A Chinese medicine composition for treating liver fibrosis and early liver cirrhosis and its preparation method

Abstract

The invention provides a Chinese medicine composition for treating liver fibrosis and early liver cirrhosis and a preparation method thereof. The Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20 parts of bupleurum, 8-12 parts of immature bitter orange, 15-35 parts of red peony root, 8-12 parts of white peony root, 5-15 parts of peach kernel, 5-15 parts of cinnamon twig, 12-18 parts of tuckahoe, 8-15 parts of trigonosciadium japonicum, 5-15 parts of curcuma, 10-20 parts of salvia miltiorrhiza, 20-35 parts of ficus indica, 5-15 parts of radix scutellariae, 12-18 parts of cat's claw, 10-20 parts of carapace of turtle, 3-6 parts of earthworm and 3-8 parts of licorice. The preparation method of the Chinese medicine composition is simple, the Chinese medicines in the prescription are strictly compatible, the dispersion has astringency, the opening has a closing, the effect is synergistic, the Chinese medicine composition is used for treating liver fibrosis and early liver cirrhosis, has the advantages of remarkable effect and good curative effect, and through clinical trials, the total effective rate of liver fibrosis reaches 100%, and the total effective rate of liver cirrhosis reaches 96.6%.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating liver fibrosis and early liver cirrhosis and a preparation method thereof. Background Art

[0002] Liver fibrosis is a common pathological process in which many chronic pathogenic factors act on the liver and cause excessive deposition of extracellular matrix (ECM). The pathogenic factors cause liver oxidative stress response and cytokine production, which is the initiation link of liver fibrosis. Liver fibrosis is an early pathological change and a necessary stage of liver cirrhosis. There are many causes of chronic liver cirrhosis caused by various pathogenic factors, including hepatitis virus, drugs, alcohol, schistosomiasis and chemical poisoning. Damage can activate hepatic stellate cells (HSC), proliferate and secrete a large amount of ECM, so that the synthesis of ECM is greater than the decomposition, and the deposition in the liver forms liver fibrosis. If liver fibrosis can be diagnosed early and treated actively and reasonably, it can still be reversed and restored to normal. However, once it develops into liver cirrhosis, it will progressively worsen and be difficult to reverse, and it can cause many serious complications and even develop into primary liver cancer, and the prognosis is very grim.

[0003] Cirrhosis is a chronic, progressive, diffuse liver disease caused by long-term effects of different causes on the liver. Its pathological basis is diffuse proliferation of liver fibrous tissue on the basis of extensive necrosis of liver cells, and the formation of regenerative nodules and pseudolobules. In the early stage, there may be no obvious symptoms due to the strong compensatory function of the liver. If the lesion continues to develop, the main manifestations in the later stage are liver function damage and portal hypertension, and multiple systems are involved. In the late stage, various complications such as cirrhosis ascites, upper gastrointestinal bleeding, hepatic encephalopathy, and hepatorenal syndrome may occur.

[0004] As an important part of the "hepatitis - cirrhosis - liver cancer" trilogy, liver fibrosis is the bridge between hepatitis and cirrhosis, and cirrhosis is an important stage in the development of hepatitis to liver cancer. Therefore, timely intervention and treatment of liver fibrosis and early cirrhosis are particularly critical. Chronic liver disease includes various liver diseases with a course of more than half a year caused by hepatitis viruses, ethanol, drugs and poisons, parasites, metabolism and genetics, cholestasis, immune abnormalities, etc. If the treatment is timely and appropriate in the early stage of liver fibrosis, its course is often reversible.

[0005] Traditional Chinese medicine believes that when exogenous pathogenic factors, diet, emotions, and fatigue act on the liver, its physiological functions will be affected, eventually leading to blood stasis and accumulation. Without the help of modern medical methods, ancient doctors have been well aware of the etiology and pathogenesis of liver fibrosis. Exogenous pathogens invade and accumulate in the liver for a long time, blocking the qi, causing qi stagnation and blood stasis, and accumulation; improper drinking and eating, not being hungry or full, or eating fat and cold food, food stagnation, insect accumulation, and phlegm and qi blocking, qi stagnation, and accumulation syndrome; depression, liver qi discomfort, viscera disharmony, blood vessels obstruction, blood stasis, and accumulation over time can form accumulation; after a long illness, damp heat lingers, qi and blood stagnation; or long-term malaria does not heal, damp phlegm stagnates, stays and does not go away, and accumulation can form. Various pathogenic factors act on the liver, eventually leading to deficiency of vital energy, blood stasis, and accumulation. Prevention before illness, prevention of changes after illness, and prevention of transmission after illness are the three core ideas of TCM "preventive treatment". From the perspective of disease progression, chronic hepatitis will inevitably lead to liver fibrosis and cirrhosis over time. In the early stage of cirrhosis, liver function is still in the compensatory stage and the condition is not very serious. If timely diagnosis and treatment are given, there is still room for maneuver. If the condition is allowed to continue to develop, the liver function is in the decompensated stage, and it becomes a symptom accumulation, soil deficiency, and horsetail, which is difficult to treat.

