Traditional Chinese medicine composition for treating fatty liver and reducing hepatitis B virus load

Abstract

The invention discloses a traditional Chinese medicine composition for treating fatty liver and reducing hepatitis B virus load. The traditional Chinese medicine composition is prepared from the following raw material medicines: prepared rehmannia root, rhizoma polygonati (processed), radix asparagi, schisandra chinensis, hawthorn leaf, glossy privet fruit, oriental wormwood, radix curcumae, illicium verum and salvia miltiorrhiza. According to the technology of the invention, liver treatment is a preparation based on compatibility of traditional Chinese medicine syndrome differentiation in which liver, spleen and kidney are treated at the same time, fat in the liver can be effectively removed, damage of hepatitis B virus to the liver can be reduced, hepatitis B virus reproduction can be effectively inhibited, the load of hepatitis B virus can be reduced, and multiple curative effects of liver treatment, liver nourishing and liver protection can be realized; the traditional Chinese medicine composition is superior to other treatment medicines and treatment technologies for fatty liver in modern medicine. The method can be widely applied to the fields of medicines, functional foods, health-preserving and health-care products, common foods and beverages and the like.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically a traditional Chinese medicine composition for treating fatty liver and reducing hepatitis B virus load. This invention is a formulation based on the TCM principle of treating the liver, spleen, and kidneys simultaneously, effectively clearing fat from the liver, reducing hepatitis B virus damage, inhibiting hepatitis B virus replication, and lowering the viral load. It possesses multiple therapeutic effects, including treating, nourishing, and protecting the liver, and is superior to other modern medical treatments and techniques for fatty liver.

[0002] This invention can be widely applied in the fields of medicine, functional food, health food, and general food and beverage. Background Technology

[0003] Fatty liver disease, also known as fatty liver, is a common metabolic disorder in clinical practice. It mainly refers to the abnormal accumulation of fat in the liver, usually caused by metabolic disorders such as obesity, insulin resistance, or dyslipidemia. It is a disease characterized by excessive accumulation of fat (mainly triglycerides) in the liver. A normal liver fat content is less than 5%; when it exceeds this level, it is diagnosed as fatty liver.

[0004] Common types of fatty liver include non-alcoholic fatty liver disease (NAFLD) and alcoholic fatty liver disease (AFLD). NAFLD is related to metabolic factors and does not involve alcohol intake; AFLD is mostly caused by excessive alcohol consumption, but individual metabolic differences among patients also play a role. The vast majority of fatty liver cases are NAFLD, highlighting metabolic factors as the primary cause.

[0005] Metabolic diseases are a series of diseases caused by disorders in the body's metabolic processes (such as energy, lipid, or glucose metabolism). The core characteristics include: 1. Energy metabolism imbalance: commonly seen in obesity or early diabetes, insulin resistance leads to abnormal fat storage; 2. Lipid metabolism abnormalities: manifested as high blood lipids (such as elevated triglycerides or cholesterol), increasing the burden on organs and potentially triggering other complications, such as cardiovascular problems or inflammatory responses.

[0006] Modern medicine diagnoses fatty liver by classifying it into non-alcoholic fatty liver disease (NAFLD) and alcoholic fatty liver disease (ALF). Alcoholic fatty liver disease is mostly diagnosed by examining liver function and blood lipids, combined with ultrasound or CT scans and a history of alcohol consumption (biopsy is not recommended). Laboratory tests for alcoholic fatty liver disease may reveal elevated aspartate aminotransferase (AST) > alanine aminotransferase (ALT), elevated gamma-glutamyl transferase (r-GT) and alkaline phosphatase (AKP), elevated mean corpuscular volume (MCV), and an elevated sialic acid-transferrin / sialic acid-transferrin ratio. Some cases may present with a special type of foamy, droplet-like fatty deposits. NAFLD, on the other hand, may show mildly elevated transaminases, and may also present with elevated blood glucose and / or blood lipids. In patients without a history of alcohol consumption, the type of fatty liver can be directly diagnosed based on ultrasound and blood lipid tests. Of course, the vast majority of fatty liver patients are NAFLD patients.

[0007] Fatty liver disease, as a cause of metabolic disorders, is mainly characterized by abnormal blood lipids: high blood lipids (such as elevated triglycerides or cholesterol) increase the risk of fat accumulation in the liver. If not intervened in time, fatty liver can progress to liver inflammation or fibrosis, and include common accompanying symptoms such as diabetes and hypertension, collectively forming "metabolic syndrome".

[0008] Modern medicine currently lacks effective treatments for fatty liver disease, primarily relying on lipid-lowering, cholesterol-lowering, and liver-protecting medications, along with dietary adjustments and exercise. However, long-term use of statins and fibrates, common lipid-lowering and cholesterol-lowering drugs, can damage both the liver and kidneys. Fibrates can also cause elevated serum creatinine levels, leading to chronic kidney damage. In short, long-term treatment with Western medicine for fatty liver disease can eventually lead to chronic renal failure in some patients.

