A product containing coenzyme q10 and a method for producing the same

Abstract

The application provides a product containing coenzyme Q10 and a preparation method thereof, and belongs to the technical field of coenzyme Q10 capsule preparation. The product is a soft capsule composed of a capsule shell and a coenzyme Q10-containing composition. The coenzyme Q10-containing composition comprises, but is not limited to, coenzyme Q10, natural vitamin E, vitamin C, plant oil and other components. The components interact with each other, so that the coenzyme Q10-containing composition has a good auxiliary blood lipid-lowering effect, helps to protect the cardiovascular health level, can effectively improve the NK cell activity, has a good immune enhancement effect, and the prepared soft capsule product is safe, non-toxic and has high bioavailability.

Description

Technical Field

[0001] This invention belongs to the field of coenzyme Q10 capsule formulation technology, specifically relating to a product containing coenzyme Q10 and its preparation method. Background Technology

[0002] Coenzyme Q10 (CoQ10), also known as ubiquinone, is a lipid-soluble quinone compound widely found in the inner mitochondrial membrane of human cells. It is a key coenzyme in the cellular respiratory chain and oxidative phosphorylation, possessing important physiological functions such as antioxidation, free radical scavenging, and protecting cell membrane integrity. With age, the body's endogenous ability to synthesize coenzyme Q10 gradually declines, leading to impaired cellular energy metabolism and increased oxidative stress, which is closely related to cardiovascular diseases, neurodegenerative diseases, and the aging process.

[0003] Plant-derived active ingredients (such as flavonoids, terpenes, and polysaccharides) have cardiovascular protective effects, regulate blood lipids, and enhance immunity. Combining them with coenzyme Q10 can broaden their functional scope. However, traditional plant extraction processes (water extraction and alcohol extraction) suffer from low extraction rates of active ingredients, poor bioavailability, and residual organic solvents. While fermentation technology can improve activity, single-strain fermentation has limited functionality, and multi-strain synergistic fermentation involves complex and difficult-to-control process parameters. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a product containing coenzyme Q10 that is highly bioavailable, multifunctional, synergistic, naturally safe, stable, controllable, and suitable for industrialization, as well as a method for its preparation. To achieve the above objectives, this invention discloses the following technical solutions: In a first aspect, the present invention provides a coenzyme Q10-containing composition, which, by weight, includes, but is not limited to, the following components: Coenzyme Q10: 25-30 servings; Natural Vitamin E: 20-30 servings; Vitamin C: 10-20 servings; Vegetable oil: 400-450 parts; The vegetable oil is at least one of olive oil, perilla seed oil, and walnut oil.

[0005] Preferably, the coenzyme Q10-containing composition further comprises, by weight, the following components: Plant extract: 20-25 parts; Compound emulsifier: 25-40 parts; The plant extract is prepared by using hawthorn, kudzu root, and schisandra as raw materials, and then by mixed fermentation with Lactobacillus pentosus, Bacillus coagulans and Bifidobacterium infantis, followed by extraction with a low eutectic solvent. The composite emulsifier is composed of lecithin and sodium caseinate in a mass ratio of 1:1 to 3.

[0006] In this invention, hawthorn contains flavonoids (hyperoside, quercetin), triterpenoids, organic acids, and other active ingredients, which have the effects of lowering blood lipids, lowering blood pressure, dilating blood vessels, improving microcirculation, and anti-oxidation. Kudzu root contains isoflavones such as puerarin and daidzein, which have the effects of improving cardiovascular and cerebrovascular circulation, lowering blood pressure, anti-arrhythmia, and protecting myocardial cells. Schisandra chinensis contains lignans (schisandrin A and B), polysaccharides, and other active ingredients, which have the effects of anti-oxidation, liver protection, enhancing immunity, anti-fatigue, and improving cognitive function. Mixed-culture fermentation using Lactobacillus pentosus, Bacillus coagulans, and Bifidobacterium infantis can degrade macromolecules and produce more easily absorbed small-molecule active substances, thereby increasing the content and bioavailability of active ingredients. The resulting metabolites have the effects of protecting the cardiovascular and cerebrovascular system and / or regulating immunity. Extraction using a eutectic solvent (DES) can efficiently extract both polar and non-polar active ingredients, improving the selectivity and extraction rate of the target components.

