A lipid-lowering and weight-reducing composition, a preparation method thereof and application thereof

Abstract

The present application mainly relates to a kind of composition for reducing fat and losing weight and its preparation method and application, belong to the field of biotechnology.The composition of the present application includes Cordyceps flower fruit body granules 30-60 parts, Morel fruit body granules 5-20 parts, bitter buckwheat flour 10-25 parts, mulberry leaf water extract 10-25 parts, Huangjing water extract 5-21 parts and Cassia seed water extract 1-6 parts.The above raw materials are mixed to obtain the composition of the present application.The composition of the present application can improve the blood lipid level of hyperlipidemia, inhibit the increase of body weight, reduce the volume of white adipose cells, inhibit the deposition of liver lipid, reverse the damage of liver tissue and liver function, effectively reduce fat and lose weight, and play a role in treating hyperlipidemia, obesity and fatty liver.

Description

Technical Field

[0001] This invention belongs to the field of biotechnology, and in particular relates to a lipid-lowering and weight-loss composition, its preparation method, and its application. Background Technology

[0002] Dyslipidemia, a common lipid metabolism disorder in clinical practice, is primarily characterized by hyperlipidemia. It is manifested by abnormally elevated levels of total cholesterol, triglycerides, and low-density lipoprotein cholesterol (LDL-C), while high-density lipoprotein cholesterol (HDL-C) levels are decreased. Long-term hyperlipidemia can lead to fatty liver, impairing liver function, and can also trigger various diseases such as atherosclerosis, coronary heart disease, and stroke. Furthermore, dyslipidemia is closely related to obesity, significantly impacting it by affecting metabolism, making fat accumulation easier and thus causing or worsening obesity. Obesity is also a significant risk factor for dyslipidemia; obese individuals often experience disordered fat metabolism due to excessive body fat, leading to dyslipidemia.

[0003] In recent years, with the improvement of people's living standards, many lifestyle habits and dietary structures have changed significantly. The intake of high-fat, high-sugar, and high-salt foods has increased, leading to a rapid expansion of the hyperlipidemia and obesity population. As a result, hyperlipidemia, fatty liver, obesity, and cardiovascular and cerebrovascular diseases such as coronary heart disease, hypertension, and cerebral embolism have become one of the main causes affecting human health.

[0004] For the prevention and treatment of dyslipidemia and related obesity, chemical drugs remain the most commonly used treatment. Statins, for example, are the first-line drugs for lowering LDL cholesterol levels. Studies have shown that statins can effectively reduce serum C-reactive protein, significantly lower blood lipid levels, and help reduce cardiovascular risk. However, as chemical drugs, statins often cause certain adverse reactions, such as hepatotoxicity (liver damage), muscle toxicity (myalgia, rhabdomyolysis), and neurotoxicity (cognitive impairment, vision problems). Compared to these drawbacks of Western medicine, the development of low-toxicity, low-side-effect lipid-lowering and weight-loss products for the effective prevention and treatment of hyperlipidemia, fatty liver, and obesity is an urgent research and development need. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide a composition for lowering lipids and losing weight, which improves the blood lipid level of hyperlipidemia, inhibits weight gain, reduces the volume of white fat cells, inhibits the deposition of lipids in the liver, reverses liver tissue and liver function damage, effectively lowers lipids and loses weight, and plays a role in treating hyperlipidemia, obesity and fatty liver.

[0006] This invention provides a lipid-lowering and weight-loss composition comprising the following raw materials in parts by weight: 30-60 parts of Cordyceps militaris fruiting body granules, 5-20 parts of Morel fruiting body granules, 10-25 parts of tartary buckwheat flour, 10-25 parts of mulberry leaf water extract, 5-21 parts of Polygonatum sibiricum water extract, and 1-6 parts of Cassia tora water extract.

[0007] Preferably, the composition comprises the following raw materials in parts by weight: 40-50 parts of Cordyceps militaris fruiting body granules, 10-16 parts of Morel fruiting body granules, 11-15 parts of tartary buckwheat flour, 11-16 parts of mulberry leaf water extract, 10-20 parts of Polygonatum sibiricum water extract, and 2-4 parts of Cassia tora water extract.

[0008] Preferably, the crude polysaccharide content of the mulberry leaf aqueous extract is 5% to 15%.

