Medicinal and edible composition for reducing blood fat and application thereof

Abstract

The invention discloses a medicinal and edible composition for reducing blood fat and application of the medicinal and edible composition, and belongs to the technical field of extraction and application of effective active ingredients of plants. The invention provides a medicinal and edible composition for reducing blood fat and application of the medicinal and edible composition. The composition is prepared by mixing main components and auxiliary components. The main components comprise chrysanthemum, honeysuckle, rose, cassia seed, lotus leaf and sword bean, the auxiliary components comprise pleurotus eryngii, mushroom, black fungus, boat-fruited sterculia seed, poria cocos and fruits rich in procyanidine, such as waxberry, blueberry and longan, and the auxiliary components can improve the taste and assist in reducing blood fat. The medicinal and edible composition prepared in the invention has the advantages of high safety, reasonable formula design, stable process, substantial reduction of blood fat, and good social and economic benefits. And the fruits rich in procyanidine play an important role in the aspects of adjusting the mouth feel and assisting in reducing blood fat.

Description

Technical Field

[0001] The present invention relates to the technical field of extraction and application of effective active ingredients of plants, and particularly relates to a medicine and food homologous composition for reducing blood lipid and its application. Background Art

[0002] Hyperlipidemia, also known as dyslipidemia, is a metabolic disease characterized by abnormal elevation of lipid levels (such as cholesterol, triglycerides, etc.) in the blood. According to the definition of the World Health Organization (WHO), hyperlipidemia usually manifests as elevated levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), or triglycerides (TG), or reduced levels of high-density lipoprotein cholesterol (HDL-C). The symptoms of hyperlipidemia are usually not obvious and it belongs to an "invisible killer", but in severe cases, patients may present symptoms such as xanthoma (fat deposition in the skin or tendon), fundus vascular changes, or pancreatitis. It is estimated that hundreds of millions of people around the world suffer from hyperlipidemia, and in China, the prevalence of hyperlipidemia among adults has exceeded 40%, and it shows a trend of getting younger.

[0003] The harm of hyperlipidemia is mainly reflected in its long-term damage to the cardiovascular system. It is one of the main risk factors for atherosclerosis and can lead to serious cardiovascular events such as coronary heart disease, myocardial infarction, and stroke. In addition, hyperlipidemia is also closely related to diseases such as diabetes, obesity, and metabolic syndrome. At the same time, hyperlipidemia may cause complications such as acute pancreatitis (especially in patients with hypertriglyceridemia), thus accelerating the progression of kidney disease. Uncontrolled hyperlipidemia over a long period of time will also increase the risk of peripheral arterial disease and fatty liver.

[0004] At present, the commonly used lipid-lowering drugs on the market mainly include statins, fibrates, cholesterol absorption inhibitors, PCSK9 inhibitors, niacin drugs, and bile acid sequestrants, etc. These drugs effectively reduce lipid levels through different mechanisms, but at the same time bring more side effects. Statins such as atorvastatin, simvastatin, and rosuvastatin reduce cholesterol synthesis by inhibiting HMG-CoA reductase, increase the expression of LDL receptors, and promote LDL clearance to lower blood lipids. The effect is significant, but it may cause side effects such as muscle pain and abnormal liver function. Long-term use may also increase the risk of diabetes; Fibrates such as fenofibrate and gemfibrozil can activate PPAR-α, promote triglyceride decomposition, and reduce TG levels. The effect of reducing triglycerides is obvious, but the effect of reducing LDL-C is weak, and it may also cause side effects such as gastrointestinal discomfort and muscle pain; Cholesterol absorption inhibitors represented by ezetimibe can inhibit the absorption of cholesterol in the small intestine and reduce LDL-C levels. However, unless combined with statins, the lipid-lowering effect is weak when used alone, and it is easy to cause mild side effects such as headache and abdominal pain; PCSK9 inhibitors such as alirocumab and evolocumab promote LDL clearance by inhibiting PCSK9 protein and increasing the number of LDL receptors. The lipid-lowering effect is powerful, especially suitable for patients with poor response to statins. However, its price is expensive, and it needs to be administered by injection, which will cause side effects such as injection site reactions and flu-like symptoms; Niacin drugs such as niacin and acipimox can inhibit lipolysis in adipose tissue, reduce TG and LDL-C, and significantly increase HDL-C, which is very suitable for patients with mixed hyperlipidemia, but it may cause side effects such as flushing and gastrointestinal discomfort. Long-term use may also lead to liver toxicity and the risk of diabetes; Bile acid sequestrants such as cholestyramine and colesevelam bind to bile acids in the intestine, promote their excretion, and reduce cholesterol absorption. Since they do not enter the blood, the safety is relatively high. The disadvantage is that the lipid-lowering effect is weak and large doses are required, resulting in gastrointestinal discomfort, constipation and other situations.

