A composition for assisting in reducing high blood pressure and tonifying kidney and protecting liver and a preparation method thereof

Abstract

The application provides a composition for assisting in reducing high blood fat and tonifying kidney and protecting liver and a preparation method thereof, and the composition comprises: compound plant seed oil 74-133 parts, synergistic auxiliary materials 1.2-5.5 parts, and synergistic auxiliary materials 7.5-19.5 parts; wherein the compound plant seed oil is composed of nine kinds of plant seed oils, i.e., maple seed oil, eucommia seed oil, sea buckthorn seed oil, walnut seed oil, milk thistle seed oil, peony seed oil, pomegranate seed oil, grape seed oil and beauty bush seed oil; the synergistic auxiliary materials are a compound of curcumin phospholipid complex, haematococcus pluvialis oil and acetyl L-carnitine; and the synergistic auxiliary materials are composed of medium-chain triglyceride, soybean lecithin and antioxidants. The preparation method adopts low-temperature cold pressing, short-path molecular distillation refining, gradient compounding and nitrogen-filling micro-positive pressure packaging processes. The composition has multiple effects of reducing blood fat, reducing uric acid, protecting liver, tonifying kidney and antioxidation, has high active ingredients, has good oxidation stability, has a green and mild process, and is suitable for industrialized production.

Description

Technical Field

[0001] This invention relates to the field of functional plant oil deep processing technology, and in particular to a composition for assisting in lowering blood pressure, blood sugar, cholesterol, and blood lipids, and for tonifying the kidneys and protecting the liver, and its preparation method. Background Technology

[0002] With changes in dietary structure and the prevalence of sedentary lifestyles among Chinese residents, the incidence of chronic metabolic diseases such as hypertension, hyperlipidemia, hyperglycemia, and hyperuricemia (represented by the "four highs") and their associated liver and kidney damage are increasing year by year, showing a trend towards affecting younger people. This has become a significant public health issue impacting national health. Clinical studies have shown that metabolic disorders caused by the "four highs" do not exist independently; they are often accompanied by progressive damage to target organs such as the liver and kidneys. Long-term dyslipidemia can induce non-alcoholic fatty liver disease and liver fibrosis; hyperuricemia easily causes renal tubular damage and renal interstitial lesions; and hypertension and hyperglycemia can exacerbate liver and kidney microvascular complications. Furthermore, the decline in liver and kidney function can further disrupt the body's metabolic balance, forming a vicious cycle of metabolic abnormalities, liver and kidney damage, and metabolic deterioration.

[0003] Current clinical interventions for hypertension, hyperlipidemia, and hyperglycemia primarily rely on chemically synthesized drugs. While these drugs can quickly control various indicators, long-term use has limitations such as increased metabolic burden on the liver and kidneys and numerous adverse reactions, making them unsuitable for long-term conditioning in sub-healthy individuals and those in the early stages of metabolic abnormalities. Therefore, developing natural, safe, multi-target synergistic food-derived conditioning products that combine metabolic regulation and target organ protection has become an important direction for development in this field.

[0004] Plant-based functional oils are rich in various bioactive components such as alpha-linolenic acid, phytosterols, natural polyphenols, and fat-soluble vitamins. They possess advantages such as high safety, mild effects, and multi-target regulation, and have attracted widespread attention in the field of adjuvant intervention for chronic metabolic diseases. However, existing plant-based oil products still suffer from several technical shortcomings: their efficacy is singular, with product designs often focusing solely on lowering blood lipids or protecting the liver, failing to integrate comprehensive regulation of the four highs (hyperlipidemia, hyperglycemia, and hyperlipidemia) with kidney and liver protection. This fails to break the vicious cycle of metabolic disorders and liver and kidney damage, making it difficult to meet the comprehensive conditioning needs of individuals with metabolic abnormalities. Furthermore, their formulation lacks a scientific synergistic mechanism; existing compound oil products are mostly simple additives of different raw materials, without precise division and ratio optimization of functional components based on the pathways and targets of active ingredients. This results in weak synergistic effects between components and limited overall efficacy. Finally, their formulation technology has significant shortcomings. Highly unsaturated vegetable oils have poor oxidative stability and are prone to rancidity and deterioration during storage at room temperature, leading to loss of active ingredients and short product shelf life. At the same time, fat-soluble active ingredients have a slow dissolution rate and low absorption efficiency in the aqueous gastrointestinal environment. Existing products have not systematically addressed these issues through delivery system design. The preparation process can easily cause loss of activity. Traditional vegetable oil processing often uses processes such as hot pressing, high-temperature alkali refining and deacidification, and high-temperature deodorization. The high temperatures during processing can cause the oxidation and degradation of heat-sensitive active ingredients such as polyphenols, nervonic acid, and polyunsaturated fatty acids, which can significantly reduce the product's bioactivity and conditioning efficacy. Summary of the Invention

[0005] In view of this, the present invention proposes a composition for assisting in lowering blood pressure, blood sugar, cholesterol, and blood lipids, and for tonifying the kidneys and protecting the liver, and a method for preparing the same, thereby solving the above problems.

