A Chinese medicine composition for treating liver disease and its preparation method and application

Abstract

The present invention relates to a Chinese medicine composition for treating liver diseases such as chronic hepatitis, liver cirrhosis, liver cancer, and a preparation method thereof, and an application thereof in preparing a medicine for treating liver diseases. The Chinese medicine composition is prepared from 0.1-15 parts by weight of white aconite root, 0.1-15 parts by weight of red ginseng, 0.3-3 parts by weight of curcuma zedoariae, and 0.3-3 parts by weight of ligusticum chuanxiong in a conventional Chinese patent medicine production process in the form of pills, granules, powders, capsules, etc. The effective rate for treating chronic hepatitis is 95.16%, the effective rate for treating liver cirrhosis is 76%, and the effective rate for treating liver cancer is 62.4%. After taking the composition for about four weeks, the biochemical indexes and clinical symptoms can be improved. The composition has the characteristics of simple drug composition, outstanding curative effect, low production cost, simple and mature production process, etc.

Description

Technical Field

[0001] The present invention relates to a Chinese medicine composition, a preparation method and application thereof, and in particular to a Chinese medicine composition for treating liver disease, a preparation method of the Chinese medicine composition and application of the Chinese medicine composition in preparing 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, there are symptoms such as 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, 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, cirrhosis is effectively controlled, and lifelong medication is implemented, the health quality of the 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: One of the purposes of the present invention is to provide a Chinese medicine composition for treating liver disease; The second object of the present invention is to provide a method for preparing the Chinese medicine composition for treating liver disease according to the first object; The third object of the present invention is to use the Chinese medicine composition of the first object in preparing medicines for treating liver diseases.

[0009] The technical solution to achieve the purpose of the present invention is:

[0010] The Chinese medicine composition for treating liver disease is prepared from the following raw materials in parts by weight: 0.1-15 parts of white aconite root, 0.1-15 parts of red ginseng, 0.3-3 parts of curcuma, and 0.3-3 parts of chuanxiong.

[0011] Preferred: 0.1-2.4 parts of white aconite root, 0.1-2.4 parts of red ginseng, 0.3-1 parts of zedoaria, 0.3-1 parts of chuanxiong; Or, 2.6-4.8 parts of white aconite root, 2.6-4.8 parts of red ginseng, 0.3-1.2 parts of zedoaria, 0.3-1.2 parts of chuanxiong; Or, 5.6-8.8 parts of white aconite root, 5.6-8.8 parts of red ginseng, 0.3-1.2 parts of zedoaria, 0.3-1.2 parts of chuanxiong; Or, 9.6-11.2 parts of white aconite root, 9.6-11.2 parts of red ginseng, 1-2.5 parts of zedoaria, 1-2.5 parts of chuanxiong; Or, 14.4-15 parts of white atractylodes root, 9.6-11.52 parts of red ginseng, 1-2.5 parts of curcuma, and 1-2.5 parts of chuanxiong.

[0012] Preferred: 4 parts of white aconite root, 3 parts of red ginseng, 0.5 parts of curcuma, and 0.5 parts of chuanxiong; Or, 6 parts of white aconite root, 4 parts of red ginseng, 0.6 parts of curcuma, and 0.6 parts of chuanxiong; Or, 10 parts of white aconite root, 9 parts of red ginseng, 1 part of curcuma, 1 part of chuanxiong; Or, 14 parts of white aconite root, 12 parts of red ginseng, 1.5 parts of curcuma, and 1.5 parts of chuanxiong; Or, 15 parts of white aconite root, 12 parts of red ginseng, 2 parts of curcuma, and 2 parts of chuanxiong.

[0013] Preparation method of Chinese medicine composition for treating liver disease: a) Select white atractylodes root, red ginseng, zedoaria, and chuanxiong 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 clinically applicable Chinese patent medicine dosage forms such as pills, granules, capsules, tablets, etc. 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.

[0014] Preferably, the drying method of Baifu Pian is one or a combination of air drying, sun drying, and oven drying.

[0015] Preferably, the clinically available Chinese patent medicine dosage form is pills or granules.

[0016] The preparation of various dosage forms of the Chinese medicine composition of the present invention adopts the conventional preparation process of the corresponding dosage forms of Chinese patent medicine.

