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

Abstract

The invention relates to a traditional Chinese medicine composition for treating liver diseases such as chronic hepatitis, liver cirrhosis, liver cancer and the like, a preparation method and application in preparation of medicines for treating liver diseases. The traditional Chinese medicine composition is prepared into pills or granules, powder, capsules and the like from 0.15-36 parts by weight of sliced white aconite and 0.3-6 parts by weight of ligusticum wallichii according to the conventional preparation process of Chinese patent medicines. The effective rates of the traditional Chinese medicine composition for treating chronic hepatitis, cirrhosis and liver cancer respectively reach 87%, 75% and 70% or above. The traditional Chinese medicine composition has the characteristics of simple medicine composition, prominent curative effect, low production cost, simple and mature preparation process and the like.

Description

Technical Field

[0001] The present invention relates to a Chinese medicine composition and a preparation method and use thereof, and in particular to a Chinese medicine composition for treating liver disease, a preparation method of the Chinese medicine composition and use of the Chinese medicine composition in preparing a medicine for treating liver disease

[0002] The liver disease referred to in the present invention refers to chronic hepatitis, cirrhosis and liver cancer. Background Art

[0003] Chronic hepatitis, cirrhosis and liver cancer are caused by the failure of the human body to clear the hepatitis virus in time after infection due to dysfunctional human body, resulting in chronic damage to the liver, liver fibrosis, cell mutation, loss of human yang energy, blood stasis and microcirculation disorder. Clinically, symptoms include pale and sallow complexion, fatigue, chest and abdominal distension, liver pain, hepatosplenomegaly or liver atrophy, spider nevi, liver palms, ascites, abnormal liver function, etc. Chronic hepatitis, cirrhosis and liver cancer seriously endanger human health, and even cause people to lose their ability to work, have problems with their quality of life, and even lose their lives in a short period of time, causing great harm to social production, study, life and family.

[0004] There are many people suffering from hepatitis B in my country, but there is no effective cure on the market, and the chance of developing chronic hepatitis, cirrhosis and liver cancer is very high. If chronic hepatitis is effectively treated and cirrhosis is effectively controlled, lifelong medication is implemented, and the disease is prolonged, the health quality of the Chinese population will be greatly improved; if liver cancer patients are treated to reduce pain and prolong life, the quality of life of liver cancer patients will be greatly improved.

[0005] At present, there are many ways to treat chronic hepatitis and liver cirrhosis at home and abroad, and there are certain effects, but the overall effect is not very obvious. For example, the inventor's Chinese medicine composition for treating chronic hepatitis and its preparation method (201410720380.6) is compatible with Atractylodes macrocephala and red ginseng, and a Chinese medicine composition for treating chronic hepatitis and its preparation method (201410720618.5) is compatible with Aconite and Biejia, which have certain effects on treating chronic hepatitis, liver cirrhosis and other liver diseases. These are the initial research results of the inventor, but they strictly follow the principle of compatibility of TCM chronic disease treatment, which emphasizes the principle of assistant, main and envoy, and there are still many deficiencies, and the treatment effect is not good. The effect of TCM in treating liver cancer is even worse and is rarely used.

[0006] The best Western medical treatments for liver cancer are surgery plus targeted therapy, chemotherapy, radiotherapy, etc., but these methods have many limitations. Surgical treatment must be performed when the cancer cells have not yet metastasized, and targeted therapy requires relatively targeted drugs, and many patients do not have matching targeted drugs. Radiotherapy and chemotherapy kill cancer cells while also killing many people's normal cells, causing great pain to patients, long cycles, and high costs.

[0007] Traditional Chinese medicine has a long history in my country. Our ancestors and colleagues have explored many prescriptions and methods for treating liver diseases, which have certain effects. However, liver cancer is different from chronic hepatitis, cirrhosis and other liver diseases. The treatment methods and methods used to treat these liver diseases have little effect on liver cancer. Summary of the invention

[0008] Purpose of the invention:

[0009] One of the purposes of the present invention is to provide a Chinese medicine composition for treating chronic hepatitis, liver cirrhosis and liver cancer;

[0010] The second object of the present invention is to provide a method for preparing the Chinese medicine composition of the first object;

[0011] The third object of the present invention is to use the traditional Chinese medicine composition of the first object in preparing medicines for treating chronic hepatitis, cirrhosis and liver cancer.

[0012] The technical solution to achieve the above-mentioned purpose of the present invention is:

[0013] The raw materials for preparing the traditional Chinese medicine composition for treating chronic hepatitis, liver cirrhosis and liver cancer of the present invention are calculated by weight as follows: 0.15-36 parts of white aconite root and 0.3-6 parts of chuanxiong.