[0006] The technical solution of this invention is implemented as follows: A composition for assisting in lowering blood pressure, blood sugar, cholesterol, and blood lipids, and for tonifying the kidneys and protecting the liver, comprising the following raw materials in parts by weight: 74-133 parts of compound plant seed oil, 1.2-5.5 parts of synergistic excipients, and 7.5-19.5 parts of potentiating excipients; wherein the compound plant seed oil comprises the following raw materials in parts by weight: 8-15 parts of Acer truncatum seed oil, 10-18 parts of Eucommia ulmoides seed oil, 7-12 parts of Hippophae rhamnoides seed oil, 9-16 parts of walnut seed oil, 6-12 parts of milk thistle seed oil, 10-17 parts of peony seed oil, 5-10 parts of pomegranate seed oil, 8-14 parts of grape seed oil, and 11-19 parts of Sapindus mukorossi seed oil; wherein the synergistic excipients are one or more of curcumin phospholipid complex, Haematococcus pluvialis oil, acetyl-L-carnitine, and icariin phospholipid complex; wherein the potentiating excipients are composed of medium-chain triglycerides, soybean lecithin, and antioxidants.

[0007] Furthermore, the compound plant seed oil comprises the following raw materials in parts by weight: 10-13 parts of Acer truncatum seed oil, 12-16 parts of Eucommia ulmoides seed oil, 8-11 parts of Hippophae rhamnoides seed oil, 11-14 parts of walnut seed oil, 7-10 parts of milk thistle seed oil, 12-15 parts of peony seed oil, 6-9 parts of pomegranate seed oil, 10-12 parts of grape seed oil, and 13-17 parts of Sapindus mukorossi seed oil.

[0008] Furthermore, the synergistic excipients are compounded from curcumin phospholipid complex, Haematococcus pluvialis oil, and acetyl L-carnitine in a weight ratio of 1:(0.3~0.8):(1~3).

[0009] Furthermore, the synergistic excipient is composed of 5-15 parts of medium-chain triglycerides (MCT), 1-4 parts of soybean lecithin, and 0.15-0.5 parts of antioxidant.

[0010] Furthermore, the antioxidant is ascorbate palmitate and D-α-tocopherol succinate in a weight ratio of 1:(1-3).

[0011] Medium-chain triglycerides (MCTs) and soy lecithin jointly construct a self-microemulsifying delivery system. Upon contact with gastrointestinal fluids, they spontaneously microemulsify, significantly enhancing the dissolution rate and intestinal absorption efficiency of fat-soluble active ingredients. Simultaneously, MCTs are rapidly metabolized, do not accumulate in fat, and help regulate blood lipids, reducing the metabolic burden on the liver. Soy lecithin possesses both emulsifying and hepatoprotective effects, repairing hepatocyte membranes, promoting hepatocyte regeneration, and helping to improve fatty liver. The antioxidants are fat-soluble vitamin derivatives that synergistically construct a lipid-phase antioxidant barrier, inhibiting the oxidative rancidity of polyunsaturated fatty acids while retaining the physiological activity of vitamins, thus synergistically enhancing the body's antioxidant capacity.

[0012] The dosage form of the above composition is any one of soft capsules, oral liquids, microcapsule powders, gel candies, ready-to-eat oil packets, or solid beverages.

[0013] The method for preparing the above composition includes the following steps: S1. Raw material pretreatment: Select mature and plump kernels of Acer truncatum, Eucommia ulmoides, Hippophae rhamnoides, walnut, milk thistle, peony, pomegranate, grape, and sacha indica. After air separation to remove impurities and washing with clean water, dry them in low-temperature hot air at 35~40℃ until the kernel moisture content is ≤6% by mass. S2. Low-temperature physical cold pressing: Various types of kernels are fed into a cold press and physically pressed under the conditions of material temperature ≤45℃ and pressing pressure 25~35MPa. The first crude oil is collected and the oil residue is removed by plate and frame filter press to obtain the virgin oil of each individual. S3. Distillation and Refining: Each monomer virgin essential oil is fed into a distillation device and deacidified and deodorized under the conditions of system vacuum degree ≤10Pa, distillation temperature 120~140℃, and scraper speed 200~250r / min to remove free fatty acids and small molecule odor impurities, and obtain refined monomer oils. S4. Gradient compounding: First, add the synergistic excipients to a sealed mixing tank, purge the air in the tank with nitrogen gas of ≥99.9% purity, control the residual oxygen content in the tank to ≤0.5%, and stir at 40~60 r / min for 10~15 min at 30~35℃ until a matrix system is formed; then add the refined monomer oil to the matrix system, and maintain constant temperature and speed stirring for 15~20 min until the oil phase is completely homogeneous; finally, add the synergistic excipients, and continue stirring for 20~30 min until the system is completely homogeneous; S5. Aseptic nitrogen-filled packaging: After the compounded oil is filtered through a 0.22μm precision filter, it is aseptically packaged under nitrogen protection throughout the process to obtain the final product.

