A traditional Chinese medicine composition for treating autoimmune hepatitis with the syndromes of liver-kidney yin deficiency and heat-toxin stasis, and a preparation method thereof

Abstract

A traditional Chinese medicine composition for treating autoimmune hepatitis of the type of liver-kidney yin deficiency and heat-toxin stasis is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: 10-20 parts of glossy privet fruit, 10-20 parts of dwarf lilyturf tuber, 10-14 parts of forsythia, 5-15 parts of white peony root, 10-14 parts of turmeric, 10-20 parts of chicken gizzard-membrane. Under the guidance of the theory of syndrome differentiation and disease differentiation in traditional Chinese medicine, the prescription is formulated according to the principle of monarch, minister, assistant and guide. The combination of various medicines mainly nourishes the kidney and yin, softens the liver and detoxifies, activates blood circulation and eliminates stasis, and also has the effects of supplementing qi and nourishing blood, dissipating stagnation and dredging collaterals, soothing the liver and strengthening the spleen. It is mainly aimed at autoimmune hepatitis of the type of liver-kidney yin deficiency and heat-toxin stasis, and also has a certain therapeutic effect on autoimmune hepatitis of other syndromes.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition for treating liver-kidney yin deficiency, heat-toxicity and blood stasis syndrome autoimmune hepatitis and a preparation method thereof, belonging to the technical field of traditional Chinese medicine. Background Art

[0002] Autoimmune hepatitis is an inflammation of the liver parenchyma mediated by an autoimmune response against hepatocytes, characterized by positive serum autoantibodies, hyperimmunoglobulinemia, and interface hepatitis in liver histology, with diverse clinical manifestations. Autoimmune hepatitis is an autoimmune disorder, and clinical manifestations vary among different ethnic groups. It is generally chronic and insidious in onset, but can also develop acutely. If left untreated, it can often lead to cirrhosis and liver failure. In 20%-59% of patients, immune damage affects not only the liver, but also other organs, resulting in extrahepatic manifestations and comorbidities with other autoimmune diseases. The overall treatment goal of autoimmune hepatitis is to achieve and maintain liver histological remission, prevent progression to cirrhosis and / or liver failure, and thereby improve patient survival and quality of life. Modern medicine uses prednisone combined with azathioprine as the initial first-line standard treatment option. For patients who have a poor response to first-line treatment or are intolerant to the side effects of glucocorticoids or azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, methotrexate, 6-mercaptopurine, etc. can be selected. However, these drugs have many adverse reactions. Traditional Chinese medicine has unique advantages in treating chronic liver disease from the perspective of syndrome differentiation and holistic treatment. Summary of the invention

[0003] In view of the deficiencies in the prior art, the purpose of the present invention is to provide a Chinese medicine composition for treating autoimmune hepatitis of liver-kidney yin deficiency and heat-toxic stasis type and a preparation method thereof, which can effectively treat autoimmune hepatitis of liver-kidney yin deficiency and heat-toxic stasis type.

[0004] In order to achieve the above object, the technical solution of the present invention is:

[0005] A traditional Chinese medicine composition for treating autoimmune hepatitis of liver-kidney yin deficiency and heat-toxic stasis type is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: 10-20 parts of Ligustrum lucidum fruit, 10-20 parts of Ophiopogon japonicus, 10-14 parts of Forsythia suspensa, 5-15 parts of White Peony Root, 10-14 parts of Curcuma longa, and 10-20 parts of Chicken's Gizzard Stone Endothelial Gizzard.

[0006] The Chinese medicine composition for treating liver-kidney yin deficiency and heat-toxic stasis type autoimmune hepatitis is prepared by extracting the following Chinese medicine raw materials in parts by weight: 15 parts of Ligustrum lucidum, 15 parts of Ophiopogon japonicus, 12 parts of Forsythia suspensa, 10 parts of White Peony Root, 12 parts of Curcuma longa, and 15 parts of Chicken Gizzard Stone Endothelial Gizzard.

