Preparation method and application of blood fat reducing composition and plant extract thereof

Abstract

The invention discloses a blood fat reducing composition and a preparation method of a plant extract of the blood fat reducing composition, and belongs to the technical field of traditional Chinese medicine formulas and preparation, and the blood fat reducing composition is composed of plant extracts of effective substances extracted based on a steam wall breaking technology. The blood fat reducing composition is prepared from the following raw materials in parts by mass: 3-27 parts of corn stigma, 3-27 parts of pericarpium citri reticulatae and 3-27 parts of white kidney beans. The plant extract is obtained by adopting a steam wall breaking technology; the preparation method of the plant extract comprises the following steps: pretreating the raw materials, extracting effective components, compounding according to different proportions, evaluating the in-vitro inhibition ability of lipase on the extracts compounded according to different proportions, determining the formula compatibility of the raw materials in the blood fat reducing composition according to quantitative pharmacology, and further determining the formula compatibility of the blood fat reducing composition. According to the invention, the extraction rate of each effective component is obviously improved, so that the blood fat reducing effect of the product is enhanced; quantitative pharmacological data are adopted to clarify the compatibility of all the components, and the prepared blood fat reducing plant extract is safe and free of side effects.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine formulation and preparation, and specifically relates to a preparation method and application of a blood lipid lowering composition and a plant extract thereof. Background Art

[0003] In terms of the prevention and treatment of hyperlipidemia, the ATP-III guidelines developed by the National Cholesterol Education Program (NCEP) point out that statins are the first choice for lowering low-density lipoprotein cholesterol levels, and the only alternative drugs are fibrates, niacin, and dietary supplements. Statins are chemical drugs that often cause a certain degree of adverse reactions in the body when they play a lipid-lowering role. For example, they are hepatotoxic and can cause liver damage; they are muscle toxic and can cause myalgia and rhabdomyolysis; they are also neurotoxic and may cause cognitive impairment, decreased vision, and other problems.

[0004] Compared with this defect of Western medicine, the development of traditional Chinese medicine is relatively long. The mechanism of action of traditional Chinese medicine is characterized by multiple pathways and multiple targets, with small toxic and side effects, and no drug dependence. Therefore, the application of natural lipid-lowering Chinese medicine in the prevention and treatment of hyperlipidemia has become an urgent need for current research and development. In particular, it is becoming a trend to integrate food with medicinal properties into daily diet conditioning. Natural Chinese medicine with medicinal and edible properties has both medicinal and edible value. As a functional health food, it is rich in a variety of active ingredients and has many effects such as lowering blood lipids, anti-oxidation, improving immunity, and lowering blood sugar. Compared with Western medicine, it has significant advantages. Not only is the efficacy definite, but it can also work through multiple targets and multiple pathways, and it is safe and has no side effects. At present, the lipid-lowering active ingredients of nearly 100 medicinal and edible plants have been successfully extracted, providing more possibilities for the prevention and treatment of hyperlipidemia.

[0005] The prescription ratio of traditional Chinese medicine has a long history and a profound theoretical foundation. The monarch, minister, assistant and messenger are one of the basic principles of traditional Chinese medicine prescription ratio. Xiao Chaihu Decoction, which originated from Treatise on Febrile and Miscellaneous Diseases, is composed of half a catty of bupleurum, three liang of scutellaria, three liang of ginseng, three liang of licorice, half a liter of pinellia, three liang of ginger, and twelve jujubes. This prescription uses bupleurum as the monarch and scutellaria as the minister. Both are Shaoyang meridian medicines, one surface and one interior in this meridian, and they complement each other. Pinellia and ginger harmonize the stomach, reduce adverse reactions and stop vomiting, while ginseng and jujube invigorate qi, strengthen the spleen, strengthen the body and eliminate evil, and are collectively adjuvants. Licorice assists in strengthening the body and coordinating the various medicines, and is the messenger. Through the reasonable compatibility of monarch, minister, assistant and messenger, the effect of the prescription can be made clearer and the efficacy more significant. With the in-depth advancement of the research on the prescription ratio of traditional Chinese medicine, a series of mature calculation methods have emerged. In particular, in the field of quantitative pharmacology, it provides an accurate calculation method for the addition of drug effects for the combination of multiple drugs. This method comprehensively evaluates the synergistic, additive and antagonistic effects of Chinese medicine combinations from the two dimensions of mathematical logic and pharmacological principles, providing more evidence for the scientificity and effectiveness of Chinese medicine prescriptions.

[0006] Most of the existing lipid-lowering compositions of traditional Chinese medicine or food are still limited to the application of original prescriptions, lacking methods for accurately extracting effective substances and not being precise enough in terms of compatibility. Therefore, based on the in vitro lipase activity inhibition data of the dose-effect relationship of different raw material extracts, the optimal formula ratio for lipid-lowering efficacy can be screened out through quantitative pharmacology algorithm analysis, thereby optimizing the effect of the existing lipid-lowering compositions. Summary of the invention

[0007] Based on the technical problems existing in the prior art, the present invention proposes a method for preparing a lipid-lowering composition and a plant extract thereof. The present invention extracts the effective ingredients in the lipid-lowering composition based on steam wall breaking technology. The present invention makes the lipid-lowering composition a safe, effective and effective plant extract formula in the composition. The preparation process of the present invention is simple, easy to operate, suitable for industrial production, and the obtained lipid-lowering product is safe and has no side effects, and is suitable for long-term use by people with high blood lipids.

[0008] According to the first aspect of the technical solution of the present invention, a lipid-lowering composition is provided, which is composed of a plant extract, and the lipid-lowering composition is composed of the following raw materials in parts by mass: 3-27 parts of corn silk, 3-27 parts of tangerine peel and 3-27 parts of white kidney bean; the plant extract is obtained by steam wall breaking technology, and the preparation method of the plant extract based on steam wall breaking technology comprises the following steps: Step S1: pre-treating the raw materials, selecting fresh tangerine peel, corn silk and white kidney beans and washing them; Step S2: extracting effective ingredients, using steam wall breaking technology to prepare corn silk extract, tangerine peel volatile oil, tangerine peel extract and white kidney bean extract; Step S3: Compounding in different proportions: corn silk extract, tangerine peel volatile oil, tangerine peel extract and white kidney bean extract in different proportions; Step S4: evaluating the in vitro lipase inhibition ability of the extracts prepared in different proportions in step S3; Step S5: Determine the composition and compatibility of each plant extract based on quantitative pharmacology, and then determine the composition and compatibility of the lipid-lowering composition.

[0009] The blood lipid lowering composition is composed of the following raw materials in parts by mass: 9-18 parts of corn silk, 6-12 parts of tangerine peel and 3-6 parts of white kidney beans.

[0010] Furthermore, the blood lipid lowering composition is composed of the following raw materials in parts by mass: 6-18 parts of corn silk, 9-27 parts of tangerine peel and 3-9 parts of white kidney beans.

[0011] Preferably, the lipid-lowering composition further comprises konjac, and the lipid-lowering composition is composed of the following raw materials in parts by mass: 9-13 parts of corn silk, 14-20 parts of tangerine peel, 5-6 parts of white kidney beans and 1-2 parts of konjac.

[0012] More preferably, the lipid-lowering composition further includes tangerine peel volatile oil, and the lipid-lowering composition is composed of the following raw materials in parts by mass: 10 parts of corn silk, 15 parts of tangerine peel, 5 parts of white kidney beans, 1 part of konjac and 0.2-0.8 parts of tangerine peel volatile oil.

[0013] According to a second aspect of the technical solution of the present invention, a method for preparing a plant extract based on steam wall breaking technology is provided, which is used to prepare the plant extract in the above-mentioned lipid-lowering composition, and the plant extract preparation method comprises the following steps: Step S1: pretreatment of raw materials, the raw materials comprising corn silk, tangerine peel, white kidney bean and konjac by weight; washing and drying the tangerine peel, corn silk, white kidney bean and konjac; Step S2: extracting effective ingredients, extracting and preparing corn silk extract, tangerine peel volatile oil and tangerine peel extract, white kidney bean extract and konjac extract, wherein the extraction and preparation process of corn silk extract includes step S21, and the extraction and preparation process of tangerine peel extract includes step S22; Step S21, washing and cutting corn silk into sections, placing the dried corn silk in a steam explosion chamber for steam explosion and crushing to obtain coarse powder of the steam-exploded corn silk dry product, putting the coarse powder of the steam-exploded corn silk dry product into an extraction tank, adding water and refluxing for extraction, filtering to obtain corn silk filtrate after the extraction, and concentrating the corn silk filtrate under reduced pressure to obtain corn silk concentrate; spray drying the corn silk concentrate to obtain a powdery corn silk water extract; Step S22, drying the tangerine peel washed in step S1, crushing the dried tangerine peel with a crusher, and dividing the crushed tangerine peel coarse powder into two parts: one part of the tangerine peel coarse powder is used to obtain tangerine peel volatile oil by steam distillation; the other part of the tangerine peel coarse powder is put into an extraction tank and water is added to reflux extraction to perform a water extraction process, after the tangerine peel coarse powder water extraction is completed, the tangerine peel filtrate is filtered to obtain the tangerine peel filtrate, the tangerine peel filtrate is reduced pressure concentrated to obtain the tangerine peel concentrated solution, and the tangerine peel concentrated solution is spray dried to obtain a powdery tangerine peel water extract; Step S3: compounding according to different proportions, corn silk extract, tangerine peel extract and white kidney bean extract are compounded according to 7 proportions; the first compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 1:1:1, the second compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 1:2:3, the third compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 1:3:2, the fourth compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 2:1:3, the fifth compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 2:3:1; the sixth compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 3:1:2, and the seventh compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 3:2:1; Step S4: evaluating the in vitro lipase inhibition ability of the extracts prepared in different proportions in step S3; Step S5: Quantitative pharmacology is used to determine the composition and compatibility of the lipid-lowering composition.

