A medicinal and food homologous traditional Chinese medicine composition for preventing and / or treating alcoholic liver disease

Abstract

The application provides a kind of prophylaxis and / or treatment of alcoholic liver disease, and belong to the technical field of traditional Chinese medicine.The application includes the following components by weight: turmeric extract 4.5~6 parts, radix puerariae extract 2~3 parts, raspberry extract 1~2 parts and sea buckthorn extract 0.5~1 part.The application provides a kind of prophylaxis and / or treatment of alcoholic liver disease, and belong to the technical field of traditional Chinese medicine.The application includes the following components by weight: turmeric extract 4.5~6 parts, radix puerariae extract 2~3 parts, raspberry extract 1~2 parts and sea buckthorn extract 0.5~1 part.The application provides a kind of prophylaxis and / or treatment of alcoholic liver disease, and belong to the technical field of traditional Chinese medicine.The application includes the following components by weight: turmeric extract 4.5~6 parts, radix puerariae extract 2~3 parts, raspberry extract 1~2 parts and sea buckthorn extract 0.5~1 part.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a medicinal and edible traditional Chinese medicine composition for preventing and / or treating alcoholic liver disease. BACKGROUND

[0002] Alcoholic liver disease (ALD) is a liver disease caused by long-term heavy drinking. In the early stage, it usually presents as fatty liver, and then can develop into alcoholic hepatitis, liver fibrosis and cirrhosis, and can be complicated with liver failure and upper gastrointestinal bleeding, etc. When drinking heavily, it can induce extensive hepatocyte necrosis, and even liver failure. Timely intervention and treatment of ALD is crucial for improving its prognosis.

[0003] The drugs for treating ALD mainly include anti-endotoxin drugs, antioxidants, drugs for countering and improving ethanol metabolism, etc. However, these drugs are all chemically synthesized, have great toxic and side effects, and if taken for a long time, they will increase the burden on the liver to varying degrees, and further damage the liver. For severe alcoholic hepatitis, hormone therapy is recommended, but hormones have many adverse reactions and can cause more complications and aggravate the disease. Therefore, there is an urgent need to seek a safe and effective alternative therapy.

[0004] Traditional Chinese medicine has the characteristics of multi-component, multi-link, multi-target comprehensive action, and can protect the liver through multiple mechanisms. The medicinal and edible traditional Chinese medicine has high safety, and can be both eaten and used as a drug to treat diseases. Using medicinal and edible traditional Chinese medicine to treat ALD not only avoids the harm and adverse reactions of drugs to the human body, but also can prevent the occurrence and development of diseases. However, there is still a lack of medicinal and edible traditional Chinese medicine products with more significant effects for preventing and treating alcoholic liver disease, and some reported medicinal and edible traditional Chinese medicine products use medicinal and edible traditional Chinese medicine fermentation compositions, and the safety of the components after fermentation is not guaranteed. SUMMARY

[0005] The present application aims to provide a medicinal and edible traditional Chinese medicine composition for preventing and / or treating alcoholic liver disease, which has a significant effect of improving alcoholic liver disease and can achieve the prevention and / or treatment of alcoholic liver disease.

[0006] The present application provides a medicinal and edible traditional Chinese medicine composition, which comprises the following components in parts by weight: turmeric extract 4.5-6 parts, pueraria extract 2-3 parts, raspberry extract 1-2 parts, and sea buckthorn extract 0.5-1 part.

[0007] Preferably, the mass percentage content of curcumin in the turmeric extract is ≥10%.

[0008] Preferably, the mass percentage content of puerarin in the pueraria extract is ≥4%.

[0009] Preferably, the mass percentage of proanthocyanidins in the raspberry extract is ≥ 5%.

[0010] Preferably, the mass percentage of total flavones in the sea buckthorn extract is ≥ 0.015%.

[0011] The present application also provides a preparation method of the medicinal and edible traditional Chinese medicine composition, comprising the following steps: mixing the turmeric extract, the radix puerariae extract, the raspberry extract and the sea buckthorn extract to obtain the medicinal and edible traditional Chinese medicine composition.

[0012] The present application also provides an application of the medicinal and edible traditional Chinese medicine composition or the medicinal and edible traditional Chinese medicine composition prepared by the preparation method in the preparation of a medicine for preventing and / or treating alcoholic liver disease.

[0013] Preferably, the alcoholic liver disease includes alcoholic fatty liver or alcoholic hepatitis.

[0014] The present application also provides an application of the medicinal and edible traditional Chinese medicine composition or the medicinal and edible traditional Chinese medicine composition prepared by the preparation method in the preparation of a medicine for reducing liver inflammation, reducing liver damage and improving the degree of liver oxidative stress.

[0015] The present application also provides a medicine for preventing and / or treating alcoholic liver disease, wherein the medicine comprises the medicinal and edible traditional Chinese medicine composition or the medicinal and edible traditional Chinese medicine composition prepared by the preparation method and an excipient.