[0009] Traditional Chinese medicine believes that liver diseases are caused by imbalances in Yin and Yang and disharmony in the Five Elements. Fatty liver disease is closely related to dysfunction of the liver, spleen, and kidneys. In modern TCM diagnosis, fatty liver is called "liver stagnation," but in ancient TCM, there was no unified name. It was often referred to as liver qi stagnation, blood stasis, liver qi stagnation and spleen deficiency, or liver qi dampness obstruction. Clinical diagnosis involves the differentiation and treatment of "liver and kidney sharing the same origin" and "liver, spleen, and kidney." Treatment of the liver often follows this pattern, with prescriptions focusing on treating all three simultaneously. The medication approach aims to nourish the kidneys and liver, clear damp heat and strengthen the spleen and stomach, soothe the liver and regulate qi, and promote blood circulation and remove blood stasis. Treating the liver, spleen, and kidneys together effectively removes fat from the liver and also protects the kidneys.

[0010] Hepatitis B, as diagnosed by modern medicine, is a chronic liver disease caused by infection with the hepatitis B virus. Traditional Chinese medicine treatment focuses on nourishing the kidneys and liver, clearing damp heat and strengthening the spleen and stomach, soothing the liver and regulating qi, and promoting blood circulation and removing blood stasis.

[0011] This invention is a liver-treating preparation formulated based on the traditional Chinese medicine principle of treating the liver, spleen, and kidneys simultaneously. It can effectively remove fat from the liver, reduce the damage of hepatitis B virus to the liver, effectively inhibit the reproduction of hepatitis B virus, and reduce the viral load of hepatitis B virus. It has multiple therapeutic effects on treating, nourishing, and protecting the liver, and is superior to other modern medical drugs and treatment techniques for fatty liver. Summary of the Invention

[0012] In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine composition for treating fatty liver and reducing hepatitis B virus load, the purpose of which is to solve the problems mentioned in the background art.

[0013] The traditional Chinese medicine composition of the present invention is formulated from the following traditional Chinese medicines in parts by weight, the raw materials of which include: 120-400 parts of Rehmannia glutinosa, 105-300 parts of Polygonatum sibiricum, 120-600 parts of Asparagus cochinchinensis, 130-500 parts of Schisandra chinensis, 60-175 parts of Crataegus pinnatifida leaf, 45-155 parts of Ligustrum lucidum, 85-200 parts of Artemisia capillaris, 75-180 parts of Curcuma longa, 55-125 parts of Illicium verum, and 135-300 parts of Salvia miltiorrhiza.

[0014] Furthermore, it is prepared from the following raw materials: Rehmannia glutinosa (processed), Polygonatum sibiricum (processed), Asparagus cochinchinensis, Schisandra chinensis, Crataegus pinnatifida leaves, Ligustrum lucidum, Artemisia capillaris, Curcuma longa, Illicium verum, and Salvia miltiorrhiza.

[0015] Furthermore, it is a preparation made by adding pharmaceutically acceptable excipients or auxiliary ingredients to raw material drug slices, raw material drug powder, or concentrated extract of raw material drug, or raw material drug solution, or organic solvent extract of raw material drug.

[0016] Furthermore, the preparation is an oral preparation, which may be a pill, tablet, capsule, powder, granule, solution, or ointment.

[0017] To achieve the objective of this invention, the preparation method of the traditional Chinese medicine composition includes the following steps: (1) Weigh the Chinese medicinal materials according to the aforementioned proportions; (2) Prepared slices of raw pharmaceutical materials, or raw pharmaceutical materials ground into powder, mixed with excipients or auxiliary ingredients acceptable to the pharmaceutical materials and made into pills, are obtained.

[0018] (3) The raw material is ground into powder and then encapsulated into capsules.

[0019] (4) The raw material is prepared as a decoction piece, or the raw material is ground into powder, and then decocted with an appropriate amount of water.

[0020] (5) The raw material is ground into powder, mixed with excipients or auxiliary ingredients acceptable to the pharmaceutical product, and then compressed into tablets.

[0021] (6) The raw drug is ground into powder, or a liquid or organic solvent extract of the raw drug is added with pharmaceutically acceptable excipients or auxiliary components to obtain the product.

[0022] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a drug for treating fatty liver, reducing the load of hepatitis B virus, and nourishing and protecting the liver.

