Composition for preventing cardiovascular and cerebrovascular diseases and preparation method thereof

Abstract

The invention relates to a composition for preventing cardiovascular and cerebrovascular diseases and a preparation method thereof, and belongs to the technical field of health food. The composition for preventing cardiovascular and cerebrovascular diseases is prepared from the following components in parts by weight: 20 to 100 parts of dihydroquercetin, 100 to 300 parts of red yeast rice, 50 to 150 parts of nattokinase, 50 to 200 parts of earthworm protein, 100 to 300 parts of hawthorn fruit extract, 100 to 300 parts of radix puerariae extract and 100 to 300 parts of sea-buckthorn extract. The composition prepared by the invention has the characteristics of lowering lipid, dissolving thrombus and protecting heart and blood vessels.

Description

Technical Field

[0001] This invention belongs to the field of health food technology, and relates to a composition and its preparation method that have multiple effects of thrombolysis, lipid reduction, anti-oxidation and vascular endothelial protection, which can prevent cardiovascular and cerebrovascular diseases. Background Technology

[0002] The occurrence and development of cardiovascular and cerebrovascular diseases are closely related to two major pathological processes: atherosclerosis, based on hyperlipidemia caused by lipid metabolism disorders; and thrombosis, a direct cause of acute events such as myocardial infarction and cerebral infarction. Cardiovascular and cerebrovascular diseases, such as atherosclerosis, thrombosis, and hyperlipidemia, are common diseases that seriously endanger human health. Currently, most related health foods or drugs on the market have single-target effects. For example, statins, while having a clear lipid-lowering effect, may be accompanied by side effects such as muscle soreness and liver damage. Aspirin, as an antiplatelet agent, carries a risk of gastrointestinal bleeding with long-term use. Single plant extracts, such as nattokinase or red yeast rice, have relatively limited functions and cannot comprehensively address complex cardiovascular and cerebrovascular problems. Therefore, there is an urgent need in this field to develop a multi-target, synergistic, and safer natural source composition to comprehensively improve cardiovascular and cerebrovascular health. Summary of the Invention

[0003] The purpose of this invention is to overcome the shortcomings of the prior art and provide a compound composition based on natural ingredients. Through scientific formulation, this composition achieves synergistic effects in thrombolysis, lipid reduction, anti-oxidation and vascular protection, providing a comprehensive health care solution for cardiovascular and cerebrovascular health.

[0004] The objective of this invention can be achieved through the following technical solutions: A composition for the prevention of cardiovascular and cerebrovascular diseases, characterized in that it comprises the following active ingredients in parts by weight: • Dihydroquercetin 20-100 parts • Red yeast rice (monacolin K content 2%-4%) 100-300 servings • Nattokinase (2000-20000 FU / g) 50-150 servings • 50-200 servings of earthworm protein • Hawthorn extract (containing 30-60 parts by weight of hawthorn flavonoids) 100-300 parts • Pueraria lobata extract (puerarin content 40-120 parts by weight) 100-300 parts • Sea buckthorn extract (total flavonoid content 30-90 parts by weight) 100-300 parts Preferably, the composition comprises the following active ingredients in parts by weight: 30 parts dihydroquercetin, 200 parts red yeast rice, 100 parts nattokinase, 100 parts earthworm protein, 200 parts hawthorn extract, 200 parts kudzu root extract, and 200 parts sea buckthorn extract.

[0005] The compositions of the present invention may also include pharmaceutically or food-grade excipients, such as fillers, disintegrants, lubricants, flavoring agents, etc., and may be prepared into any conventional dosage form, including but not limited to capsules, tablets, granules or powders.

[0006] Another object of the present invention is to provide a method for preparing the above composition, the specific steps of which are as follows: 1. Weigh out each active ingredient and excipient according to the above proportions; 2. Add dihydroquercetin, red yeast rice, earthworm protein, hawthorn extract, kudzu root extract, sea buckthorn extract, and some excipients (such as microcrystalline cellulose) into a three-dimensional mixer and mix for 30-45 minutes until homogeneous; 3. After mixing nattokinase with the remaining excipients (such as magnesium stearate), add it to the mixture obtained in step 2, and mix for another 10-15 minutes to ensure that the mixture is homogeneous. 4. Fill the mixed materials into capsules, tablets, or powder.

