Traditional Chinese medicine composition for treating hepatic nodule as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for hepatic nodule and a preparation method and application thereof, and relates to the field of traditional Chinese medicines. The invention discloses a traditional Chinese medicine composition for cirrhosis nodules. Comprising the following raw materials in parts by weight: 3-40 parts of radix salviae miltiorrhizae, 5-20 parts of radix paeoniae alba, 3-25 parts of rhizoma cyperi, 5-30 parts of poria cocos, 3-20 parts of fructus gardeniae, 3-19 parts of pericarpium citri reticulatae viride, 5-18 parts of fructus aurantii, 3-25 parts of radix aucklandiae, 3-40 parts of endothelium corneum gigeriae galli, 5-25 parts of fructus amomi, 3-26 parts of rhizoma corydalis, 5-16 parts of cortex magnoliae officinalis, 3-19 parts of betel nuts, 3-30 parts of rhizoma alismatis, 3-12 parts of liquorice, 5-50 parts of herba artemisiae scopariae, 5-30 parts of radix isatidis and 3-25 parts of massa medicata fermentata fujianensis. The traditional Chinese medicine composition has the effects of promoting blood circulation to remove blood stasis, replenishing qi to invigorate the spleen, soothing the liver, removing stasis and the like, strengthens the body resistance, eliminates evil and can obviously reduce the volume of cirrhosis nodules, and the curative effect is good. Moreover, the traditional Chinese medicine composition can enhance the oxidative stress resistance of liver cells, inhibit hepatic fibrosis, avoid liver injury, regulate the metabolic microenvironment and improve the immune balance.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for liver nodules, a preparation method thereof, and an application thereof. Background Art

[0002] Severe liver nodules can damage liver function, leading to metabolic disorders or blood flow obstruction. Among them, metabolic disorders: the mass occupation effect of nodules can compress normal liver tissue, resulting in a decline in detoxification, synthesis, and storage functions, causing jaundice, hypoproteinemia, etc.; blood flow obstruction: nodule hyperplasia may compress the portal vein or hepatic vein, aggravating portal hypertension. There may also be the following symptoms: dull pain in the upper right abdomen, abdominal distension, and fatigue. The risk of cirrhotic nodules progressing to hepatocellular carcinoma in the later stage is significantly increased. Hepatocellular carcinoma is one of the malignant diseases that seriously threaten human life safety. Therefore, it is very important to detect and intervene in cirrhotic nodules in a timely manner, and it is of great significance to develop a traditional Chinese medicine composition for liver nodules. Summary of the Invention

[0003] In view of this, the present invention provides a traditional Chinese medicine composition for liver nodules, a preparation method thereof, and an application thereof to solve the above problems.

[0004] Salvia miltiorrhiza: Promote blood circulation to remove stasis, relieve pain, dredge meridians, clear the heart and remove vexation. It is used for irregular menstruation, amenorrhea and dysmenorrhea, mass accumulation, chest and abdomen stabbing pain, heat arthralgia pain, swelling and pain of sores and ulcers, vexed insomnia; hepatosplenomegaly, angina pectoris.

[0005] White peony root: Soothe the liver and relieve pain, nourish blood and regulate menstruation, astringe yin and stop sweating. It is used for headache and dizziness, hypochondriac pain, abdominal pain, limb contracture pain, blood deficiency and sallow complexion, irregular menstruation, spontaneous sweating, night sweating.

[0006] Cyperus rotundus: Regulate qi and relieve depression, regulate menstruation and relieve pain. It is used for liver qi stagnation, chest, hypochondriac, and epigastric distending pain, indigestion, chest and epigastric stuffiness, cold hernia pain, breast swelling pain, irregular menstruation, amenorrhea and dysmenorrhea.

[0007] Poria cocos: Promote diuresis and percolate dampness, strengthen the spleen and calm the heart. It is used for edema with scanty urine, phlegm retention and dizziness and palpitation, spleen deficiency with less food intake, loose stools and diarrhea, restlessness of mind, palpitations and insomnia.

