Ce-2 oligopeptide SOD (superoxide dismutase) compound and application of synergistic application of Ce-2 oligopeptide SOD compound and Ke-1 oligopeptide enzyme in vascular repair and treatment of metabolic syndrome

Abstract

The invention relates to the technical field of SOD (superoxide dismutase) compounds, in particular to a Ce-2 oligopeptide SOD compound and application of synergistic application of the Ce-2 oligopeptide SOD compound and Ke-1 oligopeptide enzyme in vascular repair and metabolic syndrome treatment, and the Ce-2 oligopeptide SOD compound comprises the following components in percentage by weight: 20-50% of superoxide dismutase (SOD) yeast powder, 5-15% of coenzyme Q10, 15-35% of collagen peptide and 10-25% of broccoli powder. According to the present invention, multiple mechanisms of Ce-2, such as direct superoxide anion free radical removal through SOD, mitochondria protection through coenzyme Q10, Nrf2 pathway activation through broccoli powder and the like are adopted, such that a hierarchical anti-oxidation network is formed, the SOD activity is improved, and the MDA level is reduced;

Description

Technical Field

[0001] The present invention relates to the technical field of SOD complexes, in particular to the application of Ce-2 oligopeptide SOD complex and its synergistic application with Ke-1 oligopeptide enzyme in blood vessel repair and the treatment of metabolic syndrome. Background Art

[0002] Oxidative stress is widely regarded as the common pathological basis of vascular diseases and metabolic syndrome. Excessively produced reactive oxygen species (ROS) and reactive nitrogen species (RNS) can cause lipid peroxidation, protein oxidation and DNA damage, ultimately leading to vascular endothelial dysfunction, vascular sclerosis and chronic inflammatory responses. In a healthy state, vascular endothelium maintains vascular dilation ability and elasticity by releasing nitric oxide (NO), while oxidative stress directly disrupts this function by reducing the bioavailability of NO.

[0003] Currently, the antioxidant products on the market mainly have the following problems: First, most of them are single-component, making it difficult to cope with the complex oxidative damage network; second, antioxidant intervention and metabolic regulation are often treated separately, lacking a synergistic strategy; third, existing products rarely pay attention to the integration of blood vessel structure repair and function improvement. Therefore, developing multi-component synergistic antioxidant products and using them in combination with metabolic regulators is of great significance for comprehensively improving vascular health and metabolic syndrome. Summary of the Invention

[0004] The present invention provides a multi-component antioxidant complex of Ce-2 oligopeptide SOD and a method for its combined application with Ke-1 oligopeptide enzyme, which are used for blood vessel repair, antioxidant and improving metabolic syndrome. Based on the core antioxidant mechanism of superoxide dismutase (SOD), the present invention combines the blood vessel repair effect of collagen peptide and the Nrf2 activation ability of broccoli pollen to form a multi-level blood vessel protection system. At the same time, through the synergistic application with Ke-1 oligopeptide enzyme, dual intervention of antioxidant and metabolic regulation is achieved.

[0005] The present invention proposes a Ce-2 oligopeptide SOD complex, which comprises the following components: 20-50% by weight of superoxide dismutase (SOD) yeast powder, 5-15% by weight of coenzyme Q10, 15-35% by weight of collagen peptide, 10-25% by weight of broccoli pollen, 1-5% by weight of vitamin B1, 1-5% by weight of vitamin B2, 2-10% by weight of zinc selenium yeast, 2-8% by weight of citric acid, 0.1-1% by weight of natural flavor, and 0.5-2% by weight of stevioside.

[0006] Specifically, the collagen peptide is mainly composed of collagen tripeptide (Pro-Hyp-Gly), and its content accounts for 50-80% of the total weight of the collagen peptide.

[0007] Specifically, the standardized content of sulforaphane in the broccoli powder is not less than 5%.

[0008] The preparation method of the Ce-2 oligopeptide SOD complex includes the following steps:

[0009] (1) Mix SOD yeast powder and coenzyme Q10 evenly at 30-40 °C;

[0010] (2) Add collagen peptide and broccoli powder, and dry and mix at low temperature;

[0011] (3) Add auxiliary components such as vitamin B1, B2, zinc and selenium yeast;

[0012] (4) Add citric acid, natural flavor and stevioside to make a homogeneous mixture;

[0013] (5) Freeze-dry to make powder or press into tablets.

[0014] A Ke-1 oligopeptide enzyme contains the following components: 25-45% by weight of glycolytic enzyme complex, 15-35% by weight of lipoprotease, 10-25% by weight of ACE inhibitory peptide, 10-20% by weight of dietary fiber, and 5-15% by weight of auxiliary components.

[0015] A synergistic application method of the Ce-2 oligopeptide SOD complex and the Ke-1 oligopeptide enzyme is to orally take 400-600 mg of Ce-2 oligopeptide SOD and 400-600 mg of Ke-1 oligopeptide enzyme every day, respectively in the morning and evening, for 8-12 consecutive weeks.

[0016] Specifically, the preferred plan is to orally take 500 mg of Ce-2 oligopeptide SOD and 500 mg of Ke-1 oligopeptide enzyme every day, respectively within 30 minutes after breakfast and dinner, and 12 weeks is a course of treatment.

[0017] Specifically, the application of the Ce-2 oligopeptide SOD complex in the preparation of drugs or functional foods for improving vascular elasticity, reducing oxidative stress and inhibiting inflammatory reactions.

[0018] Specifically, the application of the Ke-1 oligopeptide enzyme in the preparation of drugs or functional foods for regulating blood sugar, blood lipids and blood pressure.

[0019] Specifically, the application of the synergistic application method in the preparation of drugs or functional foods for treating metabolic syndrome, hypertension, atherosclerosis and vascular aging-related diseases. This synergistic application significantly improves the flow-mediated vasodilation (FMD) ability and pulse wave velocity (PWV) index through the complementary mechanism of antioxidant and metabolic regulation, while reducing the C-reactive protein (CRP) level, fasting blood glucose and triglyceride level.

[0020] The Ce-2 oligopeptide SOD complex provided by the present invention and its synergistic application method with the Ke-1 oligopeptide enzyme have the following outstanding advantages:

[0021] 1. Multiple antioxidant mechanisms: Ce-2 forms a hierarchical antioxidant network through multiple mechanisms such as directly scavenging superoxide anion radicals by SOD, protecting mitochondria by coenzyme Q10, and activating the Nrf2 pathway by broccoli pollen, significantly increasing SOD activity and reducing MDA levels. Experimental data show that the SOD activity in the intervention group increased from the baseline of 125±10U / mL to 165±12U / mL, while the MDA level decreased from 4.8±0.5nmol / mL to 3.0±0.3nmol / mL.

[0022] 2. Comprehensive vascular protection: Collagen peptides repair vascular endothelium and enhance vascular structure, and broccoli pollen reduces the release of inflammatory factors, jointly improving vascular elasticity, reducing PWV and increasing FMD values. Experimental data show that the PWV value in the intervention group decreased from 12.5±1.2m / s to 10.5±1.0m / s, while the FMD value increased from 7.2±1.0% to 10.0±1.1%, indicating a significant improvement in vascular function.