[0016] The present application provides a medicinal and edible traditional Chinese medicine composition, wherein the raw materials only include turmeric, radix puerariae, raspberry and sea buckthorn, the raw materials are easy to obtain, the price is low and the safety is guaranteed. In the traditional Chinese medicine composition, the turmeric is the monarch drug with pungent and warm nature, which dominates soothing liver and relieving depression and improving liver microcirculation; the radix puerariae is the minister drug with sweet and cool nature, which assists the monarch drug in detoxifying alcohol and ascending clear and descending turbid, and focuses on reducing alcohol absorption and free radical generation; the raspberry is the auxiliary drug with sour and sweet neutral nature, which restricts the partiality of the monarch and minister drugs, and is attributed to liver and kidney channels, and assists the monarch and minister drugs in nourishing yin and tonifying kidney to relieve liver oxidative stress; and the sea buckthorn is the ministerial drug with sour and astringent and warm nature, which leads the drugs into liver channel, promotes bile secretion and accelerates the excretion of alcohol metabolism products. The traditional Chinese medicine composition has a significant effect of improving alcoholic liver disease, can realize the prevention and / or treatment of alcoholic liver disease, and the traditional Chinese medicine composition is composed of extracts of raw materials, which are extracted by water extraction, alcohol extraction, pressing extraction and the like, and is simple and easy to implement. BRIEF DESCRIPTION OF DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings needed in the embodiments will be briefly introduced as follows. Obviously, the drawings in the following description only constitute some embodiments of the present application, and for those skilled in the art, other drawings can also be obtained from these drawings without creative labor.

[0018] Figure 1 The figure of the influence of different treatment groups on the body weight and liver index of C57BL / 6j mice with alcoholic liver disease provided for application example 1 of the present application; wherein A is a figure of the body weight change of mice in each treatment group; B is a columnar graph of the liver index of mice in each treatment group;

[0019] Figure 2 The HE staining graph of liver tissue of a C57BL / 6j mouse alcoholic liver disease model provided for application example 1 of the present application;

[0020] Figure 3 The figure of the blood biochemical index of a C57BL / 6j mouse alcoholic liver disease model provided for application example 1 of the present application; wherein A is a mouse serum ALT index; B is a mouse serum AST index;

[0021] Figure 4 The figure of the liver tissue damage of a C57BL / 6j mouse fatty liver damage model provided for application example 1 of the present application; wherein A is a figure of the MDA index of mouse liver tissue; B is a figure of the GSH-Px index of mouse liver tissue; C is a figure of the T-SOD index of mouse liver tissue;

[0022] Figure 5 The HE staining graph of liver tissue of a C57BL / 6j mouse alcoholic liver disease model provided for application example 2 of the present application;

[0023] Figure 6 The figure of the blood biochemical ALT index of a C57BL / 6j mouse alcoholic liver disease model provided for application example 2 of the present application;

[0024] Figure 7 The figure of the liver tissue damage of a C57BL / 6j mouse fatty liver damage model provided for application example 2 of the present application; wherein A is a figure of the MDA index of mouse liver tissue; B is a figure of the GSH-Px index of mouse liver tissue; C is a figure of the T-SOD index of mouse liver tissue. DETAILED DESCRIPTION

[0025] It should be understood that, although the terms first, second, third, etc. can be used herein to describe various information, the information should not be limited to these terms. These terms are only used to distinguish one type of information from another type of information. For example, without departing from the scope of the present application, first information can also be referred to as second information, and similarly, second information can also be referred to as first information.

[0026] The present application provides a kind of medicinal and edible traditional Chinese medicine composition, including the following weight parts of component: turmeric extract 4.5~6 parts, radix puerariae extract 2~3 parts, raspberry extract 1~2 parts and sea buckthorn extract 0.5~1 part.

[0027] The components of the traditional Chinese medicine composition described in the present application are from the extract of medicinal and edible traditional Chinese medicine, which is safe, has little side effects and low cost and price. All drugs in the present application are traditional Chinese medicines in the National Public Medicinal and Edible Directory (2024), which have no toxic side effects.

[0028] The medicinal and edible traditional Chinese medicine composition described in the present application includes 4.5~6 parts of turmeric extract, which can be 5~6 parts, and specifically can be 4.5 parts, 5 parts or 6 parts. In specific embodiments, the mass percentage content of curcumin in the turmeric extract is ≥10%. In the present application, the preparation method of the turmeric extract includes the following steps: crushing turmeric to obtain crushed turmeric; mixing the crushed turmeric with ethanol aqueous solution for extraction, filtering to obtain first filtrate and first filter residue; mixing the first filter residue with ethanol aqueous solution for re-extraction to obtain second filtrate and second filter residue; combining the first filtrate and the second filtrate, drying under reduced pressure, crushing, sieving to obtain turmeric extract. In specific embodiments, the volume percentage content of ethanol in the ethanol aqueous solution is 90~95%, and specifically can be 95%. In specific embodiments, the mass ratio of the crushed turmeric or the first filter residue to the ethanol aqueous solution for mixing is 1: (6~10), and specifically is 1:8. In specific embodiments, the extraction temperature is 60~80℃, and specifically is 80℃. In specific embodiments, the extraction time is 1~2h, and specifically is 1h. In specific embodiments, the conditions for drying under reduced pressure are 80~90℃, -0.05~-0.09Mpa, and specifically are 90℃, -0.09Mpa. In specific embodiments, the sieving includes passing through a 100-mesh sieve. In the present application, the turmeric extract plays a role in soothing liver and relieving depression, improving liver microcirculation, inhibiting liver fibrosis and reducing inflammatory response.