[0007] The traditional Chinese medicine composition for treating autoimmune hepatitis of liver-kidney yin deficiency and heat-toxin stasis type is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: Glossy Privet Fruit 10 parts, Dwarf Lilyturf Tuber 20 parts, Forsythia Fruit 10 parts, White Peony Root 10.5 parts, Turmeric 10 parts, and Chicken Gizzard-membrane 20 parts.

[0008] The traditional Chinese medicine composition for treating autoimmune hepatitis of liver-kidney yin deficiency and heat-toxin stasis type is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: Glossy Privet Fruit 20 parts, Dwarf Lilyturf Tuber 10 parts, Forsythia Fruit 14 parts, White Peony Root 0.5 parts, Turmeric 14 parts, and Chicken Gizzard-membrane 10 parts.

[0009] The traditional Chinese medicine composition for treating autoimmune hepatitis of liver-kidney yin deficiency and heat-toxin stasis type is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: Glossy Privet Fruit 15 parts, Dwarf Lilyturf Tuber 15 parts, Forsythia Fruit 12 parts, White Peony Root 10 parts, Turmeric 12 parts, and Chicken Gizzard-membrane 15 parts.

[0010] The preparation method of the traditional Chinese medicine composition for treating autoimmune hepatitis of liver-kidney yin deficiency and heat-toxin stasis type comprises the following steps: (1) Weigh Chicken Gizzard-membrane according to the weight, dry, pulverize, and sieve to obtain powder A; (2) Weigh Glossy Privet Fruit, Dwarf Lilyturf Tuber, Forsythia Fruit, White Peony Root, and Turmeric according to the weight, mix them, add water with a weight 10 times that of the mixed raw materials, reflux and extract twice, each time for 1 h, filter, combine the filtrates, concentrate under reduced pressure to a clear paste with a relative density of 1.16 - 1.18 (60 °C), add ethanol to make the alcohol content 70 - 80%, stand for 12 - 24 h, filter, and take the supernatant and concentrate it into an extract paste B with a relative density of 1.18 - 1.20 (60 °C); (3) Mix powder A and extract paste B evenly, dry under vacuum to obtain a dry extract paste, pulverize, and prepare it into a powder.

[0011] The preparation method of the traditional Chinese medicine composition for treating autoimmune hepatitis of liver-kidney yin deficiency and heat-toxin stasis type comprises the following steps: (1) Weigh Chicken Gizzard-membrane according to the weight, dry, pulverize, and sieve to obtain powder A; (2) Weigh Glossy Privet Fruit, Dwarf Lilyturf Tuber, Forsythia Fruit, White Peony Root, and Turmeric according to the weight, mix them, add water with a weight 10 times that of the mixed raw materials, reflux and extract twice, each time for 1 h, filter, combine the filtrates, concentrate under reduced pressure to a clear paste with a relative density of 1.16 - 1.18 (60 °C), add ethanol to make the alcohol content 70 - 80%, stand for 12 - 24 h, filter, and take the supernatant and concentrate it into an extract paste B with a relative density of 1.18 - 1.20 (60 °C); (3) Mix powder A and extract paste B evenly, dry, pulverize, add a certain amount of auxiliary materials, and prepare it into granules.

[0012] The preparation method of the traditional Chinese medicine composition for treating autoimmune hepatitis of liver-kidney yin deficiency and heat-toxin stasis type comprises the following steps: (1) Weigh chicken gizzard-membrane by weight, dry it, crush it, and sieve it to obtain powder A; (2) Weigh glossy privet fruit, dwarf lilyturf tuber, forsythia fruit, white peony root, and turmeric by weight, mix them, add water with a weight 10 times that of the mixed raw material drugs, reflux and extract twice, each time for 1 h, filter, combine the filtrates, concentrate them under reduced pressure to obtain a clear paste with a relative density of 1.16 - 1.18 (60 °C), add ethanol to make the alcohol content 70 - 80%, let it stand for 12 - 24 h, filter, take the supernatant and concentrate it into an extract paste B with a relative density of 1.18 - 1.20 (60 °C); (3) Mix powder A and extract paste B evenly, perform fluidized bed granulation with a certain amount of auxiliary materials, sieve it, put the obtained granules and a certain amount of magnesium stearate into a total mixer for mixing, and press tablets with a rotary tablet press to prepare tablets.