[0008] Gardenia jasminoides: Clear heat, purge fire, cool the blood. It is used to treat vexed insomnia due to febrile disease, jaundice, gonorrhea, diabetes, red eyes, sore throat, hematemesis, epistaxis, bloody dysentery, hematuria, heat-toxic sores and ulcers, sprain and swelling pain.

[0009] Pericarpium citri reticulatae viride: Soothe the liver and break qi, eliminate accumulation and resolve stagnation. It is used for chest and hypochondriac distending pain, hernia, breast nodule, breast abscess, abdominal pain due to food accumulation.

[0010] Fructus aurantii: Fullness and stuffiness in the chest and diaphragm; distending pain in the hypochondrium and costal region; indigestion; fullness and distension in the epigastrium; tenesmus after dysentery; rectal prolapse; uterine prolapse.

[0011] Radix Aucklandiae: Promote qi circulation to relieve pain; regulate the middle energizer and promote digestion. It is mainly used for distension and fullness in the chest and hypochondrium; epigastric and abdominal distending pain; vomiting and diarrhea; tenesmus after dysentery.

[0012] Endothelium Corneum Gigeriae Galli: It can promote digestion and relieve stomachache, astringe essence and stop involuntary discharge. It is used for indigestion, vomiting and diarrhea, infantile malnutrition, enuresis, and spermatorrhea.

[0013] Amomum villosum: It can regulate qi and harmonize the middle-jiao, soothe the stomach and arouse the spleen. It is used to treat abdominal pain and distension, indigestion, dysphagia and vomiting, cold diarrhea, and fetal movement during pregnancy.

[0014] Rhizoma Corydalis: It can activate blood circulation, promote qi movement, and relieve pain. It is used for chest and hypochondrium pain, epigastric and abdominal pain, amenorrhea and dysmenorrhea, postpartum stasis obstruction, and traumatic swelling and pain.

[0015] Magnolia officinalis: It can dry dampness and eliminate phlegm, lower qi and relieve fullness. It is used for dampness stagnating the middle-jiao, epigastric discomfort, vomiting and diarrhea, food accumulation and qi stagnation, abdominal distension and constipation, and cough with phlegm retention.

[0016] Areca catechu: It can expel worms, eliminate accumulation, lower qi, promote diuresis, and prevent malaria. It is mainly used for worm accumulation, food stagnation, epigastric and abdominal distension pain, tenesmus after diarrhea, beriberi, edema, and malaria.

[0017] Alisma orientale: It can promote diuresis and percolate dampness, clear heat and promote diuresis. It is mainly used for oliguria, dysuria, edema, diarrhea, phlegm retention and dizziness, and spermatorrhea.

[0018] Glycyrrhiza uralensis: It can clear heat and detoxify, moisten the lungs and relieve cough, and harmonize various medicinal herbs; roasted licorice can invigorate the spleen and replenish qi. It is mainly used for sore throat, cough, weakness of the spleen and stomach, gastric and duodenal ulcers, carbuncles and sores, drug and food poisoning.

[0019] Artemisia capillaris: It can clear away damp-heat and reduce jaundice. It is used for jaundice with oliguria, itchy eczema; infectious jaundice hepatitis.

[0020] Isatis indigotica: It can clear heat and detoxify, cool blood and relieve sore throat. It is used for epidemic febrile disease with maculae, purple and dark tongue with crimson color, mumps, sore throat, scarlet fever, epidemic encephalitis B, erysipelas, and carbuncles.

[0021] Jianqu: It can aromatize dampness, disperse wind and relieve exterior syndrome, promote digestion and improve appetite. It is used for common cold, heatstroke in summer, aversion to cold and fever, headache and body pain, vomiting and diarrhea, indigestion, chest distress and abdominal distension.

[0022] The technical solution of the present invention is realized as follows: A traditional Chinese medicine composition for liver nodules, comprising the following raw materials in parts by weight: 3 - 40 parts of Salvia miltiorrhiza, 5 - 20 parts of Paeonia lactiflora, 3 - 25 parts of Cyperus rotundus, 5 - 30 parts of Poria cocos, 3 - 20 parts of Gardenia jasminoides, 3 - 19 parts of Pericarpium Citri Reticulatae Viride, 5 - 18 parts of Fructus Aurantii, 3 - 25 parts of Aucklandia lappa, 3 - 40 parts of Endothelium Corneum Gigeriae Galli, 5 - 25 parts of Amomum villosum, 3 - 26 parts of Rhizoma Corydalis, 5 - 16 parts of Magnolia officinalis, 3 - 19 parts of Areca catechu, 3 - 30 parts of Alisma orientale, 3 - 12 parts of Glycyrrhiza uralensis, 5 - 50 parts of Artemisia capillaris, 5 - 30 parts of Isatis indigotica, 3 - 25 parts of Jianqu.