[0007] In this invention, lecithin and sodium caseinate in a specific mass ratio are selected as emulsifiers, which solves the problem of poor compatibility between fat-soluble and water-soluble active ingredients in the same system, forming a homogeneous emulsion system that is compatible with water and oil, ensuring that the contents of the soft capsules have suitable fluidity (facilitating pelleting) and filling stability (preventing stratification).

[0008] More preferably, the method for preparing the plant extract includes the following steps: S1. Take dried hawthorn, kudzu root and schisandra, grind them into powder and pass them through a 40-60 mesh sieve. Mix the hawthorn powder, kudzu root powder and schisandra powder together, add 10-20 times the weight of purified water, boil and cool to room temperature to obtain the mixture. S2. Based on the mass of the mixture, add 1-2 wt% glucose, 0.05-0.1 wt% yeast powder, 0.01-0.05 wt% K2HPO4, and 0.01-0.05 wt% MgSO4·7H2O, mix well, and sterilize at 121℃ for 15-25 min to obtain the fermentation substrate. S3. Inoculate the fermentation substrate with a mixed inoculum consisting of Lactobacillus pentosus, Bacillus coagulans and Bifidobacterium infantis, and sterilize at high temperature after anaerobic fermentation to obtain the fermentation product. S4. After mixing glucose, citric acid and deionized water, stir under a water bath at 50-60°C until a transparent liquid is formed, which is the eutectic solvent. Mix the fermentation product obtained in step S3 with the eutectic solvent and then perform ultrasonic extraction. S5. After ultrasonic extraction, centrifuge, take the supernatant and filter it through a 0.22μm filter membrane, freeze-dry until the water content is ≤5wt%, and the plant extract is obtained.

[0009] More preferably, in step S1, the hawthorn powder, kudzu root powder, and schisandra powder are mixed in a mass ratio of 1:0.5-0.7:0.2-0.3.

[0010] More preferably, in step S2, based on the mass of the mixture, 1.5wt% glucose, 0.07wt% yeast powder, 0.03wt% K2HPO4, and 0.02wt% MgSO4·7H2O are added.

[0011] More preferably, in step S3, the preservation number of the *Lactobacillus pentosaceus* is CCTCC NO: M2023711, the preservation number of the *Bacillus coagulans* is CCTCC NO: M2017813, the preservation number of the *Bifidobacterium infantis* is CGMCC NO. 1.15639, the inoculum amount of the mixed bacterial agent is 3-6% v / v of the fermentation substrate, and the effective viable count of the mixed bacterial agent is 1.8 × 10⁻⁶. 7 ~2.5×10 7 The effective viable count ratio of Lactobacillus pentosus, Bacillus coagulans, and Bifidobacterium infantis is 1:0.3-0.7:1.2-1.5. The anaerobic fermentation temperature is 35-37℃ and the time is 48-72h. The high-temperature instantaneous sterilization is sterilization at 135-140℃ for 5-10s.

[0012] More preferably, in step S4, the molar ratio of glucose, citric acid and deionized water is 1:2 to 4:2.5 to 5, the volume ratio of fermentation product and eutectic solvent is 1:4 to 10, and the ultrasonic extraction temperature is 60 to 70°C, the power is 180 to 220W, and the time is 30 to 50 min.

[0013] In a further preferred embodiment, in step S5, the centrifugation speed is 4000-5000 rpm and the time is 18-22 min.

[0014] In a second aspect, the present invention provides a product containing coenzyme Q10, said product being a soft capsule composed of a capsule shell and the coenzyme Q10-containing composition described in the first aspect.