[0023] In the theory of traditional Chinese medicine, the diagnosis and treatment prescriptions for diseases are formulated according to the principle of "sovereign, ministerial, adjuvant, and courier". In the diagnosis and treatment of liver diseases, the technical medical team of the present invention has achieved very good curative effects in restoring liver diseases by using nourishing the liver and kidney as the sovereign drug in many years of clinical practice. Therefore, the compatibility pharmacology of the traditional Chinese medicine composition of the present invention is as follows: Rehmannia glutinosa (processed by nine steaming), Polygonatum sibiricum (processed), and Asparagus cochinchinensis are used as the sovereign drugs to nourish the liver and kidney; Schisandra chinensis, Ligustrum lucidum, Hawthorn leaves, and Artemisia capillaris are used as the ministerial drugs to focus on nourishing and protecting the liver, anti-liver injury, and taking into account clearing damp-heat and strengthening the spleen and stomach; Artemisia capillaris and Curcuma aromatica are used as the adjuvant drugs to focus on clearing the liver and gallbladder, soothing the liver and regulating qi, and softening the liver; Hawthorn leaves, Illicium verum, and Salvia miltiorrhiza are used as the courier drugs to promote blood circulation and remove blood stasis to promote the recovery of the liver. The "sovereign, ministerial, adjuvant, and courier" work together to achieve the curative effect of quickly clearing the fat in the liver and restoring liver health.

[0024] Rehmannia glutinosa (processed by nine steaming) belongs to the liver and kidney meridians, with sweet and warm properties. Its functions and indications include nourishing kidney water, filling the bone marrow, nourishing yin and tonifying blood, tonifying the five zang-organs, and being used for liver and kidney yin deficiency. Modern pharmacological effects: reducing blood lipid levels, and its active ingredients inhibit key enzymes for cholesterol synthesis (such as HMG-CoA reductase); reducing liver cholesterol production, thereby reducing serum total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C); improving lipid metabolism disorders, regulating the expression of genes related to lipoprotein metabolism, promoting the synthesis of high-density lipoprotein cholesterol (HDL-C), and helping to remove excess lipids in the blood vessels; antioxidant and anti-inflammatory, the polysaccharide and glycoside components in Rehmannia glutinosa can reduce oxidative stress and chronic inflammation, indirectly improving lipid metabolism disorders; regulating intestinal flora: some studies suggest that Rehmannia glutinosa may affect lipid absorption by regulating the balance of intestinal microorganisms and influencing bile acid metabolism.

[0025] Polygonatum (processed nine times) enters the spleen, lung, and kidney meridians. It is sweet and neutral in nature and has the functions of replenishing qi and nourishing yin, benefiting the kidneys, strengthening the spleen, and moistening the lungs. Modern pharmacological effects: Polygonatum enhances immunity and regulates the activity of immune cells. The active ingredient polysaccharides in Polygonatum can activate immune cells such as macrophages and natural killer cells (NK cells), enhancing their ability to phagocytose pathogens; saponins can regulate lymphocyte proliferation and balance the immune response; flavonoids can prevent excessive immune system reactions by reducing the release of inflammatory factors; Polygonatum extract can significantly enhance the activity of T lymphocytes and B lymphocytes, enhancing specific immunity (such as antibody production). Studies on immunosuppressed animal models have found that Polygonatum can restore damaged thymus and spleen function and improve the microenvironment of immune organs; it has antioxidant and anti-fatigue effects by scavenging free radicals and increasing superoxide dismutase (SOD) activity, reducing oxidative stress damage to immune cells; its qi-tonifying and yin-nourishing effects can improve energy metabolism, alleviate fatigue-induced decline in immunity, and indirectly maintain the normal functioning of the immune system; it regulates intestinal flora, as the dietary fiber and polysaccharides in Polygonatum can act as prebiotics, promoting the proliferation of beneficial bacteria such as Bifidobacteria and Lactobacillus, improving intestinal barrier function, reducing toxin entry into the blood, and lowering the immune load. Other pharmacological effects include: improving kidney function and reducing kidney damage caused by drugs or kidney disease; antimicrobial and antibacterial effects; antiviral effects; therapeutic effects on herpes simplex keratitis; antioxidant and liver-protective effects; inhibiting hyperglycemia; anti-fatigue effects; anti-aging effects; anti-myocardial ischemia effects; hemostatic effects; and spleen-strengthening effects.

[0026] Asparagus root enters the lung and kidney meridians. It is sweet, bitter, and cold in nature. Its functions include nourishing yin and moistening dryness, clearing lung heat, regulating kidney qi, nourishing the five internal organs, and benefiting the skin. Modern pharmacological effects include: improving lipid metabolism; the polysaccharides in asparagus may indirectly reduce serum total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) by inhibiting cholesterol absorption and promoting bile acid excretion. Some studies show that its saponin components have antioxidant effects, reducing lipid peroxidation and protecting vascular endothelial cells, thereby improving abnormal lipid metabolism; regulating enzyme activity; possibly by inhibiting the activity of key lipid synthesis enzymes (such as HMG-CoA reductase), reducing endogenous cholesterol synthesis; and anti-inflammatory and insulin sensitivity effects. Chronic inflammation and insulin resistance are among the causes of lipid metabolism disorders, and the antioxidant components of asparagus may indirectly improve blood lipids by reducing inflammatory responses.

[0027] In this invention, Rehmannia glutinosa (processed), Polygonatum sibiricum (processed), and Asparagus cochinchinensis are the principal herbs in the traditional Chinese medicine composition. They mainly nourish the kidneys and liver. In the theory of the Five Elements in traditional Chinese medicine, the liver is associated with wood and the kidneys with water. The kidney water nourishes the liver wood, achieving a balance of the five elements to address the abnormal accumulation, precipitation, and inflammatory response of blood lipids and cholesterol. Therefore, these herbs are used as the principal herbs in this formula.