[0023] A further technical solution is that the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20 parts of Salvia miltiorrhiza, 12 parts of Paeonia lactiflora, 14 parts of Cyperus rotundus, 17 parts of Poria cocos, 12 parts of Gardenia jasminoides, 10 parts of Pericarpium Citri Reticulatae Viride, 12 parts of Fructus Aurantii, 14 parts of Aucklandia lappa, 20 parts of Endothelium Corneum Gigeriae Galli, 15 parts of Amomum villosum, 15 parts of Corydalis yanhusuo, 10 parts of Magnolia officinalis, 10 parts of Areca catechu, 15 parts of Alisma orientale, 8 parts of Glycyrrhiza uralensis, 25 parts of Artemisia capillaris, 15 parts of Isatis tinctoria, 14 parts of Medicated Leaven.

[0024] A further technical solution is that the preparation method of the traditional Chinese medicine composition comprises the following steps:

[0025] 1) Weigh Salvia miltiorrhiza, Paeonia lactiflora, Cyperus rotundus, Gardenia jasminoides, Fructus Aurantii, Endothelium Corneum Gigeriae Galli, Amomum villosum, Corydalis yanhusuo, Magnolia officinalis, Alisma orientale, Glycyrrhiza uralensis, Artemisia capillaris, Isatis tinctoria, crush them, and use ultrasonic-microwave synergistic extraction to obtain an extractive solution. Filter it, collect the filtrate, and concentrate it under reduced pressure to obtain an extract;

[0026] 2) Weigh Areca catechu, Aucklandia lappa, Pericarpium Citri Reticulatae Viride, Poria cocos, crush them, add water, and then add bacterial powder for fermentation to obtain a fermented product;

[0027] 3) Mix the fermented product obtained in step 2) with Medicated Leaven, and then add the extract obtained in step 1) and mix them to granulate, thus obtaining the product.

[0028] A further technical solution is that in step 1), the solvent is a 50%-60% v / v ethanol solution, and the solid-liquid ratio kg / L is 1:6-8.

[0029] A further technical solution is that in step 1), the microwave frequency is 1500-2000 MHz, the ultrasonic frequency is 20-30 KHz, the extraction temperature is 55-65 °C, and the extraction time is 2-4 h.

[0030] A further technical solution is that in step 2), the bacterial powder is 0.3%-0.8% of the total weight of the Areca catechu, Aucklandia lappa, Pericarpium Citri Reticulatae Viride, and Poria cocos herbs.

[0031] A further technical solution is that in step 2), the water is 30%-40% of the total weight of the Areca catechu, Aucklandia lappa, Pericarpium Citri Reticulatae Viride, and Poria cocos herbs.

[0032] A further technical solution is that in step 2), the bacterial powder is composed of Saccharomyces cerevisiae, Monascus purpureus, and Aspergillus oryzae with a mass ratio of 1:0.2-0.5:0.5-0.8.

[0033] A further technical solution is that in step 2), the fermentation temperature is 28-32 °C, and the fermentation time is 24-48 h.

[0034] The traditional Chinese medicine composition described in the present invention is used in the preparation of a drug for liver cirrhosis nodules.