[0014] Furthermore, in step S2, the single pressing time is 25-35 seconds, and the oil yield of each monomer's virgin essential oil is controlled at 28%-35%. In step S3, the distillation refining process employs short-path molecular distillation, with a feed flow rate of 1.0-1.5 mL / min and a condensation surface temperature of 20-25°C. After refining, the acid value of each monomer's oil is ≤0.2 mg KOH / g, and the peroxide value is ≤0.08 g / 100 g.

[0015] Furthermore, during the stirring process in step S4, the pressure inside the tank is maintained at 0.02~0.05MPa throughout to prevent outside air from seeping in.

[0016] Application of the compound plant oil composition of the present invention in the preparation of health foods or medicines with functions of lowering blood pressure, blood sugar, cholesterol, and blood lipids, protecting the liver, and antioxidation. Compared with the prior art, the beneficial effects of the present invention are: 1. This invention is based on nine kinds of plant seed oils and is divided into three groups according to function: metabolic regulation, liver and kidney repair and matrix enhancement. It synergistically covers the regulatory pathways of blood pressure, blood lipids, blood sugar and uric acid, while also having the effects of tonifying the kidney and protecting the liver. It forms an endogenous metabolic regulation layer with curcumin phospholipid complex, Haematococcus pluvialis oil and acetyl L-carnitine, and constructs a formulation enhancement and delivery layer with medium chain triglycerides, soybean lecithin and antioxidants to achieve multi-target synergistic intervention.

[0017] 2. This invention constructs a self-microemulsifying delivery system using medium-chain triglycerides and soybean lecithin. Upon contact with gastrointestinal fluid, it spontaneously forms nanoscale microemulsions, which can be directly absorbed by the intestinal wall without relying on the emulsification effect of bile salts. This avoids the absorption barrier of fat-soluble components caused by insufficient bile secretion in patients with impaired liver and gallbladder function, and significantly improves bioavailability. Furthermore, all excipients in the formulation are physiologically active, replacing traditional inert excipients and achieving a dual improvement in formulation performance and conditioning efficacy.

[0018] 3. The process of low-temperature cold pressing combined with short-path molecular distillation is adopted to avoid thermal oxidation of unsaturated fatty acids and the formation of trans fatty acids. The acid value of the refined monomer oil is ≤0.2mgKOH / g and the peroxide value is ≤0.08g / 100g. Combined with gradient compounding and nitrogen-filled micro-positive pressure technology, along with antioxidants, the product shelf life is extended, solving the industry pain point of easy oxidation and rancidity of highly unsaturated vegetable oils.

[0019] 4. All raw materials used in this invention are food-grade and compliant, ensuring high safety. They can be prepared into various dosage forms such as soft capsules and microcapsule powders, making them suitable for long-term conditioning in people with metabolic disorders. The invention has broad prospects for industrial application. Detailed Implementation

[0020] To better understand the technical content of this invention, specific embodiments are provided below to further illustrate the invention.

[0021] Unless otherwise specified, the experimental methods used in the embodiments of this invention are all conventional methods.

[0022] Unless otherwise specified, all materials and reagents used in the embodiments of this invention are commercially available.

[0023] The specifications of the raw materials used in the embodiments of this invention are as follows: Acer truncatum seed oil, Eucommia ulmoides seed oil, Hippophae rhamnoides seed oil, walnut seed oil, milk thistle seed oil, peony seed oil, pomegranate seed oil, grape seed oil, and Sacha indica seed oil: all are physically cold-pressed virgin oils, food grade; Curcumin phospholipid complex: curcumin content ≥20%, food grade; Haematococcus pluvialis oil: Astaxanthin content ≥2%, food grade; Acetyl-L-carnitine: Food grade; Medium-chain triglycerides (MCT): Food grade, caprylic / capric triglycerides; Soy lecithin: Phosphatidylcholine content ≥70%, food grade; Ascorbyl palmitate, D-α-tocopherol succinate: food grade.

[0024] Example 1 This embodiment provides a composition for assisting in lowering blood pressure, blood sugar, cholesterol, and blood lipids, and for tonifying the kidneys and protecting the liver. By weight, the raw material composition is as follows: 100 parts of compound vegetable seed oil, 3.2 parts of synergistic excipients, and 11.8 parts of synergistic excipients.

[0025] The compound plant seed oils include: 11 parts of Acer truncatum seed oil, 14 parts of Eucommia ulmoides seed oil, 9 parts of Hippophae rhamnoides seed oil, 12 parts of walnut seed oil, 8 parts of milk thistle seed oil, 13 parts of peony seed oil, 7 parts of pomegranate seed oil, 11 parts of grape seed oil, and 15 parts of Sapindus mukorossi seed oil.

[0026] Synergistic excipient composition: 0.8 parts curcumin phospholipid complex, 0.4 parts Haematococcus pluvialis oil, and 2.0 parts acetyl L-carnitine (weight ratio 1:0.5:2.5).

