CN112791147A

CN112791147A - Traditional Chinese medicine for treating nodules of breast and preparation method thereof

Info

Publication number: CN112791147A
Application number: CN202110147212.2A
Authority: CN
Inventors: 张文博; 唐佳艳; 王海鹏
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-02-03
Filing date: 2021-02-03
Publication date: 2021-05-14

Abstract

The invention relates to a traditional Chinese medicine for treating nodules of breast and a preparation method thereof, wherein the traditional Chinese medicine is prepared from the following raw material medicines in parts by weight: 90-110 parts of radix linderae, 90-110 parts of caulis spatholobi, 70-90 parts of ginseng, 70-90 parts of cassia twig, 50-70 parts of white paeony root, 50-70 parts of rhizoma cyperi, 50-70 parts of angelica sinensis, 50-70 parts of rheum officinale, 50-70 parts of earthworm, 50-70 parts of poria cocos, 50-70 parts of thunberg fritillary bulb, 50-70 parts of pseudo-ginseng, 40-60 parts of spina gleditsiae and 40-60 parts of trichosanthes root. The traditional Chinese medicine can be clinically used for treating symptoms of lump and pain in breast, small menstrual flow, intolerance of cold, chest and hypochondrium distending pain, mental fatigue and hypodynamia and the like, and is particularly suitable for breast nodules with symptoms of Chong and conception vessel disorder, liver depression and qi stagnation accompanied with yang deficiency.

Description

Traditional Chinese medicine for treating nodules of breast and preparation method thereof

Technical Field

The invention relates to a traditional Chinese medicine for treating nodules of breast and a preparation method thereof, belonging to the field of traditional Chinese medicines.

Background

Mammary nodules (mammary hyperplasia in Western medicine for short) are a common proliferative mammary disease, which is frequently seen in middle-aged and young women, and the incidence rate of the hyperplasia accounts for the front row of all mammary diseases. The essence of the disease is the degenerative changes in the structure of ducts and milk lobules in the mammary tissue and the progressive growth of connective tissue. According to the results of epidemiological investigation, as the social status of women rises and the responsibility of participating in social affairs becomes heavier, the work and life pressure of the women increases, and the incidence rate of the women reaches 70-80% in some areas. And the incidence rate in most urban areas is higher than that in rural areas, the incidence of the disease presents the characteristic of youthful appearance and tends to rise year by year. The patients are most common to women of 30-50 years old and mainly have symptoms of breast pain, breast lumps and the like in clinic. Modern studies have shown that when estrogen or progestin imbalance, which causes a decrease in luteinizing hormone, is highly correlated with the secretion of hormones in women, the estrogen increases and the mammary tissue is stimulated by the estrogen to form hyperplasia in the ducts and lobules of the mammary tissue, resulting in the disease.

The traditional Chinese medicine considers that: hyperplasia of mammary glands is mainly caused by phlegm turbidity generated in the breast due to emotional disorder, stagnation of liver qi, incoordination between liver and stomach, etc.; or disharmony of thoroughfare and conception vessels, which can cause phlegm accumulation for a long time. The hyperplasia of mammary glands belongs to the category of mammary nodules in the traditional Chinese medicine. It is highly related to liver-qi stagnation and disharmony of thoroughfare and conception vessels in women. According to the traditional Chinese medicine, the liver pulse is distributed in the chest and hypochondrium, the nipple is blue and belongs to the liver, and if the liver is not smooth and the veins in the chest and hypochondrium are obstructed, the qi activity of the breast is not smooth, so that the breast is distended and painful. The breast of women is the organ for qi and blood and milk perfusion, and is easy to generate qi stagnation, blood stasis and phlegm coagulation. The disease is also caused by dysfunction of spleen in transportation, endogenous phlegm-dampness, intermingled phlegm and qi, and obstruction of channels and collaterals is nodules of breast; over-exertion, insufficiency of the liver and kidney, or insufficiency of the spleen and kidney yang, accumulation of phlegm-dampness, and obstruction of the meridians can lead to breast pain.

At present, western medicine therapy is available for treating the breast nodule diseases, including clinical surgery and drug therapy, the surgical therapy is mainly to perform fixed-point excision and the like through breast lumps, while western medicine treatment traditional hormone preparations mainly use male hormone to resist estrogen, but the administration of male hormone drugs may have side effects of liver damage, dizziness, nausea and the like. For mastoproliferation caused by endocrine disorder, which is the imbalance of ovarian endocrine hormone, and is also affected by endocrine hormones such as hypothalamus and pituitary, patients can use bromocriptine to inhibit prolactin secretion, but the side effects of these drugs can be amenorrhea, menostaxis, weight gain, etc. Therefore, the western medicines for the diseases have large toxic and side effects on patients, but the traditional Chinese medicine has unique advantages in treating the diseases and has the advantages of definite curative effect and small toxic and side effects.

We systematically tease out the patents and documents that are closely related to the prior art of the present invention by referring to patent and document databases and summarize the following: patent document with publication number CN101524452A reports: a Chinese medicinal composition for treating hyperplasia of mammary glands comprises effective components and/or pharmaceutically acceptable carriers, wherein the effective components are prepared by extracting radix bupleuri, rhizoma cyperi, ligusticum wallichii, salvia miltiorrhiza, red paeony root, white paeony root, caulis spatholobi, angelica sinensis, cowherb seed, figwort root, selfheal, poria cocos, liquorice and the like. The medicine has effects of dispersing stagnated liver qi, resolving stagnation, removing blood stasis, eliminating phlegm and resolving hard mass, and is mainly used for treating hyperplasia of mammary glands, benign tumor of mammary glands, acute mastitis, etc. Patent document No. CN102058845A discloses: a pharmaceutical composition for treating macular degeneration, 10-40 parts of radix astragali, 10-40 parts of angelica, 10-40 parts of tuckahoe, 5-20 parts of thunberg fritillary bulb, 3-18 parts of pseudo-ginseng, 1-10 parts of rhubarb charcoal, 10-40 parts of raw pollen typhae and 10-40 parts of radix curcumae. The application of a traditional Chinese medicine preparation in preparing an external patch for treating irregular menstruation is also described in the patent application with the publication number of CN104906307A, and the traditional Chinese medicine preparation is characterized by being prepared from the following raw material medicines in parts by weight: 5-10 parts of angelica sinensis, 10-15 parts of fructus evodiae, 15-20 parts of salvia miltiorrhiza, 5-10 parts of pteris multifida, 15-20 parts of donkey-hide gelatin, 10-15 parts of perilla, 10-15 parts of caulis spatholobi, 10-15 parts of rhizoma cyperi, 5-10 parts of elecampane, 3-8 parts of spina date seeds, 2-8 parts of common yam rhizome, 5-10 parts of semen cuscutae, 15-20 parts of cassia twig, 5-10 parts of motherwort, 5-10 parts of dandelion, 10-15 parts of combined spicebush root, 5-10 parts of Chinese redbud bark, 5-10 parts of grape root, 5-10 parts of cinnamon, 5-10 parts of lilac and 5-10 parts of rhizoma alismatis. The medicine has remarkable curative effect on menoxenia, and is convenient for application. In addition, no obvious adverse reaction is found in the application process, but the medicines have the defects of overlarge formula, indefinite active substance components and the like, and the traditional Chinese medicine has the obvious advantages of accumulating rich clinical experience knowledge in the aspect of treating hyperplasia of mammary glands. Therefore, the development of a Chinese medicinal preparation with reliable clinical curative effect is very important.