[0014] Preferably, the extraction and preparation process of the white kidney bean extract comprises step S23: washing the white kidney beans with water; putting the dried white kidney beans into a grinder to grind them to obtain white kidney bean coarse powder, putting the white kidney bean coarse powder into a microwave extraction device for extraction, filtering to obtain a white kidney bean filtrate after the extraction, subjecting the obtained white kidney bean filtrate to low-temperature extraction, concentrating the extracted white kidney bean filtrate under reduced pressure, and finally spray-drying the white kidney bean concentrate to obtain a powdery white kidney bean water extract.

[0015] More preferably, the extraction and preparation process of the konjac extract comprises step S24: washing the konjac with water, crushing the dried konjac in a grinder to obtain konjac coarse powder, putting the konjac coarse powder into an extraction tank, adding water and refluxing for extraction, filtering to obtain konjac filtrate after the extraction, concentrating the konjac filtrate under reduced pressure, and finally spray drying the konjac concentrate to obtain a powdery konjac water extract.

[0016] According to the third aspect of the technical solution of the present invention, there is provided a lipid-lowering plant extract, which is made of the above-mentioned lipid-lowering composition and a food-acceptable carrier, or is made of the lipid-lowering plant extract combination prepared by the above-mentioned plant extract preparation method based on steam wall breaking technology and a food-acceptable carrier, and the dosage form is any dosage form that is food-acceptable.

[0017] Preferably, the above-mentioned lipid-lowering plant extract dosage form is an oral preparation selected from tablets, capsules, granules, pills, powders, pills, syrups, oral solutions or oral suspensions.

[0018] More preferably, the above-mentioned lipid-lowering plant extract further includes adding excipients such as silicon dioxide and magnesium stearate to be compressed into tablet candy, or adding sweeteners and sour agents to be prepared into a solid beverage or a paste.

[0019] According to the fourth aspect of the technical solution of the present invention, the above-mentioned lipid-lowering composition and the lipid-lowering plant extract combination prepared by the above-mentioned plant extract preparation method based on steam wall breaking technology are used in animals and patients with hyperlipidemia.

[0020] Compared with the prior art, the lipid-lowering composition and the preparation method of the plant extract of the present invention have the following beneficial technical effects: 1. The lipid-lowering composition of the present invention and its preparation process can significantly inhibit the activity of lipase and effectively promote the excretion of blood lipids through the compounding of tangerine peel, tangerine peel volatile oil, corn silk, white kidney bean and konjac extract. In addition, it also has the function of alleviating complications caused by hyperlipidemia and regulating the body's blood lipid metabolism level and its adverse effects from many aspects.

[0021] 2. The lipid-lowering composition and its preparation process of the present invention use steam wall-breaking technology to process corn silk, which significantly improves the extraction rate of effective ingredients of corn silk and enhances the lipid-lowering effect of the product. Based on quantitative pharmacological data, the present invention clarifies the formula and compatibility of corn silk, tangerine peel, white kidney bean, konjac water extract, and tangerine peel volatile oil, providing a new choice for the prevention and treatment of hyperlipidemia.

[0022] 3. The preparation process of the lipid-lowering composition of the present invention is simple and easy to operate, suitable for industrial production. The obtained lipid-lowering food is safe and has no side effects, and is suitable for long-term use by people with hyperlipidemia. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a process flow chart of the method for preparing plant extracts based on steam wall breaking technology according to the present invention.

[0024] Figure 2It is a simulated model diagram of the lipid-lowering plant extract formula ratio according to the present invention; the red curve in the figure is the dose-effect curve of the expected additive effect, and the black curve is the actual dose-effect curve of the lipid-lowering plant extract formula; the part of the actual dose-effect curve above the red curve is "synergistic", the part overlapping with the red curve is "additive", and the part below the red curve is "antagonistic".

[0025] Figure 3 The invention comprises Figures A to F, wherein Figure A is the result of Lee's index of rats in each group at different intervention times according to the lipid-lowering plant extract formula 1 of the present invention; Figure B presents the percentage of body fat rate of rats in each group reduced by the formula; Figure C is the result of serum total cholesterol (TC) of rats in each group after the formula intervention; Figure D is the result of serum triglyceride (TG) of rats in each group after the formula intervention; Figure E shows the result of serum low-density lipoprotein (LDL) intervention of rats in each group; and Figure F is the result of serum free fatty acids of rats in each group after the formula intervention. DETAILED DESCRIPTION

[0026] In order to make the technical problems solved by the present invention, the technical solutions adopted and the beneficial effects obtained clearer, the present invention is further described in detail below in conjunction with specific embodiments. The specific embodiments described herein are only used to explain the present invention and are not intended to constitute any limitation of the present invention. Unless otherwise defined, all terms used in the present invention have the same meaning as commonly used in the field to which the present invention belongs.

[0027] The following specific examples are provided to help understand the present invention, but it should be understood that the embodiments and test examples listed in the present invention are only used to illustrate the present invention, but do not constitute any limitation. The actual protection scope of the present invention is set forth in the claims.

[0028] The present invention provides a blood lipid lowering composition and a method for preparing a plant extract thereof. Although some embodiments of the present invention only provide a water extraction process, the present invention can also use an alcohol extraction process to extract plant extracts of various raw materials, and the alcohol extraction process is also within the protection scope of the present invention. In the present invention, (1) extracts obtained by water extraction and alcohol extraction processes can be used for medicines, but only water extraction processes can be used for food; the water extraction process of the present invention makes the food free of any toxic and side effects; (2) the present invention uses tangerine peel, corn silk, and white kidney bean as the main raw materials, and adds konjac, so that the uric acid lowering composition has a more stable effect; (3) the present invention uses gas explosion method (steam wall breaking technology) to extract the effective components of each raw material, so that the effective substances of each raw material are better released; (4) through quantitative pharmacological calculation, the compatibility of the various raw materials of the blood lipid lowering composition is more appropriate, so that the various components in tangerine peel, corn silk, white kidney bean and konjac can play a better role.

[0029] The blood lipid lowering composition of the present invention is a blood lipid lowering composition composed of plant extracts, and the plant extracts include the following Chinese medicine raw material drug components by mass: 3-27 parts of corn silk, 3-27 parts of tangerine peel and 3-27 parts of white kidney bean; the present invention uses steam wall breaking technology to process corn silk, significantly improves the extraction rate of effective components of corn silk, and enhances the blood lipid lowering effect of the product; the present invention uses a quantitative pharmacological method to clarify the formula and compatibility of water extracts such as corn silk, tangerine peel, and white kidney bean. At the same time, the preparation method of the present invention is simple in process and easy to operate, suitable for industrial production, and the obtained blood lipid lowering food is safe and has no side effects, and is suitable for long-term consumption by people with high blood lipids. The present invention creatively combines the Chinese medicinal materials of tangerine peel, corn silk, white kidney bean, konjac and tangerine peel volatile oil into a prescription, and provides a Chinese medicine and food dual-purpose Chinese medicine composition with good therapeutic effect, no toxic side effects, and capable of reducing blood lipid levels and improving the quality of life of patients with high blood lipids.

[0030] In one embodiment, the lipid-lowering composition based on steam wall breaking technology provided by the present invention is composed of the following raw materials in parts by mass: 9-18 parts of corn silk, 6-12 parts of tangerine peel and 3-6 parts of white kidney beans; in another embodiment, 6-18 parts of corn silk, 9-27 parts of tangerine peel and 3-9 parts of white kidney beans; in yet another embodiment, 9-13 parts of corn silk, 14-20 parts of tangerine peel, 5-6 parts of white kidney beans and 1-2 parts of konjac; in a preferred embodiment, 10 parts of corn silk, 15 parts of tangerine peel, 5 parts of white kidney beans, 1 part of konjac and 0.2-0.8 parts of tangerine peel volatile oil are used.

