Composition for preventing and ablating plaque and application thereof

Abstract

The invention discloses a composition for preventing and ablating plaques and application of the composition. The composition comprises the following components in parts by weight: 1-100 parts of a chicory extract and 1 part of nattokinase, wherein the cichorium intybus extract is an extract of a dry overground part of cichorium intybus, and the activity of the nattokinase per gram is 30000-40000 FU. Also disclosed are formulations, health food and food compositions comprising the compositions. The composition provided by the invention can be used for preventing and ablating plaques, and the problem that no oral special-effect plaque-dissolving medicine exists in the market is solved. From the microscopic perspective, the active components in the composition provided by the invention act together to clear away blood vessel wall deposited plaques, so that the elasticity and permeability of blood vessels are improved, the blood viscosity is reduced, and the blood circulation state is improved.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a composition for preventing and ablating plaques and an application thereof. Background Art

[0002] At present, the number of patients with vascular embolism (myocardial infarction, cerebral infarction), coronary artery stenosis, atherosclerosis, and carotid artery plaque in China is increasing year by year, posing a serious threat to life and health.

[0003] Plaques in blood vessels can develop into hardening, leading to vascular stenosis and vascular embolism. Early prevention in the early stages of plaque formation can prevent plaques from worsening.

[0004] There is no specific oral drug on the market that can ablate plaques. Statins and fibrates can only reduce blood lipids and slow down the formation of plaques; aspirin, ticagrelor, etc. can inhibit platelet aggregation and prevent plaque and thrombosis formation. Summary of the invention

[0005] In order to solve the above technical problems, the present invention aims to find a safe and effective drug for preventing and ablating plaques.

[0006] The present invention solves the above technical problems through the following technical solutions.

[0007] The first aspect of the present invention provides a composition, comprising, by weight: 1-100 parts of chicory extract and 1 part of nattokinase;

[0008] The chicory extract is an extract of the dry aerial part of chicory (Cichorium intybus L.), and the activity of the nattokinase is 30000-40000 FU / g.

[0009] In some embodiments, the chicory extract is present in an amount of 1-4 parts, 10-20 parts, or 40-80 parts by weight.

[0010] In some embodiments, the weight of the portion by weight is 10-200 g; preferably 10-20 g, 20-100 g or 150-200 g; for example, 10 g, 20 g, 30 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, 100 g, 110 g, 120 g, 130 g, 140 g, 150 g, 160 g, 170 g, 180 g, 190 g or 200 g.

[0011] In some embodiments, the composition includes the following components in parts by weight:

[0012] 20-40 parts chicory extract and 1 part nattokinase; or,

[0013] 40-80 parts chicory extract and 1 part nattokinase; or,

[0014] 10-20 parts chicory extract and 1 part nattokinase; or,

[0015] 1-2 parts chicory extract and 1 part nattokinase; or,

[0016] 2-4 parts chicory extract and 1 part nattokinase; or,

[0017] 4-10 parts chicory extract and 1 part nattokinase.

[0018] In some specific embodiments, the composition includes the following components in parts by weight:

[0019] 20 parts chicory extract and 1 part nattokinase; or,

[0020] 40 parts chicory extract and 1 part nattokinase; or,

[0021] 80 parts chicory extract and 1 part nattokinase; or,

[0022] 10 parts chicory extract and 1 part nattokinase; or,

[0023] 1 part chicory extract and 1 part nattokinase; or,

[0024] 2 parts chicory extract and 1 part nattokinase; or,

[0025] 4 parts chicory extract and 1 part nattokinase.

[0026] In some specific embodiments, the composition includes the following components in parts by weight:

[0027] 20 parts of chicory extract and 1 part of nattokinase, wherein each part weighs 200g or 100g; or,

[0028] 40 parts of chicory extract and 1 part of nattokinase, wherein each part weighs 100g or 50g; or,

[0029] 80 parts of chicory extract and 1 part of nattokinase, each weighing 50 g; or,

[0030] 10 parts of chicory extract and 1 part of nattokinase, wherein each part weighs 200g; or,

[0031] 1 part chicory extract and 1 part nattokinase, each weighing 200g; or,

[0032] 2 parts chicory extract and 1 part nattokinase, wherein each part weighs 100g.

[0033] In some embodiments, in the composition, the chicory extract is prepared by an alcohol-water extraction method.

[0034] In some preferred embodiments, in the composition, the alcohol-water extraction method further comprises the steps of resin enrichment, complexation purification, and refined extraction.

[0035] In some specific embodiments, the nattokinase is prepared by fermenting, centrifuging and purifying Bacillus natto.

[0036] In some embodiments, the main active ingredient of the chicory extract is flavonoids, and the mass percentage of the flavonoids in the chicory extract is ≥1.0%; preferably, the mass percentage of the flavonoids in the chicory extract is ≥4.0%.