[0013] The preparation method of the traditional Chinese medicine composition for treating autoimmune hepatitis of liver-kidney yin deficiency and heat-toxin stasis type comprises the following steps: (1) Weigh chicken gizzard-membrane by weight, dry it, crush it, and sieve it to obtain powder A; (2) Weigh glossy privet fruit, dwarf lilyturf tuber, forsythia fruit, white peony root, and turmeric by weight, mix them, add water with a weight 10 times that of the mixed raw material drugs, reflux and extract twice, each time for 1 h, filter, combine the filtrates, concentrate them under reduced pressure to obtain a clear paste with a relative density of 1.16 - 1.18 (60 °C), add ethanol to make the alcohol content 70 - 80%, let it stand for 12 - 24 h, filter, take the supernatant and concentrate it into an extract paste B with a relative density of 1.18 - 1.20 (60 °C); (3) Mix powder A and extract paste B evenly, perform fluidized bed granulation with a certain amount of auxiliary materials, sieve it, put the obtained granules into hollow capsules to prepare capsule agents.

[0014] The preparation method of the traditional Chinese medicine composition for treating autoimmune hepatitis of liver-kidney yin deficiency and heat-toxin stasis type is to weigh each raw material drug by weight, mix them, add water with a weight 7 times that of the total weight of the raw material drugs, soak for 30 min, and decoct 3 times, each time for 1 h, filter, combine the filtrates to make a mixture.

[0015] The application of the traditional Chinese medicine composition for treating autoimmune hepatitis of liver-kidney yin deficiency and heat-toxin stasis type in the preparation of drugs for autoimmune hepatitis.

[0016] The pharmacological effects of the above raw material drugs are as follows:

[0017] Glossy privet fruit: Slight odor, sweet taste, slightly bitter and astringent. Sweet, bitter, and cool in nature. It belongs to the liver and kidney meridians. It nourishes the liver and kidney, improves eyesight and blackens hair. It is used for liver-kidney yin deficiency, dizziness and tinnitus, soreness and weakness of the waist and knees, premature whitening of hair, unclear vision, internal heat and polydipsia, and hectic fever due to yin deficiency.

[0018] Ophiopogon japonicus: It has a slight fragrance, tastes sweet and slightly bitter. It is sweet, slightly bitter, and slightly cold in nature. It belongs to the heart, lung, and stomach meridians. It nourishes yin and moistens the lungs, benefits the stomach and promotes the production of body fluid, clears the heart and relieves vexation. It is used for dry cough due to lung dryness, consumptive cough due to yin deficiency, sore throat due to throat obstruction. Insufficient stomach yin, thirst due to body fluid injury, internal heat and polydipsia, constipation due to intestinal dryness, heart yin deficiency and restlessness of the heart due to warm disease disturbing the nutrient system, and insomnia due to restlessness.

[0019] Forsythia suspensa: It has a slight fragrance and tastes bitter. It is bitter and slightly cold in nature. It belongs to the lung, heart, and small intestine meridians. It clears heat and detoxifies, reduces swelling and dissipates nodules, disperses wind-heat. It is used for carbuncles, scrofula, breast abscess, erysipelas, wind-heat cold, the initial stage of warm disease, heat entering the nutrient and blood system, high fever and restlessness, coma and maculae, and painful and difficult urination.