[0007] This invention first utilizes the isoflavone derivatives abundant in kudzu root extract, which have a mild promoting effect on improving cerebral vascular tension, elasticity, and pulsatility in patients with hypertension and coronary heart disease. This lays the foundation for symptom improvement in patients. Dihydroquercetin and sea buckthorn extract are rich in highly active flavonoids, which are powerful antioxidants that can effectively eliminate oxygen free radicals in the body. This antioxidant effect can prevent cell degeneration and aging, prevent the occurrence of cancer, improve blood circulation, and lower cholesterol. These effects greatly reduce the incidence of cardiovascular and cerebrovascular diseases and can also improve the symptoms of cardiovascular and cerebrovascular diseases. Nattokinase and earthworm protein can dissolve blood clots, soften blood vessels, reduce blood viscosity, and regulate blood pressure in both directions through the proteases they contain. Red yeast rice and hawthorn can inhibit the activity of cholesterol synthesis enzymes and reduce serum total cholesterol and low-density lipoprotein levels.

[0008] The beneficial effects and inventiveness of this invention are as follows: 1. Multi-target synergistic mechanism: The lipid-lowering pathway involves two mechanisms: red yeast rice acts as a "natural statin," inhibiting the synthesis of endogenous cholesterol at its source; hawthorn aids digestion and promotes lipid metabolism. Together, they achieve a dual lipid-lowering effect of both "increasing supply" and "reducing expenditure."

[0009] Dual protection for thrombolysis: Nattokinase can efficiently dissolve fibrin thrombi; earthworm protein contains fibrinolytic enzymes, providing another thrombolytic pathway. The combination of the two creates a rapid and sustained thrombolytic synergistic effect, reducing the risk of dose dependence on a single component.

[0010] Comprehensive vascular protection: Both dihydroquercetin and sea buckthorn are rich in highly active flavonoids, providing powerful antioxidant and anti-inflammatory protection and repairing damaged vascular endothelium; puerarin in kudzu root can dilate coronary arteries and improve microcirculation. This "protective layer" effectively slows down the progression of atherosclerosis.

[0011] 2. The mutually reinforcing mechanism of synergistic effects There is a mutually reinforcing "network effect" among the three sectors: Lowering lipids → Helping to protect blood vessels and dissolve thrombi: Lowering blood lipids reduces blood viscosity, decreases inflammation of the blood vessel walls, directly reduces the burden on the vascular protection system, and makes blood flow more easily, improving the contact efficiency between thrombolytic components and thrombi.

[0012] Vascular protection → Consolidate lipid-lowering and thrombolysis results: Healthy vascular endothelium can effectively maintain blood lipid balance and consolidate the lipid-lowering effect; at the same time, smooth and stable blood vessel walls greatly reduce the risk of new thrombus formation, prevent the formation of new thrombi during thrombolysis, and ensure the long-term effectiveness of thrombolysis.

[0013] Thrombolysis → a pathway for lipid-lowering and vascular protection and restoration: It dissolves microthrombi in a timely manner, restoring the patency of blood vessels (especially microcirculation). This ensures that lipid-lowering components and nutrients can be delivered to tissues throughout the body, and also improves the distribution and conditions of action of vascular protective components.

[0014] 3. Significant technical effects: Through the synergistic effects described above, this composition is significantly more effective than any single ingredient or simple ingredient combination in preventing and assisting in improving atherosclerosis, reducing blood viscosity, dissolving microthrombi, and improving blood circulation. 4. High safety: All ingredients are of natural origin. Through scientific formulation, the potential side effects of chemicals are reduced while ensuring efficacy, making it more suitable for long-term health maintenance. Detailed Implementation

[0015] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the following detailed description of the specific implementation methods, structures, features, and effects of the present invention, in conjunction with embodiments, is provided below.