[0006] At present, for liver fibrosis or early cirrhosis, Western medicine mainly adopts etiological treatment methods, such as long-term antiviral treatment for liver fibrosis / cirrhosis related to hepatitis B; strict abstinence for alcoholic liver fibrosis / cirrhosis; and discontinuation of suspected drugs for drug-related liver fibrosis / cirrhosis, etc. However, there are still certain limitations in the effectiveness of etiological treatment of liver fibrosis, and it cannot completely suppress inflammation. Once the mechanism of liver fibrosis is activated, it often progresses actively. Therefore, anti-liver fibrosis treatment targeting fibrous tissue proliferation and degradation is very necessary and is an important treatment measure for chronic liver disease. There are no ideal anti-liver fibrosis drugs at home and abroad. It is necessary to use the advantages of multi-component and multi-target effects of traditional Chinese medicine compound to develop traditional Chinese medicine prescriptions suitable for such patients, and combine it with the theory of traditional Chinese medicine to achieve personalized treatment to solve the clinical problem that liver fibrosis / cirrhosis is difficult to cure. Summary of the invention

[0007] In view of this, the present invention provides a Chinese medicine composition for treating liver fibrosis and early liver cirrhosis and a preparation method thereof to solve the above problems.

[0008] The technical scheme of the present invention is achieved as follows: a traditional Chinese medicine composition for treating liver fibrosis and early liver cirrhosis is prepared from the following raw materials in parts by weight: 10-20 parts of bupleurum, 8-12 parts of immature bitter orange, 25-35 parts of red peony root, 8-12 parts of white peony root, 5-15 parts of peach kernel, 5-15 parts of cinnamon twig, 12-18 parts of poria, 8-15 parts of triangularis, 5-15 parts of curcuma, 10-20 parts of salvia miltiorrhiza, 25-35 parts of ficus indica, 5-15 parts of scutellaria baicalensis, 12-18 parts of cat's claw, 10-20 parts of turtle shell, 3-6 parts of earthworm and 3-8 parts of roasted liquorice.

[0009] Furthermore, a traditional Chinese medicine composition for treating liver fibrosis and early cirrhosis is made from the following raw materials in parts by weight: 12-18 parts of bupleurum, 9-11 parts of white peony root, 18-32 parts of red peony root, 8-11 parts of peach kernel, 8-11 parts of cinnamon twig, 14-17 parts of poria, 9-12 parts of trillium, 8-12 parts of curcuma, 12-18 parts of salvia miltiorrhiza, 9-11 parts of immature bitter orange, 28-32 parts of ficus benjamina, 8-11 parts of scutellaria baicalensis, 14-18 parts of cat's claw, 12-18 parts of turtle shell, 3-5 parts of earthworm, and 4-7 parts of roasted liquorice.

[0010] Furthermore, a Chinese medicine composition for treating liver fibrosis and early cirrhosis is made from the following raw materials in parts by weight: made from the following raw materials in parts by weight: 15 parts of bupleurum, 10 parts of white peony root, 30 parts of red peony root, 10 parts of peach kernel, 10 parts of cinnamon twig, 15 parts of poria, 10 parts of trillium, 10 parts of curcuma, 15 parts of salvia miltiorrhiza, 10 parts of immature bitter orange, 30 parts of ficus indica, 10 parts of scutellaria baicalensis, 15 parts of cat's claw, 15 parts of turtle shell, 4 parts of earthworm, and 6 parts of roasted liquorice.

[0011] Furthermore, a method for preparing a Chinese medicine composition for treating liver fibrosis and early liver cirrhosis comprises the following steps:

[0012] Step 1: according to the formula, bupleurum root, white peony root, red peony root, peach kernel and cinnamon twig are mixed, and water is added to boil to obtain liquid medicine I;

[0013] Step 2: Take Poria cocos, Trigonella ternata, Curcuma zedoaria, Salvia miltiorrhiza, and Citrus aurantium, dry them, crush and sieve them to obtain powder, add the powder to the above medicinal solution I, heat and continue to decoct to obtain medicinal solution II;

[0014] Step 3: extract the Ficus microcarpa, Cyathula capitata, Cat's Claw, Biejia, Eupolyphaga sinensis, and Glycyrrhiza uralensis with 3-5 times the amount of 80-95wt% ethanol aqueous solution twice, extract for 2-5h for the first time, filter, concentrate and dry, add 1-3 times the amount of water to the residue, extract for 0.8-1.2h, filter, take the filtrate and set aside;

[0015] Step 4: Vibrate and filter the medicinal solution II in step 2, combine the supernatant with the filtrate in step 3, mix and stir evenly at a rate of 1200-1800 rpm under ultrasonic action, then filter and concentrate to obtain a Chinese medicine composition.

[0016] Furthermore, the amount of water added in step 1 is 8-15 times the mass of the mixed raw materials.

[0017] Furthermore, the decoction temperature in step 1 is set at 80-100° C., and the decoction time is 3-8 hours.

[0018] Furthermore, in step 2, the mass volume ratio of the powder to the drug solution I is 0.3-0.9:10 g / mL.

[0019] Furthermore, in step 2, the heating temperature is 50-80° C. and the decocting time is 8-12 hours.

[0020] Furthermore, in step 4, the ultrasonic power is 10-30 W, the frequency is 25-85 kHz, and the time is 25-55 min.

[0021] Furthermore, the Chinese medicine composition is used in the preparation of a method for treating liver fibrosis and early liver cirrhosis.