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

[0036] (1) The traditional Chinese medicine composition of the present invention uses Salvia miltiorrhiza, Paeonia lactiflora, and Artemisia capillaris as the monarch drugs, Gardenia jasminoides, Aucklandia lappa, Endothelium corneum gigeriae galli, Corydalis yanhusuo, and Areca catechu as the minister drugs, Cyperus rotundus, Poria cocos, Citrus reticulata Blanco var. austera, Aurantii Fructus Immaturus, Magnolia officinalis, Alisma orientale, Isatis indigotica, and Medicated leaven as the adjuvant drugs, and Glycyrrhiza uralensis and Amomum villosum as the guiding drugs, exerting the effects of promoting blood circulation to remove blood stasis, replenishing qi and strengthening the spleen, soothing the liver and dissipating nodules, etc., dispelling pathogenic factors while strengthening the healthy qi, being able to significantly reduce the volume of liver cirrhosis nodules, and having good curative effects. Moreover, the traditional Chinese medicine composition of the present invention can enhance the antioxidant stress ability of hepatocytes, inhibit liver fibrosis, avoid liver damage, and at the same time regulate the metabolic microenvironment and improve the immune balance.

[0037] (2) Using the preparation method of the traditional Chinese medicine composition of the present invention, adopting the fermentation process of the present invention combined with the ultrasonic-microwave synergistic extraction process can increase the extraction amount of the active ingredients for reducing liver cirrhosis nodules, and at the same time enhance the drug absorption ability and improve the bioavailability. Detailed implementation mode

[0038] In order to better understand the technical content of the present invention, specific examples are provided below to further illustrate the present invention.

[0039] The experimental methods used in the embodiments of the present invention are all conventional methods unless otherwise specified.

[0040] The materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial channels unless otherwise specified.

[0041] The Saccharomyces cerevisiae, Monascus purpureus, and Aspergillus oryzae used in the embodiments of the present invention are all commercially available bacterial powders.

[0042] Example 1

[0043] A traditional Chinese medicine composition for liver nodules is prepared from the following raw materials in parts by weight: 20 parts of Salvia miltiorrhiza, 12 parts of Paeonia lactiflora, 14 parts of Cyperus rotundus, 17 parts of Poria cocos, 12 parts of Gardenia jasminoides, 10 parts of Citrus reticulata Blanco var. austera, 12 parts of Aurantii Fructus Immaturus, 14 parts of Aucklandia lappa, 20 parts of Endothelium corneum gigeriae galli, 15 parts of Amomum villosum, 15 parts of Corydalis yanhusuo, 10 parts of Magnolia officinalis, 10 parts of Areca catechu, 15 parts of Alisma orientale, 8 parts of Glycyrrhiza uralensis, 25 parts of Artemisia capillaris, 15 parts of Isatis indigotica, and 14 parts of Medicated leaven.

[0044] The preparation method of the above traditional Chinese medicine composition includes the following steps:

[0045] 1) Weigh Salvia miltiorrhiza, Paeonia lactiflora, Cyperus rotundus, Gardenia jasminoides, Aurantii Fructus Immaturus, Endothelium corneum gigeriae galli, Amomum villosum, Corydalis yanhusuo, Magnolia officinalis, Alisma orientale, Glycyrrhiza uralensis, Artemisia capillaris, and Isatis indigotica, pulverize them, and use ultrasonic-microwave synergistic extraction. The solvent is a 55% v / v ethanol solution, the solid-liquid ratio kg / L is 1:7, the microwave frequency is 1800 MHz, the ultrasonic frequency is 25 KHz, the extraction temperature is 60 °C, and the extraction time is 3 h to obtain an extract solution. Filter it, collect the filtrate, and concentrate it under reduced pressure to obtain an extract;

[0046] 2) Weigh areca, Aucklandiae Radix, Citri Reticulatae Viride Pericarpium, and Poria, pulverize them, add deionized water, and the amount of added water is 35% of the total weight of the areca, Aucklandiae Radix, Citri Reticulatae Viride Pericarpium, and Poria herbs; then add the bacterial powder for fermentation, and the added weight of the bacterial powder is 0.5% of the total weight of the areca, Aucklandiae Radix, Citri Reticulatae Viride Pericarpium, and Poria herbs. The bacterial powder is composed of Saccharomyces cerevisiae, Monascus purpureus, and Aspergillus oryzae with a mass ratio of 1:0.3:0.7. The fermentation temperature is 30°C ± 2°C, and the fermentation time is 36 h to obtain the fermentation product;

[0047] 3) Mix the fermentation product in step 2) with Jianqu, and then add the extract in step 1) and mix them, followed by granulation to obtain the product.

