A lipid-lowering composition, its preparation method and application

Abstract

This invention belongs to the field of pharmaceutical and health product technology, specifically relating to a lipid-lowering composition, its preparation method, and its application. The lipid-lowering composition comprises the following components by weight: 120-480 parts of deer antler powder and 30-120 parts of birch bark extract. The preparation method of the birch bark extract is as follows: birch bark is pulverized and sieved to obtain birch bark powder; ethanol solution is added to the birch bark powder and refluxed multiple times for extraction, and the extracts are combined; the extract is concentrated under reduced pressure until no alcohol odor is detected, yielding a concentrated solution, which is then spray-dried to obtain the birch bark extract. The composition of this invention utilizes the synergistic effect of deer antler powder and birch bark extract to significantly lower serum total cholesterol and triglycerides. Furthermore, the raw materials are natural, with few side effects, and the preparation process is simple, making it suitable for developing lipid-lowering drugs or health foods.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical and health product technology, specifically relating to a lipid-lowering composition, its preparation method, and its application. Background Technology

[0002] Hyperlipidemia is a group of lipid metabolism disorders characterized by abnormally elevated levels of total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C), and / or decreased levels of high-density lipoprotein cholesterol (HDL-C) in blood plasma. As a major risk factor for atherosclerotic cardiovascular disease (ASCVD), hyperlipidemia poses a significant threat to public health. Studies have shown that hyperlipidemia can promote the formation and development of atherosclerotic plaques, significantly increasing the risk of cardiovascular and cerebrovascular events such as coronary heart disease, ischemic stroke, and peripheral artery disease. With the accelerating aging of the population, high-fat diets, and sedentary lifestyles, the prevalence of hyperlipidemia continues to rise. Furthermore, due to the lack of obvious early clinical symptoms, there is a widespread problem of underdiagnosis and delayed intervention, further exacerbating the disease burden.

[0003] From an etiological perspective, hyperlipidemia can be divided into primary and secondary types. Primary hyperlipidemia is mostly related to genetic factors, caused by gene mutations leading to abnormal lipoprotein metabolism pathways; secondary hyperlipidemia often occurs secondary to diseases such as diabetes, hypothyroidism, and nephrotic syndrome, or is induced by factors such as medications and unhealthy lifestyles. Modern medicine believes that the occurrence of hyperlipidemia is often the result of the combined effects of genetic background and environmental factors.

[0004] In Traditional Chinese Medicine (TCM) theory, blood lipids are categorized as "fatty substances," sharing the same origin as body fluids. They rely on the coordinated functions of the spleen and stomach (transportation and transformation), liver (drainage and regulation), and kidney (warming and nourishing) to distribute throughout the body, fulfilling the physiological functions of "nourishing bones, benefiting marrow, and moisturizing skin." If organ function is imbalanced, especially if the spleen fails to function properly, the liver fails to regulate properly, or kidney qi is deficient, fatty substance metabolism can be impaired, leading to the accumulation of turbidity, forming "fatty turbidity." The deposition of fatty turbidity in the blood vessels results in phlegm and blood stasis, obstructing the meridians and causing conditions such as chest pain and stroke. Modern medicine widely uses chemically synthesized drugs such as statins and fibrates in lipid-lowering treatment. While their efficacy is clear, long-term use may be accompanied by adverse reactions such as abnormal liver function, muscle toxicity, and abnormal glycemic metabolism, limiting their clinical applicability and patient compliance. In contrast, TCM herbs are mostly derived from natural plants and have shown certain lipid-regulating effects in long-term clinical practice, with a generally high safety profile and minimal impact on liver and kidney function. Therefore, in-depth research on traditional Chinese medicines and compound formulas with lipid-lowering potential is of great significance for enriching the prevention and treatment strategies for dyslipidemia, reducing the adverse reactions of Western medicines, and improving treatment adherence. Summary of the Invention