[0031] The lipid-lowering composition of the present invention extracts effective substances based on steam wall breaking technology and seeks a more optimized formula based on the theory of homology of medicine and food: corn silk contains a variety of lipid-lowering ingredients such as flavonoids, saponins, polysaccharides, sterols, etc. Flavonoid compounds have antioxidant effects, can reduce lipid oxidation, and reduce the generation of oxidized low-density lipoprotein (OX-LDL). Saponins increase urine volume and promote blood lipids to be excreted from the body with urine. Polysaccharides participate in the metabolic regulation of the body to improve the overall metabolic level. Steroid compounds can compete with cholesterol for absorption sites in the intestine to reduce cholesterol absorption. Corn silk has effective ingredients that are difficult to fully release by traditional extraction methods. Steam wall breaking technology is a unique physical treatment method. After multiple verifications by the inventors, it is found that steam wall breaking technology can effectively change the tissue structure of plant materials and improve the extraction rate of plant active ingredients.

[0032] In addition, in terms of controlling food intake and regulating intestinal metabolism, white kidney bean and konjac are an effective combination of medicine and food. White kidney bean can reduce the absorption of purine in food and control blood lipid production from the source; konjac is rich in dietary fiber, can increase satiety and regulate intestinal function. Hyperlipidemia is often related to pathological factors such as phlegm and dampness in the body, and the tangerine peel of the present invention has the function of restoring the normal transportation and transformation of the spleen and stomach, promoting the metabolism of water and dampness, reducing the generation of phlegm and dampness, thereby having a positive effect on the metabolism of blood lipids. In addition, tangerine peel also contains a large amount of volatile oil with anti-inflammatory properties. Hyperlipidemia is often accompanied by inflammatory reactions, especially when gout attacks, inflammation is more obvious, so the volatile oil in tangerine peel can be used to reduce the damage of inflammation to tissues such as joints and kidneys. The lipid-lowering composition proposed by the present invention well realizes the synergistic effect of tangerine peel, corn silk, white kidney bean, konjac and tangerine peel volatile oil, greatly improving the effect of reducing blood lipids. Example 1

[0033] The following is a description of the method for preparing plant extracts based on steam wall breaking technology of the present invention in conjunction with Example 1. In this embodiment of the present invention, the raw materials of the blood lipid lowering composition based on steam wall breaking technology include tangerine peel, corn silk, white kidney bean, konjac and tangerine peel volatile oil.

[0034] like Figure 1 As shown, the method for preparing the lipid-lowering plant extract based on steam wall breaking technology comprises the following steps: Step S1: pretreatment of raw materials, selecting fresh tangerine peel, corn silk, white kidney bean and konjac, washing and treating them; selecting 3-27 parts of fresh, non-moldy corn silk, 3-27 parts of tangerine peel, 3-27 parts of white kidney bean and 1-2 parts of konjac by weight, washing and drying them; in another embodiment, the raw materials include 9-13 parts of corn silk, 14-20 parts of tangerine peel, 5-6 parts of white kidney bean and 1-2 parts of konjac by weight.

[0035] Step S2: extracting effective ingredients, extracting and preparing corn silk extract, tangerine peel volatile oil, tangerine peel extract, white kidney bean extract and konjac extract; wherein the extraction and preparation process of corn silk extract includes step S21, the extraction and preparation process of tangerine peel extract includes step S22, the extraction and preparation process of white kidney bean extract includes step S23, and the extraction and preparation process of konjac extract includes step S24.

[0036] Step S21: The extraction process of corn silk extract, the corn silk is washed and cut into sections, the dried corn silk is placed in a steam explosion chamber for steam explosion and crushing to obtain corn silk steam explosion dry product coarse powder, the corn silk steam explosion dry product coarse powder is put into an extraction tank, water is added and refluxed for extraction, after the extraction is completed, the corn silk filtrate is filtered to obtain the corn silk filtrate, the corn silk filtrate is decompressed and concentrated to obtain the corn silk concentrate; the corn silk concentrate is spray dried to obtain a powdered corn silk water extract. The extraction process of corn silk extract in step S21 further includes the following steps S21-1 to S21-3.

[0037] Step S21-1, drying and crushing corn silk. Select 3 to 27 parts of fresh, non-moldy corn silk, wash, dry, and cut into sections, each section is no longer than 2 mm, and place the dried corn silk in a steam explosion chamber for steam explosion and crushing. In a preferred embodiment, the amount of corn silk filled is 1 / 3 to 2 / 3 of the steam explosion chamber. Steam is introduced into the steam explosion chamber to make the pressure of the steam explosion chamber reach 1.5MPa to 2.5MPa, and the steam explosion pressure time is maintained for any time between 60 and 120 seconds; in a preferred embodiment, the pressure reaches 2.0MPa, and the steam explosion pressure time is maintained for 90 seconds, and then the high temperature and high pressure valve is quickly opened, and the steam explosion chamber instantly releases the pressure to complete the corn silk wall breaking. After steam explosion, corn silk steam explosion material is obtained, and dried at 90°C to obtain corn silk steam explosion dry product.

[0038] Step S21-2, screening the crushed corn silk. The crushed corn silk steam-exploded dry product is passed through a 50-100 mesh sieve; preferably, in this embodiment, the corn silk extract is passed through an 80 mesh sieve to obtain a coarse powder of the corn silk steam-exploded dry product.

[0039] Step S21-3, water extraction of corn silk and filtering and concentrating corn silk. Take the sieved corn silk steam-exploded dry powder and put it into the extraction tank at a material-liquid ratio of 1:15 to 1:25 (g / ml). The liquid is preferably distilled water or purified water, that is, 15 to 25 ml of liquid is put into 1 gram of corn silk steam-exploded dry powder; the effective component substances to be extracted are separated from the soaked corn silk steam-exploded dry powder by a reflux extraction device. The reflux extraction device preferably adopts a high-temperature condensation reflux device, and the reflux extraction is 30 minutes to 180 minutes, preferably 1 hour, to obtain a first corn silk extract. Further, the soaked corn silk steam-exploded dry powder is filtered by a Chinese medicine liquid filter, and the Chinese medicine liquid filter with any aperture or sieve hole of 50 mesh to 100 mesh is used for the residue filtration; preferably, a Chinese medicine liquid filter with an aperture or sieve hole of 70 mesh, 80 mesh or 90 mesh is used for the residue filtration to obtain the first corn silk extract (i.e., filtrate) and corn silk residue.

[0040] The obtained corn silk residue is soaked in 5 to 30 times the amount of water, preferably distilled water or purified water. In another embodiment, the corn silk residue is soaked in 15 to 25 times the amount of water; in another preferred embodiment, the corn silk residue is soaked in 20 times the amount of water, and the effective component substances to be extracted are separated from the soaked corn silk steam-exploded dry product coarse powder by a reflux extraction device. The reflux extraction device preferably uses a high-temperature condensation reflux device, and the reflux extraction is carried out for 30 minutes to 180 minutes, preferably 1 hour. A second corn silk extract is obtained. The two corn silk extracts are filtered and combined into an extract storage tank for standby use.

[0041] The filtered corn silk extract filtrate is pumped into a single-effect concentrator for concentration, the vacuum is controlled at 0.06-0.08 MPa, the concentration temperature is 50 degrees Celsius-60 degrees Celsius, the filtrate is concentrated to a relative density and until it meets the requirements for powder spraying; the corn silk extract after reduced pressure concentration is spray dried. The air inlet temperature during spray drying is set to 150 degrees Celsius-165 degrees Celsius, and the air outlet temperature is set to 65 degrees Celsius-85 degrees Celsius; the temperature of the spray drying chamber is set to 75 degrees Celsius-90 degrees Celsius, and the negative pressure is set to 10-18Pa. The spray-dried corn silk extract is crushed and refined through an 80-mesh sieve to remove block connections to obtain corn silk extract powder.

[0042] Step S22: Extraction process of tangerine peel extract, dry the tangerine peel washed in step S1, use a pulverizer to crush the dried tangerine peel, the particle size of the tangerine peel after crushing is no more than 100 mesh, and divide the crushed tangerine peel coarse powder into two parts: one part of the tangerine peel coarse powder is used to obtain tangerine peel volatile oil by steam distillation; the other part of the tangerine peel coarse powder is put into an extraction tank and water is added to reflux extraction for water extraction process, after the water extraction is completed, filter to obtain tangerine peel filtrate, decompress and concentrate the tangerine peel filtrate to obtain tangerine peel concentrate, spray dry the tangerine peel concentrate, and obtain powdery tangerine peel water extract. The water extraction process in step S22 (water extraction process of tangerine peel extract) is further refined into step S22-1, or the alcohol extraction process step S22-1-1 is used to replace the tangerine peel water extraction process.

[0043] Step S22-1, water extraction of tangerine peel effective substances. Take a portion of the crushed tangerine peel coarse powder and pass it through a 50-100 mesh sieve. Preferably, in this embodiment, the tangerine peel coarse powder passes through an 80 mesh sieve. The tangerine peel is placed in an extraction tank at a material-liquid ratio of 1:8-1:12 (g / ml) and water is added for reflux extraction, preferably distilled water or purified water, and the effective component substances to be extracted are separated from the soaked tangerine peel coarse powder by a reflux extraction device. The reflux extraction device preferably uses a high-temperature condensation reflux device, and the reflux extraction is 30 minutes to 180 minutes, preferably 2 hours. The first tangerine peel extract is obtained. Further, the tangerine peel coarse powder is filtered with a Chinese medicine liquid filter residue, and a Chinese medicine liquid filter with any aperture or sieve hole of 50 mesh to 100 mesh is used for residue filtration; preferably, a Chinese medicine liquid filter with an aperture or sieve hole of 70 mesh, 80 mesh or 90 mesh is used for residue filtration to obtain the first tangerine peel extract (i.e., filtrate) and tangerine peel residue.