[0009] Preferably, the crude polysaccharide content of the Polygonatum hydropiper aqueous extract is 5% to 15%.

[0010] Preferably, the total anthraquinone content of the cassia seed water extract is 1% to 4%.

[0011] Preferably, the preparation method of the Cordyceps flower fruiting body particles and Morel fruiting body particles includes: crushing, steaming and drying the Cordyceps flower fruiting body and Morel fruiting body to obtain Cordyceps flower fruiting body particles and Morel fruiting body particles.

[0012] Preferably, the particle size of the Cordyceps flower fruiting body after crushing is 10-20 mesh, and the particle size of the morel fruiting body after crushing is 20-60 mesh.

[0013] The present invention also provides a method for preparing the composition, comprising the following steps: mixing Cordyceps militaris fruiting body granules, Morel fruiting body granules, tartary buckwheat flour, mulberry leaf water extract, Polygonatum sibiricum water extract and Cassia tora water extract to prepare the composition.

[0014] The present invention also provides the use of the described composition or the described preparation method in the preparation of lipid-lowering and / or weight-loss products.

[0015] The present invention also provides the use of the described composition or the described preparation method in the preparation of products for treating hyperlipidemia and / or fatty liver.

[0016] The beneficial effects of this invention are:

[0017] This invention provides a lipid-lowering and weight-loss composition. In vitro tests have shown that the composition of this invention has a lipid-lowering effect. In vivo tests have shown that the composition of this invention can reduce serum triglyceride and total cholesterol levels, effectively improve the blood lipid levels of hyperlipidemia, and treat hyperlipidemia; it can inhibit weight gain, reduce the volume of white fat cells, and treat obesity; it can inhibit the deposition of lipids in the liver, reduce the levels of aspartate aminotransferase and alanine aminotransferase, increase the content of glutathione and total antioxidant capacity in liver tissue, reverse liver tissue and liver function damage, and effectively treat fatty liver. Furthermore, the fruiting bodies of Cordyceps militaris and morel mushrooms, and buckwheat flour in the composition of this invention are common food ingredients, while mulberry leaves, Polygonatum sibiricum, and cassia seeds are ingredients that are both food and medicine. Therefore, the composition of this invention is safer than Western medicines prepared from chemical raw materials. Attached Figure Description

[0018] Figure 1 Oil Red staining images of LO-2 cells under different formulations are shown. CTL is the blank control group, OA is the model group, 1-100, 1-200, and 1-400 are the oleic acid treatment groups under formulation one at 100 μg / mL, 200 μg / mL, and 400 μg / mL, respectively; 2-100, 2-200, and 2-400 are the oleic acid treatment groups under formulation two at 100 μg / mL, 200 μg / mL, and 400 μg / mL, respectively; and 3-100, 3-200, and 3-400 are the oleic acid treatment groups under formulation three at 100 μg / mL, 200 μg / mL, and 400 μg / mL, respectively.

[0019] Figure 2 The graph shows the percentage of positive staining area of ​​LO-2 cells under different formulations. CTL represents the blank control group, OA represents the model group, 1-100, 1-200, and 1-400 represent the oleic acid treatment groups under formulation one (100 μg / mL, 200 μg / mL, and 400 μg / mL), 2-100, 2-200, and 2-400 represent the oleic acid treatment groups under formulation two (100 μg / mL, 200 μg / mL, and 400 μg / mL), and 3-100, 3-200, and 3-400 represent the oleic acid treatment groups under formulation three (100 μg / mL, 200 μg / mL, and 400 μg / mL). ** indicates P < 0.01 compared to OA, *** indicates P < 0.001 compared to OA, **** indicates P < 0.0001 compared to OA, and #### indicates P < 0.0001 compared to CTL.

[0020] Figure 3 The effect of the composition of the present invention on the change in body weight in mice.

[0021] Figure 4The effect of the composition of the present invention on blood lipid levels in mice; wherein, A is total cholesterol, B is triglycerides, C is low-density lipoprotein cholesterol, and D is high-density lipoprotein cholesterol; # indicates P < 0.05 compared with CTL, ## indicates P < 0.01 compared with CTL; * indicates P < 0.05 compared with HFD, and ** indicates P < 0.01 compared with HFD.

