Traditional Chinese medicine composition for reducing content of cholesterol in blood as well as preparation method and application of traditional Chinese medicine composition

By using a specific ratio of traditional Chinese medicine composition, and taking advantage of the synergistic effects of black beans, vegetables and walnuts, cholesterol synthesis is inhibited and its excretion is promoted. This solves the problems of adverse reactions and resource burden in existing drug treatments, and achieves safe and effective cholesterol management, with significant lipid-lowering effects and comprehensive health care functions.

CN120884625APending Publication Date: 2025-11-04MENTOUGOU HOSPITAL
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Patent Information

Application Number
CN202510997409.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-07-18
Publication Date
2025-11-04

AI Technical Summary

Technical Problem

Existing drug treatments for lowering blood cholesterol have adverse effects and increase the burden on medical resources. Furthermore, while lowering cholesterol, existing lipid-lowering drugs cannot effectively address the incidence of hypercholesterolemia and the risk of atherosclerosis.

Method used

A traditional Chinese medicine composition with a specific ratio is made of black beans, specific vegetables (such as spinach or asparagus and pumpkin) and walnuts. Through ultrasonic soaking, low-temperature cooking of beans and blanching of vegetables, combined with low-temperature pulping and cellulase-assisted processes, multiple synergistic effects are formed to inhibit cholesterol synthesis and promote its excretion. It is prepared into dosage forms such as beverages, concentrated liquids, freeze-dried powders or capsules.

Benefits of technology

It significantly reduces serum total cholesterol and low-density lipoprotein cholesterol, improves vascular endothelial function, reduces the risk of atherosclerosis, and is characterized by high safety, low cost, no obvious side effects, and suitability for long-term use. It also has comprehensive health benefits such as assisting in blood sugar control, anti-oxidation, and hormone regulation.

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Abstract

The invention relates to the technical field of traditional Chinese medicines, and discloses a traditional Chinese medicine composition for reducing the content of cholesterol in blood and a preparation method and application thereof. The traditional Chinese medicine composition for reducing the cholesterol content in the blood is prepared from the following raw material medicines in parts by weight: 3-6 parts of black beans, 1-3 parts of vegetables and 0.1-0.3 part of walnuts. The vegetables are selected from spinach or a combination of asparagus and pumpkins; wherein the black beans are black-peel and yellow-kernel varieties, the anthocyanin content is more than or equal to 2.5 mg / g, and the total amount of soy isoflavone is more than or equal to 4.0 mg / g; the spinach is an overwintering variety, and the proportion of soluble dietary fibers is greater than or equal to 16%; according to the traditional Chinese medicine composition for reducing the content of cholesterol in blood, active ingredients such as anthocyanin, isoflavone, unsaturated fatty acid and the like of black beans are fully utilized and have a synergistic effect with dietary fibers and vitamins of specific vegetables, the activity of thermosensitive ingredients is reserved by optimizing a process, the blood cholesterol is effectively reduced, and the traditional Chinese medicine composition is safe, free of side effects, low in cost and suitable for industrial production. The traditional Chinese medicine composition is suitable for prevention or adjuvant treatment of hypercholesteremia and atherosclerosis.
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Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, more particularly to a traditional Chinese medicine composition for reducing blood cholesterol content and a preparation method and application thereof. BACKGROUND

[0002] With the development of social economy and the change of residents' lifestyle, the significant change of dietary structure leads to the continuous increase of the prevalence rate of hyperlipidemia and coronary atherosclerotic heart disease, and presents a phenomenon of obvious age advancement of onset, especially the growth rate of the incidence of hypercholesterolemia is particularly prominent.

[0003] Modern medical research has confirmed that the increase of serum total cholesterol level is an independent risk factor for atherosclerotic cardiovascular disease, and its pathogenic mechanism lies in that high cholesterol state can cause dysfunction of vascular endothelial cells, promote abnormal deposition of lipids in the blood vessel wall, and thus accelerate the formation and progression of atherosclerotic plaques. Although controlling cholesterol level can effectively reduce the incidence risk of cardiovascular disease, in the actual clinical treatment process, the existing drug treatment means not only causes inevitable adverse drug reactions, but also significantly increases the resource burden and operating pressure of the medical system, which makes it a key problem to be solved in the current medical field to explore safer and more effective cholesterol management strategies. SUMMARY

[0004] The present application aims at solving the problems of adverse reactions and increased medical resource burden caused by the existing drug treatment means, and provides a traditional Chinese medicine composition for reducing blood cholesterol content and a preparation method and application thereof. The traditional Chinese medicine composition for reducing blood cholesterol content has the characteristics of safety and effectiveness, low cost and long-term use, and can avoid the side effects and medical burden of existing lipid-lowering drugs.

[0005] In order to achieve the above-mentioned purpose, the present application specifically adopts the following technical solutions: The present application provides a traditional Chinese medicine composition for reducing blood cholesterol content, which is made of the following weight parts of raw medicinal materials: 3-6 parts of black beans, 10-30 parts of vegetables, and 1-3 parts of walnuts; the vegetables are selected from spinach or a combination of asparagus and pumpkin; wherein the black beans are black skin yellow kernel variety, the anthocyanin content is ≥2.5mg / g, and the total amount of soy isoflavones is ≥4.0mg / g; the spinach is a wintering variety, and the soluble dietary fiber accounts for ≥16%.

[0006] The anthocyanin content of common black beans is 1.8 mg / g on average, and the total amount of soybean isoflavones is 1.0-3.0 mg / g, the black beans of the black skin and yellow kernel variety selected in the application have an anthocyanin content of ≥2.5 mg / g and a total amount of soybean isoflavones of ≥4.0 mg / g (calculated based on the dry weight of beans), the black beans are subjected to acidolysis or enzymatic hydrolysis treatment before the detection, and the specificity index of the black beans ensures the basis of active ingredients.

[0007] The soluble fiber accounts for about 5-15% (fresh weight) of the dietary fiber in common spinach, the overwintering cold-resistant variety of spinach selected in the application has a soluble fiber content of ≥16% in the dietary fiber, and a folate content of ≥200 μg / 100 g, the specificity index of the spinach enhances the synergistic antioxidant effect of the black beans.

[0008] Further, the above-mentioned traditional Chinese medicine composition further comprises 0.05-0.1 parts of sea buckthorn fruit powder, and the sea buckthorn fruit powder has a vitamin E content of ≥150 mg / 100 g (fresh weight).

[0009] The vitamin E contained in the above-mentioned sea buckthorn fruit powder can form an "antioxidant network" with selenium in the black beans, and experiments have verified that the variant has an improved 29% clearance capacity for oxidized LDL compared with the original formula, and does not affect the original lipid-lowering effect.

[0010] Further, the spinach has a vitamin K content of (400-500) μg / 100 g; and / or, the black beans have a selenium content of ≥0.15 mg / kg; and / or, the walnuts have an α-linolenic acid content of ≥55%; and / or, the mass ratio of asparagus to pumpkin is 8:(5-8).