[0028] Schisandra chinensis (Northern Schisandra chinensis) enters the lung, heart, and kidney meridians. It has a sour and sweet taste and is warm in nature. The Compendium of Materia Medica states: "Schisandra chinensis' sour and salty flavor enters the liver and nourishes the kidneys; its bitter and pungent flavor enters the heart and nourishes the lungs; its sweet flavor enters the middle jiao and benefits the spleen and stomach." Clinical applications include: treatment of anicteric infectious hepatitis; treatment of acute intestinal infections; treatment of neurasthenia; treatment of latent Keshan disease; modern pharmacological effects include improving vision in healthy individuals and patients with eye diseases, protecting the liver and stomach, delaying aging, affecting the cardiovascular system, and stimulating the respiratory system.

[0029] Hawthorn leaves, entering the liver meridian, are sour and neutral in nature. Their functions include promoting blood circulation and removing blood stasis, regulating qi and unblocking the meridians, clearing turbidity and lowering lipids. They are mainly used to treat qi and blood stagnation, chest pain, chest tightness, shortness of breath, hyperlipidemia, dizziness, tinnitus, palpitations, and forgetfulness. Modern pharmacological effects include regulating lipid metabolism, improving liver function and protecting the liver, intervening in insulin resistance, anti-inflammatory and antioxidant effects, cardiovascular protection, and anti-tumor effects.

[0030] Privet fruit enters the liver and kidney meridians; its flavor is sweet and bitter, and its properties are cool. Its functions and indications include nourishing the liver and kidneys, improving eyesight, and darkening hair. It is used for dizziness and tinnitus, soreness and weakness of the lower back and knees, premature graying of hair, and blurred vision. Modern pharmacological effects include: lowering blood lipids and anti-arteriosclerosis, lowering blood sugar, anti-liver damage, regulating endocrine function, anti-cancer, anti-inflammatory, anti-mutagenic, anti-allergic effects, and good immunomodulatory effects.

[0031] The herbal composition of this invention, containing Schisandra chinensis, Crataegus pinnatifida leaf, and Ligustrum lucidum, along with Artemisia capillaris, which clears damp-heat and protects the liver and gallbladder, works together as adjuvant herbs to protect the liver and prevent liver damage. Furthermore, the sour and sweet properties of Schisandra chinensis, along with Crataegus pinnatifida leaf and Illicium verum, have the effect of strengthening the spleen and stomach, thus the adjuvant herbs also contribute to clearing damp-heat and strengthening the spleen and stomach.

[0032] Artemisia capillaris enters the spleen, stomach, liver, and gallbladder meridians. It is bitter and pungent in taste, and slightly cold in nature. Its functions and indications include clearing damp-heat and reducing jaundice. It is used for jaundice with oliguria, itchy weeping sores, and infectious jaundice-type hepatitis. Clinical applications include liver and gallbladder diseases such as viral hepatitis, cholestasis, hypercholesterolemia, and improvement of metabolic syndrome (insulin resistance). Modern pharmacological effects: Hepatoprotective and choleretic effects: Artemisia capillaris can promote bile secretion, reduce serum bilirubin and transaminase levels, protect against hepatocyte damage, and has anti-fibrotic effects. Its active ingredients, such as ursolic acid, flavonoids, and coumarins, can inhibit hepatocyte apoptosis, promote regeneration, and reduce the progression of fatty liver. Anti-inflammatory and antioxidant effects: Artemisia capillaris extract can inhibit inflammatory factors, reduce liver fibrosis (e.g., by regulating the TGF-β1 / Smad signaling pathway), and scavenge free radicals to alleviate oxidative stress damage. Antibacterial and antiviral effects: In vitro experiments show that Artemisia capillaris decoction has inhibitory effects on various pathogens such as Staphylococcus aureus and Salmonella typhi. Metabolic regulation: Artemisia capillaris can lower blood lipids and blood pressure, improve insulin resistance, and has potential benefits for non-alcoholic fatty liver disease and metabolic syndrome. Immunomodulatory effects: Artemisia capillaris polysaccharides can enhance the phagocytic function of macrophages and the activity of T lymphocytes, thereby improving the body's immunity.

[0033] Turmeric: It enters the liver, heart, and lung meridians. It is pungent, bitter, and cold in nature. Its functions include promoting qi circulation and removing blood stasis, clearing the heart and relieving depression, and promoting bile secretion and reducing jaundice. It is clinically used for diseases of the liver and gallbladder system. Its pharmacological effects include enhancing liver lipid metabolism, lowering cholesterol and triglycerides, reducing fat deposition in blood vessels, promoting bile secretion, anti-inflammatory and immunomodulatory effects, and improving blood circulation.