[0037] In some embodiments, the nattokinase is nattokinase from Bacillus subtilis (natto), and the nattokinase preferably has an amino acid sequence as shown in SEQ ID NO: 1.

[0038] In some embodiments, the flavonoid component is selected from one or more of aconitine, quercetin-3-O-glucuronide, isoquercetin, kaempferol-3-O-glucuronide, kaempferol-3-O-β-D-pyranoglucopyranoside, isorhamnetin-3-O-β-D-pyranoglucopyranoside and isorhamnetin-3 / 7-O-β-D-glucuronide.

[0039] The second aspect of the present invention provides a preparation, which comprises the composition as described in the first aspect.

[0040] In some embodiments, the formulation further comprises a pharmaceutically acceptable carrier and / or excipient.

[0041] In some embodiments, the auxiliary material is selected from excipients, diluents, binders and additives; the additive is selected from pigments, preservatives and flavor enhancers;

[0042] In some specific embodiments, the excipient is selected from one or more of starch, pregelatinized starch, lactose, sucrose, talc, dextrin, cyclodextrin, beeswax, microcrystalline cellulose, sodium carboxymethyl cellulose, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, glucose, meglumine, magnesium stearate, dextran, glycerol, ethanol, propylene glycol, polyethylene glycol, mannitol, sorbitol, xylitol, fiber vegetable oil, sodium benzoate, sodium salicylate, hydrochloric acid, citric acid, sodium citrate, sodium dihydrogen phosphate, disodium hydrogen phosphate, gelatin, lecithin and vitamin C.

[0043] In some embodiments, the pharmaceutical form of the preparation is tablets, capsules, soft capsules, oral liquids, granules, pills, pellets, powders, ointments, pills, injections, suppositories, patches, drops, sprays, creams, suspensions, tinctures, emulsions, water injections, powder injections, targeted preparations, sustained-release preparations, or controlled-release preparations.

[0044] In some specific embodiments, the formulation is in the form of a pill.

[0045] The third aspect of the present invention provides a health food, which comprises the composition as described in the first aspect.

[0046] The fourth aspect of the present invention provides a food composition, which comprises the composition as described in the first aspect.

[0047] The fifth aspect of the present invention provides a use of the composition as described in the first aspect or the preparation as described in the second aspect in the preparation of a drug for preventing and ablating vascular plaques.

[0048] In some embodiments, the vascular plaque is a cerebrovascular plaque; and the cerebrovascular plaque is a carotid artery plaque.

[0049] In addition to the foregoing, when used in the specification and claims of this application, unless otherwise specifically indicated, the following terms have the following meanings:

[0050] The term "health food" refers to foods that have specific health benefits in addition to providing basic nutrition. Such foods usually contain specific ingredients that can help improve or maintain a healthy state, prevent certain diseases, or provide other health benefits.

[0051] The term "food composition" refers to a product that is a mixture of multiple food ingredients, food additives or nutrients in a certain proportion. This combination can be for the purpose of achieving a specific nutritional purpose, taste effect, preservation characteristics or functional requirements.

[0052] On the basis of being in accordance with the common sense in the art, the above-mentioned preferred conditions can be arbitrarily combined to obtain the preferred embodiments of the present invention.

[0053] The reagents and raw materials used in the present invention are commercially available.

[0054] The positive and progressive effects of the present invention are:

[0055] The composition provided by the present invention can be used to prevent and ablate plaques, solving the problem that there is no oral specific plaque-dissolving drug on the market. From a microscopic perspective, the active ingredients of each component in the composition provided by the present invention work together to reduce blood lipids and remove plaque deposits on the blood vessel wall, thereby improving blood vessel elasticity and permeability, while reducing blood viscosity and improving blood circulation. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Figure 1 This is the color Doppler ultrasound image of the carotid artery of the patient in case 1 of the experimental example before taking the medicine;

[0057] Figure 2 This is the color Doppler ultrasound image of the carotid artery of the patient in Case 1 of the experimental example after taking the medicine;

[0058] Figure 3 This is the color Doppler ultrasound image of the carotid artery of the patient in case 2 of the experimental example before taking the medicine;

[0059] Figure 4 This is the color Doppler ultrasound image of the carotid artery of the patient in Case 2 of the experimental example after taking the medicine;

[0060] Figure 5 This is the color Doppler ultrasound image of the carotid artery of the patient in case 3 of the experimental example before taking the medicine;

[0061] Figure 6 This is the color Doppler ultrasound image of the carotid artery of the patient in case 3 of the experimental example after taking the medicine;

[0062] Figure 7 This is the color Doppler ultrasound image of the carotid artery of the patient in case 4 of the experimental example before taking the medicine;

[0063] Figure 8 This is the color Doppler ultrasound image of the carotid artery of the patient in case 4 of the experimental example after taking the medicine;