[0048] Example 2

[0049] A traditional Chinese medicine composition for liver nodules is prepared from the following raw materials in parts by weight: 3 parts of Salvia miltiorrhiza, 5 parts of Paeonia lactiflora, 3 parts of Cyperus rotundus, 5 parts of Poria, 3 parts of Gardenia jasminoides, 3 parts of Citri Reticulatae Viride Pericarpium, 5 parts of Aurantii Fructus Immaturus, 3 parts of Aucklandiae Radix, 3 parts of Endothelium Corneum Gigeriae Galli, 5 parts of Amomum villosum, 3 parts of Corydalis yanhusuo, 5 parts of Magnolia officinalis, 3 parts of Areca, 3 parts of Alisma orientale, 3 parts of Glycyrrhiza uralensis, 5 parts of Artemisia capillaris, 5 parts of Isatis indigotica, and 3 parts of Jianqu. The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0050] Example 3

[0051] A traditional Chinese medicine composition for liver nodules is prepared from the following raw materials in parts by weight: 40 parts of Salvia miltiorrhiza, 20 parts of Paeonia lactiflora, 25 parts of Cyperus rotundus, 30 parts of Poria, 20 parts of Gardenia jasminoides, 19 parts of Citri Reticulatae Viride Pericarpium, 18 parts of Aurantii Fructus Immaturus, 25 parts of Aucklandiae Radix, 40 parts of Endothelium Corneum Gigeriae Galli, 25 parts of Amomum villosum, 26 parts of Corydalis yanhusuo, 16 parts of Magnolia officinalis, 19 parts of Areca, 30 parts of Alisma orientale, 12 parts of Glycyrrhiza uralensis, 50 parts of Artemisia capillaris, 30 parts of Isatis indigotica, and 25 parts of Jianqu. The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0052] Comparative Example 1

[0053] The difference from Example 1 is that Artemisia capillaris is replaced by Citrus reticulata Blanco. A traditional Chinese medicine composition for liver nodules is prepared from the following raw materials in parts by weight: 20 parts of Salvia miltiorrhiza, 12 parts of Paeonia lactiflora, 14 parts of Cyperus rotundus, 17 parts of Poria, 12 parts of Gardenia jasminoides, 10 parts of Citri Reticulatae Viride Pericarpium, 12 parts of Aurantii Fructus Immaturus, 14 parts of Aucklandiae Radix, 20 parts of Endothelium Corneum Gigeriae Galli, 15 parts of Amomum villosum, 15 parts of Corydalis yanhusuo, 10 parts of Magnolia officinalis, 10 parts of Areca, 15 parts of Alisma orientale, 8 parts of Glycyrrhiza uralensis, 25 parts of Citrus reticulata Blanco, 15 parts of Isatis indigotica, and 14 parts of Jianqu.

[0054] Comparative Example 2

[0055] The difference from Example 1 is that Corydalis Rhizoma is replaced by Radix Paeoniae Rubra. A traditional Chinese medicine composition for liver nodules is prepared from the following raw materials in parts by weight: 20 parts of Salvia Miltiorrhiza, 12 parts of White Peony Root, 14 parts of Cyperus Rotundus, 17 parts of Poria, 12 parts of Gardenia Jasminoides, 10 parts of Pericarpium Citri Reticulatae Viride, 12 parts of Fructus Aurantii, 14 parts of Aucklandia Radix, 20 parts of Endothelium Corneum Gigeriae Galli, 15 parts of Amomum Villosum, 15 parts of Radix Paeoniae Rubra, 10 parts of Magnolia Officinalis, 10 parts of Areca Catechu, 15 parts of Alisma Orientalis, 8 parts of Licorice Root, 25 parts of Artemisia Capillaris, 15 parts of Isatis Root, and 14 parts of Medicated Leaven.

