A liver-protecting medicinal and edible Chinese medicine composition, medicinal and edible Chinese medicine preparation, preparation method and application

Abstract

The application provides a liver-protecting medicinal and edible Chinese medicine composition, a medicinal and edible Chinese medicine preparation and a preparation method and application, and specifically belongs to the technical field of medicinal and edible Chinese medicines. The medicinal and edible Chinese medicine composition comprises the following components in parts by weight: Cassia seed 1-3.5 parts, jujube seed 0.5-2.5 parts, Phyllanthus emblica 0.1-1.5 parts and Prunella vulgaris 0.1-1.5 parts. The medicinal and edible Chinese medicine composition has the effects of significantly improving fatty liver and non-alcoholic fatty hepatitis, and can provide a low-cost and non-toxic side-effect strategy for preventing or treating non-alcoholic fatty hepatitis.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medicinal and edible Chinese medicine, and particularly relates to a medicinal and edible Chinese medicine composition for protecting liver, a medicinal and edible Chinese medicine preparation, and a preparation method and application thereof. BACKGROUND

[0002] Non-alcoholic fatty liver disease (NAFLD) refers to a clinical and pathological syndrome with excessive deposition of fat in liver cells as the main feature, except for alcohol and other clear liver damage factors. With the global epidemic trend of obesity and its related metabolic syndrome, NAFLD has become an important cause of chronic liver disease. NAFLD is a new challenge in the field of modern medicine. Therefore, effective prevention and treatment of NAFLD has important practical significance.

[0003] There is no specific treatment drug for NAFLD in Western medicine, and the clinical treatment is mainly lifestyle intervention, improvement of insulin resistance, correction of metabolic disorders, and liver protection treatment. However, the treatment cost is relatively high, and the efficacy, benefits after drug withdrawal, and long-term drug safety cannot be clearly determined. Chinese medicine has unique advantages and good efficacy in preventing and treating NAFLD, and has no obvious adverse reactions, and has broad application prospects. Therefore, finding high-efficiency traditional Chinese medicine composition for improving fatty liver from plants has become one of the focuses of domestic and foreign research on drugs for preventing and treating NAFLD. SUMMARY

[0004] The application aims to provide a medicinal and edible Chinese medicine composition for protecting liver, a medicinal and edible Chinese medicine preparation, and a preparation method and application thereof. The medicinal and edible Chinese medicine composition has the effect of improving fatty liver, and can realize prevention and treatment of non-alcoholic steatohepatitis.

[0005] The application provides a medicinal and edible Chinese medicine composition, which comprises the following components in parts by weight: Cassia seed 1-3.5 parts, jujube seed 0.5-2.5 parts, Phyllanthus emblica 0.1-1.5 parts, and Prunella vulgaris 0.1-1.5 parts.

[0006] Preferably, the medicinal and edible Chinese medicine composition comprises the following components in parts by weight: Cassia seed 1.2-3 parts, jujube seed 0.8-2 parts, Phyllanthus emblica 0.4-1.1 parts, and Prunella vulgaris 0.4-1.1 parts.

[0007] The application further provides a medicinal and edible Chinese medicine composition, which is composed of the following components in parts by weight: Cassia seed 1-3.5 parts, jujube seed 0.5-2.5 parts, Phyllanthus emblica 0.1-1.5 parts, and Prunella vulgaris 0.1-1.5 parts.

[0008] Preferably, the medicinal and edible herbal composition consists of the following components in parts by weight: 1.2-3 parts of Cassia seed, 0.8-2 parts of Hovenia dulcis seed, 0.4-1.1 parts of Phyllanthus emblica seed, and 0.4-1.1 parts of Prunella vulgaris.

[0009] The present invention also provides a method for preparing the medicinal and edible herbal composition described in the above technical solution, including preparation by water extraction.

[0010] Preferably, the water extraction method includes the following steps: mixing each component with water, soaking, heating and extracting, filtering, concentrating and drying the extract to obtain the medicinal and edible herbal composition.

[0011] The present invention also provides the application of the medicinal and edible herbal composition described in the above technical solution or the medicinal and edible herbal composition prepared by the preparation method described in the above technical solution in the preparation of drugs for improving fatty liver or improving non-alcoholic steatohepatitis.