[0029] The medicinal and edible traditional Chinese medicine composition comprises 2-3 parts of pueraria extract, which can be 2 parts, 2.5 parts or 3 parts. In specific embodiments, the mass percentage of puerarin in the pueraria extract is ≥4%. In the present application, the extraction method of the pueraria extract comprises the following steps: crushing pueraria to obtain crushed pueraria; mixing the crushed pueraria with water, extracting, filtering to obtain a third filtrate and a third residue; mixing the third residue with water, extracting, filtering to obtain a fourth filtrate and a fourth residue; combining the third filtrate and the fourth filtrate, concentrating, spray drying, crushing, sieving to obtain the pueraria extract. In specific embodiments, the mass ratio of the crushed pueraria or the third residue mixed with water is 1:(6-8), specifically 1:8 or 1:6. In specific embodiments, the extraction temperature is 80-100℃, specifically 100℃. In specific embodiments, the extraction time is 1-2h, specifically 2h. In specific embodiments, the concentration conditions are 50-70℃, -0.06 to -0.09Mpa, specifically 70℃, -0.09Mpa. In specific embodiments, the spray drying conditions are inlet air temperature 185-205℃, outlet air temperature 85-105℃. Specifically, the inlet air temperature is 200℃ and the outlet air temperature is 100℃. In specific embodiments, the sieving comprises passing through a 100-mesh sieve. In the present application, the pueraria extract plays a role in delaying gastric emptying speed and reducing alcohol absorption and free radical generation, thereby reducing liver damage.

[0030] The medicinal and edible traditional Chinese medicine composition comprises 1-2 parts of raspberry extract, which can be 1 part, 1.5 parts or 2 parts. In specific embodiments, the mass percentage of proanthocyanidins in the raspberry extract is ≥5%. The raspberry is crushed to obtain crushed raspberry; the crushed raspberry is mixed with water, extracted, filtered to obtain a fifth filtrate and a fifth residue; the fifth residue is mixed with water, extracted, filtered to obtain a sixth filtrate and a sixth residue; the fifth filtrate and the sixth filtrate are combined, concentrated, spray dried, crushed, sieved to obtain the raspberry extract. In specific embodiments, the mass ratio of the crushed raspberry or the fifth residue mixed with water is 1:(6-8), specifically 1:8 or 1:6. In specific embodiments, the extraction temperature is 80-100℃, specifically 100℃. In specific embodiments, the extraction time is 1-2h, specifically 2h. In specific embodiments, the concentration conditions are 50-70℃, -0.06 to -0.09Mpa, specifically 70℃, -0.09Mpa. In specific embodiments, the spray drying conditions are inlet air temperature 185-205℃, outlet air temperature 85-105℃. Specifically, the inlet air temperature is 200℃ and the outlet air temperature is 100℃. In the present application, the raspberry extract plays a role in neutralizing free radicals generated during alcohol metabolism and reducing liver cell oxidative stress.

[0031] The medicinal and edible Chinese medicine composition comprises 0.5-1 parts of sea buckthorn extract, which can be 0.5 parts or 1 part. In specific embodiments, the mass percentage of total flavones in the sea buckthorn extract is ≥0.015%. In the present application, the extraction method of the sea buckthorn extract comprises the following steps: washing sea buckthorn, peeling and removing the core, squeezing juice, filtering, concentrating, spray drying, crushing, sieving, and obtaining sea buckthorn extract. In specific embodiments, the concentration conditions are 50-70℃, -0.06 to -0.09 Mpa, specifically 70℃, -0.09 Mpa. In specific embodiments, the spray drying conditions are an inlet air temperature of 185-205℃ and an outlet air temperature of 85-105℃. Specifically, the inlet air temperature is 200℃ and the outlet air temperature is 100℃. In specific embodiments, the sieving comprises passing through a 100-mesh sieve. In the present application, the sea buckthorn extract plays a role in promoting bile secretion and accelerating the excretion of alcohol metabolism products.

[0032] Turmeric is the monarch drug with pungent and warm nature, which dominates soothing liver and relieving depression and improving liver microcirculation. The core component curcumin can inhibit liver fibrosis and reduce inflammatory response. Pueraria is the minister drug with sweet and cool nature, which assists the monarch drug in detoxifying alcohol and ascending clear and descending turbid, and focuses on reducing alcohol absorption and free radical generation. Raspberry is the auxiliary drug with sour, sweet and neutral nature, which restricts the partiality of the monarch and minister drugs, and is meridian-pertaining to liver and kidney, and assists the monarch and minister drugs in nourishing yin and tonifying kidney to relieve liver oxidative stress. Sea buckthorn is the ministerial drug with sour and astringent and warm nature, which leads the drugs into liver meridian, promotes bile secretion, and accelerates the excretion of alcohol metabolism products, thereby being combined for preventing and / or treating alcoholic liver disease.