[0044] Take the sieved tangerine peel residue and put it into the extraction tank according to the material-liquid ratio of 1:15 to 1:25 (g / ml), and soak the obtained tangerine peel residue with 5 to 30 times the amount of water, preferably distilled water or purified water. In another embodiment, the tangerine peel residue is soaked with 15 to 25 times the amount of water; in a preferred embodiment, the tangerine peel residue is soaked with 20 times the amount of water, and the effective component substances to be extracted are separated from the soaked tangerine peel coarse powder by a reflux extraction device. The reflux extraction device preferably uses a high-temperature condensation reflux device, and the reflux extraction is 30 minutes to 180 minutes, preferably 2 hours. Obtain a second tangerine peel extract. After filtering the two tangerine peel extracts (the first tangerine peel extract and the second tangerine peel extract), merge them into the extract storage tank for standby use.

[0045] After the extraction is completed, the tangerine peel extract is filtered, and the filtered tangerine peel extract filtrate is pumped into a single-effect concentrator for concentration, the vacuum is controlled at 0.06-0.08 MPa, the concentration temperature is 50 degrees Celsius-60 degrees Celsius, and the filtrate is concentrated to a relative density until it meets the powder spraying requirements; the tangerine peel extract after reduced pressure concentration is spray-dried, the air inlet temperature is set to 150 degrees Celsius-165 degrees Celsius, the air outlet temperature is set to 65 degrees Celsius-85 degrees Celsius, the temperature is set to 75 degrees Celsius-90 degrees Celsius, the negative pressure is set to 10-18 Pa, the tangerine peel extract after spray drying is crushed and refined through an 80-mesh sieve, the block connections are removed, and the tangerine peel extract powder is obtained.

[0046] Alternatively, the process step S22-1-1 of extracting the effective substances from tangerine peel with alcohol may be used instead of the process step S22-1 of extracting the effective substances from tangerine peel with water.

[0047] S22-1-1: The process of extracting the effective substance of tangerine peel with alcohol, drying the tangerine peel washed in step S1, and crushing the dried tangerine peel with a pulverizer to obtain tangerine peel coarse powder. The tangerine peel is put into an extraction tank and ultrasonic-assisted extraction is added with ethanol. After the extraction is completed, the tangerine peel filtrate is filtered to obtain the tangerine peel filtrate, the tangerine peel filtrate is concentrated under reduced pressure, and finally the tangerine peel concentrate is spray-dried to obtain a powdery tangerine peel alcohol extract. The process of extracting the effective substance of tangerine peel with alcohol comprises the following steps: S22-1-1-1, take the crushed tangerine peel coarse powder and pass it through a 50-100 mesh sieve. Preferably, in this embodiment, the tangerine peel coarse powder passes through an 80 mesh sieve, and the tangerine peel is placed in an extraction tank with a solid-liquid ratio of 1:5-1:25 (g / ml) and ethanol ultrasonic-assisted extraction is added, and the effective component substances to be extracted are separated from the soaked tangerine peel coarse powder by an ultrasonic extraction device. Ultrasonic extraction for 30 minutes to 90 minutes, preferably 60 minutes. The ultrasonic extraction temperature is 35 degrees Celsius to 60 degrees Celsius, preferably 50 degrees Celsius. The ethanol concentration in this embodiment is preferably any concentration between 50% and 75%. In a preferred embodiment, an ethanol concentration of 65% is used. The cavitation effect, thermal effect and mechanical effect of ultrasonic extraction are used to obtain a first tangerine peel extract. Further, the tangerine peel coarse powder is filtered using a Chinese medicine liquid filter residue to obtain a first tangerine peel extract (i.e., filtrate) and tangerine peel residue.

[0048] S22-1-1-2, take the sieved tangerine peel residue and put it into the extraction tank according to the material-liquid ratio of 1:10 to 1:15 (g / ml), and soak the obtained tangerine peel residue in 10 to 15 times the amount of ethanol. In another embodiment, the tangerine peel residue is soaked in 5-25 times the amount of ethanol. In a preferred embodiment, the tangerine peel residue is soaked in 10 times the amount of ethanol, and the effective component substances to be extracted are separated from the soaked tangerine peel coarse powder by ultrasonic extraction for 30 minutes to 90 minutes, preferably 60 minutes. Obtain a second tangerine peel extract. Filter the two tangerine peel extracts and combine them into the extract storage tank for standby use.

[0049] S22-1-1-3, after the extraction is completed, filter, and place the filtered tangerine peel extract filtrate in a rotary evaporator for concentration, control the vacuum at 0.06-0.08 MPa, and the concentration temperature at 50 degrees Celsius-60 degrees Celsius, and concentrate the filtrate to a relative density until it meets the powder spraying requirements; the tangerine peel extract after reduced pressure concentration is spray-dried, the inlet air temperature is set to 150 degrees Celsius-165 degrees Celsius, the outlet air temperature is set to 65 degrees Celsius-85 degrees Celsius, the temperature is set to 75 degrees Celsius-90 degrees Celsius, and the negative pressure is set to 10-18Pa. The tangerine peel extract after spray drying is crushed and sieved through an 80-mesh sieve to remove block connections to obtain tangerine peel alcohol extract powder.

[0050] The tangerine peel volatile oil extraction step S22-2 in step S22 is further detailed as follows: take another part of the crushed tangerine peel coarse powder and pass it through an 80-mesh sieve, and put the crushed and sieved tangerine peel fine powder into a distillation flask, and the tangerine peel fine powder occupies 1 / 3 to 1 / 2 of the volume of the distillation flask. The tangerine peel fine powder and water are in a weight ratio of 1:10, soaked in water for 1 hour and stirred evenly, and after soaking for 1 hour, the soaked tangerine peel fine powder is heated to boiling using a slow fire, and kept boiling for 15 minutes to 30 minutes, preferably kept boiling for 20 minutes; the slow fire temperature in this embodiment is preferably controlled at any temperature between 90 degrees Celsius and 150 degrees Celsius, and more preferably controlled at any temperature between 95 degrees Celsius and 105 degrees Celsius. In a preferred embodiment, a slow fire of 100 degrees Celsius is used. The water vapor is cooled by a condenser, and the water vapor in the oil-water mixture is condensed into liquid. The oil layer and the water layer are separated by utilizing the difference in density between oil and water to obtain preliminary tangerine peel oil; the preliminary extracted tangerine peel oil is dehydrated and dried using anhydrous sodium sulfate to obtain tangerine peel volatile oil.

[0051] Step S23: extraction process of white kidney bean extract, washing the white kidney beans with water; putting the dried white kidney beans into a grinder to grind them to obtain white kidney bean coarse powder, putting the white kidney bean coarse powder into a microwave extraction device for extraction, filtering the white kidney bean filtrate after the extraction, subjecting the obtained white kidney bean filtrate to low-temperature extraction (low temperature refers to below 30° C.), decompressing and concentrating the extracted white kidney bean filtrate, and finally spray-drying the white kidney bean concentrate to obtain a powdered white kidney bean water extract.

[0052] Step S23-1, washing the white kidney bean raw material with tap water twice, each time using twice the amount of the white kidney bean raw material; after the white kidney bean raw material is dried, the raw material is crushed with a grinder until it passes through a 40-80 mesh standard sieve. Preferably, in this embodiment, after the white kidney bean raw material is dried, the raw material is crushed with a grinder until it passes through a 60 mesh standard sieve to obtain white kidney bean fine powder.

[0053] Step S23-2, the white kidney bean powder is put into a microwave extraction device at a material-liquid ratio of 1:5-1:10 (g / ml) for extraction, preferably distilled water or purified water, the microwave penetrates the medium to the inside of the material, converted into heat energy to rupture the white kidney bean cells, and the effective components flow out and dissolve in the extraction medium. The temperature of the microwave extraction device is below 60 degrees Celsius. In a preferred embodiment, the temperature is controlled below 30°C, and the extraction time is 5 to 10 minutes. Further, the white kidney bean coarse powder is filtered with a Chinese medicine liquid filter residue, and a Chinese medicine liquid filter with any aperture or sieve hole of 40 mesh to 80 mesh is used for residue filtration; preferably, a Chinese medicine liquid filter with an aperture or sieve hole of 50 mesh, 60 mesh or 70 mesh is used for residue filtration to obtain a first white kidney bean extract (i.e., filtrate) and white kidney bean residue.

[0054] Take the sieved white kidney bean residue and put it into the extraction tank at a material-liquid ratio of 1:15 to 1:25 (g / ml), and soak the obtained white kidney bean residue with 15-25 times the amount of water, preferably distilled water or purified water. In another embodiment, the white kidney bean residue is soaked with 15-25 times the amount of water. In a preferred embodiment, the white kidney bean residue is soaked with 20 times the amount of water, and the effective component substances to be extracted are separated from the soaked white kidney bean coarse powder by a microwave extraction device. The temperature of the microwave extraction device is controlled below 30°C, and the extraction time is 5-10 minutes to obtain a second white kidney bean extract (i.e., filtrate) and white kidney bean residue. The two white kidney bean extracts are filtered and combined into the extract storage tank for standby use.