Disclosure of Invention

The technical problem to be solved by the invention is to provide a traditional Chinese medicine for treating nodules of breast and a preparation method thereof. Another object of the invention is: the preparation method has the advantages that the preparation process is stable and reliable, the effective substance components of the traditional Chinese medicine can be effectively enriched, and the stability of the traditional Chinese medicine particles can be improved. The preparation method has stable and reliable technological parameters, and has obvious advantages in industrialization prospect.

The mammary gland hyperplasia belongs to the category called as the breast nodule disease in the traditional Chinese medicine, the aetiology of the mammary gland hyperplasia is depressed due to the fact that women are calm, irritable and dysphoria, the female takes the liver as the congenital foundation, the liver fails to reach the original condition, the qi movement is not comfortable, the qi stagnation occurs, the symptom of liver qi stagnation occurs, the qi and blood are dependent, the qi and blood circulation is not smooth, the breast meridian is blocked, the obstruction causes pain, the breast pain is caused, and the qi stagnation and the blood stasis are accumulated as the nucleus. The spleen failing to transport and transform and phlegm-dampness failing to nourish the Chong and ren channels. Failure to warm spleen yang will not transport and transform food fluids, gather dampness and form phlegm, long-term stagnation of liver qi will transform into heat and internal fire, scorching fluid into phlegm, and then qi and blood stasis will form nodules of breast.

After years of clinical experience and repeated dialectical summary research, the inventor finally finds out a prescription with remarkable clinical curative effect for treating the nodules of breast. The symptoms of distending pain in the hypochondrium and breast agglomeration are caused by stagnation of liver qi in women with hyperplasia of mammary glands. Therefore, the combination of radix Linderae and caulis Spatholobi is the principal drug in the recipe. Wu Yao, pungent and warm in flavor, is good at warming kidney and descending energizer and has the actions of guiding qi downward and alleviating pain. Also, the stagnation of liver qi may lead to the obstruction of qi movement, so that food, body fluids and menstrual blood cannot fill uterus and overflow breast, which may cause obstruction of mammary vessels, coagulation and pain due to qi and blood obstruction. The combination of caulis Spatholobi for its action of tonifying blood is bitter but not dry, warm but not drastic, good at dispelling blood stasis. However, in clinical practice, it is found that most of the patients with mammary nodules are accompanied by the symptoms of abdominal pain, preference for warmth, cold hands and feet, and pale and white tongue coating. The etiology of the disease is determined, and women cold pathogen can affect the circulation of blood and qi by invading the Chong channel and the ren channel, so that the abdominal pain is caused by the formation of blood stasis.

The ginseng is used as the minister of the recipe, is sweet and warm, can improve cold womb of women, can greatly tonify spleen and lung vigor, promote the production of body fluid and calm the nerves. In the book Ben Cao Hui Yan, it is said to tonify qi and generate blood, and the recipe is used mainly to tonify qi and generate blood to help women's blood vessels through the whole body. And the cassia twig is matched to achieve warm nature, promote and remove yang qi, warm and remove cold. The two medicines are matched as ministerial medicines, and the qi is vigorous to promote blood circulation, so that the Chong and ren blood of women can be filled, and the whole blood vessels of women can be benefited.

The auxiliary materials in the prescription are white paeony root, bitter, sour and cold in taste, enter liver and spleen meridians, and have the effects of astringing yin, nourishing blood, softening liver and relieving pain. Treating both ying and wei, dispersing and contracting, warming yang and releasing exterior, opening striae, and leading yang qi to be expressed from inside to the whole body. The white peony root can also prevent the yin and body fluids from being damaged by the excessive evacuation of the pungent and warm monarch and ministerial drugs in the formula. The auxiliary material is added with nutgrass galingale rhizome which is good at dispersing and can enter blood system, is called as 'blood qi-regulating medicine' and can pass through twelve meridians, sooth liver and regulate qi, regulate menstruation and relieve pain. Because qi and blood depend on each other, qi can generate blood and promote blood circulation, so the formula combined with Dang Gui can tonify blood and promote blood circulation. For women with liver depression and blood stagnation for a long time, it must generate heat and internal fire. The rhubarb is matched with the prescription, so the medicine is bitter and cold, can clear away heat and blood stasis, and wash away damp-heat and blood stasis toxin in the intestines. Assisting with the sexual movement of earthworm, it can move through meridians and collaterals, break blood and remove stasis. Poria may be added to strengthen spleen and dry dampness. With Zhejiang fritillaria bulb, it can resolve phlegm and dissipate nodulation to promote lactation. So as to make the spleen healthy and well-moving and eliminate turbid phlegm internally. The addition of notoginseng, which is sweet and warm in nature, can better dispel blood stasis without damaging the body resistance, is a delicate product for regulating blood and can enhance the functions of promoting blood circulation and removing obstruction in channels in the formula, and the above medicines are matched as adjuvant medicines. Finally, with the addition of Chinese honeylocust spine, it can resolve swelling and expel pus, and can direct the herbs upward to treat mammary abscess in upper energizer. The last prescription is matched with trichosanthes root, and has the functions of clearing heat, promoting fluid, detoxifying and eliminating carbuncle. The medicines are matched to play the efficacies of promoting qi circulation, warming yang, nourishing blood, dredging collaterals, reducing phlegm and resolving masses, can enable women to be full of blood and smooth qi and blood, and can sooth liver, relieve depression, soften hardness and dissipate blood stasis to eliminate nodules of breast, relieve pain and achieve the aim of curing.

The technical scheme provided by the invention is as follows:

the dosage of the traditional Chinese medicine is obtained by a large amount of grope and summary, and the dosage of each component has better curative effect within the following weight part range.