[0012] The present invention also provides the application of the medicinal and edible herbal composition described in the above technical solution or the medicinal and edible herbal composition prepared by the preparation method described in the above technical solution in the preparation of drugs for the prevention and / or treatment of non-alcoholic steatohepatitis.

[0013] The present invention also provides a liver-protecting traditional Chinese medicine preparation that is both food and medicine, the preparation comprising the traditional Chinese medicine composition that is both food and medicine as described in the above technical solution or the traditional Chinese medicine composition that is both food and medicine prepared by the preparation method described in the above technical solution and excipients.

[0014] Preferably, the dosage form of the traditional Chinese medicine preparation includes tablets, pills, powders, capsules, granules, mixtures, or drops.

[0015] This invention provides a hepatoprotective composition of traditional Chinese medicine (TCM) that is both food and medicine. Based on the study of the effects of TCM on lipid accumulation in hepatocytes using fluorescence imaging and high content analysis techniques, this invention screened TCM substances with the function of reducing cellular lipid accumulation. Through animal experiments, it was verified that the TCM composition of this invention has the function of improving fatty liver and has a significant effect on improving non-alcoholic steatohepatitis (NAH). This provides a low-cost and non-toxic strategy for the prevention or treatment of NHA. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1 The image shows the results of screening effective extracts using a human hepatocyte model provided in Application Example 1 of this invention; where A: bar chart of cell spheroid fluorescence intensity; B: high-content image.

[0018] Figure 2 This is a graph showing the toxicity results of AML12 cell extract detection provided in Application Example 1 of the present invention;

[0019] Figure 3 The figure shows the effect of the extract provided in Application Example 1 of this invention on body weight and liver index in a C57BL / 6j mouse fatty liver injury model; where A: figure of mouse body weight change; B: bar chart of liver index of mice in each treatment group.

[0020] Figure 4 HE staining image of liver tissue from the C57BL / 6j mouse fatty liver injury model provided in Application Example 1 of this invention; where A is the staining result image and B is the lipid droplet percentage result image;

[0021] Figure 5 The graph shows the blood biochemical index results of the C57BL / 6j mouse fatty liver injury model provided in Application Example 1 of this invention; where A: mouse serum AST index graph; B: mouse serum ALT index graph;

[0022] Figure 6 The image shows the liver tissue damage results of the C57BL / 6j mouse fatty liver injury model provided in Application Example 1 of this invention; where A: TG index of mouse liver tissue; B: MDA index of mouse liver tissue.

[0023] Figure 7 HE staining images of liver tissue from the C57BL / 6j mouse fatty liver injury model provided in Application Example 2 of this invention; wherein, A is the staining results of the control group, model group, Example 3, Example 4, Example 6, Example 7, Example 9 and Example 10, and B is the lipid droplet percentage results of the control group, model group and Examples 2 to 10;

[0024] Figure 8 The graph shows the blood biochemical ALT index results of the C57BL / 6j mouse fatty liver injury model provided in Application Example 2 of this invention;

[0025] Figure 9 The image shows the liver tissue damage results of the C57BL / 6j mouse fatty liver injury model provided in Application Example 2 of this invention; where A: TG index of mouse liver tissue; B: MDA index of mouse liver tissue. Detailed Implementation

[0026] This invention provides a medicinal and edible herbal composition comprising the following components in parts by weight: 1-3.5 parts of Cassia Seed, 0.5-2.5 parts of Hoveniae Fructus Aurantii Immaturus, 0.1-1.5 parts of Phyllanthus Phyllanthus, and 0.1-1.5 parts of Prunella Vulgaris. The medicinal and edible herbal composition of this invention has a significant effect in improving non-alcoholic steatohepatitis. The medicinal and edible herbal composition of this invention is safe, has no side effects, is low in cost, and is easily accepted by the public.

[0027] The medicinal and edible herbal composition of this invention includes 1 to 3.5 parts of cassia seed, specifically 1.2 to 3 parts, or more specifically 1.2, 2, or 3 parts. In this invention, the role of cassia seed in the medicinal and edible herbal composition is to lower lipids and alleviate metabolic disorders. This invention does not have a specific limitation on the source of cassia seed; conventional commercially available products known to those skilled in the art can be used.