[0056] Control Example 3

[0057] The difference from Example 1 is that Salvia Miltiorrhiza is replaced by American Ginseng. A traditional Chinese medicine composition for liver nodules is prepared from the following raw materials in parts by weight: 20 parts of American Ginseng, 12 parts of White Peony Root, 14 parts of Cyperus Rotundus, 17 parts of Poria, 12 parts of Gardenia Jasminoides, 10 parts of Pericarpium Citri Reticulatae Viride, 12 parts of Fructus Aurantii, 14 parts of Aucklandia Radix, 20 parts of Endothelium Corneum Gigeriae Galli, 15 parts of Amomum Villosum, 15 parts of Corydalis Rhizoma, 10 parts of Magnolia Officinalis, 10 parts of Areca Catechu, 15 parts of Alisma Orientalis, 8 parts of Licorice Root, 25 parts of Artemisia Capillaris, 15 parts of Isatis Root, and 14 parts of Medicated Leaven.

[0058] Control Example 4

[0059] The traditional Chinese medicine formula is the same as that in Example 1. The difference from Example 1 lies in the preparation process. Take the herbs of Salvia Miltiorrhiza, White Peony Root, Cyperus Rotundus, Poria, Gardenia Jasminoides, Pericarpium Citri Reticulatae Viride, Fructus Aurantii, Aucklandia Radix, Endothelium Corneum Gigeriae Galli, Amomum Villosum, Corydalis Rhizoma, Magnolia Officinalis, Areca Catechu, Alisma Orientalis, Licorice Root, Artemisia Capillaris, and Isatis Root, crush them, mix them, decoct them with water, the material-liquid ratio in kg / L is 1:8, decoct for 3 hours, filter, collect the filtrate, concentrate it under reduced pressure to obtain an extract, add Medicated Leaven, and granulate to obtain the product.

[0060] Test Example

[0061] Collect patients with hepatitis B liver cirrhosis nodules. Abdominal color Doppler ultrasound examination shows that the liver cirrhosis nodules are ≥4 cm * 4 cm, aged 18 - 60 years old, and there is no gender limitation. Randomly divide them into groups, including Research Groups 1 - 7, with 30 cases in each group. Before treatment, there is no significant difference in the total volume of liver cirrhosis nodules among the groups, and there is no significant difference in age and male-female ratio.

[0062] Research Groups 1 - 7 respectively use the traditional Chinese medicine compositions of Example 1 - 3 and Control Examples 1 - 4, 30 g each time, twice a day, after meals, and take continuously for 14 days. After 14 days, conduct abdominal color Doppler ultrasound examination on the liver cirrhosis nodules, and statistically calculate the percentage reduction in the volume of liver cirrhosis nodules after treatment, and calculate the average value of each group. Statistically count the number of cases where the liver cirrhosis nodules disappear as indicated by abdominal color Doppler ultrasound examination after treatment. The results are shown in Table 1.

[0063] Percentage reduction in the volume of liver cirrhosis nodules after treatment = (Volume of liver cirrhosis nodules before treatment - Volume of liver cirrhosis nodules after treatment) / Volume of liver cirrhosis nodules before treatment * 100%

[0064] Table 1 Conditions of liver cirrhosis nodules after treatment

[0065] Grouping Disappearance of liver cirrhosis nodules (cases) Percentage of reduction in the volume of liver cirrhosis nodules after treatment Example 1 28 98.7％ Example 2 25 95.0％ Example 3 26 96.7％ Comparative Example 1 21 88.0％ Comparative Example 2 23 89.5％ Comparative Example 3 20 83.3％ Comparative Example 4 24 93.0％

[0066] The results showed that most of the cirrhotic nodules in the patients disappeared after treatment. Among them, the percentage reduction in the volume of cirrhotic nodules after treatment in Examples 1-3 was above 95.0%, showing a good effect in dissipating nodules.

[0067] Compared with Example 1, the treatment effects of Comparative Examples 1-3 decreased. Compared with Example 1, the curative effect also decreased after adjusting the process in Comparative Example 4.