[0015] Preferably, the capsule shell, by weight, includes, but is not limited to, the following components: 50-120 parts gelatin, 35-40 parts glycerin, 0.1-1 parts titanium dioxide, 3-10 parts caramel color, and 50-120 parts purified water.

[0016] Secondly, the present invention provides a method for preparing a product containing coenzyme Q10, comprising the following steps: (1) Preparation of the coenzyme Q10-containing composition: Coenzyme Q10 and natural vitamin E are added to vegetable oil and stirred until completely dissolved in a water bath at 65-75°C. Plant extract, vitamin C, and compound emulsifier are added and stirred evenly. The mixture is then homogenized at 5000-10000 rpm for 2-5 minutes and degassed under vacuum at -0.07MPa to -0.1MPa until no bubbles are present, thus obtaining the coenzyme Q10-containing composition. (2) Preparation of capsule shell solution: Titanium dioxide and 1 / 2 volume of purified water are mixed evenly and passed through a colloid mill to obtain titanium dioxide solution. Then caramel color is added and mixed evenly to obtain pigment solution. Gelatin, glycerin and the remaining purified water are mixed and heated to 70-80℃. Stir until the gelatin dissolves. Then vacuum degassing is performed at -0.07MPa to -0.1MPa until no bubbles are present. The mixture is passed through a 120-mesh sieve. Pigment solution is added and mixed evenly. The mixture is kept warm at 55-65℃ for later use. (3) Capsule pressing: The coenzyme Q10-containing composition obtained in step (1) and the capsule shell solution obtained in step (2) are pressed into soft capsules; wherein the capsule shell thickness of the soft capsule is 0.7±0.05mm and each soft capsule contains 500mg of the composition; (4) Setting: Set for 1 to 2.5 hours at a temperature of 18 to 26°C and a relative humidity of 25 to 30%; (5) Drying: Dry at a temperature of 20-30℃ and a relative humidity of 18-22% for 20-30 hours; (6) Selecting capsules: Remove substandard soft capsules that are irregularly shaped, leaking oil, or have bubbles; (7) Packaging: The qualified soft capsules are bottled and sealed to obtain products containing coenzyme Q10.

[0017] The beneficial effects of this invention are: This invention provides a product containing coenzyme Q10 and its preparation method. The product is a soft capsule composed of a capsule shell and a coenzyme Q10-containing composition. The components in the coenzyme Q10-containing composition interact with each other, resulting in a good auxiliary effect in lowering blood lipids, helping to protect cardiovascular health, and effectively improving NK cell activity, thus having a good immune-enhancing effect. The prepared soft capsule product is safe, non-toxic, and has high bioavailability. Detailed Implementation

[0018] To better illustrate the objectives, technical solutions, and advantages of this invention, the invention will be further described below with reference to specific embodiments. Those skilled in the art should understand that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0019] Unless otherwise specified, the experimental methods used in the specific embodiments are all conventional methods; the materials and reagents used are all commercially available unless otherwise specified; and the percentages mentioned in the specific embodiments are all mass percentages unless otherwise specified. Example 1

[0020] This embodiment provides a coenzyme Q10-containing composition, which, by weight, consists of the following components: Coenzyme Q10: 28 servings; Natural Vitamin E: 25 servings; Vitamin C: 15 servings; Vegetable oil: 420 parts; The vegetable oil in question is olive oil.