[0005] The purpose of this invention is to provide a lipid-lowering composition, its preparation method, and its application, thereby overcoming the shortcomings of the prior art. Utilizing the synergistic effect of deer antler powder and birch bark extract, it has a significant effect on reducing serum total cholesterol and triglycerides. Moreover, the raw materials are natural, with few side effects, and the preparation process is simple. It can be used to develop lipid-lowering drugs or health foods.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: In a first aspect, the present invention provides a lipid-lowering composition, which comprises the following components in parts by weight: 120-480 parts of deer antler powder and 30-120 parts of birch bark extract; The preparation method of the birch bark extract is as follows: The birch bark was crushed and sieved to obtain birch bark powder. Ethanol solution was added to the birch bark powder and refluxed for extraction multiple times. The extracts were combined and concentrated under reduced pressure until no alcohol odor was detected. The concentrated solution was then spray-dried to obtain birch bark extract.

[0007] Reindeer lichen (Cladonia rangiferina), also known as deer lichen, is a light-colored, shrub-like lichen belonging to the Cladoniaceae family. It is a unique organism formed by a symbiotic relationship between fungi and algae and is extremely cold-resistant. Material composition analysis shows that it mainly contains bioactive compounds such as lichen-β-oligosaccharides, phenolic acids, phenolic acid cyclic ethers, usnic acid, polysaccharides, and amino acids. Modern pharmacological studies have shown that it possesses antibacterial, anti-inflammatory, immunomodulatory, antioxidant, anti-apoptotic, and antitumor drug activities.

[0008] Birch bark extract is a bioactive substance extracted from the bark of birch trees, possessing a wide range of pharmacological effects. Rich in triterpenoids, alkanols, lanosterol, polysaccharides, and antioxidants, birch bark extract exhibits various bioactive compounds, including those promoting wound healing and skin repair, inhibiting angiogenesis and anti-tumor activity, antibacterial and immunomodulatory effects, and antioxidant and anti-inflammatory properties. Betulinic acid from birch bark has shown lipid-lowering activity similar to statins in a high-fat diet-induced rat model.

[0009] The combined use of deer antler extract and birch bark extract showed a significant synergistic effect in lowering blood lipids and intervening in their complications, with the mechanism of action following the logic of "core lipid-lowering - multi-dimensional control of complications". In terms of lipid-lowering effects, the two form a complementary pattern of direct and indirect action. Betulinic acid in birch bark extract exhibited statin-like activity in a high-fat diet-induced rat model, directly intervening in lipid metabolism and reducing blood levels of cholesterol, triglycerides, and other lipids. Meanwhile, the lichen-β-oligosaccharides and polysaccharides in deer antler extract indirectly affect lipid metabolism through immunomodulation, and their amino acids can provide raw materials for the synthesis of lipid metabolism-related enzymes, helping to improve metabolic disorders and further enhancing the overall lipid-lowering effect.

[0010] In the intervention of complications of hyperlipidemia, both play a role through multiple targets such as anti-inflammatory and antioxidant effects, vascular protection, and immune regulation. Hyperlipidemia is often accompanied by chronic inflammation and oxidative stress, which can easily lead to vascular endothelial damage and atherosclerosis. The phenolic acids and usnic acid in *Deer antler stamens*, along with the triterpenoids and antioxidants in *Birch bark* extract, can synergistically scavenge free radicals, inhibit the release of inflammatory factors, and reduce oxidative damage and inflammatory responses in the vascular endothelium. Simultaneously, the anti-apoptotic effect of *Deer antler stamens* can protect vascular endothelial cells, working in conjunction with the vascular protective effect of *Birch bark* extract to maintain vascular wall integrity and slow the progression of atherosclerosis. Regarding the impaired immune function and infection risk caused by metabolic disorders in hyperlipidemic patients, the usnic acid and phenolic acid cyclic ethers in *Deer antler stamens*, along with the triterpenoids in *Birch bark* extract, possess antibacterial activity, inhibiting the proliferation of pathogenic bacteria. The polysaccharide components of both can regulate the body's immune function, reducing the aggravation of infection-induced complications. For lipid deposition damage to target organs such as the liver and kidneys caused by hyperlipidemia, *Birch bark* extract can assist in repairing visceral tissue damage, while *Deer antler stamens* reduces inflammation and oxidative damage to target organs through immune regulation and antioxidation, jointly reducing the degree of target organ damage.