[0027] The synergistic excipients include: 10 parts medium-chain triglycerides, 1.5 parts soybean lecithin, and 0.3 parts antioxidants; wherein the antioxidants are ascorbyl palmitate and D-α-tocopherol succinate in a weight ratio of 1:2.

[0028] Preparation method: S1. Raw material pretreatment: Select mature and plump kernels of Acer truncatum, Eucommia ulmoides, Hippophae rhamnoides, walnut, milk thistle, peony, pomegranate, grape, and Sacha indica. Remove impurities and empty shells by wind separation. After repeatedly washing with clean water to remove surface dust, spread them on a stainless steel mesh tray and place them in a hot air circulating oven. Dry them at a low temperature of 38℃ until the moisture content of the kernels is measured to be 5.2%. Remove them and cool them to room temperature for later use.

[0029] S2. Low-temperature physical cold pressing: The dried kernels of each variety are fed into a hydraulic cold press, with the material temperature controlled at 40℃, the pressing pressure at 30MPa, and the single pressing time at 30s. The crude oil obtained from the first pressing is filtered by a plate and frame filter press (filter cloth pore size 5μm) to remove oil residue, yielding the virgin refined oil of each monomer.

[0030] The measured oil yields of each monomer virgin essential oil were as follows: Acer truncatum seed oil 31%, Eucommia ulmoides seed oil 33%, Hippophae rhamnoides seed oil 28%, Walnut seed oil 35%, Milk thistle seed oil 30%, Peony seed oil 32%, Pomegranate seed oil 29%, Grape seed oil 30%, and Sacha indica seed oil 34%.

[0031] S3. Distillation and Refining: Each monomer virgin essential oil is fed into a scraped-film short-path molecular distillation device for deacidification and deodorization under the conditions of system vacuum of 5 Pa, distillation temperature of 130℃, scraped film speed of 220 r / min, feed flow rate of 1.2 mL / min, and condensation surface temperature of 22℃.

[0032] The acid value and peroxide value of each monomeric oil after refining are as follows:

[0033] All meet the quality standards of acid value ≤0.2mgKOH / g and peroxide value ≤0.08g / 100g.

[0034] S4. Gradient Compounding: First, add the synergistic excipients to a sealed mixing tank, and purge the air inside the tank with 99.99% pure nitrogen to control the residual oxygen level at 0.3% and maintain a slight positive pressure of 0.03 MPa. Start stirring and maintain the mixture at 32°C and 50 rpm for 12 minutes until the synergistic excipients are completely mixed, forming a clear and transparent matrix system. Then, add the nine refined monomer oils obtained in step S3 to the matrix system according to the formulation amount, and continue stirring at 32°C and 50 rpm for 18 minutes until the oil phase is completely homogeneous and no stratification is observed visually. Finally, add the synergistic excipients and continue stirring for 25 minutes until the system is a homogeneous orange-red liquid with no visible particles, thus obtaining the composition.

[0035] S5. Aseptic nitrogen filling and packaging: The composition obtained in step S4 is filtered through a 0.22μm polytetrafluoroethylene (PTFE) precision filter element, and then filled into a brown glass bottle under nitrogen protection (nitrogen flow rate 3L / min). After headspace nitrogen filling for 5s, the bottle is screwed on and sealed to obtain the finished composition.

[0036] Example 2 This embodiment provides a composition for assisting in lowering blood pressure, blood sugar, cholesterol, and blood lipids, and for tonifying the kidneys and protecting the liver. By weight, the raw material composition is as follows: 74 parts of compound vegetable seed oil, 1.2 parts of synergistic excipients, and 19.5 parts of synergistic excipients.

[0037] The compound plant seed oils include: 8 parts of Acer truncatum seed oil, 10 parts of Eucommia ulmoides seed oil, 7 parts of Hippophae rhamnoides seed oil, 9 parts of walnut seed oil, 6 parts of milk thistle seed oil, 10 parts of peony seed oil, 5 parts of pomegranate seed oil, 8 parts of grape seed oil, and 11 parts of Sapindus mukorossi seed oil.

[0038] The synergistic excipients include: 0.3 parts curcumin phospholipid complex, 0.2 parts Haematococcus pluvialis oil, and 0.7 parts acetyl L-carnitine (weight ratio 1:0.67:2.33).

[0039] The synergistic excipients include: 14.5 parts medium-chain triglycerides, 4 parts soybean lecithin, and 1 part antioxidant; the antioxidant is ascorbyl palmitate and D-α-tocopherol succinate in a weight ratio of 1:3.

[0040] The preparation method is the same as in Example 1, except that: the drying temperature of S1 is 40℃; the pressing pressure of S2 is 28MPa and the material temperature is 42℃; and the distillation temperature of S3 is 135℃ and the vacuum degree is 3Pa.

[0041] Example 3 This embodiment provides a composition for assisting in lowering blood pressure, blood sugar, cholesterol, and blood lipids, and for tonifying the kidneys and protecting the liver. By weight, the raw material composition is as follows: 133 parts of compound plant seed oil, 5.5 parts of synergistic excipients, and 7.5 parts of synergistic excipients.