[0055] The white kidney bean extract in the storage tank is pumped into a low-temperature extraction device for low-temperature extraction (low temperature refers to below 30°C), and the filtrate in the storage tank is pumped into a low-temperature reactor. The reactor is placed in a low-temperature environment and the temperature is adjusted to be below 60°C; the agitator is turned on to fully stir the white kidney bean extract under low-temperature conditions; after a period of time, the stratification of the mixture is observed, and when the organic layer and the aqueous layer are obviously stratified, the agitator is turned off; the organic layer and the aqueous layer are separated using a separatory funnel; and the separated organic layer is transferred to a beaker.

[0056] Step S23-3, the filtrate in the beaker is pumped into a single-effect concentrator for concentration, the vacuum is controlled at 0.06-0.08MPa, the concentration temperature is 60 degrees Celsius to 80 degrees Celsius, and the filtrate is concentrated to a relative density until it meets the powder spraying requirements; the white kidney bean extract after reduced pressure concentration is spray-dried, the inlet air temperature is set to 150 degrees Celsius to 165 degrees Celsius, the outlet air temperature is set to 65 degrees Celsius to 85 degrees Celsius, the temperature is set to 75 degrees Celsius to 90 degrees Celsius, and the negative pressure is set to 10 to 18Pa. The spray-dried white kidney bean extract is crushed and refined through an 80-mesh sieve to remove block connections to obtain a white kidney bean extract powder.

[0057] Step S24: the extraction process of konjac extract, washing konjac with water. The dried konjac is put into a pulverizer and crushed to obtain konjac meal, the konjac meal is put into an extraction tank and water is added for reflux extraction, after the extraction is completed, konjac filtrate is filtered to obtain konjac filtrate, the konjac filtrate is concentrated under reduced pressure, and finally the konjac concentrate is spray-dried to obtain a powdery konjac water extract.

[0058] The further detailed steps of step S24 are as follows: Step S24-1, wash the konjak raw material 2 times with tap water, each dosage is 2 times the amount of the konjak raw material. After the konjak raw material is dried, the konjak raw material is crushed to pass through a 10-100 mesh standard sieve with a pulverizer, preferably, in the present embodiment, after the konjak raw material is dried, the raw material is crushed to pass through a 60 mesh standard sieve with a pulverizer to obtain konjak meal.

[0059] Konjac flour is put into a microwave extraction equipment according to a material-liquid ratio of 1:50 to 1:200 (g / ml) for extraction. The power of the microwave extraction equipment is set to 140 to 700 W. In a preferred embodiment, the extraction power is controlled to 450 W, and the extraction time is 10 to 30 minutes. Further, the konjac flour is filtered through a Chinese medicine liquid filter to remove the residue. The Chinese medicine liquid filter with any pore size or sieve hole of 40 mesh to 80 mesh is used for the residue filtration; preferably, a Chinese medicine liquid filter with a pore size or sieve hole of 60 mesh or 70 mesh is used for the residue filtration to obtain a first konjac flour extract (i.e., filtrate) and konjac flour residue.

[0060] Take the sieved konjak flour residue and put it into the extraction tank according to the material-liquid ratio of 1:80 to 1:150 (g / ml), and soak the obtained konjak flour residue with 80 to 150 times of water, preferably distilled water or purified water. In another embodiment, soak the konjak flour residue with 50 to 200 times of water, and in a preferred embodiment, soak the konjak flour residue with 100 times of water, and use a microwave extraction device to separate the effective component substances to be extracted from the soaked konjak flour. The power of the microwave extraction device is controlled at 450W, and the extraction time is 5 to 30 minutes. In this embodiment, preferably 25 minutes, a second konjak flour extract (i.e., filtrate) and konjak flour residue are obtained. After filtering the two konjak flour extracts, merge them into the extract storage tank for standby use.

[0061] Step S24-2, after extraction is completed, filtering is performed, and the konjac extract filtrate after the filtration is drawn into a single-effect concentrator for concentration, and the vacuum is controlled at 0.06-0.08 MPa, and the concentration temperature is at 60 degrees Celsius-80 degrees Celsius. The filtrate is concentrated to a relative density until the dusting requirement is met; the konjac extract after reduced pressure concentration is spray-dried, and the inlet air temperature is set to 150 degrees Celsius-165 degrees Celsius, the outlet air temperature is set to 65 degrees Celsius-85 degrees Celsius, and the temperature is set to 75 degrees Celsius-90 degrees Celsius, and the negative pressure is set to 10-18Pa, and the konjac extract after spraying is pulverized and refined through an 80-mesh sieve, and block connections are removed to obtain konjac extract powder.

[0062] Step S3: Compounding according to different proportions, corn silk extract, tangerine peel extract and white kidney bean extract are compounded according to 7 proportions; the first compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 1:1:1; the second compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 1:2:3; the third compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 1:3:2; the fourth compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 2:1:3; the fifth compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 2:3:1; the sixth compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 3:1:2; the seventh compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 3:2:1.

[0063] Step S4: evaluating the in vitro lipase inhibition ability of the extracts prepared in different proportions in step S3; Lipase can catalyze the substrate to produce thiol compounds, which react with the color-developing substrate DTNB. TNB should be generated, which has maximum absorption at 412 nm. The lipase activity in the sample can be calculated by detecting the change in absorbance per unit time.

[0064] Take 10 μL of mouse liver tissue protein (protein concentration is 11.00 gprot / L) and add it to the corresponding wells of the ELISA plate. Add 10 μL of PBS to the control wells, and add 10 μL of corn silk, tangerine peel, and white kidney bean water extract solution (0.25, 0.5, 1, 4, 5, 6, 8, 10 mg / mL) to the test wells. Determine the LPS activity according to the instructions of the Elabscience® lipase (LPS) colorimetric test kit. Estimate the half inhibitory concentration (IC) based on the concentration-inhibition rate curve. 50 ). The assay was repeated three times to determine the lipase activity inhibition rate.

[0065] The resulting calculation is as follows: .

[0066] Where: ∆A: OD value of the test well minus OD value of the control well; ε: molar absorption coefficient, 14150 L•mol -1 •cm -1 ; b: height of the reaction system, 0.6 cm; T: incubation reaction time, 20 min; C pr : Tissue sample protein concentration: gprot / L; f: dilution factor of the sample before adding it to the detection system.

[0067] Table 1. Lipase activity inhibition rate of corn silk, tangerine peel and white kidney bean in different proportions

[0068] Step S5: using a quantitative pharmacological method to determine the composition and compatibility of the lipid-lowering composition.

[0069] Based on the results of in vitro lipase inhibition ability, a dose-effect relationship table of corn silk, tangerine peel, white kidney bean water extract and each combined dose level and lipase activity inhibition rate was prepared, and the dose-effect curve equation was fitted; the dose-effect data that constitute the expected additive effect under the combined condition were calculated; the dose-effect curve of the combined group dose and the expected additive effect was reconstructed and the dose-effect curve equation was fitted.

[0070] The calculation formula is as follows: .

[0071] Where: Y: drug effect; f and g: represent the dose-effect functions of drugs A and B, respectively; Subscript " g（Bn） ”: is the starting point of f(Am); Subscript "f （Am） ”: is the starting point of g(Bn); Bn and An: equivalent dose; Am and Bm: equivalent dose; Lo: Low means the lowest drug dose; Hi: High means the highest drug dose; : Sorting symbol, indicating that the function values ​​of the units in the number set must be arranged from low to high; [ ]: Closed interval symbol.

[0072] Through the sequential conversion of equivalent doses, the various dose-effect data constituting the expected additive drug effect under the combined use condition were calculated. The dose-effect curve of the combined group dose and the expected additive effect and the equation of the fitted dose-effect relationship curve were reconstructed. The position relationship between the dose-effect curve band of the expected additive effect of the combined group and the actual dose-effect curve was compared, and the relevant indicators were calculated.

[0073] Figure 2 This is a simulated model diagram of the plant extract formula ratio in the lipid-lowering composition of the present invention; the red curve in the figure is the expected additive effect curve, and the black curve is the actual dose-effect curve of the plant extract formula in the lipid-lowering composition; the actual dose-effect curve is higher than the red curve for "synergy", the part that overlaps with the red curve is "addition", and the part below the red curve is "antagonism". Figure 2As shown, the combined dosage points are all located above the expected effect curve. This result indicates that the preferred ratio of the formula, that is, the preferred ratio by mass is: corn silk extract: tangerine peel extract: white kidney bean extract = 2:3:1, which has a good synergistic effect.

[0074] Embodiment 2: Effects of lipid-lowering plant extract formula 1 on blood lipids in hyperlipidemic rats

[0075] (1) Establishment of rat hyperlipidemia model.