The invention aims to provide a traditional Chinese medicine for treating nodules of breast, which is prepared from the following raw material medicines in parts by weight: 90-110 parts of radix linderae, 90-110 parts of caulis spatholobi, 70-90 parts of ginseng, 70-90 parts of cassia twig, 50-70 parts of white paeony root, 50-70 parts of rhizoma cyperi, 50-70 parts of angelica sinensis, 50-70 parts of rheum officinale, 50-70 parts of earthworm, 50-70 parts of poria cocos, 50-70 parts of thunberg fritillary bulb, 50-70 parts of pseudo-ginseng, 40-60 parts of spina gleditsiae and 40-60 parts of trichosanthes root.

As the optimization of the traditional Chinese medicine prescription, the traditional Chinese medicine is prepared from the following raw materials in parts by weight: 95-105 parts of radix linderae, 95-105 parts of caulis spatholobi, 75-85 parts of ginseng, 75-85 parts of cassia twig, 55-65 parts of radix paeoniae alba, 55-65 parts of rhizoma cyperi, 55-65 parts of angelica sinensis, 55-65 parts of rheum officinale, 55-65 parts of lumbricus, 55-65 parts of poria cocos, 55-65 parts of thunberg fritillary bulb, 55-65 parts of pseudo-ginseng, 45-55 parts of spina gleditsiae and 45-55 parts of trichosanthes root.

The traditional Chinese medicine prescription is further preferred, and the traditional Chinese medicine is prepared from the following raw materials in parts by weight: 110 parts of radix linderae, 90 parts of caulis spatholobi, 90 parts of ginseng, 90 parts of cassia twig, 70 parts of radix paeoniae alba, 50 parts of rhizoma cyperi, 70 parts of angelica, 50 parts of rheum officinale, 70 parts of lumbricus, 50 parts of poria cocos, 70 parts of thunberg fritillary bulb, 70 parts of pseudo-ginseng, 60 parts of spina gleditsiae and 40 parts of trichosanthes root.

The preparation method of the traditional Chinese medicine for nodules of breast comprises the following steps:

taking radix linderae, caulis spatholobi, ginseng, cassia twig, radix paeoniae alba, rhizoma cyperi, angelica sinensis, rheum officinale, earthworm, poria cocos, thunberg fritillary bulb, pseudo-ginseng, spina gleditsiae and radix trichosanthis, adding water 7-10 times of the weight of the medicinal materials for the first time, decocting for 0.5-2 hours, filtering, adding water 6-9 times of the weight of the medicinal materials for the second time, decocting for 0.5-1 hour, filtering, combining water filtrates of the two times, concentrating the filtrate under reduced pressure into a clear paste with the relative density of 1.02-1.06, concentrating and drying under reduced pressure to obtain dry paste powder, crushing and sieving to obtain mixed dry paste fine powder;

the method comprises the steps of mixing fine dry paste powder, uniformly mixing, and adding common auxiliary materials in pharmacy.

As the optimization of the preparation method of the traditional Chinese medicine for nodules of breast, the preparation method comprises the following steps:

the preparation method comprises the steps of taking radix linderae, caulis spatholobi, ginseng, cassia twig, radix paeoniae alba, rhizoma cyperi, angelica sinensis, rheum officinale, earthworm, poria cocos, thunberg fritillary bulb, pseudo-ginseng, spina gleditsiae and radix trichosanthis, adding water 9 times the weight of the medicinal materials for the first time, decocting for 1 hour, filtering, adding water 8 times the weight of the medicinal materials for the second time, decocting for 0.6 hour, filtering, combining water filtrate obtained in the two times, concentrating the filtrate under reduced pressure into a clear paste with the relative density of 1.02-1.06, concentrating and drying under reduced pressure to obtain dry paste powder, crushing and sieving to obtain mixed dry paste fine powder;

Preferably, the clear paste in the preparation method further comprises purifying by using a chitosan solution, wherein the concentration of the chitosan solution is 3%, the amount of the added chitosan solution is 10% of the volume of the traditional Chinese medicine purification liquid, the adding temperature is controlled at 50 ℃, and the stirring time is 10 minutes.

The dosage form of the traditional Chinese medicine is preferably granules.

The traditional Chinese medicine comprises a traditional Chinese medicine formula which is similar to the traditional Chinese medicine formula and contains the medicinal materials of radix linderae, caulis spatholobi, ginseng, cassia twig, radix paeoniae alba, rhizoma cyperi, angelica sinensis, rheum officinale, lumbricus, poria cocos, thunberg fritillary bulb, pseudo-ginseng, spina gleditsiae, radix trichosanthis and the like.

The invention improves the preparation process technology

However, the decoction of the traditional Chinese medicine is prepared by decocting and extracting the traditional Chinese medicine in mixed water, so that the traditional Chinese medicine extract contains a large amount of starch, mucilage or tannin and other impurity components, and has the defects of inconvenient carrying, difficult storage, poor taste and the like. If the granules prepared by conventional concentration and extraction are adopted, the granules are found to be easy to absorb moisture in a stability investigation stage, so that a large number of preliminary tests are carried out in a test research stage, and in a preparation process research process, a chitosan flocculation method is accidentally found in an extracting solution purification process, so that the retention of active ingredients such as total flavonoids, total polysaccharides and the like in the traditional Chinese medicine can be increased, and better removal effects on impurities such as tannin, mucoid and the like can be achieved, so that the stability of the granules can be increased.

In order to further illustrate the superiority of the technical scheme of the technical process of the invention, the specific experimental contents are as follows.

Test 1 group preparation of the Chinese medicinal extract of the present invention

The optimal prescription composition and proportion of the invention are as follows:

the traditional Chinese medicine composition has the following best experience formula: 100g of radix linderae, 100g of caulis spatholobi, 80g of ginseng, 80g of cassia twig, 60g of radix paeoniae alba, 60g of rhizoma cyperi, 60g of angelica, 60g of rheum officinale, 60g of earthworm, 60g of poria cocos, 60g of thunberg fritillary bulb, 60g of pseudo-ginseng, 50g of spina gleditsiae and 50g of radix trichosanthis;

the preparation method comprises the following steps: the method comprises the steps of taking radix linderae, caulis spatholobi, ginseng, cassia twig, radix paeoniae alba, rhizoma cyperi, angelica sinensis, rheum officinale, earthworm, poria cocos, thunberg fritillary bulb, pseudo-ginseng, spina gleditsiae and radix trichosanthis, adding water 9 times the weight of the medicinal materials for the first time, decocting for 1h, filtering, adding water 8 times the weight of the medicinal materials for the second time, decocting for 0.6h, filtering, combining water filtrates of the two times, concentrating, filtering to obtain an analysis sample, and measuring the content of total flavonoids in the traditional Chinese medicine extracting solution for later use.