[0017] The conventional process includes water extraction, ethanol extraction, water extraction and alcohol precipitation, etc., or further purification after extraction, such as macroporous resin column. The extraction method includes decoction, immersion extraction, percolation extraction, reflux extraction, ultrasonic extraction, etc.

[0018] In order to realize the above dosage forms, it is necessary to add drug-acceptable excipients when preparing these dosage forms. For example: fillers, disintegrants, lubricants, suspending agents, adhesives, 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; adhesives include: starch slurry, polyvinylpyrrolidone; sweeteners include: saccharin sodium, sucrose, sodium cyclamate; flavoring agents include: sweeteners and various flavors; preservatives include: parabens, benzoic acid; bases include: PEG6000, PEG4000, insect wax, etc.

[0019] The preparation of various dosage forms of the present invention adopts conventional production processes, and the production processes are well known to those skilled in the art, so the production methods are not described in detail.

[0020] The invention discloses an application of a Chinese medicine composition in preparing medicines for treating chronic hepatitis, liver cirrhosis and liver cancer, that is, the Chinese medicine composition is used to prepare medicines for treating chronic hepatitis, liver cirrhosis and liver cancer.

[0021] 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.

[0022] The white atractylodes root in the Chinese medicine composition of the present invention greatly replenishes the yang energy of the human body, warms and circulates the twelve meridians, promotes the absorption of liver tissue inflammation, regenerates liver cells, supplemented with red ginseng to replenish vital energy, promotes liver cell growth, and is supplemented with zedoaria to promote blood circulation and remove blood stasis, improve microcirculation disorders, and use chuanxiong to communicate with the upper and lower organs, and guide the medicine directly to the liver. All the medicines are used together to play the role of supporting yang, helping the essence and removing blood stasis, anti-cancer, protecting the liver and protecting the liver, and are suitable for chronic hepatitis, cirrhosis, and liver cancer. The clinical trial study of 1587 people carried out by the inventor shows that patients generally take about four weeks to improve biochemical indicators and clinical symptoms. The Chinese medicine composition of the present invention has an effective rate of 95.16% in the treatment of chronic hepatitis, 76.76% in the treatment of cirrhosis, and 62.4% in the treatment of liver cancer. The drug composition of the present invention is simple in composition, outstanding in curative effect, and has no toxic and side effects. In the process of specific application, different pathological stages and different age stages use different preferred schemes to achieve the best therapeutic effect. The basis for this is that the degree of liver damage varies at different pathological stages; secondly, the physiological functions are different at different age stages.

[0023] The Chinese medicine composition of the present invention is based on the etiology and pathology of chronic hepatitis, cirrhosis and liver cancer and the pharmacology of various raw materials, after more than 30 years of continuous exploration and improvement of clinical research, strictly in accordance with the compatibility principle of Zuochengjunshi, through thousands of compatibility and ratio screening experiments and clinical application experiments summary and analysis, and finally proposed the compatibility and ratio of various raw materials, and its ratio scheme has been summarized into a calculation formula. In the process of specific application, different preferred schemes can be used according to different pathological stages and different ages to achieve the best therapeutic effect.

[0024] The invention uses white aconite root, red ginseng, zedoaria and chuanxiong, four Chinese medicinal materials with large output and low price in my country, and has simple drug composition, low cost of raw materials and outstanding curative effect.

[0025] The invention adopts the method of soaking white aconite slices in boiling water, soaking in clear water, boiling and then preparing various dosage forms according to the conventional preparation process of Chinese patent medicine. The process is simple, mature and easy to master.

[0026] Clinical application studies of the present invention show that the effective rate of the Chinese medicine composition in treating chronic hepatitis is 95.16%, the effective rate of treating liver cirrhosis is 76.76%, and the effective rate of treating liver cancer is 62.4%. There are also many cases with significant efficacy, indicating that the Chinese medicine composition is effective in preparing drugs for treating chronic hepatitis, liver cirrhosis, and liver cancer. Implementation

[0027] The present invention is further described below in conjunction with clinical application examples and clinical application statistical data, but is not limited thereto.

[0028] 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.