[0022] Figure 5 The image shows the effect of the composition of this invention on lipid deposition in the liver. From top to bottom, the images are: Oil Red O staining observation of lipid deposition in liver tissue (200×), and a statistical graph of the positive area of ​​lipid deposition. ### indicates P<0.001 compared with CTL; * indicates P<0.05 compared with HFD; ** indicates P<0.01 compared with HFD; and *** indicates P<0.001 compared with HFD.

[0023] Figure 6 The image shows the effect of the composition of the present invention on the morphology of white adipose tissue; wherein, A is a 200× image of subperitoneal white adipose tissue observed by H&E staining, B is a 200× image of epididymal white adipose tissue observed by H&E staining, C is the cell count of subperitoneal white adipose tissue in the field of view, and D is the cell count of epididymal white adipose tissue in the field of view; ### indicates P<0.001 compared with CTL; * indicates P<0.05 compared with HFD, and ** indicates P<0.01 compared with HFD.

[0024] Figure 7 The effects of the composition of the present invention on liver function are shown in the figure. A represents the morphology of liver tissue observed by H&E staining (200×), B represents the glutathione assay result, C represents the total antioxidant capacity assay result, D represents the malondialdehyde assay result, E represents the serum aspartate aminotransferase (AST) level assay result, and F represents the serum alanine aminotransferase (ALT) level assay result. # indicates P < 0.05 compared to CTL, ## indicates P < 0.01 compared to CTL, ### indicates P < 0.001 compared to CTL, * indicates P < 0.05 compared to HFD, ** indicates P < 0.01 compared to HFD, and *** indicates P < 0.001 compared to HFD. Detailed Implementation

[0025] This invention provides a lipid-lowering and weight-loss composition comprising the following raw materials in parts by weight: 30-60 parts of Cordyceps militaris fruiting body granules, 5-20 parts of Morel mushroom fruiting body granules, 10-25 parts of tartary buckwheat flour, 10-25 parts of mulberry leaf water extract, 5-21 parts of Polygonatum sibiricum water extract, and 1-6 parts of cassia seed water extract; preferably, 40-50 parts of Cordyceps militaris fruiting body granules, 10-16 parts of Morel mushroom fruiting body granules, 11-15 parts of tartary buckwheat flour, 11-16 parts of mulberry leaf water extract, 10-20 parts of Polygonatum sibiricum water extract, and 2-4 parts of cassia seed water extract; more preferably, 45 parts of Cordyceps militaris fruiting body granules, 12 parts of Morel mushroom fruiting body granules, 14.5 parts of tartary buckwheat flour, 14 parts of mulberry leaf water extract, 11 parts of Polygonatum sibiricum water extract, and 3.5 parts of cassia seed water extract.

[0026] In this invention, the crude polysaccharide content of the mulberry leaf aqueous extract is preferably 5%–15%, more preferably 8%–12%, and even more preferably 10%; the crude polysaccharide content of the polygonatum aqueous extract is preferably 5%–15%, more preferably 8%–12%, and even more preferably 10%; the total anthraquinone content of the cassia seed aqueous extract is preferably 1%–4%, more preferably 1.5%–3%, and even more preferably 2%. This invention does not specifically limit the sources of the mulberry leaf aqueous extract, polygonatum aqueous extract, and cassia seed aqueous extract; conventional commercially available products or self-prepared products can be used. When self-prepared, there are no specific limitations on the extraction methods for the mulberry leaf aqueous extract, polygonatum aqueous extract, and cassia seed aqueous extract; conventional water extraction processes in this field can be used.

[0027] In this invention, Cordyceps militaris (L.) Fr., also known as Cordyceps militaris, has edible and medicinal value. The method for preparing the Cordyceps militaris fruiting body granules includes: crushing, steaming, and drying the Cordyceps militaris fruiting bodies to obtain Cordyceps militaris fruiting body granules. The polysaccharide content of the Cordyceps flower fruiting body is preferably 15%–25%, more preferably 17%–21%, and even more preferably 19%, and the cordycepin content is preferably 0.5%–1.2%, more preferably 0.6%–0.8%, and even more preferably 0.7%. The Cordyceps flower fruiting body is first pulverized. The present invention does not have a special limitation on the pulverization method, and conventional pulverization methods in the art are acceptable. The particle size of the pulverized particles is preferably 10–20 mesh. The preferred method for screening the particle size is to pass through 10-mesh and 20-mesh sieves, retaining particles that pass through the 10-mesh sieve and those that do not pass through the 20-mesh sieve. After sieving, the particles are steamed. The present invention does not have a special limitation on the steaming method, and conventional steaming methods in the art are acceptable. In one embodiment, boiling water steam can be used for steaming for 20 minutes. After steaming, the particles are dried. The present invention does not have a special limitation on the drying method, and conventional drying methods in the art are acceptable. In one embodiment, drying at 60°C can be used.