[0022] Compared with the prior art, the invention has the following beneficial effects: in the prescription of the invention, bupleurum, immature bitter orange and red peony root are the main drugs, which can relieve liver depression, promote qi and activate blood circulation, and disperse blood stasis and resolve knots; white peony root, peach kernel, cinnamon twig, tuckahoe, three-edged sword, curcuma and salvia miltiorrhiza are the assistant drugs, which can invigorate the spleen and soften the liver, promote blood circulation and resolve knots; Ficus microcarpa, scutellaria baicalensis, cat's claw, turtle shell, earthworm and roasted liquorice are the adjuvant drugs, and the whole prescription can play the effects of clearing away heat and detoxifying, promoting blood circulation and removing blood stasis, promoting qi and resolving phlegm, softening and resolving knots, etc., and the compatibility of various Chinese medicines is rigorous, with astringency in the dispersing and closing in the opening, and the effect is synergistic, and the prescription has the advantages of remarkable effect and good efficacy in treating liver fibrosis and early liver cirrhosis. Through clinical trials, the total effective rate of liver fibrosis reaches 100%, and the total effective rate of liver cirrhosis reaches 96.6%. DETAILED DESCRIPTION

[0023] In order to better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0024] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0025] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.

[0026] 1. Basic information of the main raw materials of the present invention

[0027] Bupleurum: pungent and bitter in nature, slightly cold in nature. Enters the liver and gallbladder meridians. Functions: reconcile the exterior and interior, relieve liver depression, raise yang and lift depression, reduce fever and stop malaria. It can treat chest and flank pain, resolve phlegm, clear the exterior and interior evil qi, eliminate restlessness and heat, and relieve hot flashes. Pharmacological studies have shown that Bupleurum has anti-inflammatory and antipyretic, sedative and analgesic, antitussive and anticonvulsant effects; can reduce liver damage and promote bile secretion; has blood pressure lowering, serum cholesterol lowering and hemolytic effects; has anti-ulcer, antibacterial, antiviral, anti-tumor, blood sugar raising, blood fat lowering, and anti-radiation damage effects.

[0028] Citrus aurantium: bitter and cold in nature, enters the liver, spleen and stomach meridians. Function: breaks up qi and eliminates stagnation, resolves phlegm and relieves lumps. It can treat abdominal distension and pain caused by food stagnation, constipation due to heat accumulation, abdominal distension and pain, damp-heat diarrhea, tenesmus, gastroptosis, uterine prolapse, rectal prolapse, etc. Pharmacological studies have shown that Citrus aurantium has a dual effect of inhibition and excitation on gastrointestinal motility and uterine smooth muscle; anti-inflammatory; antibacterial, antiviral; anti-allergic; antioxidant; analgesic and other effects.

[0029] Red peony root: bitter, slightly cold, belongs to the liver meridian and spleen meridian. Function: clearing heat and cooling blood, promoting blood circulation and dispersing blood stasis. It can treat various bleeding, metrorrhagia, dysmenorrhea, abdominal pain caused by blood stasis, etc. Pharmacological studies have shown that red peony root can resist thrombosis, platelet aggregation, lower blood lipids, resist arteriosclerosis, and fight tumors. It has the effects of protecting the liver, scavenging oxygen free radicals, relieving intestinal spasm, and inhibiting bacteria.

[0030] White peony root: slightly cold in nature, bitter and sour in taste. Enters the liver meridian and spleen meridian. Functions: soothes the liver and relieves pain, nourishes blood and regulates menstruation, restrains yin and stops sweating, and suppresses liver yang. This medicine can purge and disperse, replenish and astringe, and can treat gynecological diseases caused by blood deficiency and blood stasis, abdominal and rib pain, dysmenorrhea, etc. Pharmacological studies have shown that white peony root can relieve fever and lower temperature, calm and hypnotize; it has antispasmodic, anti-inflammatory, anti-ulcer, enhances cellular immunity and humoral immunity, dilates blood vessels, increases blood flow, tolerates hypoxia, lowers blood pressure, inhibits platelet aggregation, protects the liver, resists mutation, and has anti-tumor effects.

[0031] Peach kernel: neutral in nature, bitter and sweet in taste. It enters the heart meridian, liver meridian, and large intestine meridian. Function: promoting blood circulation and removing phlegm, moistening the intestines and relieving constipation. It can treat chest pain, amenorrhea, chest tightness, etc. Pharmacological studies have shown that peach kernel has anticoagulant, antithrombotic, blood flow improvement, anti-inflammatory, analgesic and anti-allergic effects. It can also relieve cough and asthma, and has a certain effect on tuberculosis. It also has an anthelmintic effect.

[0032] Cinnamon twig: pungent, sweet, warm in nature, enters the lung, heart, and bladder meridians. Functions: releases wind and relaxes muscles, warms the meridians and dredges blood vessels, assists yang and transforms qi, and balances and descends qi. It is used to treat colds, cold pain in the abdomen, amenorrhea due to cold blood, joint pain, edema due to phlegm, palpitations, and other symptoms. Pharmacological studies have shown that cinnamon twig has certain anti-inflammatory, antibacterial, and antiviral effects; it has antipyretic, analgesic, sedative, and anticonvulsant effects on the central nervous system; it can increase myocardial nutritional blood flow, and it also has anti-allergic and anticoagulant effects.