[0021] This embodiment also provides a product containing coenzyme Q10, which is a soft capsule composed of a capsule shell and the above-mentioned coenzyme Q10-containing composition. The capsule shell, by weight, consists of the following components: 100 parts gelatin, 38 parts glycerin, 0.6 parts titanium dioxide, 5 parts caramel color, and 100 parts purified water. The preparation method of the coenzyme Q10-containing product includes the following steps: (1) Preparation of the coenzyme Q10-containing composition: Coenzyme Q10 and natural vitamin E were added to vegetable oil and stirred until completely dissolved in a water bath at 70°C. Vitamin C was added and stirred evenly. The mixture was then homogenized at 6000 rpm for 3 min and degassed under vacuum at -0.08 MPa until no bubbles were present, thus obtaining the coenzyme Q10-containing composition. (2) Preparation of capsule shell solution: Titanium dioxide and 1 / 2 volume of purified water are mixed evenly and passed through a colloid mill to obtain titanium dioxide solution. Then caramel color is added and mixed evenly to obtain pigment solution. Gelatin, glycerin and the remaining purified water are mixed and heated to 75°C. The mixture is stirred until the gelatin dissolves. Then, vacuum degassing is performed at -0.09MPa until no bubbles are present. The mixture is passed through a 120-mesh sieve. The pigment solution is added and mixed evenly. The mixture is kept warm at 60°C for later use. (3) Capsule pressing: The composition obtained in step (1) and the capsule shell solution obtained in step (2) are pressed into soft capsules; wherein the capsule shell thickness of the soft capsule is 0.7±0.05mm and each soft capsule contains 500mg of the composition; (4) Setting: Set for 2 hours at a temperature of 22℃ and a relative humidity of 28%; (5) Drying: Dry at 25℃ and 20% relative humidity for 24 hours; (6) Selecting capsules: Remove substandard soft capsules that are irregularly shaped, leaking oil, or have bubbles; (7) Packaging: The qualified soft capsules are bottled and sealed to obtain products containing coenzyme Q10. Example 2

[0022] This embodiment provides a coenzyme Q10-containing composition, which, by weight, consists of the following components: Coenzyme Q10: 28 servings; Plant extracts: 22 parts; Natural Vitamin E: 25 servings; Vitamin C: 15 servings; Compound emulsifier: 30 parts; Vegetable oil: 420 parts; The composite emulsifier is composed of lecithin and sodium caseinate in a mass ratio of 1:1.5. The vegetable oil is olive oil; The plant extract is prepared from hawthorn, kudzu root, and schisandra chinensis as raw materials, through mixed fermentation with Lactobacillus pentosus, Bacillus coagulans, and Bifidobacterium infantis, followed by extraction with a low-melting-point solvent. The specific preparation method includes the following steps: S1. Take dried hawthorn, kudzu root and schisandra, grind them into powder and pass them through a 50-mesh sieve. Mix the hawthorn powder, kudzu root powder and schisandra powder in a mass ratio of 1:0.6:0.25. Add 12 times the mass of purified water, boil and cool to room temperature to obtain the mixture. S2. Based on the mass of the mixture, add 1.5wt% glucose, 0.07wt% yeast powder, 0.03wt% K2HPO4, and 0.02wt% MgSO4·7H2O, mix well, and sterilize at 121℃ for 20 min to obtain the fermentation substrate. S3. Inoculate the fermentation substrate with a mixed inoculum consisting of *Lactobacillus pentosus*, *Bacillus coagulans*, and *Bifidobacterium infantis*. After anaerobic fermentation at 36°C for 60 hours, sterilize at 135°C for 10 seconds to obtain the fermentation product. The *Lactobacillus pentosus* has the preservation number CCTCC NO: M2023711, the *Bacillus coagulans* has the preservation number CCTCC NO: M2017813, and the *Bifidobacterium infantis* has the preservation number CGMCC NO. 1.15639. The inoculation amount of the mixed inoculum is 5% v / v of the fermentation substrate, and the effective viable count of the mixed inoculum is 2.0 × 10⁻⁶. 7 CFU / mL, wherein the effective viable count ratio of Lactobacillus pentosus, Bacillus coagulans and Bifidobacterium infantis is 1:0.5:1.3; S4. Mix glucose, citric acid and deionized water in a molar ratio of 1:3:3.5 and stir in a 55°C water bath until a transparent liquid is formed, which is the eutectic solvent. Mix the fermentation product obtained in step S3 with the eutectic solvent in a volume ratio of 1:6 and then perform ultrasonic extraction at a temperature of 65°C and a power of 200 W for 40 min. S5. After ultrasonic extraction, centrifuge at 4500 rpm for 20 min, take the supernatant and filter it through a 0.22 μm filter membrane, freeze-dry until the water content is 5 wt%, and obtain the plant extract.