[0023] 3. Synergy between metabolism and antioxidant: When Ce-2 and Ke-1 are used in combination, they show better effects than using them alone in terms of improving vascular elasticity and reducing inflammatory markers, and at the same time significantly improving blood glucose and lipid metabolism indicators. The SOD activity (180±14U / mL) in the combined intervention group is higher than that in the group using Ce-2 alone (165±15U / mL) or Ke-1 alone (135±12U / mL), and the PWV value (9.8±0.7m / s) is lower than that in the group using Ce-2 alone (10.5±0.8m / s) or Ke-1 alone (11.0±1.0m / s).

[0024] 4. Multi-target intervention strategy: Through the synergistic action of multiple components, the present invention realizes comprehensive intervention from antioxidant defense, vascular structure repair to regulation of metabolic disorders. This multi-target strategy is particularly suitable for the treatment of complex metabolic syndrome.

[0025] 5. Good safety: All components in each example are derived from natural foods and generally recognized as safe additives, and no obvious adverse reactions were observed in clinical trials.

[0026] 6. Personalized plan: The various formulations and application plans provided by the present invention can be personalized adjusted according to the needs of different populations, so as to achieve precise intervention. Description of the Drawings

[0027] Figure 1 : Schematic diagram of the preparation process of Ce-2 oligopeptide SOD;

[0028] Figure 2 : Schematic diagram of the antioxidant mechanism of Ce-2 oligopeptide SOD;

[0029] Figure 3 : Schematic diagram of the synergistic effect of Ce-2 oligopeptide SOD and Ke-1 oligopeptide enzyme;

[0030] Figure 4 : Graph of the changing trend of SOD activity in clinical trials;

[0031] Figure 5 : Graph of the changing trends of PWV and FMD in clinical trials;

[0032] Figure 6 : Comparative graph of the improvement of metabolic indicators by the combined use of Ce-2 and Ke-1. Specific implementation manners

[0033] The present invention will be further described in detail below through specific embodiments, but the protection scope of the present invention is not limited to the following embodiments.

[0034] In the Ce-2 oligopeptide SOD complex of the present invention, the detailed information of each component and its preparation method are as follows:

[0035] Superoxide dismutase (SOD) yeast powder, as the core active ingredient of the present invention, accounts for 20-50% of the total weight of the Ce-2 complex, preferably 35%. The SOD yeast powder used in the present invention is a functional product with baker's yeast (Saccharomyces cerevisiae) as the biological carrier, which is rich in Cu-Zn SOD (copper-zinc superoxide dismutase, EC1.15.1.1). This component can be selected from the product produced by Lesaffre Human Care Company of France Its SOD activity is not less than 15,000 IU / g. For the preparation of this component, it is preferably to use the special strain Saccharomyces cerevisiae NCYCR397 for liquid deep fermentation, and by controlling the concentrations of trace elements such as copper and zinc in the fermentation medium, cultivate for 48-72 hours at 25-30 °C and pH 5.0-6.0. After the fermentation is completed, the thalli are separated by centrifugation and obtained as yeast powder rich in SOD through freeze-drying treatment.

[0036] Coenzyme Q10 accounts for 5-15% by weight in this complex, preferably 10%, and is an important fat-soluble antioxidant, which plays a key role in the electron transport chain and ATP generation in living organisms. The present invention preferably uses Kaneka QH produced by Kaneka Corporation of Japan TM , and its purity is not less than 98% (determined by HPLC method).

[0037] Collagen peptide accounts for 15 - 35% in the present invention, preferably 25%, and is mainly composed of collagen tripeptide Pro-Hyp-Gly (proline-hydroxyproline-glycine). This component is produced by Rousselot Company of France P, with an average molecular weight of about 2000 Da and the content of Pro-Hyp-Gly not less than 8%. To obtain high-quality collagen peptide, the present invention adopts a two-step enzymatic hydrolysis method: First, pretreat the collagen from cowhide or pigskin, and then under the condition of pH 2.0 - 3.0, use pepsin (EC 3.4.23.1) for preliminary hydrolysis; then adjust the pH to 7.0 - 8.0, add collagenase (EC 3.4.24.3) and continue hydrolysis for 4 - 6 hours; after the hydrolysis is terminated, separate and purify through an ultrafiltration membrane to remove components with too large or too small molecular weights, and then obtain the final product through spray drying.

[0038] Broccoli pollen accounts for 10 - 25% by weight in this complex, preferably 15%. This component is a powder made from the dried and crushed flower buds of broccoli (Brassica oleracea var. italica), rich in sulforaphane and its precursor glucosinolate. The broccoli pollen used in the present invention is from Cyvex Nutrition Company of the United States Its standardized sulforaphane content is not less than 5%. During the preparation process, the key is to maintain the stability of the active ingredients: Immediately after harvesting, conduct low-temperature hot air drying treatment on the broccoli flower buds (temperature not exceeding 40°C), crush the dried flower buds under low-temperature conditions (-20°C), screen out the powder with a mesh size of 90 - 120, and then adopt supercritical CO2 extraction technology for concentration treatment to increase the sulforaphane content, and finally standardize to make the content of sulforaphane and its precursor stable above 5%.

[0039] Vitamin B1 and vitamin B2 each account for 1 - 5% by weight in this complex, preferably both 2%. As water-soluble vitamins, vitamin B1 and vitamin B2 are respectively involved in carbohydrate metabolism and various oxidation-reduction reactions. The present invention selects Thiamine HCl USP (purity ≥ 99%) from DSM Company of Switzerland and Riboflavin USP (purity ≥ 98%) from BASF Company of Germany.

[0040] Zinc selenium yeast accounts for 2 - 10% by weight in this complex, preferably 5%. This component is a functional yeast powder made by enriching and absorbing zinc and selenium elements in yeast through a special process, and selects the product of Cypress Systems Company of the United States Plus Zn, with a selenium content of 1000 - 1200 μg / g (in the form of organic selenium) and a zinc content of 5000 - 6000 μg / g (in the form of organic zinc). The preparation method is to use a special strain, Saccharomyces cerevisiae CNCM I - 3399, for liquid fermentation in a medium containing sodium selenite and zinc sulfate at controlled concentrations, enabling yeast cells to convert inorganic selenium and zinc into organic forms and enrich them in the body. After the fermentation ends, the bacterial cells are collected, washed, inactivated, and then freeze - dried to obtain zinc - selenium yeast powder.

[0041] Citric acid accounts for 2 - 8% by weight in this complex, preferably 5%, and is mainly used as a pH regulator and antioxidant stabilizer. Citric Acid Anhydrous USP / FCC from Jungbunzlauer AG, Switzerland, with a purity of not less than 99.5% is selected.

[0042] Natural flavor accounts for 0.1 - 1% by weight in this complex, preferably 0.5%. Natural Vanilla Extract from Givaudan SA, Switzerland, with vanillin as the main component and a content of not less than 1% is selected in this invention.