[0029] 1. Application Examples

[0030] Application Example 1

[0031] Liu, male, 62 years old, visited the hospital on March 8, 2018. His typical symptoms at the time of consultation included: weight loss, sallow complexion, loss of appetite, a mass of about 3 cm in the liver, and an enlarged spleen.

[0032] Biochemical examination: total bile 17.5, straight bile 5.8, intercalated bile 11.7, alanine aminotransferase 33, alanine 27, glutamyl 43, alkaline phosphatase 117, alpha-fetoprotein 118, hepatitis B positive.

[0033] Color Doppler ultrasound: portal vein trunk 1.4, and a 3.3×2.8×2.5cm echogenic nodule was seen in the right anterior lobe of the liver.

[0034] Diagnosis: Liver cancer.

[0035] Treatment: Five levels of strengthening the body, warming and activating blood circulation.

[0036] Prescription: 15 parts of white aconite root, 12 parts of red ginseng, 2 parts of Curcuma zedoaria, and 1 part of Chuanxiong.

[0037] The water pills were made according to the conventional process, and 45g of Zhebaifu Pian was taken three times a day. The patient took the medicine until April 20, 2018, and his spirit improved, his symptoms disappeared, his liver function was normal, and his fetal alpha was 197.

[0038] Color Doppler ultrasound: about 1.2×1cm parenchymal enhanced echo was seen in the right lobe of the liver.

[0039] He took the medicine until July 21, 2021, and died in hospital due to high blood sugar.

[0040] Application Example 2

[0041] Ms. Jia, female, 67 years old, was admitted to the hospital on December 28, 2006. Typical symptoms at the time of the visit: unable to take care of herself, needed help to walk, fatigue, loss of appetite, sallow complexion and liver pain.

[0042] Biochemical examination: total bile 13.4, intercalated bile 8.1, alanine 29, aspartate 43, glutamyl 82, alkaline phosphatase 249, lactic acid 169, albumin 35, globulin 29, alpha-fetoprotein 56, carcinoembryonic antigen 48.

[0043] CT: The liver section was normal in size, the capsule was intact, the inner diameter of the portal vein was 10 mm, a slightly enhanced echo with acoustic shadow of 14x7 mm was seen in the right lobe of the right liver, and a weakened echo of 18×16 mm and 21×18 mm was seen in the posterior lobe of the left liver, with unclear edges.

[0044] Diagnosis: Liver cancer.

[0045] Treatment: Level 5 strengthening the body. Warming and activating blood circulation.

[0046] Prescription: 14 parts of white aconite root, 11 parts of red ginseng, 1.5 parts of curcuma zedoaria, and 1.5 parts of chuanxiong. Make them into pills according to conventional techniques, take three times a day, and take 42 grams of white aconite root daily.

[0047] Follow-up visit on January 10, 2007, typical symptoms: the patient can take care of himself, does not need any help, and lives and eats as usual.

[0048] Biochemical examination: total bile 13.14, straight bile 5.3, interstitial bile 8.1, alanine aminotransferase 29, aspartate aminotransferase 43, glutamyl transpeptidase 45, alkaline phosphatase 168, albumin 34, globulin 26, lactate dehydrogenase 168, alpha-fetoprotein 28, carcinoembryonic antigen 30.

[0049] Color Doppler ultrasound: liver is normal.

[0050] If the above medication was taken for 5 years without stopping, the patient is now 84 years old and still healthy, with no other adverse reactions.

[0051] Application Example 3

[0052] Ms. Pi, female, 56 years old. Visited the hospital on January 14, 2017.

[0053] Typical symptoms: distended abdomen, swollen feet, loss of appetite, fatigue, and difficulty moving.

[0054] Biochemical examination: total bile 26.5, straight bile 16.4, alanine aminotransferase 46, aspartate aminotransferase 67, alkaline phosphatase 190, albumin 39.7, globulin 30.1.

[0055] Color Doppler ultrasound: The liver showed increased echogenicity, uneven thickening, rough capsule, unclear blood vessels, irregular liquid dark area of ​​11.8 cm in liver and kidney cross section, gallbladder size was about 7.3×3.6 cm, bilateral shadow, spleen was about 7 cm thick, no abnormal echo was found, common bile duct was not obviously dilated, pancreas, spleen and kidney were normal, irregular liquid dark area of ​​about 12.8 cm deep was found in the abdomen, and intestinal echo was seen inside.