[0014] Further: 0.15-3.4 parts of Baifu Pian, 0.3-0.6 parts of Chuanxiong; Or, 3.6-5.6 parts of Baifu Pian and 1-1.5 parts of Chuanxiong; Or, 6.4-8 parts of Baifu Pian and 1.8-2.1 parts of Chuanxiong; Or, 9.6-11.2 parts of Baifu Pian and 2.4-3 parts of Chuanxiong; Or, 12.8-15 parts of Baifu Pian and 3-6 parts of Chuanxiong.

[0015] Further: 8 parts of Baifu Pian and 1 part of Chuanxiong; Or, 8 parts of Baifu Pian and 1.5 parts of Chuanxiong; Or, 8 parts of Baifu Pian and 3 parts of Chuanxiong; Or, 12 parts of Baifu Pian and 1 part of Chuanxiong.

[0016] Preparation method of Chinese medicine composition for treating chronic hepatitis, liver cirrhosis and liver cancer: a) Selecting Baifu Pian and Chuanxiong that meet the requirements of the Pharmacopoeia, soaking the Baifu Pian in boiling water for 6-14 hours, washing and draining the water, soaking in clean water for 6-14 hours, washing and draining the water, boiling for 2.5-3 hours, washing and draining the water, and drying; b) Weighing each raw material according to the formula, adding excipients and preparing a clinically applicable Chinese patent medicine dosage form according to conventional processes; Alternatively, the raw materials are crushed into powder to prepare a powder; Alternatively, the raw materials are crushed into powder and made into capsules.

[0017] Further: the drying method of white aconite root is air drying, sun drying, oven drying or the like or a combination of these methods.

[0018] Furthermore: the preferred dosage form of the clinically available Chinese patent medicine is pills and granules.

[0019] Dosage forms of the Chinese medicine composition of the present invention: The Chinese medicine composition of the present invention can be prepared into clinically available dosage forms acceptable to Chinese patent medicines such as pills, granules, capsules, tablets, etc. by conventional processes and adding conventional excipients. The Chinese medicine composition of the present invention is preferably prepared into granules and pills.

[0020] In order to realize the above dosage forms, it is necessary to add pharmaceutically acceptable excipients when preparing these dosage forms, such as fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, etc. Fillers include starch, pregelatinized starch, lactose; disintegrants include starch, pregelatinized starch, microcrystalline cellulose; lubricants include magnesium stearate, sodium lauryl sulfate, silicon dioxide, etc.; suspending agents include microcrystalline cellulose, sucrose, agar; binders include starch slurry, polyvinylpyrrolidone; sweeteners include sodium saccharin, sucrose, sodium cyclamate; flavoring agents include sweeteners and various flavors; preservatives include parabens, benzoic acid; bases include PEG6000, PEG4000, insect wax, etc.

[0021] The use of a Chinese medicine composition in preparing a medicine for treating chronic hepatitis, liver cirrhosis and liver cancer. That is, the Chinese medicine composition is used to prepare a medicine for treating chronic hepatitis, liver cirrhosis and liver cancer.

[0022] The Chinese medicine composition for treating chronic hepatitis, liver cirrhosis and liver cancer of the present invention is used in dosage and administration: oral administration, with a daily dosage of 3-48 grams calculated based on white aconite root.

[0023] The white atractylodes root in the Chinese medicine composition of the present invention greatly replenishes human yang, warms and circulates through the twelve meridians, promotes the absorption of liver tissue inflammation, regenerates liver cells, is supplemented with Chuanxiong to promote blood circulation and dissipate blood stasis, improve microcirculation disorders, and communicate the upper and lower organs. The two medicines are used together to play the functions of supporting yang and dissolving blood stasis, anti-fibrosis, anti-cancer and liver protection. It is suitable for the yang deficiency and blood stasis syndrome caused by chronic hepatitis, cirrhosis and liver cancer, and the symptoms are cold limbs, pale or sallow complexion, chest and abdominal distension, liver pain and other symptoms. In the specific application process, according to the difference in the degree of liver damage in different pathological stages and the physiological functions of different age stages, different preferred schemes are used to achieve the best therapeutic effect. The clinical trial study of 398 people carried out by the inventor shows that the patient can improve biochemical indicators and clinical symptoms after taking it for about four weeks. The effective rate of the Chinese medicine composition of the present invention for treating chronic hepatitis, cirrhosis and liver cancer reaches 87%, 75% and more than 70% respectively. The invention combines two Chinese medicinal materials, namely, white aconite root and chuanxiong, which are large-scale and low-priced in my country, and has a simple drug composition, low raw material cost and outstanding curative effect.