[0011] In the present application, the protein content of black beans (dry beans) is as high as 36%, containing 8 kinds of essential amino acids for the human body, which belongs to complete protein and has high digestibility (especially after cooking). More than 80% of the fat in black beans is unsaturated fatty acid such as linoleic acid and oleic acid, which helps to regulate blood lipids and maintain cardiovascular health. Black bean milk retains the soluble and insoluble dietary fiber in black beans, among which the soluble fiber: delays sugar absorption and helps to control blood sugar; the insoluble fiber: promotes intestinal peristalsis and prevents constipation. Further, the main components of black beans contain anthocyanins, and the black bean skin is rich in anthocyanins (antioxidants), which have the following effects: neutralizing free radicals and delaying cell aging; protecting blood vessel endothelium and reducing the risk of arteriosclerosis; improving visual fatigue (especially for electronic screen users); containing soy isoflavones (phytoestrogens) to regulate estrogen levels and relieve menopausal hot flashes and insomnia; reducing the risk of breast cancer and osteoporosis (requires long-term and appropriate intake). At the same time, it contains vitamin E + selenium, a strong antioxidant combination, which synergistically protects cell membranes and enhances immunity. It also contains minerals such as calcium, iron, magnesium, and zinc, which have certain effects on strengthening bones, preventing iron deficiency anemia, regulating neuromuscular function, promoting wound healing, taste sensitivity, etc. After adding vegetables, vitamin A / C / E / K is fully covered, folic acid is supplemented, the synergistic effect is increased, the diet is balanced, both traditional nutrition and modern antioxidant needs are considered, which can effectively reduce the cholesterol content in serum and reduce the incidence of cardiovascular and cerebrovascular diseases.

[0012] In the present application, black bean anthocyanins can inhibit cholesterol biosynthesis, specifically, anthocyanins (such as cyanidin-3-glucoside) reduce the generation of endogenous cholesterol precursor (mevalonic acid) in liver cells by down-regulating the gene expression and activity of HMG-CoA reductase, eliminate free radicals, reduce low-density lipids (LDL) oxidation, inhibit the deposition of oxidized LDL on the vascular wall to form plaques, and accelerate the clearance of LDL in blood by activating the expression of liver LDL receptors; vegetable dietary fiber can block intestinal cholesterol absorption, specifically, soluble fiber (pectin) forms a gel matrix in the intestine, directly wraps free cholesterol and bile acids through hydrophobic interaction and hydrogen bonding, and phytosterols compete with cholesterol for absorption sites on intestinal microvilli; the formed complex is excreted with feces, forcing the liver to mobilize blood cholesterol to synthesize new bile acids, reducing serum total cholesterol levels, and the two form a "inhibition of synthesis + promotion of excretion" double pathway.

[0013] The combination in the present application embodies the "ternary synergistic system" of medicinal and edible homology: for the first time, black beans (3-6 parts), specific vegetables (spinach / asparagus + pumpkin), and walnuts (0.1-0.3 parts) form a "lipid-lowering triangle" - black beans provide the basis for antioxidant and hormone regulation, vegetables strengthen intestinal excretion, and walnuts supplement long-chain unsaturated fatty acids, which have not been reported in the prior art.

[0014] The application provides a preparation method of the traditional Chinese medicine composition for reducing blood cholesterol content. Step one, black beans and water are mixed, ultrasonic soaking, cooking beans, and then first beating is performed to obtain black bean milk; Step two, the vegetables are blanched or steamed to obtain blanched vegetables or steamed vegetables; Step three, the black bean milk obtained in step one is mixed with the blanched vegetables or steamed vegetables, and second beating is performed to obtain the traditional Chinese medicine composition for reducing blood cholesterol content.

[0015] Further, in step one, the mass-volume ratio of black beans to water is 1g:(6-7)mL; And / or, the ultrasonic soaking conditions include: power of 300W-500W, temperature of 20℃-25℃, and time of 8h-10h; And / or, the cooking bean conditions include: temperature of 100℃-110℃, and time of 10 minutes-15 minutes; And / or, the first beating process is: running at a speed of 15000rpm-25000rpm for 20s-30s, stopping for 10s-15s, and repeating 4-5 times.

[0016] Preferably, the ultrasonic soaking is optimized as "double-frequency ultrasonic (20kHz+40kHz) alternating soaking", which can shorten the time from 8-10h to 5h, and the softening degree of black beans is more uniform (hardness deviation ≤5%), which is more suitable for large-scale production line.

[0017] Further, in step two, the blanching conditions include: temperature of 60℃-70℃, pressure of 0.08MPa-0.10MPa, and time of 20s-60s; And / or, the steaming conditions include: temperature of 60℃-70℃, pressure of 0.08MPa-0.10MPa, and time of 3 minutes-8 minutes.

[0018] Further, in step three, the mixing conditions include: temperature of 40℃-50℃; And / or, the second beating conditions include: temperature of 45℃-48℃, speed of 15000rpm-25000rpm, and time of 60s-120s; And / or, 0.01% cellulase is added during the second beating, and the temperature is kept at 45℃-48℃ for 10 minutes; And / or, sea buckthorn fruit powder is added after the second beating.

[0019] In the present application, the complete protein, unsaturated fatty acids (especially linoleic acid and oleic acid), anthocyanins, soy isoflavones, vitamin E, selenium and minerals (calcium, magnesium, zinc, etc.) in black beans form a multiple synergistic effect with the rich dietary fiber, vitamins (A, C, E, K, folic acid, etc.) and minerals provided by the preferred vegetable combination (asparagus / squash or spinach) to effectively regulate lipid metabolism (reduce total cholesterol and low-density lipoprotein cholesterol), improve vascular endothelial function, and inhibit the formation of atherosclerosis. Walnuts further supplement beneficial unsaturated fatty acids.

[0020] In the present application, the activity of heat-sensitive components such as anthocyanins and soy isoflavones and vitamins is maximally retained through a specific process (soaking softening, high-temperature short-time bean enzyme inactivation, moderate heat treatment of vegetables, and 40-50℃ warm soy milk mixing and rapid whipping), ensuring their bioavailability.

[0021] Compared with traditional high-temperature cooking methods, the 45-48℃ low-temperature whipping + cellulase-assisted process of the present application can increase the retention rate of anthocyanins by 41% and the retention rate of vitamin C by 53%, solving the technical problem of "active ingredients and process adaptability".

[0022] In the present application, the use of medicinal and edible raw materials avoids harmful chemicals during the preparation process, is safe for long-term use, and has no obvious side effects. The preparation method is simple and easy to implement, and is suitable for family or industrial production. Compared with drugs, the cost is significantly reduced, reducing the economic burden on patients.

[0023] In addition to lowering cholesterol, the composition also has comprehensive health care effects such as assisting in controlling blood sugar, antioxidant and anti-aging, regulating hormones (especially the benefits of soy isoflavones for women), and promoting intestinal health.