[0076] 72 SPF grade SD male rats were purchased from Sibeifu Biotechnology Co., Ltd. After 7 days of adaptation to ordinary maintenance feed, they were randomly divided into 2 groups according to body weight. 12 rats in the blank group were fed with ordinary feed, and 60 rats in the model group were fed with customized high-fat feed for 4 weeks for modeling. After the model control group was fed with high-fat feed for 4 weeks, blood was collected from the tail vein of each group (fasting but not water for about 12 hours before blood collection), and the blood lipid content was measured after separating the serum. The model group was significantly higher than the normal control group, and it was determined that the hyperlipidemia model was successfully established.

[0077] (2) The intervention effect of lipid-lowering plant extract formula on blood lipids in hyperlipidemic rats.

[0078] The model group was randomly divided into model group, positive control group, low-dose group, medium-dose group and high-dose group of functional food formula 1 according to blood lipid stratification, with 12 rats in each group. Except for the blank group, the other groups continued to be fed with high-fat diet. Oral gavage was used to administer lipid-lowering plant extract formula 1 (the mass proportion of lipid-lowering plant extract formula 1 was: corn silk extract: tangerine peel extract: white kidney bean extract = 2:3:1), once a day. The blank group and the model group were given distilled water for 8 consecutive weeks. The gavage volume of each group was 20mL / kg BW, and the dose of lipid-lowering plant extract formula was 2.5g / kg BW.

[0079] The rats were weighed for the last time on an empty stomach, and the Lee's index and body fat percentage were calculated using the corresponding formulas.

[0080] After the last administration, all rats were fasted for 12 h and anesthetized by intraperitoneal injection of xylazine hydrochloride (12.5 mg / kg BW) combined with Shutai® 50 (25 mg / kg BW). The chest and abdominal cavities were cut open and blood was collected from the abdominal aorta. The collected blood was placed at 4°C for 30 min and then centrifuged at 4°C, 3000 rpm for 10 min to separate the upper serum. Serum TC, TG, LDL, HDL, and free fatty acids were measured using a biochemical analyzer (HITACHI 7180, produced by Hitachi, Japan).

[0081] As shown in Table 2, compared with the blank group, the body weight, Lee's index and body fat percentage of the rats in the model group were significantly increased, and after administration of the plant extract formula 1 in the composition, the body weight, Lee's index and body fat percentage were significantly reduced.

[0082] As shown in Table 3 and Figure 3 As shown, Figure 3 Figure A in the figure is the result of Lee's index of rats in each group at different intervention times according to the lipid-lowering plant extract formula 1 of the present invention; Figure B shows the percentage of body fat rate of rats in each group reduced by the formula; Figure C is the result of serum total cholesterol (TC) of rats in each group after the formula intervention; Figure D is the result of serum triglyceride (TG) of rats in each group after the formula intervention; Figure E shows the result of the formula intervention on serum low-density lipoprotein (LDL) of rats in each group; Figure F is the result of the formula intervention on serum free fatty acids of rats in each group. Compared with the blank group, TC, TG, LDL and free fatty acids of rats in the model group increased, while HDL decreased. After administration of plant extract formula 1 in the composition, TC, TG, LDL and free fatty acids of rats were significantly reduced, indicating that plant extract formula 1 in the composition can reduce blood lipid levels in rats with hyperlipidemia and regulate lipid metabolism disorders. Figure 3 Compared with the control group, ##: p < 0.01; compared with the model group, *: p < 0.05, **: p < 0.01.

[0083] Table 2. Effects of Formula 1 on body weight, Lee's index and body fat percentage in hyperlipidemic rats

[0084] Note: Compared with the control group, #: p<0.05, ##: p<0.01; compared with the model group, *: p<0.05, **: p<0.01.

[0085] Table 3. Effects of Formula 1 on the levels of TC, TG, LDL, HDL and free fatty acids in the serum of rats with hyperlipidemia

[0086] Note: Compared with the control group, ##: p<0.01; compared with the model group, *: p<0.05, **: p<0.01.

[0087] Embodiment 3: Effects of lipid-lowering plant extract formula 2 on blood lipids in hyperlipidemic rats

[0088] (1) Establishment of rat hyperlipidemia model.

[0089] 72 SPF grade SD male rats were purchased from Sibeifu Biotechnology Co., Ltd. After 7 days of adaptation to ordinary maintenance feed, they were randomly divided into 2 groups according to body weight. 12 rats in the blank group were fed with ordinary feed, and 60 rats in the model group were fed with customized high-fat feed for 4 weeks for modeling. After the model control group was fed with high-fat feed for 4 weeks, blood was collected from the tail vein of each group (fasting but not water for about 12 hours before blood collection), and the blood lipid content was measured after separating the serum. The model group was significantly higher than the normal control group, and it was determined that the hyperlipidemia model was successfully established.

[0090] (2) The intervention effect of lipid-lowering plant extract formula 2 on blood lipids in hyperlipidemic rats.

[0091] The model group was randomly divided into model group, positive control group and functional food formula 2 low-dose group, medium-dose group and high-dose group according to blood lipid stratification (represented by "formulation 2 low, formula 2 medium, formula 2 high" in Table 4 and Table 5, respectively), with 12 rats in each group. Except for the blank group, the other groups continued to be fed with high-fat diet. Oral gavage was used to administer lipid-lowering plant extract formula 2 (the ratio of lipid-lowering plant extract formula 2 by mass was: corn silk extract: tangerine peel extract: white kidney bean extract: konjac = 2:3:1:0.2), once a day. The blank group and the model group were given distilled water for 8 consecutive weeks. The gavage volume of each group was 20mL / kg BW, and the dose of lipid-lowering plant extract formula 2 was 2.5g / kg BW.

[0092] The rats were weighed for the last time when fasting, and the Lee's index and body fat percentage were calculated using the corresponding formula.

[0093] After the last administration, all rats were fasted for 12 h and anesthetized by intraperitoneal injection of xylazine hydrochloride (dose: 12.5 mg / kg BW) combined with Shutai® 50 (dose: 25 mg / kg BW). The thoracic and abdominal cavities were opened and blood was collected from the abdominal aorta. The collected blood was placed at 4°C for 30 min and then centrifuged at 3000 rpm for 10 min at 4°C to separate the upper serum. Serum TC, TG, LDL, HDL, and free fatty acids were measured using a biochemical analyzer (HITACHI 7180, produced by Hitachi, Japan).

[0094] After administration of Formulation 2, the body weight, Lee's index and body fat percentage of rats were significantly reduced (Table 4), and TC, TG, LDL and free fatty acids were significantly decreased (Table 5), and the degree of reduction was higher than that of Formulation 1, indicating that the lipid-lowering effect of adding konjac to tangerine peel, corn silk and white kidney bean is better.

[0095] Table 4. Effects of Formula 2 on body weight, Lee's number and body fat percentage in hyperlipidemic rats .

[0097] Note: Compared with the control group, #: p<0.05, ##: p<0.01; compared with the model group, *: p<0.05, **: p<0.01.

[0098] Table 5. Effects of Formula 2 on the levels of TC, TG, LDL, HDL, and free fatty acids in the serum of rats with hyperlipidemia

[0099] Note: Compared with the control group, ##: p<0.01; compared with the model group, *: p<0.05, **: p<0.01.

[0100] Embodiment 4: Study on the toxicity of the lipid-lowering plant extract formula 2

[0101] (1) Single-dose toxicity study.

[0102] Forty SPF SD rats (half male and half female) that passed quarantine were selected and randomly divided into a vehicle control group (group N) and a maximum dose test group (group H) according to body weight. Each group had 20 animals, half male and half female. D1 (the day of the first administration of the test substance was designated as D1) was orally administered with a solvent 0.5% sodium carboxymethyl cellulose solution (group N) and a plant extract formula in the test substance combination twice according to the animal weight, with an interval of 5-6 hours and a volume of 20 mL / kg / time. Close observation was performed for at least 3 hours after administration on D1, and clinical symptoms were observed once a day for the rest of the days. The amount of added feed and (or) the amount of remaining feed was weighed on D1, D5, D8, D11, and D15. The weight of the animals was tested on D1, D2, D3, D5, D8, D11, and D15. At the end of the experiment, the average food intake and weight gain, total food intake and weight gain of the animals were calculated; gross pathological examination of the animals was performed on D15.

[0103] SD rats were given the plant extract formula in the combination by oral gavage within 24 hours. No obvious abnormal reactions were observed in clinical symptoms from the day of administration of the test substance or solvent to D15, and all animals survived. Compared with the same-sex solvent control group (N group), there was no significant statistical difference in the average food intake of male and female animals from D1 to D15, body weight from D8 to D15, and average body weight gain from D1 to D15. All animals were autopsied and gross pathological examinations showed no obvious abnormalities.

[0104] (2) 28-day continuous toxicity study.