[0023] This embodiment also provides a product containing coenzyme Q10, which is a soft capsule composed of a capsule shell and the above-mentioned coenzyme Q10-containing composition. The capsule shell, by weight, consists of the following components: 100 parts gelatin, 38 parts glycerin, 0.6 parts titanium dioxide, 5 parts caramel color, and 100 parts purified water. The preparation method of the coenzyme Q10-containing product includes the following steps: (1) Preparation of the coenzyme Q10-containing composition: Coenzyme Q10 and natural vitamin E were added to vegetable oil and stirred until completely dissolved in a water bath at 70°C. Plant extract, vitamin C, lecithin, and sodium caseinate were added and stirred evenly. The mixture was then homogenized at 6000 rpm for 3 min and degassed under vacuum at -0.08 MPa until no bubbles were present, thus obtaining the coenzyme Q10-containing composition. (2) Preparation of capsule shell solution: Titanium dioxide and 1 / 2 volume of purified water are mixed evenly and passed through a colloid mill to obtain titanium dioxide solution. Then caramel color is added and mixed evenly to obtain pigment solution. Gelatin, glycerin and the remaining purified water are mixed and heated to 75°C. The mixture is stirred until the gelatin dissolves. Then, vacuum degassing is performed at -0.09MPa until no bubbles are present. The mixture is passed through a 120-mesh sieve. The pigment solution is added and mixed evenly. The mixture is kept warm at 60°C for later use. (3) Capsule pressing: The composition obtained in step (1) and the capsule shell solution obtained in step (2) are pressed into soft capsules; wherein the capsule shell thickness of the soft capsule is 0.7±0.05mm and each soft capsule contains 500mg of the composition; (4) Setting: Set for 2 hours at a temperature of 22℃ and a relative humidity of 28%; (5) Drying: Dry at 25℃ and 20% relative humidity for 24 hours; (6) Selecting capsules: Remove substandard soft capsules that are irregularly shaped, leaking oil, or have bubbles; (7) Packaging: The qualified soft capsules are bottled and sealed to obtain products containing coenzyme Q10. Example 3

[0024] This embodiment provides a coenzyme Q10-containing composition, which, by weight, consists of the following components: Coenzyme Q10: 25 servings; Plant extracts: 20 parts; Natural Vitamin E: 20 servings; Vitamin C: 10 servings; Compound emulsifier: 25 parts; Vegetable oil: 400 parts; The composite emulsifier is composed of lecithin and sodium caseinate in a mass ratio of 1:1. The vegetable oil is perilla seed oil; The plant extract is prepared from hawthorn, kudzu root, and schisandra chinensis as raw materials, through mixed fermentation with Lactobacillus pentosus, Bacillus coagulans, and Bifidobacterium infantis, followed by extraction with a low-melting-point solvent. The specific preparation method includes the following steps: S1. Take dried hawthorn, kudzu root and schisandra, grind them into powder and pass them through a 50-mesh sieve. Mix the hawthorn powder, kudzu root powder and schisandra powder in a mass ratio of 1:0.5:0.2. Add 10 times the mass of purified water, boil and cool to room temperature to obtain the mixture. S2. Based on the mass of the mixture, add 1.5wt% glucose, 0.07wt% yeast powder, 0.03wt% K2HPO4, and 0.02wt% MgSO4·7H2O, mix well, and sterilize at 121℃ for 20 min to obtain the fermentation substrate. S3. Inoculate the fermentation substrate with a mixed inoculum consisting of *Lactobacillus pentosus*, *Bacillus coagulans*, and *Bifidobacterium infantis*. After anaerobic fermentation at 36°C for 60 hours, sterilize at 135°C for 10 seconds to obtain the fermentation product. The *Lactobacillus pentosus* has the preservation number CCTCC NO: M2023711, the *Bacillus coagulans* has the preservation number CCTCC NO: M2017813, and the *Bifidobacterium infantis* has the preservation number CGMCC NO. 1.15639. The inoculation amount of the mixed inoculum is 3% v / v of the fermentation substrate, and the effective viable count of the mixed inoculum is 2.5 × 10⁻⁶. 7 CFU / mL, wherein the effective viable count ratio of Lactobacillus pentosus, Bacillus coagulans and Bifidobacterium infantis is 1:0.3:1.2; S4. Mix glucose, citric acid and deionized water in a molar ratio of 1:2:2.5 and stir in a 50°C water bath until a transparent liquid is formed to obtain a eutectic solvent. Mix the fermentation product obtained in step S3 with the eutectic solvent in a volume ratio of 1:4 and then perform ultrasonic extraction at a temperature of 60°C and a power of 180 W for 50 min. S5. After ultrasonic extraction, centrifuge at 4500 rpm for 20 min, take the supernatant and filter it through a 0.22 μm filter membrane, freeze-dry until the water content is 5 wt%, and obtain the plant extract.