[0042] The compound plant seed oils include (parts by weight): 15 parts of Acer truncatum seed oil, 18 parts of Eucommia ulmoides seed oil, 12 parts of Hippophae rhamnoides seed oil, 16 parts of walnut seed oil, 12 parts of milk thistle seed oil, 17 parts of peony seed oil, 10 parts of pomegranate seed oil, 14 parts of grape seed oil, and 19 parts of Sapindus mukorossi seed oil.

[0043] The synergistic excipients include: 1.2 parts curcumin phospholipid complex, 0.8 parts Haematococcus pluvialis oil, and 3.5 parts acetyl L-carnitine (weight ratio 1:0.67:2.92).

[0044] The synergistic excipients include: 5 parts medium-chain triglycerides, 1 part soybean lecithin, and 1.5 parts antioxidants; wherein the antioxidants are ascorbyl palmitate and D-α-tocopherol succinate in a weight ratio of 1:1.

[0045] The preparation method is the same as in Example 1, except that: the pressing pressure in S2 is 33 MPa; and the mixing temperature of the synergistic excipients in S4 is 35°C.

[0046] Application Example 1: Preparation of soft capsules The composition obtained in Example 1 was used to prepare soft capsules according to the soft capsule manufacturing process: a gelatin:glycerin:water ratio of 1:0.4:1 was used, the gelatin thickness was 0.8 mm, and the content was 500 mg / capsule. After pelleting, shaping, washing, and drying, the finished soft capsules were obtained. The disintegration time of the soft capsules (in artificial gastric juice at 37°C) was ≤15 min.

[0047] Application Example 2: Preparation of Microencapsulated Powder After step S4 in Example 1 and before encapsulation in step S5, the obtained composition was microencapsulated: the composition was mixed with a wall material solution at a weight ratio of 1:3. The wall material solution was a compound of sodium octenyl succinate starch, gum arabic, and maltodextrin at a weight ratio of 3:1.5:1, with a total solids content of 25%. After high-speed shear emulsification at 12000 rpm for 8 min (temperature 28°C), spray drying was performed: inlet air temperature 160°C, outlet air temperature 80°C. The resulting microcapsule powder had an encapsulation rate of 94.2%, D 90 The particle size is 12.3 μm. Microencapsulated powder can be used as a raw material for solid beverages.

[0048] Comparative Example 1 The comparative formulation is exactly the same as that of Example 1, but step S4 uses a one-time addition method: the synergistic excipients, nine refined monomeric oils, and co-excipients are all added to the mixing tank at once and mixed under the same temperature and time. The remaining steps are the same as in Example 1.

[0049] Comparative Example 2 The formulation of this comparative example is exactly the same as that of Example 1, except that step S4 is carried out in an atmospheric pressure air environment without nitrogen purging or nitrogen protection. The remaining steps are the same as those in Example 1.

[0050] Comparative Example 3 This comparative formulation contains only compound vegetable seed oil and synergistic excipients, and no co-synergistic excipients. The ratio of compound vegetable seed oil and synergistic excipients is the same as in Example 1, and is made up to a total of 100 parts. The preparation method is the same as in Example 1.

[0051] Comparative Example 4 The formulation of this comparative example is exactly the same as that of Example 1, but step S2 adopts a conventional hot pressing process: the kernels are roasted at 110°C for 30 minutes before pressing, and the pressing temperature is about 80~90°C. The remaining steps are the same as those in Example 1.

[0052] Comparative Example 5 The formulation of this comparative example is exactly the same as that of Example 1, but step S3 uses conventional alkali refining for deacidification: 0.5% NaOH solution is added for neutralization and deacidification, followed by water washing, decolorization with bleaching clay, and vacuum deodorization (200℃, 1h). The remaining steps are the same as in Example 1.

[0053] Comparative Example 6 In this comparative example, all nine plant seed oils in Example 1 were replaced with Acer truncatum seed oil. The remaining components and preparation methods were the same as in Example 1.

[0054] Comparative Example 7 In this comparative example, milk thistle seed oil and peony seed oil in Example 1 were replaced with walnut seed oil and sacha in a proportional manner. The remaining components and preparation methods are the same as in Example 1.

[0055] Experimental Example 1: Accelerated Oxidation Stability Test Take 50g of each of the composition samples from Example 1 and Comparative Examples 1-5, dispense them into sealed brown glass bottles, and place them in a constant temperature incubator at 60℃±1℃ for accelerated oxidation testing. Samples were taken at 0, 5, 10, 15, 20, 25, and 30 days, and the peroxide value (POV) was determined by titration according to GB5009.227-2016 "Determination of Peroxide Value in Food".