[0005] Modern pharmacological studies have shown that many single Chinese herbs have the effect of reducing blood lipids. However, when treating hyperlipidemia with traditional Chinese medicine, it is different from the treatment methods of other diseases, that is, it focuses on the individual differences of patients and the characteristics of compound use. Traditional Chinese medicine not only aims to reduce blood lipid levels, but also attaches great importance to preventing and treating cardiovascular diseases and other complications caused by hyperlipidemia, so as to improve overall health, improve quality of life and extend lifespan. In recent years, the research on extracting active ingredients from natural products for the prevention and treatment of hyperlipidemia has become an important hotspot. Therefore, seeking natural drugs and health products with high efficiency, low toxicity and low cost from Chinese herbs with rich resources has become a significant development trend. These natural drugs and health products can not only effectively regulate blood lipid metabolism, but also improve hemorheology, possess antioxidant and anti-inflammatory effects through multi-target and multi-pathway mechanisms of action, providing a safe and sustainable treatment option for hyperlipidemia patients. With the increasing public recognition of natural drugs and health foods, their application prospects in the field of prevention and treatment of hyperlipidemia will be broader.

[0006] Diet has a profound and comprehensive impact on hyperlipidemia patients. The dietary principles for hyperlipidemia patients should include: increasing the intake of dietary fiber, consuming more foods rich in vitamins and trace elements, ensuring the supply of high-quality protein, and strictly controlling the intake of saturated fat and cholesterol. "Medicine and food sharing the same origin" is one of the important contributions of traditional Chinese medicine to human health. Traditional Chinese medicine has always emphasized that "food therapy is better than medicine therapy", so food therapy has become an ideal choice for modern people to pursue health and return to nature. Through scientific and reasonable diet collocation, not only can the blood lipid level be effectively reduced, but also health can be improved while enjoying delicious food, avoiding the pain brought by long-term dependence on drugs or surgery. For hyperlipidemia patients, a reasonable diet structure can not only regulate blood lipid metabolism, but also prevent the occurrence of cardiovascular diseases and improve the overall quality of life. Therefore, diet therapy has an irreplaceable position in the management of hyperlipidemia. Summary of the Invention

[0007] The purpose of the present invention is to provide a medicine and food homology composition for reducing blood lipids and its application to solve the problems existing in the above-mentioned prior art.

[0008] To achieve the above purpose, the present invention provides the following solutions:

[0009] One of the technical solutions of the present invention, a medicine and food homology composition with the effect of reducing blood lipids, comprises the following components in parts by weight: 30-50 parts of chrysanthemum, 30-50 parts of honeysuckle, 30-40 parts of rose, 20-40 parts of cassia seed, 20-40 parts of lotus leaf and 20-40 parts of jack bean.

[0010] The second technical solution of the present invention, a preparation method of the medicine and food homology composition, comprises the following steps:

[0011] (1) Mix, pulverize chrysanthemum, honeysuckle, rose, cassia seed, lotus leaf and jack bean, and obtain Extract I through ethanol extraction;

[0012] (2) Mix and pulverize Pleurotus eryngii, Lentinus edodes, Auricularia auricula-judae, Sterculia lychnophora and Poria cocos to obtain powder; Mix and make slurry of Chinese bayberry, blueberry and longan pulp to obtain crude fruit pulp; Mix the powder and the crude fruit pulp, and obtain Extract II through ethanol extraction;

[0013] (3) Combine Extract I and Extract II, evaporate and concentrate, and add auxiliary materials to prepare granules.

[0014] The third technical solution of the present invention is the application of the said medicine and food homology composition in the preparation of drugs for treating hyperlipidemia.

[0015] Based on the above technical solutions, the present invention has the following technical effects:

[0016] (1) Through screening the hypolipidemic activities of various medicine and food homology plants, and optimizing the formula in combination with traditional Chinese medicine theory and modern medical technology, the present invention finally determines to use chrysanthemum, honeysuckle, rose, cassia seed, lotus leaf and jack bean as the main components, and at the same time selects one or more of Pleurotus eryngii, Lentinus edodes, Auricularia auricula-judae, Sterculia lychnophora, Poria cocos and Chinese bayberry, blueberry and longan pulp rich in proanthocyanidins as auxiliary materials to achieve the goal of assisting in reducing blood lipid.

