present: both breasts still have distending pain, a 1cm-sized lump can be touched in the upper quadrant of the right breast, with obvious tenderness, high local skin temperature, and a sense of fluctuation when pressed. A little red bloody discharge is seen after squeezing the breasts, which is clear in quality, with a good appetite, poor sleep at night, dry stool, and no difference in urine. The tongue is dark red, with thick yellow fur, and a stringy pulse. Diagnosis: plasma cell mastitis. After one course of treatment with the Chinese medicine composition prepared by Example 3 of the present invention, the distending pain of both breasts is significantly improved compared with before, the lump of the right breast has obviously subsided, and the tenderness is not obvious. After another 2 months of treatment, both breasts have no obvious tenderness, and a small amount of clear water-like liquid can be seen to ooze out after the nipple is squeezed occasionally, and there is no local skin temperature increase. After continuing to consolidate medication for 1 month, follow-up by phone, the patient reported that there was no swelling and pain in both breasts, no discharge from the nipple, and no discomfort.

[0132] Case 5: Zhang, female, 32 years old, first diagnosed on November 24, 2021. She reported that she had a left breast lump without obvious cause 3 months ago, with occasional pain, which worsened when pressed. She did not receive special treatment. In order to prevent the condition from worsening and seek systematic treatment, she came to our outpatient clinic for treatment. Ultrasound showed: bilateral breast hyperplasia and low echo area in the left breast. Past history of menstrual cycle, color, blood volume, texture, etc. were basically normal. She denied a history of drug and food allergies, had normal bowel movements, often ate spicy and irritating foods, and had acceptable sleep quality. Physical examination: A lump about the size of a ping-pong ball can be touched in the left breast, which is slightly red, slightly warm, tough, with no damage on the skin surface, no sense of fluctuation, obvious tenderness, and aggravated when pressed. The tongue is red with a thin white coating and a stringy pulse. Diagnosed as left breast plasma cell mastitis (mass stage); bilateral breast hyperplasia. The symptoms belong to the treatment scope of the present invention. After one course of treatment with the Chinese medicine composition prepared in Example 1 of the present invention, the breast lump has slightly shrunk and the skin temperature has decreased. The patient continued to take the medicine for two courses of treatment during the follow-up visit. The patient had basically no lump or pain in the breast, and there was no recurrence after a half-year follow-up.

[0133] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A method for preparing a Chinese medicine composition, characterized in that: The Chinese medicine composition comprises, by weight: 150-180 parts of nectarine nest, 130-160 parts of sophora flavescens, 130-160 parts of barbata scabra, 130-160 parts of tribulus truncatum, 130-160 parts of antler frost, 130-160 parts of pulsatilla, 70-90 parts of bitter liquorice, 70-90 parts of liquorice, 70-90 parts of bupleurum, 50-80 parts of green peel, and 1-3 parts of musk; The preparation method of the Chinese medicine composition comprises the following steps: Weigh each medicine according to the proportion; Mixing Scutellaria barbata and Psoralea corylifolia to obtain a mixture 1, mixing the mixture 1 with 50-70% by mass ethanol and performing reflux extraction to obtain an extract 1; Mixing the honeycomb, Sophora flavescens, Licorice and Citrus aurantium to obtain a mixture 2, mixing the mixture 2 with anhydrous ethanol and performing ultrasonic extraction to obtain an extract 2; Mix antler powder, pulsatilla, bitter liquorice and radix bupleuri to obtain mixture 3, soak mixture 3 in water and filter it, collect the water filtrate, add 70-80% methanol by mass to the filter residue and perform ultrasonic extraction, collect the alcohol filtrate after filtering, and mix the water filtrate and the alcohol filtrate to obtain extract 3; The musk is frozen and then crushed, and the musk powder is mixed with 70-80% ethanol by mass and then subjected to microwave extraction to obtain extract 4; The extract 1, the extract 2, the extract 3 and the extract 4 are mixed and concentrated under reduced pressure to form a paste to obtain a Chinese medicine composition.

2. The preparation method according to claim 1, characterized in that: The mixture 1 is mixed with 50-70% ethanol by mass at a solid-liquid ratio of 1 g:16-25 mL. The temperature of the reflux extraction is 40-60° C. and the time of the reflux extraction is 40-70 min.

3. The preparation method according to claim 1, characterized in that: The mixture 2 is mixed with anhydrous ethanol at a solid-liquid ratio of 1 g:10-20 mL. The temperature of the ultrasonic extraction is 20-35° C., the power of the ultrasonic extraction is 150-200 W, and the time of the ultrasonic extraction is 20-40 min.

4. The preparation method according to claim 1, characterized in that: The mixture 3 is mixed with water at a solid-liquid ratio of 1 g: 5-8 mL, and the soaking time is 1-2 h; the filter residue is mixed with methanol with a mass fraction of 70-80% at a solid-liquid ratio of 1 g: 8-15 mL, the temperature of the ultrasonic extraction is 30-45° C., the power of the ultrasonic extraction is 150-200 W, and the time of the ultrasonic extraction is 20-40 min.

5. The preparation method according to claim 1, characterized in that: The musk is frozen at -80°C for 12 to 20 hours, musk powder is mixed with 70 to 80% ethanol by mass at a solid-liquid ratio of 1 g:5 to 10 mL, the microwave extraction power is 200 to 400 W, and the microwave extraction time is 50 to 70 seconds.

6. The preparation method according to claim 1, characterized in that: The temperature of the reduced pressure concentration is 50 to 65° C., and the pressure is -0.05 to -0.07 MPa.

7. The preparation method according to claim 1, characterized in that: The paste is dried and crushed to obtain medicine powder, and the medicine powder is prepared into water pills.

8. The preparation method according to claim 7, characterized in that: The medicine powder is mixed with vaseline to prepare an external preparation.

9. Use of the traditional Chinese medicine composition obtained by the preparation method according to claims 1 to 8 in preparing medicine for treating thyroid nodules.

10. Use of the Chinese medicine composition obtained by the preparation method according to claims 1 to 8 in preparing a drug for treating mastitis, characterized in that: The mastitis is plasma cell mastitis.