[0056] The experimental results are shown in Table 1 below:

[0057] Note: POV units are in g / 100g. Conclusion: After accelerated oxidation at 60℃ for 30 days, the peroxide value of Example 1 was only 0.34 g / 100 g, which was much lower than that of Comparative Examples 2, 4, and 5. This indicates that the quadruple antioxidant process of the present invention, consisting of low-temperature cold pressing + molecular distillation purification, antioxidants, and nitrogen-filled micro-positive pressure protection, has a significant synergistic protective effect.

[0058] Experiment Example 2: Lipid-lowering efficacy trial One hundred male SD rats (weighing 180-220g) were randomly divided into 10 groups of 10 rats each: blank control group, high-fat model group, low / medium / high dose group of Example 1 (corresponding to 5 times, 10 times, and 30 times the recommended human dose, respectively), medium dose group of Example 2, medium dose group of Example 3, medium dose group of Comparative Example 6, medium dose group of Comparative Example 7, and positive control group (atorvastatin 10mg / kg·d).

[0059] Administration: The composition was administered by gavage at low doses of 250 mg / kg·d, medium doses of 500 mg / kg·d, and high doses of 1500 mg / kg·d, once daily for 45 consecutive days.

[0060] Except for the blank control group, which was fed a normal maintenance diet, all other groups were fed a high-fat diet throughout the course of treatment (78.8% basal diet, 10% lard, 10% egg yolk powder, 1% cholesterol, and 0.2% sodium cholate). The drugs were administered via gavage for 45 consecutive days. After the last administration, the patients were fasted for 12 hours. Blood was collected from the abdominal aorta, and serum was separated. Total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) were measured using an automated biochemical analyzer.

[0061] The experimental results are shown in Table 2 below:

[0062] Note: Compared with the high-fat model group, *P<0.05, **P<0.01; compared with the blank control group, ## P<0.01 Experimental conclusions: (1) All three dosage groups in Example 1 significantly reduced serum TC, TG, and LDL-C levels in high-fat model rats and increased HDL-C levels, showing a clear dose-response relationship. The indicators of the high-dose group were similar to those of the positive drug group, but this invention is a natural plant oil composition and does not produce adverse reactions such as elevated liver enzymes and muscle toxicity common in statin drugs. (2) The lipid-lowering effect of Comparative Example 6 was significantly weaker than that of Example 1, indicating that the synergistic effect of the compounding of nine plant seed oils is more important for the lipid-lowering effect. (3) The lipid-lowering effect of Comparative Example 7 was also weaker than that of Example 1, indicating that milk thistle seed oil and peony seed oil improved liver lipid metabolism function while protecting the liver.

[0063] Experiment Example 3: Uric Acid Lowering Efficacy Test Ninety male SD rats were randomly divided into nine groups of ten each, based on their body weight. Except for the control group, all other groups were treated with potassium oxonate (300 mg / kg / day intraperitoneal injection) combined with hypoxanthine (100 mg / kg / day gavage) for 7 consecutive days to establish a hyperuricemia model. The drugs were administered via gavage concurrently with model establishment for 14 consecutive days. After the last administration, serum was collected to measure uric acid (UA) and xanthine oxidase (XOD) activities.

[0064] The experimental results are shown in Table 3 below:

[0065] Conclusion: Example 1 significantly reduced serum uric acid levels and inhibited xanthine oxidase activity in rats with hyperuricemia. The high-dose group showed a similar uric acid-lowering effect to allopurinol, but overcame the risk of hypersensitivity reactions associated with allopurinol. Silybin in milk thistle seed oil and nervonic acid in Acer truncatum seed oil had a synergistic effect in inhibiting xanthine oxidase.

[0066] Experiment Example 4: Blood Pressure Lowering Efficacy Experiment Experimental animals: Fifty SPF-grade male spontaneously hypertensive rats (SHR), weighing 180-220g; another 10 age-matched male WKY rats were used as a blank control group. After acclimatization for 7 days, baseline blood pressure was measured before use in the experiment.

[0067] Experimental grouping: SHR rats were randomly divided into 5 groups according to their baseline blood pressure, with 10 rats in each group. The groups were: model control group, Example 1 group, Comparative Example 1 group, Comparative Example 2 group, and positive drug group (captopril 10 mg / kg·d).

[0068] Administration method: Each group of rats was given the corresponding sample by gavage at a dose of 10 mL / kg body weight. The blank control group and the model control group were given the same volume of vegetable oil by gavage. The administration was once a day for 4 consecutive weeks.

[0069] Detection indicators: After fasting for 12 hours following the last administration, the systolic blood pressure (SBP) and diastolic blood pressure (DBP) of rats in an awake state were measured using a non-invasive tail artery blood pressure measuring instrument; blood was collected from the abdominal aorta to separate serum, and the serum nitric oxide (NO) and endothelin-1 (ET-1) levels were measured.

[0070] The experimental results are shown in Table 4 below:

[0071] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0072] The composition of this invention can significantly reduce systolic and diastolic blood pressure in spontaneously hypertensive rats, while increasing serum NO levels and decreasing ET-1 levels. It exerts its antihypertensive effect by improving vascular endothelial function and dilating blood vessels. The antihypertensive effect was best in Group 1, with systolic blood pressure reduced by 24.5% compared to the model control group, approaching the level of the positive control drug captopril.