[0024] The invention adopts the conventional preparation process of preparing Chinese patent medicine by soaking white aconite root in boiling water, clear water or water, and then preparing various dosage forms with chuanxiong root. The process is simple, mature and easy to master.

[0025] Clinical application studies of the present invention show that the Chinese medicine composition is effective in treating chronic hepatitis at 87%, cirrhosis at 75%, and liver cancer at more than 70%. There are also many cases with significant efficacy, indicating that the Chinese medicine composition is effective in preparing drugs for treating chronic hepatitis, cirrhosis, and liver cancer. Implementation

[0026] The present invention is further described below in conjunction with clinical application examples, clinical application formulas and clinical application statistical data, but is not limited thereto.

[0027] The implementation examples of the present invention are not only cases for guiding the application of the technology of the present invention, but also examples for verifying the technical effects of the present invention.

[0028] 1. Clinical application examples

[0029] Clinical application example 1

[0030] Yang Moumou, gender: male, age: 34 years old, date of consultation: 2020.7.18, chronic liver disease.

[0031] Test results during the consultation: total bile 15.2, alanine 136, aspartate 68, GGT30, alkaline kinase 110, albumin 44, globulin 31, albumin-globulin ratio 1.42, intermolecular bile 9.1, direct bile 6.1, lactic acid 196, total protein 75, alpha-fetoprotein 14.02, hepatitis B surface antigen 20.02, hepatitis B surface antibody 0.376, e antigen 0.426, e antibody 2.027, core antibody 0.517, triglycerides 2.4, cholesterol 5.9, high density 1.8, low density 3.02, fasting blood glucose 5.3, creatinine 54, urea 2.9.

[0032] Treatment plan: 10.6 parts of Baifu Pian and 2.4 parts of Chuanxiong, grind them into fine powder and make into water pills. Take orally 13g each time, 3 times a day.

[0033] Follow-up visit on August 5, 2020: the symptoms disappeared and liver function improved.

[0034] Re-examination test: total bile 16.1, Alanine 117, Aspartate 112, GGT 31, alkaline kinase 115, albumin 42, globulin 31, albumin-globulin ratio 1.36, intermolecular bile 9.7, direct bile 6.4, lactic acid 182, total protein 73, alpha-fetoprotein 11.4, hepatitis B surface antigen 19.95, hepatitis B surface antibody 0.488, e antigen 0.725, e antibody 1.151, core antibody 0.909, triglycerides 2.1, cholesterol 5.6, high density 1.8, low density 2.9, fasting blood glucose 4.6, creatinine 50, urea: 2.8.

[0035] Then add 10.2 parts of Baifu Pian and 2.4 parts of Chuanxiong, grind them into fine powder, and make them into water pills. Take 12.6g orally each time, 3 times a day.

[0036] Re-diagnosis on August 22, 2020, liver function improved.

[0037] Re-examination test: total bile 15.2, alanine 76, aspartate: 51, GGT28, alkaline kinase 103, albumin 42, globulin 30, albumin-globulin ratio 1.4, intermolecular bile 9.1, direct bile 6.1, lactic acid 138, total protein 72, alpha-fetoprotein 10.3, hepatitis B surface antigen 20.00, hepatitis B surface antibody 0.659, e antigen 0.609, e antibody 0.770, core antibody 0.893, triglycerides 2.0, cholesterol 5.4, high density 1.7, low density 2.8, fasting blood glucose 4.6, creatinine 51, urea 2.6.

[0038] 13.6 parts of Baifu Pian and 2.4 parts of Chuanxiong were added, ground into fine powder and made into water pills. Take 16g orally, 3 times a day.

[0039] The patient was examined again on September 12, 2020. The symptoms had disappeared and the patient was clinically cured and stopped taking the medication.

[0040] Re-examination test: total bile 14.5, alanine 17, aspartate: 14, GGT25, alkaline kinase 78, albumin 45, globulin 30, albumin-globulin ratio 1.5, intermolecular bile 8.7, direct bile 5.8, lactic acid 159, total protein 75, alpha-fetoprotein 10.3, hepatitis B surface antigen 18.32, hepatitis B surface antibody 0.942, e antigen 0.526, e antibody 0.809, core antibody 0.850, triglycerides 2.2, cholesterol 5.6, high density 1.8, low density 2.8, fasting blood glucose 4.4, creatinine 71, urea 3.9.

[0041] This case uses segmented medication to explore the effects of different drug ratios on the same person.

[0042] Clinical application example 2

[0043] Name: Wang, Gender: Female, Age: 38 years old, Date of consultation: 2022.6.20, Chronic liver disease.

