Preparation method of high-proportion open ring statin monascus for regulating blood fat and vascular plaque

Abstract

The application discloses a preparation method of high-proportion open-loop statin red koji for regulating blood fat and blood vessel plaques, and belongs to the technical field of microbial fermentation and functional food / medicine. The method takes Monascus purpureus CGMCC No. 18110 as a starting strain, and high-proportion open-loop monacolin K red koji powder is prepared by a core process of compound metabolic regulation substrate preparation + phased variable-temperature gradient oxygen supply fermentation and combined with precise post-processing technology. The total monacolin K content in the obtained red koji powder is greater than or equal to 8 mg / g, the open-loop monacolin K proportion is greater than or equal to 85%, and the citrinin content is less than or equal to 50 ppb. The red koji disclosed by the application can significantly inhibit HMG-CoA reductase activity, realize efficient blood fat regulation, and stabilize, resolve and repair blood vessel endothelium through multi-target synergistic effect, and can be widely applied to the preparation of functional food, medicinal preparations and special medical use formula food. The process has the advantages of high product proportion, high safety, strong process stability and controllable cost, solves the technical pain points of low open-loop rate, large liver and kidney burden and insufficient safety of existing red koji products, and has good industrialization prospect and market value.

Description

Technical Field

[0001] This invention relates to the field of microbial fermentation technology, specifically to a method for preparing red yeast rice with a high proportion of open-chain statins; at the same time, this invention also relates to the application of this red yeast rice in the fields of blood lipid regulation, vascular plaque stabilization and regression, and vascular endothelial repair, belonging to the interdisciplinary technology field of functional food and medicine. Background Technology

[0002] Red yeast rice (Monascus) is a traditional food and medicine product made from rice and other grains through solid-state fermentation using Monascus spp., with a history of use spanning over a thousand years. Its core functional component, **Monacolin K (lovastatin)**, is a competitive inhibitor of HMG-CoA reductase. It achieves its core effects of regulating blood lipids and preventing atherosclerosis by blocking the endogenous cholesterol synthesis pathway, making it a popular research target for lipid-regulating functional foods and drugs both domestically and internationally.

[0003] Monacolin K exists in two structural configurations, and the two configurations have significant differences in biological activity and metabolic characteristics:

[0004] 1. Closed-ring lactone type Monacoline K: It is an inactive precursor substance that needs to be hydrolyzed by human liver hydroxy esterase to be converted into an open-ring acid form before it can exert its effect. The conversion process depends on the activity of liver metabolic enzymes, which can easily lead to delayed onset of action, large individual differences, and increased metabolic burden on the liver and kidneys.

[0005] 2. Monacoline K (open-chain acid form): This is the direct active form, which can be directly absorbed by the intestines and inhibits HMG-CoA reductase without liver conversion. It has the advantages of rapid onset of action, high bioavailability, and good hepatic and renal safety.

[0006] Currently, most mainstream red yeast rice products on the market are conventionally fermented red yeast rice, which has technical defects such as failing to meet core technical indicators:

[0007] First, the open-ring rate is generally low, only 30%~50%, and a large number of ineffective closed-ring configurations limit the lipid-regulating efficiency; second, the total monacolin K content is insufficient, with most products having a total content ≤4 mg / g, which is difficult to meet the requirements for efficient lipid regulation.

[0008] Third, there is a high risk of citrinin contamination, and conventional fermentation processes can easily lead to excessive levels of citrinin (citrinin is a fungal toxin produced by Monascus purpureus metabolism, which is nephrotoxic and has been listed as a limit control indicator for red yeast rice products by many countries).

[0009] Fourth, the process stability is poor, the fermentation process parameters are controlled in a single way, there is a lack of systematic intervention on metabolic pathways, and the product batches vary greatly.

[0010] Furthermore, existing research on the application of red yeast rice products mainly focuses on lipid-lowering alone, with a lack of research on their synergistic effects on stabilizing and regressing vascular plaques and repairing vascular endothelial tissues. The core pathological process of atherosclerotic cardiovascular disease is the formation and rupture of vascular plaques. Lipid-lowering alone cannot completely halt disease progression. There is an urgent need to develop red yeast rice products with multiple effects, including lipid-lowering, plaque regulation, and endothelial protection, to meet the advanced needs of clinical practice and public health management.

