Liver-protecting traditional Chinese medicine composition and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine preparation, and particularly relates to a liver-protecting traditional Chinese medicine composition which is prepared from the following raw material medicines in parts by weight: 10-15 parts of poria cocos, 8-12 parts of pericarpium citri reticulatae, 5-10 parts of sedum sarmentosum, 3-6 parts of schisandra chinensis, 2-5 parts of scorched hawthorn fruit, 2-5 parts of hypericum perforatum, 2-5 parts of fried medicated leaven, 4-8 parts of sweet-scented osmanthus and 2-4 parts of amomum cardamomum. According to the scheme, the serum ALT and AST levels of a carbon tetrachloride induced liver injury model mouse can be remarkably reduced, the pathological injury of liver tissue is relieved, the liver protection effect in an NAFLD mouse model is remarkable, and the preparation method has the advantages of being stable in preparation process and exact in curative effect. The traditional Chinese medicine composition is suitable for acute and chronic abnormal liver functions caused by various reasons, the formula follows the medication principle of liver diseases, liver awareness and spleen transmission and when the spleen is solid, and the liver protection effect is enhanced by adding the medicine for regulating the spleen and the stomach on the basis of the medicine for regulating the liver and adding the medicine for regulating the spleen and the stomach.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a liver-protecting traditional Chinese medicine composition and its preparation method. Background Technology

[0002] As a vital metabolic and detoxification organ, the liver's health directly impacts the body's overall physiological state. With changing modern lifestyles, factors such as prolonged sleep deprivation, high-fat diets, drug abuse, and exposure to environmental toxins have led to a year-on-year increase in the incidence of chronic liver damage and mild liver dysfunction, with a trend towards affecting younger individuals.

[0003] However, existing formulas and drugs generally have shortcomings such as complex formulations, numerous ingredients, and single target points. For example, enzyme-lowering drugs can only reduce serum ALT and AST levels in the short term and cannot fundamentally repair liver cell damage or improve liver metabolic function. Most other similar products only focus on the liver itself and do not take into account the relationship between the liver and spleen from the perspective of traditional Chinese medicine when formulating their formulations. They cannot achieve the maximum protective effect on the liver through "harmonizing the liver and spleen". Summary of the Invention

[0004] The purpose of this invention is to provide a liver-protecting traditional Chinese medicine composition and its preparation method to solve the problems mentioned in the background art.

[0005] This regimen can significantly reduce serum ALT and AST levels in mice with carbon tetrachloride-induced liver injury, alleviate pathological damage to liver tissue, and has a significant effect on liver protection. It has the advantages of stable preparation process and definite curative effect.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] A liver-protecting traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10-15 parts Poria cocos, 8-12 parts Citrus reticulata peel, 5-10 parts Sedum sarmentosum, 3-6 parts Schisandra chinensis, 2-5 parts Crataegus pinnatifida (roasted), 2-5 parts St. John's wort, 2-5 parts stir-fried Shenqu (medicated leaven), 4-8 parts Osmanthus fragrans, and 2-4 parts Amomum villosum.

[0008] Further preferred, a liver-protecting traditional Chinese medicine composition is made from the following raw materials in parts by weight: 12-14 parts Poria cocos, 9-10 parts Citrus reticulata peel, 6-8 parts Sedum sarmentosum, 4-6 parts Schisandra chinensis, 3-5 parts Crataegus pinnatifida (roasted), 3-5 parts St. John's wort, 3-5 parts stir-fried Shenqu (medicated leaven), 5-7 parts Osmanthus fragrans, and 3-4 parts Amomum villosum.

[0009] A preparation process for a liver-protecting traditional Chinese medicine composition includes the following steps:

[0010] 1) Weigh out each ingredient according to the formula, and wrap the osmanthus and white cardamom separately for later addition;

[0011] After removing impurities and sand from the raw materials, they are pulverized to 20-40 mesh to increase the contact area between the medicinal materials and the solvent; Osmanthus and white cardamom are pulverized separately to 60 mesh, and then added to the medicinal materials to refine the particle size and improve the dissolution of volatile components. They are then sealed and refrigerated for later use.

[0012] 2) Soak the remaining raw materials in water for 20-40 minutes. The amount of water added should be 10-15 times the total weight of the medicinal materials.

[0013] Place all raw materials except for those added later into an extraction tank, add 12-14 times the total weight of the herbs in purified water, soak for 30 minutes, stirring 1-3 times during the process to ensure the herbs are fully moistened, and control the soaking water temperature at 20-25℃ to avoid high temperature damaging heat-sensitive components.

[0014] 3) After soaking, the medicinal liquid and herbs are boiled under high pressure in a sealed environment at a pressure of 0.1-0.15 MPa and a temperature of 110-120℃ for 40-60 minutes.

[0015] High-pressure closed-loop extraction method is used, with a pressure of 0.12-0.14 MPa and a temperature of 115-118℃, maintained for 50 minutes, during which the mixture is circulated and stirred once every 10 minutes at a speed of 30 r / min to promote uniform dissolution of active ingredients;

[0016] 4) Add the above-mentioned post-medication ingredients and continue to decoct at normal pressure and 90-105℃ for 5-15 minutes;

[0017] When the pressure is reduced to normal (pressure ≤ 0.02 MPa) and the temperature is 95-100℃, add osmanthus and white cardamom, and simmer for 8-12 minutes while maintaining a gentle boil. Strictly control the time to avoid excessive loss of volatile components.