[0064] Fig. 9 This is the color Doppler ultrasound image of the carotid artery of the patient in case 5 of the experimental example before taking the medicine;

[0065] Fig.10 This is the color Doppler ultrasound image of the carotid artery of the patient in Case 5 of the experimental example after taking the medicine;

[0066] Fig.11 This is the color Doppler ultrasound image of the carotid artery of the patient in case 6 of the experimental example before taking the medicine;

[0067] Fig.12 This is the color Doppler ultrasound image of the carotid artery of the patient in case 6 of the experimental example after taking the medicine;

[0068] Fig.13 This is the color Doppler ultrasound image of the carotid artery of the patient in case 7 in the experimental example before taking the medicine;

[0069] Fig.14This is the color Doppler ultrasound image of the carotid artery of the patient in Case 7 of the experimental example after taking the medicine;

[0070] Fig.15 This is the color Doppler ultrasound image of the carotid artery of the patient in case 8 of the experimental example before taking the medicine;

[0071] Fig.16 This is the color Doppler ultrasound image of the carotid artery of the patient in case 8 of the experimental example after taking the medicine;

[0072] Fig.17 This is the color Doppler ultrasound image of the carotid artery of the patient in case 9 in the experimental example before taking the medicine;

[0073] Fig.18 This is the color Doppler ultrasound image of the carotid artery of the patient in case 9 in the experimental example after taking the medicine;

[0074] Fig.19 This is the color Doppler ultrasound image of the carotid artery of the patient in case 10 in the experimental example before taking the medicine;

[0075] Fig. 20 This is the color Doppler ultrasound image of the carotid artery of the patient in case 10 of the experimental example after taking the medicine;

[0076] Fig.21 This is the color Doppler ultrasound image of the carotid artery of the patient in case 11 of the experimental example before taking the medicine;

[0077] Fig. 22 This is the color Doppler ultrasound image of the carotid artery of the patient in case 11 of the experimental example after taking the medicine;

[0078] Fig.23 This is the color Doppler ultrasound image of the carotid artery of the patient in case 12 of the experimental example before taking the medicine;

[0079] Fig.24 This is the color Doppler ultrasound image of the carotid artery of the patient in Case 12 in the experimental example after taking the medicine. DETAILED DESCRIPTION

[0080] The present invention is further described below by way of examples, but the present invention is not limited to the scope of the examples. The experimental methods in the following examples without specifying specific conditions are carried out according to conventional methods and conditions, or selected according to the product specifications.

[0081] Example 1

[0082] Weigh the following raw materials:

[0083] Chicory extract 4000g, nattokinase 200g, sodium carboxymethylcellulose 30g, beeswax 500g, microcrystalline cellulose 960g, starch 1500g.

[0084] Mix the powders of the above formula and make 1000 pills by a pill making machine. The pills can be film coated as needed. Take 2 to 3 times a day, 2 to 4 pills at a time.

[0085] Example 2

[0086] Weigh the following raw materials:

[0087] Chicory extract 4000g, nattokinase 100g, sodium carboxymethylcellulose 30g, beeswax 500g, microcrystalline cellulose 1070g, starch 1500g.

[0088] Mix the powders of the above formula and make 1000 pills by a pill making machine. The pills can be film coated as needed. Take 2 to 3 times a day, 2 to 4 pills at a time.

[0089] Example 3

[0090] Chicory extract 4000g, nattokinase 50g, sodium carboxymethylcellulose 30g, beeswax 500g, microcrystalline cellulose 1120g, starch 1500g.

[0091] Mix the powders of the above formula and make 1000 pills by a pill making machine. The pills can be film coated as needed. Take 2 to 3 times a day, 2 to 4 pills at a time.

[0092] Example 4

[0093] Weigh the following raw materials:

[0094] Chicory extract 2000g, nattokinase 200g, sodium carboxymethylcellulose 30g, beeswax 500g, microcrystalline cellulose 900g, starch 1170g.

[0095] Mix the powders of the above formula and make 1000 pills by a pill making machine. The pills can be film coated as needed. Take 2 to 3 times a day, 2 to 4 pills at a time.

[0096] Example 5

[0097] Weigh the following raw materials:

[0098] Chicory extract 2000g, nattokinase 100g, sodium carboxymethylcellulose 30g, beeswax 500g, microcrystalline cellulose 900g, starch 1270g.

[0099] Mix the powders of the above formula and make 1000 pills by a pill making machine. The pills can be film coated as needed. Take 2 to 3 times a day, 2 to 4 pills at a time.

[0100] Example 6

[0101] Weigh the following raw materials:

[0102] Chicory extract 2000g, nattokinase 50g, sodium carboxymethylcellulose 30g, beeswax 500g, microcrystalline cellulose 900g, starch 1320g.