[0028] The medicinal and edible herbal composition of this invention includes 0.5-2.5 parts of Hovenia dulcis seeds, specifically 0.8-2 parts, 1 part, or 2 parts. In this invention, the role of Hovenia dulcis seeds in the medicinal and edible herbal composition is to regulate lipid metabolism and protect hepatocytes. This invention does not have a specific limitation on the source of Hovenia dulcis seeds; conventional commercially available products known to those skilled in the art can be used.

[0029] The medicinal and edible herbal composition of this invention includes 0.1 to 1.5 parts of Phyllanthus emblica, specifically 0.4 to 1.1 parts, or 0.4, 1, or 1.1 parts. In this invention, Phyllanthus emblica functions as an antioxidant and regulates lipid metabolism in the medicinal and edible herbal composition. This invention does not have a specific limitation on the source of Phyllanthus emblica; conventional commercially available products known to those skilled in the art can be used.

[0030] The medicinal and edible herbal composition of this invention includes 0.1 to 1.5 parts of Prunella vulgaris, which can be 0.4 to 1.1 parts, specifically 0.4 parts, 1 part, or 1.1 parts. In this invention, the function of Prunella vulgaris in the medicinal and edible herbal composition is to soothe the liver, regulate qi, and reduce inflammation. This invention does not have a specific limitation on the source of Prunella vulgaris; conventional commercially available products known to those skilled in the art can be used.

[0031] This invention also provides a medicinal and edible herbal composition, comprising the following components in parts by weight: 1-3.5 parts of Cassia tora seed, 0.5-2.5 parts of Hovenia dulcis seed, 0.1-1.5 parts of Phyllanthus emblica seed, and 0.1-1.5 parts of Prunella vulgaris herb. In a specific embodiment, the medicinal and edible herbal composition comprises the following components in parts by weight: 1.2-3 parts of Cassia tora seed, 0.8-2 parts of Hovenia dulcis seed, 0.4-1.1 parts of Phyllanthus emblica seed, and 0.4-1.1 parts of Prunella vulgaris herb. In another specific embodiment, the medicinal and edible herbal composition comprises the following components in parts by weight: 2 parts of Cassia tora seed, 1 part of Hovenia dulcis seed, 1 part of Phyllanthus emblica seed, and 1 part of Prunella vulgaris herb. The medicinal and edible herbal composition provided by this invention consists only of four raw materials: Phyllanthus emblica seed, Prunella vulgaris herb, Hovenia dulcis seed, and Cassia tora seed. These raw materials are readily available and inexpensive. Cassia seed is the principal herb, primarily responsible for clearing heat, lowering lipids, promoting bowel movements, and detoxifying, targeting the core pathogenesis of fatty liver: "internal accumulation of lipid turbidity." Hovenia dulcis seed is the assistant herb, assisting the principal herb in strengthening lipid-lowering and liver-protecting effects, focusing on regulating lipid metabolism and repairing liver damage. Phyllanthus emblica seed is the adjuvant herb, restraining the biases of the principal and assistant herbs, while also clearing damp-heat, providing antioxidant effects, and alleviating liver inflammation and damage. Prunella vulgaris is the guiding herb, directing the medicine to the liver meridian, relieving liver stagnation, harmonizing qi, and alleviating hypochondriac pain.

[0032] All the drugs claimed in this patent application are traditional Chinese medicines listed in the National Catalogue of Food and Medicine Homologous (2024), and have no toxic side effects.

[0033] This invention also provides a method for preparing the medicinal and edible herbal composition described in the above-mentioned technical solution, including preparation by water extraction. The medicinal and edible herbal composition provided by this invention can be prepared using the traditional water extraction method, which is simple and easy to implement. In a specific embodiment, the water extraction method includes the following steps: mixing each component with water, soaking, heating for extraction, filtering, concentrating, and drying the extract to obtain the medicinal and edible herbal composition. In this invention, each component is further pulverized before being mixed with water. In a specific embodiment, the soaking time is 1-2 hours, which can be 1 hour. In a specific embodiment, the heating extraction includes heating reflux extraction. In a specific embodiment, the heating reflux extraction can be performed 2-3 times, specifically 2 times. In a specific embodiment, 10-12 times the volume of water is added during the heating reflux extraction process. In a specific embodiment, the filtration method can be gauze filtration. In a specific embodiment, the concentration method can be vacuum concentration. In a specific embodiment, the drying method can be freeze drying. In a specific embodiment, each component is extracted separately with water extracts, and then mixed to ensure the extraction rate of each medicinal material.