[0018] Temperature and pressure are monitored in real time during the decoction process. After concentration, the content of characteristic components such as flavonoids (≥1.2mg / mL) and schisandrol A (≥0.08mg / mL) is tested to ensure stable product quality.

[0019] 5) Filter to obtain the decoction of the liver-protecting Chinese herbal medicine composition; adopt double-layer filtration, first coarse filtration through a 100-mesh filter, and then fine filtration through a 5μm ceramic membrane to remove the dregs and impurities; the filtrate is concentrated under reduced pressure at 60-70℃ and vacuum degree -0.09~0.08MPa to a relative density of 1.10-1.15 (25℃) to obtain concentrated decoction, which can be taken directly or further prepared into other dosage forms.

[0020] Based on the obtained decoction, four practical dosage forms can be developed, and the process is as follows:

[0021] Oral liquid: Add steviol glycosides (0.1%-0.2%) and ethylparaben (0.05%) to the concentrated decoction, stir to dissolve, filter through a 1μm microporous membrane, fill into vials (10mL / vial), sterilize at 100℃ for 30 minutes, and store the finished product in a cool place;

[0022] Excipient selection: Stevia glycosides are natural sweeteners with no calories;

[0023] Sterilization process: Sterilize with flowing steam at 100℃ for 30 minutes. After sterilization, cool to room temperature (≤30℃) before packaging to avoid bottle breakage due to temperature difference.

[0024] Granules: Add dextrin (ratio 1:1.5) and lactose (ratio 1:0.5) to the concentrated decoction, stir evenly, spray dry (inlet air temperature 160-170℃, outlet air temperature 80-85℃), granulate and make into granules (5g / bag), and seal packaging.

[0025] Excipient selection: For those with lactose intolerance, maltitol (1:0.5) can be substituted.

[0026] Spray drying parameters: inlet air temperature 165℃, outlet air temperature 82℃, atomization pressure 0.3MPa, particle moisture content ≤5%, flowability ≥18cm / s;

[0027] Tea bags: Mix all raw materials (without crushing) according to the formula ratio, put them into filter paper bags (3g / bag), seal them and sterilize them with hot air at 60℃ for 20 minutes. Suitable for daily brewing and drinking.

[0028] Raw material processing: Preserve the original form of the medicinal materials to ensure the slow release of active ingredients during brewing;

[0029] Packaging specifications: 3g / bag; the filter paper bag is made of food-grade non-woven fabric, which is breathable and odorless.

[0030] Sterilization process: 60℃ hot air sterilization for 20 minutes, moisture content ≤8% after sterilization, shelf life 18 months;

[0031] Usage: Decoction / oral liquid: 20mL once a day, taken 30 minutes after meals, for one month as one maintenance cycle; those with mild liver function abnormalities can take 20mL twice a day for 2-3 months.

[0032] Granules: Take 1 sachet 1-2 times daily, dissolved in 100mL of warm water, after meals;

[0033] Tea bags: 1-2 bags per day, brewed with 200mL of boiling water, can be brewed repeatedly until the flavor fades.

[0034] Pills: Add refined honey (the weight ratio of concentrated decoction to refined honey is 1:0.8-1.2) and microcrystalline cellulose (the amount added is 5%-8% of the weight of concentrated decoction) to the concentrated decoction, and stir until a uniform soft material is formed.

[0035] The soft material is placed in a pelleting machine to make honey pellets. During the pelleting process, the ambient temperature is controlled at 20-25℃ and the relative humidity at 40%-50%.

[0036] The prepared honey pills were placed in a 60℃ hot air drying oven and dried until the moisture content was ≤9%. After cooling to room temperature, they were packaged in aluminum-plastic blister packs.

[0037] Take 1-2 pills daily with warm water. The pills are highly stable, easy to carry, and have a mild, pleasant taste with honey flavoring, making them widely acceptable.

[0038] Compared with the prior art, the beneficial effects of the present invention are:

[0039] This solution targets common causes of liver damage in modern populations, such as staying up late, high-fat diets, and drug metabolism burden. It constructs a multi-target, gentle traditional Chinese medicine formula system: it improves the liver's metabolic environment by strengthening the spleen and removing dampness, and soothing the liver and regulating qi; it repairs liver cell damage by clearing heat and detoxifying, and nourishing liver yin; and it also helps to reduce the liver's digestive burden by promoting digestion and eliminating food stagnation. Attached Figure Description

[0040] Figure 1 The images show Oil Red O staining of liver tissue from mice in each group. A represents the model group, B the control group, C the positive drug group, D the low-dose group, and E the high-dose group. Detailed Implementation

[0041] Example:

[0042] This method can significantly reduce serum ALT and AST levels in a carbon tetrachloride-induced liver injury model mouse, alleviate liver tissue pathological damage, and has a significant effect on liver protection. It also has the advantages of stable preparation process and definite therapeutic effect. The present invention provides the following technical solution:

[0043] A liver-protecting traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10-15 parts Poria cocos, 8-12 parts Citrus reticulata peel, 5-10 parts Sedum sarmentosum, 3-6 parts Schisandra chinensis, 2-5 parts Crataegus pinnatifida (roasted), 2-5 parts St. John's wort, 2-5 parts stir-fried Shenqu (medicated leaven), 4-8 parts Osmanthus fragrans, and 2-4 parts Amomum villosum.