[0020] White peony root: It tastes bitter and sour and is slightly cold in nature. It belongs to the liver and spleen meridians. It nourishes the blood and soothes the liver, alleviates pain in the middle energizer, astringes yin and stops sweating. It is used for pain in the chest, abdomen, hypochondrium and costal region, diarrhea and dysentery pain, spontaneous sweating and night sweating, yin deficiency fever, irregular menstruation, metrorrhagia and metrostaxis, and leukorrhea.

[0021] Turmeric: It tastes bitter and pungent. It is pungent, bitter, and warm in nature. It belongs to the liver and spleen meridians. It promotes blood circulation and qi movement, dredges channels and stops pain. It is used for qi stagnation and blood stasis, stabbing pain in the chest and hypochondrium, chest impediment pain, dysmenorrhea and amenorrhea, mass in the abdomen, swelling and pain from falls and bruises, and pain in the shoulder and arm due to wind-dampness.

[0022] Fried Endothelium Corneum Gigeriae Galli: It has a slight fishy smell and tastes slightly bitter. It is sweet and flat in nature. It belongs to the spleen, stomach, small intestine, and bladder meridians. It strengthens the stomach and promotes digestion, astringes essence and stops seminal emission, promotes diuresis and removes calculi. It is used for indigestion, vomiting, diarrhea, infantile malnutrition. Spermatorrhea, enuresis, painful and difficult urination with calculus, and pain in the hypochondrium due to distension of the gallbladder.

[0023] Advantages of the present invention:

[0024] Throughout the ages, physicians have had different understandings of the physiology and pathology of the liver. Ye Tianshi recorded in "Medical Records of Clinical Practice - Liver Wind": "Therefore, the liver is an organ of wind and wood, with ministerial fire internally stored. Its body is yin and its function is yang. Its nature is rigid, active and ascending. It entirely depends on the kidney water to nourish it and the blood to moisten it... to become a soft body and fulfill its smooth and flourishing nature." The population of patients with autoimmune hepatitis is mainly middle-aged and elderly women. "Plain Questions - Treatise on the Correspondence between Yin and Yang and Manifestations of Nature" states that "at the age of forty, yin qi is reduced by half, and daily activities decline." After a long time of deficiency of liver and kidney yin, qi movement is not smooth, the liver collaterals lose nourishment, and stasis, heat toxin cannot be cleared. Therefore, patients with autoimmune hepatitis mostly show the syndrome of deficiency of liver and kidney yin and stasis of heat toxin, with symptoms such as lassitude and weakness, dull pain in the hypochondrium, dry mouth and dry eyes, soreness and weakness of the waist and knees, thin and yellow or little coating, red tongue, stasis of the sublingual collaterals, and thready and taut pulse. The present invention mainly aims at the treatment of autoimmune hepatitis with the syndrome of deficiency of liver and kidney yin and stasis of heat toxin.

[0025] In the formula of the present invention, Glossy Privet Fruit and White Peony Root are the sovereign drugs. Glossy Privet Fruit is sweet, bitter, and cool in nature, and belongs to the liver and kidney meridians, with the function of nourishing the liver and kidney. "Shennong Ben Cao Jing" states that it "is mainly used for tonifying the middle, calming the five internal organs, nourishing the spirit, and eliminating all diseases." White Peony Root is bitter, sour, and slightly cold in nature, and belongs to the liver and spleen meridians. Its functions include astringing yin and softening the liver, nourishing blood and regulating menstruation. "Compendium of Materia Medica of Yunnan" records that it can: "relieve the reverse pain of the liver qi, regulate the qi and blood of the heart, liver, and spleen, soothe the liver and lower qi, and stop the pain of the liver qi." When combined with Glossy Privet Fruit, it enhances the excellent effect of nourishing yin, softening the liver, and dredging collaterals.