[0028] In this invention, morel mushroom refers to the fungus *Morchella esculer* Ua(L) Pers., belonging to the family Morohellaceae. It is a well-known edible and medicinal fungus among ascomycetes, valued as both a vegetable and a medicine. The preparation method of the morel mushroom fruiting body granules includes: pulverizing, steaming, and drying the morel mushroom fruiting bodies to obtain morel mushroom fruiting body granules. The polysaccharide content of the morel mushroom fruiting bodies is preferably 5%–15%, more preferably 8%–12%, and even more preferably 10%. The morel fruiting bodies are first pulverized. This invention does not specifically limit the pulverization method; any conventional pulverization method in the art is acceptable. The particle size of the pulverized particles is preferably 20-60 mesh. The preferred method for screening the particle size is to pass them through 20-mesh and 60-mesh sieves, retaining particles that pass through the 20-mesh sieve and those that do not pass through the 60-mesh sieve. After sieving, the mushrooms are steamed. This invention does not specifically limit the steaming method; any conventional steaming method in the art is acceptable. In one embodiment, boiling water steam can be used for steaming for 20 minutes. After steaming, the mushrooms are dried. This invention does not specifically limit the drying method; any conventional drying method in the art is acceptable. In one embodiment, drying at 60°C is acceptable.

[0029] The present invention does not have any special limitation on the source of the Cordyceps flower fruiting body, morel fruiting body, and buckwheat flour. They can be prepared in-house or use commercially available products in the field.

[0030] The present invention also provides a method for preparing the composition, comprising the following steps: mixing Cordyceps militaris fruiting body granules, Morel fruiting body granules, tartary buckwheat flour, mulberry leaf water extract, Polygonatum sibiricum water extract and Cassia tora water extract to prepare the composition.

[0031] The present invention also provides the use of the described composition or the described preparation method in the preparation of lipid-lowering and / or weight-loss products. The lipid-lowering products preferably include those that help maintain healthy blood lipid (cholesterol / triglyceride) levels, and the weight-loss products preferably include those that help control body fat.

[0032] The present invention also provides the use of the described composition or the described preparation method in the preparation of products for treating hyperlipidemia and / or fatty liver.

[0033] The composition of this invention can improve blood lipid levels in hyperlipidemia, inhibit weight gain, reduce the volume of white fat cells, reverse liver tissue and liver function damage, effectively reduce lipids and lose weight, and play a role in treating hyperlipidemia, obesity and fatty liver.

[0034] The present invention does not specifically limit the dosage form of the product, including but not limited to pills, tablets, capsules, granules or oral liquids.

[0035] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0036] Unless otherwise specified, the following embodiments are all conventional methods.

[0037] Unless otherwise specified, all materials and reagents used in the following examples are commercially available.

[0038] The raw materials used in the following examples and test cases were sourced as follows: Cordyceps flower fruiting bodies (polysaccharide content 19%, cordycepin content 0.7%) were cultivated and produced by Sichuan Qiying Fungi Industry Co., Ltd.; Morel fruiting bodies (polysaccharide content 10%) were purchased from Shaanxi Xintianyu Biotechnology Co., Ltd.; Tartary buckwheat flour (crude polysaccharide content 5%) was purchased from Fufeng Sinote Biotechnology Co., Ltd.; Mulberry leaf water extract (crude polysaccharide content 10%) was purchased from Shanghai Changyu Biotechnology Co., Ltd.; Polygonatum odoratum water extract (crude polysaccharide content 10%) and Cassia tora water extract (total anthraquinone content 2%) were purchased from Xi'an Tianyi Biotechnology Co., Ltd.