And (3) determining the extract yield:

precisely measuring 50ml of the above compound Chinese medicinal decoction, placing in a constant weight evaporating dish, drying at 105 deg.C to constant weight, and weighing. The method for calculating the extract yield comprises the following steps: the extract yield (%) -, the amount of extract solid in the extract/the amount of fed material x 100%.

And (3) total flavone content determination:

the invention adopts an ultraviolet spectrophotometry, wherein rutin is taken as a reference substance, sodium nitrite, aluminum nitrate, sodium hydroxide and the like are taken as color developing agents, and the absorbance (A) is measured at the wavelength of 508nm under an ultraviolet lamp. The linear range of the detection concentration of the rutin solution is 12-72 mug/mL (r is 0.9993), the RSD of the precision, stability and repeatability tests of the test method is less than 3%, the sample recovery rate is 99.69-102.76%, and the detection result shows that the method is accurate and reliable, has good linearity and stability, and can be used for determining the content of total flavonoids in the decoction extract of Chinese medicinal herbs.

Total polysaccharide assay

The content of total polysaccharide in the traditional Chinese medicine extracting solution is determined by adopting a phenol-sulfuric acid method, taking a glucose standard substance as a reference substance and adopting an ultraviolet-visible spectrophotometry method. Wherein the maximum absorption wavelength of total polysaccharide ultraviolet measurement is 621nm, the mass concentration range of anhydrous glucose is 0.021-0.126 mg/ml, and the absorbance and the concentration form a good linear relationship. The precision, stability and repeatability of the test method are all less than 3.6 percent, the sample recovery rate is 98.34-103.52 percent, and the result shows that the method is simple, convenient, accurate, reliable in repeatability and stability and can be used as a method for measuring the content of total polysaccharides in a decoction extract of Chinese herbal medicines.

TABLE 1 measurement results of the contents of effective substances in the Chinese medicinal extract of the present invention

From the experimental results in Table 1, the extract yield of the Chinese medicinal extract of the present invention is about 21.7%, the total flavone content of the extract is about 5.56mg/mL, and the total polysaccharide content is 9.53 mg/mL.

Experiment 2 group of the present invention on the purification process of the Chinese medicinal extract

The Chinese medicine extract prepared by the preparation method of the test 1 group is purified by the following 3 different processes. Wherein, in test 1, the Chinese medicine extract clear paste is taken, 3 percent of chitosan solution is added, the amount of the added chitosan solution is 5 percent of that of the Chinese medicine extract, the temperature is 50 ℃, the heating and stirring time is 10min, the Chinese medicine extract liquid is naturally cooled, and after the flocculation liquid is clarified, the filtration is carried out, thus obtaining Chinese medicine extraction purification liquid 1; test 2 groups: taking the Chinese medicinal extract fluid paste, adding ethanol to ensure that the alcohol content reaches 70 percent, and filtering to obtain Chinese medicinal extraction purified liquid 2; run 3 groups: taking the Chinese medicinal extract clear paste, performing centrifugal separation at 3000r/min for 10min, refrigerating, standing for 12h, filtering, and filtering to obtain Chinese medicinal extract purified liquid 3; and detecting and analyzing the 3 parts of Chinese medicine extraction and purification solution, and determining the extract yield, the total flavone content and the total polysaccharide content in the Chinese medicine extracting solution 1, the Chinese medicine extracting solution 2 and the Chinese medicine extracting solution 3 which are processed by the purification step, and comparing the front difference and the rear difference.

Table 2 influence of different purification methods on flocculation effect of Chinese medicine extract of the present invention

From the experimental results in table 2, it can be seen that the retention rate of the effective components of the total flavonoids and the total polysaccharides in the Chinese medicine extract is the highest by adopting chitosan flocculation, although the extract yield is reduced after purification. The total polysaccharide and the total flavone in the traditional Chinese medicine extracting solution are greatly lost by adopting 70% ethanol and centrifugal separation method for treatment, and the chitosan is comprehensively compared, and the chitosan is used for treatment by adopting a chitosan purification method. In addition, the invention also carries out the inspection of the components of the pituitous substances and the tannins of the purified traditional Chinese medicine solution of the chitosan flocculating solution, and the result shows that the impurity components such as the pituitous substances, the tannins and the like in the traditional Chinese medicine extracting solution of the invention are removed by the treatment of the chitosan flocculating solution.

In conclusion, through chitosan treatment, the effective components in the traditional Chinese medicine extracting solution are relatively high in retention, so that the effective components are relatively enriched, and the granule has relatively good curative effect and good quality stability.

The preparation process of the granules

Through the screening of the preliminary experiment of the invention, the experiments are carried out on the pharmaceutic adjuvants such as starch, lactose, aerosil, microcrystalline cellulose, mannitol, hydroxypropyl methylcellulose and the like, and the pharmaceutic adjuvants with good granule formability are selected according to the following proportion: dried paste powder: the pharmaceutical excipients (or diluents) are 1:3, wherein the components of the diluents and the excipients are mannitol and lactose 3: 2. Finally weighing the traditional Chinese medicine dry paste fine powder prepared according to the invention: the proportion of the diluent is 1:3, after being mixed evenly, a small amount of ethanol is dripped, soft materials are prepared, the soft materials are screened by a 14-mesh screen, 75 percent ethanol is added, granules are prepared, the granules are dried for 30min at 65 ℃, and the granules are prepared.

Inventive sample 1 was the granules prepared by the preparation method of inventive example 1 group, and inventive sample 2 was the granules prepared by the preparation method of inventive example 2 group. The quality of the granules was evaluated separately.

TABLE 3 results of sample testing of the granules of the invention

As can be seen from the test results shown in Table 3, the quality inspection results show that the particle properties, particle size and melting performance of the granules all meet the relevant regulations of granule detection. From the above results, it can be seen that the granules prepared in example 2 of the present invention have higher contents of active ingredients of total flavonoids and total polysaccharides than the granules prepared in example 1 of the present invention, which indicates that the novel process for preparing the traditional Chinese medicine of the present invention has certain innovativeness.

Long-term stability test on the preferred traditional Chinese medicine granules (prepared by the method of the embodiment 1) and the preferred traditional Chinese medicine granules (prepared by the method of the embodiment 2) of the invention, the traditional Chinese medicine granules do not absorb moisture and have no obvious change in appearance and content after observation for 0 month, 3 months, 6 months and 12 months, which shows that the traditional Chinese medicine granules of the invention have good stability.