[0034] The present invention also provides the application of the medicinal and edible herbal composition described in the above technical solution or the medicinal and edible herbal composition prepared by the preparation method described in the above technical solution in the preparation of drugs for improving fatty liver or improving non-alcoholic steatohepatitis.

[0035] The present invention also provides the application of the medicinal and edible herbal composition described in the above technical solution or the medicinal and edible herbal composition prepared by the preparation method described in the above technical solution in the preparation of drugs for the prevention and / or treatment of non-alcoholic steatohepatitis.

[0036] The traditional Chinese medicine composition described in this invention is safe and non-toxic. Compared with the model group, the liver tissue slices showed a significant reduction in vacuoles and a significant decrease in the proportion of lipid droplets, which can significantly reduce hepatic fat accumulation and improve non-alcoholic fatty liver disease. Moreover, when the liver is damaged, the traditional Chinese medicine composition of this invention can significantly reduce ALT content, exhibiting better hepatoprotective effects, reducing hepatocyte necrosis, and improving liver function impairment; it also significantly reduces TG and MDA content in liver tissue, reducing liver damage caused by high lipid levels.

[0037] This invention also provides a traditional Chinese medicine preparation that improves fatty liver, comprising the traditional Chinese medicine composition described in the above-mentioned technical solution or the traditional Chinese medicine composition prepared by the preparation method described in the above-mentioned technical solution and excipients. In specific embodiments, the dosage form of the traditional Chinese medicine preparation includes tablets, pills, powders, capsules, granules, mixtures, or drops.

[0038] To further illustrate the present invention, the following detailed description, in conjunction with embodiments, provides a liver-protecting traditional Chinese medicine composition, a traditional Chinese medicine preparation, a preparation method, and an application provided by the present invention. However, these descriptions should not be construed as limiting the scope of protection of the present invention.

[0039] Example 1

[0040] Preparation method of water extract of traditional Chinese medicine

[0041] Weigh 100 g of dried medicinal materials, pulverize them, and place them in a round-bottom flask. Add 1.2 L of water and soak for 1 h. Reflux extraction is performed for 1 h using a heating mantle. Filter through four layers of gauze to obtain the extract. Mix the medicinal materials again with 1.0 L of pure water and perform a second reflux extraction for 1 h. Filter through four layers of gauze to obtain the extract. Combine the extracts, concentrate them under reduced pressure, and freeze-dry to obtain the final extract.

[0042] Example 2

[0043] Referring to the preparation method of Example 1, extracts of Phyllanthus emblica, Prunella vulgaris, Hovenia dulcis, and Cassia tora were prepared respectively. Each extract was prepared into a solution with a concentration of 40 mg / mL. 2 mL of Cassia tora extract, 1 mL of Hovenia dulcis extract, 1 mL of Phyllanthus emblica extract, and 1 mL of Prunella vulgaris extract were mixed to obtain traditional Chinese medicine composition 1-1.

[0044] Example 3

[0045] Following the preparation method of Example 1, extracts of Phyllanthus emblica, Prunella vulgaris, Hovenia dulcis, and Cassia tora were prepared. Each extract was prepared into a solution with a concentration of 40 mg / mL. 3 mL of Cassia tora extract, 0.8 mL of Hovenia dulcis extract, 1.1 mL of Phyllanthus emblica extract, and 1.1 mL of Prunella vulgaris extract were mixed to obtain traditional Chinese medicine compositions 1-2.

[0046] Example 4

[0047] Referring to the preparation method of Example 1, extracts of Phyllanthus emblica, Prunella vulgaris, Hovenia dulcis, and Cassia tora were prepared respectively. Each extract was prepared into a solution with a concentration of 40 mg / mL. 1.2 mL of Cassia tora extract, 2 mL of Hovenia dulcis extract, 0.4 mL of Phyllanthus emblica extract, and 0.4 mL of Prunella vulgaris extract were mixed to obtain traditional Chinese medicine compositions 1-3.