[0043] Steviol glycosides account for 0.5 - 2% by weight in this complex, preferably 1%. The main components are Stevioside A and Rebaudioside A. EverSweet from Cargill, Inc., USA is selected. TM , with a total steviol glycoside content of not less than 95% and a Rebaudioside A content of not less than 50%.

[0044] The glycolytic enzyme complex accounts for 25 - 45% of the total weight of Ke - 1, preferably 35%. This complex consists of various digestive enzymes acting on carbohydrates, mainly including α - amylase (EC 3.2.1.1, derived from Bacillus subtilis, activity ≥ 10,000 SKB units / g), glucoamylase (glucose amylase, EC 3.2.1.3, derived from Aspergillus niger, activity ≥ 300 AGU units / g), and glucose isomerase (EC 5.3.1.5, derived from Streptomyces murinus, activity ≥ 2,000 IGIU units / g). EnzymePro TM GC.

[0045] The preparation of these enzymes involves a multi-step process: First, the enzyme-producing strains are cultured separately through a fermentation process. After collecting the fermentation broth, ultrafiltration and concentration are carried out to remove cell debris and impurities. Then, the processed enzyme solutions are mixed in a predetermined ratio, and maltodextrin is added as a stabilizer. Finally, spray drying or freeze drying is performed to produce the final product.

[0046] Lipoproteinase accounts for 15-35% of the total weight of Ke-1, preferably 25%. This component is a complex of lipase and protease, including lipase (EC 3.1.1.3, derived from Candida lipolytica, activity ≥ 8,000 LU units / g) and protease (EC 3.4.21.62, derived from Bacillus subtilis, activity ≥ 6,000 PC units / g). In the present invention, Lipozyme X from Amano Enzyme Co., Ltd., Japan is selected. TM . The preparation method is as follows: Candida lipolytica and Bacillus subtilis are cultured separately to obtain fermentation broths containing lipase and protease; the fermentation broths are purified by ultrafiltration and ion exchange chromatography to remove impurities; the two enzyme solutions are mixed in an appropriate ratio, mannitol is added as a stabilizer, and the final product is obtained by freeze drying.

[0047] ACE inhibitory peptide accounts for 10-25% of the total weight of Ke-1, preferably 15%. This component is mainly milk-derived tripeptides IPP (Ile-Pro-Pro, isoleucine-proline-proline, molecular weight 325.4 Da) and VPP (Val-Pro-Pro, valine-proline-proline, molecular weight 311.4 Da). In the present invention, The total content of IPP and VPP is not less than 5%.

[0048] The preparation process of ACE inhibitory peptide is special: Using defatted milk powder as the raw material, it is fermented with a specific lactic acid bacteria strain (Lactobacillus helveticus CM4); during the fermentation process, the protease produced by the lactic acid bacteria hydrolyzes casein, releasing ACE inhibitory peptides IPP and VPP; after the fermentation is completed, the cells are removed by centrifugation, and the fermentation broth is subjected to ultrafiltration and nanofiltration to remove macromolecular substances and inorganic salts; finally, it is further purified by reverse phase chromatography and obtained by freeze drying to produce the final product.

[0049] Dietary fiber accounts for 10-20% of the total weight of Ke-1, preferably 15%. The dietary fiber used in the present invention is a mixture of water-soluble fructooligosaccharides and inulin, and is selected from Synergy1 has a dietary fiber content of not less than 90% (dry basis). Among them, the average degree of polymerization of fructooligosaccharides (β-D-fructose-(2→1)n-D-fructose, n = 2 - 8) is 3 - 5, and the average degree of polymerization of inulin (β-D-fructose-(2→1)n-D-glucose, n = 10 - 60) is 20 - 25.

[0050] The auxiliary components account for 5 - 15% of the total weight of Ke-1, preferably 10%. These auxiliary components include vitamin D3 (cholecalciferol, (3β,5Z,7E)-9,10-seco-5,7,10(19)-cholatriene-3-ol, CAS No. 67-97-0), magnesium citrate, and mixed tocopherols (the main component is d-α-tocopherol). Among the auxiliary components, the content of vitamin D3 is 0.1% (w / w), the content of magnesium citrate is 8% (w / w), and the content of mixed tocopherols is 1.9% (w / w).

[0051] In the present invention, when the Ce-2 oligopeptide SOD complex and the Ke-1 oligopeptide zymase are used in combination, their biological functions are complementary: Ce-2 scavenges free radicals through SOD and coenzyme Q10, collagen peptides repair blood vessel structures, and sulforaphane in broccoli pollen activates the Nrf2 pathway to enhance the endogenous antioxidant system; while the glycolytic enzyme complex and lipase in Ke-1 optimize glycolipid metabolism, ACE inhibitory peptides regulate blood pressure, and dietary fiber maintains the balance of the intestinal microecosystem. This multi-dimensional synergistic effect gives the present invention unique advantages in improving metabolic syndrome and cardiovascular function.

[0052] Example 1: Preparation of Ce-2 oligopeptide SOD complex (basic formula)

[0053] This example provides a method for preparing a Ce-2 oligopeptide SOD complex with a basic formula. The Ce-2 oligopeptide SOD complex contains the following components: 35% by weight of superoxide dismutase (SOD) yeast powder, 10% by weight of coenzyme Q10, 25% by weight of collagen peptides, 15% by weight of broccoli pollen, 2% by weight of vitamin B1, 2% by weight of vitamin B2, 5% by weight of zinc selenium yeast, 5% by weight of citric acid, 0.5% by weight of natural flavor, and 0.5% by weight of stevioside.

[0054] The preparation method includes the following steps:

[0055] (1) First, place 35 g of SOD yeast powder and 10 g of coenzyme Q10 in a thermostatic stirrer and mix them at a low speed at 37°C for 30 minutes to ensure that the two are fully and evenly mixed;

[0056] (2) Then, add 25 g of collagen peptide (wherein the collagen tripeptide Pro-Hyp-Gly accounts for 65%) and 15 g of broccoli pollen (the sulforaphane content is 5.5%), and mix in a vacuum environment for 45 minutes to evenly distribute each component;

[0057] (3) Next, add 2 g of vitamin B1, 2 g of vitamin B2, and 5 g of zinc and selenium yeast, and continue stirring for 15 minutes;

[0058] (4) Again, add 5 g of citric acid as a pH regulator (to keep the final pH value between 5.8 - 6.2), 0.5 g of natural flavor, and 0.5 g of stevioside to improve the taste, and mix for 10 minutes until uniform;

[0059] (5) Finally, use a low-temperature freeze-drying technology at -40 °C for 8 hours to make a powder, and then fill it into plant capsules (500 mg per capsule) or press it into tablets.

[0060] In this example, SOD provides the ability to directly scavenge superoxide anion radicals, and can quickly convert O2 - into H2O2, which is further decomposed into water and oxygen by CAT; coenzyme Q10 reduces ROS production by protecting mitochondrial function and can regenerate other antioxidants such as vitamin E; collagen peptide, especially the Pro-Hyp-Gly tripeptide component therein, can promote the regeneration of vascular endothelial cells and the reconstruction of collagen fibers, directly enhancing the vascular structure; sulforaphane in broccoli pollen forms a second line of defense by activating the Nrf2 / ARE signaling pathway and enhancing the expression of endogenous antioxidant enzymes.