[0025] This embodiment also provides a product containing coenzyme Q10, which is a soft capsule composed of a capsule shell and the above-mentioned coenzyme Q10-containing composition. The capsule shell, by weight, is composed of the following components: 50 parts gelatin, 35 parts glycerin, 0.1 parts titanium dioxide, 3 parts caramel color, and 50 parts purified water. The preparation method of the coenzyme Q10-containing product is the same as in Example 2. Example 4

[0026] This embodiment provides a coenzyme Q10-containing composition, which, by weight, consists of the following components: Coenzyme Q10: 30 servings; Plant extracts: 25 parts; Natural Vitamin E: 30 servings; Vitamin C: 20 servings; Compound emulsifier: 40 parts; Vegetable oil: 450 parts; The composite emulsifier is composed of lecithin and sodium caseinate in a mass ratio of 1:3. The vegetable oil is walnut oil; The plant extract is prepared from hawthorn, kudzu root, and schisandra chinensis as raw materials, through mixed fermentation with Lactobacillus pentosus, Bacillus coagulans, and Bifidobacterium infantis, followed by extraction with a low-melting-point solvent. The specific preparation method includes the following steps: S1. Take dried hawthorn, kudzu root and schisandra, grind them into powder and pass them through a 50-mesh sieve. Mix the hawthorn powder, kudzu root powder and schisandra powder in a mass ratio of 1:0.7:0.3. Add 20 times the mass of purified water, boil and cool to room temperature to obtain the mixture. S2. Based on the mass of the mixture, add 1.5wt% glucose, 0.07wt% yeast powder, 0.03wt% K2HPO4, and 0.02wt% MgSO4·7H2O, mix well, and sterilize at 121℃ for 20 min to obtain the fermentation substrate. S3. Inoculate the fermentation substrate with a mixed inoculum consisting of *Lactobacillus pentosus*, *Bacillus coagulans*, and *Bifidobacterium infantis*. After anaerobic fermentation at 36°C for 60 hours, sterilize at 135°C for 10 seconds to obtain the fermentation product. The *Lactobacillus pentosus* has the preservation number CCTCC NO: M2023711, the *Bacillus coagulans* has the preservation number CCTCC NO: M2017813, and the *Bifidobacterium infantis* has the preservation number CGMCC NO. 1.15639. The inoculation amount of the mixed inoculum is 6% v / v of the fermentation substrate, and the effective viable count of the mixed inoculum is 1.8 × 10⁻⁶. 7 CFU / mL, wherein the effective viable count ratio of Lactobacillus pentosus, Bacillus coagulans and Bifidobacterium infantis is 1:0.7:1.5; S4. Glucose, citric acid and deionized water are mixed in a molar ratio of 1:4:5 and stirred in a 60°C water bath until a transparent liquid is formed, which is the eutectic solvent. The fermentation product obtained in step S3 is mixed with the eutectic solvent in a volume ratio of 1:10 and then subjected to ultrasonic extraction at a temperature of 70°C and a power of 220 W for 30 min. S5. After ultrasonic extraction, centrifuge at 4500 rpm for 20 min, take the supernatant and filter it through a 0.22 μm filter membrane, freeze-dry until the water content is 5 wt%, and obtain the plant extract.