[0011] Meanwhile, with the widespread adoption of high-fat diets, the population suffering from hyperlipidemia and atherosclerosis continues to expand, creating an increasingly urgent demand for highly effective, safe, and readily available lipid-regulating products. Therefore, developing a method for preparing a high-proportion open-ring statin red yeast rice and clarifying its multi-effect properties in the field of vascular health has significant technological value and market implications.

[0012] In existing technologies, the synthesis efficiency of open-ring monacolin K is influenced by a combination of factors, including strain characteristics, culture medium composition, oxygen transfer efficiency, temperature control, and metabolic flux distribution. Optimizing a single variable is insufficient to significantly improve the ring-opening rate. It is generally believed in the art that there is an inverse relationship between the ring-opening rate and the total monacolin K content; that is, processes that produce high total monacolin K often lead to an increased proportion of closed-ring configurations. This invention, through the synergistic regulation of multiple factors, overcomes this technical bias and achieves a simultaneous increase in both the total monacolin K content and the ring-opening rate. Summary of the Invention

[0013] The primary objective of this invention is to overcome the defects of existing red yeast rice preparation processes and provide a method for preparing red yeast rice with a high proportion of open-ring statin, achieving an open-ring monacolin K ratio ≥85%, total monacolin K content ≥8 mg / g, and citrinin content ≤50 ppb, while ensuring high process stability, controllable cost, and no safety hazards.

[0014] Another objective of this invention is to provide the application of this high-proportion open-ring statin red yeast rice in the fields of lipid regulation, vascular plaque stabilization and regression, and vascular endothelial repair, clarify its mechanism of action and application forms, and provide a safe and efficient new solution for cardiovascular health.

[0015] To achieve the above objectives, this application provides the following technical solution:

[0016] I. Preparation method of high-proportion open-chain statin red yeast rice

[0017] The preparation method includes five core steps: strain activation, seed liquid preparation, solid-state fermentation substrate preparation, inoculation and fermentation, and post-treatment drying, as detailed below:

[0018] 1. Activation of microbial strains

[0019] The purple Monascus purpureus with accession number CGMCC No.18110 was selected as the starting strain (this strain is a non-citrusin-producing strain, and has been verified by previous screening to have high-monacolin K production genetic characteristics and no safety risk).

[0020] The strain was inoculated onto PDA slant medium (formulation: 200 g potato, 20 g glucose, 15-20 g agar, 1000 mL water, with 0.5% peptone added) and incubated at 30℃ for 5-7 days. After the slant was covered with red spores, it was rinsed with sterile physiological saline to prepare a spore suspension. The concentration of the spore suspension was adjusted to 1×10⁻⁶. 6 ~1×10 7 CFU / mL, for later use.

[0021] 2. Seed liquid preparation

[0022] The seed culture medium was prepared with the following formula (g / L): glucose 40, peptone 15, yeast extract 5, KH2PO4 1.5, MgSO4·7H2O 0.8, nicotinamide ribose 0.02, and 1,5-p-coumaroylquinic acid 0.1. The pH was adjusted to 5.0 with citrate-sodium citrate buffer.

[0023] The above spore suspension was inoculated into the seed culture medium at an inoculation rate of 10% (v / v), and cultured in a constant temperature shaker at 30℃ and 180 rpm for 48 h until dense mycelial balls formed in the culture medium, and OD... 600 A value ≥ 2.5 indicates the seed solution has been obtained.

[0024] 3. Preparation of solid-state fermentation substrate

[0025] Using indica rice as the base fermentation substrate, the rice is crushed and passed through a 20-mesh sieve. The substrate moisture content is adjusted to 53%~55%, and the rice is sterilized by high-pressure steam at 121℃ for 30 minutes. It is then cooled to room temperature for later use.

[0026] Add the compound regulating additive to the sterilized matrix, stir well, and continue to adjust the pH of the matrix to 4.2~4.5 with citrate-sodium citrate buffer.