The Chinese medicinal materials selected by the traditional Chinese medicine have the following sources, properties, flavors, channels and efficacies, and are clinically applied as follows:

radix Linderae is rattan stem of Polygonum multiflorum Thunb of Polygonaceae. The nature and flavor of the herb enter meridians, the nature is mild, and the taste is sweet. It enters heart and liver meridians. Has effects of nourishing blood, tranquilizing mind, dispelling pathogenic wind, and dredging collaterals. It is used clinically to treat abdominal distention and pain due to adverse qi, indigestion, regurgitation, cold hernia, tinea pedis, frequent micturition, etc.

Caulis Spatholobi, rattan of Spatholobus suberectus Dunn of Leguminosae. It is warm in nature, bitter and sweet in taste. It enters liver and kidney meridians. Has effects of tonifying blood, promoting blood circulation, and dredging collaterals. It is used clinically to treat menoxenia, blood deficiency, chlorosis, numbness, paralysis, and arthralgia due to wind-dampness.

Ginseng, source, root of Panax ginseng c.a.mey. It is warm in nature, sweet and slightly bitter. They enter heart, lung, spleen and kidney meridians. Has effects of invigorating primordial qi, restoring pulse, relieving depletion, invigorating spleen, benefiting lung, promoting fluid production, and tranquilizing mind. In clinical application, the medicine is used for treating symptoms of weak body, desire for losing, shortness of breath, dyspnea, spontaneous perspiration, cold limbs, mental fatigue, poor appetite, vomiting and diarrhea, asthma due to qi deficiency or chronic cough, body fluid deficiency, thirst, diabetes, insomnia, dreaminess, palpitation with fear, amnesia, impotence, frequent micturition and all qi, blood and body fluid deficiency.

Ramulus Cinnamomi, a twig of Cinnamomum cassia Presl. It is pungent, sweet and warm in nature. It enters bladder meridian, heart meridian and lung meridian. Has the effects of relieving exterior syndrome, expelling pathogenic factors from muscles, warming meridians, activating collaterals, supporting yang, regulating qi, and calming the adverse-rising energy. The clinical application of the medicine is mainly used for treating abdominal psychroalgia, vomiting and diarrhea, soreness and coldness of waist and knees, cold hernia and abdominal pain, cold-damp arthralgia, stasis and dysmenorrheal, bloody flux, intestinal wind, traumatic swelling and pain and the like.

White peony root, source, root of Paeonia lactiflora pall. The nature and flavor enter meridians, the nature is slightly cold, the taste is bitter and sour. It enters liver and spleen meridians. Has the functions of calming liver, relieving pain, nourishing blood, regulating menstruation, astringing yin and arresting sweating. It is indicated for headache, vertigo, chest and hypochondrium pain, dysentery, abdominal pain, spontaneous perspiration, night sweat, fever due to yin deficiency, irregular menstruation, metrorrhagia, leukorrhagia, etc. in clinical practice.

Cyperus rotundus L. is a rhizome of Cyperus rotundus L. belonging to Cyperus. The nature and flavor of the herb is meridian tropism, mild nature, pungent, slightly bitter and slightly sweet. It enters liver meridian and triple energizer meridian. Has the functions of promoting the circulation of qi, resolving stagnation, regulating menstruation and relieving pain. It is used clinically to treat incoordination between liver and stomach, qi stagnation, distending pain in chest, abdomen and hypochondrium, phlegm and fluid retention, menoxenia, metrorrhagia, metrostaxis and leukorrhagia.

Angelica sinensis, source, root of Angelica sinensis (Oliv.) Diels. The nature and flavor of the herb enter meridians, the nature is warm, the taste is sweet and pungent. It enters liver meridian, heart meridian and spleen meridian. Has the effects of tonifying blood, promoting blood circulation, regulating menstruation, relieving pain, and loosening bowel to relieve constipation. It is used clinically to treat blood deficiency, sallow complexion, vertigo, palpitation, menoxenia, amenorrhea, dysmenorrhea, abdominal pain due to deficiency cold, constipation due to intestinal dryness, rheumatic arthralgia, traumatic injury, carbuncle, cellulitis, and pyocutaneous disease.

Rhubarb, the source, dried root and rhizome of Rheum palmatum L.L., Rheum tanguticum Maxim. ex Balf. or Rheum officinale Rheum j-flcinale Baill. of Polygonaceae. It is cool in nature and bitter in taste. It enters spleen meridian, stomach meridian, large intestine meridian, liver meridian and pericardium meridian. Has the effects of clearing away heat, relieving constipation, cooling blood, removing toxic substances, removing blood stasis, and dredging channels. It is used clinically to treat constipation due to excess heat, abdominal pain due to stagnation, dysentery, jaundice due to damp-heat, hematemesis and epistaxis, conjunctival congestion, pharyngeal swelling, intestinal abscess, furuncle, amenorrhea due to blood stasis, and traumatic injury.

Lumbricus, the eviscerated totality of several species of earthworms of the lumbriculidae family, the lumbriculidae Pheretima aspergillum (e.perrier), the lumbriculidae Pheretim vulgare, the lumbriculidae Pheretima guillelmi (Michaelsen), or the aspergillus pectinifera. It is cool in nature and salty in taste. It enters liver meridian, spleen meridian and bladder meridian. Has the effects of clearing away heat, arresting convulsion, dredging meridians, relieving asthma, and promoting urination. It is used clinically to treat high fever, coma, epilepsy, convulsion, arthralgia, numbness of limbs, hemiplegia, cough due to lung heat, oliguria, edema and hypertension.

Poria, sclerotium of wolf of the family Polyporaceae, Poria cocos cos (Schw.) wolf. The nature and flavor of the herb enter meridians, the nature is mild, and the taste is sweet and bland. They enter heart, lung, spleen and kidney meridians. Has the effects of promoting diuresis, eliminating dampness, invigorating spleen, and calming heart. In clinical application, it is indicated for edema, oliguria, phlegm-fluid retention, dizziness, palpitation, spleen deficiency, poor appetite, loose stool, diarrhea, uneasiness, palpitation, and insomnia.

Thunberg fritillary bulb, source, bulb of Fritillaria thunbergii Mig. It is cool in nature and bitter in taste. It enters lung meridian and heart meridian. Has the effects of clearing away heat, dispersing pathogenic accumulation, eliminating phlegm, and relieving cough. It is indicated for cough due to wind-heat, lung abscess, sore throat, scrofula, sores and ulcers, and other diseases in clinical practice.