[0061] Example 2: Preparation of Ce-2 oligopeptide SOD complex (high SOD content formula)

[0062] This example provides a method for preparing a Ce-2 oligopeptide SOD complex with a high SOD content. The Ce-2 oligopeptide SOD complex contains the following components: 50% by weight of superoxide dismutase (SOD) yeast powder, 5% by weight of coenzyme Q10, 20% by weight of collagen peptide, 10% by weight of broccoli pollen, 1% by weight of vitamin B1, 1% by weight of vitamin B2, 2% by weight of zinc and selenium yeast, 8% by weight of citric acid, 0.5% by weight of natural flavor, and 2.5% by weight of stevioside.

[0063] The preparation method includes the following steps:

[0064] (1) First, place 50 g of SOD yeast powder and 5 g of coenzyme Q10 in a thermostatic stirrer and mix at a low speed at 30 °C for 25 minutes;

[0065] (2) Then, add 20 g of collagen peptide (wherein the collagen tripeptide Pro-Hyp-Gly accounts for 50%) and 10 g of broccoli pollen (the sulforaphane content is 6%), and mix in a vacuum environment for 40 minutes;

[0066] (3) Next, add 1 g of vitamin B1, 1 g of vitamin B2, and 2 g of zinc and selenium yeast, and continue stirring for 15 minutes;

[0067] (4) Again, add 8 g of citric acid (to keep the final pH value between 5.5 - 6.0), 0.5 g of natural flavor, and 2.5 g of stevioside to improve the taste, and mix for 10 minutes until homogeneous;

[0068] (5) Finally, use a low-temperature freeze-drying technology at -45°C for 10 hours to make a powder, and fill it into plant capsules (600 mg per capsule).

[0069] The high-SOD-content formula in this example is particularly suitable for people with a relatively high level of oxidative stress, such as those who are exposed to a polluted environment for a long time, smokers, or patients with chronic inflammation. A high dose of SOD can quickly increase the activity of antioxidant enzymes in the body, enhance the ability to scavenge free radicals, and significantly reduce the levels of peroxides such as MDA.

[0070] Example 3: Preparation of Ce-2 oligopeptide SOD complex (high collagen peptide content formula)

[0071] This example provides a method for preparing a Ce-2 oligopeptide SOD complex with a high collagen peptide content. The Ce-2 oligopeptide SOD complex contains the following components: 25% by weight of superoxide dismutase (SOD) yeast powder, 8% by weight of coenzyme Q10, 35% by weight of collagen peptide, 15% by weight of broccoli pollen, 3% by weight of vitamin B1, 3% by weight of vitamin B2, 4% by weight of zinc and selenium yeast, 5% by weight of citric acid, 0.2% by weight of natural flavor, and 1.8% by weight of stevioside.

[0072] The preparation method includes the following steps:

[0073] (1) First, place 25 g of SOD yeast powder and 8 g of coenzyme Q10 in a thermostatic stirrer and mix at a low speed at 35°C for 35 minutes;

[0074] (2) Then, add 35 g of collagen peptide (wherein the collagen tripeptide Pro-Hyp-Gly accounts for 80%) and 15 g of broccoli pollen (the sulforaphane content is 5%), and mix in a vacuum environment for 50 minutes;

[0075] (3) Next, add 3 g of vitamin B1, 3 g of vitamin B2, and 4 g of zinc and selenium yeast, and continue stirring for 20 minutes;

[0076] (4) Next, add 5 g of citric acid (to keep the final pH value between 6.0 - 6.5), 0.2 g of natural flavor, and 1.8 g of stevioside to improve the taste, and mix for 15 minutes until homogeneous;

[0077] (5) Finally, use low-temperature freeze-drying technology at -42 °C for 9 hours to make it into powder, and press it into tablets (400 mg per tablet).

[0078] The high collagen peptide formula of this example particularly emphasizes the blood vessel repair function. The high content (35%) of collagen peptide, especially Pro-Hyp-Gly tripeptide (accounting for 80% of the collagen peptide), can significantly promote the regeneration of vascular endothelial cells and the reconstruction of collagen fibers. This formula is suitable for people with reduced vascular elasticity or impaired endothelial function, such as the elderly, patients with hypertension, or early-stage patients with atherosclerosis.

[0079] Example 4: Preparation of Ce-2 oligopeptide SOD complex (formula with high content of broccoli pollen)

[0080] This example provides a method for preparing a Ce-2 oligopeptide SOD complex with a high content of broccoli pollen. The Ce-2 oligopeptide SOD complex contains the following components: 30% by weight of superoxide dismutase (SOD) yeast powder, 12% by weight of coenzyme Q10, 15% by weight of collagen peptide, 25% by weight of broccoli pollen, 2% by weight of vitamin B1, 2% by weight of vitamin B2, 6% by weight of zinc and selenium yeast, 6% by weight of citric acid, 0.1% by weight of natural flavor, and 1.9% by weight of stevioside.

[0081] The preparation method includes the following steps:

[0082] (1) First, place 30 g of SOD yeast powder and 12 g of coenzyme Q10 in a constant-temperature stirrer and mix at a low speed at 40 °C for 40 minutes;

[0083] (2) Then, add 15 g of collagen peptide (wherein the collagen tripeptide Pro-Hyp-Gly accounts for 60%) and 25 g of broccoli pollen (the sulforaphane content is 7.5%), and mix in a vacuum environment for 55 minutes;

[0084] (3) Next, add 2 g of vitamin B1, 2 g of vitamin B2, and 6 g of zinc and selenium yeast, and continue to stir for 25 minutes;

[0085] (4) Next, add 6 g of citric acid (to keep the final pH value between 5.7 - 6.2), 0.1 g of natural flavor, and 1.9 g of stevioside to improve the taste, and mix for 20 minutes until homogeneous;

[0086] (5) Finally, it is processed by low-temperature freeze-drying technology at -38°C for 7.5 hours to make a powder, which is filled into plant capsules (450 mg per capsule).

[0087] In this example, the formulation with high-content broccoli powder (25%) and high sulforaphane concentration (7.5%) particularly emphasizes activating the endogenous antioxidant system through the Nrf2 pathway. This mechanism can significantly increase the expression of antioxidant enzymes in the body and form a long-term antioxidant defense. At the same time, various active ingredients in broccoli powder can also effectively inhibit the NF-κB signaling pathway and reduce the release of inflammatory factors, being suitable for patients with chronic inflammation and metabolic inflammation.

[0088] Example 5: Preparation of Ce-2 oligopeptide SOD complex (balanced formulation)

[0089] This example provides a preparation method of a Ce-2 oligopeptide SOD complex with balanced component contents. The Ce-2 oligopeptide SOD complex contains the following components: 33% by weight of superoxide dismutase (SOD) yeast powder, 11% by weight of coenzyme Q10, 22% by weight of collagen peptide, 18% by weight of broccoli powder, 2.5% by weight of vitamin B1, 2.5% by weight of vitamin B2, 5% by weight of zinc selenium yeast, 4% by weight of citric acid, 0.3% by weight of natural flavor, and 1.7% by weight of stevioside.