[0017] (2) The hypolipidemic traditional Chinese medicine composition of the present invention takes medicine and food homology plants as the main components, has high safety and no toxic and side effects, is suitable for long-term use, effectively avoids the risk of liver damage caused by the combined use of multiple traditional Chinese medicine components, thereby improving the safety of the drug and enhancing the compliance of patients.

[0018] (3) The preparation process of the present invention is simple and low in cost, and is suitable for large-scale production. Description of the Drawings

[0019] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required to be used in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0020] Figure 1 For the average body weight of each group of mice after four weeks of treatment (n = 6).

[0021] Figure 2 For measuring the levels of TG (A), TC (B), HDL (C), LDL (D) in the serum of each group of mice (n = 6).

[0022] Figure 3 Pathological analysis of mouse liver tissue for different treatment methods.

[0023] Figure 4 Results of Western blot, where a: Detection results of protein expression levels related to lipid metabolism pathway; b: Semi - quantitative analysis of protein expression levels related to lipid metabolism pathway, n = 6. Detailed implementation manners

[0024] Now, various exemplary implementation manners of the present invention will be described in detail. This detailed description should not be regarded as a limitation of the present invention, but should be understood as a more detailed description of certain aspects, characteristics and implementation schemes of the present invention.

[0025] It should be understood that the terms used in the present invention are only for describing specific implementation manners and are not used to limit the present invention. Additionally, for the numerical ranges in the present invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Each intermediate value within any stated value or stated range, as well as each smaller range between any other stated value or intermediate value within the stated range, is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded from the range.

[0026] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention pertains. Although the present invention only describes preferred methods and materials, any methods and materials similar or equivalent to those described herein can also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials related to the documents. In case of conflict with any incorporated document, the content of this specification shall prevail.

[0027] Without departing from the scope or spirit of the present invention, various improvements and changes can be made to the specific implementation manners of the present invention specification, which are obvious to those skilled in the art. Other implementation manners obtained from the specification of the present invention are obvious to those skilled in the art. The specification and examples of this application are only exemplary.

[0028] Regarding the terms "comprising", "including", "having", "containing", etc. used herein, they are all open - ended terms, meaning including but not limited to.

[0029] The technical solutions of the present invention, unless otherwise specified, are all conventional solutions in the art. The reagents or raw materials used, unless otherwise specified, are all purchased from commercial channels or have been publicly disclosed.

[0030] An embodiment of the present invention provides a medicine-food homologous composition with lipid-lowering effects, comprising the following components in parts by weight: 30-50 parts of chrysanthemum, 30-50 parts of honeysuckle, 30-40 parts of rose, 20-40 parts of cassia seed, 20-40 parts of lotus leaf, and 20-40 parts of jack bean.

[0031] In some specific embodiments, it comprises the following components in parts by weight: 1-100 parts of chrysanthemum, 1-90 parts of honeysuckle, 1-90 parts of rose, 1-90 parts of cassia seed, 1-90 parts of lotus leaf, and 1-90 parts of jack bean.

[0032] In some specific embodiments, it comprises the following components in parts by weight: 20-80 parts of chrysanthemum, 30-80 parts of honeysuckle, 20-85 parts of rose, 30-80 parts of cassia seed, 30-80 parts of lotus leaf, and 30-80 parts of jack bean.

[0033] In some specific embodiments, it further comprises the following components in parts by weight: 5-15 parts of Pleurotus eryngii, 1-10 parts of Lentinus edodes, 5-15 parts of Auricularia auricula-judae, 20-40 parts of Sterculia lychnophora, 1-20 parts of Poria cocos, 10-20 parts of Myrica rubra, 10-30 parts of blueberry, and 10-30 parts of longan pulp.

[0034] In some specific embodiments, it further comprises the following components in parts by weight: 1-40 parts of Pleurotus eryngii, 1-25 parts of Lentinus edodes, 1-20 parts of Auricularia auricula-judae, 1-40 parts of Sterculia lychnophora, 1-20 parts of Poria cocos, 1-25 parts of Myrica rubra, 1-30 parts of blueberry, and 1-30 parts of longan pulp.