[0024] The present application provides a ready-to-drink beverage, a concentrated liquid, a freeze-dried powder or a capsule made of the above-mentioned traditional Chinese medicine composition for lowering blood cholesterol content or the traditional Chinese medicine composition prepared by the above-mentioned preparation method.

[0025] In addition to the above-mentioned dosage forms, the traditional Chinese medicine composition can also be made into chewable tablets and probiotic complex preparations by adding Lactobacillus plantarum LP-6. The probiotics can promote the fermentation of dietary fiber to produce short-chain fatty acids (such as propionic acid), further inhibit the synthesis of liver cholesterol, and are suitable for children and people with difficulty swallowing.

[0026] In the preparation of the above-mentioned ready-to-drink beverage, 0.02wt% rosemary extract is added, with the mass of the ready-to-drink beverage being 100%. The additive is a natural antioxidant, which extends the shelf life of the ready-to-drink beverage from 7 days to 14 days at room temperature, and reduces the hygroscopicity of the freeze-dried powder by 40% (verified by accelerated experiment, stored at 40℃, RH75% for 3 months).

[0027] The application provides application of the traditional Chinese medicine composition for reducing blood cholesterol content or the traditional Chinese medicine composition for reducing blood cholesterol content prepared by the preparation method in preparation of medicines or health products for reducing blood cholesterol content.

[0028] The application provides application of the traditional Chinese medicine composition for reducing blood cholesterol content or the traditional Chinese medicine composition for reducing blood cholesterol content prepared by the preparation method in preparation of medicines or health products for preventing or assisting in treating hypercholesterolemia or atherosclerosis.

[0029] The application is more suitable for menopausal women with hypercholesterolemia, and the black soybean isoflavones can relieve menopausal metabolic disorders; experiments show that after the population takes the composition for 3 months, the serum cholesterol reduction rate is 15% higher than that of ordinary population (n=50, p<0.05).

[0030] The application has the following beneficial effects: The application realizes effective regulation of blood lipid metabolism and improvement of vascular endothelial function by optimizing the synergistic compatibility of black soybeans and specific vegetables and a preparation process, utilizing complete proteins, unsaturated fatty acids and anthocyanins and other active ingredients contained in the black soybeans, combining dietary fibers and vitamin groups in the vegetables to form a complex system with multiple synergistic effects; the biological activities of heat-sensitive components such as anthocyanins and soybean isoflavones are maximized by specific temperature control and mixing process treatment, the antioxidant combination and the mineral network together strengthen the cardiovascular protection effect; the bioavailability is significantly improved by the double enzyme inactivation process of black soybean precooking and vegetable heat treatment, compared with the existing drug treatment scheme, the adverse reactions of drugs can be avoided, and the dual needs of dietary nutrition supplementation and chronic disease prevention can be met, thereby fundamentally reducing the incidence of atherosclerotic cardiovascular diseases, and solving the problem that safety and effectiveness are difficult to be considered in the existing cholesterol-lowering methods.

[0031] In the application, the black soybeans are selected from black skin and yellow kernel varieties, the anthocyanin content is greater than or equal to 2.5 mg / g, and the total amount of soybean isoflavones is greater than or equal to 4.0 mg / g, which is significantly higher than that of ordinary black soybeans. The specific variety of black soybeans provides a higher active ingredient basis for the composition, thereby enhancing the cholesterol-lowering effect.

[0032] In the application, the vegetables in the composition are selected from the combination of spinach or asparagus and pumpkin, and in particular, the overwintering variety of spinach is selected, and the soluble dietary fiber accounts for greater than or equal to 16%, thereby further enhancing the synergistic antioxidant effect with the black soybeans.

[0033] In the application, the raw materials are scientifically proportioned, the best synergistic effect between the components is realized by accurate weight proportioning (3-6 parts of black soybeans, 10-30 parts of vegetables and 1-3 parts of walnuts), and the blood cholesterol content is effectively reduced.

[0034] The synergistic mechanism in the present application has the following two points: First, the synergy of black beans and vegetables: the active ingredients such as anthocyanins and soy isoflavones in black beans and the dietary fiber and vitamins in vegetables form multiple synergies, effectively reducing cholesterol through the dual pathways of "inhibiting synthesis + promoting excretion".

[0035] Second, ternary synergistic system: for the first time, black beans, specific vegetables (spinach / asparagus + pumpkin), and walnuts form a "lipid-lowering triangle". Black beans provide the basis for antioxidant and hormone regulation, vegetables enhance intestinal excretion, and walnuts supplement long-chain unsaturated fatty acids. This combination has not been reported in the prior art.

[0036] The optimized preparation process in the present application has the following three points: 1. Retaining heat-sensitive components: through ultrasonic soaking process and low-temperature pulping process, the activity of heat-sensitive components such as anthocyanins, soy isoflavones, and vitamins can be maximally retained, ensuring their bioavailability.

[0037] 2. Dual enzyme inactivation process: using black bean precooking and vegetable heat treatment dual enzyme inactivation process, the bioavailability is significantly improved, making the active ingredients more easily absorbed by the human body.

[0038] 3. Low-temperature pulping and enzymatic hydrolysis technology: compared with traditional high-temperature decoction method, the 45-48℃ low-temperature pulping + cellulase auxiliary process of the present application can increase the anthocyanin retention rate by 41% and the vitamin C retention rate by 53%, solving the technical problem of compatibility of active ingredients and process.

[0039] The present application has significant clinical effects and safety, mainly reflected in the following two points: 1. Significant cholesterol-lowering effect: experimental data show that the traditional Chinese medicine composition has significant effect in reducing serum total cholesterol and low-density lipoprotein cholesterol, comparable to low-dose statins, but with significantly reduced adverse reaction rate.

[0040] 2. High long-term safety: 12-month toxicity experiment shows that rats do not have liver and kidney function abnormalities after long-term administration, and the intestinal flora diversity does not change significantly, proving the safety of long-term administration.

[0041] The present application has wide application prospects and comprehensive health care effects, mainly reflected in the following two aspects: 1. Multiple dosage forms: the traditional Chinese medicine composition can be made into various dosage forms such as instant drinks, concentrated liquids, freeze-dried powders, and capsules, meeting the needs of different groups of people.

[0042] II. Comprehensive health effects: In addition to lowering cholesterol, the composition also has the effects of assisting in blood sugar control, antioxidant anti-aging, hormone regulation, promoting intestinal health, etc. It is especially suitable for postmenopausal women with high cholesterol.

[0043] In the present application, the selection of black beans has a significant and specific impact on the activity of the composition, mainly in the following aspects: I. Anthocyanin content: The black soybean variety selected in the present application has an anthocyanin content of ≥2.5 mg / g, which is significantly higher than the average anthocyanin content of ordinary black beans (1.8 mg / g). As a powerful antioxidant, anthocyanin can neutralize free radicals, delay cell aging, protect vascular endothelium, and reduce the risk of arteriosclerosis. High content of anthocyanin makes the composition show stronger activity in antioxidant and cardiovascular protection.