[0044] Test results during the consultation: Alanine 612, aspartate 227, total protein 64, albumin 36, total bilirubin 21, choline 11, choline 11.9, alkaline kinase 102, GGT 144, urea 3.9, creatinine 59, uric acid 330, glucose 4.63, cholesterol 3.67, triglycerides 1.23, high density 0.73, low density 2.15.

[0045] Color Doppler ultrasound: The liver is normal in size and shape, with a smooth capsule, uniform echo of the substance, clear intrahepatic blood vessels, and a narrow portal vein; the gallbladder is normal in size and shape, with edema of the wall, about 0.5 cm thick, and no obvious abnormal echo mass in the capsule; the intrahepatic and extrahepatic bile ducts are not dilated. The pancreas is normal in size and shape, with uniform glandular echo, and the main pancreatic duct is not dilated; the spleen is normal in size and shape, with a smooth capsule, uniform echo of the substance, and no dilation of the splenic portal vein; the kidneys are normal in size and shape, with a smooth capsule, uniform echo of the substance, and no separation of the collecting system, and no definite space-occupying mass is found inside.

[0046] CDFI: No abnormal blood flow signal was found.

[0047] Supine examination: A fluid dark area with a depth of about 2.5 cm was found in the right chest cavity.

[0048] Chest CT: bilateral chest width is symmetrical, mediastinum is in the middle, trachea and main bronchi are unobstructed. The texture of both lungs is natural, small patchy shadows are seen in the middle lobe of the right lung, no enlarged lymph nodes are seen in the bilateral hilum and mediastinum; arc-shaped liquid density shadows are seen in the right chest cavity; no thickening of the pleura is seen.

[0049] Prepare 8 parts of Baifu Pian and 1 part of Chuanxiong, grind them into fine powder and make into water pills. Take orally 12g each time, 3 times a day.

[0050] Follow-up visit on July 19, 2022 showed that the symptoms had been relieved, but there were slight abnormalities in the liver.

[0051] Re-examination test: total bile 18.9, direct bile 7.6, intermolecular bile 11.3, alanine 41, aspartate 48, glutamyl 47, alkaline 86, lactase 297, total protein 73, albumin 43, globulin 30, albumin-globulin ratio 1.43, alpha-fetoprotein 17.2, surface antigen 0.378, surface antibody 11.98, e antigen 0.395, e antibody 0.671, core antibody 0.658, triglycerides 2.7, cholesterol 6.2, high density 1.6, low density 3.4, fasting blood glucose 5.8, creatinine 73, urea 3.5.

[0052] Then prepare 8 parts of Baifu Pian and 1.5 parts of Chuanxiong, grind them into fine powder, make them into water pills, take orally 12g each time, 3 times a day.

[0053] Re-examination on July 26, 2022 showed that the symptoms had disappeared, liver function was normal, the patient was clinically cured, and the medication was stopped.

[0054] Clinical application example 3

[0055] Name: Liu, Gender: Female, Age: 48, Date of visit: 2011.3.11. Liver cirrhosis. Typical symptoms: Drum-like abdomen, difficulty in movement.

[0056] Test results during consultation: ALP 101.6, aspartate 167.5, ALP / aspartate 1.6, total bile: 41.3, direct bile 14.9, indirect bile 26.4, total protein 74.9, albumin 28.3, globulin 46.6, albumin-globulin ratio 0.61, alkaline enzyme 73, total bile acid 6.8, acyl deaminase 11, glutamyl 32, creatinine 189.3, uric acid 682, urea 8.2, hepatitis B surface antigen negative, hepatitis B surface antibody negative, e antigen negative, e antibody negative, core antibody negative, hemoglobin 125, red blood cells 4.12, platelets 118, white blood cells 13.5.

[0057] Prepare granules with 7.5 parts of Baifu Pian and 2 parts of Chuanxiong, and take 10g orally 3 times a day.

[0058] After two months of treatment, the ascites disappeared completely and the patient was clinically cured.

[0059] Clinical application example 4

[0060] Ran, gender: female, age: 62 years old, date of consultation: 2010.4.14, liver cirrhosis. Typical symptoms: distended abdomen, swollen legs, fatigue.

[0061] Test results during consultation: total bilirubin 14.5, bile saccharide: 5.1, bile saccharide 9.4, alanine 19, aspartate 26, glutamyl 63, alkaline enzyme 141, lactase 194, total protein 67, albumin 38, alpha-fetoprotein 20, total bile acid 9.5, prealbumin 219.