[0033] Poria: sweet and light in nature, enters the heart, lung, spleen and kidney meridians. Function: diuresis and dampness, spleen and qi. It can be used to treat edema, oliguria, phlegm and fluid, palpitations, spleen deficiency, poor appetite, loose stools, palpitations and insomnia. Pharmacological studies have shown that Poria can prevent gastric ulcers, prevent and treat liver damage; has anti-cancer effects; has diuretic and antibacterial effects, and can improve the body's immune ability.

[0034] Tripterygium wilfordii: bitter in nature and flavor, neutral. Enters the liver and spleen meridians. Function: breaks blood and promotes qi, eliminates stagnation and relieves pain. Used to treat lumps and masses, dysmenorrhea, amenorrhea due to blood stasis, chest pain, and food stagnation and pain. Pharmacological studies have shown that the water extract of Tripterygium wilfordii can significantly prolong the coagulation time of thrombin on fibrin; it has the effect of resisting in vitro thrombosis; the decoction has an excitatory effect on the isolated rabbit uterine smooth muscle; the drug can be anti-tumor.

[0035] Curcuma: warm in nature, pungent and bitter in taste. It enters the spleen meridian and liver meridian. It is a Hainanese medicine, mainly used for promoting qi and removing blood, eliminating accumulation and relieving pain. It can treat abdominal pain caused by blood stasis, hepatosplenomegaly, abdominal distension and pain, accumulation, amenorrhea caused by blood stasis in women, pain caused by trauma, and food stagnation. Pharmacological studies have shown that Curcuma has the effects of anti-tumor, antibacterial, increasing white blood cells, promoting blood circulation and removing blood stasis; it has a liver-protecting effect; it has an improvement effect on acute renal failure; it can inhibit platelet aggregation and anti-thrombosis; it has anti-inflammatory effects.

[0036] Danshen: bitter and slightly cold in nature, it belongs to the heart meridian and liver meridian. Function: remove blood stasis and relieve pain, activate blood circulation and relieve dysmenorrhea, clear the heart and relieve restlessness. It is used to treat irregular menstruation, amenorrhea and dysmenorrhea, accumulation of lumps and masses, stabbing pain in the chest and abdomen, hepatosplenomegaly, pain caused by heat arthralgia, swelling and poison of sores, restlessness and insomnia, angina pectoris, etc. Pharmacological studies have shown that Danshen can protect the heart and brain system, lower blood lipids, resist atherosclerosis and enhance the ability to tolerate hypoxia; it can enhance immune function; it can resist inflammation and allergy; it can protect the liver; it can resist oxidation, antibacterial and anti-tumor; it can calm and relieve pain; it can improve kidney function; it can promote the healing of skin wounds and fractures, etc.

[0037] Ficus microcarpa: slightly warm in nature, sweet in taste. It enters the lung meridian, spleen meridian, stomach meridian, large intestine meridian, and liver meridian. It is a Hainanese medicine, and its functions are: invigorating qi and strengthening the spleen, removing phlegm and relieving asthma, promoting qi and removing dampness, and relaxing muscles and activating collaterals. It is used to treat lung deficiency, phlegm, asthma, cough, limb fatigue and weakness due to spleen and stomach qi deficiency, poor appetite and abdominal distension, spleen deficiency edema, leucorrhea, rheumatic pain, and waist and leg pain; it is also used to treat chronic hepatitis and ascites due to liver cirrhosis. Pharmacological studies have shown that the decoction and ethanol extract of Ficus microcarpa have good antitussive and expectorant effects on mice; and have good antibacterial effects on Staphylococcus aureus and Streptococcus A.

[0038] Chuanpo Stone: cool in nature, light in taste, slightly bitter. It enters the heart meridian and liver meridian. It is a Hainan Li medicine, and its functions are to dispel wind and dredge meridians, clear away heat and dampness, and detoxify and reduce swelling. It can treat jaundice, gastric and duodenal ulcers, mumps, rheumatic pain, traumatic injuries, pulmonary tuberculosis, hemoptysis due to overwork, furuncles, carbuncles, etc. Pharmacological studies have shown that Chuanpo Stone has an anti-tuberculosis effect.

[0039] Cat's Claw: warm in nature, sweet and spicy in taste. Enters the liver meridian and lung meridian. Function: dissipates stagnation and reduces swelling, detoxifies and resolves phlegm. Used to treat scrofula, tuberculosis, pulmonary tuberculosis, furuncles, caries and pain. Pharmacological studies suggest that cat's claw has anti-tumor and anti-tuberculosis effects.

[0040] Turtle shell: slightly cold in nature, salty in taste. Enters the liver and kidney meridians. Functions: nourishing yin and suppressing yang, softening and dispersing lumps, reducing fever and removing steam. Used for fever due to yin deficiency, fever due to fatigue and bone steaming, internal movement of wind due to deficiency, amenorrhea, leukorrhea, chronic malaria, etc. Pharmacological studies have shown that turtle shell has the effects of nourishing blood, resisting liver fibrosis, and resisting cancer, and can enhance the immunity of experimental animals.