[0105] 24 SPF SD rats that passed the quarantine were selected and randomly divided into a solvent control group (N group) and a low-, medium-, and high-dose group of the test extract according to their body weight, with a total of 4 groups, 6 rats in each group, half male and half female. The intragastric volume of each test group was 20mL / kgBW, the dose of lipid-lowering plant extract formula 2 was 2.5g / kg BW, and the solvent control group (N group) was given the same volume of normal saline. The drug was administered once a day for 28 consecutive days. At the end of the experiment, the average food intake and weight gain, total food intake and weight gain of the animals were calculated; on D28, the animals were subjected to gross pathological examination, blood routine, and blood biochemical indexes.

[0106] After SD rats were given the plant extracts in the composition by oral gavage within 24 hours for 28 days, no obvious abnormal reactions were observed in clinical symptoms, and all animals survived. Compared with the same sex of the vehicle control group (N group), there was no significant statistical difference in blood routine and blood biochemical indicators in the test group. There was no significant statistical difference in the average food intake, body weight, and average weight gain on D1-28. All animals were autopsied and gross pathological examinations showed no obvious abnormalities.

[0107] Under the above test conditions, SD rats did not show obvious toxicity after oral administration of the plant extract formula in the composition once or for 28 consecutive days, reflecting good safety.

[0108] Embodiment 5: A human trial study on the lipid-lowering plant extract formula 2 to assist in lowering blood lipids

[0109] (1) Experimental methods

[0110] This comparative experiment adopts the double-blind method. 56 voluntary subjects who meet the conditions after clinical physical examination are randomly divided into the experimental group and the control group according to the blood lipid level before the test, taking into account factors such as age, gender, and diet. The number of cases in each group is the same. The experimental group takes the plant extract formula 2 in the composition once a day for 30 consecutive days. The control group does not take any product.

[0111] (2) Evaluation of lipid-lowering efficacy.

[0112] Before and after the trial diet, the subjects' total cholesterol (TC) level and reduction percentage, triglyceride (TG) level and reduction percentage, high-density lipoprotein cholesterol (HDL-C) level and increase were tested.

[0113] Total cholesterol (TC) decrease percentage (%) = (TC before the test - TC after the test) × 100 / TC before the test; Triglyceride (TG) decrease percentage (%) = (TG before the test - TG after the test) × 100 / TG ​​before the test; Efficacy criteria: Effective: TC decreased by >10%; TG decreased by >15%; HDL-C increased by >0.104mmol / L. Ineffective: those who did not meet the effective criteria.

[0114] Table 6 Changes in serum total cholesterol in the experimental group and the control group before and after the trial (mmol / L)

[0115] Table 7 Changes in triglycerides in the experimental group and the control group before and after the trial (mmol / L)

[0116] Table 8 Changes in high-density lipoprotein in the experimental group and the control group before and after the trial (mmol / L)

[0117] After the 30th day of taking the plant extract formula 2 in the test group, the number of effective cases in lowering total cholesterol was 16, with an effective rate of 59.26%, which was significantly different from the effective rate of 3.85% (1 / 26) in the control group; the number of effective cases in lowering triglycerides was 24, with an effective rate of 88.89%, which was significantly different from the effective rate of 19.23% (5 / 26) in the control group; the number of effective cases in increasing high-density lipoprotein was 12, with an effective rate of 44.44%, which was not significantly different from the effective rate of 23.07% (6 / 26) in the control group (see Tables 6, 7 and 8).

[0118] The lipid-lowering composition of the present invention is composed of plant extracts, which are obtained by steam wall breaking technology. The lipid-lowering composition of the present invention and the steam wall breaking technology used are highly creative or innovative compared to traditional technologies. The details are as follows: (I) The corn silk steam cell wall breaking technology of the present invention revolutionizes the efficiency of cell wall breaking. Compared with the traditional water decoction method (80-100℃ / 2-4h), the traditional water decoction method (80-100℃ / 2-4h) can only slowly release ingredients through osmosis, while steam cell wall breaking (0.8-2.5MPa / 30-300s) penetrates the cell wall through high-pressure steam, and the mechanical shear force generated by instantaneous pressure relief disintegrates the lignocellulose structure. The steam cell wall breaking technology used optimizes the active ingredient protection mechanism. In the technical solution of the present invention, heat-sensitive ingredient protection is adopted. Although the steam cell wall breaking temperature reaches 160-230℃, the processing time is measured in seconds (usually <5 minutes). Compared with the traditional reflux extraction (60℃ / 6h or more), the total heat exposure is reduced by 85%, which significantly reduces the decomposition of heat-labile ingredients such as flavonoid glycosides. By adopting the steam wall breaking technology of the present invention, the molecular structure of the effective ingredients of each component changes: the applicant of this patent has found that steam wall breaking can degrade corn silk cellulose to produce oligosaccharides (DP 2-6), and the antioxidant activity (DPPH clearance rate) of these small molecular polysaccharides is increased by 42% compared with the original ingredients.

[0119] In addition, the steam cell wall breaking technology used enables multiple components to produce a synergistic effect, which is specifically manifested in (1) physical effect: cell wall porosity increased by 300-500%; (2) chemical effect: hemicellulose hydrolysis to produce synergistic ingredients such as ferulic acid; (3) biological effect: promoting the conversion of bound polyphenols into free state. Experiments have shown that the corn silk extract treated with steam cell wall breaking technology has a 58% increase in blood sugar lowering effect (α-glucosidase inhibition rate), which is significantly different from the traditional extract (p<0.01).

[0120] (II) Different from the prior art which uses many different types of components and different combinations of components, in the preferred embodiment, the blood lipid lowering composition of the present invention only includes plant extracts such as tangerine peel, corn silk, white kidney bean and konjac. It mainly uses the following effects of tangerine peel, corn silk, white kidney bean and konjac.

[0121] (1) Tangerine peel: bitter and pungent in taste, warm in nature, enters the spleen and lung meridians. It has the effects of promoting qi and strengthening the spleen, regulating the middle and stimulating appetite, and drying dampness and resolving phlegm.

[0122] (2) Corn silk: sweet, light, neutral in nature, enters the kidney, stomach, liver, and gallbladder meridians. It has the effects of diuresis, swelling, heat relief, liver calming, and gallbladder promoting.

[0123] (3) White kidney bean: sweet, slightly warm, enters the spleen and stomach meridians. It has the effects of warming the middle and strengthening the spleen, regulating qi and moistening the intestines.

[0124] (4) Konjac: Spicy in taste, cold in nature. It has the effects of detoxification, dispersing stagnation and diuresis.

[0125] (III) In a preferred embodiment of the present invention, only a small amount of konjac is added to konjac, and its proportion is extremely low. For example, konjac only accounts for about one-tenth of the corn silk component, which is different from the high proportion of konjac or konjac as the main component in the prior art. The core component of konjac used in the present invention is glucomannan, of which about 70%-80% of the konjac tuber is water-soluble dietary fiber, which can expand 80-100 times after absorbing water to form a gel-like substance with high viscosity and strong adsorption. Konjac contains a small amount of trace elements and amino acids, such as calcium, selenium, potassium, etc., of which the calcium content is about 43mg / 100g, and selenium has antioxidant function; there are 16 kinds of amino acids in konjac, including 7 essential amino acids, such as lysine, tryptophan, etc. In the present invention, konjac presents the characteristics of low calories, and each 100 grams of konjac contains only about 7-20 kcal, and almost no fat and protein.

[0126] The konjac in the present invention is used to regulate intestinal health and play a prebiotic role. After fermentation, it produces short-chain fatty acids (such as butyric acid) to nourish the intestinal probiotics. At the same time, it controls blood sugar and blood lipids and delays sugar absorption; the gel layer in the konjac wraps the food, slows down the speed at which glucose enters the blood, and reduces the postprandial blood sugar peak; and binds cholesterol, adsorbs bile acid and cholesterol, reduces lipid absorption, and assists in reducing low-density lipoprotein (LDL). More importantly, the konjac in the present invention will make the eater feel full, for example, the water absorption and swelling characteristics prolong the gastric emptying time, reduce hunger, and is suitable for low-calorie diet plans.

[0127] The konjac in the present invention can produce effects such as efficient adsorption and promotion of uric acid excretion, such as the molecular sieve effect of glucomannan: the glucomannan in konjac flour is a reticular macromolecular structure, which can adsorb uric acid, purine metabolites and toxins in the intestine, reducing the probability of them being reabsorbed into the blood. Enhanced intestinal uric acid excretion: About 30% of the human body's uric acid is excreted through the intestine. Konjac flour increases the volume and viscosity of feces, accelerates intestinal peristalsis, shortens the residence time of uric acid in the intestinal cavity, and indirectly improves the excretion efficiency.

[0128] In addition, the konjac in the present invention can produce metabolic regulation and inflammation relief effects, inhibiting the activity of xanthine oxidase: konjac polysaccharides have been shown in animal experiments to inhibit the activity of xanthine oxidase (XO), reducing the key link of uric acid production; the selenium element and polysaccharide components in konjac can reduce the levels of serum pro-inflammatory factors such as IL-1β and TNF-α, and relieve the local inflammatory response of gouty arthritis, that is, produce an anti-inflammatory synergistic effect.

[0129] The konjac of the present invention has low calories and satiety: the calories of taro powder are only 7kcal / 100g, and it occupies stomach space after absorbing water and swelling, reducing the desire to take high-purine food; and improving insulin resistance: by regulating blood sugar fluctuations and lipid metabolism, it indirectly improves insulin resistance (a common cause of hyperuricemia), forming a comprehensive metabolic regulation.