[0033] The present application also provides a preparation method of the medicinal and edible Chinese medicine composition described in the above technical solution, which comprises the following steps: mixing turmeric extract, pueraria extract, raspberry extract and sea buckthorn extract to obtain the medicinal and edible Chinese medicine composition.

[0034] The present application also provides the application of the medicinal and edible Chinese medicine composition described in the above technical solution or the medicinal and edible Chinese medicine composition prepared by the preparation method described in the above technical solution in the preparation of a medicine for preventing and / or treating alcoholic liver disease. The medicinal and edible Chinese medicine composition can improve alcoholic liver disease, and achieve the prevention and / or treatment of alcoholic liver disease. In specific embodiments, the alcoholic liver disease includes alcoholic fatty liver or alcoholic hepatitis.

[0035] The present application also provides the application of the medicinal and edible Chinese medicine composition described in the above technical solution or the medicinal and edible Chinese medicine composition prepared by the preparation method described in the above technical solution in the preparation of a medicine with any one or more of the following effects: reducing liver inflammation, reducing liver damage and improving the degree of liver oxidative stress. In specific embodiments, the medicine includes a traditional Chinese medicine preparation.

[0036] The present application also provides a medicine for preventing and / or treating alcoholic liver disease, which comprises the above-mentioned traditional Chinese medicine composition or the above-mentioned traditional Chinese medicine composition prepared by the preparation method and an excipient. In specific embodiments, the excipient can be a pharmaceutically acceptable excipient. In specific embodiments, the medicine comprises a traditional Chinese medicine preparation. In the present application, the type of the traditional Chinese medicine preparation can be a decoction, a powder, a tablet, a pill, a powder, a capsule or a granule.

[0037] In order to further illustrate the present application, the present application provides a traditional Chinese medicine composition, a medicine and a preparation method and application for preventing and / or treating alcoholic liver disease are described in detail below in combination with examples, but they cannot be understood as limiting the scope of protection of the present application.

[0038] Other raw material sources:

[0039] Gegenin (Shanghai Yuan Ye Biotechnology Co., Ltd., S30646);

[0040] Curcumin (Shanghai Yuan Ye Biotechnology Co., Ltd., S31628);

[0041] Saxifrage flavone (Shanghai Yuan Ye Biotechnology Co., Ltd., S27676);

[0042] Example 1

[0043] Extraction method of curcuma extract:

[0044] The curcuma was crushed to obtain crushed curcuma; the crushed curcuma was mixed with 8 times the mass of 95% ethanol aqueous solution by volume percentage, and extracted at 80℃ for 1h, filtered to obtain a first filtrate and a first filter residue; the first filter residue was mixed with 8 times the mass of 95% ethanol aqueous solution by volume percentage for re-extraction for 1h to obtain a second filtrate and a second filter residue; the first filtrate and the second filtrate were combined, dried under reduced pressure, crushed, sieved to 100 mesh to obtain curcuma extract; the drying under reduced pressure was at 90℃ and-0.09Mpa. The content of curcumin was detected by high performance liquid chromatography (general rule 0512), and the mass percentage content of curcumin in the curcuma extract was 10% by detection.

[0045] The pueraria extract is prepared by the following method: the pueraria is crushed to obtain crushed pueraria; the crushed pueraria is mixed with 8 times the mass of water, extracted at 100 DEG C for 2 hours, filtered to obtain a third filtrate and a third residue; the third residue is mixed with 6 times the mass of water, extracted at 100 DEG C for 2 hours, filtered to obtain a fourth filtrate and a fourth residue; the third filtrate and the fourth filtrate are combined, concentrated at 70 DEG C and -0.09 MPa, and spray dried at an inlet air temperature of 200 DEG C and an outlet air temperature of 100 DEG C, crushed, and sieved to 100 mesh to obtain the pueraria extract. The content of puerarin in the pueraria extract is detected by high performance liquid chromatography (general rule 0512). The mass percentage of puerarin in the pueraria extract is 4% by detection.

[0046] The raspberry extract is prepared by the following method: the raspberries are crushed to obtain crushed raspberries; the crushed raspberries are mixed with 8 times the mass of water, extracted at 100 DEG C for 2 hours, filtered to obtain a fifth filtrate and a fifth residue; the fifth residue is mixed with 6 times the mass of water, extracted at 100 DEG C for 2 hours, filtered to obtain a sixth filtrate and a sixth residue; the fifth filtrate and the sixth filtrate are combined, concentrated at 70 DEG C and -0.09 MPa, and spray dried at an inlet air temperature of 200 DEG C and an outlet air temperature of 100 DEG C, crushed, and sieved to 100 mesh to obtain the raspberry extract. The content of procyanidins in the raspberry extract is detected by spectrophotometry. The mass percentage of procyanidins in the raspberry extract is 5% by detection.