[0026] When liver and kidney yin deficiency persists for a long time, body fluids will be deficient, endogenous stagnant heat will transform into fire, and the pathogenic fire will accumulate and not be resolved, becoming "heat toxin". Due to the lack of body fluids, the vessels are not well moistened, blood circulation is sluggish, and in addition, the heat toxin is intense, which easily causes stasis by boiling and burning body fluids and blood. Moreover, if the heat toxin is not resolved, it will consume qi and damage yin, forming a vicious cycle, so stubborn diseases are difficult to cure. In the formula, Turmeric and Forsythia are the ministerial drugs. Turmeric can promote blood circulation, activate qi, and dredge collaterals. "Newly Revised Materia Medica" records that it "is mainly used for treating abdominal masses, rebellious qi, promoting qi downward, breaking blood stasis, removing wind-heat, and dissipating carbuncles and swelling." Forsythia has a thin smell and taste, is light, clear, and floating, with the functions of clearing heat and detoxifying, and dissipating nodules and swelling. The combination of the two has the effects of clearing heat and promoting qi, activating blood circulation and removing stasis, and detoxifying and reducing enzymes.

[0027] Ophiopogon japonicus is an adjuvant drug. This product is sweet, slightly bitter, and slightly cold in nature, and belongs to the heart, lung, and stomach meridians. Its function is to nourish yin, benefit the stomach, and promote the production of body fluids, and can enhance the power of Glossy Privet Fruit, the sovereign drug, to nourish the true yin of the liver and kidney. "Synopsis of the Golden Chamber" states: "When liver disease is seen, it is known that the liver will transmit to the spleen, so the spleen should be strengthened first." The liver and the spleen are physiologically related and pathologically connected. Liver disease can transmit to the spleen, and strengthening the spleen can treat the liver. Endothelium Corneum Gigeriae Galli is the guiding drug. In chronic liver disease, the spleen earth is weak, food intake is reduced, the face is sallow, and the body is fatigued. Therefore, this product is used to strengthen the spleen and promote transportation, eliminate food stagnation, so that qi and blood can be transported sufficiently, and the earth is strengthened to prevent the liver from attacking. When combined with Ophiopogon japonicus and Glossy Privet Fruit, it can also regulate the liver, spleen, and kidney simultaneously, playing a role in consolidating the root and cultivating the yuan. In addition, Endothelium Corneum Gigeriae Galli also has the effect of slowly dissipating stasis. "Medical Compendium of Chinese and Western Medicine" records: "Moreover, in all cases of consumptive disease, there are often stasis in the meridians. Adding Endothelium Corneum Gigeriae Galli to nourishing drugs can dissolve the stasis in the meridians and the disease can be cured." This product can assist the ministerial drug White Peony Root to dredge the liver meridian and enhance the effect of softening the liver, detoxifying, and removing stasis.

[0028] Under the guidance of the theory of syndrome differentiation and disease treatment in traditional Chinese medicine, the present invention formulates prescriptions according to the principle of sovereign, ministerial, adjuvant, and guiding drugs. The combination of various drugs mainly nourishes the kidney and yin, softens the liver and detoxifies, activates blood circulation and eliminates stasis, and also has the effects of supplementing qi and nourishing blood, dissipating nodules and dredging collaterals, soothing the liver and strengthening the spleen. It is mainly aimed at autoimmune hepatitis of the type of liver and kidney yin deficiency and heat toxin stasis, and also has a certain therapeutic effect on other types of autoimmune hepatitis.

[0029] The present invention is a pure traditional Chinese medicine preparation, which is safe, convenient to use, has no toxic and side effects, is not easy to produce drug resistance, does not pollute the environment, does not cause drug-induced diseases, has a wide range of raw material sources, low cost, obvious effects, and can effectively treat autoimmune hepatitis of the liver and kidney yin deficiency type.

[0030] Explanation of attached diagrams

[0031] Figure 1 Comparison of ALT and AST levels at the first, second, and third consultations for patients

[0032] Figure 2 Comparison of GGT and ALP levels at the first, second, and third consultations for patients

[0033] Figure 3 Comparison of TB and DB levels at the first, second, and third consultations for patients Specific implementation manners

[0034] The present invention will be further described below in conjunction with specific implementation manners. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the content recorded in the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms also fall within the scope defined by the appended claims of this application.