[0035] In some specific embodiments, it further comprises the following components in parts by weight: 10-30 parts of Pleurotus eryngii, 5-20 parts of Lentinus edodes, 10-20 parts of Auricularia auricula-judae, 30-40 parts of Sterculia lychnophora, 10-20 parts of Poria cocos, 15-25 parts of Myrica rubra, 20-30 parts of blueberry, and 20-30 parts of longan pulp.

[0036] In some specific embodiments, it further comprises water, filler, binder, diluent, lubricant, and glidant.

[0037] In some specific embodiments, it further comprises one or a mixture of two or more of starch, isomaltooligosaccharide, maltodextrin, xylitol, microcrystalline cellulose, erythritol, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, benzoic acid, or ethanol as excipients.

[0038] In some specific embodiments, it comprises the following components in parts by weight: 40 parts of chrysanthemum, 40 parts of honeysuckle, 35 parts of rose, 30 parts of cassia seed, 30 parts of lotus leaf, 30 parts of jack bean, 10 parts of Pleurotus eryngii, 5 parts of Lentinus edodes, 10 parts of Auricularia auricula-judae, 30 parts of Sterculia lychnophora, 10 parts of Poria cocos, 15 parts of Myrica rubra, 20 parts of blueberry, and 20 parts of longan pulp.

[0039] The embodiments of the present invention also provide a preparation method of the medicine and food homology composition, comprising the following steps:

[0040] (1) Mix and pulverize chrysanthemum, honeysuckle, rose, cassia seed, lotus leaf and jack bean, and obtain extract I through ethanol extraction;

[0041] (2) Mix and pulverize pleurotus eryngii, lentinus edodes, auricularia auricula-judae, sterculia lychnophora and poria cocos to obtain powder; Mix and make a thick fruit pulp from waxberry, blueberry and longan pulp; Mix the powder and the thick fruit pulp, and obtain extract II through ethanol extraction;

[0042] (3) Combine extract I and extract II, evaporate and concentrate, and add adjuvants to prepare granules.

[0043] In some specific embodiments, the adjuvants include 10 parts of erythritol and 10 parts of maltodextrin.

[0044] The embodiments of the present invention also provide the application of the medicine and food homology composition in the preparation of a medicament for treating hyperlipidemia.

[0045] In some specific embodiments, the medicine and food homology composition plays a role in reducing blood lipid by activating FRX, PPARα and LPL and inhibiting the activity of CYP7A1.

[0046] In some specific embodiments, the method for preparing the granule dosage form includes:

[0047] (1) Dry or sun-dry chrysanthemum, honeysuckle, rose, cassia seed, lotus leaf and jack bean, and put them into a pulverizer to make powder;

[0048] (2) Add 30% - 50% ethanol to the obtained raw material powder according to a mass ratio of 1:40, mix and blend evenly; Put it in a water bath at 90 - 95°C for heating extraction for 120 - 180 min, repeat the extraction 2 - 3 times, and perform centrifugal separation after extraction to obtain supernatant and precipitate, and the supernatant is extract I;

[0049] (3) Dry or sun-dry pleurotus eryngii, lentinus edodes, auricularia auricula-judae, sterculia lychnophora and poria cocos; Wash, peel and pit waxberry, blueberry and longan;

[0050] (4) Put the dried or sun-dried pleurotus eryngii, lentinus edodes, auricularia auricula-judae, sterculia lychnophora and poria cocos into a pulverizer to make powder; Make a thick fruit pulp from waxberry, blueberry and longan pulp and pure water with a mass ratio of 1:1;

[0051] (5) Mix the raw material powder and the crude fruit pulp obtained in steps (3) and (4) in a mass ratio of 1:40, add 50% ethanol, and mix evenly; heat and extract in a water bath at 90 - 95 °C for 120 - 180 min, repeat the extraction 2 - 3 times, and after extraction, perform centrifugal separation to obtain the supernatant and the precipitate. The supernatant is the extract II;

[0052] (6) Combine extract I and extract II, place them on a rotary evaporator, evaporate and concentrate until 1 g of the concentrated solution is equivalent to 5 g of the raw materials, then add excipients, mix evenly, and obtain the corresponding solid powder through spray drying.

[0053] The preparation of the granule is a conventional preparation method and will not be elaborated here.