[0103] Mix the powders of the above formula and make 1000 pills by a pill making machine. The pills can be film coated as needed. Take 2 to 3 times a day, 2 to 4 pills at a time.

[0104] Example 7

[0105] Weigh the following raw materials:

[0106] Chicory extract 200g, nattokinase 200g, sodium carboxymethylcellulose 30g, beeswax 500g, microcrystalline cellulose 470g, starch 1000g.

[0107] Mix the powders of the above formula and make 1000 pills by a pill making machine. The pills can be film coated as needed. Take 2 to 3 times a day, 2 to 4 pills at a time.

[0108] Example 8

[0109] Weigh the following raw materials:

[0110] Chicory extract 200g, nattokinase 100g, sodium carboxymethylcellulose 30g, beeswax 500g, microcrystalline cellulose 570g, starch 1000g.

[0111] Mix the powders of the above formula and make 1000 pills by a pill making machine. The pills can be film coated as needed. Take 2 to 3 times a day, 2 to 4 pills at a time.

[0112] Example 9

[0113] Weigh the following raw materials:

[0114] Chicory extract 200g, nattokinase 50g, sodium carboxymethylcellulose 30g, beeswax 500g, microcrystalline cellulose 620g, starch 1000g.

[0115] Mix the powders of the above formula and make 1000 pills by a pill making machine. The pills can be film coated as needed. Take 2 to 3 times a day, 2 to 4 pills at a time.

[0116] Example 10

[0117] Weigh the following raw materials:

[0118] Chicory extract 4000g, sodium carboxymethylcellulose 30g, beeswax 500g, microcrystalline cellulose 1170g, starch 1500g.

[0119] Mix the powders of the above formula and make 1000 pills by a pill making machine. The pills can be film coated as needed. Take 2 to 3 times a day, 2 to 4 pills at a time.

[0120] Embodiment 11

[0121] Weigh the following raw materials:

[0122] Nattokinase 200g, sodium carboxymethylcellulose 30g, beeswax 500g, microcrystalline cellulose 670g, starch 1000g.

[0123] Mix the powders of the above formula and make 1000 pills by a pill making machine. The pills can be film coated as needed. Take 2 to 3 times a day, 2 to 4 pills at a time.

[0124] Experimental example:

[0125] The clinical treatment effect of the present invention is described below through clinical data.

[0126] 1. Case 1, male, 53 years old, physical examination blood lipids, carotid artery ultrasound in April 2024, four blood lipids (CHO 8.17↑, HDL-C0.91, LDL-C 2.23, TG 13.34↑), ultrasound report ( Figure 1 ) showed a medium echo plaque on the posterior wall of the right carotid bifurcation, with a size of about 1.34×0.30 cm. In April 2024, the patient began to take the pills prepared in Example 1 of the present invention, twice a day, 2 pills each time, for 2 consecutive months. In June 2024, the carotid artery was reexamined by color Doppler ultrasound ( Figure 2 ) showed a strong echo plaque on the posterior wall of the right carotid bifurcation, about 1.03×0.22cm in size, and four blood lipids (CHO 5.55↑, HDL-C 1.66, LDL-C 2.28, TG 0.94). It can be seen that in a short period of time, total cholesterol decreased by 32%, triglycerides decreased by 93%; plaque length decreased by 3.1mm, an average of 1.55mm per month; thickness decreased by 0.8mm, an average of 0.40mm per month, blood lipids improved significantly, and plaques were significantly reduced.

[0127] 2. Case 2, female, 50 years old, physical examination blood lipids, carotid artery ultrasound in April 2024, four blood lipids (CHO 5.70↑, HDL-C 1.64, LDL-C 3.36, TG 2.89↑), ultrasound report ( Figure 3) showed an inhomogeneous plaque on the posterior wall of the left carotid artery, with a size of about 2.58×0.26 cm. In April 2024, the patient began to take the pills prepared in Example 2 of the present invention, twice a day, 2 pills each time, for more than 3 consecutive months. In July 2024, the carotid artery was reexamined by color Doppler ultrasound ( Figure 4 ) showed a low-echo plaque on the posterior wall of the left carotid artery, about 2.33×0.22cm in size, and four blood lipids (CHO 3.27, HDL-C 1.78, LDL-C 2.24, TG 0.75). It can be seen that total cholesterol decreased by 43%, triglycerides decreased by 74%; plaque length decreased by 2.5mm, an average monthly decrease of 0.83mm; thickness decreased by 0.4mm, an average monthly decrease of 0.13mm, blood lipids improved significantly, and plaques were significantly reduced.