[0062] Color Doppler ultrasound: The shape and size of the liver section are basically normal, the liver capsule is irregular, the echo of the liver parenchyma is thickened and enhanced, the distribution is uneven, the duct structure is clearly displayed, and a cord-like strong echo is mentioned in the right posterior lobe of the liver, followed by a faint acoustic shadow. The shape and size of the gallbladder section are normal, the wall is thin and not smooth, and no abnormalities are found inside. There is no dilatation of the intrahepatic and extrahepatic bile ducts. The shape and size of the pancreas are normal, the echo is uniform, and no obvious abnormalities are found inside. The spleen is about 4.2cm thick, and the length from the spleen hilum to the spleen apex is about 7.8cm. The echo of the parenchyma is uniform, and no abnormalities are found inside. The shape and size of both kidneys are normal, the capsule is smooth, the echo of the parenchyma is uniform, and the collecting system is not separated, and no definite space is found inside. Irregular liquid dark areas are mentioned in the abdominal cavity, the deepest of which is about 7.0cm.

[0063] Prepare 5 parts of Baifu Pian and 2 parts of Chuanxiong, grind them into fine powder and make granules. Take orally 20g each time, 3 times a day.

[0064] After 23 days of treatment, 3 parts of Baifu Pian and 1 part of Chuanxiong are prepared, ground into fine powder and made into granules. Take orally 20g each time, 3 times a day.

[0065] Re-diagnosis on June 28, 2011: Color Doppler ultrasound: The liver section is normal in shape and size, with multiple strong echogenic spots in the right lobe, the largest of which is about 0.7 cm in diameter. The remaining liver parenchyma has more and thicker spots, and the echo is uneven. The gallbladder section is normal in shape and size, with a slightly thick and rough wall, and no abnormalities are found inside. There is no dilatation of the intrahepatic and extrahepatic bile ducts. The pancreas is normal in shape and size, with uniform echoes, and no obvious abnormalities are found inside. The spleen is about 3.6 cm thick, and the length from the spleen hilum to the spleen apex is about 6.3 cm. The parenchyma has uniform echoes, and no abnormalities are found inside. Both kidneys are normal in shape and size, with smooth capsules and uniform parenchyma echoes. There is no separation of the collecting system, and no definite space-occupying mass is found inside. CDFI: No abnormal blood flow signals are found.

[0066] Re-diagnosis test: total bilirubin 24.6, direct bilirubin 8.2, indirect bilirubin 16.4, alanine 28, aspartate 36, glutamyl 53, alkaline enzyme 257, lactase 195, total protein 65, albumin 38, globulin 27, hepatitis B surface antigen 0.820, hepatitis B surface antibody 0.700, e antigen 0.520, e antibody 3.720, core antibody 0.630, triglycerides 2.58, cholesterol 6.14, high density 1.61, low density 3.15, fasting blood glucose 7.3, uric acid 478, creatinine 162.5, urea: 12.4.

[0067] 5 parts of Baifu Pian and 2 parts of Chuanxiong are added, and the mixture is ground into fine powder to make granules. Take orally 20g each time, 3 times a day.

[0068] I have been taking the medicine till now and am still healthy.

[0069] Clinical application example 5

[0070] Mao, male, age: 70, date of consultation: 2022.3.18, liver cancer. Symptoms: belly as big as a drum, swollen feet, bloating, fatigue, occasional mental confusion, liver pain.

[0071] CT: The liver volume is reduced, the liver fissure is widened, the liver capsule is wavy, and the density of the substance is thick. Multiple nodular enhancement shadows are seen in the liver during the arterial phase. The larger one is located in the caudate lobe, about 3.1cm*3.2cm. The lesion in the caudate lobe of the liver is slightly low-density during the portal phase. The remaining nodules are similar to the enhancement degree of the liver parenchyma during the portal phase, and seem to be slightly low-density shadows during the delayed phase. Small nodules without enhancement are seen in the liver S8 segment, with clear boundaries. The portal vein is thickened. The spleen is enlarged, and no abnormal density shadows are seen in the substance. The gallbladder is not large, the wall is slightly thickened, and high-density shadows with mural dots can be seen. The shape and density of the pancreas are normal. The portal vein is about 1.5cm thick. The umbilical vein is open, and the abdominal wall is varicose. Varicose veins are seen in the fundus of the stomach and the lower esophagus. Nodular low-density shadows are seen in both kidneys, the larger one is about 1.2cm in diameter, and no enhancement is seen. A large amount of fluid is accumulated in the abdominal cavity.

[0072] Prepare 5 parts of Baifu Pian and 1 part of Chuanxiong, grind them into fine powder, make into water pills, take 15g orally, 3 times a day. Also prepare 20mg of spironolactone, 20mg of furosemide, and 10ml of potassium chloride.

[0073] Follow-up visit on May 22, 2022, the ascites had disappeared, and the patient was able to eat, sleep, and move around.