[0044] II. Total soy isoflavone content: In the selected black bean variety, the total soy isoflavone content is ≥4.0 mg / g, which is also higher than that of ordinary black beans (1.0-3.0 mg / g). As a phytoestrogen, soy isoflavone has multiple physiological functions such as regulating estrogen levels, relieving menopausal symptoms, and reducing the risk of breast cancer and osteoporosis. High content of soy isoflavone enhances the activity of the composition in regulating hormones and bone health.

[0045] III. Unsaturated fatty acid composition: More than 80% of black bean fat is composed of unsaturated fatty acids such as linoleic acid and oleic acid, which helps to regulate blood lipids and maintain cardiovascular health. Although all black bean varieties contain these unsaturated fatty acids, specific varieties of black beans may have more optimized fatty acid composition due to their growth conditions and genetic characteristics, thereby further enhancing the blood lipid-lowering effect of the composition.

[0046] IV. Other active ingredients: In addition to anthocyanins and soy isoflavones, black beans also contain a variety of active ingredients such as vitamin E, selenium, and minerals (such as calcium, iron, magnesium, and zinc). The selected black bean variety may be rich in these ingredients due to its growth environment or genetic characteristics, thereby enhancing the comprehensive health effects of the composition, such as enhancing immunity and promoting wound healing.

[0047] V. Synergistic effect enhancement: High content of anthocyanins and soy isoflavones form a synergistic effect with other active ingredients (such as unsaturated fatty acids, vitamin E, selenium, etc.), which together enhance the biological activity of the composition. For example, anthocyanins and soy isoflavones can jointly protect vascular endothelium and reduce the risk of arteriosclerosis; unsaturated fatty acids and vitamin E can jointly regulate blood lipid metabolism and improve cardiovascular health.

[0048] Six, the effect of experimental verification: experimental data show that the composition prepared by using a specific variety of black beans has a significant effect on reducing serum total cholesterol and low-density lipoprotein cholesterol, and the incidence of adverse reactions is low. This further verifies the important influence of black bean selection on the activity of the composition.

[0049] The synergistic antioxidant effect of vegetables and black beans is embodied in the present application through multiple dimensional mechanisms, as follows: I. Complementary active ingredients: targeted free radical scavenging and oxidative stress inhibition Antioxidant core component of black beans: anthocyanins: anthocyanins (such as cyanidin-3-glucoside) rich in black bean skin are potent free radical scavengers, which can directly neutralize reactive oxygen species (ROS) produced by oxidative stress, reduce low-density lipoprotein (LDL) oxidation, and inhibit the deposition of oxidized LDL on the vascular wall to form plaques.

[0050] Soy isoflavones: as phytoestrogens, soy isoflavones can regulate the activity of antioxidant enzymes (such as superoxide dismutase SOD and glutathione peroxidase GSH-Px), and enhance the antioxidant defense system of cells.

[0051] Synergistic components of vegetables: Vitamin C / E / K: vegetables such as spinach are rich in vitamin C (about 28-45 mg / 100 g fresh weight) and vitamin E (alpha-tocopherol), which form an "antioxidant network" with vitamin E in black beans, regenerate oxidized vitamin E, and prolong its antioxidant period.

[0052] Folic acid and carotenoids: folic acid (≥200 μg / 100 g) and beta-carotene in vegetables can reduce homocysteine levels (high homocysteine is an independent risk factor for cardiovascular disease), while carotenoids (such as lutein) can absorb blue light and reduce photooxidative damage.

[0053] Experimental verification: In the drink of Example 1, the addition of sea buckthorn powder (containing vitamin E ≥ 150 mg / 100 g) makes the composition's ability to clear oxidized LDL increase by 29% compared to the original formula, proving that multi-component synergy can significantly enhance antioxidant efficiency.

[0054] II. Dietary fiber binds with bile acids: blocking intestinal cholesterol absorption Dietary fiber of black beans: Black beans contain soluble fiber (such as galacto-oligosaccharides) and insoluble fiber. Soluble fiber forms a viscous matrix in the intestine, which encapsulates bile acids and cholesterol, reducing their reabsorption.

[0055] Vegetable dietary fiber reinforcement: Spinach: The soluble dietary fiber of overwintering spinach accounts for ≥16% (fresh weight), which is 1.3-3 times that of ordinary spinach. The pectin component can form insoluble complexes with cholesterol, promoting excretion.

[0056] Asparagus / Pumpkin: Asparagus contains inulin (a soluble fructan), and pumpkin contains pectin and polysaccharides, both of which can adsorb cholesterol and bile acids, reducing serum cholesterol levels.

[0057] Mechanism of action: Vegetable dietary fiber and black bean fiber form a "double interception network": 1. In the intestine, soluble fiber wraps around free cholesterol, reducing its contact with microvilli absorption sites; 2. Insoluble fiber increases stool volume, accelerating cholesterol excretion; 3. Phytosterols (naturally occurring in vegetables) compete with cholesterol for intestinal absorption sites, further reducing absorption rates.

[0058] Experimental data: The inhibition rate of the complex formed by black bean anthocyanins and spinach pectin on intestinal cholesterol transport protein NPC1L1 increased by 32% compared to single components (verified by in vitro intestinal cell models), indicating that synergistic effects can more efficiently block cholesterol absorption.

[0059] Three, synergistic activation of minerals and antioxidant enzymes Selenium and zinc in black beans: Black beans contain ≥0.15 mg / kg of selenium, which is a good source of plant selenium. Selenium is the active center of glutathione peroxidase (GSH-Px), which can catalyze the reduction of hydrogen peroxide and organic hydroperoxide, protecting cell membranes from oxidative damage.

[0060] Zinc (black beans contain about 3-5 mg / 100g) is a cofactor for superoxide dismutase (SOD), which can accelerate the dismutation reaction of superoxide anion (O2⁻), reducing oxidative stress.

[0061] Mineral supplementation of vegetables: Spinach contains magnesium (about 79 mg / 100g) and iron (about 2.7 mg / 100g), magnesium is an activator of SOD, and iron is a cofactor for catalase (CAT), together enhancing the activity of the antioxidant enzyme system.

[0062] Synergistic effect: The combination of minerals in black beans and vegetables can simultaneously activate SOD, GSH-Px, and CAT, three antioxidant enzymes, forming an "enzyme defense triangle" to comprehensively eliminate ROS and reduce the generation of oxidized LDL.

[0063] Four, synergistic lipid-lowering effect verified by pharmacodynamic experiments Clinical data: The test shows that after drinking the beverage of Example 1 for 3 months, the decrease of serum total cholesterol (TC) is 32.62%, the decrease of low density lipoprotein cholesterol (LDL-C) is significant, and the incidence of adverse reactions is 0 (the incidence of statins is 8%).

[0064] Dose effect: The effect of the 400 mL / day dose group is the best (TC decrease of 32.62%), the decrease of the 200 mL / day group is 24.02%, and the effect of the 600 mL / day group does not significantly improve, proving that there is an optimal matching range for the synergistic effect of black beans and vegetables.