[0039] Example 1

[0040] After the fruiting bodies of Cordyceps militaris are crushed, they are passed through 10-mesh and 20-mesh sieves, retaining particles of 10-20 mesh. They are then steamed with boiling water for 20 minutes and dried at 60°C to obtain Cordyceps militaris fruiting body particles.

[0041] Morel fruiting bodies are crushed and passed through 20-mesh and 60-mesh sieves, retaining particles of 20-60 mesh. They are then steamed with boiling water for 20 minutes and dried at 60°C to obtain morel fruiting body particles.

[0042] Weigh out 45g of Cordyceps militaris fruiting body granules, 12g of Morel fruiting body granules, 14.5g of tartary buckwheat flour, 14g of mulberry leaf water extract, 11g of Polygonatum sibiricum water extract and 3.5g of Cassia tora water extract, mix them to prepare the composition of this invention, named Formula 1 (or Formula 1).

[0043] Example 2

[0044] After the fruiting bodies of Cordyceps militaris are crushed, they are passed through 10-mesh and 20-mesh sieves, retaining particles of 10-20 mesh. They are then steamed with boiling water for 20 minutes and dried at 60°C to obtain Cordyceps militaris fruiting body particles.

[0045] Morel fruiting bodies are crushed and passed through 20-mesh and 60-mesh sieves, retaining particles of 20-60 mesh. They are then steamed with boiling water for 20 minutes and dried at 60°C to obtain morel fruiting body particles.

[0046] Weigh out 40g of Cordyceps militaris fruiting body granules, 14g of Morel fruiting body granules, 11g of tartary buckwheat flour, 11.5g of mulberry leaf water extract, 20g of Polygonatum sibiricum water extract and 3.5g of Cassia tora water extract, mix them to prepare the composition of this invention, named Formula 2 (or Formula 2).

[0047] Example 3

[0048] After the fruiting bodies of Cordyceps militaris are crushed, they are passed through 10-mesh and 20-mesh sieves, retaining particles of 10-20 mesh. They are then steamed with boiling water for 20 minutes and dried at 60°C to obtain Cordyceps militaris fruiting body particles.

[0049] Morel fruiting bodies are crushed and passed through 20-mesh and 60-mesh sieves, retaining particles of 20-60 mesh. They are then steamed with boiling water for 20 minutes and dried at 60°C to obtain morel fruiting body particles.

[0050] Weigh out 50g of Cordyceps militaris fruiting body granules, 10g of Morel fruiting body granules, 12g of tartary buckwheat flour, 16g of mulberry leaf water extract, 10g of Polygonatum sibiricum water extract, and 2g of Cassia tora water extract, mix them, and prepare the composition of this invention, named Formula 3 (or Formula 3).

[0051] Example 4

[0052] After the fruiting bodies of Cordyceps militaris are crushed, they are passed through 10-mesh and 20-mesh sieves, retaining particles of 10-20 mesh. They are then steamed with boiling water for 20 minutes and dried at 60°C to obtain Cordyceps militaris fruiting body particles.

[0053] Morel fruiting bodies are crushed and passed through 20-mesh and 60-mesh sieves, retaining particles of 20-60 mesh. They are then steamed with boiling water for 20 minutes and dried at 60°C to obtain morel fruiting body particles.

[0054] Weigh out 60g of Cordyceps militaris fruiting body granules, 5g of Morel fruiting body granules, 25g of tartary buckwheat flour, 10g of mulberry leaf water extract, 21g of Polygonatum sibiricum water extract, and 1g of Cassia tora water extract, mix them, and prepare the composition of this invention, named Formula 4 (or Formula 4).

[0055] Example 5

[0056] After the fruiting bodies of Cordyceps militaris are crushed, they are passed through 10-mesh and 20-mesh sieves, retaining particles of 10-20 mesh. They are then steamed with boiling water for 20 minutes and dried at 60°C to obtain Cordyceps militaris fruiting body particles.

[0057] Morel fruiting bodies are crushed and passed through 20-mesh and 60-mesh sieves, retaining particles of 20-60 mesh. They are then steamed with boiling water for 20 minutes and dried at 60°C to obtain morel fruiting body particles.

[0058] Weigh out 30g of Cordyceps militaris fruiting body granules, 20g of Morel fruiting body granules, 10g of tartary buckwheat flour, 25g of mulberry leaf water extract, 5g of Polygonatum sibiricum water extract, and 6g of Cassia tora water extract, mix them, and prepare the composition of this invention, named Formula 5 (or Formula 5).