[0054] The present invention provides a medicine - food homologous composition for reducing blood lipid and its application. The composition is mixed by main components and auxiliary components. The main components include chrysanthemum, honeysuckle, rose, cassia seed, lotus leaf and sword bean, while the auxiliary components are Pleurotus eryngii, Lentinus edodes, Auricularia auricula, Sterculia lychnophora, Poria cocos, and fruits rich in proanthocyanidins, such as Chinese bayberry, blueberry and longan. These excipients can improve the taste and assist in reducing blood lipid. The specific preparation steps are as follows: extract and concentrate all raw materials with pure water and ethanol, add appropriate amounts of maltodextrin and erythritol, and perform wet granulation treatment to finally obtain the granule of the blood - lipid - reducing composition. The medicine - food homologous composition prepared by the present invention has high safety, reasonable formula design, stable process, can significantly reduce blood lipid, and has good social and economic benefits. Fruits rich in proanthocyanidins play an important role in regulating the taste and assisting in reducing blood lipid.

[0055] The medicine - food homologous composition with blood - lipid - reducing effect of the present invention comprises the following components in parts by weight: main medicine: 1 - 100 parts of chrysanthemum, 1 - 90 parts of honeysuckle, 1 - 90 parts of rose, 1 - 90 parts of cassia seed, 1 - 90 parts of lotus leaf and 1 - 90 parts of sword bean; auxiliary medicine: 1 - 40 parts of Pleurotus eryngii, 1 - 25 parts of Lentinus edodes, 1 - 20 parts of Auricularia auricula, 1 - 40 parts of Sterculia lychnophora, 1 - 20 parts of Poria cocos, 1 - 25 parts of Chinese bayberry, 1 - 30 parts of blueberry and 1 - 30 parts of longan pulp.

[0056] In order to better enable the composition to be used for the daily administration of patients, excipients are added to the medicine - food homologous composition with blood - lipid - reducing effect to change its dosage form. Preferably, the excipients include one or more of water, filler, binder, diluent, lubricant, glidant, flavoring agent, coating agent. Preferably, the dosage form of the medicine - food homologous composition with blood - lipid - reducing effect is granule.

[0057] The medicated and edible homologous plant composition for assisting in reducing blood lipid of the present invention selects chrysanthemum extract, honeysuckle extract, rose extract, cassia seed extract, lotus leaf extract and jack bean extract as the main drugs; supplemented with pleurotus eryngii extract, lentinus edodes extract, auricularia auricula extract, sterculia lychnophora extract, poria cocos extract, and fruits rich in procyanidins: myrica rubra extract, blueberry extract and longan extract to formulate the medicated and edible homologous plants. And this patent first discovers that the granule composed of jack bean and longan pulp has a good blood lipid-lowering effect. This granule achieves the purpose of assisting in reducing blood lipid, reducing the patient's dependence on lipid-lowering drugs, and improving the patient's quality of life.

[0058] The sources of raw materials in each embodiment of the present invention are as follows:

[0059] The manufacturers of raw materials such as chrysanthemum, honeysuckle whiskers, rose, cassia seed, lotus leaf, jack bean, pleurotus eryngii, and lentinus edodes are Hunan Yangyijun Biotechnology Co., Ltd.; raw materials such as auricularia auricula, sterculia lychnophora, poria cocos, blueberry, myrica rubra, and longan pulp are purchased from Shaanxi Tiandiyuan Biotechnology Co., Ltd.

[0060] Erythritol, maltodextrin (food grade): The manufacturer is Jiangsu Jinyuanyuan Bioengineering Co., Ltd.

[0061] Example 1

[0062] A medicated and edible homologous composition with blood lipid-lowering effect, comprising the following components in parts by weight:

[0063] 40 parts of chrysanthemum, 40 parts of honeysuckle, 35 parts of rose, 30 parts of cassia seed, 30 parts of lotus leaf, 30 parts of jack bean, 10 parts of pleurotus eryngii, 5 parts of lentinus edodes, 10 parts of auricularia auricula, 30 parts of sterculia lychnophora, 10 parts of poria cocos, 15 parts of myrica rubra, 20 parts of blueberry and 20 parts of longan pulp.

[0064] After mixing them evenly, a granule is made. 20 parts of auxiliary materials are added, and through mixing, granulation, drying and sizing, a granule dosage form for assisting in reducing blood lipid is made. In the auxiliary materials, there are 10 parts of erythritol and 10 parts of maltodextrin.