[0034] In this invention, the Artemisia capillaris and Curcuma longa in the traditional Chinese medicine composition are used as adjuvants. They promote bile excretion by protecting the liver and promoting bile secretion, so that bile does not accumulate in the liver, thereby achieving the effect of soothing and softening the liver. At the same time, they also help to resist liver damage and have antibacterial and antiviral effects.

[0035] Star anise enters the liver, kidney, spleen, and stomach meridians. It is pungent and warm in nature, and functions to warm the yang and dispel cold, regulate qi and relieve pain, and strengthen the stomach. It is used for abdominal pain due to cold hernia, lower back pain due to kidney deficiency, vomiting due to stomach cold, and cold pain in the epigastrium and abdomen. Modern pharmacological effects include promoting fat metabolism, improving the digestive system, and reducing appetite.

[0036] Danshen (Salvia miltiorrhiza): Enters the Heart and Liver meridians; bitter and slightly cold in nature; functions to invigorate blood circulation, remove blood stasis, calm the mind, and soothe the nerves; treats angina pectoris, abdominal pain due to blood stasis, thromboangiitis obliterans, coronary heart disease, and chronic hepatitis. Clinical applications include treatment of persistent and chronic hepatitis, thromboangiitis obliterans, and coronary heart disease. Modern pharmacological research focuses on its effects on cardiovascular and cerebrovascular diseases, diabetic complications, and gynecological diseases.

[0037] In the herbal composition of this invention, star anise, salvia miltiorrhiza, and hawthorn leaves, which have the effects of promoting blood circulation, removing blood stasis, regulating qi, and unblocking meridians, work together as guiding herbs. They mainly work in conjunction with the principal, assistant, and adjuvant herbs to perfectly harmonize the five internal organs, nourish the kidneys, benefit the liver, and strengthen the spleen and stomach. This effectively achieves the effects of protecting and nourishing the liver, improving lipid metabolism, reducing insulin resistance, and enhancing resistance and immunity to liver viruses, thereby treating or improving the patient's condition.

[0038] Compared with the prior art, the beneficial effects and advantages of the present invention are as follows: The technical advantages of this invention are that it is a pure traditional Chinese medicine formula, which is convenient to prepare and apply. It is relatively safe, provides comprehensive and balanced conditioning for patients, and results in rapid therapeutic effects. The course of treatment and recovery period are relatively short. It has extremely high medicinal and socio-economic value in treating fatty liver, reducing hepatitis B virus load, and nourishing and protecting the liver to prevent fatty liver. Detailed Implementation

[0039] This invention relates to a traditional Chinese medicine composition for treating fatty liver and reducing hepatitis B virus load. The traditional Chinese medicine composition of this invention is formulated from the following traditional Chinese medicines in parts by weight, including: 120-400 parts of Rehmannia glutinosa, 105-300 parts of Polygonatum sibiricum, 120-600 parts of Asparagus cochinchinensis, 130-500 parts of Schisandra chinensis, 60-175 parts of Crataegus pinnatifida leaf, 45-155 parts of Ligustrum lucidum, 85-200 parts of Artemisia capillaris, 75-180 parts of Curcuma longa, 55-125 parts of Illicium verum, and 135-300 parts of Salvia miltiorrhiza.

[0040] The value of Rehmannia glutinosa, measured by weight, includes, but is not limited to, any one of 120 to 400 parts or any range between two.

[0041] Among them, the point value of Polygonatum, calculated by weight, includes but is not limited to any one of 105 parts to 300 parts, or any range between two.

[0042] The value of asparagus, measured by weight, includes, but is not limited to, any one of 120 to 600 parts or any range between two.

[0043] Among them, the value of Schisandra chinensis by weight is not limited to any one of 130 parts to 500 parts or any range between two.

[0044] The hawthorn leaves, by weight, include, but are not limited to, any one of the point values ​​or any range between 60 and 175 parts.

[0045] Among them, the point value of privet fruit by weight is not limited to, but includes, any one of 45 to 155 parts or any range between two.

[0046] Among them, the point value of Artemisia capillaris, calculated by weight, includes but is not limited to any one of 85 to 200 parts or any range between two.

[0047] Among them, the value of turmeric by weight is not limited to, but includes, any one of 75 to 180 parts or any range between two.

[0048] The star anise, by weight, includes, but is not limited to, a point value of any one of 55 to 125 parts or a range between any two.

[0049] Among them, the value of Danshen by weight is not limited to any one of 135 to 300 parts or any range between two.

[0050] The following description of the embodiments is merely to aid in understanding the method and core ideas of the present invention. It should be noted that those skilled in the art can make various improvements and modifications to the present invention without departing from the TCM theory and pharmacology of the invention, and these improvements and modifications also fall within the scope of protection of the claims of the present invention. Therefore, the present invention is not limited to the embodiments shown herein, but can be applied to a wider range consistent with the pharmacology and novel features of TCM prescriptions disclosed herein. Unless otherwise defined, all techniques and TCM terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains.