[0056] Diagnosis: Decompensated cirrhosis.

[0057] Treatment: Strengthen the body, warm the body and activate blood circulation.

[0058] Prescription: 9.6 parts of white aconite root, 9.6 parts of red ginseng, 1.5 parts of curcuma zedoaria, 1.5 parts of chuanxiong. Grind them into fine powder, process into granules according to the routine method, take orally, three times a day, and the daily dosage of white aconite root is 30 grams.

[0059] Follow-up visit on January 21, 2017:

[0060] Typical symptoms: no abnormalities in the abdomen and normal life.

[0061] Biochemical examination: total bile 16.8, straight bile 5.2, intercalated bile 11.6, alanine aminotransferase 45, aspartate aminotransferase 52, glutamate aminotransferase 47, alkaline phosphatase 187, lactate dehydrogenase 221, albumin 35, globulin 30, alpha-fetoprotein: 20.

[0062] Color Doppler ultrasound: No changes in the liver, everything else is normal, no ascites.

[0063] The patient took the medicine as described above until August 23, 2019, when he was asymptomatic, biochemical tests were normal, and color Doppler ultrasound examinations were normal, so the medication was stopped.

[0064] Application Example 4

[0065] Ran, female, 60 years old. She was admitted to the hospital on April 14, 2010. Her typical symptoms at the time of the visit were ascites that had not disappeared for ten years, a drum-like abdomen, a dark complexion, palpable spleen, loss of appetite, and inability to take care of herself.

[0066] Biochemical examination: total bile 14.5, straight bile 5.1, intercalated bile 9.4, alanine aminotransferase 19, aspartate aminotransferase 26, glutamyl transpeptidase 90, alkaline phosphatase 141, lactate dehydrogenase 194, albumin 38, globulin 29, alpha-fetoprotein 20.

[0067] Color Doppler ultrasound: The cross-section of the liver was basically normal in shape, the liver capsule was irregular, the echo of the liver parenchyma was thickened, enhanced, and unevenly distributed, and strong echoes of flocculent fibers were detected in the right lobe of the liver, followed by faint acoustic shadows. The cross-section of the gallbladder was normal in size and shape, with thin and rough walls. The spleen was 4.2 cm thick and about 7.8 cm long from the splenic hilum to the apex of the spleen. A liquid dark area was detected in the abdominal cavity, with the deepest area being about 7.2 cm.

[0068] Diagnosis: Decompensated cirrhosis.

[0069] Treatment: Level 5 to support Yang, warm and activate blood circulation.

[0070] Prescription: 12 equal parts of white aconite, 12 parts of red ginseng, 1.5 parts of curcuma, 1.5 parts of chuanxiong. Process into pills according to conventional technology. Take orally three times a day, equivalent to 35 grams of white aconite per day.

[0071] Take the medicine until 2010.7.5 Follow-up visit:

[0072] Biochemistry: Alkaline phosphatase was elevated, other parameters were normal.

[0073] Color Doppler ultrasound: There is a lot of gastrointestinal gas, the sonogram is not clear, the liver section is normal in shape and size, multiple enhanced spots are seen in the right lobe of the liver, followed by a larger acoustic shadow of about 0.5 cm, the remaining liver parenchyma has slightly more and thicker spots, and the echo is not homogeneous. The spleen, pancreas, and kidneys are normal without ascites.

[0074] He then took the medicine consistently, once a day, and is still alive with no abnormal changes.

[0075] Application Example 5

[0076] Liu, female, 86 years old. She visited the hospital on January 29, 2015. Her typical symptoms at the time of consultation were: sallow complexion, cinnabar nevus, fatigue, and enlarged spleen.

[0077] Biochemical examination: total bile 32, straight bile 13, alanine: 30, aspartate: 75, glutamyl transpeptidase 192, alkaline phosphatase 124, lactate dehydrogenase 253, albumin 41, globulin 32, small triple positive.

[0078] Color Doppler ultrasound: The liver has abnormal morphology, the echo of the parenchyma is rough and uneven, and it has a nodular feel. High-frequency scanning revealed several anechoic nodules in the right liver, the larger of which was about 0.4 cm in size, with clear boundaries and regular shapes. The spleen was about 5.5 cm thick.