[0073] Experiment Example 5: Blood Glucose Lowering Efficacy Trial Experimental animals: 60 SPF-grade male SD rats, weighing 180-220g, were acclimatized for 7 days.

[0074] Modeling method: Except for the blank control group, the other rats were fed a high-fat, high-sugar diet (basal diet 66.5%, sucrose 20%, lard 10%, cholesterol 2.5%, sodium cholate 1%) for 4 weeks, followed by fasting for 12 hours and intraperitoneal injection of 35 mg / kg streptozotocin (STZ, prepared in 0.1 mol / L citrate buffer). After 72 hours, fasting blood glucose was measured by tail vein sampling. A fasting blood glucose level ≥11.1 mmol / L was considered a successful model of type 2 diabetes.

[0075] Experimental grouping: Rats with successfully induced model were randomly divided into 6 groups, with 10 rats in each group: model control group, Example 1 group, Comparative Example 1 group, Comparative Example 2 group, and positive drug group (metformin hydrochloride 200mg / kg). d) and a separate blank control group.

[0076] Administration method: Rats in each group were administered the drug by gavage at a dose of 10 mL / kg body weight once a day for 4 consecutive weeks. During the administration period, except for the blank control group, the other groups continued to be fed a high-fat and high-sugar diet.

[0077] Detection indicators: Fasting blood glucose (FBG) was measured 12 hours after the last administration of the drug; 2-hour postprandial blood glucose (2hPG) was measured after gavage administration of glucose solution at 2 g / kg body weight; Fasting serum insulin (FINS) was measured by ELISA, and the insulin resistance index HOMA-IR was calculated as FBG × FINS / 22.5; Glycated hemoglobin (HbA1c) content was measured at the same time.

[0078] The experimental results are shown in Table 5 below:

[0079] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0080] The composition of this invention can significantly reduce fasting blood glucose, 2-hour postprandial blood glucose, and glycated hemoglobin levels in type 2 diabetic rats, while also reducing serum insulin levels and insulin resistance index. It exerts an auxiliary hypoglycemic effect by improving insulin resistance and enhancing the body's glucose utilization capacity. In Example 1, fasting blood glucose was reduced by 46.4% compared to the model control group, demonstrating a significant effect.

[0081] Experiment 6: Liver Protection Efficacy Test Seventy male SD rats were used to induce a non-alcoholic fatty liver model by feeding them a high-fat diet (same as in Example 2) for 8 weeks. After 8 weeks, they were randomly divided into 7 groups according to body weight and serum ALT levels: model group, low / medium / high dose group of Example 1, medium dose group of Example 2, medium dose group of Comparative Example 3, and positive drug group (silymarin capsules 50 mg / kg·d). After continuing to feed them a high-fat diet and administer the drug by gavage for 6 weeks, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were measured. The liver was weighed and the liver index (liver weight / body weight × 100%) was calculated. The left lobe of the liver was also taken for HE staining and pathological scoring (NAS score, 0-8 points).

[0082] The test results are shown in Table 6 below:

[0083] Note: Compared with the model group, ** P<0.01; NAS score includes three items: steatosis (0-3), intralobular inflammation (0-3), and hepatocellular ballooning degeneration (0-2). Conclusion: (1) Example 1 can significantly reduce ALT and AST levels, liver index and NAS pathological score in non-alcoholic fatty liver model rats, and the liver protection effect is dose-dependent.

[0084] (2) The liver protection indicators of the dose group in Example 1 were better than those of the dose group in Comparative Example 3, indicating that the synergistic excipients made a significant contribution to the liver protection effect: curcumin promotes liver fatty acid oxidation through the AMPK pathway, acetyl-L-carnitine transports fatty acids to mitochondria for combustion, and astaxanthin protects the mitochondrial membrane. The three work together to reduce liver lipid accumulation and oxidative damage.

[0085] (3) The NAS score of the high-dose group in Example 1 (1.1±0.3) was lower than that of the positive drug group (1.5±0.3), indicating that the composition of the present invention has comprehensive advantages in improving the histopathology of non-alcoholic fatty liver.

[0086] Experiment 7: Kidney-tonifying efficacy test Seventy male SD rats were randomly divided into seven groups of ten each. Except for the blank control group, all other groups were administered adenine 100 mg / kg / day via gavage to establish a model for 21 days. The drug intervention was administered via gavage simultaneously with model establishment for 21 consecutive days. Serum creatinine (Cr) and blood urea nitrogen (BUN) were measured after the last administration, and kidney histology was observed using HE staining.

[0087] The experimental results are shown in Table 7 below:

[0088] Conclusion: Example 1 significantly reduced serum Cr and BUN levels in rats with kidney-yang deficiency, protecting renal function. Flavonoids and SOD in sea buckthorn seed oil reduced oxidative damage to the kidneys, while paeoniflorin in peony seed oil and silybin in milk thistle seed oil exerted synergistic anti-inflammatory effects and improved renal microcirculation.