[0041] Earthworm: cold in nature, salty in taste, belongs to the liver meridian. Function: breaks blood and removes blood stasis, connects tendons and bones. Used to treat traumatic injuries, tendon injuries and fractures, blood stasis and amenorrhea, abdominal pain caused by postpartum blood stasis, lumps and masses, etc. Pharmacological studies have shown that earthworm can improve cardiovascular and cerebrovascular function, has significant lipid-regulating effects and inhibits leukemia cells. Animal experiments have shown that the water extract of this product has an anticoagulant effect. It also has the effects of anti-hypoxia, anti-mutation, lowering total cholesterol and increasing the ratio of high-density lipoprotein to cholesterol.

[0042] Roasted Licorice: warm in nature, sweet in taste. It enters the heart meridian, lung meridian, stomach meridian, and spleen meridian. Function: tonifies the spleen and stomach, replenishes qi and restores the pulse. It is used to treat spleen and stomach weakness, fatigue, palpitations, and irregular pulse. Modern research shows that roasted licorice contains glycyrrhizin, glycyrrhetinic acid, glycyrrhizin polysaccharides, and other licorice ingredients.

[0043] The chemical components have anti-inflammatory and anti-allergic effects, can regulate the body's immune function, and have anti-tumor and analgesic effects; licorice preparations such as glycyrrhizin, magnesium isoglycyrrhizinate, ammonium glycyrrhizinate, etc. have the effects of protecting the liver and lowering enzymes, and the effect is definite. Example 1

[0044] A traditional Chinese medicine composition for treating liver fibrosis and early liver cirrhosis is prepared from the following raw materials in parts by weight: 10 parts of bupleurum, 8 parts of immature bitter orange, 25 parts of red peony root, 8 parts of white peony root, 5 parts of peach kernel, 5 parts of cinnamon twig, 12 parts of tuckahoe, 8 parts of trigonosciadium japonicum, 5 parts of curcuma, 10 parts of salvia miltiorrhiza, 25 parts of ficus indica, 5 parts of radix scutellariae, 12 parts of cat's claw, 10 parts of turtle shell, 3 parts of earthworm and 3 parts of roasted liquorice. Example 2

[0045] A traditional Chinese medicine composition for treating liver fibrosis and early liver cirrhosis is prepared from the following raw materials in parts by weight: 20 parts of bupleurum, 12 parts of immature bitter orange, 35 parts of red peony root, 12 parts of white peony root, 15 parts of peach kernel, 15 parts of cinnamon twig, 18 parts of poria, 15 parts of trigonosciadium japonicum, 15 parts of curcuma, 20 parts of salvia miltiorrhiza, 35 parts of ficus indica, 15 parts of radix scutellariae, 18 parts of cat's claw, 20 parts of turtle shell, 6 parts of earthworm, and 8 parts of roasted liquorice. Example 3

[0046] A traditional Chinese medicine composition for treating liver fibrosis and early liver cirrhosis is prepared from the following raw materials in parts by weight: 12 parts of bupleurum, 9 parts of white peony root, 18 parts of red peony root, 8 parts of peach kernel, 8 parts of cinnamon twig, 14 parts of poria, 9 parts of triangularis, 8 parts of curcuma, 12 parts of salvia miltiorrhiza, 9 parts of immature bitter orange, 28 parts of ficus indica, 8 parts of radix scutellariae, 14 parts of cat's claw, 12 parts of turtle shell, 3 parts of earthworm, and 4 parts of roasted liquorice. Example 4

[0047] A traditional Chinese medicine composition for treating liver fibrosis and early liver cirrhosis is prepared from the following raw materials in parts by weight: 18 parts of bupleurum, 11 parts of white peony root, 32 parts of red peony root, 11 parts of peach kernel, 11 parts of cinnamon twig, 17 parts of poria, 12 parts of triangularis, 12 parts of curcuma, 18 parts of salvia miltiorrhiza, 11 parts of immature bitter orange, 32 parts of ficus indica, 11 parts of radix scutellariae, 18 parts of cat's claw, 18 parts of turtle shell, 5 parts of earthworm, and 7 parts of roasted liquorice. Example 5

[0048] A traditional Chinese medicine composition for treating liver fibrosis and early liver cirrhosis is prepared from the following raw materials in parts by weight: 15 parts of bupleurum, 10 parts of white peony root, 30 parts of red peony root, 10 parts of peach kernel, 10 parts of cinnamon twig, 15 parts of poria, 10 parts of triangularis, 10 parts of curcuma, 15 parts of salvia miltiorrhiza, 10 parts of immature bitter orange, 30 parts of ficus indica, 10 parts of radix scutellariae, 15 parts of cat's claw, 15 parts of turtle shell, 4 parts of earthworm, and 6 parts of roasted liquorice.

[0049] The above-mentioned Examples 1-5 adopt the following preparation method.

[0050] Step 1: according to the formula, bupleurum root, white peony root, red peony root, peach kernel and cinnamon twig are mixed, and water is added for decoction, the amount of water added is 12 times the mass of the mixed raw materials, the decoction temperature is 90°C, the decoction time is 5h, and liquid I is obtained.

[0051] Step 2: Take Poria cocos, Trillium, Curcuma, Salvia miltiorrhiza, and Citrus aurantium, dry them, crush and sieve them to obtain powder, add the powder to the above-mentioned medicinal solution I, the mass volume ratio of the powder to the medicinal solution I is 0.7:10 g / mL, heat and continue to decoct, the heating temperature is 70°C, the decoction time is 10 hours, and medicinal solution II is obtained.