[0044] A preparation process for a liver-protecting traditional Chinese medicine composition includes the following steps:

[0045] 1) Weigh out each ingredient according to the formula, and wrap the osmanthus and white cardamom separately for later addition;

[0046] After removing impurities and sand from the raw materials, they are pulverized to 20-40 mesh to increase the contact area between the medicinal materials and the solvent; Osmanthus and white cardamom are pulverized separately to 60 mesh, and then added to the medicinal materials to refine the particle size and improve the dissolution of volatile components. They are then sealed and refrigerated for later use.

[0047] 2) Soak the remaining raw materials in water for 20-40 minutes. The amount of water added should be 10-15 times the total weight of the medicinal materials.

[0048] Place all raw materials except for those added later into an extraction tank, add 12-14 times the total weight of the herbs in purified water, soak for 30 minutes, stirring 1-3 times during the process to ensure the herbs are fully moistened, and control the soaking water temperature at 20-25℃ to avoid high temperature damaging heat-sensitive components.

[0049] 3) After soaking, the medicinal liquid and herbs are boiled under high pressure in a sealed environment at a pressure of 0.1-0.15 MPa and a temperature of 110-120℃ for 40-60 minutes.

[0050] High-pressure closed-loop extraction method is used, with a pressure of 0.12-0.14 MPa and a temperature of 115-118℃, maintained for 50 minutes, during which the mixture is circulated and stirred once every 10 minutes at a speed of 30 r / min to promote uniform dissolution of active ingredients;

[0051] 4) Add the above-mentioned post-medication ingredients and continue to decoct at normal pressure and 90-105℃ for 5-15 minutes;

[0052] When the pressure is reduced to normal (pressure ≤ 0.02 MPa) and the temperature is 95-100℃, add osmanthus and white cardamom, and simmer for 8-12 minutes while maintaining a gentle boil. Strictly control the time to avoid excessive loss of volatile components.

[0053] Temperature and pressure are monitored in real time during the decoction process. After concentration, the content of characteristic components such as flavonoids (≥1.2mg / mL) and schisandrol A (≥0.08mg / mL) is tested to ensure stable product quality.

[0054] 5) Filter to obtain the decoction of the liver-protecting Chinese herbal medicine composition; adopt double-layer filtration, first coarse filtration through a 100-mesh filter, and then fine filtration through a 5μm ceramic membrane to remove the dregs and impurities; the filtrate is concentrated under reduced pressure at 60-70℃ and vacuum degree -0.09~0.08MPa to a relative density of 1.10-1.15 (25℃) to obtain concentrated decoction, which can be taken directly or further prepared into other dosage forms.

[0055] Based on the obtained decoction, four practical dosage forms can be developed, and the process is as follows:

[0056] Oral liquid: Add steviol glycosides (0.1%-0.2%) and ethylparaben (0.05%) to the concentrated decoction, stir to dissolve, filter through a 1μm microporous membrane, fill into vials (10mL / vial), sterilize at 100℃ for 30 minutes, and store the finished product in a cool place;

[0057] Excipient selection: Steviosides are a natural sweetener with no calories; Ethylparaben is a preservative that meets food additive standards.

[0058] Sterilization process: Sterilize with flowing steam at 100℃ for 30 minutes. After sterilization, cool to room temperature (≤30℃) before packaging to avoid bottle breakage due to temperature difference.

[0059] Granules: Add dextrin (ratio 1:1.5) and lactose (ratio 1:0.5) to the concentrated decoction, stir evenly, spray dry (inlet air temperature 160-170℃, outlet air temperature 80-85℃), granulate and make into granules (5g / bag), and seal packaging.

[0060] Excipient selection: For those with lactose intolerance, maltitol (1:0.5) can be substituted.

[0061] Spray drying parameters: inlet air temperature 165℃, outlet air temperature 82℃, atomization pressure 0.3MPa, particle moisture content ≤5%, flowability ≥18cm / s;

[0062] Tea bags: Mix all raw materials (without crushing) according to the formula ratio, pack them into filter paper bags (3g / bag), seal them, and sterilize them with hot air at 60℃ for 20 minutes.

[0063] Raw material processing: Preserve the original form of the medicinal materials to ensure the slow release of active ingredients during brewing;

[0064] Packaging specifications: 3g / bag; the filter paper bag is made of food-grade non-woven fabric, which is breathable and odorless.

[0065] Sterilization process: 60℃ hot air sterilization for 20 minutes, moisture content ≤8% after sterilization, shelf life 18 months;

[0066] Usage: Decoction / oral liquid: 20mL once a day, taken 30 minutes after meals, for one month as one maintenance cycle; those with mild liver function abnormalities can take 20mL twice a day for 2-3 months.

[0067] Granules: Take 1 sachet 1-2 times daily, dissolved in 100mL of warm water, after meals;

[0068] Tea bags: 1-2 bags per day, brewed with 200mL of boiling water, can be brewed repeatedly until the flavor fades.