[0047] The sea buckthorn extract is prepared by the following method:

[0048] The sea buckthorn is washed, peeled, and juiced, filtered, concentrated at 70 DEG C and -0.09 MPa, and spray dried at an inlet air temperature of 200 DEG C and an outlet air temperature of 100 DEG C, crushed, and sieved to 100 mesh to obtain the sea buckthorn extract. The content of total flavonoids in the sea buckthorn extract is detected by total flavonoid detection method (according to the second part (fifteenth) of the Technical Guidelines for the Detection and Evaluation of Physical and Chemical and Hygienic Indicators of Health Foods (2020 edition)). The mass percentage of total flavonoids in the sea buckthorn extract is 0.015% by detection.

[0049] The curcuma extract, the pueraria extract, the raspberry extract, and the sea buckthorn extract prepared by the above preparation method are mixed in a mass ratio of 6:2.5:1:0.5 to prepare a traditional Chinese medicine composition.

[0050] A preparation method of a medicine-food homologous traditional Chinese medicine composition for preventing and treating alcoholic liver disease is provided.

[0051] 6 g of the curcuma extract, 2.5 g of the pueraria extract, 1 g of the raspberry extract, and 0.5 g of the sea buckthorn extract are uniformly mixed to prepare a traditional Chinese medicine composition powder for preventing and treating alcoholic liver disease.

[0052] Example 2

[0053] The curcuma extract, the pueraria extract, the raspberry extract and the sea buckthorn extract prepared by the preparation method described in Example 1 are prepared into the traditional Chinese medicine composition according to a mass ratio of 4.5:3:1.5:1.

[0054] A preparation method of a medicinal and edible traditional Chinese medicine composition for preventing and treating alcoholic liver disease:

[0055] 4.5 g of the curcuma extract, 3 g of the pueraria extract, 1.5 g of the raspberry extract and 1 g of the sea buckthorn extract are uniformly mixed to prepare a traditional Chinese medicine composition powder for preventing and treating alcoholic liver disease.

[0056] Example 3

[0057] The curcuma extract, the pueraria extract, the raspberry extract and the sea buckthorn extract prepared by the preparation method described in Example 1 are prepared into the traditional Chinese medicine composition according to a mass ratio of 5:2:2:1.

[0058] A preparation method of a medicinal and edible traditional Chinese medicine composition for preventing and treating alcoholic liver disease:

[0059] 5 g of the curcuma extract, 2 g of the pueraria extract, 2 g of the raspberry extract and 1 g of the sea buckthorn extract are uniformly mixed to prepare a traditional Chinese medicine composition powder for preventing and treating alcoholic liver disease.

[0060] Comparative Example 1

[0061] The puerarin, the curcumin and the sea buckthorn flavone are mixed uniformly according to a mass ratio of 1:1:1.

[0062] Preparation method:

[0063] 1 g of the puerarin, 1 g of the curcumin and 1 g of the sea buckthorn flavone are uniformly mixed.

[0064] Comparative Example 2

[0065] The pueraria extract, the raspberry extract and the sea buckthorn extract prepared by the preparation method described in Example 1 are mixed uniformly according to a mass ratio of 3:2:1.

[0066] Preparation method:

[0067] 3 g of the pueraria extract, 2 g of the raspberry extract and 1 g of the sea buckthorn extract are uniformly mixed.

[0068] Comparative Example 3

[0069] The curcuma extract, the pueraria extract and the sea buckthorn extract prepared by the preparation method described in Example 1 are mixed uniformly according to a mass ratio of 6:3:1.

[0070] Preparation method:

[0071] Mix 6 g of turmeric extract, 3 g of pueraria extract and 1 g of sea buckthorn extract evenly.

[0072] Comparative Example 4

[0073] The turmeric extract, raspberry extract and sea buckthorn extract prepared by the preparation method described in Example 1 are mixed in a mass ratio of 6:2:1.

[0074] Preparation method:

[0075] Mix 6 g of turmeric extract, 2 g of raspberry extract and 1 g of sea buckthorn extract evenly.

[0076] Comparative Example 5

[0077] The turmeric extract, pueraria extract and raspberry extract prepared by the preparation method described in Example 1 are mixed in a mass ratio of 6:3:2.

[0078] Preparation method:

[0079] Mix 6 g of turmeric extract, 3 g of pueraria extract and 2 g of raspberry extract evenly.

[0080] Application Example 1

[0081] 1. Experimental materials

[0082] 1.1 Experimental animals

[0083] C57BL / 6j mice were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd.

[0084] 1.2 Experimental reagents and consumables

[0085] The experimental reagents and consumables include ice acetic acid, anhydrous ethanol, PBS buffer, 4% paraformaldehyde, 96-well culture plates, 1.5 ml EP tubes, 15 ml centrifuge tubes, 50 ml centrifuge tubes, BCA (bicinchoninic acid) protein detection kit, T-SOD colorimetric test box, MDA colorimetric test box, GSH-Px colorimetric test box, AST colorimetric test box and ALT colorimetric test box, etc. Lieber-DeCarli liquid feed was purchased from Hangzhou Ruisheng Biological Technology Co., Ltd.