[0079] Diagnosis: Cirrhosis of the liver.

[0080] Treatment: Five levels of strengthening the body, warming and activating blood circulation.

[0081] Prescription: 10 parts of white aconite, 10 parts of red ginseng, 2 parts of curcuma, 1 part of chuanxiong, made into capsules according to conventional technology. Take orally three times a day, and the daily dosage of white aconite is 30 grams.

[0082] Follow-up visit on February 29, 2015. Typical symptoms: good complexion, fatigue improved, and good appetite.

[0083] Biochemical examination: total bile 16.8, straight bile 5.2, alanine aminotransferase 29, aspartate aminotransferase 34, glutamyl transpeptidase 36, alkaline phosphatase 184, lactate dehydrogenase 162, albumin 45, globulin 30.

[0084] He died at the age of 88.

[0085] 2. Formula example

[0086] Formula Example 1 (Upper Limit Example) 15 parts of white aconite root, 15 parts of red ginseng, 3 parts of curcuma, and 3 parts of ligusticum chuanxiong.

[0087] Formula Example 2 (Lower Limit Example) 0.1 part of white aconite root, 0.1 part of red ginseng, 0.3 part of curcuma, and 0.3 part of chuanxiong.

[0088] Formula Example 3 4 parts of white aconite root, 3 parts of red ginseng, 0.5 parts of curcuma, and 0.5 parts of ligusticum chuanxiong.

[0089] Formula Example 4 6 parts of white aconite root, 4 parts of red ginseng, 0.6 parts of curcuma, and 0.6 parts of chuanxiong; Formula Example 5 7.5 parts of white aconite root, 5 parts of red ginseng, 1 part of curcuma, and 1 part of ligusticum chuanxiong.

[0090] Formula Example 6 12 parts, red ginseng 9.6 parts, Curcuma 1.5 parts, Ligusticum chuanxiong 1.5 parts.

[0091] Formula Example 7 10 parts of white aconite root, 9 parts of red ginseng, 1 part of curcuma, and 1 part of ligusticum chuanxiong.

[0092] Formula Example 8 14 parts of white aconite root, 12 parts of red ginseng, 1.5 parts of curcuma, and 1.5 parts of ligusticum chuanxiong.

[0093] Formula Example 9 15 parts of white aconite root, 12 parts of red ginseng, 2 parts of curcuma, and 2 parts of ligusticum chuanxiong.

[0094] The above formula was proposed by the inventor after careful analysis. The production process is made according to conventional process and will not be described in detail here. It has been verified through clinical application and has good effects.

[0095] 3. Clinical statistics

[0096] The inventors conducted clinical application experimental research on 1,587 people in total according to the technical solution of the present invention, and achieved good results. This has guiding and exemplary significance for verifying the technical effect of the technical solution of the present invention and guiding the application of the technical solution of the present invention.

[0097] Liver Cancer Clinical Trials

[0098] From 2000 to 2024, the inventor clinically treated 250 liver cancer patients according to the technical scheme of the present invention, including 202 males and 48 females.

[0099] Diagnostic criteria for liver cancer

[0100] (1) Medical history 1) History of acute or chronic hepatitis; 2) History of cirrhosis.

[0101] (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.

[0102] (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.

[0103] (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.

[0104] (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.

[0105] Liver cancer treatment efficacy criteria

[0106] (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.

[0107] (2) Effective 1) Clinical symptoms are effectively controlled; 2) One or more biochemical, physical, or tumor marker indicators have improved.

[0108] (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.

[0109] (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 disease has not recurred within six months.

[0110] (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.

[0111] Liver cancer diagnosis and treatment efficacy table

[0112] Clinical trials in cirrhosis.

[0113] From 2000 to 2024, 328 patients with liver cirrhosis were clinically treated according to the technical scheme of the present invention, including 242 males and 172 females.

[0114] Diagnostic criteria for liver cirrhosis

[0115] (1) Medical history History of chronic hepatitis or severe hepatitis.

[0116] (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.

[0117] (3) Biochemical indicators 1) Mild 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.