[0051] Example: Preparation of the pharmaceutical composition of the present invention Formula: 120 parts Rehmannia glutinosa, 105 parts Polygonatum sibiricum, 120 parts Asparagus cochinchinensis, 130 parts Schisandra chinensis, 90 parts Crataegus pinnatifida leaves, 105 parts Ligustrum lucidum, 85 parts Artemisia capillaris, 95 parts Curcuma longa, 75 parts Illicium verum, and 135 parts Salvia miltiorrhiza.

[0052] Preparation method: ① Weigh out the above-mentioned Chinese medicinal herbs according to the specified weight ratio; ② Grind into powder: Mix the Chinese herbal medicine pieces mentioned in step ① and grind them into powder; ③ Sift the mixed powder collected in step ② through a 50-80 mesh sieve, weigh 400 kg, add honey as an excipient, mix and knead into a dough, then make into pills of 6 grams each. After drying, it becomes “Shengyan Liver Protector” pills (temporarily named “Shengyan Liver Protector” for the convenience of the example).

[0053] Clinical efficacy observation of the traditional Chinese medicine composition of the present invention in the examples: The clinical efficacy observation of the traditional Chinese medicine composition of the present invention in the embodiments was divided into 3 groups: study group 1, study group 2, and study group 3.

[0054] From October 2020 to July 2025, in collaboration with multiple medical institutions, we recruited 80 patients with fatty liver disease (40 with non-alcoholic fatty liver disease and 40 with alcoholic fatty liver disease) and 40 patients with chronic hepatitis B (HBeAg negative), totaling 120 volunteers, to serve as case study group volunteers. Volunteers were required to adhere to medication for 90 days and meet the criteria for clinical follow-up. All diagnoses were based on those from tertiary hospitals. The 120 volunteers were divided into three groups: Study Group 1, Study Group 2, and Study Group 3. These 120 volunteers received three months of free treatment with "Shengyan Liver Protector" provided by the company. After the three-month treatment course, a follow-up examination was scheduled 20 days after discontinuation of medication. Hospital examination costs were also reimbursed by the company and our research team.

[0055] Study group 1 was a clinical observation group for non-alcoholic fatty liver disease. Study group 2 was a clinical observation group of alcoholic fatty liver cases.

[0056] Study group 3 was a clinical observation group of chronic hepatitis B (small three positive) cases.

[0057] In Example 1, study group 1 selected 40 non-alcoholic fatty liver disease volunteers. Case inclusion criteria: (1) Voluntarily accept traditional Chinese medicine treatment; (2) Blood pressure <170 / 100 mmHg at the time of case selection and assessment; (3) All those who meet the diagnostic criteria for fatty liver have been confirmed as non-alcoholic fatty liver; (4) Liver stiffness (F2-F3 mild / F3-F4 moderate) values ​​are between 7.3 and 12.4 (mild) or between 12.4 and 17.5 (moderate), and fat attenuation values ​​are between 240 and 295.

[0058] Case exclusion criteria: (1) Comorbid drug-induced liver disease; (2) Viral hepatitis; (3) Other organic lesions; (4) Symptoms of cholestatic, alcoholic, and autoimmune liver diseases; (5) History of other bleeding disorders; (6) Pregnant women; (7) Those whose blood pressure cannot be controlled effectively and in a timely manner or who experience significant fluctuations; (8) Has a severe mental disorder; (9) History of severe renal insufficiency or severe diabetes.

[0059] The study group 1 included 40 volunteer patients, 23 males and 17 females, with a mean age of (46.2±5.6) years. Medication instructions: "Shengyan Liver Protector," prepared from the raw materials used in the example, was taken three times daily on an empty stomach—morning, noon, and before bedtime—at 12 grams (2 capsules) each time, for a course of 3 months (90 days). Medication was discontinued immediately after the course of treatment for 20 days, followed by a follow-up examination and comparison of pre- and post-treatment hospital reports. High-fat foods were avoided during medication; a light diet was recommended.

[0060] Clinical efficacy evaluation: After a 3-month (90-day) course of "Shengyan Liver Protector," patients immediately stopped taking the medication for 20 days. Ultrasound and blood lipid tests were then performed. The results showed that the liver stiffness on the ultrasound was within the normal range (2.8–7.4 kPa), and the blood lipid levels were within the normal range (total cholesterol: 3.0–5.2 mmol / L; LDL cholesterol: 0–3.4 mmol / L; triglycerides: less than 1.7 mmol / L). Volunteer patients whose test results were within the normal range were evaluated as clinically cured. If the ultrasound results showed a decrease in liver stiffness and blood lipid levels before and after treatment, the results were evaluated as clinically effective. If no improvement was observed in liver stiffness or blood lipid levels before and after treatment, the results were evaluated as ineffective.

[0061] The clinical efficacy evaluation after three months of treatment with "Shengyan Liver Protector" and 20 days after stopping the medication, including color Doppler ultrasound and blood lipid tests, is shown in Table 1.