[0086] 1.3 Experimental instruments

[0087] The main experimental instruments include multifunctional enzyme label instrument, full-automatic sample grinder, -80℃ refrigerator, -20℃ refrigerator, 4℃ ice cabinet, constant temperature water bath, table centrifuge, micropipette and vortex shaker.

[0088] 2. Experimental method

[0089] 2.1 Animal feeding and feed preparation

[0090] The Lieber-DeCarli liquid feed used in this experiment was purchased from Hangzhou Ruisheng Biological Technology Co., Ltd., specifically L10015 control liquid feed and L10016 alcohol liquid feed. The liquid feed bottles on the cage were replaced and cleaned every day, and the remaining feed was discarded. The liquid feeding bottle was cleaned and then sterilized at high temperature every day.

[0091] 2.2 C57BL / 6j mouse alcoholic liver disease model

[0092] 60 male C57BL / 6j mice were randomly divided into 10 groups, namely: control (C) group, model (M) group, Example 1 group, Example 2 group, Example 3 group and Comparative Example 1 group. This experiment was carried out according to the NIAAA model preparation method. In short, all groups of mice were adaptively fed L10015 control liquid feed for 5 days. From the 6th day, the control group was fed L10015 control liquid feed, and the remaining groups were fed L10016 alcohol liquid feed, and the liquid feeding was continuously administered for 10 days. The control group and the model group were administered with ultrapure water, the Example 1 group, the Example 2 group and the Example 3 group were administered with a dose of 2 g / kg, and the Comparative Example 1 group was administered with a dose of 0.3 g / kg. From 7:00 to 9:00 on the 16th day, the control group was administered with 0.02 ml / g of 45% malt dextrin, and the remaining groups were administered with 0.02 ml / g of 31.5% ethanol aqueous solution. 9 hours after the end of gavage, the samples were taken and related tests were performed.

[0093] 2.3 Determination of various indicators in serum and liver tissue

[0094] The serum was taken, and the AST and ALT activity was detected according to the kit instructions. An appropriate amount of liver tissue was weighed, ground with 9 times pre-cooled PBS, and then the grinding liquid was centrifuged at 4°C, with a centrifugal force of 10000xg, for 10 min. The supernatant was used for MDA, GSH-Px and T-SOD detection. Each index was detected according to the kit operation instruction.

[0095] 3. Experimental results

[0096] Figure 1 The results of the effects of different treatment groups (control group, model group, Example 1-Example 3 group and Comparative Example 1 group) on the body weight and liver index of C57BL / 6j mice with alcoholic liver disease are shown in the figure; wherein A: the change of mouse body weight; B: the liver index column chart of each treatment group. The significant difference from the control (C) group is marked with "#", and the significant difference from the model (M) group is marked with "*". p < 0.05. The significant difference from the model (M) group is marked with "*".p < 0.05. As shown in Figure 1 , the body weight of the model group and other administration groups decreased significantly after feeding 5% alcohol feed, and there was a significant difference between the model group and the control group Figure 1 , indicating that the alcoholic liver disease mouse model was successfully established. The initial body weight of all mice was similar during the 5-day adaptation feeding at the beginning of the experiment, and there was no significant difference in liver index between each group after modeling, indicating that the modeling for 10 days was not enough in time and dose to affect the change of liver index Figure 1 .

[0097] H&E staining directly shows the condition of alcoholic liver injury. Figure 2 The HE staining of liver tissue of C57BL / 6j mice in different treatment groups alcoholic liver disease model. Magnification: 200 times, scale: 50 μm. As shown in Figure 2 , compared with the control (C) group, the liver cells of the model (M) group mice were arranged irregularly, the boundary between cells was not clear, the fatty degeneration was serious, and was accompanied by focal necrosis of hepatocytes and inflammatory infiltration, and the central vein was severely deformed and arranged in disorder, which also indicated that the alcoholic liver disease mouse model was successfully established. Compared with the model group, the cell arrangement of the comparative example 1 group was compact, the boundary between cells was clear, the degree of inflammatory cell infiltration of the central vein was reduced, and there were still some inflammatory cells aggregation, and the fatty degeneration was improved. Compared with the comparative example 1 group, the degree of inflammatory cell infiltration and fatty degeneration of the example 1 group, the example 2 group and the example 3 group were further reduced, so it was concluded that the improvement effect of the example 1 group, the example 2 group and the example 3 group was better than that of the comparative example 1. It is proved that the composition of the example can reduce the liver cell damage, fatty degeneration and inflammation caused by alcohol, and alleviate alcoholic liver disease to a certain extent.