[0074] CT: The liver is abnormally shaped, with widened liver fissures. The intrahepatic and extrahepatic bile ducts are dilated, the gallbladder is full, and the wall is thickened. A high-density nodule with a diameter of about 0.50m is seen in the cyst, and there is fluid in the gallbladder fossa. The spleen is slightly enlarged. There is no abnormality in the pancreas and adrenal glands. The right abdominal peritoneum and mesentery are thickened and swollen, and some intestinal walls are slightly swollen. There is fluid around the liver and in the liver-kidney space, and the lymph nodes in the mesenteric region are increased and enlarged.

[0075] After that, he was still treated with the above method, and all aspects of his life were still good. In December 2023, he died of a severe cold with pneumonia.

[0076] Clinical application example 6

[0077] Mr. Fei, gender: male, age: 58 years old, date of consultation: 2015.12.11, liver cancer. Symptoms: cough, shortness of breath, liver pain, fatigue, loss of appetite.

[0078] Test results: total bilirubin 12.8, direct bilirubin 5.0, indirect bilirubin 7.8, total albumin 63.8, albumin 63.8, globulin 24.9, albumin-globulin ratio 1.562, alanine 28, aspartate 25, aspartate / alanine 0.92, alkaline phosphatase 85, glutamyl 18gt / ALP: 0.21, GT / AST 0.70, lactate 148, LDH / AST 5.81, urea nitrogen 8.7, creatinine 70 .3, uric acid 358.9, cysteine ​​0.72, triglycerides 0.73, glucose 5.32, total cholesterol 4.48, creatine 200.7, creatine isoenzyme 13.1, hydroxybutyric acid 111, bicarbonate 27.2, C-reactive protein 0.2, glycosylated hemoglobin 5.8, hepatitis B surface antigen 40.280, hepatitis B surface antibody 2.28, hepatitis B e antigen 0.05, hepatitis B e antibody 12, hepatitis B core antibody 96.

[0079] CT: The chest is asymmetrical, slightly collapsed on the right upper part, the trachea and mediastinum are not significantly offset, the bilateral bronchi are patent, the shadows of the bilateral hilums are slightly larger, there are suspicious enlarged lymph nodes in front of the carina and behind the superior vena cava, and there are small millet-like and patchy high-density lesions in the upper and middle fields of both lungs. The lesions are obvious in the near hilar area of ​​the bilateral upper lungs, with fibrous cord-like shadows, some lesions are aggregated, and there are small calcium spots in some parts. The bilateral upper pleura is thickened and adhered. The heart shadow is not large, there is no effusion in the bilateral pleural cavity, and there is a round low-density lesion on the right liver diaphragm.

[0080] Color Doppler ultrasound: Liver: The liver is normal in size and shape, with a smooth capsule and uneven echo of the substance. An echo-free area is detected in the liver, about 22x18mm in size, with regular shape, clear boundaries, clear vascular texture, and no sound attenuation in the far field. The inner diameter of the portal vein is 11mm. Postprandial gallbladder: The inner diameter of the common bile duct is 5mm, and the intrahepatic bile duct is dilated. Pancreas: Normal in size and shape, clear outline, homogeneous echo, and no dilatation of the main pancreatic duct. Spleen: Not large, homogeneous echo of the substance, and no abnormality is found inside. Both kidneys: Both kidneys are normal in size and shape, with smooth capsules and homogeneous echo of the substance. A strong echo is detected in the renal sinus of the right kidney, about 4x4mm in size, followed by a faint acoustic shadow. No stones, hydrops, or masses are found in the left kidney.

[0081] Prepare 4 parts of Baifu Pian and 1 part of Chuanxiong, grind them into fine powder, make into water pills, take orally 20g each time, 3 times a day.

[0082] After a follow-up visit four months later, the symptoms disappeared and the medication was stopped. He died of COVID-19 in December 2019.

[0083] 2. Formula example

[0084] Formula Example 1 8 parts of Baifu Pian and 1 part of Chuanxiong.

[0085] Formula Example 2 8 parts of Baifu Pian and 1.5 parts of Chuanxiong.

[0086] Formula Example 3 8 parts of Baifu Pian and 3 parts of Chuanxiong.

[0087] Formula Example 5 14 parts of Baifu Pian and 3 parts of Chuanxiong.

[0088] Formula Example 6 (Upper Limit Example) 6 parts of Baifu Pian and 1 part of Chuanxiong.

[0089] Formula Example 7 (Lower Limit Example) 1 part of Baifu Pian and 2 parts of Chuanxiong.

[0090] In the above formula example, a) select Baifu Pian and Chuanxiong that meet the requirements of the Pharmacopoeia. Soak Baifu Pian in boiling water for about 12 hours, rinse and drain, soak in clean water for about 12 hours, rinse and drain, boil for 2.5-3 hours, rinse and drain, and then air-dry / dry.