[0065] The method for preparing the granule dosage form includes:

[0066] (1) Dry or sun-dry chrysanthemum, honeysuckle, rose, cassia seed, lotus leaf and jack bean, and put them into a pulverizer to make powder;

[0067] (2) For the obtained raw material powder, add 50% ethanol according to the mass ratio of 1:40 and mix evenly; put it into a water bath at 90-95°C and heat for extraction for 120 minutes, repeat the extraction 3 times, and after extraction, centrifuge to separate to obtain supernatant and precipitate, and the supernatant is the extract I;

[0068] (3) Dry or sun-dry Pleurotus eryngii, Lentinus edodes, Auricularia auricula-judae, Sterculia lychnophora, and Poria cocos; wash, peel, and pit Chinese bayberries, blueberries, and longans.

[0069] (4) Put the dried or sun-dried Pleurotus eryngii, Lentinus edodes, Auricularia auricula-judae, Sterculia lychnophora, and Poria cocos into a pulverizer to make powder; add pure water with a mass ratio of 1:1 to the flesh of Chinese bayberries, blueberries, and longans to make pulp, obtaining crude pulp.

[0070] (5) Mix the raw material powder and crude pulp obtained in steps (3) and (4) and add 50% ethanol according to a mass ratio of 1:40 and mix evenly; heat and extract in a water bath at 90 - 95 °C for 180 min, repeat the extraction 3 times, and perform centrifugal separation after extraction to obtain supernatant and precipitate. The supernatant is the extraction solution II.

[0071] (6) Combine extraction solution I and extraction solution II, place them on a rotary evaporator, evaporate and concentrate until 1 g of concentrated solution is equivalent to 5 g of raw materials, then add auxiliary materials, mix evenly, and obtain the corresponding solid powder through spray drying.

[0072] The preparation of the granule is a conventional preparation method and will not be elaborated here.

[0073] 2 Effects of the medicine and food homologous composition on hyperlipidemic mice

[0074] Randomly divide 42 male ICR mice into 6 groups, including a normal control group, a model control group, a positive control group, a low-dose administration group, a medium-dose administration group, and a high-dose administration group.

[0075] Before the experiment, all mice were adaptively fed in the experimental environment for 7 days to ensure sufficient feed and water, and the temperature and humidity were kept stable. After one week, except for the blank group, the remaining 6 groups were changed to customized high-fat feed. The formula includes 58.8% of basic feed, 10% of lard, 20% of fructose, 10% of egg yolk powder, 1% of cholesterol, and 0.2% of sodium cholate.

[0076] Three weeks later, the mice were fasted for 12 hours, and then their body weights were measured and the levels of triglyceride (TG), total serum cholesterol (TC), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) were detected to comprehensively judge whether the hyperlipidemia model of the mice was successfully established.

[0077] According to the changes in body weight and blood lipid indicators, the 6 groups of mice were grouped again to reduce the experimental error caused by individual differences.

[0078] Once the hyperlipidemia model was successfully established, immediately stop feeding the high-fat feed and resume the normal feed.

[0079] According to the previous grouping arrangement, corresponding drugs were given for treatment. The positive control group was intragastrically administered the commercially available lipid-lowering drug fenofibrate at a dose of 100 mg / kg; the low-dose administration group was intragastrically administered the aqueous solution of the food-drug homologous composition at a dose of 50 mg / kg; the medium-dose group was given the same composition at a dose of 100 mg / kg; the high-dose group was administered at a dose of 150 mg / kg. The volume of each administration was uniformly 0.3 mL. In addition, the blank group and the model group were given the same volume of purified water as a control. Each mouse was orally administered the therapeutic drug once a day for 4 weeks.

[0080] Body weight changes after drug administration

[0081] Four weeks after drug administration, the body weights of the mice in each group were recorded and the average values were taken. The results are as Figure 1 shown. When the drug administration was stopped, there was a significant difference in body weight between the model group mice and the blank group mice (P < 0.01), indicating that the established hyperlipidemia model in mice was relatively stable. At the same time, although the body weights of the mice in the positive control group and the food-drug homologous composition administration group given different therapeutic drugs were still higher than those of the blank control group, they were significantly lower than those of the model group mice given purified water. In particular, the body weight of the mice in the high-dose food-drug homologous composition administration group decreased significantly (P < 0.01), proving that the food-drug homologous composition can effectively reduce the body weight of mice.

[0082] 3 Changes in common determination indexes of hyperlipidemia after drug administration

[0083] Common determination indexes of hyperlipidemia include triglyceride (TG), total serum cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL). An increase in TG may increase the risks of cardiovascular diseases and pancreatitis. An increase in TC indicates an increased risk of atherosclerosis and cardiovascular diseases. As the "bad cholesterol", an increase in the content of LDL will promote atherosclerosis and increase the risk of cardiovascular diseases. While HDL, as the "good cholesterol", helps to remove cholesterol from the blood vessels and reduce the risk of cardiovascular diseases.