[0128] 3. Case 3, male, 54 years old, physical examination blood lipids, carotid artery ultrasound in March 2024, four blood lipids (CHO 7.80↑, HDL-C 0.89, LDL-C 1.86, TG 9.95↑), liver function (alanine aminotransferase 23.6, aspartate aminotransferase 112.5↑). Ultrasound report ( Figure 5 ) showed a mixed echo plaque behind the left common carotid sinus, with a size of about 1.03*0.26cm. In March 2024, the patient began to take the pills prepared in Example 3 of the present invention, twice a day, 2 pills each time, for 2 consecutive months. In May 2024, the carotid artery was rechecked by color Doppler ultrasound ( Figure 6 ) showed that the posterolateral wall of the left common carotid sinus had a medium echo plaque, with a plaque size of 0.90*0.26cm, four blood lipids (CHO 3.26, HDL-C 1.84, LDL-C 2.70, TG 1.60), and liver function (alanine aminotransferase 18.5, aspartate aminotransferase 20.7). It can be seen that total cholesterol decreased by 58%, triglycerides decreased by 84%; plaque length decreased by 1.3mm, with an average monthly decrease of 0.65mm; thickness remained unchanged, blood lipids improved significantly, and plaques decreased; at the same time, the two indicators of liver function returned to normal levels.

[0129] 4. Case 4, male, 56 years old, physical examination blood lipids, carotid artery ultrasound in March 2024, four blood lipids (CHO 6.44↑, HDL-C1.16, LDL-C 3.86, TG 2.56↑), ultrasound report ( Figure 7 ) showed a mixed echo plaque on the posterior wall of the right carotid sinus, with a size of about 2.06×0.29 cm. In late March 2024, the patient began to take the pills prepared in Example 4 of the present invention, twice a day, 2 pills each time, for more than one month. At the end of April 2024, the carotid artery was re-examined by color Doppler ultrasound ( Figure 8) showed a medium echo plaque on the posterior wall of the right common carotid sinus, about 1.85×0.28cm in size, and four blood lipids (CHO 6.45↑, HDL-C 1.11, LDL-C 1.19, TG0.84). It can be seen that in a short period of time, triglycerides decreased by 67%; plaque length decreased by 2.1mm, an average of 2.1mm per month; thickness decreased by 0.1mm, an average of 0.1mm per month, blood lipids improved, and plaques were significantly reduced.

[0130] 5. Case 5, female, 37 years old, physical examination blood lipids, carotid artery ultrasound in March 2024, four blood lipids (CHO 4.55, HDL-C1.23, LDL-C 2.19, TG 2.02↑), ultrasound report ( Fig. 9 ) showed a medium to low echo plaque in the right carotid sinus, with a size of about 0.73×0.19 cm. At the end of March 2024, the patient began to take the pills prepared in Example 5 of the present invention, twice a day, 2 pills each time, for nearly 4 consecutive months. In July 2024, the carotid artery was rechecked by color Doppler ultrasound ( Fig.10 ) showed a medium to low echo plaque in the right carotid sinus, about 0.49×0.14cm in size. The four blood lipid items (CHO 3.20, HDL-C 1.63, LDL-C 2.33, TG 0.91) showed that triglycerides were significantly reduced, plaques were significantly reduced, total cholesterol was reduced by 30%, and triglycerides were reduced by 55%; the plaque length was reduced by 2.4mm, with an average monthly reduction of 0.6mm; the thickness was reduced by 0.5mm, with an average monthly reduction of 0.13mm, and blood lipids improved.

[0131] 6. Case 6, male, 47 years old, physical examination blood lipids, carotid artery ultrasound in April 2024, four blood lipids (CHO 8.19↑, HDL-C1.05, LDL-C 5.36↑, TG 3.20↑), liver function (alanine aminotransferase 70.4↑, aspartate aminotransferase 50.7↑). Ultrasound report ( Fig.11 ) showed a medium echo plaque on the posterior wall of the right subclavian artery bifurcation, with a size of about 0.98*0.28cm. At the end of April 2024, the patient began to take the pills prepared in Example 6 of the present invention, twice a day, 2 pills each time, for nearly 3 months. In July 2024, the carotid artery was reexamined by color Doppler ultrasound ( Fig.12) showed a medium to low echo plaque on the posterior wall of the right subclavian artery bifurcation, about 0.85*0.29cm in size, four blood lipids (CHO3.74, HDL-C 2.11, LDL-C 3.07, TG 0.71), and liver function (alanine aminotransferase 12.3, aspartate aminotransferase 15.9). It can be seen that total cholesterol decreased by 54%, triglycerides decreased by 78%; plaque length decreased by 1.3mm, with an average monthly decrease of 0.43mm; thickness increased by 0.1mm, with an average monthly increase of 0.03mm, blood lipid levels were restored, plaque length decreased but thickness increased slightly, and plaques improved; at the same time, both liver function indicators returned to normal levels.