[0090] The preparation method includes the following steps:

[0091] (1) First, 33 g of SOD yeast powder and 11 g of coenzyme Q10 are placed in a constant-temperature stirrer and mixed at a low speed at 38°C for 32 minutes;

[0092] (2) Then, 22 g of collagen peptide (wherein collagen tripeptide Pro-Hyp-Gly accounts for 70%) and 18 g of broccoli powder (sulforaphane content is 6.5%) are added and mixed in a vacuum environment for 48 minutes;

[0093] (3) Next, 2.5 g of vitamin B1, 2.5 g of vitamin B2, and 5 g of zinc selenium yeast are added and stirring is continued for 22 minutes;

[0094] (4) Again, 4 g of citric acid (to keep the final pH value between 5.9 - 6.3), 0.3 g of natural flavor, and 1.7 g of stevioside are added to improve the taste and mixed for 18 minutes until uniform;

[0095] (5) Finally, it is processed by low-temperature freeze-drying technology at -40°C for 8.5 hours to make a powder, which can either be filled into plant capsules (500 mg per capsule) or pressed into tablets.

[0096] This balanced formula is suitable for a broad spectrum of people, especially those in the early stage of metabolic syndrome or with multiple cardiovascular risk factors. It is characterized by a balanced proportion of SOD yeast powder, collagen peptide, and broccoli powder, which can provide instant antioxidant protection, vascular structure repair, and activation of a long-term antioxidant system simultaneously, comprehensively improving vascular health.

[0097] Example 6: Preparation of Ce-2 oligopeptide SOD complex (special low-temperature process)

[0098] This example provides a Ce-2 oligopeptide SOD complex prepared by a special low-temperature process. The Ce-2 oligopeptide SOD complex contains the following components: 40% by weight of superoxide dismutase (SOD) yeast powder, 15% by weight of coenzyme Q10, 20% by weight of collagen peptide, 12% by weight of broccoli powder, 1.5% by weight of vitamin B1, 1.5% by weight of vitamin B2, 3% by weight of zinc selenium yeast, 5% by weight of citric acid, 0.5% by weight of natural flavor, and 1.5% by weight of stevioside.

[0099] The preparation method includes the following steps:

[0100] (1) First, place 40 g of SOD yeast powder and 15 g of coenzyme Q10 in a special low-temperature stirrer, and mix at low speed for 45 minutes under the protection of inert gas at 30°C;

[0101] (2) Then, under the condition that the temperature drops to 20°C, add 20 g of collagen peptide (wherein collagen tripeptide Pro-Hyp-Gly accounts for 75%) and 12 g of broccoli powder (the sulforaphane content is 8%), and mix in a vacuum environment under the protection of inert gas for 60 minutes;

[0102] (3) Next, maintain the temperature at 15°C, add 1.5 g of vitamin B1, 1.5 g of vitamin B2, and 3 g of zinc selenium yeast, and continue to stir for 30 minutes;

[0103] (4) Again, under the condition of 10°C, add 5 g of citric acid (to keep the final pH value between 5.6 - 6.1), 0.5 g of natural flavor, and 1.5 g of stevioside to improve the taste, and mix for 25 minutes until uniform;

[0104] (5) Finally, adopt gradient cooling freeze-drying technology, first treat at -30°C for 4 hours, and then treat at -50°C for 8 hours to make ultrafine powder, which is filled into special moisture-proof plant capsules (550 mg per capsule).

[0105] In this embodiment, the low-temperature special process uses inert gas protection and gradient cooling treatment throughout, which can maximize the retention of the activity of SOD yeast powder and coenzyme Q10. This process is particularly suitable for formulations with a high SOD content (40%) and a high coenzyme Q10 content (15%), can significantly improve the stability and biological activity of the product, and is suitable for people who need high-strength antioxidant protection.

[0106] Example 7: Preparation of Ke-1 Oligopeptide Enzyme (Basic Formula)

[0107] This embodiment provides a method for preparing Ke-1 oligopeptide enzyme with a basic formula. The Ke-1 oligopeptide enzyme comprises the following components: 35% by weight of glycolytic enzyme complex, 25% by weight of lipoprotein lipase, 15% by weight of ACE inhibitory peptide, 15% by weight of dietary fiber, and 10% by weight of auxiliary components.

[0108] The preparation method comprises the following steps:

[0109] (1) First, pretreat 35 g of glycolytic enzyme complex (containing α-amylase, glucoamylase, and glucose isomerase) at 35 °C for 20 minutes to activate the enzyme activity;

[0110] (2) Then, add 25 g of lipoprotein lipase and mix in a buffer solution with a pH of 6.8 for 30 minutes;

[0111] (3) Next, add 15 g of ACE inhibitory peptide (where the content of tripeptides IPP and VPP is not less than 5%) and 15 g of dietary fiber (including inulin and fructooligosaccharides), and mix evenly;

[0112] (4) Again, add 10 g of auxiliary components (including vitamin D3, magnesium salt, and antioxidant), and mix for 15 minutes;

[0113] (5) Finally, use spray drying technology (inlet air temperature 120 °C, outlet air temperature 60 °C) to make microparticle powder and fill it into enteric-coated capsules (500 mg per capsule).

[0114] The mechanism of action of Ke-1 oligopeptide enzyme mainly focuses on metabolic regulation. Among them, the glycolytic enzyme complex can effectively decompose complex carbohydrates and reduce the postprandial blood glucose peak; lipoprotein lipase reduces plasma triglyceride and LDL cholesterol levels by promoting fatty acid metabolism; ACE inhibitory peptide reduces blood pressure and improves microcirculation by inhibiting the activity of angiotensin-converting enzyme. This basic formula is suitable for most patients with metabolic syndrome.

[0115] Example 8: Synergistic Application of Ce-2 Oligopeptide SOD Complex and Ke-1 Oligopeptide Enzyme (Basic Scheme)

[0116] This embodiment provides a basic co - application scheme of Ce - 2 oligopeptide SOD complex and Ke - 1 oligopeptide enzyme. The scheme is as follows:

[0117] Orally take 500 mg of the Ce - 2 oligopeptide SOD complex prepared in Example 1 and 500 mg of the Ke - 1 oligopeptide enzyme prepared in Example 7 every day, and take them within 30 minutes after breakfast and dinner respectively. A 12 - week course of treatment is carried out.

[0118] This scheme is applicable to patients with metabolic syndrome who simultaneously have elevated oxidative stress levels and manifestations of metabolic disorders. Through clinical trials, it is verified that for patients adopting this scheme, after 12 weeks of treatment, the SOD activity increases from the baseline of 125 ± 10 U / mL to 180 ± 14 U / mL, the MDA level decreases from 4.8 ± 0.5 nmol / mL to 2.5 ± 0.3 nmol / mL, the CRP decreases from 3.2 ± 0.4 mg / L to 1.8 ± 0.2 mg / L, the PWV decreases from 12.5 ± 1.2 m / s to 9.8 ± 0.7 m / s, the FMD increases from 7.2 ± 1.0% to 11.5 ± 1.3%, the fasting blood glucose decreases from 6.8 ± 0.5 mmol / L to 5.5 ± 0.3 mmol / L, and the triglyceride decreases from 2.3 ± 0.3 mmol / L to 1.6 ± 0.2 mmol / L.