[0098] When the liver is damaged, glutamic oxalacetic transaminase (AST) and glutamic pyruvic transaminase (ALT) in hepatocytes are released into the blood, resulting in an increase in the activity of these two enzymes in the blood. Figure 3 The blood biochemical index results of C57BL / 6j mice in different treatment groups alcoholic liver disease model; A: mouse serum ALT index; B: mouse serum AST index. There is a significant difference between the control (C) group and the model (M) group marked with “#”, and p < 0.01;### p < 0.001. There is a significant difference between the model (M) group and the control (C) group marked with “*”, and p < 0.05;** p <0.01;*** p <0.001. Figure 3A in FIG. 6 shows that the serum ALT content of the Example 1 group, the Example 2 group, the Example 3 group and the Comparative Example 1 group is significantly reduced, and is reduced by 46.06%, 58.48%, 59.71% and 45.1% respectively compared with the model group. The effect of reducing ALT of each of the example groups is better than that of the comparative example. Figure 3 B in FIG. 6 shows that the serum AST content of the Example 2 group and the Example 3 group is significantly reduced, and is reduced by 39.05% and 34.13% respectively compared with the model group. It is shown that the Example 2 group and the Example 3 group have good liver protection effect, reduce liver cell necrosis and improve the liver function damage of the mice. ALT is generally considered to be more sensitive in reflecting liver cell damage, so the Example 1 group, the Example 2 group and the Example 3 group have better function of reducing liver damage, and the liver protection effect of the composition is better than that of being used alone.

[0099] Under the intervention of a large amount of alcohol, the synthesis and metabolism of fatty acids in the liver lose homeostatic balance. The levels of MDA, T-SOD and GSH-Px can better reflect the degree of liver oxidation. The content of MDA can reflect the level of lipid oxidation in the body, indirectly indicating the degree of liver cell damage; T-SOD can remove free radicals generated by peroxidation to regulate metabolic balance; GSH-Px, as an important antioxidant in the body, can remove active oxygen. Therefore, the levels of MDA, T-SOD and GSH-Px in the liver are generally determined clinically to judge the degree of liver oxidative stress. Figure 4 FIG. 7 is a diagram showing the results of liver tissue damage of the fatty liver injury model of C57BL / 6j mice in different treatment groups; wherein, A: the results of MDA index of mouse liver tissue; B: the results of GSH-Px index of mouse liver tissue; C: the results of T-SOD index of mouse liver tissue. The symbol "#" indicates a significant difference from the control (C) group, p < 0.01;### p < 0.001. The symbol "*" indicates a significant difference from the model (M) group, p < 0.05;** p <0.01;*** p <0.001. As Figure 4As shown, compared with the control group of mice, the MDA content of the model group of mice was significantly increased, and the activities of GSH-Px and T-SOD were significantly reduced, indicating that ethanol induced oxidative stress in the liver of mice, leading to liver damage. Compared with the model group of mice, the MDA content of the example 1 group, the example 2 group and the example 3 group was significantly reduced, and the activities of GSH-Px and T-SOD were significantly increased, indicating that the example 1 group, the example 2 group and the example 3 group had the ability to improve endogenous antioxidant capacity, reduce the generation of oxygen free radicals in the blood, and improve the oxidative stress level of alcoholic liver injury mice; the decrease of MDA level indicated that the composition could reduce the damage of liver caused by oxidative stress. In summary, the composition represented by the example 1 group, the example 2 group and the example 3 group improved the ability of oxidative stress better than the combination of puerarin, curcumin and seabuckthorn flavonoids in the comparative example 1 group.

[0100] Application Example 2

[0101] 1. Experimental materials

[0102] 1.1 Experimental animals

[0103] C57BL / 6j mice were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd.

[0104] 1.2 Experimental reagents and consumables

[0105] The experimental reagents and consumables included ice acetic acid, anhydrous ethanol, PBS buffer, 4% paraformaldehyde, 96-well culture plates, 1.5 ml EP tubes, 15 ml centrifuge tubes, 50 ml centrifuge tubes, BCA protein detection kit, total superoxide dismutase colorimetric test box, malondialdehyde colorimetric test box, glutathione peroxidase colorimetric test box and glutamic transaminase colorimetric test box, etc. Lieber-DeCarli liquid feed was purchased from Hangzhou Ruisheng Biological Technology Co., Ltd.

[0106] 1.3 Experimental instruments

[0107] The main experimental instruments included multifunctional enzyme label instrument, full-automatic sample grinder, -80℃ refrigerator, -20℃ refrigerator, 4℃ ice cabinet, constant temperature water bath, table centrifuge, micropipette and vortex shaker.

[0108] 2. Experimental method

[0109] 2.1 Preparation of animal feed

[0110] Lieber-DeCarli liquid feed was used in this experiment, which was purchased from Hangzhou Ruisheng Biological Technology Co., Ltd., specifically L10015 control liquid feed and L10016 alcohol liquid feed. The liquid feed bottles on the cage were replaced and cleaned every day, and the remaining feed was discarded. The liquid feeding bottle was cleaned and sterilized at high temperature every day.