[0059] Experimental Example 1

[0060] In vitro lipid-lowering activity evaluation of the composition of the present invention

[0061] Formulas 1, 2, and 3 in this experiment were prepared in accordance with Examples 1, 2, and 3, respectively.

[0062] 1. Experimental Methods

[0063] 1.1 Cell Culture

[0064] LO-2 cells (normal human hepatocytes) were cultured in RPMI 1640 cell culture medium containing 10% fetal bovine serum and 1% penicillin / streptomycin at 5% CO2 and 37°C.

[0065] 1.2 Construction and evaluation of oleic acid-induced hyperlipidemia model in LO-2 cells

[0066] A lipid-lowering cell model was constructed by treating normal human hepatocytes (LO-2) with oleic acid (OA). 100 μL of LO-2 cell suspension (containing 1 × 10⁻⁶ cells) was added to each well of a 96-well plate. 4 LO-2 cells were cultured at 37℃ for 24 h. The blank control group (CTL) medium was replaced with serum-free medium without OA, while the model group (OA) and oleic acid treatment group were replaced with serum-free medium containing 1 mmol / L OA. The oleic acid treatment group was treated with different concentrations (100 μg / mL, 200 μg / mL, 400 μg / mL) of formulation one (1-100, 1-200, 1-400 groups), two (2-100, 2-200, 2-400 groups), and three (3-100, 3-200, 3-400 groups) in combination with oleic acid. After culturing at 37℃ for another 24 h, the intracellular lipid droplet content was measured by Oil Red O staining.

[0067] 2. Experimental Results

[0068] LO-2 cells were treated with different concentrations (100 μg / mL, 200 μg / mL, 400 μg / mL) of formulations one, two, and three in combination with oleic acid. Oil Red staining results are shown below. Figure 1 The results showed that no lipid droplets were present in the blank control group (CTL), while lipid droplets were present in the model group (OA). After treatment with formulations one, two, and three, the number of intracellular lipid droplets was significantly reduced. With the increase of the concentration of each formulation, the reduction of intracellular lipid droplets increased more and more, showing a certain concentration dependence.

[0069] The percentage of positive staining area of ​​LO-2 cells under different formulations is as follows: Figure 2 As shown, the area of ​​LO-2 cells showing positive staining decreased significantly in treatment groups of different concentrations of formulas one, two, and three. Formulas two and three showed a dose-dependent decrease, with formula two showing a more significant decrease. These experimental results indicate that formulas one, two, and three all possess potential in vitro lipid-lowering activity, with formulas one and two exhibiting better in vitro lipid-lowering effects.

[0070] Experimental Example 2

[0071] In vivo efficacy evaluation of the compositions of the present invention for treating hyperlipidemia, obesity, and fatty liver.

[0072] Formulas 1, 2, and 3 in this experiment were prepared in accordance with Examples 1, 2, and 3, respectively.

[0073] 1. Experimental Materials and Methods

[0074] 1.1 Experimental Materials

[0075] High-fat feed was purchased from Jiangsu Xietong Biotechnology Co., Ltd.; triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, malondialdehyde, total antioxidant capacity, glutathione, aspartate aminotransferase and alanine aminotransferase reagent kits were purchased from Nanjing Jiancheng Bioengineering Institute; simvastatin was purchased from Shanghai Yuanye Biotechnology Co., Ltd.; and Oil Red O was purchased from Beijing Solarbio Biotechnology Co., Ltd.

[0076] 1.2 Establishment and Experimental Design of Mouse Hyperlipidemia Model

[0077] Forty-five healthy adult male Kunming mice, weighing 18–21 g, were used in a noise-free environment with a room temperature of 21–27°C and a relative humidity of 45%–55%. After acclimatization for 7 days, the mice were randomly divided into 9 groups (n=5) according to their body weight: a blank control group (CTL), a hyperlipidemia model group (HFD), low- and high-dose groups of formulations 1, 2, and 3 (formula 1-L: 400 mg / kg, formula 1-H: 800 mg / kg; formula 2-L: 400 mg / kg, formula 2-H: 800 mg / kg; formula 3-L: 400 mg / kg, formula 3-H: 800 mg / kg, equivalent to approximately 3 g / day and 6 g / day for human use (70 kg), respectively), and a positive control group (SIM) receiving simvastatin 8 mg / kg. Except for the blank control group, all other mice were fed a high-fat diet; at the same time, the mice in different formulation intervention groups and the positive control group were given the corresponding dose of the test substance by gavage daily, while the mice in the blank control group and the hyperlipidemia model group were given the same volume of physiological saline, and the intervention was continued for 8 weeks.