[0119] The advantage of this co - application scheme lies in the complementary effects of antioxidant and metabolic regulation. Ce - 2 reduces the damage of oxidative stress to blood vessels by scavenging free radicals and simultaneously repairs the blood vessel structure; while Ke - 1 regulates metabolic disorders, reduces the metabolic load, and reduces the production of inflammatory factors. The two work together to significantly improve all the core manifestations of metabolic syndrome.

[0120] Example 9: Co - application of Ce - 2 oligopeptide SOD complex and Ke - 1 oligopeptide enzyme (dose - increasing scheme)

[0121] This embodiment provides a co - application scheme of Ce - 2 oligopeptide SOD complex and Ke - 1 oligopeptide enzyme with increasing doses.

[0122] The scheme is as follows:

[0123] Weeks 1 - 2: Orally take 400 mg of the Ce - 2 oligopeptide SOD complex prepared in Example 2 and 400 mg of the Ke - 1 oligopeptide enzyme prepared in Example 7 every day, and take them within 30 minutes after breakfast and dinner respectively;

[0124] Weeks 3 - 4: Orally take 450 mg of Ce - 2 oligopeptide SOD complex and 450 mg of Ke - 1 oligopeptide enzyme every day, and take them within 30 minutes after breakfast and dinner respectively;

[0125] Weeks 5 - 12: Orally take 600 mg of Ce-2 oligopeptide SOD complex and 600 mg of Ke-1 oligopeptide zymase daily, within 30 minutes after breakfast and dinner respectively.

[0126] This escalating dose regimen is particularly suitable for patients with severe and long-term metabolic disorders, such as those with long-term obesity, insulin resistance, or diagnosed type 2 diabetes. The dose escalation design can reduce the discomfort that may occur initially, while providing a stronger intervention intensity in the later stage of treatment. Clinical data shows that after 12 weeks of treatment, patients using this regimen have a 15% greater reduction in fasting blood glucose and an 18% greater reduction in triglycerides compared to the fixed-dose regimen, and at the same time, the increase in SOD activity is more significant.

[0127] Example 10: Synergistic application of Ce-2 oligopeptide SOD complex and Ke-1 oligopeptide zymase (pulse strategy regimen)

[0128] This example provides a synergistic application regimen of Ce-2 oligopeptide SOD complex and Ke-1 oligopeptide zymase with a pulse strategy.

[0129] The regimen is as follows:

[0130] Weeks 1 - 4: Orally take 500 mg of Ce-2 oligopeptide SOD complex prepared in Example 3 within 30 minutes after breakfast; take 500 mg of Ke-1 oligopeptide zymase prepared in Example 7 within 30 minutes after dinner;

[0131] Week 5: Discontinue both products and take a 1-week break;

[0132] Weeks 6 - 9: Resume orally taking 500 mg of Ce-2 oligopeptide SOD complex and 500 mg of Ke-1 oligopeptide zymase daily, within 30 minutes after breakfast and dinner respectively;

[0133] Week 10: Discontinue both products and take a 1-week break;

[0134] Weeks 11 - 14: Resume orally taking 500 mg of Ce-2 oligopeptide SOD complex and 500 mg of Ke-1 oligopeptide zymase daily, within 30 minutes after breakfast and dinner respectively.

[0135] This pulse strategy regimen is suitable for patients who need long-term maintenance treatment. By periodically discontinuing the drugs briefly, it can reduce the body's adaptability and maintain a better treatment response. Research shows that this strategy can prevent the compensatory downregulation of the body's antioxidant system and maintain the long-term effectiveness of treatment. The treatment effect of patients using this regimen at week 14 is better than that after continuous use for 12 weeks, especially in maintaining SOD activity and improving FMD.

[0136] To further verify the unique effects of the Ce-2 oligopeptide SOD complex of the present invention and its synergistic application with the Ke-1 oligopeptide enzyme, the following comparative tests were conducted.

[0137] Comparative Example 1: Comparison between the Ce-2 oligopeptide SOD complex and a single antioxidant

[0138] Test objective: To compare the differences in antioxidant capacity between the Ce-2 oligopeptide SOD complex and a single vitamin C or a single SOD supplement.

[0139] Test method:

[0140] 1. Ninety subjects with elevated oxidative stress levels (plasma MDA > 4.5 nmol / mL) were selected and randomly divided into three groups of 30 people each:

[0141] Group A: Took 500 mg of the Ce-2 oligopeptide SOD complex daily (prepared in Example 1)

[0142] Group B: Took 1000 mg of vitamin C daily

[0143] Group C: Took 500 mg of the SOD supplement daily (containing only SOD yeast powder)

[0144] 2. The intervention period was 8 weeks. The following indicators were measured at baseline, the 4th week, and the 8th week of the intervention:

[0145] SOD activity (measured by spectrophotometry, unit: U / mL)

[0146] MDA level (measured by the thiobarbituric acid method, unit: nmol / mL)

[0147] 8-isoprostaglandin F2α (8-iso-PGF2α, measured by ELISA, unit: pg / mL)

[0148] Total antioxidant capacity (measured by the FRAP method, unit: μmol / L)

[0149] Table 1. Effects of different antioxidant intervention regimens on oxidative stress indicators (mean ± standard deviation)

[0150]

[0151]

[0152] The P value is the significance of the within-group change at the 8th week compared with the baseline

[0153] Result analysis: The data in the above table show that although all three intervention methods can improve oxidative stress indicators, the Ce-2 oligopeptide SOD complex has the most significant effect. In terms of the increase in SOD activity, the Ce-2 group (+35.5%) was significantly better than the pure SOD supplement group (+22.0%) and the vitamin C group (+8.0%); in terms of reducing lipid peroxidation products MDA and 8-iso-PGF2α, the improvement ranges of the Ce-2 group were -36.7% and -41.5% respectively, which were also better than the other two groups; in terms of the increase in total antioxidant capacity, the Ce-2 group reached +35.3%, while the SOD supplement group and the vitamin C group were +17.4% and +12.9% respectively.

[0154] This result indicates that the synergistic effect of multiple components in the Ce-2 oligopeptide SOD complex does bring an effect beyond that of a single antioxidant, especially in enhancing the activity of endogenous antioxidant enzymes and reducing lipid peroxidation.

[0155] Comparative Example 2: Comparison between the Ce-2 oligopeptide SOD complex and commercially available compound antioxidant products

[0156] Test objective: To compare the differences in the improvement of vascular health indicators between the Ce-2 oligopeptide SOD complex and commercially available compound antioxidant products.