[0016] It should be noted that, unless otherwise specified, the present invention does not specifically limit the source of the raw materials used in the following embodiments. Commercially available products or products prepared by conventional preparation methods that are well known to those skilled in the art can be used. Experimental methods that do not specify specific conditions are all conventional methods and conventional conditions well known in the art.

[0017] Example 1: Preparation of the composition capsule Take 30g of dihydroquercetin, 200g of red yeast rice (containing 2.5% monacolin K), 100g of nattokinase (active 4000 FU / g), 100g of earthworm protein, 200g of hawthorn extract (40% flavonoids), 200g of kudzu root extract (50% puerarin), 200g of sea buckthorn extract (35% total flavonoids), 140g of microcrystalline cellulose, and 10g of magnesium stearate.

[0018] Add all ingredients except nattokinase and magnesium stearate to a mixer and mix for 40 minutes. Then, premix nattokinase and magnesium stearate and add them to the total mixture, then mix for another 12 minutes. Finally, fill the mixture into size 0 capsules, with each capsule containing 400 mg.

[0019] Example 2: Preparation of the composite sheet The formula is the same as in Example 1. The mixed materials are directly compressed into tablets, each weighing 500mg.

[0020] Comparative experiments were conducted using animal models (such as hyperlipidemic rat models and arterial thrombosis mouse models) to compare the single-component group (e.g., containing only nattokinase), the partial-component group (e.g., excluding dihydroquercetin and sea buckthorn), and the complete formula of this invention. The experimental results confirmed that the complete formula of this invention was significantly superior to any single or partial-component group in terms of lowering blood lipids (TC, TG, LDL-C), thrombolysis rate, and vascular endothelial function improvement indicators (p<0.01), fully demonstrating the synergistic effect of this invention.

[0021] Verification of lipid-lowering efficacy (rat hyperlipidemia model) 1. Experimental Methods: Healthy SD rats were randomly divided into 6 groups: normal control group, model control group, positive drug (simvastatin) group, the whole formula of this invention group (formulated according to Example 1), red yeast rice single formula group (dosage is the same as the red yeast rice content in the whole formula group), and deletion group (red yeast rice and hawthorn are removed from the whole formula).

[0022] Except for the normal control group, all other groups were fed a high-fat diet to establish a hyperlipidemia model. Simultaneously with model establishment, each drug administration group was administered the corresponding test substance by gavage for 4 consecutive weeks.

[0023] At the end of the experiment, serum total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) were measured.

[0024] 2. Experimental Results: Group TC (mmol / L) TG (mmol / L) LDL-C (mmol / L) HDL-C (mmol / L) normal control group 1.85 0.65 0.51 1.42 Model control group 6.92 1.89 4.95 0.81 Simvastatin group 3.01 1.12 1.89 1.15 This invention is a complete formula 2.95 0.98 1.75 1.28 Red yeast rice single ingredient group 3.88 1.45 2.61 1.01 Missing group 4.52 1.61 3.12 0.92 Conclusion: The lipid-lowering effect (TC, TG, LDL-C) of the whole formula group of this invention was significantly better than that of the red yeast rice single formula group and the missing formula group (p<0.05), and there was no significant difference with the effect of the chemical drug simvastatin (p>0.05). This fully demonstrates the synergistic effect of red yeast rice, hawthorn, and other components in lowering blood lipids.

[0025] thrombolytic efficacy verification (Mouse tail vein thrombosis model) 1. Experimental Methods: KM mice were randomly divided into 5 groups: blank control group, model control group, positive drug (aspirin) group, the whole formula of this invention group, and nattokinase single formula group (the dosage was the same as the nattokinase content in the whole formula group).

[0026] A mouse tail vein thrombosis model was established by injecting carrageenan-based inducing agents. All groups were administered the drugs via gavage for 7 days prior to the model.

[0027] Observe and compare the formation rate and average thrombus length of tail vein thrombosis in mice of different groups.