[0078] 1.3 Determination Method

[0079] After fasting for 12 hours following the last administration, blood was collected from the orbital cavity on the second day after weighing. Serum was separated by centrifugation, and total cholesterol and triglycerides were determined by enzymatic colorimetry. Low-density lipoprotein cholesterol and high-density lipoprotein cholesterol were determined by precipitation method. Liver homogenate was prepared and the contents of malondialdehyde, total antioxidant capacity, glutathione, aspartate aminotransferase and alanine aminotransferase were determined.

[0080] H&E staining was performed on specimens of liver, subperitoneal white adipose tissue, and epididymal white adipose tissue; liver tissue was stained with Oil Red O to determine lipid droplet deposition.

[0081] 1.4 Statistical Methods

[0082] All data were statistically analyzed using SPSS 18.0 software. ANOVA was used for comparisons among multiple groups, and P < 0.05 was considered statistically significant.

[0083] 2. Experimental Results

[0084] 2.1 Effects on mouse body weight changes

[0085] A high-fat diet is a major contributing factor to hyperlipidemia. Mouse body weight was monitored weekly throughout the modeling process. Results showed no significant difference in body weight among the groups before the experiment. During the modeling period, the body weight of mice in all groups increased with time. Compared to the model group (HFD), the rate of weight gain was significantly slower after administration of the compositions of this invention, especially formulations 1 and 2, which showed more pronounced alleviating effects. Figure 3 ).

[0086] 2.2 Effects on blood lipid levels in mice

[0087] The typical clinical features of hyperlipidemia are elevated serum triglycerides (TG) and / or total cholesterol (TC), including elevated low-density lipoprotein cholesterol (LDL-C) and decreased high-density lipoprotein cholesterol (HDL-C). Both LDL-C and HDL-C are lipid components of the blood, but excessively high LDL-C levels can have adverse health effects. Normally, LDL-C is responsible for transporting cholesterol from the liver to other parts of the body to meet the cells' cholesterol needs. However, when LDL-C levels are too high, it can deposit on the walls of blood vessels, leading to atherosclerosis. Conversely, HDL-C is an anti-atherosclerotic lipoprotein that transports cholesterol from extrahepatic tissues to the liver for metabolism and excretion via bile. Its levels are negatively correlated with the risk of cardiovascular disease.

[0088] This experiment determined the effects of the test substance on serum TG, TC, LDL-C, and HDL-C in hyperlipidemic mice. The results showed that the TG, TC, and LDL-C levels in the model group (HFD) were significantly higher than those in the blank control group (CTL), while the HDL-C level was significantly lower, indicating that the mouse hyperlipidemic model was successfully established. Intervention with the test substance could improve the serum TG, TC, LDL-C, and HDL-C levels in hyperlipidemic mice to varying degrees. Figure 4 Comparison among different formulations revealed that formulations 1 and 2 showed better effects on improving blood lipid levels in hyperlipidemic mice, and were superior to formulation 3.

[0089] 2.3 Effects on hepatic lipid deposition

[0090] Hyperlipidemia, often caused by excess blood lipids, can lead to fatty degeneration of hepatocytes and damage to hepatocytes by fatty acids, resulting in a series of diseases such as fatty liver and cirrhosis. Hyperlipidemia is a marker of metabolic disorder and one of the main causes of fatty liver. Oil Red O can specifically bind to intracellular lipid droplets and is a specific staining method for lipid deposition in cells and tissues, widely used in research on diseases such as atherosclerosis and fatty liver. Therefore, this experiment used this staining to determine lipid deposition in liver tissue.

[0091] The results showed that, compared with the blank control group CTL, the model group HFD mice had a large amount of lipid accumulation in their liver tissue (red area), indicating that the high-fat diet caused obvious fatty liver symptoms in the mice; after gavage administration of the test substance, this symptom was significantly relieved, and different formulations all showed good improvement effects, with formulations 1 and 2 showing better effects. Figure 5 ).