[0011] In some other embodiments, the lipid-lowering composition comprises, by weight, 240-300 parts of deer antler powder and 60-75 parts of birch bark extract; In some other embodiments, the particle size of the deer stamen powder is 80-120 mesh, and in the preparation method of the birch bark extract, the particle size of the birch bark powder is 30-50 mesh, and 8-12 mL of ethanol solution is added per gram of birch bark powder, with the volume concentration of the ethanol solution being 40-60%.

[0012] Preferably, the deer antler powder has a particle size of 100 mesh, and the birch bark powder has a particle size of 40 mesh, ensuring the dissolution of active ingredients while avoiding excessive extraction of impurities due to excessive fineness. Each gram of birch bark powder is added to 10 mL of ethanol solution, with a volume concentration of 50%.

[0013] In some other embodiments, the reflux extraction temperature is 55-65°C, the reflux extraction is performed 2-4 times, and the extraction time for each extraction is 1.5-2.5 h. Preferably, the reflux extraction temperature is 60°C, the reflux extraction is performed 3 times, and the extraction time for each extraction is 2 h.

[0014] In some other embodiments, in the preparation method of birch bark extract, the inlet air temperature of spray drying is 170-180°C, and the outlet air temperature is 70-90°C. Preferably, the inlet air temperature of spray drying is 175°C, and the outlet air temperature is 80°C, which can ensure the stability of the extract activity and sufficient drying.

[0015] Secondly, the present invention provides a method for preparing the lipid-lowering composition described in the first aspect, which is obtained by mixing deer antler powder with birch bark extract.

[0016] Thirdly, the present invention provides the use of the lipid-lowering composition described in the first aspect in the preparation of products with lipid-lowering function.

[0017] In some other embodiments, the lipid-lowering function is to reduce at least one of total cholesterol and triglycerides.

[0018] In some other embodiments, the product is one of a drug, food, or health product.

[0019] In some other embodiments, the product is in the form of one of capsules, tablets, granules, powders, and oral liquids.

[0020] The beneficial effects of this invention are: (1) All active ingredients in this invention are derived from natural plants. Compared with chemically synthesized lipid-lowering drugs, they are mild in nature and avoid common side effects such as liver damage and muscle soreness from the source. Therefore, they are safer for long-term use and help improve patient compliance.

[0021] (2) In a zebrafish hyperlipidemia model, the composition significantly reduced the lipid level increase induced by high lipid levels. Specifically, compared with the high lipid model group, the lipid-lowering composition significantly reduced the Oil Red O staining integrated optical density (IOD) value of juvenile zebrafish, and also significantly reduced the levels of triglycerides (TG) and total cholesterol (TC) in their bodies. This composition has application value for the prevention and / or treatment of hyperlipidemia and related diseases. Attached Figure Description

[0022] The accompanying drawings, which form part of this invention, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an improper limitation of the invention.

[0023] Figure 1 This is a graph showing the results of determining the safe dosage of the lipid-lowering composition in the embodiments of the present invention; Figure 2 The effects of the lipid-lowering composition on zebrafish lipids are shown in the following figures: A represents the effects of Oil Red O staining on blood lipids in the blank group, atorvastatin calcium group, and lipid-lowering composition group, with whole fish magnified 32 times and local trunk areas magnified 100 times; B is a statistical graph of IOD (Index Difference) of blood lipids in the zebrafish tail; and C is a statistical graph of the lipid-lowering rate of the atorvastatin calcium group and the lipid-lowering composition. P<0.0001, P < 0.05 vs. Model indicates a significant difference; Figure 3 Statistical charts of triglyceride and total cholesterol levels, where A represents triglyceride level detection and B represents total cholesterol level detection. ####P<0.0001, ##P<0.05 vs. Control. P<0.0001, P<0.01, P < 0.05 vs. Model indicates a significant difference.