[0068] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for liver nodules, characterized in that, It comprises the following raw materials in parts by weight: 3 - 40 parts of Salvia miltiorrhiza, 5 - 20 parts of Paeonia lactiflora, 3 - 25 parts of Cyperus rotundus, 5 - 30 parts of Poria cocos, 3 - 20 parts of Gardenia jasminoides, 3 - 19 parts of Pericarpium Citri Reticulatae Viride, 5 - 18 parts of Fructus Aurantii, 3 - 25 parts of Aucklandia lappa, 3 - 40 parts of Endothelium Corneum Gigeriae Galli, 5 - 25 parts of Fructus Amomi, 3 - 26 parts of Corydalis yanhusuo, 5 - 16 parts of Magnolia officinalis, 3 - 19 parts of Areca catechu, 3 - 30 parts of Alisma orientale, 3 - 12 parts of Glycyrrhiza uralensis, 5 - 50 parts of Artemisia capillaris, 5 - 30 parts of Isatis indigotica, 3 - 25 parts of Jianqu.

2. The traditional Chinese medicine composition according to claim 1, wherein, It comprises the following raw materials in parts by weight: 20 parts of Salvia miltiorrhiza, 12 parts of Paeonia lactiflora, 14 parts of Cyperus rotundus, 17 parts of Poria cocos, 12 parts of Gardenia jasminoides, 10 parts of Pericarpium Citri Reticulatae Viride, 12 parts of Fructus Aurantii, 14 parts of Aucklandia lappa, 20 parts of Endothelium Corneum Gigeriae Galli, 15 parts of Fructus Amomi, 15 parts of Corydalis yanhusuo, 10 parts of Magnolia officinalis, 10 parts of Areca catechu, 15 parts of Alisma orientale, 8 parts of Glycyrrhiza uralensis, 25 parts of Artemisia capillaris, 15 parts of Isatis indigotica, 14 parts of Jianqu.

3. The preparation method of the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It comprises the following steps: 1) Weigh Salvia miltiorrhiza, Paeonia lactiflora, Cyperus rotundus, Gardenia jasminoides, Fructus Aurantii, Endothelium Corneum Gigeriae Galli, Fructus Amomi, Corydalis yanhusuo, Magnolia officinalis, Alisma orientale, Glycyrrhiza uralensis, Artemisia capillaris, Isatis indigotica, crush them, use ultrasonic - microwave synergistic extraction to obtain an extract, filter, collect the filtrate, and concentrate it under reduced pressure to obtain an extractive. 2) Weigh Areca catechu, Aucklandia lappa, Pericarpium Citri Reticulatae Viride, Poria cocos, crush them, add water, and then add bacterial powder for fermentation to obtain a fermented product. 3) Mix the fermented product in step 2) with Jianqu, and then add the extractive in step 1) and mix them, followed by granulation to obtain the product.

4. The preparation method of the traditional Chinese medicine composition according to claim 3, wherein In step 1), the solvent is a 50% - 60% v / v ethanol solution, and the solid - liquid ratio kg / L is 1:6 - 8.

5. The preparation method of the traditional Chinese medicine composition according to claim 3, characterized in that, In step 1), the microwave frequency is 1500 - 2000 MHz, the ultrasonic frequency is 20 - 30 KHz, the extraction temperature is 55 - 65 °C, and the extraction time is 2 - 4 h.

6. The preparation method of the traditional Chinese medicine composition according to claim 3, characterized in that, In step 2), the bacterial powder is 0.3% - 0.8% of the total weight of the medicinal materials of Areca catechu, Aucklandia lappa, Pericarpium Citri Reticulatae Viride, and Poria cocos.

7. The preparation method of the traditional Chinese medicine composition according to claim 3, characterized in that, In step 2), the water is 30% - 40% of the total weight of the medicinal materials of Areca catechu, Aucklandia lappa, Pericarpium Citri Reticulatae Viride, and Poria cocos.

8. The preparation method of the traditional Chinese medicine composition according to claim 3, characterized in that, In step 2), the bacterial powder is composed of Saccharomyces cerevisiae, Monascus purpureus, and Aspergillus oryzae with a mass ratio of 1:0.2 - 0.5:0.5 - 0.

8.

9. The preparation method of the traditional Chinese medicine composition according to claim 3, characterized in that, In step 2), the fermentation temperature is 28 - 32 °C, and the fermentation time is 24 - 48 h.

10. The application of the traditional Chinese medicine composition according to any one of claims 1 - 2 or the traditional Chinese medicine composition obtained by the preparation method according to any one of claims 3 - 9 in the preparation of a drug for treating liver nodules.