[0157] Test method:

[0158] 1. Sixty subjects with reduced vascular elasticity (PWV > 12 m / s) were selected and randomly divided into two groups, with 30 people in each group:

[0159] Group A: Take 500 mg of the Ce-2 oligopeptide SOD complex (prepared in Example 3) daily

[0160] Group B: Take commercially available compound antioxidant products (containing vitamin C, vitamin E, coenzyme Q10 and selenium) daily

[0161] 2. The intervention period was 10 weeks. The following indicators were measured at baseline (before intervention), the 5th week and the 10th week of intervention:

[0162] Pulse wave velocity (PWV, measured by pressure sensor method, unit: m / s)

[0163] Flow-mediated vasodilation (FMD, measured by ultrasound, unit: %)

[0164] Angiotensin II level (Ang II, measured by ELISA method, unit: pg / mL)

[0165] Endothelin-1 level (ET-1, measured by ELISA method, unit: pg / mL)

[0166] Nitric oxide metabolites (NOx, measured by Griess reaction, unit: μmol / L)

[0167] Test results:

[0168] Table 2. Effects of Ce-2 and commercially available compound antioxidant products on vascular function indicators (mean ± standard deviation)

[0169]

[0170] The P value is the significance of within-group change compared with the baseline at the 10th week

[0171] Result analysis: The data in the above table clearly show that in all vascular health-related indicators, the Ce-2 oligopeptide SOD complex is significantly superior to commercially available compound antioxidant products. Notably, the Ce-2 group is particularly outstanding in improving endothelial function, with the improvement rate of FMD reaching +43.7%, much higher than +13.9% in the commercially available product group; meanwhile, the nitric oxide metabolites (NOx) in the Ce-2 group increased by 59.1%, while the commercially available product group only increased by 17.4%. This indicates that Ce-2 can significantly improve endothelium-dependent vasodilation function, which may be related to the promotion of endothelial repair by collagen peptides in it and the improvement of NO bioavailability by sulforaphane in broccoli pollen.

[0172] In addition, the Ce-2 group also shows obvious advantages in reducing vasoconstrictive factors (Ang II and ET-1). These factors work together to make Ce-2 significantly superior to commercially available products in reducing PWV (improving vascular elasticity).

[0173] Comparative Example 3: Comparison of Ce-2 and Ke-1 used alone and in combination

[0174] Test purpose: To verify the synergistic effect of the Ce-2 oligopeptide SOD complex and the Ke-1 oligopeptide zymase used in combination.

[0175] Test method:

[0176] 1. Select 120 patients with metabolic syndrome (meeting the International Diabetes Federation criteria) and randomly divide them into four groups, with 30 people in each group:

[0177] Group A: Take 500 mg of Ce-2 oligopeptide SOD complex daily (prepared in Example 1)

[0178] Group B: Take 500 mg of Ke-1 oligopeptide zymase daily (prepared in Example 7)

[0179] Group C: Take 500 mg of Ce-2 and 500 mg of Ke-1 simultaneously daily (Scheme of Example 8)

[0180] Group D: Placebo control group

[0181] 2. The intervention period was 12 weeks, and the following indicators were measured before the intervention (baseline) and at the 12th week of the intervention:

[0182] Antioxidant indicators: SOD activity (U / mL), MDA level (nmol / mL)

[0183] Vascular function indicators: PWV (m / s), FMD (%)

[0184] Inflammatory indicators: CRP (mg / L), IL-6 (pg / mL)

[0185] Metabolic indicators: fasting blood glucose (mmol / L), triglyceride (mmol / L), insulin resistance index (HOMA-IR)

[0186] 3. Detection methods:

[0187] SOD activity: Xanthine oxidase method

[0188] MDA level: Thiobarbituric acid method

[0189] PWV: Pulse wave velocity measuring instrument (Complior Analyse, ALAM Medical, France)

[0190] FMD: High-resolution ultrasound equipment (GE Vivid E9, GE Healthcare, USA)

[0191] CRP: High-sensitivity C-reactive protein immunoturbidimetry

[0192] IL-6: Enzyme-linked immunosorbent assay

[0193] Fasting blood glucose: Glucose oxidase method

[0194] Triglyceride: Enzymatic method

[0195] HOMA-IR: Fasting insulin (mU / L) × fasting blood glucose (mmol / L) ÷ 22.5

[0196] Test results:

[0197] Table 3. Effects of Ce-2 and Ke-1 alone and in combination on multiple indicators in patients with metabolic syndrome (mean ± standard deviation)

[0198]

[0199]

[0200] The P value is the significance of within-group changes at the 12th week compared with the baseline

[0201] Result analysis: This comparative experiment comprehensively evaluated the multi-dimensional effects of Ce-2 and Ke-1 used alone and in combination on patients with metabolic syndrome. The data clearly showed that in all test indicators, the combined use group showed better effects than the single use groups. It is worth noting that Ce-2 was outstanding in antioxidant and vascular function improvement, while Ke-1 was more obvious in improving metabolic indicators. The combined use group integrated the advantages of both and also showed a certain synergistic effect.

[0202] Specifically, in terms of antioxidant, the SOD activity in the combined group increased by 44.0%, higher than 33.1% in the Ce-2 group and 7.1% in the Ke-1 group; in terms of vascular function, the FMD in the combined group improved by 59.7%, higher than 38.9% in the Ce-2 group and 26.0% in the Ke-1 group; in terms of metabolic indicators, the triglyceride in the combined group decreased by 30.4%, higher than 21.7% in the Ke-1 group and 4.5% in the Ce-2 group.

[0203] This result strongly supports the core innovation of the present invention - the synergistic strategy of antioxidant and metabolic regulation. Ce-2 reduces oxidative stress and repairs vascular endothelium through multiple antioxidant mechanisms, while Ke-1 optimizes the metabolic state and reduces the metabolic load through a multi-enzyme complex system. The two work together to form a comprehensive intervention strategy from cause to result biologically.

[0204] Comparative Example 4: Comparison of the efficacy of different formulations of Ce-2 oligopeptide SOD complex

[0205] Test purpose: To compare the differences in the effects of different formulations of Ce-2 oligopeptide SOD complex on vascular endothelium repair.

[0206] Test method:

[0207] 1. Select 150 subjects with impaired endothelial function (FMD < 7.5%), and randomly divide them into five groups, with 30 people in each group:

[0208] Group A: Take 500 mg of basic formulation Ce-2 daily (prepared in Example 1)

[0209] Group B: Take 500 mg of Ce-2 with high SOD content formulation daily (prepared in Example 2)

[0210] Group C: Take 500 mg of Ce-2 with high collagen peptide content formulation daily (prepared in Example 3)

[0211] Group D: Take 500 mg of Ce-2 with high xylan pollen content formulation daily (prepared in Example 4)

[0212] Group E: Placebo control group

[0213] 2. The intervention period was 8 weeks. The following endothelial function and vascular repair indicators were measured before the intervention (baseline) and at the 8th week of the intervention:

[0214] Flow-mediated dilation (FMD, %)

[0215] Endothelial progenitor cell (EPCs) count (flow cytometry, cells / μL)

[0216] Endothelial microparticle (EMPs) level (flow cytometry, cells / μL)

[0217] Vascular endothelial growth factor (VEGF, pg / mL)

[0218] Endothelial nitric oxide synthase (eNOS) activity (indirect measurement, unit: pmol / mg protein / min)

[0219] 3. Detailed description of the detection methods:

[0220] FMD: In the early morning on an empty stomach, after the subject rested for 10 minutes, a high-resolution B-mode ultrasound device (equipped with a 10MHz linear probe) was used to measure the diameter of the brachial artery. First, the basal diameter was measured, and then the cuff was inflated to 50 mmHg above the systolic pressure at the distal end of the brachial artery for 5 minutes, and then quickly deflated. The maximum vascular diameter within 60 - 90 seconds was continuously monitored. FMD was calculated as: (maximum dilated diameter - basal diameter) / basal diameter × 100%.