[0024] Figure 4 Under the same concentration conditions, the lipid-lowering activities of each example and the comparative sample were compared. Detailed Implementation

[0025] It should be noted that the following detailed descriptions are exemplary and intended to provide further illustration of the invention. Unless otherwise specified, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0026] As mentioned earlier, hyperlipidemia is a significant risk factor for cardiovascular disease, leading to serious conditions such as atherosclerosis, coronary heart disease, and stroke. While traditional Western medicines (such as statins) are effective in lowering lipids, they may be accompanied by side effects such as liver damage. Natural plant extracts, due to their high safety and fewer side effects, have become an important direction in lipid-lowering drug research. This invention, based on a zebrafish hyperlipidemia model, uses a lipid-lowering composition to verify its ameliorative effect on the pathological changes in the body caused by high-fat intake.

[0027] The citation abbreviations and their corresponding full Chinese and English names involved in the specific embodiments are shown in Table 1 below.

[0028] Table 1 English Annotation Table

[0029] The reagents, experimental instruments, and experimental animals used are as follows: (1) Reagents: Atorvastatin calcium (Catalog No.: C15914532, Shanghai Maclean Biotechnology Co., Ltd.); Egg yolk powder (Catalog No.: 24231223001, Beijing Solarbio Technology Co., Ltd.); Oil Red O (Catalog No.: B01E10107, Beijing Dingguo Changsheng Biotechnology Co., Ltd.); Triglyceride (TG) test kit (Catalog No. A110-1-1, Nanjing Jiancheng Biotechnology Institute); Total cholesterol (TC) content test kit (Catalog No.: BC1980, Beijing Solarbio Technology Co., Ltd.).

[0030] (2) Experimental instruments: light incubator (HPG280-BX, Donglian Electronic Technology Co., Ltd.); low temperature centrifuge (Centrifuge 5804R, Eppendorf); small centrifuge (G508010, Shanghai Sangon Biotech Co., Ltd.); vortex apparatus (Vortex-genie2, Qilinbell Instrument Manufacturing Co., Ltd.); ultrasonic cleaner (SB-5200DT, Xinzhi Biotechnology Co., Ltd.); electronic balance (IE204E, Mettler Toledo Instruments Ltd.); stereo microscope (COIC-ZSA302, Olympus Corporation, Japan); microplate reader (BMGLABTECH, SPECTROstar Nano, Germany).

[0031] (3) The wild-type AB zebrafish used in the experiment were provided by the Drug Screening Laboratory of the Institute of Biology, Shandong Academy of Sciences. Adult zebrafish were raised according to the standards in "The zebrafish book: a guide for the laboratory use of zebrafish Danio (Brachydanio) rerio". Male and female adult zebrafish were kept in separate tanks. One hour after feeding on the afternoon of the day before the experiment, the male and female zebrafish were placed in the spawning tank at a ratio of 2:2 or 2:3, with a partition separating the males and females in the middle of the spawning tank. The partition was removed the next morning, at which time the male and female zebrafish began to mate, reproduce, and lay eggs. The eggs were collected 2 hours later.

[0032] The solution of the present invention will be further described below with reference to specific embodiments: 1. Lipid-lowering composition and its preparation method Example 1 A lipid-lowering composition comprises the following raw materials in parts by weight: 120 parts of deer antler powder and 30 parts of birch bark extract. The deer antler powder has a particle size of 100 mesh. The preparation method of the birch bark extract is as follows: take birch bark, pulverize it, and pass it through a 40-mesh sieve to obtain birch bark powder; take the birch bark powder, add 10 mL of 50% ethanol solution per gram of birch bark powder according to the material-to-liquid ratio, and reflux extract at 60°C for a total of 3 extractions, with each reflux extraction lasting 2 hours; collect all the filtrates after reflux extraction and combine them to obtain a mixed extract; concentrate the combined extract under reduced pressure until the concentrate has no alcohol odor; spray dry the obtained concentrate, controlling the inlet air temperature at 175°C and the outlet air temperature at 80°C; after spray drying, collect the solid powder, which is the birch bark extract.

[0033] Example 2 Unlike Example 1, the lipid-lowering composition consists of the following raw materials in parts by weight: 200 parts of deer antler powder and 50 parts of birch bark extract.

[0034] Example 3 Unlike Example 1, the lipid-lowering composition consists of the following raw materials in parts by weight: 240 parts of deer antler powder and 60 parts of birch bark extract.