[0092] 2.4 Effects on the morphology of white adipose tissue

[0093] White adipose tissue exhibits strong plasticity; high lipid levels can lead to an increase in the size of white adipocytes and an increase in lipid content. This experiment used H&E staining to observe the morphological effects of different formulations on white adipose tissue (including subperitoneal white adipose tissue and epididymal white adipose tissue) in hyperlipidemic mice.

[0094] The results showed that, compared with the blank control group, the volume of subperitoneal white adipose tissue and epididymal white adipocytes in the model group (HFD) was increased. After intervention with different formulations, the cell volume was reduced compared with the model group. Figure 6 ).

[0095] 2.5 Effects on liver function

[0096] Hyperlipidemia is a recognized major risk factor for liver damage. A high-fat diet not only leads to fat accumulation in the liver but also increases the burden on the liver, damaging hepatocytes and causing abnormal liver function. Therefore, this experiment used H&E staining to observe liver tissue morphology and measured its oxidative stress response and serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels.

[0097] The results showed that the liver tissue of the blank control group (CTL) was normal, with intact hepatic acinar structure and regular hepatic plate morphology; the liver tissue of the model group (HFD) mice showed obvious macrovesicular steatosis and enlarged hepatocytes; after intervention with different formulations, the damaged liver tissue was significantly improved. Figure 7 (A) Measurements of liver tissue oxidative stress-related indicators revealed that, compared to the control group, the model group showed significantly decreased glutathione (GSH) and total antioxidant capacity (T-AOC) in liver tissue, and significantly increased malondialdehyde (MDA). This indicates that a high-fat diet leads to significant oxidative stress in mouse liver tissue, and intervention with different formulations via gavage can significantly improve this pathological response. Figure 7 (BD in the text). Comparison among different formulations revealed that formulation 3 was the most effective in alleviating oxidative stress in the liver of hyperlipidemic mice. Furthermore, serum AST and ALT are classic indicators of hepatocyte damage. This study found that serum AST and ALT levels in the model group mice were significantly higher than those in the control group, and these levels could be reversed to varying degrees after intervention with different formulations. Figure 7 (E and F in the text).

[0098] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A lipid-lowering and weight-reducing composition, characterized by comprising: The composition is composed of the following raw materials by weight: 40-45 parts of Cordyceps militaris fruiting body granules, 12-16 parts of Morchella fruiting body granules, 11-14.5 parts of tartary buckwheat powder, 11-14 parts of water extract of mulberry leaves, 11-20 parts of water extract of Rhizoma Polygonati and 3.5-6 parts of water extract of Cassiae Semen.

2. The composition of claim 1, wherein, The crude polysaccharide content of the water extract of mulberry leaves is 5%-15%.

3. The composition of claim 1, wherein, The crude polysaccharide content of the water extract of Rhizoma Polygonati is 5%-15%.

4. The composition of claim 1, wherein, The total anthraquinone content of the water extract of Cassiae Semen is 1%-4%.

5. The composition of claim 1, wherein, The preparation method of the Cordyceps militaris fruiting body granules and the Morchella fruiting body granules comprises the following steps: crushing, steaming and drying Cordyceps militaris fruiting bodies and Morchella fruiting bodies to obtain the Cordyceps militaris fruiting body granules and the Morchella fruiting body granules.

6. The composition of claim 5, wherein, The particle size of the crushed Cordyceps militaris fruiting bodies is 10-20 mesh, and the particle size of the crushed Morchella fruiting bodies is 20-60 mesh.

7. Process for the preparation of a composition according to any one of claims 1 to 6, characterized in that, The method comprises the following steps: The composition is prepared by mixing the Cordyceps militaris fruiting body granules, the Morchella fruiting body granules, the tartary buckwheat powder, the water extract of mulberry leaves, the water extract of Rhizoma Polygonati and the water extract of Cassiae Semen.

8. Use of the composition of any one of claims 1-6 or the composition prepared by the preparation method of claim 7 in the preparation of a lipid-lowering and / or weight-reducing drug.

9. Use of the composition of any one of claims 1-6 or the composition prepared by the preparation method of claim 7 in the preparation of a drug for treating hyperlipidemia and / or fatty liver.

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