[0027] The dosage and formulation of the composite regulatory additive, based on the dry weight of the matrix, are as follows:

[0028] (1) Carbon and nitrogen metabolism precursors: glucose 3%~5%, peptone 1%~2%, yeast extract 0.5%~1%, thermally modified soybean protein isolate polysaccharide sulfate complex 1%~3%;

[0029] (2) Open-ring metabolic regulators: sodium acetate 0.2%~0.5%, sodium citrate 0.1%~0.3%;

[0030] Antioxidant and gene activator: 1,5-p-coumaryl quinic acid 0.05%~0.2%, ascorbic acid 0.05%~0.1%;

[0031] (3) Coenzymes and trace elements: Nicotinamide ribose 0.01%~0.03%, Biotin 0.001%~0.005%, Zinc sulfate 0.001%~0.01%, Manganese sulfate 0.005%~0.01%.

[0032] 4. Inoculation and fermentation

[0033] Seed liquid was inoculated into the pretreated solid fermentation substrate at an inoculation rate of 20% (v / w). The mixture was thoroughly stirred and then placed into fermentation trays (3-5 cm thick). The trays were then placed in a constant temperature and humidity fermentation chamber for synergistic fermentation using a composite metabolic regulation substrate and a staged variable temperature gradient oxygen supply. The specific process is as follows:

[0034] This invention is the first to synergistically combine a composite metabolic regulation matrix with staged variable temperature gradient aerobic fermentation, forming a three-pronged fermentation regulation strategy of "metabolic pathway induction—oxygen environment adaptation—temperature gradient regulation." Specifically, the thermally modified soybean protein isolate polysaccharide sulfate complex, nicotinamide ribose, and 1,5-p-coumaryl quinic acid in the composite metabolic regulation matrix synergistically induce the expression of key enzymes in the synthesis of ring-opening monacolin K. Staged variable temperature gradient aerobic supply significantly improves the synthesis efficiency and product stability of ring-opening monacolin K by regulating cell metabolic polarity, oxygen transfer efficiency, and product synthesis rate. Neither the composite matrix nor a single variable temperature process can achieve the synergistic improvement in ring-opening rate and total monacolin K content described in this invention.

[0035] The specific fermentation process is divided into the following three stages:

[0036] (1) First stage (mycelial growth stage, 0~48 h): temperature 32℃, relative humidity 85%, static culture to promote rapid colonization, growth and reproduction of mycelium, and to build a stable fermentation system;

[0037] (2) Second stage (product synthesis stage, 48~120 h): the temperature is reduced to 26℃ and the relative humidity is maintained at 85%; the first 24 h are rested and cultured, and the culture is turned over once every 12 h in the next 48 h (to achieve gradient oxygen supply) to promote the synthesis of open-ring monacolin K and inhibit the formation of closed-ring configuration.

[0038] (3) Third stage (product stabilization stage, 120~144 h): The temperature is reduced to 24℃, the relative humidity is 80%, and the product is incubated statically to maintain the stability of the open ring structure and prevent product degradation.

[0039] 5. Post-treatment drying

[0040] After fermentation, the fermentation product is taken out and dried in constant temperature hot air at 45℃ for 16~20 h, and the moisture content of the product is controlled to be ≤6%; after drying, it is pulverized by ultra-micro pulverizer and passed through a 200-mesh sieve to obtain high-proportion open-ring statin red yeast rice powder.

[0041] II. Application of high-proportion open-ring statins and red yeast rice

[0042] The high-proportion open-ring statin red yeast rice can be used in the preparation of functional foods, pharmaceutical preparations, and special medical purpose formula foods related to lipid regulation, vascular plaque stabilization and regression, and vascular endothelial repair. The specific application forms and mechanisms of action are as follows:

[0043] 1. Application Forms

[0044] (1) Functional foods: can be directly made into products such as red yeast rice powder, red yeast rice capsules, red yeast rice tablets, and red yeast rice solid beverages. The recommended daily dose is 10-20 mg of monacolin K.

[0045] (2) Pharmaceutical preparations: It can be used as the core active ingredient to prepare oral capsules, tablets, granules and other lipid-regulating and anti-atherosclerotic drugs; or it can be compounded with other active ingredients to make compound preparations;

[0046] (3) Special medical purpose formula foods: special nutritional formula foods are developed for high-risk groups of hyperlipidemia and atherosclerosis.

[0047] 2. Mechanism of action (multi-target synergy)

[0048] (1) Direct lipid reduction: High-ratio open-ring monacolin K does not require liver conversion, directly inhibits HMG-CoA reductase activity, blocks endogenous cholesterol synthesis, reduces serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and increases high-density lipoprotein cholesterol (HDL-C).