[0065] Therefore, the synergistic antioxidant effect of vegetables and black beans is achieved through three mechanisms of active ingredient complementation (anthocyanins + vitamins C / E), dietary fiber blocking absorption (soluble fiber + phytosterols), and mineral activation of enzyme systems (selenium + zinc + magnesium). Experimental data show that this combination can significantly reduce oxidative stress and reduce cholesterol absorption, and is superior to single components or non-synergistic formulations, providing a safe and effective solution for the prevention of hypercholesterolemia and atherosclerosis. DETAILED DESCRIPTION

[0066] To make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme of the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments.

[0067] Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of protection of the present application.

[0068] In the embodiments of the present application, the black beans are black-skinned yellow kernel varieties, the anthocyanin content is ≥2.5 mg / g, and the total amount of soy isoflavones is ≥4.0 mg / g; the spinach is a wintering variety, and the soluble dietary fiber content is ≥16%; The vitamin K content of the spinach is (400-500) μg / 100 g; the selenium content of the black beans is ≥0.15 mg / kg; the alpha-linolenic acid content of the walnuts is ≥55%; and the vitamin E content of the sea buckthorn fruit powder is ≥150 mg / 100 g.

[0069] Example 1 A black bean walnut asparagus pumpkin beverage Made from the following weight parts of raw medicinal materials: black beans 50 g, asparagus 80 g, pumpkin 50 g, and walnut kernels 10 g.

[0070] The preparation steps are as follows: Soaking: soak 50 g of black beans in 320 mL of normal temperature water for 9 hours with ultrasonic (power of 300 W).

[0071] Boiling and beating: The soaked beans were removed, 320 mL of water was added to boil, and boiled in 100℃ boiling water for 12 minutes. The boiled black beans were poured into the blender along with the cooking liquid, and run at 20000 rpm for 30 seconds, stop for 10 seconds, repeat 4 times, to get black bean juice.

[0072] Vegetable processing: Asparagus was washed and cut into sections, blanched at 60℃ and 0.08MPa for 40 seconds, and then drained; pumpkin was steamed at 60℃ and 0.08MPa for 5 minutes, and then ready for use.

[0073] Mixing and beating: After the black bean juice was cooled to 45℃, the black bean juice, blanched asparagus, steamed pumpkin, and walnut kernels were put into the blender, and 0.01wt% cellulase was added, based on the total mass of raw materials being 100%, and then incubated at 45℃ for 10 minutes. Then, the mixture was beaten at 45℃ and 20000 rpm for 90 seconds to obtain 450 mL of asparagus pumpkin black bean walnut drink.

[0074] Example 2 An asparagus pumpkin black bean walnut drink It is made from the following raw materials by weight: 30g of black beans, 50g of asparagus, 50g of pumpkin, and 10g of walnut kernels.

[0075] The preparation steps are as follows: Soaking: 50g of black beans were soaked in 320 mL of water at room temperature for 9 hours.

[0076] Boiling and beating: The soaked beans were removed, 320 mL of water was added to boil, and boiled in 100℃ boiling water for 12 minutes. The boiled black beans were poured into the blender along with the cooking liquid, and run at 20000 rpm for 30 seconds, stop for 10 seconds, repeat 4 times, to get black bean juice.

[0077] Vegetable processing: Asparagus was washed and cut into sections, blanched at 60℃ and 0.08MPa for 40 seconds, and then drained; pumpkin was steamed at 60℃ and 0.08MPa for 5 minutes, and then ready for use.

[0078] Mixing and beating: After the black bean juice was cooled to 45℃, the black bean juice, blanched asparagus, steamed pumpkin, and walnut kernels were put into the blender, and 0.01wt% cellulase was added, based on the total mass of raw materials being 100%, and then incubated at 45℃ for 10 minutes. Then, the mixture was beaten at 45℃ and 20000 rpm for 90 seconds to obtain 450 mL of asparagus pumpkin black bean walnut drink.

[0079] Example 3 An asparagus pumpkin black bean walnut drink It is prepared from the following raw materials by weight: black beans 60 g, asparagus 160 g, pumpkin 140 g, and walnut kernels 30 g.

[0080] The preparation steps are as follows: Soaking: 50 g of black beans are soaked in 320 mL of normal temperature water for 9 hours by ultrasonic (power 300 W).

[0081] Boiling and grinding: the soaked beans are taken out, 320 mL of clean water is added to boil, and the boiled black beans are boiled in 100°C boiling water for 12 minutes. The boiled black beans are poured into a food processor along with the cooking liquid, and ground at a speed of 20,000 rpm for 2 minutes to obtain black bean milk.

[0082] Vegetable processing: the asparagus is washed and cut into sections, blanched at a temperature of 60°C and a pressure of 0.08 MPa for 40 seconds, and then taken out and drained; the pumpkin is steamed at a temperature of 60°C and a pressure of 0.08 MPa for 5 minutes, and then used.

[0083] Mixing and rapid grinding: after the black bean milk is cooled to 45°C, the black bean milk, blanched asparagus, steamed pumpkin, and walnut kernels are placed in a food processor, 0.01wt% cellulase is added based on the total mass of the raw materials, and then incubated at a temperature of 45°C for 10 minutes. Then, the mixture is ground at a temperature of 45°C and a speed of 20,000 rpm for 90 seconds to obtain 450 mL of asparagus pumpkin black bean walnut drink.

[0084] Example 4 An asparagus pumpkin black bean walnut drink It is prepared from the following raw materials by weight: black beans 50 g, asparagus 80 g, pumpkin 50 g, walnut kernels 10 g, and 0.6 g of sea buckthorn fruit powder (the vitamin E content of the sea buckthorn fruit powder is ≥ 150 mg / 100 g).

[0085] The preparation steps are as follows: Soaking: 50 g of black beans are soaked in 320 mL of normal temperature water for 9 hours by ultrasonic (power 300 W).

[0086] Boiling and grinding: the soaked beans are taken out, 320 mL of clean water is added to boil, and the boiled black beans are boiled in 100°C boiling water for 12 minutes. The boiled black beans are poured into a food processor along with the cooking liquid, and ground at a speed of 20,000 rpm for 2 minutes to obtain black bean milk.

[0087] Vegetable processing: the asparagus is washed and cut into sections, blanched at a temperature of 60°C and a pressure of 0.08 MPa for 40 seconds, and then taken out and drained; the pumpkin is steamed at a temperature of 60°C and a pressure of 0.08 MPa for 5 minutes, and then used.

[0088] Mixing and speed beating: after the black bean milk is cooled to 45℃, the black bean milk, blanched asparagus, steamed pumpkin, and walnut kernels are put into a food processor together. 0.01wt% cellulase is added, and the mixture is incubated at 45℃ for 10 min. Then the mixture is beaten at 20000 rpm for 90 seconds at 45℃ to obtain 450 mL of asparagus pumpkin black bean walnut drink.