[0091] b) Weigh each raw material according to the formula, add excipients and prepare clinically usable Chinese patent medicine dosage forms such as pills and granules according to conventional processes.

[0092] All have good effects.

[0093] 3. Clinical trial statistics

[0094] The inventors conducted clinical application experimental research on 398 people in total, and achieved good results according to the technical scheme of the present invention, which has guiding significance for verifying the technical effect of the technical scheme of the present invention and guiding the application of the technical scheme of the present invention.

[0095] Clinical application experiment in treating liver cancer

[0096] From 2000 to 2024, the inventor clinically treated 78 patients with liver cancer according to the method of the present invention, including 48 males and 30 females.

[0097] Diagnostic criteria for liver cancer

[0098] (1) Medical history 1) History of acute or chronic hepatitis; 2) History of cirrhosis.

[0099] (2) Typical symptoms 1) Sudden weight loss and fatigue; 2) Sudden onset of gastrointestinal symptoms; 3) Sudden onset of ascites; 4) A mass can be felt in the liver.

[0100] (3) Biochemical indicators 1) Increased total bilirubin, direct bilirubin, and indirect bilirubin; 2) Elevated alanine aminotransferase and aspartate aminotransferase, with aspartate aminotransferase higher than alanine aminotransferase; 3) GGT, alkaline phosphatase, and lactate dehydrogenase are abnormal and higher than alanine aminotransferase and aspartate aminotransferase.

[0101] (4) Immune indicators The tumor marker is positive, and the higher the tumor marker, the more serious the condition, especially alpha-fetoprotein and carcinoembryonic antigen are particularly important.

[0102] (5) Physical indicators 1) Color Doppler ultrasound and CT scans showed liver mass and splenomegaly; 2) Color Doppler ultrasound and CT scans of critically ill patients show pleural effusion or ascites; 3) Gastroscopy showed esophageal varices; 4) Cancer cells can be seen under the microscope in the sections of the diseased tissue.

[0103] Liver cancer treatment efficacy criteria

[0104] (1) Invalid 1) No improvement in clinical symptoms; 2) No improvement in biochemical, physical, and tumor marker indicators; 3) Maintain the status quo; 4) The condition worsens.

[0105] (2) Effective 1) Clinical symptoms are effectively controlled; 2) One or more biochemical, physical, or tumor marker indicators have improved.

[0106] (3) Clinical cure 1) Clinical symptoms disappear; 2) Able to take care of themselves; 3) Most of the biochemical, physical and tumor marker indicators are normal; 4) The condition is effectively controlled.

[0107] (4) Basically cured 1) Clinical symptoms disappear; 2) Able to take care of themselves; 3) Be able to perform certain work; 4) Tumor markers turn negative; 5) Most of the biochemical and physical indicators are normal; 6) The condition has not recurred within six months.

[0108] (5) Cure 1) Clinical symptoms disappear; 2) Self-care; 3) Be able to perform the job; 4) Negative tumor markers; 5) Biochemical and physical indicators are normal; 6) The disease has not recurred for more than one year.

[0109] Liver cancer diagnosis and treatment efficacy table

[0110] Clinical application experiment of treating liver cirrhosis

[0111] From 2000 to 2024, 110 patients with liver cirrhosis were treated according to the method of the present invention, including 60 males and 50 females.

[0112] Diagnostic criteria for liver cirrhosis:

[0113] (1) Medical history History of chronic hepatitis or severe hepatitis.

[0114] (2) Typical symptoms 1) Fatigue, sallow complexion; 2) Palmar erythema and spider nevi; 3) Ascites occurs in severe cases or during the exhaustion stage; 4) Splenomegaly and liver atrophy; There are two exceptions above.

[0115] (3) Biochemical indicators 1) Mild to moderate abnormalities in total bilirubin, direct bilirubin, and indirect bilirubin; 2) Abnormal alanine aminotransferase and aspartate aminotransferase, with aspartate aminotransferase higher than alanine aminotransferase; 3) Abnormalities of GGT, alkaline phosphatase, and lactate dehydrogenase; 4) Low albumin and high globulin; There are two exceptions above.

[0116] (4) Physical indicators ①B-ultrasound and CT scans showed an enlarged spleen and a shrunken liver; ② B-ultrasound and CT scans of critically ill patients showed pleural effusion and ascites; ③ Gastroscopy of patients with severe advanced disease showed esophageal varices; The diagnosis can be confirmed if any of the above is abnormal.

[0117] Cirrhosis efficacy criteria:

[0118] (1) Invalid There is no improvement in clinical symptoms, biochemical indicators, and physical indicators. Instead, the condition worsens or remains the same.