[0035] Example 1: Take 150 g of Glossy Privet Fruit, 150 g of Dwarf Lilyturf Tuber, 120 g of Forsythia Fruit, 100 g of White Peony Root, 120 g of Turmeric, and 150 g of Chicken Gizzard-membrane. The preparation method includes the following steps: (1) Weigh Chicken Gizzard-membrane by weight, dry it, crush it, and sieve it to obtain powder A; (2) Weigh Glossy Privet Fruit, Dwarf Lilyturf Tuber, Forsythia Fruit, White Peony Root, and Turmeric by weight, mix them, add 10 times the weight of water of the mixed raw material drugs, reflux and extract twice, each time for 1 h, filter, combine the filtrates, concentrate them under reduced pressure to a clear paste with a relative density of 1.17 (60 °C), add ethanol to make the alcohol content 75%, let it stand for 18 h, filter, and take the supernatant and concentrate it into an extract B with a relative density of 1.19 (60 °C); (3) Mix powder A and extract B evenly, dry it, crush it, add a certain amount of auxiliary materials; granulate by dry granulation to obtain the granule.

[0036] Example: Take 100 g of Glossy Privet Fruit, 200 g of Dwarf Lilyturf Tuber, 100 g of Forsythia Fruit, 105 g of White Peony Root, 100 g of Turmeric, and 200 g of Chicken Gizzard-membrane. The preparation method includes the following steps: (1) Weigh Chicken Gizzard-membrane by weight, dry it, crush it, and sieve it to obtain powder A; (2) Weigh Glossy Privet Fruit, Dwarf Lilyturf Tuber, Forsythia Fruit, White Peony Root, and Turmeric by weight, mix them, add 10 times the weight of water of the mixed raw material drugs, reflux and extract twice, each time for 1 h, filter, combine the filtrates, concentrate them under reduced pressure to a clear paste with a relative density of 1.16 (60 °C), add ethanol to make the alcohol content 80%, let it stand for 12 h, filter, and take the supernatant and concentrate it into an extract B with a relative density of 1.20 (60 °C); (3) Mix powder A and extract B evenly, perform fluidized bed granulation with a certain amount of auxiliary materials, sieve it, put the obtained granules and a certain amount of magnesium stearate into a total mixer and mix, and press tablets with a rotary tablet press to obtain tablets.

[0037] Example 3: Take 200 g of Glossy Privet Fruit, 100 g of Dwarf Lilyturf Tuber, 140 g of Forsythia Fruit, 50 g of White Peony Root, 140 g of Turmeric Root-Tuber, and 100 g of Chicken Gizzard-membrane. The preparation method includes the following steps: (1) Weigh Chicken Gizzard-membrane according to the weight, dry it, pulverize it, and sieve it to obtain powder A; (2) Weigh Glossy Privet Fruit, Dwarf Lilyturf Tuber, Forsythia Fruit, White Peony Root, and Turmeric Root-Tuber according to the weight, mix them, add water with a weight 10 times that of the mixed raw material drugs, reflux and extract twice, each time for 1 h, filter, combine the filtrates, concentrate them under reduced pressure to obtain a clear paste with a relative density of 1.18 (60 °C), add ethanol to make the alcohol content 70%, let it stand for 24 h, filter, and take the supernatant and concentrate it into an extract B with a relative density of 1.18 (60 °C); (3) Mix powder A and extract B evenly, perform fluidized bed granulation with a certain amount of excipients, sieve, and fill the obtained granules into hollow capsules to obtain the capsule preparation.