[0048] Example 5

[0049] Following the preparation method of Example 1, extracts of Ophiopogon japonicus, Prunella vulgaris, Phyllanthus emblica, Hovenia dulcis, Astragalus membranaceus, and Cassia tora were prepared. Each extract was prepared into a solution with a concentration of 40 mg / mL. 1 mL of Ophiopogon japonicus extract, 1 mL of Prunella vulgaris extract, 1 mL of Phyllanthus emblica extract, 1 mL of Hovenia dulcis extract, 1 mL of Astragalus membranaceus extract, and 1 mL of Cassia tora extract were mixed to obtain traditional Chinese medicine composition 2-1.

[0050] Example 6

[0051] Following the preparation method of Example 1, extracts of Ophiopogon japonicus, Prunella vulgaris, Phyllanthus emblica, Hovenia dulcis, Astragalus membranaceus, and Cassia tora were prepared. Each extract was prepared into a solution with a concentration of 40 mg / mL. 0.8 mL of Ophiopogon japonicus extract, 1.2 mL of Prunella vulgaris extract, 1.5 mL of Phyllanthus emblica extract, 0.5 mL of Hovenia dulcis extract, 0.5 mL of Astragalus membranaceus extract, and 1.5 mL of Cassia tora extract were mixed to obtain traditional Chinese medicine composition 2-2.

[0052] Example 7

[0053] Following the preparation method of Example 1, extracts of Ophiopogon japonicus, Prunella vulgaris, Phyllanthus emblica, Hovenia dulcis, Astragalus membranaceus, and Cassia tora were prepared. Each extract was prepared into a solution with a concentration of 40 mg / mL. 0.5 mL of Ophiopogon japonicus extract, 0.8 mL of Prunella vulgaris extract, 1.8 mL of Phyllanthus emblica extract, 1.5 mL of Hovenia dulcis extract, 0.2 mL of Astragalus membranaceus extract, and 1.2 mL of Cassia tora extract were mixed to obtain traditional Chinese medicine compositions 2-3.

[0054] Example 8

[0055] Following the preparation method of Example 1, extracts of Ophiopogon japonicus, Prunella vulgaris, Astragalus membranaceus, and Cassia tora were prepared. Each extract was prepared into a solution with a concentration of 40 mg / mL. 2 mL of Ophiopogon japonicus extract, 2 mL of Prunella vulgaris extract, 1 mL of Astragalus membranaceus extract, and 1 mL of Cassia tora extract were mixed to obtain traditional Chinese medicine composition 3-1.

[0056] Example 9

[0057] Following the preparation method of Example 1, extracts of Ophiopogon japonicus, Prunella vulgaris, Astragalus membranaceus, and Cassia tora were prepared. Each extract was prepared into a solution with a concentration of 40 mg / mL. 3 mL of Ophiopogon japonicus extract, 1 mL of Prunella vulgaris extract, 0.5 mL of Astragalus membranaceus extract, and 1.5 mL of Cassia tora extract were mixed to obtain traditional Chinese medicine composition 3-2.

[0058] Example 10

[0059] Following the preparation method of Example 1, extracts of Ophiopogon japonicus, Prunella vulgaris, Astragalus membranaceus, and Cassia tora were prepared. Each extract was prepared into a solution with a concentration of 40 mg / mL. 1.5 mL of Ophiopogon japonicus extract, 1.5 mL of Prunella vulgaris extract, 0.3 mL of Astragalus membranaceus extract, and 2.7 mL of Cassia tora extract were mixed to obtain the traditional Chinese medicine composition 3-3.

[0060] Application Example 1

[0061] 1. Experimental Materials

[0062] 1.1 Experimental cells and animals

[0063] Human hepatocytes were purchased from Livo Biotechnology (Shenzhen) Co., Ltd., AML12 cells were purchased from China Center for Type Culture Collection, and C57BL / 6j mice were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd.