[0052] Step 3: Extract the Ficus microcarpa, Cyathula capitata, Cat's Claw, Biejia, Eupolyphaga sinensis, and Glycyrrhiza uralensis with 4 times the amount of 85wt% ethanol aqueous solution twice, extract for 3h for the first time, filter, concentrate and dry, extract the residue with 2 times the amount of water for 1.0h, filter, and take the filtrate.

[0053] Step 4: Oscillate and filter the medicinal solution II in step 2, take the supernatant and combine it with the filtrate in step 3, mix and stir evenly at a rate of 1500 rpm under ultrasonic action, the ultrasonic power is 20 W, the frequency is 55 kHz, and the time is 45 min, then filter and concentrate to obtain a Chinese medicine composition.

[0054] Verification Example 1-Effect of the pharmaceutical composition of the embodiment on liver fibrosis

[0055] 1. General information: A total of 82 patients with liver disease in outpatient clinics and inpatients of a traditional Chinese medicine hospital were selected. All patients were confirmed to have obvious liver fibrosis (Fibroscan, four liver fibrosis items) by examination. The average age of the patients was 25-70 years old, with 42 males and 40 females. Example 3 and Example 5 of the present invention were used respectively.

[0056] 2. Western medicine case criteria: patients diagnosed with liver fibrosis and meeting the criteria for Qi stagnation and blood stasis syndrome;

[0057] 3. TCM syndrome differentiation standards:

[0058] Main symptoms: ① distension or pain in the ribs; ② dull complexion; ③ dark red tongue or ecchymosis, varicose veins under the tongue.

[0059] Secondary symptoms: ① Distension of the stomach; ② Rough skin and nails or dark eye sockets; ③ Fatigue and drowsiness; ④ Nausea or poor appetite; ⑤ Yellowing of the body and eyes; ⑥ Thin or slightly yellow tongue coating, and thin or stringy pulse.

[0060] 4. Treatment method: Use the Chinese medicine composition of Example 3 and Example 5 of the present invention, take one dose per day, twice a day, morning and evening, 3 months as a course of treatment, and 2 courses of treatment are performed.

[0061] 5. Efficacy evaluation criteria: refer to the "Grading and Quantification Table of Traditional Chinese Medicine Four Diagnostic Data":

[0062] Efficacy classification:

[0063] Cure: Symptoms disappear after the treatment.

[0064] Markedly effective: After the treatment, the symptom score decreased by 2 levels; the clinical symptoms improved significantly, and liver function tests ALT, AST, and GGT decreased by >50%.

[0065] Effective: After the treatment, the symptom score decreased by 1 level; clinical symptoms improved, and liver function ALT, AST, and GGT decreased by 20%-50%.

[0066] Ineffective: There was no improvement in clinical symptoms and blood biochemical indicators after treatment.

[0067] 6. Test results

[0068]

[0069] Verification Example 2-Example Medicinal Composition for Cirrhosis

[0070] 1. General information: There were 57 cases in total, aged between 30 and 80 years old, including 38 males and 19 females.

[0071] 2. Diagnostic criteria: "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases"

[0072] 3. Treatment method: The patient takes the medicine of Examples 3 and 5 of the present invention. Adults take 2 tablets 3 times a day, with warm water within half an hour after meals. One course of treatment is 7 days, and the medicine should be taken continuously for 3 to 4 courses.

[0073] 4. Efficacy criteria:

[0074] Significant effect: Symptoms of liver cirrhosis such as fatigue, weight loss, dull complexion, oliguria, lower limb edema, loss of appetite, abdominal distension, gastrointestinal dysfunction, ascites, etc. were cured.

[0075] Effective: The above symptoms were alleviated.

[0076] Ineffective: No change in symptoms.

[0077] 5. Test results

[0078]

[0079] Typical Cases

[0080] Case 1: Xing Moumou, female, 52 years old, visited the hospital on September 9, 2020.

[0081] The patient was admitted to the outpatient department of liver disease of Hainan Provincial Hospital of Traditional Chinese Medicine on September 9, 2020 because of "intermittent dull pain in the liver area for 3 months, aggravated with bitter taste in the mouth for 3 days". He had a history of hepatitis C and has been cured. Symptoms at the time of consultation: dull pain in the liver area, tingling, obvious at night, bitter taste in the mouth, nausea, poor appetite, drowsiness, soft stool, yellow urine, dark red tongue with white and slightly greasy coating, and stringy pulse. Auxiliary examination: normal liver function. Color Doppler ultrasound: fatty liver, four items of liver fibrosis: hyaluronic acid: 135.6ng / ml. Fibroscan examination: liver hardness: 8.3 Kpa, fat degree: 253 dB / m Tips: 1. Mild liver fibrosis 2. Mild fatty liver. Diagnosis: 1. Mild liver fibrosis 2. Mild fatty liver. The syndrome is diagnosed as qi stagnation and blood stasis. The medicine is: 15g of Bupleurum, 10g of Citrus aurantium, 25g of Red Peony Root, 10g of White Peony Root, 10g of Peach Kernel, 15g of Cinnamon Twig, 15g of Poria, 10g of Trigonum multiflorum, 10g of Curcuma Atractylodes, 10g of Salvia miltiorrhiza, 25g of Ficus microcarpa, 10g of Cyathula capitata, 15g of Cat's Claw, 10g of Biejia, 5g of Eupolyphaga, and 5g of Radix Glycyrrhizae. I gave 7 sets, decocted in water, 1 dose per day. Second visit on September 16, 2020. Self-reported relief of tingling in the liver area, slightly worse sleep at night, no bitter taste in the mouth, increased appetite, normal bowel movements, dark red tongue with slightly greasy white fur, and stringy and astringent pulse. 7 doses of decoction were taken according to the prescription. Third visit on September 23, 2020. The symptoms have basically disappeared. Reexamination of liver fibrosis showed that the four items were normal. Fibroscan examination showed: liver stiffness: 6.3 Kpa, fat content: 209dB / m. Hint: no obvious liver fibrosis was found.