[0049] (2) Plaque regulation: inhibits abnormal proliferation of vascular smooth muscle cells, reduces lipid deposition and foam cell formation in plaques, reduces the expression of inflammatory factors (TNF-α, IL-6) in plaques, increases collagen content in plaques, enhances plaque stability, and promotes the regression of plaque lipid core;

[0050] (3) Endothelial protection: promotes the synthesis of nitric oxide (NO) in vascular endothelial cells, improves vasodilatory function, removes oxidative stress free radicals in blood vessels, reduces vascular endothelial damage, accelerates endothelial cell repair, and delays the progression of atherosclerosis.

[0051] (4) Synergistic effect: The active ingredients in red yeast rice, such as β-glucan, unsaturated fatty acids, and γ-aminobutyric acid, work synergistically with Monacolin K to further enhance the effects of lipid regulation, anti-inflammation, and vascular protection.

[0052] Compared with the prior art, the beneficial effects of this application are as follows: 1. Excellent product indicators: The total monacolin K content in the red yeast rice powder prepared by this invention is ≥8 mg / g, which is more than 100% higher than that of conventional processes; the open-ring monacolin K ratio is ≥85%, which is much higher than that of conventional products (30%~50%), resulting in faster onset of action, higher bioavailability, and less burden on the liver and kidneys; furthermore, through the synergistic process of "compound metabolic regulation matrix + staged temperature gradient oxygen supply", compared with the use of compound metabolic regulation matrix alone (the ring opening rate is only increased to 62.3%) or staged temperature gradient oxygen supply alone (the ring opening rate is only increased to 58.7%), the ring opening rate is synergistically increased to more than 85%, and the total monacolin K content is synergistically increased by more than 40%, which fully demonstrates the non-obviousness and synergistic effect of the process combination.

[0053] 2. High safety: Using non-citrus-producing strain CGMCC No.18110, combined with precise fermentation process control, the final product has a citrus-producing content of ≤50 ppb, which meets the national food and pharmaceutical red yeast rice product citrus-producing limit standards and has no safety hazards;

[0054] 3. Stable and controllable process: The core process of compound metabolic regulation substrate + staged temperature gradient oxygen supply fermentation solves the problems of low open-loop rate and large batch differences in conventional processes. The fermentation cycle is shortened by 14.3% compared with conventional processes. The process has good repeatability and controllable cost, making it suitable for large-scale industrial production.

[0055] 4. Synergistic effect: It not only achieves efficient blood lipid regulation, but also has the functions of stabilizing and resolving vascular plaques and repairing vascular endothelium. Compared with single lipid-lowering red yeast rice products, it is more in line with the health needs of high-risk groups of cardiovascular diseases.

[0056] 5. Wide range of applications: It can be adapted to multiple fields such as functional foods, pharmaceutical preparations, and special medical purpose formula foods, meeting the health management needs of different groups of people, and has huge market potential. Detailed Implementation

[0057] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0058] Example 1: Preparation of high-proportion open-chain statin red yeast rice

[0059] 1. Strain activation: *Monascus purpureus* CGMCC No. 18110 was inoculated onto a PDA slant and cultured at 30℃ for 6 days, with a spore suspension concentration of 1×10⁻⁶. 7 CFU / mL.

[0060] 2. Seed culture preparation: The culture medium contained 40 g / L glucose, 15 g / L peptone, 5 g / L yeast extract, 1.5 g / L KH2PO4, 0.8 g / L MgSO4·7H2O, 0.02 g / L nicotinamide ribose, and 0.1 g / L 1,5-coumaroylquinic acid, pH 5.0; cultured at 30℃ and 180 rpm for 48 h.

[0061] 3. Solid-state fermentation: The indica rice substrate had a moisture content of 54%, and a compound regulator was added (glucose 4%, peptone 1.5%, yeast extract 0.8%, thermally modified soybean protein isolate polysaccharide sulfate complex 2%, sodium acetate 0.3%, sodium citrate 0.2%, 1,5-p-coumaryl quinic acid 0.1%, ascorbic acid 0.08%, nicotinamide ribose 0.02%, biotin 0.003%, zinc sulfate 0.005%, manganese sulfate 0.008%), pH 4.3; inoculum size 20%, cultured at 32℃ for 48 h, at 26℃ for 72 h, and at 24℃ for 24 h.