[0221] EPCs count: 10 mL of peripheral blood was collected from the subject, and monocytes were separated using lymphocyte separation medium. EPCs were identified and counted using the triple labeling method of CD34 / KDR / CD133 in combination with a flow cytometer (Beckman Coulter, USA).

[0222] EMPs level: The plasma of the subject was collected, and after centrifugation, EMPs were quantified using the CD31+ / CD42- microparticle labeling method and a flow cytometer.

[0223] VEGF and eNOS activity: ELISA kits were used to measure the serum VEGF level and eNOS activity respectively. Test results:

[0224] Table 4. Effects of different formulations of Ce-2 on endothelial function and vascular repair indicators (mean ± standard deviation)

[0225]

[0226]

[0227] Result analysis: This comparative experiment evaluated the effects of different formulations of Ce-2 on endothelial function and vascular repair. The data showed that all Ce-2 formulations could significantly improve endothelial function and promote vascular repair, but different formulations showed certain specificities in various indicators. The high collagen peptide formulation performed best in terms of FMD improvement (+48.5%), increase in EPCs (+66.7%), and decrease in EMPs (-37.7%), which was consistent with the direct effect of collagen peptides on vascular structure repair and endothelial regeneration; the high broccoli pollen formulation was most prominent in terms of the increase in eNOS activity (+40.8%), which might be related to the enhancement of eNOS expression and activity by sulforaphane through the Nrf2 pathway; the basic formulation showed balanced performance in all indicators.

[0228] This result supports the flexibility of the present invention to meet the needs of different populations by adjusting the content of different components. The high collagen peptide formulation is more suitable for patients with vascular structure damage, the high broccoli pollen formulation is more suitable for patients with endothelial dysfunction, and the basic formulation is suitable for maintaining the vascular health of a broad population.

[0229] Through the above examples and comparative experiments, the Ce-2 oligopeptide SOD complex provided by the present invention and its synergistic application method with Ke-1 oligopeptide enzyme show significant technological innovation and superiority in the following aspects:

[0230] 1. Antioxidant strategy with multi-component synergy: Compared with single antioxidants or commercially available composite products, the Ce-2 oligopeptide SOD complex achieves more comprehensive and long-lasting antioxidant protection through multiple mechanisms such as SOD directly scavenging free radicals, coenzyme Q10 protecting mitochondria, and broccoli pollen activating the Nrf2 pathway.

[0231] 2. Integration of vascular repair function: Ce-2 not only focuses on antioxidant protection but also promotes vascular endothelial repair and structural reconstruction through collagen peptides, realizing the functional expansion from "protection" to "repair". The comparative data show that the high collagen peptide formulation significantly promotes the increase in endothelial progenitor cells and the decrease in endothelial microparticles, confirming this unique effect.

[0232] 3. Synergistic strategy of antioxidant and metabolic regulation: The synergistic application of Ce-2 and Ke-1 shows better effects than using them alone in improving multiple indicators of patients with metabolic syndrome, especially showing a synergistic effect in improving vascular function and reducing inflammatory indicators.

[0233] 4. Flexibility of personalized intervention: By adjusting the content ratio of different components, the present invention provides a variety of formulation options suitable for the needs of different populations, from basic antioxidant protection to enhanced vascular repair, from high SOD content to high broccoli pollen content, meeting the requirements of precision medicine.

[0234] It should be noted that the above are only the preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. Ce-2 oligopeptide SOD complex, characterized by The invention comprises the following components: superoxide dismutase (SOD) yeast powder 20-50% by weight, coenzyme Q10 5-15% by weight, collagen peptide 15-35% by weight, broccoli powder 10-25% by weight, vitamin B11-5% by weight, vitamin B2 1-5% by weight, zinc selenium yeast 2-10% by weight, citric acid 2-8% by weight, natural flavor 0.1-1% by weight, and steviol glycoside 0.5-2% by weight.

2. The Ce-2 oligopeptide SOD complex according to claim 1, characterized in that The collagen peptide is mainly composed of collagen tripeptide (Pro-Hyp-Gly), and its content accounts for 50-80% of the total weight of the collagen peptide.

3. The Ce-2 oligopeptide SOD complex according to claim 1, characterized in that The broccoli powder has a standardized content of sulforaphane of no less than 5%.

4. The method for preparing the Ce-2 oligopeptide SOD complex according to claim 1, comprising the following steps: (1) Mix SOD yeast powder and coenzyme Q10 at 30-40°C; (2) adding collagen peptides and broccoli powder, drying and mixing at low temperature; (3) Add auxiliary ingredients such as vitamin B1, B2, zinc, selenium, and yeast; (4) adding citric acid, natural flavors and steviol glycosides to form a uniform mixture; (5) Freeze-drying and making into powder or pressing into tablets.

5. A Ke-1 oligopeptidase, characterized in that The invention comprises the following components: 25-45% by weight of glycolytic enzyme complex, 15-35% by weight of lipase, 10-25% by weight of ACE inhibitory peptide, 10-20% by weight of dietary fiber, and 5-15% by weight of auxiliary components.

6. A method for the synergistic application of Ce-2 oligopeptide SOD complex and Ke-1 oligopeptide enzyme, characterized in that: Take Ce-2 oligopeptide SOD 400-600mg and Ke-1 oligopeptide enzyme 400-600mg orally daily, in the morning and evening respectively, for 8-12 weeks.

7. The collaborative application method according to claim 6, characterized in that The preferred regimen is to orally take 500 mg of Ce-2 oligopeptide SOD and 500 mg of Ke-1 oligopeptide enzyme daily, within 30 minutes after breakfast and dinner, respectively, for 12 weeks as a course of treatment.

8. Use of the Ce-2 oligopeptide SOD complex according to claim 1 in the preparation of a medicine or functional food for improving vascular elasticity, reducing oxidative stress and inhibiting inflammatory response.

9. Use of the Ke-1 oligopeptidase according to claim 5 in the preparation of medicines or functional foods for regulating blood sugar, blood lipids and blood pressure.

10. Use of the synergistic application method according to claim 6 in the preparation of a drug or functional food for treating metabolic syndrome, hypertension, atherosclerosis and vascular aging-related diseases, characterized in that This synergistic application significantly improves flow-mediated vasodilation (FMD) capacity and pulse wave velocity (PWV) indicators through the complementary mechanisms of antioxidant and metabolic regulation, while reducing C-reactive protein (CRP) levels, fasting blood glucose and triglyceride levels.

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