[0089] Example 5 A spinach black bean walnut drink It is made from the following raw materials by weight: black beans 50g, spinach 100g, and walnut kernels 10g.

[0090] The preparation steps are as follows: Soaking: same as Example 1.

[0091] Bean cooking and beating: same as Example 1.

[0092] Vegetable processing: the spinach is washed and blanched at 60℃ and 0.08 MPa for 30 seconds. It is immediately immersed in ice water to cool, and then squeezed to remove water.

[0093] Mixing and speed beating: the black bean milk is cooled to 48℃. The black bean milk, blanched spinach, and walnut kernels are put into a food processor together. 0.01wt% cellulase is added, and the mixture is incubated at 48℃ for 10 min. Then the mixture is beaten at 20000 rpm for 75 seconds at 48℃ to obtain 450 mL of spinach black bean walnut drink.

[0094] Example 6 A spinach black bean walnut drink It is made from the following raw materials by weight: black beans 30g, spinach 100g, and walnut kernels 10g.

[0095] The preparation steps are as follows: Soaking: same as Example 1.

[0096] Bean cooking and beating: same as Example 1.

[0097] Vegetable processing: the spinach is washed and blanched at 60℃ and 0.08 MPa for 30 seconds. It is immediately immersed in ice water to cool, and then squeezed to remove water.

[0098] Mixing and whipping: cool the black bean slurry to about 48℃. Put the black bean slurry, blanched spinach, and walnut kernels into the food processor. Add 0.01wt% cellulase, based on the total mass of the raw materials, and incubate at 48℃ for 10 minutes. Then whip the slurry at 48℃ and 20000 rpm for 75 seconds to obtain 450 mL of the spinach black bean walnut drink.

[0099] Example 7 A spinach black bean walnut drink Made from the following raw materials by weight: black beans 60g, spinach 300g, walnut kernels 30g.

[0100] The preparation steps are as follows: Soaking: same as Example 1.

[0101] Boiling and whipping the beans: same as Example 1.

[0102] Vegetable processing: wash the spinach, blanch it at 60℃ and 0.08 MPa for 30 seconds, immediately immerse it in ice water to cool, and squeeze out the water.

[0103] Mixing and whipping: cool the black bean slurry to about 48℃. Put the black bean slurry, blanched spinach, and walnut kernels into the food processor. Add 0.01wt% cellulase, based on the total mass of the raw materials, and incubate at 48℃ for 10 minutes. Then whip the slurry at 48℃ and 20000 rpm for 75 seconds to obtain 450 mL of the spinach black bean walnut drink.

[0104] Comparative Example 1 A spinach black bean walnut drink Made from the following raw materials by weight: black beans 60g, spinach 300g, walnut kernels 30g.

[0105] The preparation steps are as follows: Soaking: soak the black beans 50g in 320 mL of water at room temperature for 9 hours using ultrasonic waves (power 300W).

[0106] Boiling and whipping the beans: remove the soaked beans, add 320 mL of water to boil, and boil them in 100℃ boiling water for 12 minutes. Pour the boiled black beans and the cooking liquid into the food processor and whip at 20000 rpm for 2 minutes to obtain the black bean slurry.

[0107] Vegetable processing: wash the asparagus, cut it into sections, blanch it in water at 60℃ and 0.08 MPa for 40 seconds, remove it, and drain the water.

[0108] Mixing and speed beating: after the black bean milk is cooled to 45℃, the black bean milk, blanched asparagus, and walnut kernels are put into a food processor together, 0.01wt% cellulase is added based on the total mass of the raw medicinal materials, and then the mixture is incubated at 45℃ for 10 min, and then the mixture is beaten at 20000 rpm for 90 s at 45℃ to obtain 450 mL of asparagus black bean walnut drink.

[0109] Comparative Example 2 A pumpkin black bean walnut drink The drink is prepared from the following raw medicinal materials by weight: black beans 50 g, pumpkin 130 g, and walnut kernels 10 g.

[0110] The preparation steps are as follows: Soaking: 50 g of black beans are soaked in 320 mL of normal temperature water for 9 hours by ultrasonic (power 300 W).

[0111] Boiling and beating: the soaked beans are taken out, 320 mL of water is added to boil, and the black beans are boiled in 100℃ boiling water for 12 min. The boiled black beans and the boiling liquid are poured into a food processor and beaten at 20000 rpm for 2 min to obtain black bean milk.

[0112] Vegetable processing: the pumpkin is steamed at 60℃ and 0.08 MPa for 5 min.

[0113] Mixing and speed beating: after the black bean milk is cooled to 45℃, the black bean milk, steamed pumpkin, and walnut kernels are put into a food processor together, 0.01wt% cellulase is added based on the total mass of the raw medicinal materials, and then the mixture is incubated at 45℃ for 10 min, and then the mixture is beaten at 20000 rpm for 90 s at 45℃ to obtain 450 mL of pumpkin black bean walnut drink.

[0114] Comparative Example 3 A black bean walnut drink The drink is prepared from the following raw medicinal materials by weight: black beans 50 g and walnut kernels 10 g.

[0115] The preparation steps are as follows: Soaking: same as Example 1.

[0116] Boiling and beating: same as Example 1.

[0117] Mixing and speed beating: the black bean milk is cooled to 48℃. The black bean milk and walnut kernels are put into a food processor together. 0.01wt% cellulase is added based on the total mass of the raw medicinal materials, and then the mixture is incubated at 48℃ for 10 min, and then the mixture is beaten at 20000 rpm for 75 s to obtain 450 mL of black bean walnut drink.

[0118] Comparative Example 4 A spinach black bean walnut drink Made from the following weight parts of raw materials: black beans 50 g, spinach 130 g, walnut kernels 10 g.

[0119] The preparation steps are as follows: Soaking: same as Example 1.

[0120] Boiled bean beating: same as Example 1.

[0121] Vegetable processing: the spinach was washed, blanched at a temperature of 60°C and a pressure of 0.08 MPa for 30 seconds, immediately immersed in ice water to cool, and squeezed dry.

[0122] Mixing and speed beating: the black bean milk was cooled to 35°C. The black bean milk, blanched spinach, and walnut kernels were placed together in a food processor. 0.01 wt% cellulase was added, based on the total mass of raw materials being 100%, and incubated at a temperature of 35°C for 10 min. Then, beating was performed at a temperature of 35°C and a speed of 20,000 rpm for 75 seconds to obtain 450 mL of a spinach black bean walnut drink.

[0123] Comparative Example 5 A spinach soybean walnut drink Made from the following weight parts of raw materials: soybeans 50 g, spinach 130 g, walnut kernels 10 g.

[0124] The preparation steps are as follows: Soaking: same as Example 1.

[0125] Boiled bean beating: same as Example 1.

[0126] Vegetable processing: the spinach was washed, blanched at a temperature of 60°C and a pressure of 0.08 MPa for 30 seconds, immediately immersed in ice water to cool, and squeezed dry.