[0062] 4. Drying and pulverizing: Dry at 45℃ for 18 h, then pulverize into ultrafine powder to obtain red yeast rice powder.

[0063] 5. Test results: Total Monacoline K 8.7 mg / g, ring opening rate 88.3%, Citrinin 32 ppb, moisture 5.2%.

[0064] Example 2 Comparative Experiment (Conventional Process vs. Invention Process)

[0065] Total Monacolin K (mg / g) 4.2 8.7 An increase of 107.1% Open-loop rate (%) 42.5 88.3 An increase of 107.8% Citrulline (ppb) 120 32 Reduced by 73.3% Fermentation cycle (h) 168 144 Shortened by 14.3%

[0066] Example 2: Effect of thermally modified soybean protein isolate polysaccharide sulfate complex on ring-opening rate

[0067] Three sets of comparative experiments were set up. Except for the addition of the thermally modified soybean protein isolate polysaccharide sulfate complex in the composite regulatory additive, all other process parameters were the same as in Example 1:

[0068] Group A Without adding this complex 6.2 62.3 Group B Add unmodified soy protein isolate 6.8 68.5 Group C Adding the thermally modified soybean protein isolate polysaccharide sulfate complex of the present invention 8.7 88.3

[0069] The results show that the thermally modified soybean protein isolate polysaccharide sulfate complex described in this invention plays a key role in improving the ring-opening rate. Its thermal modification and polysaccharide sulfate modification significantly enhance the complex's ability to regulate the metabolic polarity of the cells, thereby inducing the efficient synthesis of ring-opening monacolin K.

[0070] Example 4: Effect of fermentation temperature on ring-opening rate

[0071] Five fermentation experiments were set up. Except for the second stage (product synthesis stage), the temperatures were set to 22℃, 24℃, 26℃, 28℃ and 30℃ respectively. All other process parameters were the same as in Example 1 to investigate the effect of temperature on the ring-opening rate.

[0072] 22 71.2 7.1 24 85.6 8.5 26 88.3 8.7 28 80.41 8.2 30 72.5 7.3

[0073] The results showed that when the product synthesis temperature was below 24℃, the metabolic activity of the bacteria was limited, and the total synthesis of monacolin K decreased; when the temperature was above 28℃, the conversion from open-ring to closed-ring configuration intensified, and the ring-opening rate decreased significantly. Therefore, the present invention strictly controls the temperature of the second stage within the range of 24~28℃, preferably 26℃, which is the key process parameter to ensure a high ring-opening rate.

[0074] Example 5: Product Storage Stability Study

[0075] The high-proportion open-ring statin red yeast rice powder prepared in Example 1 was placed at 25℃±2℃ (room temperature storage conditions) and 40℃±2℃ (accelerated test conditions) with a relative humidity of 60%±5% to investigate the changes in the proportion of open-ring monacolin K at 0, 1, 2, 3, and 6 months. The results are as follows:

[0076] 0 88.3 88.3 1 88.1 87.6 2 87.9 86.8 3 87.5 85.9 6 86.8 83.2

[0077] The results show that the open-ring rate of the product of this invention decreases by ≤1.7% after 6 months under normal temperature storage conditions and by ≤5.8% after 6 months under accelerated testing conditions, demonstrating good storage stability and meeting the shelf life requirements of commercial products.

[0078] In summary, this invention is not limited to the specific embodiments described above. Those skilled in the art can make various modifications and alterations without departing from the spirit and scope of this invention. The scope of protection of this invention should be determined by the claims of this invention.

[0079] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions claimed by the present invention.