[0084] After the drug administration ended, all mice were fasted for 12 h without water. After the fasting ended, the eyeballs of the mice were removed to collect blood. After storing in a 37°C water bath for 30 min, the blood was centrifuged at 3700 rpm for 10 min. The upper-layer serum was aspirated, and an ELISA kit was used to measure the lipid indexes in the mouse serum by the double-antibody sandwich method, including TG, TC, HDL, and LDL.

[0085] The results are as Figure 2As shown, compared with the blank control group, the levels of TG, TC, and LDL in the mice of the model group were significantly increased, while the level of HDL was significantly decreased (P<0.01), indicating that the establishment of the hyperlipidemia model was relatively successful. When compared with the model group, the levels of TG, TC, and LDL in the mice of the positive control group and the medicated diet homologous composition group were significantly decreased, and the level of HDL was significantly increased, and this effect was enhanced with the increase of the dose. Among them, the high-dose medicated diet homologous composition group had the most significant effect in reducing TG, TC, and LDL and increasing HDL (P<0.01), even better than the positive control drug fenofibrate. This proves that the medicated diet homologous composition can effectively improve the blood lipid indexes of hyperlipidemic mice.

[0086] 4 Histopathological evaluation of mice tissues in each group after administration

[0087] After the administration was completed, all mice were fasted for 12 hours without water deprivation. After the fasting was completed, they were immediately decapitated, and the whole liver was dissected out and the attached blood was thoroughly washed with physiological saline. Then, the liver was placed on filter paper to absorb the excess moisture, and then fixed in 4% formalin solution. After washing with PBS at pH 7.4, the samples were embedded in paraffin and cut into slices about 5μm thick, and then stained with hematoxylin-eosin (HE). When observing the processed slices, the histopathological structure was evaluated by an optical microscope, and the tissue morphology of each group of mice was as Figure 3 shown.

[0088] As Figure 3 shown, the cell morphology of the liver tissue of the mice in the blank group was normal, with clear edges and good tissue elasticity. In contrast, round vacuoles of different sizes appeared in the cytoplasm of the liver tissue cells of the mice in the model group, and at the same time, the nuclei of the hepatocytes were squeezed to the cell edges. When observing the mice in the positive control group and the medicated diet homologous composition group, the organ tissue morphology was restored to varying degrees, and the overall structure was close to normal. In particular, the tissue morphology of the high-dose medicated diet homologous composition group was close to that of the blank group, indicating that the medicated diet homologous composition has a significant therapeutic effect on liver damage caused by hyperlipidemia, and the curative effect is more obvious with the increase of the administration dose, which is consistent with the results of the enzyme-linked immunosorbent assay.

[0089] 5 Protein immunoblotting (Western Blot) experiment

[0090] After the administration was completed, all mice were fasted for 12 hours without water deprivation. After fasting, they were immediately decapitated, the liver was dissected out, cut into pieces and weighed 10mg, and put into a 1.5mL centrifuge tube containing 100μL of protein lysate. The tissue was homogenized on ice using an ultrasonic instrument until there was no solid tissue left. After 30 minutes of lysis treatment, it was centrifuged at 4℃ and 12,000 rpm for 10 minutes, and the supernatant was taken as the liver tissue protein extract.

[0091] Subsequently, a protein assay kit was used to detect the contents of FXR, CYP7A1, PPARα, and LPL proteins in the supernatant of mouse liver tissue. The protein-containing lysate was mixed with the loading buffer at a ratio of 4:1 and heated at 100°C for 10 minutes for denaturation, and then loaded onto a 10% SDS-PAGE gel and run at a voltage of 120 mV for 0.5 hours. After electrophoresis, the proteins in the gel were transferred to a PVDF membrane (250 mA, 40 minutes) for membrane transfer. After membrane transfer was completed, the samples were blocked with 5% non-fat milk powder at room temperature for 1 hour, then incubated with the antibody overnight at 4°C, and then incubated with the conjugated secondary antibody for 1 hour at room temperature. Finally, the membrane was washed three times with TBST buffer, and the immunoblotting results were visualized and analyzed using a chemiluminescence imaging system.