[0127] Mixing and speed beating: the soybean milk was cooled to about 55°C. The soybean milk, blanched spinach, and walnut kernels were placed together in a food processor. 0.01 wt% cellulase was added, based on the total mass of raw materials being 100%, and incubated at a temperature of 55°C for 10 min. Then, beating was performed at a temperature of 55°C and a speed of 20,000 rpm for 75 seconds to obtain 450 mL of a spinach soybean walnut drink.

[0128] Comparative Example 6 A spinach pumpkin black bean walnut drink Different from Example 1, the black beans were of a common variety, with an anthocyanin content of 1.8 mg / g and a total amount of soy isoflavones of 2.8 mg / g; the spinach was of a common variety, with a soluble dietary fiber content of 27.6%.

[0129] In order to further verify the progressiveness of the present application, the beverage prepared in Example 1 of the present application was subjected to the following tests.

[0130] Test 1: 40 volunteers were randomly selected, 20 males aged 25-70 years old with an average age of 51.1±12.5 years old, and 20 females aged 26-73 years old with an average age of 50.2±13.4 years old.

[0131] Exclusion criteria: those with severe liver and kidney dysfunction, primary diseases of blood system or mental illness, pregnant or lactating women, thyroid function abnormalities, severe heart dysfunction (grade 3-4), combined with malignant arrhythmia, recent use of antibiotics, gastric mucosa protective agents, recent 1 week upper gastrointestinal bleeding history, gastric resection and gastrointestinal tumor cases.

[0132] Before the test, the average level of serum cholesterol content of the 40 volunteers was detected by blood sampling. The 40 volunteers drank 300ml of the beverage prepared in Example 1 every day, and the average level of serum cholesterol content was detected by blood sampling after 2 months and 3 months, respectively, to compare the average level of serum cholesterol content before and after drinking.

[0133] The experimental data is shown in Table 1.

[0134] Table 1

[0135] The data in Table 1 above is only a preliminary verification result, which proves the feasibility and preliminary effect of the traditional Chinese medicine composition and its preparation method.

[0136] Test 2: All research subjects (exclusion criteria are the same as Test 1) were detected for total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Venous blood was drawn on an empty stomach in the morning, using a separation gel coagulation tube, centrifuged at 3500 rpm for 10 min, and the serum was separated for detection.

[0137] The detection was performed using Beckman Coulter AU5800 automatic biochemical analyzer, and Beckman company matched reagents were used. The experimental parameters were set according to the instruction manual, and indoor quality control was done during the experiment to ensure the accuracy and reliability of the test results. The experimental data is shown in Table 2.

[0138] Table 2

[0139] In Table 2, TC is the initial detection of serum cholesterol content, TC3 is the detection of serum cholesterol content after 3 months of observation, and TC6 is the detection of serum cholesterol content level after 6 months of observation. The unit of measurement is mmol / L.

[0140] TG is the initial detection of serum triglyceride content, TG3 is the detection of serum triglyceride content after 3 months of observation, TG6 is the detection of serum triglyceride content level after 6 months of observation. The unit of measurement is mmol / L.

[0141] LDL is the initial detection of serum low-density lipoprotein cholesterol content, LDL3 is the detection of serum low-density lipoprotein cholesterol content after 3 months of observation, LDL6 is the detection of serum low-density lipoprotein cholesterol content level after 6 months of observation. The unit of measurement is mmol / L.

[0142] HDL is the initial detection of serum high-density lipoprotein cholesterol content, HDL3 is the detection of serum high-density lipoprotein cholesterol content after 3 months of observation, HDL6 is the detection of serum high-density lipoprotein cholesterol content level after 6 months of observation. The unit of measurement is mmol / L.

[0143] Targeted action of black bean anthocyanins and vegetable dietary fiber: Table 2 experimental data shows that cyanidin-3-glucoside (main component of anthocyanins) in black beans and pectin (soluble dietary fiber) in spinach can form a stable complex, which can inhibit the activity of NPC1L1 by 32% compared with single component (verified by in vitro intestinal cell model), thereby more efficiently blocking cholesterol absorption.

[0144] Synergistic metabolic pathway of unsaturated fatty acids: alpha-linolenic acid (≥55%) in walnuts and linoleic acid in black beans can activate the PPARα (peroxisome proliferator-activated receptor alpha) pathway, promote the conversion of liver cholesterol to bile acid, and experiments show that the bile acid excretion amount is increased by 27% when the two are used together compared with using black beans alone.

[0145] Test three: comparison experiment of supplement pharmacodynamics (1) Equivalence study with existing drugs: the added experiment shows that the traditional Chinese medicine composition provided in embodiment 1 of the present application (daily intake amount 400 mL) has equivalent cholesterol-lowering effect as low-dose statin (atorvastatin 10 mg / day) (3-month serum TC reduction rates are 32.62% and 33.57%, respectively), but the incidence of myalgia adverse reactions is 0 (statin group is 8%, n=100), and the experimental data are shown in Table 3.

[0146] Table 3

[0147] (2) Dose-effect relationship: The comparative data of different dose groups (200 mL / day, 400 mL / day, 600 mL / day) of the traditional Chinese medicine composition provided in Example 1 of the present application showed that 400 mL / day was the optimal dose (TC reduction of 32.62%), 200 mL / day (TC reduction of 24.02%, lower than 400 ml / day, the difference was significant, P<0.000), 600 mL / day did not significantly improve the effect, reduced the economic cost, and the experimental data is shown in Table 4 and Table 5.

[0148] Table 4

[0149] Table 5

[0150] In the above Table 3-Table 5, the number is the number of people in the group, and the exclusion conditions are the same as Test 1. The TC before the experiment and the TC after 3 months are the average values of 100 people in the group.

[0151] Test four: long-term safety data 12-month toxicity experiment: SD rats were given the traditional Chinese medicine composition provided in Example 1 of the present application by gavage daily (10 times the dose for humans), no abnormal liver and kidney function (ALT, BUN were within the normal range), and no significant change in intestinal flora diversity (verified by 16S rRNA sequencing), proving the safety of long-term use. The experimental data is shown in Table 6.

[0152] Table 6

[0153] In the above Table 6, the number is the number of SD rats in the group. The initial TC, ALT and BUN and the TC, ALT and BUN after 12 months are the average values.

[0154] Test five: comparative example 3 effect analysis Comparative example 3 effect difference analysis: the test personnel respectively drank 300ml of the beverage prepared by Example 1 and Comparative Example 3 daily, and after 3 months, the average level of serum cholesterol content of 200 people in the group was detected by blood test, and the average level of serum cholesterol content before and after drinking was compared. The experimental data is shown in Table 7.

[0155] Table 7

[0156] In the above Table 7, the number is the number of people in the group, and the exclusion conditions are the same as Test 1. The TC before the experiment and the TC after 3 months are the average values of 100 people in the group.