Claims

1. A method for preparing a high-proportion open-chain statin red yeast rice for regulating blood lipids and vascular plaques, characterized in that, Includes the following steps: (1) Activation of the strain: Monascus purpureus CGMCC No. 18110 was selected and inoculated into PDA slant medium (containing 0.5% peptone) and cultured at 30℃ for 5-7 days to prepare a concentration of 1×10⁻⁶. 6 ~1×10 7 CFU / mL spore suspension; (2) Seed culture preparation: The spore suspension was inoculated into the seed culture medium at an inoculation rate of 10% (v / v) and cultured at 30℃ and 180 rpm for 48 h until OD 600 ≥2.5, to obtain seed culture; the seed culture medium, by mass-volume concentration, is: glucose 40 g / L, peptone 15 g / L, yeast extract 5 g / L, KH2PO4 1.5 g / L, MgSO4・7H2O 0.8 g / L, nicotinamide ribose 0.02 g / L, 1,5-p-coumaryl quinic acid 0.1 g / L, pH 5.0; (3) Preparation of solid-state fermentation substrate: Indica rice was used as the base substrate, pulverized and passed through a 20-mesh sieve, and the moisture content was adjusted to 53%~55%. The substrate was then sterilized at 121℃ for 30 min. A compound regulatory additive was added based on the dry weight of the substrate, and after stirring evenly, the pH was adjusted to 4.2~4.5 using a citrate-sodium citrate buffer solution. The formula and dosage of the compound regulatory additive were as follows: glucose 3%~5%, peptone 1%~2%, yeast extract 0.5%~1%, thermally modified soybean protein isolate polysaccharide sulfate complex 1%~3%, sodium acetate 0.2%~0.5%, sodium citrate 0.1%~0.3%, 1,5- The following components were present: coumaroyl quinic acid 0.05%~0.2%, ascorbic acid 0.05%~0.1%, nicotinamide ribose 0.01%~0.03%, biotin 0.001%~0.005%, zinc sulfate 0.001%~0.01%, and manganese sulfate 0.005%~0.01%. (4) Co-fermentation: The seed culture was inoculated at a rate of 20% (v / w), stirred evenly, and then placed in a fermentation tank. A co-fermentation process of composite metabolic regulation substrate induction and staged variable temperature gradient oxygen supply was adopted, which was specifically divided into three stages: First stage (mycelial growth stage): 0~48 h, temperature 32℃, relative humidity 85%, static culture; Second stage (product synthesis stage): 48~120 h, temperature reduced to 26℃, relative humidity 85%, of which the first 24 h are static culture and the last 48 h are turned over once every 12 h to achieve gradient oxygen supply. Third stage (product stabilization stage): 120~144 h, temperature reduced to 24℃, relative humidity 80%, static incubation; (5) Post-processing drying: The fermentation product is dried with hot air at 45℃ for 16~20 h, and the moisture content is controlled to be ≤6%. It is then ultra-finely pulverized through a 200-mesh sieve to obtain high-proportion open-ring statin red yeast rice powder.

2. The preparation method according to claim 1, characterized in that, The preparation method of the thermally modified soybean protein isolate polysaccharide sulfate complex in step (3) is as follows: Soybean protein isolate and polysaccharide are mixed at a mass ratio of 2:1, and distilled water is added to prepare a 10% mass fraction solution. The mixture is heated in an 80°C water bath for 30 min, cooled, and then 0.1 mol / L sulfuric acid solution is added. The mixture is reacted at 60°C for 2 h, neutralized to neutral with sodium hydroxide solution, dialyzed for 24 h to remove impurities, and then freeze-dried to obtain the final product.

3. The preparation method according to claim 1, characterized in that, The core indicators of the high-proportion open-ring statin red yeast rice powder obtained in step (5) are: total monoclonal K content ≥8 mg / g, open-ring monoclonal K proportion ≥85%, citrinin content ≤50 ppb, and water content ≤6%.

4. The application of high-proportion open-ring statin red yeast rice prepared according to any one of claims 1 to 3 in the preparation of products for lipid regulation, vascular plaque stabilization or regression, and vascular endothelial repair, characterized in that, The high-proportion open-ring statin red yeast rice contains a total monacolin K content ≥8 mg / g, an open-ring monacolin K proportion ≥85%, and a citrinin content ≤50 ppb; the product is a functional food, pharmaceutical preparation, or special medical purpose formula food.

5. The application according to claim 4, characterized in that, The functional foods are in the form of red yeast rice powder, red yeast rice capsules, red yeast rice tablets, and red yeast rice solid beverages, with a recommended daily dose of 10-20 mg (monacolin K).

6. The application according to claim 4, characterized in that, The pharmaceutical preparation is an oral capsule, tablet or granule, and a high proportion of diclofenac red yeast rice is the sole active ingredient in the pharmaceutical preparation.