Notoginseng radix, root and rhizome of Panax notoginseng (Burk.) F.H.Chen. It is warm in nature, sweet and slightly bitter. It enters liver meridian and stomach meridian. Has the functions of eliminating blood stasis, stopping bleeding, eliminating swelling and relieving pain. It is used clinically to treat hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic hemorrhage, thoracico-abdominal pain, and traumatic swelling and pain.

Spina Gleditsiae, spina Gleditsiae of Gleditsia sinensis Lam. The nature and flavor enter meridians, the nature is warm, and the taste is pungent. It enters liver meridian and stomach meridian. Has the functions of relieving swelling, expelling toxin, expelling pus and killing parasites. It is indicated for early stage of abscess or pus formation without ulceration in clinic.

Trichosanthis radix, root of Trichosanthes rosthornii Harms. or Trichosanthes kirilowii Maxim. belonging to Cucurbitaceae family. It is slightly cold in nature, sweet and slightly bitter in taste. It enters lung and stomach meridians. Has the effects of clearing away heat, promoting salivation, relieving swelling, and expelling pus. It is used clinically to treat fever with polydipsia, lung heat with dry cough, internal heat with thirst, pyocutaneous disease with toxic swelling.

The traditional Chinese medicine has the beneficial effects that:

the Chinese medicine is prepared by obtaining a clinically effective prescription for treating the hyperplasia of mammary glands under the guidance of the traditional Chinese medicine theory and clinical experience. The prescription mainly comprises fourteen medicinal materials of radix linderae, caulis spatholobi, ginseng, cassia twig, white paeony root and the like. The traditional Chinese medicine composition has the effects of tonifying qi and nourishing blood, soothing liver and warming yang, dissolving stasis and relieving pain, and softening hardness and dissipating stagnation, is clinically used for treating symptoms of lump and pain in breast, small menstrual amount, intolerance of cold, chest and hypochondrium distending pain, mental fatigue and hypodynamia and the like, and is particularly suitable for nodules of breast patients with Chong and conception vessel disorder, liver depression and qi stagnation and yang deficiency symptoms.

The compatibility of the prescription is characterized in that: the whole formula mainly replenishes qi and warms yang, and is assisted by nourishing blood and dredging collaterals, so that the liver qi of women is relaxed, the yang qi is sufficient to remove cold evil, the qi and blood run smoothly, the venation is self-communicated, and the breast nodules of the women are eliminated. The combination of the qi-regulating herbs and the combined spicebush root and white peony root can nourish blood and nourish yin, and the combination of the Chinese honeylocust spine can lead the herbs to move upwards, so that the diseases of the herbs such as breast, qi and blood, liver qi and breast nodules can be gradually and automatically eliminated.

The chitosan flocculation method is adopted in the traditional Chinese medicine preparation process, so that the retention and enrichment degree of active ingredients such as total flavonoids and total polysaccharides in the traditional Chinese medicine extracting solution is improved, impurities such as tannin and mucilage in the extracting solution can be well removed, the stability of the granules is improved, the traditional Chinese medicine preparation process is more scientific and reasonable, and the requirement of industrial large-scale production is met.

According to the clinical test results of the traditional Chinese medicines, the total clinical effective rate of the test 1 group is 71.4%, while the total clinical effective rate of the test 2 group is 88.9%, and no adverse reaction is found in the patients in the using process.

In conclusion, the preparation process technology of the traditional Chinese medicine is stable and reliable, and has good market application prospect.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention and not to limit the invention.

FIG. 1 is a flow chart of a production process of the traditional Chinese medicine granule of the invention;

figure 2-graph of appearance samples of the traditional Chinese medicine granules of the invention.

Detailed Description

The following are specific examples of the present invention and further describe the technical solutions of the present invention, but the scope of the present invention is not limited to these examples. All changes, modifications and equivalents that do not depart from the spirit of the invention are intended to be included within the scope thereof.

Example 1

Taking 100g of radix linderae, 100g of caulis spatholobi, 80g of ginseng, 80g of cassia twig, 80g of radix paeoniae alba, 60g of rhizoma cyperi, 60g of angelica, 60g of rheum officinale, 60g of earthworm, 60g of poria cocos, 60g of thunberg fritillary bulb, 60g of pseudo-ginseng, 50g of spina gleditsiae and 50g of radix trichosanthis, adding water 9 times the weight of the medicinal materials for the first time, decocting for 1 hour, filtering, adding water 7 times the weight of the medicinal materials for the second time, decocting for 0.6 hour, filtering, combining water-decocted filtrates of two times, concentrating the filtrate under reduced pressure into a clear paste with the relative density of 1.02-1.06, concentrating and drying under reduced pressure, concentrating and drying under the temperature of 60 ℃ and the vacuum degree of 0.06-0.10 MPa, drying for 40 minutes to obtain dry paste powder, crushing and;

the preparation method comprises the steps of mixing fine dried paste powder uniformly, adding a diluent (mannitol: lactose 3:2), and mixing the fine dried paste powder: the diluent is mixed uniformly in a ratio of 1:3, and then 75% ethanol is added to prepare granules, and the granules are dried for 30min at 65 ℃ and are sized to obtain the traditional Chinese medicine granules.

Example 2

Taking 100g of radix linderae, 100g of caulis spatholobi, 80g of ginseng, 80g of cassia twig, 80g of radix paeoniae alba, 60g of rhizoma cyperi, 60g of angelica sinensis, 60g of rheum officinale, 60g of earthworm, 60g of poria cocos, 60g of thunberg fritillary bulb, 60g of pseudo-ginseng, 50g of spina gleditsiae and 50g of radix trichosanthis, adding water 9 times the weight of the medicinal materials for the first time, decocting for 1h, filtering, adding water 7 times the weight of the medicinal materials for the second time, decocting for 0.6h, filtering, combining water filtrates of the two times, concentrating the filtrate under reduced pressure into clear paste with relative density of 1.02-1.06, adding chitosan solution for purification, adding the chitosan solution with concentration of 3%, adding the chitosan solution with volume of 10% of the Chinese medicine purified solution, controlling the temperature at 50 ℃, stirring for 10 minutes to obtain Chinese medicine purified solution, concentrating and drying under reduced pressure, concentrating and drying at the temperature of 60 ℃ and the vacuum degree of 0., drying for 40 min to obtain dry extract powder, pulverizing and sieving to obtain mixed dry extract fine powder;

Example 3

Firstly, adding water in an amount which is 10 times of the weight of medicinal materials for 2 hours, decocting, filtering, adding water in an amount which is 9 times of the weight of the medicinal materials for the second time, decocting for 0.5 hour, filtering, combining water filtrates of two times, concentrating the filtrate under reduced pressure to obtain a clear paste with a relative density of 1.02-1.06, concentrating and drying under reduced pressure at a temperature of 60 ℃, and a vacuum degree of 0.08-0.12 MPa for 50 minutes to obtain dry paste powder, crushing and sieving to obtain mixed fine paste;

the preparation method comprises the steps of mixing fine dried paste powder uniformly, adding a diluent (lactose: dextrin 2:2), and mixing the fine dried paste powder: the diluent is mixed uniformly in a ratio of 1:3, and then 75% ethanol is added to prepare granules, and the granules are dried for 25min at 60 ℃ and are sized to obtain the traditional Chinese medicine granules.