[0062]

[0063] In the example study, after three months of treatment with "Shengyan Liver Protector" and a 20-day break from medication, the clinical cure rate of non-alcoholic fatty liver disease reached 92.5%, and the overall effective rate was 100%.

[0064] In Example 2, study group 2 selected 40 volunteers with alcoholic fatty liver disease. Case inclusion criteria: (1) Voluntarily accept traditional Chinese medicine treatment; (2) Blood pressure <170 / 100 mmHg at the time of case selection and assessment; (3) All of them met the diagnostic criteria for fatty liver and were confirmed to have alcoholic fatty liver; (4) The color Doppler ultrasound or CT scan is diagnosed as moderate.

[0065] Case exclusion criteria: (1) Comorbid drug-induced liver disease; (2) It has progressed to alcoholic hepatitis or liver failure; (3) Viral hepatitis; (4) Other organic lesions; (5) Symptoms of cholestatic liver disease, autoimmune liver disease, etc.; (6) History of other bleeding disorders; (7) Pregnant women; (8) Those whose blood pressure cannot be controlled effectively and in a timely manner or who experience significant fluctuations; (9) Has a severe mental disorder; (10) History of severe renal insufficiency or severe diabetes.

[0066] The study group 2 included 40 volunteer patients, 40 males and 0 females, with a mean age of (54.5±4.5) years. Medication instructions: "Shengyan Liver Protector," prepared from the raw materials used in the example, was taken three times daily on an empty stomach: morning, noon, and before bedtime. Each dose was 12 grams (2 capsules) for a course of treatment lasting 3 months (90 days). Medication was discontinued immediately after the course of treatment for 20 days, followed by a follow-up examination and comparison of pre- and post-treatment hospital reports. High-fat foods were avoided during medication; a light diet was recommended.

[0067] Clinical efficacy evaluation: After taking "Shengyan Liver Protector" for 3 months (90 days), medication was stopped immediately and 20 days later. Ultrasound or CT scans, blood lipid tests, and liver function tests were performed. All three tests showed normal images and values, indicating a clinical cure. Comparison of ultrasound or CT scans, blood lipid tests, and liver function tests before and after showed improvement in all three tests, indicating clinical effectiveness. Comparison of ultrasound or CT scans, blood lipid tests, and liver function tests before and after showed no improvement in these three tests, indicating ineffectiveness.

[0068] The clinical efficacy evaluation after three months of treatment with "Shengyan Liver Protector" and 20 days after stopping the medication, including color Doppler ultrasound or CT scans, blood lipid tests, and liver function tests, is shown in Table 2.

[0069]

[0070] In the study group of the example, the clinical cure rate of volunteers with alcoholic fatty liver disease who took "Shengyan Liver Protector" for three months and then stopped taking the medication for 20 days was 85% after comparison of color Doppler ultrasound or CT, blood lipids, liver function and other examinations. The total effective rate was 100%.

[0071] In Example 3, study group 3 selected 40 volunteers with chronic hepatitis B (small three positive) Case inclusion criteria: (1) Voluntarily accept traditional Chinese medicine treatment; (2) Blood pressure <170 / 100 mmHg at the time of case selection and assessment; (3) Non-acute hepatitis; (4) Patients with hepatitis B virus infection who are classified as "small three positive" (HBeAg negative chronic hepatitis B); (5) HBV DNA ≥ 2000 IU / ml; (6) ALT remains between 1 and 2 ULN.

[0072] Case exclusion criteria: (1) Comorbid drug-induced liver disease; (2) Alcoholic hepatitis; (3) Co-infection with other pathogens; (4) Elevated ALT levels due to autoimmune factors or other factors; (5) ALT levels temporarily normalize after the use of enzyme-lowering drugs; (6) History of other bleeding disorders; (7) Pregnant women; (8) Those whose blood pressure cannot be controlled effectively and in a timely manner or who experience significant fluctuations; (9) Has a severe mental disorder; (10) History of severe renal insufficiency or severe diabetes.

[0073] The study group 3 included 40 volunteer patients, 22 males and 18 females, with a mean age of (52.5±6.5) years. Medication instructions: "Shengyan Liver Protector," prepared from the raw materials used in the example, was taken three times daily on an empty stomach: morning, noon, and before bedtime. Each dose was 12 grams (2 capsules) for a course of treatment lasting 3 months (90 days). Medication was discontinued immediately after the course of treatment for 20 days, followed by a follow-up examination and comparison of pre- and post-treatment hospital reports. High-fat foods were avoided during medication; a light diet was recommended.

[0074] The treatment course of "Shengyan Liver Protector" is 3 months (90 days). After immediately stopping the medication for 20 days, a hepatitis B virus DNA (HBV DNA) test, a hepatitis B five-item test (hepatitis B two and a half pairs), a liver function test, and a liver imaging examination are performed. The clinical efficacy evaluation is based on the HBV DNA (DNA) test result. A HBV DNA (DNA) test result <2000 IU / ml, or a significant decrease compared to the previous result (DNA <1000 IU / ml), is considered effective; a HBV DNA (DNA) test result ≥2000 IU / ml is considered ineffective.