[0157] As can be seen from the data in Table 7, the effect of the beverage prepared in Example 1 of the present application is better than that of Comparative Example 3, the TC reduction of Example 1 is 32.62%, and the TC reduction of Comparative Example 3 is only 24.36%; it can be seen that, after increasing the vegetables in Example 1, the vitamins A / C / E / K are fully covered, the synergistic effect is increased, the diet is balanced, the traditional nutrition and modern antioxidant demand are considered, the cholesterol content level in the serum can be effectively reduced, and the occurrence of cardiovascular and cerebrovascular diseases can be reduced.

[0158] In order to realize large-scale production, on the basis of Example 1, Example 2, Example 3, Example 4, Example 5, Example 6 and Example 7, only the soaking process of each example is improved to improve the production efficiency, and the improvement is taken as Example 8.

[0159] Example 8[HL1] A spinach black bean walnut drink Soaking: ultrasonic conditions: 20kHz+40kHz dual-frequency alternating ultrasonic (power 400W, temperature 25℃, time 5h) is adopted. Its advantage is that the soaking time can be shortened from 8-10h to 5h, and the softness of black beans is more uniform (hardness deviation ≤5%), which is more suitable for large-scale production line.

[0160] The advantages of using 20kHz+40kHz dual-frequency alternating ultrasonic are: 1. Shorten the production cycle: Traditional single-frequency ultrasonic (such as 40kHz) needs 8-10 hours to reach the softening target of black beans, while dual-frequency alternating ultrasonic compresses the time to 5 hours through frequency complementary effect (20kHz provides macroscopic crushing force, and 40kHz enhances microscopic penetration), reduces the production time of single batch by 40%-50%, and significantly improves the turnover rate of production line.

[0161] (Data support: in the example, the hardness deviation of black beans is ≤5% after 5h dual-frequency ultrasonic, and the deviation of traditional process is 12% after 8h) 2. Softening uniformity optimization: Dual-frequency alternating action makes the sound field distribution more uniform, avoiding the problem of local overheating or insufficient softening caused by single-frequency ultrasonic. The hardness deviation ≤5% indicates that the softening consistency of the epidermis and endosperm of black beans is improved, the fiber fracture in the subsequent beating process is more synchronous, which is helpful for uniform release of active ingredients (such as anthocyanins).

[0162] (Comparison: the hardness deviation of black beans in traditional process is 12%, which leads to a 23% lower anthocyanin dissolution rate in some areas after beating) 3. Microstructure optimization: 20 kHz ultrasound generates macro-burst force of cavitation bubbles to destroy black bean cell wall, 40 kHz high frequency ultrasound further refines cell fragments to form smaller pores (SEM observation aperture from 50 μm to 20 μm), and promotes the dissolution of active ingredients in the subsequent cooking stage.

[0163] (Data: the dissolution rate of black bean isoflavone aglycone is increased by 18% after the optimized process) The above examples are the preferred embodiments of the present application, but the embodiments of the present application are not limited by the above examples, and any changes, modifications, substitutions, combinations, simplifications made without departing from the spirit and principles of the present application shall be equivalent replacement methods and shall be included in the protection scope of the present application.

[0164] The above is only the preferred embodiment of the present application and is not used to limit the present application. For those skilled in the art, the present application can have various changes and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for lowering blood cholesterol levels, characterized in that, It is made from the following raw materials in parts by weight: 3-6 parts black beans, 10-30 parts vegetables, and 1-3 parts walnuts; wherein the vegetables are selected from spinach or a combination of asparagus and pumpkin; The black beans are of the black-skinned, yellow-kernel variety, with anthocyanin content ≥2.5mg / g and total soybean isoflavones ≥4.0mg / g; the spinach is of the overwintering variety, with soluble dietary fiber accounting for ≥16%.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It also includes 0.05-0.1 parts of sea buckthorn fruit powder, wherein the vitamin E content of the sea buckthorn fruit powder is ≥150mg / 100g.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The vitamin K content of the spinach is (400-500) μg / 100g; And / or, the selenium content of the black beans is ≥0.15 mg / kg; And / or, the walnut contains ≥55% α-linolenic acid; And / or, the mass ratio of asparagus to pumpkin is 8:(5-8).

4. A method for preparing a traditional Chinese medicine composition for lowering blood cholesterol levels according to any one of claims 1-3, characterized in that, Includes the following steps: Step 1: Mix black beans and water, soak and cook the beans using ultrasonication, then grind them for the first time to obtain black bean milk; Step 2: Blanch or steam the vegetables to obtain blanched or steamed vegetables; Step 3: Mix the black soybean milk obtained in Step 1 with blanched or steamed vegetables, and blend for a second time to obtain the traditional Chinese medicine composition that lowers blood cholesterol levels.

5. The preparation method according to claim 4, characterized in that, In step one, the mass-to-volume ratio of black beans to water is 1g:(6-7)mL; And / or, the conditions for ultrasonic immersion include: power of 300W-500W, temperature of 20℃-25℃, and time of 8h-10h; And / or, the conditions for cooking the beans include: a temperature of 100℃-110℃ and a time of 10 minutes-15 minutes; And / or, the first pulping process is as follows: run for 20s-30s at a speed of 15000rpm-25000rpm, stop for 10s-15s, and repeat 4-5 times.

6. The preparation method according to claim 1, characterized in that, In step two, the blanching conditions include: a temperature of 60℃-70℃, a pressure of 0.08MPa-0.10MPa, and a time of 20-60 seconds. And / or, the cooking conditions include: a temperature of 60℃-70℃, a pressure of 0.08MPa-0.10MPa, and a time of 3 minutes-8 minutes.

7. The preparation method according to claim 1, characterized in that, In step three, the mixing conditions include a temperature of 40℃-50℃; And / or, the conditions for the second pulping include: a temperature of 45℃-48℃, a rotation speed of 15000rpm-25000rpm, and a time of 60 seconds-120 seconds; And / or, during the second pulping, 0.01% cellulase is added and the mixture is kept at 45℃-48℃ for 10 minutes; And / or, after the second pulping, sea buckthorn fruit powder is added.

8. A ready-to-drink beverage, concentrate, freeze-dried powder or capsule made from a traditional Chinese medicine composition for lowering blood cholesterol content prepared by any one of claims 1-3 or a traditional Chinese medicine composition for lowering blood cholesterol content prepared by any one of claims 4-8.

9. The ready-to-drink beverage according to claim 8, characterized in that, Based on the quality of ready-to-drink beverages, it includes 0.02 wt% rosemary extract.

10. The use of a traditional Chinese medicine composition for lowering blood cholesterol levels according to any one of claims 1-3 or a traditional Chinese medicine composition for lowering blood cholesterol levels prepared by any one of claims 4-8 in the preparation of a drug or health product for lowering blood cholesterol levels.

11. The use of a traditional Chinese medicine composition for lowering blood cholesterol levels according to any one of claims 1-3 or a traditional Chinese medicine composition for lowering blood cholesterol levels prepared by any one of claims 4-8 in the preparation of a drug or health product for the prevention or adjuvant treatment of hypercholesterolemia or atherosclerosis.