[0132] 7. Case 7, male, 57 years old, physical examination blood lipids, carotid artery ultrasound in December 2023, four blood lipids (CHO 4.65, HDL-C1.09, LDL-C 2.28, TG 2.49↑), ultrasound report ( Fig.13 ) shows that the mixed plaque size is about 0.93×0.24 cm on the posterior wall of the right carotid artery bifurcation. At the end of December 2023, the patient began to take the pills prepared in Example 7 of the present invention, twice a day, 2 pills each time, for nearly 3 consecutive months. In March 2024, the carotid artery was re-examined by color Doppler ultrasound ( Fig.14 ) shows that the posterior wall of the right carotid artery bifurcation has an inhomogeneous strong echo plaque of about 0.6×0.19cm in size, and four blood lipids (CHO 2.77, HDL-C 1.15, LDL-C2.81, TG 1.16). It can be seen that in a short period of time, total cholesterol decreased by 40%, triglycerides decreased by 53%; plaque length decreased by 3.3mm, an average of 1.1mm per month; thickness decreased by 0.5mm, an average of 0.17mm per month, blood lipids improved, and plaques were significantly reduced.

[0133] 8. Case 8, female, 48 years old, physical examination blood lipids, carotid artery ultrasound in January 2024, four blood lipids (CHO 6.00↑, HDL-C0.91, LDL-C 2.91, TG 1.74↑), ultrasound report ( Fig.15 ) showed a soft plaque on the left carotid artery, 0.83×0.19 cm. At the end of January 2024, the patient began to take the pills prepared in Example 8 of the present invention, twice a day, 2 pills each time, for nearly 5 consecutive months. In June 2024, the carotid artery was re-examined by color Doppler ultrasound ( Fig.16 ) showed a medium echo plaque on the posterior wall of the left carotid bifurcation, about 0.56×0.15cm in size, and four blood lipids (CHO 3.46, HDL-C 1.52, LDL-C 3.06, TG 0.63↓). It can be seen that total cholesterol decreased by 42%, triglycerides decreased by 64%; plaque length decreased by 2.7mm, an average monthly decrease of 0.54mm; thickness decreased by 0.4mm, an average monthly decrease of 0.08mm, blood lipids improved, and plaques decreased significantly.

[0134] 9. Case 9, male, 43 years old, physical examination blood lipids, carotid artery ultrasound in March 2024, four blood lipids (CHO 4.09, HDL-C1.33, LDL-C 3.72, TG 1.88↑), ultrasound report ( Fig.17 ) shows a low echo plaque on the posterior wall of the right carotid bifurcation, with a plaque size of about 0.75*0.16 cm. At the end of March 2024, the patient began to take the pills prepared in Example 9 of the present invention, twice a day, 2 pills each time, for 4 consecutive months. In July 2024, the carotid artery was reexamined by color Doppler ultrasound ( Fig.18 ) showed a medium to low echo plaque on the posterior wall of the right carotid bifurcation, about 0.65*0.15cm in size, and four blood lipids (CHO 3.00, HDL-C 1.50, LDL-C 2.90, TG 1.22). It can be seen that total cholesterol decreased by 27%, triglycerides decreased by 35%; plaque length decreased by 1mm, an average of 0.25mm per month; thickness decreased by 0.1mm, an average of 0.03mm per month, blood lipids improved, and plaques decreased.

[0135] 10. Case 10, female, 59 years old, physical examination blood lipids, carotid artery ultrasound in March 2024, four blood lipids (CHO 4.50, HDL-C 0.84, LDL-C 2.23, TG 6.28↑), ultrasound report ( Fig.19 ) shows a low-echo plaque on the posterior wall of the left common carotid artery bifurcation, with a size of about 0.72*0.26 cm. At the end of March 2024, the patient began to take the pills prepared in Example 10 of the present invention, twice a day, 2 pills each time, for 4 months. In July 2024, the patient underwent a color Doppler ultrasound examination of the carotid artery ( Fig. 20 ) showed a medium to low echo plaque on the posterior wall of the left common carotid artery bifurcation, about 0.70*0.23cm in size, and four blood lipids (CHO3.07, HDL-C 1.15, LDL-C 2.71, TG1.38). It can be seen that total cholesterol decreased by 32%, triglycerides decreased by 78%; plaque length decreased by 0.2mm, an average monthly decrease of 0.05mm; thickness decreased by 0.3mm, an average monthly decrease of 0.08mm, blood lipids improved significantly, and plaque size was stable.