[0035] Example 4 Unlike Example 1, the lipid-lowering composition consists of the following raw materials in parts by weight: 300 parts of deer antler powder and 75 parts of birch bark extract.

[0036] Example 5 Unlike Example 1, the lipid-lowering composition consists of the following raw materials in parts by weight: 480 parts of deer antler powder and 120 parts of birch bark extract.

[0037] Comparative Example 1 Unlike Example 3, 240 parts of a single deer antler powder were used.

[0038] Comparative Example 2 Unlike Example 3, 60 parts of a single birch bark extract were used.

[0039] 2. Performance Testing Based on a zebrafish hyperlipidemia model, this study investigated the lipid-lowering activity of the composition, aiming to verify its activity and provide a scientific basis for the development of safe and economical natural lipid-lowering drugs. The testing methods for lipid-lowering activity are as follows: Three hundred wild-type zebrafish with normal development and a 5-day pf growth rate (dpf) were selected. Fifty zebrafish were randomly selected as the control group, and the remainder were used as the model group. All zebrafish were fed a high-fat diet (0.1 g / 100 mL egg yolk liquid) for two days. After two days of culture, the model group was further randomly divided into a high-fat model group, a positive control group (atorvastatin calcium, 10 μM), and a lipid-lowering composition group (10, 15, and 20 μg / mL). The normally developed zebrafish were placed in 12-well plates with 10 zebrafish per well, and three replicates were established for each group. The plates were then incubated in a light incubator for 24 h. After treatment, the activity of one composition was evaluated using Oil Red O staining IOD value, triglyceride content, and total cholesterol content.

[0040] The preparation method of the lipid-lowering composition solution is as follows: Weigh the lipid-lowering composition (taking Example 3 as an example), add DMSO, vortex thoroughly, and prepare a 100 mg / mL drug suspension stock solution, which is then stored at -20℃. The preparation method of the positive sample is as follows: Take atorvastatin calcium powder, add DMSO, vortex thoroughly, and prepare a 50 mM drug solution stock solution, which is then stored at -20℃.

[0041] The study found that, compared with the control group, serum-related indicators in the high-fat model group and the lipid-lowering composition group showed significant changes, indicating that the model was successfully established. Compared with the high-fat model group, the lipid-lowering composition group showed a significant decrease in the Oil Red O staining IOD value; the lipid-lowering composition group also showed a significant decrease in the levels of triglycerides and total cholesterol.

[0042] The lipid-lowering composition can significantly improve the elevated Oil Red O staining IOD value, triglyceride level and total cholesterol level in juvenile zebrafish after high-fat modeling, indicating that it has a lipid-lowering effect.

[0043] Statistical analysis was performed using the statistical analysis software GraphPad Prism 8.3.0. Experimental data were expressed as (mean ± SEM). One-way ANOVA was used to analyze significant differences between groups.

[0044] (1) Safety evaluation of lipid-lowering composition Five-day-fed (dpf) zebrafish with normal development were divided into two groups: a blank control group, placed in 1×E3 aquaculture solution (5 mM NaCl, 0.17 mM KCl, 0.44 mM CaCl2, and 0.33 mM MgSO4·7H2O); and a high-fat modeling group, placed in 0.1 g / 100 mL egg yolk solution (egg yolk powder, 1×E3 aquaculture solution). After 48 h of culture, the zebrafish were washed two to three times with aquaculture solution to remove residual egg yolk powder. The normally developed zebrafish were then placed in 12-well plates, with 10 zebrafish per well and 3 replicates per group. The experiment included a blank control group (3 mL 1×E3 aquaculture solution); and lipid-lowering composition (using Example 3 as an example) concentration groups: different concentrations of drug solution (10, 20, 30, 40, 80, 160 μg / mL) were administered, followed by culturing in a light incubator for 24 h. After treatment, the mortality rate of zebrafish in each group was statistically analyzed and recorded. Finally, the median lethal concentration (LC50) of the drug was determined using GraphPad Prism 8.3 software. 50 ), determine the range of working solution concentration for the lipid-lowering composition in the later stage.