[0038] Example 4: Take 150 g of Glossy Privet Fruit, 150 g of Dwarf Lilyturf Tuber, 120 g of Forsythia Fruit, 100 g of White Peony Root, 120 g of Turmeric Root-Tuber, and 150 g of Chicken Gizzard-membrane. Preparation method: Weigh each raw material drug according to the weight, mix them, add water with a weight 7 times that of the total weight of the raw material drugs, soak for 30 min, and decoct 3 times, each time for 1 h, filter, and combine the filtrates to obtain the mixture preparation.

[0039] Example 5: Clinical research

[0040] 1. Cases: From January 2022 to September 2023, 50 patients with autoimmune hepatitis diagnosed in the outpatient department of Jiangsu Provincial Hospital of Traditional Chinese Medicine were selected and divided into two groups according to the random number table method, with 25 cases in the control group and 25 cases in the experimental group.

[0041] 2. Inclusion criteria and exclusion criteria

[0042] Inclusion criteria:

[0043] (1) Patients who meet the diagnostic criteria for autoimmune hepatitis, referring to the Diagnostic and Treatment Guidelines for Autoimmune Hepatitis of the Chinese Society of Hepatology, Chinese Medical Association in 2021;

[0044] (2) Aged 18 - 65 years old;

[0045] (3) Not taking medicine, or having taken medicine but after stopping for 2 weeks;

[0046] (4) Obtained the informed consent form.

[0047] Exclusion criteria:

[0048] (1) Exclude those with combined severe kidney, brain, and cardiovascular diseases;

[0049] (2) Under 18 years old or over 65 years old;

[0050] (3) Pregnant and lactating women;

[0051] (4) Patients with liver damage caused by viral, drug-induced, alcoholic and other reasons.

[0052] 3. TCM syndrome differentiation criteria:

[0053] Liver and kidney yin deficiency, heat toxin stasis type: Lassitude and weakness, dull pain in the hypochondrium, dry mouth and dry eyes, abdominal distension, soreness and weakness of the waist and knees, poor appetite, yellowish urine, thin or yellowish tongue coating, red tongue, stasis of the sublingual collaterals, thready and string-like pulse.

[0054] 4. Treatment plan:

[0055] The experimental group took the traditional Chinese medicine mixture in Example 4 (the daily dosage was 15 g of Glossy Privet Fruit, 15 g of Dwarf Lilyturf Tuber, 12 g of Forsythia Fruit, 10 g of White Peony Root, 12 g of Turmeric Root-Tuber, 15 g of Endothelium Corneum Gigeriae Galli), 1 dose per day, taken in 2 times. The control group took Prednisone Acetate Tablets (Approval No. H31020675 of Shanghai Shangyao Xinyi Pharmaceutical Factory Co., Ltd.) combined with Azathioprine Tablets (Approval No. H20003841 of Beijing Jialin Pharmaceutical Co., Ltd.) for treatment. Prednisone Acetate Tablets were given at 30 mg / d in the first week of treatment and gradually reduced by 10 mg per week to 5 mg / d for maintenance. Azathioprine Tablets were taken orally at 50 mg / d. Continuing to take the medicine for 4 weeks was regarded as 1 visit, and the total treatment course for both groups was 2 months.

[0056] 5. Observation indicators: ALT (alanine aminotransferase), ALP (alkaline phosphatase), AST (aspartate aminotransferase elevation), γGT (γ-glutamyl transpeptidase), and TBiL (total bilirubin) of the patients were observed before and after treatment respectively.

[0057] 6. Efficacy criteria: Recovery: Liver function returned to normal; Effective: The liver function indicators improved and decreased by more than 50%; Ineffective: Failure to meet the above criteria was regarded as ineffective. Total effective rate = (number of recovered cases + number of effective cases) / number of cases × 100%

[0058] 7. Results

[0059] 7.1 Liver function indicators are shown in Table 1:

[0060] Table 1 Changes in liver function-related indicators of 50 patients at different visits (x±s)

[0061]

[0062] 7.2 Comparison of ALT and AST levels of the two groups of patients at the first visit, second visit, and third visit is shown in Figure 1 、Comparison of GGT and ALP levels of the patients at the first visit, second visit, and third visit is shown in Figure 2 、Comparison of TB and DB levels of the patients at the first visit, second visit, and third visit is shown in Figure 3 .