[0069] Pills: Add refined honey (the weight ratio of concentrated decoction to refined honey is 1:0.8-1.2) and microcrystalline cellulose (the amount added is 5%-8% of the weight of concentrated decoction) to the concentrated decoction, and stir until a uniform soft material is formed.

[0070] The soft material is placed in a pelleting machine to make honey pills, each weighing 9g. During the pelleting process, the ambient temperature is controlled at 20-25℃ and the relative humidity at 40%-50%.

[0071] The prepared honey pills were dried in a 60℃ hot air drying oven until the moisture content was ≤9%, and then cooled to room temperature before being packaged in aluminum-plastic blister packs.

[0072] Based on the above embodiments, the mouse experimental comparison experiment is added as follows;

[0073] Experimental animals: 60 male SPF-grade ICR mice, weighing 20-22g, were used for experiments after being acclimatized for one week;

[0074] Experimental drugs: a liver-protecting traditional Chinese medicine composition, prepared as an oral liquid according to the formula in Example 2, with a concentration of 1.5 mg / mL flavonoids and 0.10 mg / mL schisandrol A; and a positive control drug, biphenyl diester drops, with a specification of 1.5 mg / pill.

[0075] Reagents: Carbon tetrachloride (CCl4), olive oil (both analytical grade); serum ALT and AST detection kits (biotechnology company);

[0076] Model establishment: Mice were randomly divided into a blank control group (n=10) and a model group (n=50). The model group received intraperitoneal injections of 5% CCl4 olive oil solution (10 mL / kg body weight) twice weekly for 4 consecutive weeks to establish a chronic liver injury model. The blank control group received an equal volume of physiological saline intraperitoneally during the same period. After model establishment, serum ALT and AST levels were measured in 5 randomly selected mice from the model group to confirm successful model establishment.

[0077] Grouped administration: 45 mice that successfully developed the model were randomly divided into a model control group, a positive control group, a low-dose traditional Chinese medicine group, a medium-dose traditional Chinese medicine group, and a high-dose traditional Chinese medicine group, with 9 mice in each group. After grouping, administration was started and continued for 4 weeks.

[0078] Blank control group: 0.2 mL / 10 g body weight of normal saline was administered by gavage daily.

[0079] Model control group: 0.2 mL / 10 g body weight of physiological saline was administered by gavage daily.

[0080] Positive control group: Biphenyl diester drop suspension was administered by gavage daily at a dose of 5 mg / kg body weight.

[0081] Low-dose traditional Chinese medicine group: Daily oral administration of liver-protecting traditional Chinese medicine liquid via gavage, dose 5mL / kg body weight, equivalent to 0.5g / kg of raw medicinal material.

[0082] Medium-dose group of traditional Chinese medicine: daily oral liquid of liver-protecting traditional Chinese medicine administered by gavage, at a dose of 10mL / kg body weight, equivalent to 1.0g / kg of raw medicinal materials.

[0083] High-dose traditional Chinese medicine group: Daily oral administration of liver-protecting traditional Chinese medicine liquid via gavage, dose 20mL / kg body weight, equivalent to 2.0g / kg of raw medicinal material.

[0084] Detection indicators and results:

[0085] After drug administration, mice were fasted for 12 hours, and blood was collected from the orbital sinus. Serum was separated by centrifugation, and ALT and AST activities were detected using a fully automated biochemical analyzer. The results are shown in Table 1 below:

[0086] Table 1 ALT and AST activities

[0087] Group Number of animals (individuals) ALT (U / L) AST (U / L) Blank control group 10 35.2±4.8 82.5±7.3 Model control group 9 286.4±25.7 312.6±28.5 Positive control group 9 112.3±18.6 135.7±16.4 Low-dose group of traditional Chinese medicine 9 185.6±22.4 203.8±21.7 Medium-dose group of traditional Chinese medicine 9 105.8±15.3 128.4±14.6 High-dose group of traditional Chinese medicine 9 89.2±12.7 05.3±13.2

[0088] Experimental data from a carbon tetrachloride-induced chronic liver injury model: Liver tissue pathological score (HE staining)

[0089] Table 2 Liver tissue pathology scores

[0090] Group Number of animals (individuals) Hepatocellular degeneration and necrosis score (0-4 points) Inflammation infiltration score (0-4 points) Liver fibrosis score (0-4 points) Blank control group 10 0.2±0.1 0.1±0.1 0.0±0.0 Model control group 9 3.5±0.4 3.2±0.3 2.8±0.3 Positive control group 9 1.8±0.3 1.6±0.2 1.5±0.2 Low-dose group of traditional Chinese medicine 9 2.5±0.3 2.3±0.2 2.0±0.2 Medium-dose group of traditional Chinese medicine 9 1.5±0.2 1.3±0.2 1.2±0.1 High-dose group of traditional Chinese medicine 9 1.0±0.2 0.9±0.1 0.8±0.1 Note: Scoring criteria: 0 points for no abnormality, 1 point for mild, 2 points for moderate, 3 points for severe, and 4 points for extremely severe; compared with the model control group, P < 0.01, the pathological improvement in the high-dose traditional Chinese medicine group was better than that in the positive control group (P < 0.05).