Example 4

Taking 90g of radix linderae, 90g of caulis spatholobi, 70g of ginseng, 90g of cassia twig, 50g of radix paeoniae alba, 70g of rhizoma cyperi, 50g of angelica, 70g of rheum officinale, 50g of earthworm, 50g of poria cocos, 70g of thunberg fritillary bulb, 50g of pseudo-ginseng, 40g of spina gleditsiae and 40g of radix trichosanthis, adding water in an amount which is 7 times of the weight of the medicinal materials for the first time, decocting for 0.5h, filtering, adding water in an amount which is 6 times of the weight of the medicinal materials for the second time, decocting for 1h, filtering, combining water filtrates of the two times, concentrating the filtrate under reduced pressure into a clear paste with a relative density of 1.02-1.06, concentrating and drying under reduced pressure, concentrating and drying under a temperature of 65 ℃ and a vacuum degree of 0.08-0.11 MPa;

the preparation method comprises the steps of mixing fine dried paste powder uniformly, adding a diluent (starch: dextrin 2:2), and mixing the fine dried paste powder: the diluent is mixed uniformly in a ratio of 1:3, and then 75% ethanol is added to prepare granules, and the granules are dried for 25min at 60 ℃ and are sized to obtain the traditional Chinese medicine granules.

Example 5

Taking 100g of radix linderae, 110g of caulis spatholobi, 80g of ginseng, 90g of cassia twig, 50g of radix paeoniae alba, 70g of rhizoma cyperi, 50g of angelica, 70g of rheum officinale, 60g of earthworm, 60g of poria cocos, 70g of thunberg fritillary bulb, 50g of pseudo-ginseng, 60g of spina gleditsiae and 60g of radix trichosanthis, adding water with the weight ratio of 8 times of that of the medicinal materials for the first time, decocting for 1h, filtering, adding water with the weight ratio of 8 times of that of the medicinal materials for the second time, decocting for 1h, filtering, combining water filtrate obtained in two times, concentrating the filtrate under reduced pressure into clear paste with the relative density of 1.02-1.06, concentrating and drying under reduced pressure, concentrating and drying at the temperature of 70 ℃, concentrating and drying under the vacuum degree of 0.06-0.12 MPa for 30;

the preparation method comprises the steps of mixing fine dried paste powder uniformly, adding a diluent (mannitol and microcrystalline cellulose in a ratio of 3:2), and mixing the fine dried paste powder: the diluent is mixed uniformly in a ratio of 1:3, and then 75% ethanol is added to prepare granules, and the granules are dried for 30min at 60 ℃ and are sized to obtain the traditional Chinese medicine granules.

Example 6

Taking 110g of radix linderae, 100g of caulis spatholobi, 80g of ginseng, 80g of cassia twig, 70g of radix paeoniae alba, 50g of rhizoma cyperi, 60g of angelica, 60g of rheum officinale, 70g of earthworm, 50g of poria cocos, 60g of thunberg fritillary bulb, 60g of pseudo-ginseng, 50g of spina gleditsiae and 50g of radix trichosanthis, adding water 9 times the weight of the medicinal materials for the first time, decocting for 1h, filtering, adding water 9 times the weight of the medicinal materials for the second time, decocting for 1h, filtering, combining water filtrates of two times, concentrating the filtrate under reduced pressure into a clear paste with the relative density of 1.02-1.06, concentrating and drying under reduced pressure to obtain dry paste powder, crushing and sieving to obtain mixed dry paste fine;

the preparation method comprises the steps of mixing fine dried paste powder uniformly, adding a diluent (starch and microcrystalline cellulose in a ratio of 3:2), and mixing the fine dried paste powder: the proportion of the diluent is 1:3, after being mixed evenly, the mixture is added with 75 percent ethanol for preparing particles, and the particles are dried for 35min at 60 ℃ and are sized, thus obtaining the granules.

Example 6

Taking 90g of radix linderae, 100g of caulis spatholobi, 70g of ginseng, 80g of cassia twig, 50g of radix paeoniae alba, 70g of rhizoma cyperi, 50g of angelica, 70g of rheum officinale, 60g of earthworm, 60g of poria cocos, 60g of thunberg fritillary bulb, 50g of pseudo-ginseng, 60g of spina gleditsiae and 60g of radix trichosanthis, adding water 9 times the weight of the medicinal materials for the first time, decocting for 1h, filtering, adding water 7 times the weight of the medicinal materials for the second time, decocting for 0.8h, filtering, combining water filtrates of the two times, concentrating the filtrate under reduced pressure into clear paste with relative density of 1.02-1.06, adding chitosan solution for purification, adding the chitosan solution with concentration of 2.5%, adding the chitosan solution with volume of 15% of the volume of the Chinese medicine purified solution, controlling the temperature at 55 ℃, stirring for 8 minutes, obtaining the Chinese medicine purified solution, concentrating and drying under reduced pressure, concentrating and drying at the temperature of 65 ℃ and the vacuum degree, drying for 40 min to obtain dry extract powder, pulverizing and sieving to obtain mixed dry extract fine powder;

the preparation method comprises the steps of mixing fine dried paste powder uniformly, adding a diluent (mannitol and microcrystalline cellulose 2:2), and mixing the fine dried paste powder: the diluent is mixed uniformly in a ratio of 1:3, and then 70% ethanol is added to prepare granules, and the granules are dried for 30min at 65 ℃ and are sized, so that the traditional Chinese medicine granules are obtained.