[0028] 2. Experimental Results: Group Thrombosis rate (%) Average thrombus length (cm) Blank control group 0 0 Model control group 95 4.8± 0.7 aspirin group 45 2.1 ± 0.5 This invention is a complete formula 30 1.5 ± 0.4 Nattokinase monotherapy group 60 2.9 ± 0.6 Conclusion: The complete formulation of this invention is significantly more effective than the nattokinase-only formulation and the aspirin-only formulation in reducing thrombus formation rate and shortening thrombus length (p<0.05). This strongly demonstrates the remarkable synergistic effect of nattokinase, earthworm protein, and dihydroquercetin in antithrombotic and thrombolytic activities.

[0029] Vascular function and inflammation testing verification (Rat hyperlipidemia model) 1. Healthy SD rats were randomly divided into 4 groups: normal control group, model control group, the whole formula group of this invention (formulated according to Example 1), kudzu root extract group, and sea buckthorn extract group (dosage and content consistent with the whole formula group). Except for the normal control group, all other groups were fed a high-fat diet to establish a hyperlipidemia model. Simultaneously with model establishment, each drug administration group was administered the corresponding test substance by gavage for 4 consecutive weeks.

[0030] At the end of the experiment, the tension of isolated microvessels and the level of systemic inflammatory factors (plasma TNF-α) were measured. 2. Experimental Results: Group Ex vivo microvascular tension (EMAX) Systemic inflammatory cytokine (TNF-α) Blank control group 80% 10 Model control group 42% 65 This invention is a complete formula 71% 20 Pueraria lobata extract and sea buckthorn extract group 55% 32 Conclusion: The vascular protective effect of the complete formula of this invention is significantly better than that of the kudzu root extract, sea buckthorn extract, and dihydroquercetin group and the model control group. This fully demonstrates that the complete formula of this invention is more effective in protecting blood vessels than the kudzu root extract and sea buckthorn extract groups, and the other components enhance the effects of kudzu root extract and sea buckthorn extract.

[0031] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention are still within the scope of the present invention.

Claims

1. A composition for preventing cardiovascular and cerebrovascular diseases, characterized in that, It is composed of the following active ingredients in parts by weight: 20-100 parts dihydroquercetin, 100-300 parts red yeast rice, 50-150 parts nattokinase, 50-200 parts earthworm protein, 100-300 parts hawthorn extract, 100-300 parts kudzu root extract, and 100-300 parts sea buckthorn extract.

2. The composition for preventing cardiovascular and cerebrovascular diseases according to claim 1, characterized in that, The content of Monacoline K in the red yeast rice is 2%-4%.

3. The composition for preventing cardiovascular and cerebrovascular diseases according to claim 1, characterized in that, The activity of the nattokinase is 2000-20000 FU / g.

4. The composition for preventing cardiovascular and cerebrovascular diseases according to claim 1, characterized in that, The hawthorn extract contains 30-60 parts by weight of hawthorn flavonoids.

5. The composition for preventing cardiovascular and cerebrovascular diseases according to claim 1, characterized in that, The content of puerarin in the kudzu root extract is 40-120 parts by weight.

6. The composition for preventing cardiovascular and cerebrovascular diseases according to claim 1, characterized in that, The total flavonoid content in the sea buckthorn extract is 30-90 parts by weight.

7. The composition for preventing cardiovascular and cerebrovascular diseases according to any one of claims 1 to 6, characterized in that, It is composed of the following active ingredients in parts by weight: 30 parts dihydroquercetin, 200 parts red yeast rice, 100 parts nattokinase, 100 parts earthworm protein, 200 parts hawthorn extract, 200 parts kudzu root extract, and 200 parts sea buckthorn extract.

8. The composition for preventing cardiovascular and cerebrovascular diseases according to any one of claims 1 to 7, characterized in that, The composition is prepared into capsules, tablets, granules or powders.

9. A method for preparing a composition for preventing cardiovascular and cerebrovascular diseases according to any one of claims 1-8, characterized in that, Includes the following steps: a) Weigh each component according to the proportion; b) Mix dihydroquercetin, red yeast rice, earthworm protein, hawthorn extract, kudzu root extract, sea buckthorn extract and some excipients evenly; c) Mix nattokinase with the remaining excipients and add it to the mixture from step b, then mix thoroughly again; d) Prepare the final mixture into the desired dosage form.