[0045] By observing and statistically analyzing the mortality of zebrafish, the results showed that all zebrafish with concentrations of 80 and 160 μg / mL died. Further calculations and analysis revealed that... Figure 1 As shown, the median lethality (LC50) was 47.12 μg / mL, and n=30. Based on the results, the safe concentration range was determined to be 0–20 μg / mL.

[0046] (2) Effects of lipid-lowering composition on blood lipids in zebrafish Based on the above experimental results, the experimental concentration for zebrafish was determined. The culture and feeding methods were the same as above. Experimental groups were set up as follows: blank group, high-fat model group, atorvastatin calcium group (10 μM), and experimental groups (10, 15, 20 μg / mL). The zebrafish were then cultured in a light incubator for 24 h. After treatment, the well plates were removed and the solution aspirated. The zebrafish were washed three times with 1×E3 fish culture water, and then stained with Oil Red O working solution to remove blood lipids. Fifteen zebrafish were randomly selected from each group, observed under a microscope, and images were acquired. Whole fish were magnified 32 times, and local trunk areas were magnified 100 times, with the left boundary at the end of the zebrafish intestine. Comparative photos were taken under the same parameters. Finally, Image-pro plus 5.1 was used to measure the integrated optical density (IOD) in the zebrafish blood vessels, and the IOD value was used as a relative quantitative indicator of Oil Red O staining. The lipid-lowering rate was calculated using the IOD value. Lipid reduction rate (%) = [(IOD high-fat model group)] [IOD drug treatment group / IOD high-fat model group] × 100% The effect of the lipid-lowering composition on blood lipids in zebrafish was analyzed based on Oil Red O staining results. No obvious lipid deposition area was observed in the tail region of the control group zebrafish. Figure 2 As shown in A, it was not included in the statistics. The high-fat model group showed a significant increase in the oil red O staining area of ​​the zebrafish tails, and a marked increase in the IOD value, as shown in Figure A. Figure 2 As shown in Figure B, egg yolk powder successfully induced an increase in blood lipids in zebrafish. The staining area and IOD value of the positive control atorvastatin calcium group were significantly reduced, consistent with its known lipid-lowering effect. The IOD value of zebrafish treated with the 15 μg / mL lipid-lowering composition also showed a significant decreasing trend, indicating that the lipid-lowering composition has certain lipid-lowering activity. Figure 2 C represents the lipid-lowering rate of the atorvastatin calcium combined with the lipid-lowering composition. These results collectively confirm the reliability of the experimental model and verify the activity of the lipid-lowering composition.

[0047] (3) Detection of triglyceride and total cholesterol levels A triglyceride assay kit was used to detect the triglyceride content in zebrafish. Thirty juvenile zebrafish were collected from each group after the experiment, weighed, and homogenized with anhydrous ethanol at a ratio of 1:9 as per the instructions. The supernatant was then obtained. The experiment was performed strictly according to the kit instructions. The absorbance of each well was measured at 500 nm using a microplate reader. The triglyceride content was calculated using the following formula: ; A represents the absorbance value; C 标准 The standard concentration is 2.26 mmol / L; W is the tissue weight (g); V is the concentration of the standard. 提取液 The total volume of the added extract (ethanol) is expressed in L.

[0048] The total cholesterol content in zebrafish was determined using a total cholesterol assay kit. Thirty juvenile zebrafish were collected from each group after the experiment. Their mass was measured, and isopropanol was added at a ratio of 1:5 as per the instructions. The mixture was homogenized, and the supernatant was obtained. The experiment was performed strictly according to the kit instructions. The absorbance of each well was measured at 500 nm using a microplate reader. A standard curve was established using the concentration (x, μmol / mL) of the standard tubes obtained from the standard solution and the absorbance ΔA standard (y, ΔA standard). Based on the standard curve, the sample concentration (x, μmol / mL) was calculated by substituting the ΔA measurement (y, ΔA measurement) into the formula. Finally, the total cholesterol content of each group of zebrafish was determined using the following formula: Total cholesterol content (μmol / g mass) = x×V extraction ÷ W×F = x ÷ W×F; x is the sample concentration, μmol / mL; V_extraction is the volume of extract solution added to the sample, 1 mL; W is the sample mass, g; F: sample dilution factor.