[0111] 2.2 Establishment of an alcoholic liver disease model in C57BL / 6j mice

[0112] Sixty male C57BL / 6j mice were randomly divided into 10 groups: control (C), model (M), comparative group 2, comparative group 3, comparative group 4, and comparative group 5. This experiment was conducted according to the NIAAA model establishment method. In short, all groups of mice were adaptively fed the L10015 control liquid diet for 5 days. Starting on day 6, except for the control group which was fed the L10015 control liquid diet, the other groups were fed the L10016 alcohol liquid diet. This was administered by gavage for 10 consecutive days. The control and model groups were administered ultrapure water by gavage. The dosage for comparative group 2 was 1.2 g / kg, for comparative group 3 it was 2 g / kg, for comparative group 4 it was 1.8 g / kg, and for comparative group 5 it was 2.2 g / kg. On day 16, between 7:00 and 9:00, the control group was administered 0.02 ml / g of 45% maltodextrin by gavage, while the other groups were administered 0.02 ml / g of 31.5% ethanol aqueous solution by gavage. Samples were collected and relevant tests were performed 9 hours after the end of gavage.

[0113] 2.3 Determination of various indicators in serum and liver tissue

[0114] Serum was collected, and AST and ALT activities were detected according to the kit instructions. An appropriate amount of liver tissue was weighed and homogenized with 9 times pre-cooled PBS. The homogenate was then centrifuged at 10000×g for 10 min at 4°C. The supernatant was used for the detection of MDA, GSH-Px, and T-SOD. All indicators were detected according to the kit instructions.

[0115] 3. Experimental Results

[0116] The drugs in Comparative Examples 2, 3, 4, and 5 were obtained by compounding after removing individual components. This application example is intended to demonstrate the necessity of each drug in this invention. Using the same method as in Application Example 1, the drug compositions obtained in Comparative Examples 2, 3, 4, and 5 were subjected to animal experiments and related indicator tests.

[0117] The results are as follows Figures 5-7 As shown, Figure 5 HE staining image of liver tissue from a C57BL / 6j mouse model of alcoholic liver disease. Figure 6 The image shows the serum ALT levels in a C57BL / 6j mouse model of alcoholic liver disease. Figure 7The results of the liver tissue damage of the fatty liver damage model of C57BL / 6j mice are shown in the figures; wherein, A: the results of the MDA index of the liver tissue of the mice; B: the results of the GSH-Px index of the liver tissue of the mice; C: the results of the T-SOD index of the liver tissue of the mice. The mice treated by Comparative Example 3, Comparative Example 4 and Comparative Example 5 have no significant improvement effect on the liver inflammation Figure 5 , damage degree Figure 6 , and liver oxidative stress degree Figure 7 . The Comparative Example 2 group also has the effect of improving the GSH-Px and T-SOD activities, but the MDA level shows an upward trend, and has no significant effect on improving the liver inflammation and damage. It can be seen that any three raw material combinations have no effect on improving the liver damage.

[0118] According to the above results, it can be known that the specific traditional Chinese medicine composition protected by the present application has the effects of preventing and treating alcoholic liver disease, and at the same time, the effects of the different amounts of Example 1 to Example 3 are better than those of other comparative examples, so that the effects of the specific traditional Chinese medicine composition protected by the present application have stability.

[0119] Although the above examples make a detailed description of the present application, it is only a part of the examples of the present application, but not all the examples, and people can also obtain other examples according to the present examples without creativity, and these examples all belong to the protection scope of the present application.

Claims

1. A composition of traditional Chinese medicine that is both food and medicine, characterized in that, It is composed of the following active ingredients in parts by weight: 4.5-6 parts of turmeric extract, 2-3 parts of kudzu root extract, 1-2 parts of raspberry extract and 0.5-1 part of sea buckthorn extract; Among them, turmeric extract is extracted by mixing turmeric with an ethanol aqueous solution, kudzu root extract is extracted by mixing kudzu root with water, raspberry extract is extracted by mixing raspberry with water, and sea buckthorn extract is extracted by pressing.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The curcumin content in the turmeric extract is ≥10% by mass.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The puerarin content in the kudzu root extract is ≥4% by mass.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The raspberry extract contains ≥5% proanthocyanidins by mass.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The total flavonoid content of the sea buckthorn extract is ≥0.015% by mass.

6. A method for preparing the medicinal and edible herbal composition according to any one of claims 1 to 5, comprising the following steps: The turmeric extract, kudzu root extract, raspberry extract and sea buckthorn extract were mixed to obtain the medicinal and edible herbal composition.

7. The use of the medicinal and edible herbal composition according to any one of claims 1 to 5 or the medicinal and edible herbal composition prepared by the preparation method according to claim 6 in the preparation of a medicament for the prevention and / or treatment of alcoholic liver disease.

8. The application according to claim 7, characterized in that, The alcoholic liver disease mentioned includes alcoholic fatty liver or alcoholic hepatitis.

9. A medicament for the prevention and / or treatment of alcoholic liver disease, characterized in that, The drug comprises the medicinal and edible herbal composition according to any one of claims 1 to 5 or the medicinal and edible herbal composition prepared by the preparation method according to claim 6 and excipients.

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