[0091] Table 3 Antioxidant Indicators of Liver Tissue

[0092] Group SOD activity (U / mg prot) GSH-Px activity (U / mg prot) MDA content (nmol / mgprot) Blank control group 128.5±10.3 95.6±8.2 3.2±0.5 Model control group 45.8±6.7 32.4±5.1 18.6±2.3 Positive control group 82.3±9.1 65.2±7.3 8.9±1.2 Low-dose group of traditional Chinese medicine 68.5±7.5 48.6±6.2 12.5±1.5 Medium-dose group of traditional Chinese medicine 95.6±8.8 72.3±7.5 7.8±1.0 High-dose group of traditional Chinese medicine 112.4±9.5 85.7±8.1 5.3±0.8 Note: SOD = superoxide dismutase, GSH-Px = glutathione peroxidase, MDA = malondialdehyde; compared with the model control group, P < 0.01.

[0093] Table 4 Serum inflammatory factor levels

[0094] Group TNF-α (pg / mL) IL-6 (pg / mL) IL-1β (pg / mL) Blank control group 15.2±2.1 12.3±1.8 8.5±1.2 Model control group 89.6±9.5 75.4±8.2 56.8±6.3 Positive control group 45.3±5.2 38.6±4.5 28.5±3.1 Low-dose group of traditional Chinese medicine 65.8±7.3 52.7±6.1 42.3±4.5 Medium-dose group of traditional Chinese medicine 38.5±4.8 32.4±4.2 22.6±2.8 High-dose group of traditional Chinese medicine 25.7±3.5 22.8±3.3 15.4±2.1 Note: TNF-α = tumor necrosis factor α, IL = interleukin; compared with the model control group, P < 0.01.

[0095] Based on the above data, the ALT and AST levels in the model control group were significantly higher than those in the blank control group (P < 0.01), indicating successful modeling. All treatment groups significantly reduced serum ALT and AST levels in mice (P < 0.01), with the medium and high dose groups of traditional Chinese medicine showing better effects than the positive control group, and this effect was dose-dependent, confirming that the formulation of this invention has a significant protective effect against CCl4-induced liver injury. The basic principles, main features, and advantages of this invention have been shown and described above. It is obvious to those skilled in the art that this invention is not limited to the details of the above exemplary embodiments, and that the invention can be implemented in other specific forms without departing from the spirit or basic characteristics of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects. The scope of this invention is defined by the appended claims rather than the foregoing description, and therefore all changes falling within the meaning and scope of the equivalents of the claims are intended to be included within this invention.

[0096] Example 1: Basic Maintenance Type

[0097] I. Raw material ratio (parts by weight)

[0098] 10 parts Poria cocos, 8 parts dried tangerine peel, 5 parts Sedum sarmentosum, 3 parts Schisandra chinensis, 2 parts roasted hawthorn, 2 parts St. John's wort, 2 parts stir-fried Shenqu (medicated leaven), 4 parts Osmanthus fragrans, and 2 parts white cardamom.

[0099] II. Preparation Process

[0100] Raw material pretreatment: Except for osmanthus and white cardamom, the remaining medicinal materials are pulverized to 20 mesh after removing impurities; osmanthus and white cardamom are pulverized separately to 60 mesh and then sealed and refrigerated for later use.

[0101] Soaking: Place the non-added herbs in the extraction tank, add purified water at 10 times the total weight of the herbs, soak at 20℃ for 20 minutes, stirring once during the process.

[0102] Decoction: High-pressure sealed decoction (pressure 0.1MPa, temperature 110℃) for 40 minutes, with circulation and stirring once every 10 minutes (speed 30r / min); when the pressure is reduced to normal (≤0.02MPa) and the temperature is 95℃, add the post-added medicine and decoct at a gentle boil for 8 minutes.

[0103] Filtration and concentration: After coarse filtration through a 100-mesh filter and fine filtration through a 5μm ceramic membrane, the sample was concentrated under reduced pressure at 60℃ and a vacuum of -0.08MPa to a relative density of 1.10 (25℃). The flavonoids were found to be 1.2mg / mL and the schisandrol A to be 0.08mg / mL, which met the quality standards.

[0104] III. Finished Product Formulation (Tea Bags)

[0105] Process Adjustment: Maintain the original form of all raw materials, mix them evenly according to the above ratio, pack them into 3g / bag food-grade non-woven filter paper bags, seal them, and sterilize them with hot air at 60℃ for 20 minutes. The moisture content of the finished product is ≤8%. Usage: Take one bag daily, brew it with 200mL of boiling water and drink it as tea. It can be brewed repeatedly until the taste is weak. One month of continuous use constitutes one maintenance cycle.

[0106] Example 2: Moderate conditioning type

[0107] I. Raw material ratio (parts by weight)

[0108] Poria cocos 12 parts, dried tangerine peel 10 parts, Sedum sarmentosum 8 parts, Schisandra chinensis 4.5 parts, charred hawthorn 3.5 parts, St. John's wort 3.5 parts, stir-fried Shenqu 3.5 parts, osmanthus 6 parts, white cardamom 3 parts.

[0109] II. Preparation Process

[0110] Raw material pretreatment: Except for the later-added herbs, the remaining herbs are pulverized to 30 mesh; osmanthus and white cardamom are pulverized to 60 mesh and sealed and refrigerated.