[0049] Depend on Figure 3 As shown in Figures A and B, compared to the control group, the levels of triglycerides and total cholesterol in zebrafish significantly increased after treatment with egg yolk powder, indicating elevated blood lipids in the zebrafish. Treatment with atorvastatin calcium significantly reduced the levels of triglycerides and total cholesterol in the zebrafish, consistent with its known lipid-lowering effect. When the concentration of the lipid-lowering composition was 15 μg / mL, the levels of triglycerides and total cholesterol in the zebrafish were significantly lower than those in the high-fat model group, showing a statistically significant difference.

[0050] To evaluate the effect of the combined treatment, the lower measured value of the lipid-lowering rate of the single component in this study was selected from the experimental replicates. This facilitated the comparison of the activity differences between the combined group and the single component, thus more intuitively reflecting the effect of the two substances used in combination. Figure 4 It can be seen that, under the same concentration conditions, the lipid-lowering rates of Examples 1-5 are 33.28%, 36.21%, 39.40%, 40.26%, and 40.77%, respectively, with Example 5 showing the highest lipid-lowering rate. The lipid-lowering rates of Comparative Examples 1 and 2 are only 13.49% and 18.03%, respectively, which are significantly lower than all examples. This indicates that the technical solution corresponding to the embodiments of the present invention can significantly improve the lipid-lowering effect compared with the comparative examples.

[0051] In summary, compared with the control group, the serum-related indicators in the high-fat model group and the lipid-lowering composition group showed significant changes, indicating that the model was successfully established. Compared with the high-fat model group, the oil red O staining IOD value of blood lipids was significantly reduced in the lipid-lowering composition group; the levels of triglycerides and total cholesterol in the body were also significantly reduced. The lipid-lowering composition can significantly improve the elevated oil red O staining IOD value, triglyceride level, and total cholesterol level in zebrafish juveniles after high-fat modeling, indicating that it has a lipid-lowering effect.

[0052] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A lipid-lowering composition, characterized in that, It consists of the following components by weight: 120-480 parts of deer antler powder and 30-120 parts of birch bark extract; The preparation method of the birch bark extract is as follows: The birch bark was crushed and sieved to obtain birch bark powder. Ethanol solution was added to the birch bark powder and refluxed for extraction multiple times. The extracts were combined and concentrated under reduced pressure until no alcohol odor was detected. The concentrated solution was then spray-dried to obtain birch bark extract.

2. The lipid-lowering composition according to claim 1, characterized in that, It consists of the following components by weight: 240-300 parts of deer antler powder and 60-75 parts of birch bark extract.

3. The lipid-lowering composition according to claim 1, characterized in that, The particle size of the deer stamen powder is 80-120 mesh. In the preparation method of the birch bark extract, the particle size of the birch bark powder is 30-50 mesh, and 8-12 mL of ethanol solution is added per gram of birch bark powder, with a volume concentration of 40-60%.

4. The lipid-lowering composition according to claim 1, characterized in that, In the preparation method of the birch bark extract, the reflux extraction temperature is 55-65℃, the reflux extraction is performed 2-4 times, and the extraction time is 1.5-2.5 h each time.

5. The lipid-lowering composition according to claim 1, characterized in that, In the preparation method of the birch bark extract, the inlet air temperature of the spray drying is 170-180℃, and the outlet air temperature is 70-90℃.

6. A method for preparing the lipid-lowering composition according to any one of claims 1-5, characterized in that, The deer antler powder is obtained by mixing it with birch bark extract.

7. The use of the lipid-lowering composition according to any one of claims 1-5 in the preparation of a product having lipid-lowering function.

8. The application according to claim 7, characterized in that, The lipid-lowering function is to reduce at least one of total cholesterol and triglycerides.

9. The application according to claim 7, characterized in that, The product is one of the following: medicine, food, and health product.

10. The application according to claim 7, characterized in that, The product is available in one of the following dosage forms: capsules, tablets, granules, powders, and oral liquids.

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