Example 7

Taking 100g of radix linderae, 90g of caulis spatholobi, 90g of ginseng, 80g of cassia twig, 60g of radix paeoniae alba, 50g of rhizoma cyperi, 60g of angelica sinensis, 60g of rheum officinale, 50g of earthworm, 60g of poria cocos, 50g of thunberg fritillary bulb, 60g of pseudo-ginseng, 50g of spina gleditsiae and 40g of radix trichosanthis, adding water with the weight ratio of 8 times of that of the medicinal materials for the first time, decocting for 2 hours, filtering, adding water with the weight ratio of 7 times of that of the medicinal materials for the second time, decocting for 0.5 hour, filtering, combining water filtrates of the two times, concentrating the filtrate under reduced pressure into clear paste with the relative density of 1.02-1.06, adding a chitosan solution for purification, adding the chitosan solution with the concentration of 3.5%, adding the chitosan solution with the volume of 8% of the Chinese medicine purified solution, controlling the temperature at 55 ℃, stirring for 6 minutes, obtaining a Chinese medicine purified solution, concentrating and;

In order to further verify the clinical efficacy of the traditional Chinese medicine of the present invention, the finished granules prepared in the above-mentioned groups of specific examples 1 and 2 were subjected to corresponding clinical tests, and the test results are summarized as follows.

1 clinical observations of the Chinese medicine of the invention

1.1 general data

The invention relates to a research experiment, which treats 103 cases of patients with hyperplasia of mammary glands, after the consent of the patients is obtained, all cases conform to the diagnosis standard of patients with hyperplasia of mammary glands in the 'traditional Chinese medicine syndrome diagnosis curative effect standard' issued by the national traditional Chinese medicine administration of 1994, and for women, pregnant women suffering from hypertension, diabetes, neoplastic disease, liver and kidney function damage, mental diseases, pregnancy or lactation are excluded, and the selected patients are 2 months before treatment, and other medicines are stopped taking.

All patients were randomized into two groups, 49 in treatment 1 and 54 in treatment 2. Wherein, the patients in the experiment 1 group are 28-56 years old, the average age is 39.5 +/-2.1 years old, the course is 4 months-3.6 years old, and the average course is 2.3 +/-0.9 years old; according to the experiment 2, the patients are 26-63 years old, the average age (37.1 +/-1.8) years old, the disease course is 5 months-4.2 years old, and the average disease course (2.1 +/-0.8) years old, and after arrangement statistical analysis, the difference of the ages, the disease courses and the disease conditions of the two groups of patients is not statistically significant (P is more than 0.05), and the patients have comparability.

1.2 therapeutic criteria

The clinical test of the invention refers to the diagnosis standard of the patients with hyperplasia of mammary glands in the 'standard of curative effect for diagnosing the traditional Chinese medicine diseases' issued by the State administration of traditional Chinese medicine. The treatment effect is comprehensively evaluated: firstly, effect is shown: after the patient is treated, the lump and pain of the breast and the mammary gland disappear. Secondly, effectively: after the patient is treated, the breast lump is reduced, and the breast pain is relieved or disappeared. ③, invalid: after the treatment, the size of the breast lump is unchanged, the symptoms of breast pain are not relieved, and the size of the breast lump is unchanged. Total effective rate (%) + effective rate (%).

1.3 methods of treatment

Inventive test 1 group: the granules prepared according to the preparation method of example 1 of the present invention were orally administered at 6 g/time and 3 times/day, and were taken during the menstrual period of patients. 1 month is a course of treatment, the medicine is stopped during menstrual period, and after continuously taking the medicine for 3 courses, the clinical curative effect of the patient is evaluated.

Inventive test 2 groups: the granules prepared according to the preparation method of example 2 of the present invention were orally administered at 6 g/time and 3 times/day, and were taken out during the menstrual period of the patients. 1 month is a course of treatment, the patients can stop taking the medicine during the menstrual period, and the clinical efficacy of the patients is evaluated after continuously taking the medicine for 3 courses.

1.4 therapeutic results

TABLE 4 comparison of clinical efficacy of two groups of patients

As can be seen from the results in Table 4, after 3 months of drug treatment, the breast mass of the patients treated in the trial treatment group 1 of the present invention is reduced, the pain of the patients is obviously relieved, and the total clinical effective rate is 71.4%. For the patients of the trial 2 groups who took the granules prepared in the group of example 2 of the present invention, the clinical effective rate was 88.9%. The results show that the clinical efficacy of the patients in trial 2 of the invention is significantly better than that in trial 1 of the invention. The traditional Chinese medicine has a satisfactory effect on treating hyperplasia of mammary glands, has small toxic and side effects, and is safe and effective. No adverse reactions were observed during the treatment of the 2 patients.

In conclusion, the traditional Chinese medicine granules have definite clinical curative effect, reliable and stable preparation process and lower production cost in the aspect of treating the hyperplasia of mammary glands, and have good market application and popularization prospects.

Claims

1. The traditional Chinese medicine for treating nodules of breasts is characterized by being prepared from the following raw material medicines in parts by weight: 90-110 parts of radix linderae, 90-110 parts of caulis spatholobi, 70-90 parts of ginseng, 70-90 parts of cassia twig, 50-70 parts of white paeony root, 50-70 parts of rhizoma cyperi, 50-70 parts of angelica sinensis, 50-70 parts of rheum officinale, 50-70 parts of earthworm, 50-70 parts of poria cocos, 50-70 parts of thunberg fritillary bulb, 50-70 parts of pseudo-ginseng, 40-60 parts of spina gleditsiae and 40-60 parts of trichosanthes root.

2. The traditional Chinese medicine according to claim 1, which is prepared from the following raw material medicines in parts by weight: 95-105 parts of radix linderae, 95-105 parts of caulis spatholobi, 75-85 parts of ginseng, 75-85 parts of cassia twig, 55-65 parts of radix paeoniae alba, 55-65 parts of rhizoma cyperi, 55-65 parts of angelica sinensis, 55-65 parts of rheum officinale, 55-65 parts of lumbricus, 55-65 parts of poria cocos, 55-65 parts of thunberg fritillary bulb, 55-65 parts of pseudo-ginseng, 45-55 parts of spina gleditsiae and 45-55 parts of trichosanthes root.

3. The traditional Chinese medicine according to claim 1, which is prepared from the following raw material medicines in parts by weight: 100 parts of radix linderae, 100 parts of caulis spatholobi, 80 parts of ginseng, 80 parts of cassia twig, 60 parts of radix paeoniae alba, 60 parts of rhizoma cyperi, 60 parts of angelica, 60 parts of rheum officinale, 60 parts of earthworm, 60 parts of poria cocos, 60 parts of thunberg fritillary bulb, 60 parts of pseudo-ginseng, 50 parts of spina gleditsiae and 50 parts of trichosanthes root.

4. The method for preparing the traditional Chinese medicine according to claim 1, wherein the preparation method comprises the following steps:

5. The method for preparing the traditional Chinese medicine according to claim 4, wherein the preparation method comprises the following steps:

6. The traditional Chinese medicine of claim 1, wherein the dosage form of the traditional Chinese medicine is preferably granules.