[0111] Soaking: Add purified water at 12 times the total weight of the medicinal materials (excluding those added later) and soak at 22℃ for 30 minutes, stirring twice during the process.

[0112] Decoction: High-pressure sealed decoction (pressure 0.13MPa, temperature 115℃) for 50 minutes, with 3 cycles of stirring; when the pressure is reduced to normal and the temperature is 98℃, add the later-added medicine and decoct at a gentle boil for 10 minutes.

[0113] Filtration and concentration: After double-layer filtration, the product was concentrated to a relative density of 1.12 (25℃) at 65℃ and a vacuum of -0.085MPa. The flavonoids were measured at 1.5mg / mL and the schisandrol A at 0.10mg / mL, which met the standards.

[0114] III. Finished Product Dosage Form (Oral Liquid)

[0115] Process adjustment: Add 0.15% steviol glycosides and 0.05% ethylparaben to the concentrated decoction, stir to dissolve, filter through a 1μm microporous membrane, fill into 10mL vials, sterilize with flowing steam at 100℃ for 30 minutes, and package after cooling to ≤30℃.

[0116] Instructions for use: For those with mild liver dysfunction, take 20mL (2 vials) twice daily, 30 minutes after meals. One treatment cycle is 2 months. For daily maintenance, take 20mL once daily.

[0117] Example 3: Enhanced Repair Type

[0118] I. Raw material ratio (parts by weight)

[0119] 15 parts Poria cocos, 12 parts dried tangerine peel, 10 parts Sedum sarmentosum, 6 parts Schisandra chinensis, 5 parts roasted hawthorn, 5 parts St. John's wort, 5 parts stir-fried Shenqu (medicated leaven), 8 parts Osmanthus fragrans, and 4 parts white cardamom.

[0120] II. Preparation Process

[0121] Raw material pretreatment: Except for the later-added herbs, the remaining herbs are pulverized to 40 mesh; osmanthus and white cardamom are pulverized to 60 mesh and sealed and refrigerated.

[0122] Soaking: Add purified water at 15 times the total weight of the medicinal materials (excluding those added later) and soak at 25℃ for 40 minutes, stirring 3 times during the process.

[0123] Decoction: High-pressure sealed decoction (pressure 0.15MPa, temperature 120℃) for 60 minutes, with 3 cycles of stirring; when the pressure is reduced to normal and the temperature is 100℃, add the later-added medicine and decoct at a gentle boil for 12 minutes.

[0124] Filtration and concentration: After double-layer filtration, the product was concentrated to a relative density of 1.15 (25℃) at 70℃ and a vacuum of -0.09MPa. The flavonoid content was 1.8 mg / mL and the schisandrol A content was 0.12 mg / mL, which met the standards.

[0125] III. Finished Product Dosage Form (Granules)

[0126] Process adjustment: Add dextrin (ratio 1:1.5) and lactose (ratio 1:0.5) to the concentrated decoction, stir evenly, and then spray dry (inlet air temperature 165℃, outlet air temperature 82℃, atomization pressure 0.3MPa). After granulation, make 5g / bag granules, seal and package (granule moisture content ≤5%, flowability ≥18cm / s); for lactose intolerant, replace with maltitol (1:0.5).

[0127] Directions for use: Take 1 sachet twice daily, dissolved in 100mL of warm water, after meals. One intensive treatment cycle consists of 3 consecutive months of use.

[0128] Example 4: Pills

[0129] I. Raw material ratio (parts by weight)

[0130] The formula consists of 12 parts Poria cocos, 10 parts dried tangerine peel, 8 parts Sedum sarmentosum, 4.5 parts Schisandra chinensis, 3.5 parts roasted hawthorn, 3.5 parts St. John's wort, 3.5 parts stir-fried Shenqu (medicated leaven), 6 parts Osmanthus fragrans, and 3 parts Amomum villosum. It follows the core formula of the moderate conditioning type in Example 2 and is suitable for the mild and long-lasting use of pills.

[0131] II. Preparation Process

[0132] Raw material pretreatment: Except for osmanthus and white cardamom, the remaining medicinal materials are pulverized to 30 mesh after removing impurities and sand to increase the dissolution efficiency of active ingredients; osmanthus and white cardamom are pulverized separately to 60 mesh and sealed and refrigerated for later use.

[0133] Soaking: Place the non-added herbs in the extraction tank, add purified water at 12 times the total weight of the herbs, soak at 22℃ for 30 minutes, stirring twice during the process to ensure that the herbs are fully moistened and to avoid high temperature damaging heat-sensitive components.

[0134] Decoction: High-pressure closed-loop extraction method is adopted, with pressure of 0.13MPa and temperature of 115℃, maintained for 50 minutes, during which the mixture is circulated and stirred once every 10 minutes (speed 30r / min); when the pressure is reduced to normal pressure (pressure ≤0.02MPa) and temperature is 98℃, osmanthus and white cardamom are added, and the mixture is simmered at a gentle boil for 10 minutes to reduce the loss of volatile components.

[0135] Filtration and concentration: After coarse filtration through a 100-mesh filter and fine filtration through a 5μm ceramic membrane, the solution was concentrated under reduced pressure at 65℃ and a vacuum degree of -0.085MPa to a relative density of 1.12 (25℃) to obtain a concentrated decoction. The flavonoid content was 1.5mg / mL and the schisandrol A content was 0.10mg / mL, which met the quality standards for intermediate products.