[0118] (4) Physical indicators 1) CT scan showed an enlarged spleen and a shrunken liver; 2) Ultrasound and CT scan of the patient showed pleural effusion and ascites; 3) Endoscopy of patients with advanced disease showed esophageal varices; The diagnosis can be confirmed if any of the above is abnormal.

[0119] Cirrhosis efficacy criteria.

[0120] (1) Invalid There is no improvement in clinical symptoms, biochemical indicators, and physical indicators. Instead, the condition worsens or remains the same.

[0121] (2) Effective 1) Clinical symptoms have improved; 2) There is improvement in one or more biochemical and physical indicators; (3) Clinical cure; 1) Symptoms disappear; 2) Most of the biochemical and physical indicators have recovered.

[0122] (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.

[0123] (5) Cure 1) Be competent for work and fully self-sufficient; 2) Biochemical and physical indicators are normal, and viral markers are negative.

[0124] Liver cirrhosis diagnosis and treatment efficacy table

[0125] Chronic Hepatitis Clinical Trials

[0126] From 2000 to 2024, 909 patients with chronic hepatitis were clinically treated according to the technical scheme of the present invention, including 628 males and 281 females.

[0127] Diagnostic criteria for chronic hepatitis

[0128] (1) Patients with latent or acute hepatitis that has not been cured for three months.

[0129] (2) Have a history of severe liver disease.

[0130] (3) Big triple positive, small triple positive, and anti-HBC positive.

[0131] (4) 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 of the above abnormalities.

[0132] (5) 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; 3) Mild to moderate abnormalities of GGT, alkaline phosphatase, and lactate dehydrogenase; Those with abnormalities in one or two of the above conditions.

[0133] Chronic hepatitis treatment standard

[0134] (1) Invalid There was no improvement in clinical symptoms, biochemical indicators, or physical indicators, but the condition worsened.

[0135] (2) Effective 1) Improvement of clinical symptoms; 2) There is improvement in one or more biochemical and physical indicators.

[0136] (3) Clinical cure The symptoms basically disappeared and most of the biochemical indicators returned to normal.

[0137] (4) Basically cured Symptoms disappear and biochemical indicators return to normal within half a year.

[0138] (5) Cure Symptoms disappear, and biochemical indicators and antigen systems turn negative for more than one year.

[0139] 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: 0.1-15 parts of white aconite root, 0.1-15 parts of red ginseng, 0.3-3 parts of curcuma zedoaria, and 0.3-3 parts of chuanxiong.

2. The Chinese medicine composition for treating liver disease according to claim 1, characterized in that: 0.1-2.4 parts of white aconite root, 0.1-2.4 parts of red ginseng, 0.3-1 parts of zedoaria, 0.3-1 parts of chuanxiong; Or, 2.6-4.8 parts of white aconite root, 2.6-4.8 parts of red ginseng, 0.3-1.2 parts of curcuma, 0.3-1.2 parts of chuanxiong; Or, 5.6-8.8 parts of white aconite root, 5.6-8.8 parts of red ginseng, 0.3-1.2 parts of zedoaria, 0.3-1.2 parts of chuanxiong; Or, 9.6-11.2 parts of white aconite root, 9.6-11.2 parts of red ginseng, 1-2.5 parts of zedoaria, 1-2.5 parts of chuanxiong; Or, 14.4-15 parts of white atractylodes root, 9.6-11.52 parts of red ginseng, 1-2.5 parts of curcuma, and 1-2.5 parts of chuanxiong.

3. The Chinese medicine composition for treating liver disease according to claim 1, characterized in that: 4 parts of white aconite root, 3 parts of red ginseng, 0.5 parts of curcuma, and 0.5 parts of chuanxiong; Or, 6 parts of white aconite root, 4 parts of red ginseng, 0.6 parts of curcuma, and 0.6 parts of chuanxiong; Or, 10 parts of white aconite root, 9 parts of red ginseng, 1 part of curcuma, 1 part of chuanxiong; Or, 14 parts of white aconite root, 12 parts of red ginseng, 1.5 parts of zedoaria, and 1.5 parts of chuanxiong; Or, 15 parts of white aconite root, 12 parts of red ginseng, 2 parts of curcuma, and 2 parts 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, red ginseng, zedoaria, and chuanxiong 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 method of Baifu Pian is 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 drugs for treating liver diseases.

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