[0092] The gray scale analysis of the target bands was performed using Image J software, and the results are as Figure 4 shown. Compared with the model group, the medicated and food homologous composition granules significantly increased the expression levels of FXR, PPARα, and LPL proteins in the mouse liver tissue, while decreasing the expression level of CYP7A1 protein. These results suggest that the medicated and food homologous composition granules may reduce blood lipids through a series of mechanisms.

[0093] Specifically, the medicated and food homologous composition granules activated the activity of FXR protein, thereby promoting the activation of downstream signaling molecules such as SHP (small intestine growth inhibitory protein). The activation of SHP inhibited the expression of CYP7A1 protein, which is an important enzyme for the conversion of cholesterol to bile acids. By reducing the activity of CYP7A1, the medicated and food homologous composition granules can slow down the conversion of cholesterol to bile acids, achieving the retention and reduction of cholesterol. In addition, the activation of FXR also increased the expression of liver LDL receptors, which helps to improve cholesterol metabolism and clearance, thereby reducing serum cholesterol levels. On the other hand, the medicated and food homologous composition granules enhanced the activity of LPL (lipoprotein lipase) by activating the PPARα pathway. The increase in LPL promoted the hydrolysis of triglycerides (TG), thereby accelerating the metabolism and clearance of blood lipids. Therefore, the medicated and food homologous composition granules effectively reduce the blood lipid level in mice by activating two important metabolic pathways, FXR and PPARα, and comprehensively acting on cholesterol conversion, LDL receptor expression, and TG hydrolysis. These results provide an important basis for the potential mechanism of the medicated and food homologous composition granules in the treatment of hyperlipidemia.

[0094] The inventors also prepared granules according to other raw material ratios of the medicated and food homologous composition provided by the present invention and conducted the same animal experiments as above, and achieved technical effects equivalent to those of Example 1.

[0095] Obviously, the above embodiments of the present invention are merely examples given to clearly illustrate the present invention, rather than limitations on the implementation manners of the present invention. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to enumerate all implementation manners here. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the claims of the present invention.

Claims

1. A medicine-food homologous composition with lipid-lowering effect, characterized in that, It comprises the following components in parts by weight: 30 - 50 parts of chrysanthemum, 30 - 50 parts of honeysuckle, 30 - 40 parts of rose, 20 - 40 parts of cassia seed, 20 - 40 parts of lotus leaf, and 20 - 40 parts of jack bean.

2. The medicine-food homology composition according to claim 1, wherein It further comprises the following components in parts by weight: 5 - 15 parts of pleurotus eryngii, 1 - 10 parts of lentinus edodes, 5 - 15 parts of auricularia auricula, 20 - 40 parts of sterculia lychnophora, 1 - 20 parts of poria cocos, 10 - 20 parts of Chinese bayberry, 10 - 30 parts of blueberry, and 10 - 30 parts of longan aril.

3. The homologous medicine and food composition according to claim 1, characterized in that, It comprises the following components in parts by weight: 40 parts of chrysanthemum, 40 parts of honeysuckle, 35 parts of rose, 30 parts of cassia seed, 30 parts of lotus leaf, 30 parts of jack bean, 10 parts of pleurotus eryngii, 5 parts of lentinus edodes, 10 parts of auricularia auricula, 30 parts of sterculia lychnophora, 10 parts of poria cocos, 15 parts of Chinese bayberry, 20 parts of blueberry, and 20 parts of longan aril.

4. The preparation method of the medicine and food homologous composition according to any one of claims 1-3, characterized in that, It comprises the following steps: (1) Mix, pulverize chrysanthemum, honeysuckle, rose, cassia seed, lotus leaf and jack bean, and obtain extract I through ethanol extraction; (2) Mix and pulverize pleurotus eryngii, lentinus edodes, auricularia auricula, sterculia lychnophora and poria cocos to obtain powder; Mix Chinese bayberry, blueberry and longan aril to make thick fruit pulp; Mix the powder and the thick fruit pulp, and obtain extract II through ethanol extraction; (3) Combine extract I and extract II, evaporate and concentrate, and add auxiliary materials to prepare into granules.

5. The preparation method according to claim 4, characterized in that, The auxiliary materials comprise 10 parts of erythritol and 10 parts of maltodextrin.

6. Use of the medicine - food homologous composition according to any one of claims 1 - 3 in the preparation of a drug for treating hyperlipidemia.

7. The application according to claim 6, wherein The medicine - food homologous composition plays a role in reducing blood lipid by activating FRX, PPARα and LPL and inhibiting the activity of CYP7A1.

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