[0089] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A composition for assisting in lowering blood pressure, blood sugar, cholesterol, and blood lipids, and for tonifying the kidneys and protecting the liver, characterized in that, The product comprises the following ingredients in parts by weight: 74-133 parts of compound plant seed oil, 1.2-5.5 parts of synergistic excipients, and 7.5-19.5 parts of synergistic excipients; the compound plant seed oil comprises the following ingredients in parts by weight: 8-15 parts of Acer truncatum seed oil, 10-18 parts of Eucommia ulmoides seed oil, 7-12 parts of Hippophae rhamnoides seed oil, 9-16 parts of walnut seed oil, 6-12 parts of milk thistle seed oil, 10-17 parts of peony seed oil, 5-10 parts of pomegranate seed oil, 8-14 parts of grape seed oil, and 11-19 parts of Sapota javanica seed oil; the synergistic excipients are one or more of the following: curcumin phospholipid complex, Haematococcus pluvialis oil, acetyl-L-carnitine, and icariin phospholipid complex; the synergistic excipients are composed of medium-chain triglycerides, soybean lecithin, and antioxidants.

2. The composition according to claim 1, characterized in that, The compound plant seed oil comprises the following raw materials in parts by weight: 10-13 parts of Acer truncatum seed oil, 12-16 parts of Eucommia ulmoides seed oil, 8-11 parts of Hippophae rhamnoides seed oil, 11-14 parts of walnut seed oil, 7-10 parts of milk thistle seed oil, 12-15 parts of peony seed oil, 6-9 parts of pomegranate seed oil, 10-12 parts of grape seed oil, and 13-17 parts of Sapindus mukorossi seed oil.

3. The composition according to claim 1, characterized in that, The synergistic excipients are composed of curcumin phospholipid complex, Haematococcus pluvialis oil, and acetyl-L-carnitine in a weight ratio of 1:(0.3~0.8):(1~3).

4. The composition according to claim 1, characterized in that, The synergistic excipient consists of 5-15 parts medium-chain triglycerides, 1-4 parts soybean lecithin, and 0.15-0.5 parts antioxidant.

5. The composition according to claim 1, characterized in that, The antioxidant is ascorbyl palmitate and D-α-tocopherol succinate in a weight ratio of 1:(1~3).

6. The composition according to any one of claims 1 to 5, characterized in that, The formulation of the composition is any one of soft capsules, oral liquids, microcapsule powders, gel candies, ready-to-eat oil packets, or solid beverages.

7. The method for preparing the composition according to any one of claims 1 to 5, characterized in that, Includes the following steps: S1. Raw material pretreatment: Select mature and plump kernels of Acer truncatum, Eucommia ulmoides, Hippophae rhamnoides, walnut, milk thistle, peony, pomegranate, grape, and sacha indica. After air separation to remove impurities and washing with clean water, dry them in low-temperature hot air at 35~40℃ until the kernel moisture content is ≤6% by mass. S2. Low-temperature physical cold pressing: Various types of kernels are fed into a cold press and physically pressed under the conditions of material temperature ≤45℃ and pressing pressure 25~35MPa. The first crude oil is collected and the oil residue is removed by plate and frame filter press to obtain the virgin oil of each individual. S3. Distillation and Refining: Each monomer virgin essential oil is fed into a distillation device and deacidified and deodorized under the conditions of system vacuum degree ≤10Pa, distillation temperature 120~140℃, and scraper speed 200~250r / min to remove free fatty acids and small molecule odor impurities, and obtain refined monomer oils. S4. Gradient compounding: First, add the synergistic excipients to a sealed mixing tank, purge the air in the tank with nitrogen gas of ≥99.9% purity, control the residual oxygen content in the tank to ≤0.5%, and stir at 40~60 r / min for 10~15 min at 30~35℃ until a matrix system is formed; then add the refined monomer oil to the matrix system, and maintain constant temperature and speed stirring for 15~20 min until the oil phase is completely homogeneous; finally, add the synergistic excipients, and continue stirring for 20~30 min until the system is completely homogeneous; S5. Aseptic nitrogen-filled packaging: After filtering the compounded oil, it is aseptically packaged under nitrogen protection throughout the process.

8. The preparation method according to claim 7, characterized in that, In step S2, the single pressing time is 25~35s, and the oil yield of each monomer virgin essential oil is controlled at 28%~35%; in step S3, the distillation and refining adopts short-path molecular distillation, with a feed flow rate of 1.0~1.5mL / min and a condensation surface temperature of 20~25℃.

9. The preparation method according to claim 7, characterized in that, During the stirring process in step S4, the pressure inside the tank is maintained at 0.02~0.05MPa throughout the entire process.

10. The use of the composition according to any one of claims 1 to 5 in the preparation of health foods or medicines having functions of lowering blood pressure, blood sugar, cholesterol, and cholesterol levels, protecting the liver, and antioxidation.

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