[0064] 1.2 Experiments and Consumables

[0065] The reagents and consumables used in the experiment included DMEM / F12 medium, William's E medium, human hepatocyte resuscitation medium, dexamethasone, ITS liquid medium supplement, fetal bovine serum, antibiotics, trypsin, trypan blue, thiazolyl blue, anhydrous ethanol, PBS phosphate buffer, cell-grade DMSO, L-glutamine, palmitic acid, oleic acid, 96-well cell culture plates, 10 cm cell culture dishes, 96-well low-absorption cell culture plates, sterile centrifuge tubes, nitroglycerin staining kit, malondialdehyde (MDA) detection kit, triglyceride (TG) colorimetric assay kit, aspartate aminotransferase (AST) GOT detection kit, alanine aminotransferase (ALT) GPT detection kit, methionine and choline-deficient MCD feed, and regular feed. The Chinese medicinal herbs were purchased from Bozhou Bohong Pharmaceutical Co., Ltd.

[0066] Using the method of Example 1, aqueous extracts of Cassia Seed, Prunella Vulgaris, Astragalus, Ophiopogon japonicus, Hovenia dulcis, and Phyllanthus emblica were obtained respectively, and subsequent effective extract screening and toxicity tests were conducted.

[0067] The traditional Chinese medicine composition 1-1 of Example 2, the traditional Chinese medicine composition 2-1 of Example 5, and the traditional Chinese medicine composition 3-1 of Example 8 were selected for subsequent mouse experiments.

[0068] 1.3 Experimental Apparatus

[0069] The main instruments used in the experiment included a CO2 incubator, an ImageXpress Confocal HT.ai high-content imaging system, a SpectraMax iD5 multi-functional microplate reader, a constant temperature water bath, a cell counter, an ultrasonic instrument, a benchtop centrifuge, an autoclave, a clean bench, micropipettes, and a vortex mixer.

[0070] 2. Experimental Methods

[0071] 2.1 Screening of effective extracts using human hepatocyte models

[0072] After resuscitating human hepatocytes, the cell suspension was adjusted to 3 × 10⁻⁶. 4 Cells / mL were seeded at 100 μL / well in 96-well low-adsorption cell culture plates, centrifuged at 250 × g for 1.5 min, and cultured in a CO2 incubator for 5–7 days to form spheroids. Modeling was achieved using William's E medium containing 240 μM oleic acid and palmitic acid, while simultaneously administering the drug at a concentration of 100 μg / mL. After one week of continuous drug administration, staining was performed using a nisin staining kit, and the fluorescence intensity of the spheroids was detected using a high-content imaging system. The fluorescence intensity reflects the lipid accumulation in the spheroids.

[0073] 2.2 AML12 cell toxicity assay for extracts

[0074] After AML12 cells were revived and passaged 1 to 2 times, they were seeded into 96-well cell culture plates at a rate of 8000 cells / well and cultured in a CO2 incubator until the cells reached 50%–60% confluence. The original culture medium was replaced with medium containing 400 μg / mL, 200 μg / mL, 100 μg / mL, and 50 μg / mL of the extract. After 24 h of incubation in a CO2 incubator, cell viability was assessed using the MTT assay. If cell viability decreased significantly, the drug concentration was considered toxic.

[0075] 2.3 Effects of the extract on the C57BL / 6j mouse model of non-alcoholic fatty liver disease

[0076] Forty-five male C57BL / 6j mice were acclimatized to the experimental environment for 7 days. The mice were randomly divided into five groups: control group (C), model group (M), and groups for Examples 2, 5, and 8. Except for the control group, which was fed a standard diet, the other groups were fed an MCD diet for a total of 8 weeks. No medication was administered for the first 4 weeks, and medication was administered via gavage for the last 4 weeks. The dosage for Example 2 was 500 mg / kg / day, and for Examples 5 and 8, the dosage was 600 mg / kg / day. After the experiment, samples were collected and relevant tests were performed.

[0077] 3. Experimental Results

[0078] like Figure 1 As shown, a model was established using 240 μM palmitic acid and oleic acid. After one week of continuous drug administration, the samples were stained with a nifedipine staining kit and detected using a high-content instrument. The results showed that the aqueous extracts of Cassia tora seed, Prunella vulgaris, Astragalus membranaceus, Ophiopogon japonicus, Hovenia dulcis seed, and Phyllanthus emblica significantly reduced fluorescence intensity, indicating reduced lipid accumulation.