[0136] 11. Case 11, male, 62 years old, physical examination blood lipids, carotid artery ultrasound in January 2024, four blood lipids (CHO 4.70, HDL-C 0.96, LDL-C 3.22, TG 3.57↑), ultrasound report ( Fig.21 ) showed mixed plaques extending from the posterior wall of the bifurcation of the right common carotid artery to the posterior wall of the starting segment of the external carotid artery, with a size of about 2.15×0.24 cm. At the end of January 2024, the patient began to take the pills prepared in Example 11 of the present invention, twice a day, 2 pills each time, for nearly 6 consecutive months. In July 2024, the carotid artery was re-examined by color Doppler ultrasound ( Fig. 22 ) showed that the posterior wall of the right common carotid artery bifurcation extended to the posterior wall of the starting section of the external carotid artery, with heterogeneous echo plaques, about 1.65×0.21cm in size, and four blood lipids (CHO 3.65, HDL-C 1.09, LDL-C 3.35, TG 2.06↑). It can be seen that total cholesterol decreased by 22%, triglycerides decreased by 42%; plaque length decreased by 5.0mm, an average monthly decrease of 0.83mm; thickness decreased by 0.3mm, an average monthly decrease of 0.05mm, blood lipids improved, and plaques were significantly reduced.

[0137] 12. Case 12, male, 46 years old, physical examination blood lipids, carotid artery ultrasound in January 2024, four blood lipids (CHO 7.90↑, HDL-C 1.74, LDL-C 4.73↑, TG 1.46), ultrasound report ( Fig.23 ) showed mixed plaques on the posterior wall of the right carotid bifurcation, with a size of about 0.79*0.31cm. At the end of January 2024, he began to take conventional lipid-lowering drugs (rosuvastatin calcium 10mg, aspirin enteric-coated tablets 100mg), one tablet each per day, for nearly 6 consecutive months. In June 2024, the carotid artery was re-examined by color Doppler ultrasound ( Fig.24 ) showed an inhomogeneous and hyperechoic plaque on the posterior wall of the right carotid bifurcation, about 0.79*0.31cm in size, and four blood lipids (CHO 5.11, HDL-C 0.92, LDL-C 4.87↑, TG 1.05). It can be seen that total cholesterol decreased by 35%, triglycerides decreased by 28%, blood lipids improved, plaques were stable, and length and thickness did not change.

[0138] 13. Case 13, male, 52 years old, has been taking lipid-lowering drugs for a long time. A physical examination in April 2024 showed liver function (alanine aminotransferase 45.2↑, aspartate aminotransferase 45.6↑). He began to take the pills prepared in Example 3 of the present invention in late April 2024, twice a day, 2 pills each time, for nearly 3 consecutive months. In July 2024, his liver function was rechecked, with alanine aminotransferase of 16.8 and aspartate aminotransferase of 17.8, and his liver function returned to normal levels.

[0139] 14. Case 14, male, 46 years old, has been taking lipid-lowering drugs for a long time. A physical examination in April 2024 showed liver function (alanine aminotransferase 52.2↑, aspartate aminotransferase 57.4↑). He began to take the pills prepared in Example 4 of the present invention in late April 2024, twice a day, 2 pills each time, for nearly 3 consecutive months. In July 2024, his liver function was rechecked (alanine aminotransferase 14.9, aspartate aminotransferase 20.8), and the aminotransferase returned to normal levels.

[0140] 15. Case 15, male, 59 years old, has been taking lipid-lowering drugs for a long time. A physical examination in April 2024 showed liver function (alanine aminotransferase 52.2↑, aspartate aminotransferase 38.5). He began to take the pills prepared in Example 5 of the present invention in late April 2024, twice a day, 2 pills each time, for nearly 3 consecutive months. In July 2024, his liver function was rechecked (alanine aminotransferase 22.4, aspartate aminotransferase 25.2), and the aminotransferase returned to normal levels.

[0141] 16. Case 16, female, 43 years old, has been taking lipid-lowering drugs for a long time. A physical examination in April 2024 showed liver function (alanine aminotransferase 63.7↑, aspartate aminotransferase 61.6↑). She started taking the pills prepared in Example 6 of the present invention in late April 2024, twice a day, 2 pills each time, for nearly 3 consecutive months. In July 2024, her liver function was rechecked (alanine aminotransferase 30.9, aspartate aminotransferase 28.7), and the aminotransferase returned to normal levels.

[0142] SEQ ID NO: 1:

[0143] MRSKKLWISLLFALTLIFTMAFSNMSAQAAGKSSTEKKYIVGFKQTMSAMSSAKKKDVISEKGGKVQKQFKYVNAAAATLDEKAVKELKKDPSVAYVEEDHIAHEYAQSVPYGISQIKAPALHSQGYTGSNVKVAVIDSGIDSSHPDLNVRGGASFVPSETNPYQDGSSHGTH VAGTIAALNNSIGVLGVAPSASLYAVKVLDSTGSGQYSWIINGIEWAISNNMDVINMSLGGPTGSTALKTVVDKAVSSGIVVAAAAGNEGSSGSTSTVGYPAKYPSTIAVGAVNSSNQRASFSSVGSELDVMAPGVSIQSTLPGGTYGAYNGTSMATPHVAGAAALILSKHPTW

[0144] The above descriptions are only some embodiments of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the protection scope of the present invention.