[0027] This embodiment also provides a product containing coenzyme Q10, which is a soft capsule composed of a capsule shell and the above-mentioned coenzyme Q10-containing composition. The capsule shell, by weight, is composed of the following components: 120 parts gelatin, 40 parts glycerin, 1 part titanium dioxide, 10 parts caramel color, and 120 parts purified water. The preparation method of the product containing coenzyme Q10 is the same as in Example 2. Comparative Example 1 (lacking Lactobacillus pentosus)

[0028] The only difference from Example 2 is the preparation step S3 of the plant extract, which is as follows: S3. Inoculate the fermentation substrate with a mixed inoculum consisting of Bacillus coagulans and Bifidobacterium infantis. After anaerobic fermentation at 36°C for 60 hours, sterilize at 135°C for 10 seconds to obtain the fermentation product. The Bacillus coagulans has the preservation number CCTCC NO: M2017813, and the Bifidobacterium infantis has the preservation number CGMCC NO.1.15639. The inoculation amount of the mixed inoculum is 5% v / v of the fermentation substrate, and the effective viable count of the mixed inoculum is 2.0 × 10⁻⁶. 7 CFU / mL, the effective viable count ratio of Bacillus coagulans and Bifidobacterium infantis is 0.5:1.3; The remaining raw materials and preparation methods are the same as in Example 2. Comparative Example 2 (lacking Bacillus coagulans)

[0029] The only difference from Example 2 is the preparation step S3 of the plant extract, which is as follows: S3. Inoculate the fermentation substrate with a mixed inoculum consisting of *Lactobacillus pentosus* and *Bifidobacterium infantis*, and anaerobic ferment at 36°C for 60 h, then sterilize at 135°C for 10 s to obtain the fermentation product; wherein, the preservation number of *Lactobacillus pentosus* is CCTCC NO: M2023711, and the preservation number of *Bifidobacterium infantis* is CGMCC NO.1.15639; the inoculation amount of the mixed inoculum is 5% v / v of the fermentation substrate, and the effective viable count of the mixed inoculum is 2.0 × 10⁻⁶. 7CFU / mL, the effective viable count ratio of the Lactobacillus pentosus and Bifidobacterium infantis is 1:1.3; The remaining raw materials and preparation methods are the same as in Example 2. Comparative Example 3 (lacking Bifidobacterium infantis)

[0030] The difference from Example 2 lies in the preparation step S3 of the plant extract, which is different, specifically: S3. Inoculate the fermentation substrate with a mixed inoculum consisting of *Lactobacillus pentosus* and *Bacillus coagulans*, and anaerobic ferment at 36°C for 60 h, then sterilize at 135°C for 10 s to obtain the fermentation product; wherein, the preservation number of *Lactobacillus pentosus* is CCTCC NO: M2023711, and the preservation number of *Bacillus coagulans* is CCTCC NO: M2017813; the inoculation amount of the mixed inoculum is 5% v / v of the fermentation substrate, and the effective viable count of the mixed inoculum is 2.0 × 10⁻⁶. 7 CFU / mL, the effective viable count ratio of Lactobacillus pentosus and Bacillus coagulans is 1:0.5; The remaining raw materials and preparation methods are the same as in Example 2. Comparative Example 4 (using Lactobacillus fermentum instead of Bifidobacterium infantis)