[0079] Figure 1 The results of screening effective extracts from a human hepatocyte model are shown in the figure; where A: bar chart of cell spheroid fluorescence intensity; B: high-content image; the drug concentration was 100 μg / mL; significant differences from the control group are marked with "#", ### p <0.001; Significant difference from the model group , p <0.01; p <0.001.

[0080] like Figure 2 As shown, the cytotoxicity results indicated that 400 μg / mL of Hovenia dulcis and 400 μg / mL of Phyllanthus emblica were toxic to AML12 cells, while the 100 μg / mL concentration used in the high content screening was non-toxic to the cells.

[0081] Figure 2This is a graph showing the toxicity results of extracts detected in AML12 cells; the unit of each value on the horizontal axis is μg / mL; and the values ​​with significant differences from the control group are marked. , p <0.01; p <0.001.

[0082] Mice were fed MCD diet for the first 4 weeks and then administered the drug concurrently with MCD diet for the next 4 weeks to establish a mouse model. Compared with the model group and the control group, the body weight of mice was significantly reduced. Figure 3 In the A group, compared with the control group, the liver index was significantly increased (in the model group). Figure 3 The B in the figure indicates that the model was successfully created.

[0083] Figure 3 The graph shows the effects of the extract on body weight and liver index in a C57BL / 6j mouse model of fatty liver injury. A: Body weight changes in mice; B: Liver index bars for each treatment group. Significant differences from the control group are marked with "#". p <0.001; Significant difference from the model group , p <0.05.

[0084] Liver tissue was taken for HE staining, and the staining results and lipid droplet percentage results are as follows: Figure 4 As shown. Figure 4 Compared to the control group, the model group showed excessive fat deposition in hepatocytes, consistent with the clinical manifestations of non-alcoholic fatty liver disease, indicating successful modeling. Simultaneously, the tissue sections from Example 2 showed a significant reduction in vacuoles and a marked decrease in the proportion of lipid droplets, indicating that Example 2 can significantly reduce hepatic lipid accumulation and improve non-alcoholic fatty liver disease.

[0085] Figure 4 HE staining images of liver tissue from a C57BL / 6j mouse fatty liver injury model; A shows the staining results, and B shows the lipid droplet percentage. The scale bar in image A is 100 μm. Significant differences from the control group are marked with "#". p <0.001. Significant difference from the model group. , p <0.05.

[0086] When the liver is damaged, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) from liver cells are released into the blood, leading to an increase in the activity of these two enzymes in the blood. Figure 5 A in the figure shows that Example 8 significantly reduced the AST content in serum, but Example 2 did not show a significant reduction. Figure 5Figure B shows that the serum ALT level in mice treated with Example 2 was significantly reduced, decreasing to 25.56% of that in the model group, indicating that Example 2 has a good hepatoprotective effect, reduces hepatocyte necrosis, and improves liver function in mice. ALT is generally considered to be more sensitive in reflecting hepatocyte damage; therefore, Example 2 is more effective in reducing liver damage.

[0087] Figure 5 Figure 1 shows the blood biochemical indicators of a C57BL / 6j mouse fatty liver injury model; where A: mouse serum AST level; B: mouse serum ALT level; significant differences from the control group are marked with "#", ### p <0.001. Significant difference from the model group. , p <0.05; p <0.01.

[0088] Fatty liver disease leads to the accumulation of triglycerides (TG) in the liver, exacerbating liver damage. Malondialdehyde (MDA) is the end product of lipid peroxidation caused by reactive oxygen species. MDA binds to cell membrane proteins, causing cell membrane protein denaturation and damaging hepatocytes. Therefore, clinically, the degree of liver damage is generally assessed by measuring serum AST, ALT, TG levels and liver MDA levels. Figure 6 A in the figure shows that Example 2 significantly reduced the TG content in liver tissue. Figure 6 B in the figure shows that Example 2 significantly reduced the MDA content in liver tissue. In summary, Example 2 can reduce liver damage caused by high lipids by reducing the accumulation of TG and MDA.

[0089] Figure 6 Images show the liver tissue damage in a C57BL / 6j mouse fatty liver injury model; A: TG index in mouse liver tissue; B: MDA index in mouse liver tissue. Significant differences compared to the control group are marked with "#". p <0.01. Significant difference from the model group. , p <0.05; p <0.01.