[0136] III. Finished Product Dosage Form (Pills)

[0137] Add refined honey (the weight ratio of concentrated decoction to refined honey is 1:1.0) and microcrystalline cellulose (6% of the weight of concentrated decoction) to the concentrated decoction. Stir for 20 minutes at 23°C and 45% relative humidity to make a soft material that is moderately soft, can be formed into a ball by hand, and can be easily crushed by light pressure.

[0138] The soft material is fed into a fully automatic pelleting machine, and the parameters are adjusted to produce round honey pills weighing 9g each. During the pelleting process, the weight difference of the pills is monitored in real time to ensure that the error is ≤±3%.

[0139] The prepared honey pills were placed in a 60℃ hot air drying oven and dried for 4 hours, turning them over once every hour, until the moisture content was ≤9%. They were then removed and cooled to room temperature (≤30℃).

[0140] The product is individually packaged in aluminum-plastic blister packs, with 10 pills per blister pack. After packaging, it is sterilized by hot air at 60℃ for 20 minutes. The finished product test showed that the flavonoids were 1.3mg / pill and the schisandrin A was 0.09mg / pill, which met the quality standards.

[0141] Directions for use: Take 1-2 pills daily with warm water. One pill daily for one month constitutes one maintenance cycle; two months constitutes one conditioning cycle. The pills are highly stable, easy to carry, and have a mild, pleasant taste with honey flavoring, making them widely acceptable.

[0142] Example 5:

[0143] Laboratory animals: 50 male SPF-grade C57BL / 6 mice, weighing 18-20g, acclimatized for 1 week;

[0144] Experimental drugs: The liver-protecting traditional Chinese medicine composition of this invention was prepared into granules according to the formula in Example 3. Each 5g bag contained 1.8mg of flavonoids and 0.12mg of schisandrin A. It was dissolved in warm water and administered by gavage. The positive control drug was silymarin capsules, with a specification of 35mg / capsule.

[0145] Reagents: High-fat feed containing 60% fat, 20% sucrose, and 20% basal feed; serum ALT and AST detection kits;

[0146] Model establishment: Mice were randomly divided into a blank control group (n=10) fed a basal diet and a model group (n=40) fed a high-fat diet. The NAFLD model was established for 12 consecutive weeks. After model establishment, four mice from the model group were randomly selected, and serum ALT and AST levels were measured. Liver tissue pathology was observed, confirming significant hepatocyte steatosis and a significantly elevated ALT / AST ratio, indicating successful model establishment.

[0147] Grouped administration: Thirty-six mice that successfully established the model were randomly divided into a model control group, a positive control group, a low-dose traditional Chinese medicine group, and a high-dose traditional Chinese medicine group, with nine mice in each group. During the administration period, the model group continued to be fed a high-fat diet, while the blank control group was fed a basal diet. The administration lasted for 8 weeks.

[0148] Blank control group: 0.2 mL / 10 g body weight of normal saline was administered by gavage daily.

[0149] Model control group: 0.2 mL / 10 g body weight of physiological saline was administered by gavage daily.

[0150] Positive control group: Daily gavage administration of silymarin suspension at a dose of 100 mg / kg body weight.

[0151] Low-dose traditional Chinese medicine group: Liver-protecting traditional Chinese medicine granule solution was administered by gavage daily at a dose of 2.5g / kg body weight, equivalent to 0.8g / kg of raw herb.

[0152] High-dose group of traditional Chinese medicine: Daily oral administration of liver-protecting traditional Chinese medicine granule solution, 10g / kg body weight, equivalent to 3.2g / kg of raw herb.

[0153] Detection indicators and results:

[0154] After administration, the mice were fasted for 12 hours, and blood was collected from the orbital sinus to detect serum ALT and AST activities. The results are as follows:

[0155] Table 5 Serum ALT and AST activities

[0156] Group Number of animals (individuals) ALT (U / L) AST (U / L) Blank control group 10 32.6±5.1 78.3±6.9 Model control group 9 198.7±21.4 225.4±23.8 Positive control group 9 95.4±14.2 112.6±15.3 Low-dose group of traditional Chinese medicine 9 142.5±18.7 168.3±19.5 High-dose group of traditional Chinese medicine 9 88.6±13.5 105.7±14.8

[0157] Based on the above data, the ALT and AST levels in the model control group were significantly higher than those in the blank control group (P < 0.01), and obvious fatty degeneration was observed in the liver tissue. All treatment groups significantly reduced serum ALT and AST levels in NAFLD mice (P < 0.01), with the high-dose group of traditional Chinese medicine being superior to the low-dose group (P < 0.05). This indicates that the formulation of this invention has a good intervention effect on fatty liver and can improve hepatocyte damage.

[0158] like Figure 1The red areas represent liver lipid deposition after Oil Red O staining. It is evident that the control group showed physiological lipid storage in the liver, while the model group exhibited significantly increased liver lipid deposition. The red areas were significantly reduced in the positive control group, the low-dose traditional Chinese medicine group, and the high-dose traditional Chinese medicine group. This indicates that both the low- and high-dose traditional Chinese medicine groups of this invention can significantly alleviate liver damage, demonstrating a marked therapeutic effect compared to the model group.