[0063] 8. Total effective rate: After the third diagnosis of 25 patients in the experimental group of the traditional Chinese medicine composition of the present invention, 17 cases were cured, 6 cases were effective, and 2 cases were ineffective, with a total effective rate of 92%; after the third diagnosis of 25 patients in the western medicine control group, 12 cases were cured, 8 cases were effective, and 5 cases were ineffective, with a total effective rate of 80%.

[0064] 9. Conclusion: The present invention is an effective prescription for treating autoimmune hepatitis of the type of liver-kidney yin deficiency and heat-toxin stasis.

[0065] Although the embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating liver-kidney yin deficiency, heat-toxic stasis type autoimmune hepatitis, characterized in that: The invention is prepared by extracting the following Chinese medicinal raw materials in parts by weight: 10-20 parts of Ligustrum lucidum fruit, 10-20 parts of Radix Ophiopogonis, 10-14 parts of Fructus Forsythiae, 5-15 parts of Radix Paeoniae Alba, 10-14 parts of Curcuma Longa and 10-20 parts of Gallus Gallus Ternifolia.

2. The Chinese medicine composition for treating liver-kidney yin deficiency, heat-toxic stasis type autoimmune hepatitis as claimed in claim 1, characterized in that: The invention is prepared by extracting the following Chinese medicinal raw materials in parts by weight: 15 parts of Ligustrum lucidum fruit, 15 parts of Radix Ophiopogonis, 12 parts of Fructus Forsythiae, 10 parts of Radix Paeoniae Alba, 12 parts of Curcuma Longa and 15 parts of Gallus Gallus Ternifolia.

3. The Chinese medicine composition for treating liver-kidney yin deficiency, heat-toxic stasis type autoimmune hepatitis according to claim 1, characterized in that: The preparation method comprises the following steps: (1) weighing chicken gizzard lining by weight, drying, crushing, and sieving to obtain powder A; (2) weighing Ligustrum lucidum, Ophiopogon japonicus, Forsythia suspensa, White Peony Root, and Curcuma longa by weight, mixing, adding water 10 times the weight of the mixed raw materials, refluxing extraction twice, each time for 1 hour, filtering, combining the filtrate and concentrating under reduced pressure to a clear paste with a relative density of 1.16-1.18 at 60°C, adding ethanol to make the alcohol content 70-80%, standing for 12-24 hours, filtering, and concentrating the supernatant to an extract B with a relative density of 1.18-1.20 at 60°C; (3) mixing powder A and extract B evenly, vacuum drying to obtain a dry extract, crushing, adding auxiliary materials, and preparing a preparation.

4. The Chinese medicine composition for treating liver-kidney yin deficiency, heat-toxic stasis type autoimmune hepatitis as claimed in claim 1, characterized in that: The preparation method comprises the following steps: weighing each raw material medicine by weight, mixing, adding water 7 times the total weight of the raw material medicine to soak for 30 minutes, and decocting for 3 times, each time for 1 hour, filtering, combining the filtrate, and preparing a liquid preparation.

5. The Chinese medicine composition for treating liver-kidney yin deficiency, heat-toxicity and blood stasis type autoimmune hepatitis as claimed in claim 3, characterized in that: The preparation is one of tablets, capsules and granules.

6. The Chinese medicine composition for treating liver-kidney yin deficiency, heat-toxicity and blood stasis type autoimmune hepatitis as claimed in claim 4, characterized in that: The liquid preparation is a mixture.

7. Use of the Chinese medicine composition for treating liver-kidney yin deficiency, heat-toxicity and blood stasis type autoimmune hepatitis as claimed in claim 1 in the preparation of drugs for treating autoimmune hepatitis.

Images