[0090] In summary, the specific traditional Chinese medicine composition protected by this invention is safe and non-toxic, and has a better liver-protective effect compared with other embodiments. It can significantly reduce hepatocyte necrosis and liver fat accumulation, while also reducing the content of TG and MDA in liver tissue and reducing liver damage caused by high lipids.

[0091] Application Example 2

[0092] Using the method described in Example 1, animal experiments and related index tests were conducted on the drug compositions obtained in Examples 3, 4, 6, 7, 9, and 10.

[0093] The results are as follows: Similar to Example 2, Example 3, and Example 4, the lipid accumulation in the liver of mice treated with these methods was significantly reduced. Figure 7 Serum ALT levels decreased significantly. Figure 8 The levels of MDA and TG in liver tissue were significantly reduced. Figure 9 Examples 6, 7, 9, and 10 showed no improvement.

[0094] Figure 7 HE staining images of liver tissue from the C57BL / 6j mouse fatty liver injury model; where A shows the staining results of the control group, model group, and examples 3, 4, 6, 7, 9 and 10, and B shows the lipid droplet percentage results of the control group, model group and examples 2 to 10; the scale bar in A is 100 μm. Figure 8 The graph shows the blood biochemical ALT index results of the C57BL / 6j mouse fatty liver injury model. Figure 9 The images show the liver tissue damage results in the C57BL / 6j mouse fatty liver injury model; where A: TG index in mouse liver tissue; B: MDA index in mouse liver tissue.

[0095] Based on the above results, the specific traditional Chinese medicine composition protected by this invention has the effect of improving fatty liver and non-alcoholic steatohepatitis. At the same time, the overall efficacy of the combination of extracts of Cassia seed, Hovenia dulcis, Phyllanthus emblica and Prunella vulgaris is better than that of the combination of extracts of Ophiopogon japonicus, Prunella vulgaris, Phyllanthus emblica, Hovenia dulcis, Astragalus membranaceus and Cassia seed, and better than the combination of extracts of Ophiopogon japonicus, Prunella vulgaris, Astragalus membranaceus and Cassia seed. The specific traditional Chinese medicine composition protected by this invention has better efficacy and stability.

[0096] Although the above embodiments have provided a detailed description of the present invention, they are only some embodiments of the present invention, and not all embodiments. People can obtain other embodiments based on these embodiments without creative effort, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A composition of traditional Chinese medicine that is both food and medicine, characterized in that, It is composed of the following components in parts by weight: 1-3.5 parts of Cassia seed, 0.5-2.5 parts of Hovenia dulcis seed, 0.1-1.5 parts of Phyllanthus emblica and 0.1-1.5 parts of Prunella vulgaris.

2. The medicinal and edible herbal composition according to claim 1, characterized in that, The medicinal and edible herbal composition consists of the following components in parts by weight: 1.2-3 parts of Cassia Seed, 0.8-2 parts of Raisin Tree Fruit, 0.4-1.1 parts of Phyllanthus emblica, and 0.4-1.1 parts of Prunella vulgaris.

3. The method for preparing the medicinal and edible herbal composition according to claim 1 or 2 includes preparation by water extraction.

4. The preparation method according to claim 3, characterized in that, The water extraction method includes the following steps: mixing each component with water, soaking, heating and extracting, filtering, concentrating and drying the extract to obtain the medicinal and edible herbal composition.

5. The use of the medicinal and edible herbal composition according to any one of claims 1 to 2 or the medicinal and edible herbal composition prepared by the preparation method according to any one of claims 3 to 4 in the preparation of a medicament for the prevention and / or treatment of non-alcoholic steatohepatitis.

6. A traditional Chinese medicine preparation that is both food and medicine, characterized in that, The medicinal and edible traditional Chinese medicine preparation includes the medicinal and edible traditional Chinese medicine composition according to any one of claims 1 to 2 or the medicinal and edible traditional Chinese medicine composition and excipients prepared by the preparation method according to any one of claims 3 to 4.

7. The traditional Chinese medicine preparation according to claim 6, characterized in that, The dosage forms of the medicinal and edible traditional Chinese medicine preparations include tablets, pills, powders, capsules, granules, mixtures, or drops.

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