[0130] (IV) The lipid-lowering composition of the present invention is added with tangerine peel volatile oil alone, which is mainly used for the pharmacological mechanism of synergistic enhancement such as inhibiting uric acid production and promoting uric acid excretion. Terpene compounds such as limonene and γ-terpinene in tangerine peel volatile oil inhibit xanthine oxidase activity, block the final step of purine metabolism into uric acid, and form dual-target inhibition with mainstream lipid-lowering ingredients (such as allopurinol). It promotes uric acid excretion by activating organic anion transporters (OAT1 / OAT3), enhancing the efficiency of renal tubular uric acid secretion (animal experiments show that the excretion amount increases by 18.6%) and antagonizing the uric acid reabsorption transporter URAT1.

[0131] Furthermore, the organic combination of tangerine peel and tangerine peel volatile oil further exerts the function of regulating qi and strengthening the spleen to improve the metabolic basis. In addition, the migration characteristics of volatile oil enhance the permeabilization of drugs.

[0132] Treating insomnia with food prescriptions that are both medicinal and edible not only takes advantage of the multi-pathway synergistic regulation of food compounds, but also has significant advantages over chemical drugs in terms of medication safety and compliance.

[0133] The present invention adopts steam wall breaking technology to process corn silk, which significantly improves the extraction rate of effective ingredients of corn silk and enhances the blood lipid lowering effect of the product; the blood lipid lowering food prepared based on the blood lipid lowering composition of the present invention is safe and has no side effects, and is suitable for long-term consumption by people with high uric acid.

[0134] The food-medicine-food homologous food of the present invention can further reduce the potential safety hazard of long-term medication and improve patient compliance.

[0135] The preferred embodiments of the present invention are described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the technical concept of the present invention, the technical solution of the present invention can be subjected to a variety of simple modifications. These simple modifications all belong to the protection scope of the present invention.

[0136] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any manner without contradiction. In order to avoid unnecessary repetition, the present invention will not further describe various possible combinations. In addition, the various different embodiments of the present invention can also be combined arbitrarily, as long as they do not violate the concept of the present invention, they should also be regarded as the contents disclosed by the present invention.

Claims

1. A lipid-lowering composition, characterized in that: The lipid-lowering composition is composed of plant extracts, which are composed of the following raw materials by mass: 3-27 parts of corn silk, 3-27 parts of tangerine peel and 3-27 parts of white kidney bean; the plant extract is obtained by steam wall breaking technology, and the preparation method of the plant extract based on steam wall breaking technology includes the following steps: Step S1: pre-treating the raw materials, selecting fresh tangerine peel, corn silk and white kidney beans and washing them; Step S2: extracting effective ingredients, using steam wall breaking technology to prepare corn silk extract, tangerine peel volatile oil, tangerine peel extract and white kidney bean extract; Step S3: Compounding in different proportions: corn silk extract, tangerine peel volatile oil, tangerine peel extract and white kidney bean extract in different proportions; Step S4: evaluating the in vitro lipase inhibition ability of the extracts prepared in different proportions in step S3; Step S5: Determine the composition and compatibility of each plant extract based on quantitative pharmacology, and then determine the composition and compatibility of the lipid-lowering composition.

2. The lipid-lowering composition according to claim 1, characterized in that: The blood lipid lowering composition is composed of the following raw materials in parts by mass: 9-18 parts of corn silk, 6-12 parts of tangerine peel and 3-6 parts of white kidney beans.

3. The lipid-lowering composition according to claim 1, characterized in that: The blood lipid lowering composition is composed of the following raw materials in parts by mass: 6-18 parts of corn silk, 9-27 parts of tangerine peel and 3-9 parts of white kidney beans.

4. The lipid-lowering composition according to claim 1, characterized in that: The blood lipid lowering composition further comprises konjac, and the blood lipid lowering composition is composed of the following raw materials in parts by mass: 9-13 parts of corn silk, 14-20 parts of tangerine peel, 5-6 parts of white kidney beans and 1-2 parts of konjac.

5. The lipid-lowering composition according to claim 4, characterized in that: The lipid-lowering composition further includes tangerine peel volatile oil. The lipid-lowering composition is composed of the following raw materials in parts by mass: 10 parts of corn silk, 15 parts of tangerine peel, 5 parts of white kidney beans, 1 part of konjac and 0.2-0.8 parts of tangerine peel volatile oil.

6. A method for preparing a plant extract based on steam wall breaking technology, which is used to prepare the plant extract in the lipid-lowering composition according to claim 1, characterized in that: The method for preparing the plant extract comprises the following steps: Step S1: pretreatment of raw materials, the raw materials comprising corn silk, tangerine peel, white kidney bean and konjac by weight; washing and drying the tangerine peel, corn silk, white kidney bean and konjac; Step S2: extracting effective ingredients, extracting and preparing corn silk extract, tangerine peel volatile oil and tangerine peel extract, white kidney bean extract and konjac extract, wherein the extraction and preparation process of corn silk extract includes step S21, and the extraction and preparation process of tangerine peel extract includes step S22; Step S21, washing and cutting corn silk into sections, placing the dried corn silk in a steam explosion chamber for steam explosion and crushing to obtain coarse powder of the steam-exploded corn silk dry product, putting the coarse powder of the steam-exploded corn silk dry product into an extraction tank, adding water and refluxing for extraction, filtering to obtain corn silk filtrate after the extraction, and concentrating the corn silk filtrate under reduced pressure to obtain corn silk concentrate; spray drying the corn silk concentrate to obtain a powdery corn silk water extract; Step S22, drying the tangerine peel washed in step S1, crushing the dried tangerine peel with a crusher, and dividing the crushed tangerine peel coarse powder into two parts: one part of the tangerine peel coarse powder is used to obtain tangerine peel volatile oil by steam distillation; the other part of the tangerine peel coarse powder is put into an extraction tank and water is added to reflux extraction to perform a water extraction process, after the tangerine peel coarse powder water extraction is completed, the tangerine peel filtrate is filtered to obtain the tangerine peel filtrate, the tangerine peel filtrate is reduced pressure concentrated to obtain the tangerine peel concentrated solution, and the tangerine peel concentrated solution is spray dried to obtain a powdery tangerine peel water extract; Step S3: compounding according to different proportions, corn silk extract, tangerine peel extract and white kidney bean extract are compounded according to 7 proportions; the first compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 1:1:1, the second compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 1:2:3, the third compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 1:3:2, the fourth compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 2:1:3, the fifth compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 2:3:1; the sixth compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 3:1:2, and the seventh compounding ratio is corn silk extract: tangerine peel extract: white kidney bean extract = 3:2:1; Step S4: evaluating the in vitro lipase inhibition ability of the extracts prepared in different proportions in step S3; Step S5: Quantitative pharmacology is used to determine the composition and compatibility of the lipid-lowering composition.

7. The method for preparing plant extracts based on steam wall breaking technology according to claim 6, characterized in that: The extraction and preparation process of the white kidney bean extract comprises step S23: washing the white kidney beans with water; putting the dried white kidney beans into a grinder to grind them to obtain white kidney bean coarse powder, putting the white kidney bean coarse powder into a microwave extraction device for extraction, filtering to obtain a white kidney bean filtrate after the extraction, performing low-temperature extraction on the obtained white kidney bean filtrate, decompressing and concentrating the extracted white kidney bean filtrate, and finally spray-drying the white kidney bean concentrate to obtain a powdery white kidney bean water extract.

8. The method for preparing plant extracts based on steam wall breaking technology according to claim 6, characterized in that: The extraction and preparation process of the konjac extract comprises step S24: washing the konjac with water, putting the dried konjac into a grinder to crush it to obtain konjac coarse powder, putting the konjac coarse powder into an extraction tank, adding water and refluxing for extraction, filtering to obtain konjac filtrate after the extraction is completed, concentrating the konjac filtrate under reduced pressure, and finally spray-drying the konjac concentrate to obtain a powdery konjac water extract.

9. A lipid-lowering plant extract, characterized in that: It is made of the lipid-lowering composition described in any one of claims 1 to 5 and a food-acceptable carrier, or it is made of the lipid-lowering plant extract combination prepared by the plant extract preparation method based on steam wall breaking technology described in any one of claims 6 to 8 and a food-acceptable carrier, and the dosage form is any food-acceptable dosage form.

10. The lipid-lowering plant extract according to claim 9, characterized in that The blood lipid lowering plant extract dosage form is an oral preparation.

11. The lipid-lowering plant extract according to claim 9, characterized in that The invention also includes adding excipients such as silicon dioxide and magnesium stearate to compress the candy into tablets, or adding sweeteners and sour agents to prepare the candy into solid beverages or pastes.

12. Use of the lipid-lowering composition according to any one of claims 1 to 5 and the lipid-lowering plant extract prepared by the plant extract preparation method based on steam wall breaking technology according to any one of claims 6 to 8 in animals and patients with hyperlipidemia.

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