[0082] Case 2: Mr. Wang, male, 56 years old, visited the hospital on January 27, 2017.

[0083] The patient was admitted to the outpatient department of liver disease of Hainan Provincial Hospital of Traditional Chinese Medicine on January 27, 2017 because of "intermittent pain in the liver area for more than 12 years, and recurred for 1 week". The patient had a history of hepatitis B "small three positive" for 12 years and took adefovir dipivoxil antiviral treatment regularly for 1 year. Symptoms at the time of consultation: dull pain in the liver area, needle-like, dark complexion, fatigue, a little dry mouth, restlessness and insomnia, dry and hard stool, once a day, dark red tongue, thin yellow fur, stringy and slightly astringent pulse. Auxiliary examination: Hepatitis B DNA (-) was checked on January 26, 2017, liver function: TBIL: 28umol / L, ALT: 76U / L, AST: 60U / L. Four liver fiber items: hyaluronic acid: 151.2ng / ml, type III procollagen N-terminal peptide: 33.12ng / ml; Fibroscan examination: liver stiffness: liver stiffness: 17.3 Kpa, fat degree: 152dB / m. Hint: severe liver fibrosis. CT: 1. Early liver cirrhosis? 2. Spleen slightly enlarged. Syndrome differentiation is qi stagnation and blood stasis syndrome, medicinal use: 15g of bupleurum, 10g of immature bitter orange, 25g of red peony root, 10g of white peony root, 10g of peach kernel, 10g of cinnamon twig, 15g of poria, 10g of three-edged lanceolate, 10g of curcuma, 10g of salvia miltiorrhiza, 25g of coarse-leaved ficus, 10g of scutellaria, 15g of cat's claw grass, 10g of turtle shell, 5g of earthworm, 5g of licorice root. Give 7 sets, decoct in water, 1 dose per day. Advise to regulate emotions, eat light food, pay attention to rest, and do not stay up late. Second visit on February 4, 2017. The patient reported that the symptoms had been alleviated, the dull pain in the liver area had been reduced, the fatigue had been alleviated, but he was still upset, occasionally had dry mouth and bitter taste, poor sleep, and his bowel movements were basically normal. His tongue was dark red, his fur was thin and yellow, and his pulse was stringy and slightly astringent. He took 10 doses of the prescription. The conditioning method was the same as before. Third visit on March 1, 2017. Symptoms: good spirits, no pain in the liver area, fatigue and upset had basically disappeared, no dry mouth and bitter taste, good sleep, and normal bowel movements. The liver function test was basically normal. He continued to take Chinese medicine orally until the next follow-up visit, and the rest of the conditioning method was the same as before. Follow-up on April 2, 2017. The patient's symptoms disappeared. Re-examination of four liver fibrosis items: hyaluronic acid: 126.7ng / ml, type III procollagen N-terminal peptide: 21.13ng / ml; Fibroscan examination: liver stiffness: 12.1 Kpa, fat content: 167dB / m. Tip: moderate liver fibrosis.

[0084] Case 3: Li, female, 48 years old, visited the hospital on June 8, 2022.

[0085] The patient visited the outpatient department of liver disease at Hainan Provincial Hospital of Traditional Chinese Medicine on June 8, 2022 because of "intermittent liver pain for 2 years". The patient has a history of hepatitis B virus (HBV) and is currently taking entecavir regularly. Symptoms at the time of consultation: dull complexion, pain in the liver area, dry mouth and bitter taste, conscious body heat, hard stool, once a day, dark red tongue, yellow fur, and stringy pulse. Auxiliary examination: Hepatitis B DNA (-), TBIL: 17.9umol / L ALT: 54U / L AST: 33U / L. Four items of liver fibrosis: Hyaluronic acid: 128.1ng / ml. Fibroscan examination: Liver hardness: 7.8 Kpa, fat degree: 204 dB / m, indicating: mild liver fibrosis. Diagnosis: 1. Chronic hepatitis B 2. Mild liver fibrosis. The syndrome was diagnosed as qi stagnation and blood stasis. The medicine used was: 15g of Bupleurum, 10g of Citrus aurantium, 30g of Red Peony Root, 10g of White Peony Root, 10g of Peach Kernel, 15g of Cinnamon Twig, 15g of Poria, 10g of Trillium, 10g of Curcuma Atractylodes, 15g of Salvia Miltiorrhiza, 20g of Ficus microcarpa, 15g of Cyathula capitata, 15g of Cat's Claw, 10g of Biejia, 5g of Eupolyphaga, and 5g of Radix Glycyrrhizae. I gave 7 packs, decocted in water, 1 dose per day. On June 15, 2022, the patient reported no pain in the liver area, normal bowel movements, and still dry mouth and bitter taste. The Chinese medicine was decocted in water for 7 packs. On June 22, 2020, the patient had no pain in the liver area, dry mouth and bitter taste disappeared, and bowel movements were normal. Reexamination of liver function and four liver fibrosis items were normal. Fibroscan examination showed: liver hardness: 7.0Kpa, fat degree: 192 dB / m. Hint: no obvious liver fibrosis was found.