[0119] (2) Effective 1) Clinical symptoms have improved; 2) There is improvement in one or more biochemical and physical indicators.

[0120] (3) Clinical cure 1) Symptoms disappear; 2) Most of the biochemical and physical indicators have recovered.

[0121] (4) Basically cured 1) The symptoms disappear, the patient is able to do appropriate work and take care of himself; 2) Most of the biochemical and physical indicators are normal.

[0122] (5) Cure 1) Be competent for work and fully self-sufficient; 2) Biochemical and physical indicators are normal, and viral markers are negative.

[0123] Liver cirrhosis diagnosis and treatment efficacy table

[0124] Clinical application experiment of treating chronic hepatitis

[0125] From 2000 to 2024, 210 patients with chronic hepatitis were admitted to the clinic, including 124 males and 86 females.

[0126] Diagnostic criteria for chronic hepatitis:

[0127] (1) Medical history 1) Patients with latent or acute hepatitis that has not been cured for three months; 2) History of severe liver disease; 3) Big triple positive, small triple positive, and anti-HBC positive.

[0128] (2) Typical symptoms 1) Frequent or recurrent fatigue, liver pain or abdominal distension, loss of appetite, and decreased labor power; 2) Hepatosplenomegaly or tenderness; 3) Spider nevi and palmar erythema; 4) Yellowing of the skin and sclera; Those with one or two abnormalities above.

[0129] (3) Biochemical indicators 1) Mild abnormalities in total bilirubin, direct bilirubin, indirect bilirubin, and total bile acid; 2) Mild or moderate abnormality of alanine aminotransferase and aspartate aminotransferase; Those with abnormalities in one or two of the above conditions.

[0130] Chronic hepatitis efficacy standards:

[0131] (1) Invalid There was no improvement in clinical symptoms, biochemical indicators, or physical indicators, but the condition worsened.

[0132] (2) Effective 1) Improvement of clinical symptoms; 2) There is improvement in one or more biochemical and physical indicators.

[0133] (3) Clinical cure The symptoms basically disappeared and most of the biochemical indicators returned to normal.

[0134] (4) Basically cured Symptoms disappear and biochemical indicators return to normal within half a year.

[0135] (5) Cure Symptoms disappear, and biochemical indicators and antigen systems turn negative for more than one year.

[0136] Chronic hepatitis diagnosis and treatment efficacy table

Claims

1. A Chinese medicine composition for treating liver disease, characterized in that: The invention is prepared from the following raw materials in parts by weight: 0.15-36 parts of white aconite root and 0.3-6 parts of chuanxiong.

2. The Chinese medicine composition for treating liver disease according to claim 1, characterized in that: 0.15-3.4 parts of Baifu Pian, 0.3-0.6 parts of Chuanxiong; Or, 3.6-5.6 parts of Baifu Pian and 1-1.5 parts of Chuanxiong; Or, 6.4-8 parts of Baifu Pian and 1.8-2.1 parts of Chuanxiong; Or, 9.6-11.2 parts of Baifu Pian and 2.4-3 parts of Chuanxiong; Or, 12.8-15 parts of Baifu Pian and 3-6 parts of Chuanxiong.

3. The Chinese medicine composition for treating liver disease according to claim 1, characterized in that: 8 parts of Baifu Pian and 1 part of Chuanxiong; Or, 8 parts of Baifu Pian and 1.5 parts of Chuanxiong; Or, 8 parts of Baifu Pian and 3 parts of Chuanxiong; Or, 12 parts of Baifu Pian and 1 part of Chuanxiong.

4. The method for preparing the Chinese medicine composition for treating liver disease according to any one of claims 1 to 3, characterized in that: a) Select white atractylodes root and chuanxiong root that meet the requirements of the Pharmacopoeia; soak the white atractylodes root in boiling water for 6-14 hours, rinse and drain, soak in clean water for 6-14 hours, rinse and drain, boil for 2.5-3 hours, rinse and drain, and dry; b) Weighing each raw material according to the formula, adding excipients and preparing a clinically applicable Chinese patent medicine dosage form according to conventional processes; Alternatively, the raw materials are crushed into powder to prepare a powder; Alternatively, the raw materials are crushed into powder and made into capsules.

5. The method for preparing the Chinese medicine composition for treating liver disease according to claim 4, characterized in that: The drying methods of Baifu Pian are air drying, sun drying, oven drying or a combination of these.

6. The method for preparing the Chinese medicine composition for treating liver disease according to claim 4, characterized in that: The clinically available Chinese patent medicine dosage forms are pills and granules.

7. Use of the Chinese medicine composition according to claims 1-3 in preparing medicines for treating chronic hepatitis, liver cirrhosis and liver cancer.

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