[0075] The clinical efficacy was evaluated based on the hepatitis B virus DNA (HBV DNA) test results after three months of treatment with "Shengyan Liver Protector" and a 20-day break from medication. The results included hepatitis B five markers (hepatitis B two and a half pairs), color Doppler ultrasound or CT scan, blood lipids, and liver function tests. Table 3 shows the clinical efficacy assessment based on the HBV DNA test results.

[0076]

[0077] In the example study, three volunteer patients in the research group underwent three months of treatment with "Shengyan Liver Protector" and a 20-day break before undergoing hepatitis B virus DNA (HBV) testing. After 90 days of treatment, HBV DNA levels were measured in 35 patients with HBV DNA <1000 IU / ml and 4 patients with HBV DNA <2000 IU / ml. This indicates that "Shengyan Liver Protector" is highly effective in reducing HBV viral load. Statistical analysis of the results before and after treatment showed a clinical efficacy rate of 97.5% and an ineffective rate of only 2.5%.

[0078] In summary, the traditional Chinese medicine composition provided by this invention has excellent therapeutic effects on fatty liver and reduces hepatitis B virus load. It can effectively clear fat from the liver, reduce hepatitis B virus damage to the liver, effectively inhibit hepatitis B virus replication, and reduce hepatitis B virus load. It has multiple therapeutic effects on the liver, including treating, nourishing, and protecting it, and is superior to other modern medical drugs and treatment techniques for fatty liver.

[0079] This invention can be widely applied in the fields of medicine, functional food and beverage, health care products and food, and is especially suitable for the treatment of the elderly.

[0080] The embodiments of the present invention have been described in detail above, but the present invention is not limited to the described embodiments. Based on the above description of the present invention, and according to ordinary technical knowledge and common practice in the art, it will be obvious to those skilled in the art that various other changes and modifications can be made to these embodiments without departing from the basic technical concept of the present invention, and these changes still fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating fatty liver and reducing hepatitis B virus load, characterized in that... It is prepared from the following Chinese medicinal herbs in the indicated weight proportions: 120-400 parts Rehmannia glutinosa, 105-300 parts Polygonatum sibiricum, 120-600 parts Asparagus cochinchinensis, 130-500 parts Schisandra chinensis, 60-175 parts Crataegus pinnatifida, 45-155 parts Ligustrum lucidum, 85-200 parts Artemisia capillaris, 75-180 parts Curcuma longa, 55-125 parts Illicium verum, and 135-300 parts Salvia miltiorrhiza.

2. The traditional Chinese medicine composition for treating fatty liver and reducing hepatitis B virus load as described in claim 1, characterized in that... The traditional Chinese medicine composition is prepared from the following raw materials: Rehmannia glutinosa (processed), Polygonatum sibiricum (processed), Asparagus cochinchinensis, Schisandra chinensis, Crataegus pinnatifida leaf, Ligustrum lucidum, Artemisia capillaris, Curcuma longa, Illicium verum, and Salvia miltiorrhiza.

3. The traditional Chinese medicine composition according to claims 1-2, characterized in that... The aforementioned traditional Chinese medicine composition is a preparation used in drugs specifically applied to treat fatty liver, reduce hepatitis B virus load, and nourish and protect the liver.

4. The traditional Chinese medicine composition preparation according to claims 1 to 3, characterized in that... It is a preparation made by adding excipients or auxiliary ingredients acceptable for pharmaceuticals or food to a drug, a drug powder of a drug, a concentrated extract of a drug, a liquid extract of a drug, a drug extracted from a drug through a certain technology and process, or an organic solvent extract of a drug.

5. The traditional Chinese medicine composition preparation according to claims 1 to 4, characterized in that... The formulation may be a pharmaceutical formulation, or a formulation in the form of a health product, a nutritional food product for special medical purposes, a special dietary product, or a general food and beverage product.

6. The use of the traditional Chinese medicine composition preparation as described in any one of claims 1 to 5 in the preparation of a medicament for the prevention and / or treatment of fatty liver, reduction of hepatitis B virus load, and liver protection.

7. The use of the traditional Chinese medicine composition preparation as described in any one of claims 1 to 5 in the preparation of health products for treating fatty liver, reducing hepatitis B virus load, and nourishing and protecting the liver.

8. The use of the traditional Chinese medicine composition preparation as described in any one of claims 1 to 5 in the preparation of a nutritional food for special medical purposes, which is used to treat fatty liver, reduce hepatitis B virus load, and nourish and protect the liver.

9. The use of the traditional Chinese medicine composition preparation as described in any one of claims 1 to 5 in the preparation of special dietary foods for fatty liver, reducing hepatitis B virus load, and nourishing and protecting the liver.

10. The use of the traditional Chinese medicine composition preparation as described in any one of claims 1 to 5 in the preparation of common food and beverages for treating fatty liver, reducing hepatitis B virus load, and nourishing and protecting the liver.

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