[0086] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating liver fibrosis and early liver cirrhosis, characterized in that: The invention is prepared from the following raw materials in parts by weight: 10-20 parts of bupleurum, 8-12 parts of white peony root, 25-35 parts of red peony root, 5-15 parts of peach kernel, 5-15 parts of cinnamon twig, 12-18 parts of tuckahoe, 8-15 parts of triangularis, 5-15 parts of curcuma, 10-20 parts of salvia miltiorrhiza, 8-12 parts of immature bitter orange, 25-35 parts of ficus indica, 5-15 parts of scutellaria baicalensis, 12-18 parts of cat's claw, 10-20 parts of turtle shell, 3-6 parts of earthworm and 3-8 parts of roasted liquorice.

2. A Chinese medicine composition for treating liver fibrosis and early liver cirrhosis according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 12-18 parts of bupleurum, 9-11 parts of white peony root, 18-32 parts of red peony root, 8-11 parts of peach kernel, 8-11 parts of cinnamon twig, 14-17 parts of poria, 9-12 parts of triangularis, 8-12 parts of curcuma, 12-18 parts of salvia miltiorrhiza, 9-11 parts of immature bitter orange, 28-32 parts of ficus indica, 8-11 parts of scutellaria baicalensis, 14-18 parts of cat's claw, 12-18 parts of turtle shell, 3-5 parts of earthworm and 4-7 parts of roasted liquorice.

3. A Chinese medicine composition for treating liver fibrosis and early liver cirrhosis according to claim 1, characterized in that: The drug is prepared from the following raw materials in parts by weight: 15 parts of bupleurum, 10 parts of white peony root, 30 parts of red peony root, 10 parts of peach kernel, 10 parts of cinnamon twig, 15 parts of poria, 10 parts of trillium, 10 parts of curcuma, 15 parts of salvia miltiorrhiza, 10 parts of immature bitter orange, 30 parts of ficus indica, 10 parts of scutellaria baicalensis, 15 parts of cat's claw, 15 parts of turtle shell, 4 parts of earthworm and 6 parts of roasted liquorice.

4. A method for preparing a Chinese medicine composition for treating liver fibrosis and early liver cirrhosis according to claim 1, characterized in that: The following steps are involved: Step 1: according to the formula, bupleurum root, white peony root, red peony root, peach kernel and cinnamon twig are mixed, and water is added to boil to obtain liquid medicine I; Step 2: Take Poria cocos, Trigonella ternata, Curcuma zedoaria, Salvia miltiorrhiza, and Citrus aurantium, dry them, crush and sieve them to obtain powder, add the powder to the above medicinal solution I, heat and continue to decoct to obtain medicinal solution II; Step 3: extract the Ficus microcarpa, Cyathula capitata, Cat's Claw, Biejia, Eupolyphaga sinensis, and Glycyrrhiza uralensis with 3-5 times the amount of 80-95wt% ethanol aqueous solution twice, extract for 2-5h for the first time, filter, concentrate and dry, add 1-3 times the amount of water to the residue, extract for 0.8-1.2h, filter, take the filtrate and set aside; Step 4: Vibrate and filter the medicinal solution II in step 2, combine the supernatant with the filtrate in step 3, mix and stir evenly at a rate of 1200-1800 rpm under ultrasonic action, then filter and concentrate to obtain a Chinese medicine composition.

5. A method for preparing a Chinese medicine composition for treating liver fibrosis and early liver cirrhosis as claimed in claim 4, characterized in that: The amount of water added in step 1 is 8-15 times the mass of the mixed raw materials.

6. A method for preparing a Chinese medicine composition for treating liver fibrosis and early liver cirrhosis as claimed in claim 4, characterized in that: The decoction temperature in step 1 is set at 80-100° C., and the decoction time is 3-8 hours.

7. A method for preparing a Chinese medicine composition for treating liver fibrosis and early liver cirrhosis as claimed in claim 4, characterized in that: The mass volume ratio of the powder and the drug solution I in step 2 is 0.3-0.9:10 g / mL.

8. A method for preparing a Chinese medicine composition for treating liver fibrosis and early liver cirrhosis as claimed in claim 4, characterized in that: In step 2, the heating temperature is 50-80° C. and the boiling time is 8-12 hours.

9. A method for preparing a Chinese medicine composition for treating liver fibrosis and early liver cirrhosis as claimed in claim 4, characterized in that: In step 4, the ultrasonic power is 10-30 W, the frequency is 25-85 kHz, and the time is 25-55 min.

10. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of medicines for treating liver fibrosis and early liver cirrhosis.

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