[0159] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for protecting liver, characterized in that, The following weight parts of raw medicinal materials are used: Poria cocos 10-15 parts, dried tangerine or orange peel 8-12 parts, sedum lineare 5-10 parts, Schisandra chinensis 3-6 parts, roasted hawthorn fruit 2-5 parts, Hypericum perforatum 2-5 parts, fried wheat gluten 2-5 parts, osmanthus 4-8 parts, and white cardamom 2-4 parts.

2. The liver-protecting traditional Chinese medicine composition according to claim 1, characterized in that, The following weight parts of raw medicinal materials are used: Poria cocos 12-14 parts, dried tangerine or orange peel 9-10 parts, sedum lineare 6-8 parts, Schisandra chinensis 4-6 parts, roasted hawthorn fruit 3-5 parts, Hypericum perforatum 3-5 parts, fried wheat gluten 3-5 parts, osmanthus 5-7 parts, and white cardamom 3-4 parts.

3. The preparation method of the liver-protecting traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The method comprises the following steps: 1) Weigh the raw medicinal materials according to the prescription, and separately package the osmanthus and white cardamom as the post-added medicinal materials; 2) Soak the remaining raw medicinal materials in water for 20-40 minutes, and the amount of water added is 10-15 times the total weight of the medicinal materials; 3) Perform high-pressure closed boiling of the soaked medicinal liquid and medicinal materials, at a pressure of 0.1-0.15 MPa and a temperature of 110-120℃, for 40-60 minutes; 4) Add the post-added medicinal materials, and continue boiling at normal pressure and at a temperature of 90-105℃ for 5-15 minutes; 5) Filter to obtain the decoction of the liver-protecting traditional Chinese medicine composition.

4. The method for preparing a liver-protecting traditional Chinese medicine composition according to claim 3, characterized in that, In step 1), the raw medicinal materials are ground to 20-40 mesh after removing impurities and mud, so as to increase the contact area of the medicinal materials and the solvent; the osmanthus and white cardamom are separately ground to 60 mesh, the particle size of the post-added medicinal materials is fine, the dissolution of volatile components is promoted, and the post-added medicinal materials are stored in a sealed cold storage.

5. The method for preparing a liver-protecting traditional Chinese medicine composition according to claim 3, characterized in that, In step 2), the raw medicinal materials except the post-added medicinal materials are placed in an extraction tank, 12-14 times the total weight of the medicinal materials of purified water is added, and the medicinal materials are soaked for 30 minutes; the medicinal materials are stirred 1-3 times during the soaking process to ensure that the medicinal materials are fully wetted; the soaking water temperature is controlled at 20-25℃ to avoid damage to heat-sensitive components caused by high temperature.

6. The method for preparing a liver-protecting traditional Chinese medicine composition according to claim 3, characterized in that, In step 3), the high-pressure closed circulation extraction method is used, the pressure is 0.12-0.14 MPa, the temperature is 115-118℃, and the process is maintained for 50 minutes; the effective components are uniformly dissolved by stirring once every 10 minutes during the process at a rotation speed of 30 r / min.

7. The method for preparing a liver-protecting traditional Chinese medicine composition according to claim 3, characterized in that, In step 4), the pressure is reduced to normal pressure (≤0.02 MPa) and the temperature is 95-100℃, the osmanthus and white cardamom are added, and the mixture is boiled for 8-12 minutes in a state of slight boiling; the time is strictly controlled to avoid excessive loss of volatile components.

8. The method for preparing a liver-protecting traditional Chinese medicine composition according to claim 3, characterized in that, In step 5), double-layer filtration is performed, the mixture is first filtered through a 100-mesh filter screen, and then filtered through a 5-μm ceramic membrane to remove the residue and impurities; the filtrate is concentrated under reduced pressure to a relative density of 1.10-1.15 at a temperature of 25℃, a vacuum degree of -0.09 to -0.08 MPa, and a temperature of 60-70℃, to obtain the concentrated decoction, which can be directly taken or further prepared into other dosage forms.

9. The method for preparing a liver-protecting traditional Chinese medicine composition according to claim 8, characterized in that, Based on the obtained decoction, the following four practical dosage forms are obtained, and the processes are as follows: Oral liquid: sweet rebaudioside and hydroxyphenyl ethyl ester are added to the concentrated decoction, stirred and dissolved, filtered through a 1-μm microporous filter membrane, filled and sealed at 10 mL per bottle, sterilized at 100℃ for 30 minutes, and the finished product is stored in a cool place; Granules: dextrin and lactose are added to the concentrated decoction, stirred uniformly, and then spray dried at an inlet temperature of 160-170℃ and an outlet temperature of 80-85℃; the granules are prepared after granulation and sealed packaging; Bagged tea: all the raw medicinal materials are mixed according to the prescription ratio, and not ground; the mixture is packed into filter paper bags, sealed, and then sterilized at 60℃ for 20 minutes. Pill: to the concentrated decoction, add refined honey, microcrystalline cellulose, stir to uniform soft material, then put into the pill machine, the prepared honey pill is placed in 60℃ hot air drying oven, and then aluminum plastic blister packaging is adopted.

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