Claims

1. A composition, characterized in that The composition comprises, by weight: 1-100 parts of chicory extract and 1 part of nattokinase; The chicory extract is an extract of the dry aerial part of chicory (Cichorium intybus L.), and the activity of the nattokinase is 30000-40000 FU / g.

2. The composition according to claim 1, characterized in that The chicory extract is present in an amount of 1-4 parts, 10-20 parts or 40-80 parts by weight; And / or, the weight of the parts by weight is 10-200g; preferably 10-20g, 20-100g or 150-200g; Preferably, the composition comprises the following components in parts by weight: 20-40 parts chicory extract and 1 part nattokinase; or, 40-80 parts chicory extract and 1 part nattokinase; or, 10-20 parts chicory extract and 1 part nattokinase; or, 1-2 parts chicory extract and 1 part nattokinase; or, 2-4 parts chicory extract and 1 part nattokinase; or, 4-10 parts chicory extract and 1 part nattokinase; More preferably, the composition comprises the following components in parts by weight: 20 parts of chicory extract and 1 part of nattokinase, wherein each part weighs 200g or 100g; or, 40 parts of chicory extract and 1 part of nattokinase, wherein each part weighs 100g or 50g; or, 80 parts of chicory extract and 1 part of nattokinase, each weighing 50 g; or, 10 parts of chicory extract and 1 part of nattokinase, wherein each part weighs 200g; or, 1 part chicory extract and 1 part nattokinase, each weighing 200g; or, 2 parts chicory extract and 1 part nattokinase, each weighing 100 g; For example, the composition includes the following components in parts by weight: 20 parts of chicory extract and 1 part of nattokinase, wherein each part weighs 200g; or, 40 parts of chicory extract and 1 part of nattokinase, wherein each part weighs 100g or 50g; or, 80 parts of chicory extract and 1 part of nattokinase, each weighing 50 g; or, 10 parts of chicory extract and 1 part of nattokinase, wherein each part weighs 200g; or, 1 part chicory extract and 1 part nattokinase, wherein each part weighs 200g.

3. The composition according to claim 1 or 2, characterized in that In the composition, the chicory extract is prepared by an alcohol-water extraction method; preferably, the alcohol-water extraction method further comprises the steps of resin enrichment, complexation purification, and refined extraction; And / or, the main active ingredient of the chicory extract is flavonoids, and the mass percentage of the flavonoids in the chicory extract is ≥1.0%; And / or, the nattokinase is nattokinase from Bacillus subtilis (natto), and the nattokinase preferably has an amino acid sequence as shown in SEQ ID NO:

1.

4. The composition according to claim 3, characterized in that The flavonoid component is selected from one or more of aconitine, quercetin-3-O-glucuronide, isoquercetin, kaempferol-3-O-glucuronide, kaempferol-3-O-β-D-pyranoglucoside, isorhamnetin-3-O-β-D-pyranoglucoside and isorhamnetin-3 / 7-O-β-D-glucuronide; and / or the mass percentage of the flavonoid component in the chicory extract is ≥4.0%.

5. A preparation, characterized in that The preparation comprises the composition according to any one of claims 1 to 4.

6. The preparation according to claim 5, characterized in that The preparation further comprises a pharmaceutically acceptable carrier and / or excipient; Preferably, the auxiliary material is selected from excipients, diluents, binders and additives; the additive is selected from pigments, preservatives and flavor enhancers; More preferably, the auxiliary material is selected from one or more of starch, pregelatinized starch, lactose, sucrose, talc, dextrin, cyclodextrin, beeswax, microcrystalline cellulose, sodium carboxymethyl cellulose, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, glucose, meglumine, magnesium stearate, dextran, glycerol, ethanol, propylene glycol, polyethylene glycol, mannitol, sorbitol, xylitol, fiber vegetable oil, sodium benzoate, sodium salicylate, hydrochloric acid, citric acid, sodium citrate, sodium dihydrogen phosphate, disodium hydrogen phosphate, gelatin, lecithin and vitamin C.

7. The preparation according to claim 5 or 6, characterized in that The pharmaceutical form of the preparation is tablets, capsules, soft capsules, oral liquids, granules, pills, pellets, powders, ointments, pills, injections, suppositories, patches, drops, sprays, creams, suspensions, tinctures, emulsions, water injections, powder injections, targeted preparations, sustained-release preparations or controlled-release preparations. Preferably, the pharmaceutical form of the preparation is pills.

8. A health food, characterized in that: The health food comprises the composition according to any one of claims 1 to 4.

9. A food composition, characterized in that The food composition comprises the composition according to any one of claims 1 to 4.

10. Use of the composition according to any one of claims 1 to 4 or the preparation according to any one of claims 5 to 7 in the preparation of a drug for preventing and ablating vascular plaques; Preferably, the vascular plaque is a cerebral vascular plaque; and the cerebral vascular plaque is a carotid artery plaque.

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