[0031] The only difference from Example 2 is the preparation step S3 of the plant extract, which is as follows: S3. Inoculate the fermentation substrate with a mixed inoculum consisting of *Lactobacillus pentosus*, *Bacillus coagulans*, and *Lactobacillus fermentum*. After anaerobic fermentation at 36°C for 60 hours, sterilize at 135°C for 10 seconds to obtain the fermentation product. The *Lactobacillus pentosus* has the preservation number CCTCC NO: M2023711, the *Bacillus coagulans* has the preservation number CCTCC NO: M2017813, and the *Lactobacillus fermentum* has the preservation number CGMCC NO. 24476. The inoculation amount of the mixed inoculum is 5% v / v of the fermentation substrate, and the effective viable count of the mixed inoculum is 2.0 × 10⁻⁶. 7 CFU / mL, wherein the effective viable count ratio of Lactobacillus pentosus, Bacillus coagulans and Lactobacillus fermentum is 1:0.5:1.3; The remaining raw materials and preparation methods are the same as in Example 2. Comparative Example 5 (Bifidobacterium infantis with different accession numbers)

[0032] The only difference from Example 2 is the preparation step S3 of the plant extract, which is as follows: S3. Inoculate the fermentation substrate with a mixed inoculum consisting of *Lactobacillus pentosus*, *Bacillus coagulans*, and *Bifidobacterium infantis*. After anaerobic fermentation at 36°C for 60 hours, sterilize at 135°C for 10 seconds to obtain the fermentation product. The *Lactobacillus pentosus* has the preservation number CCTCC NO: M2023711, the *Bacillus coagulans* has the preservation number CCTCC NO: M2017813, and the *Bifidobacterium infantis* has the preservation number CGMCC NO. 20868. The inoculation amount of the mixed inoculum is 5% v / v of the fermentation substrate, and the effective viable count of the mixed inoculum is 2.0 × 10⁻⁶. 7 CFU / mL, wherein the effective viable count ratio of Lactobacillus pentosus, Bacillus coagulans and Bifidobacterium infantis is 1:0.5:1.3; The remaining raw materials and preparation methods are the same as in Example 2. Comparative Example 6 (Adjusting the ratio of effective live bacteria to fermentation bacteria)

[0033] The only difference from Example 2 is the preparation step S3 of the plant extract, which is as follows: S3. Inoculate the fermentation substrate with a mixed inoculum consisting of *Lactobacillus pentosus*, *Bacillus coagulans*, and *Bifidobacterium infantis*. After anaerobic fermentation at 36°C for 60 hours, sterilize at 135°C for 10 seconds to obtain the fermentation product. The *Lactobacillus pentosus* has the preservation number CCTCC NO: M2023711, the *Bacillus coagulans* has the preservation number CCTCC NO: M2017813, and the *Bifidobacterium infantis* has the preservation number CGMCC NO. 1.15639. The inoculation amount of the mixed inoculum is 5% v / v of the fermentation substrate, and the effective viable count of the mixed inoculum is 2.0 × 10⁻⁶. 7 CFU / mL, wherein the effective viable count ratio of Lactobacillus pentosus, Bacillus coagulans and Bifidobacterium infantis is 1:1.3:0.5; The remaining raw materials and preparation methods are the same as in Example 2. Comparative Example 7 (using choline chloride instead of glucose)

[0034] The only difference from Example 2 is the preparation step S4 of the plant extract, which is as follows: S4. Mix choline chloride, citric acid and deionized water in a molar ratio of 1:3:3.5 and stir in a 55°C water bath until a transparent liquid is formed to obtain a eutectic solvent. Mix the fermentation product obtained in step S3 with the eutectic solvent in a volume ratio of 1:6 and then perform ultrasonic extraction at a temperature of 65°C and a power of 200 W for 40 min. The remaining raw materials and preparation methods are the same as in Example 2. Comparative Example 8 (using ethanol instead of the eutectic solvent)

[0035] The only difference from Example 2 is the preparation step S4 of the plant extract, which is as follows: S4. The fermentation product obtained in step S3 is mixed with anhydrous ethanol at a volume ratio of 1:6 and then subjected to ultrasonic extraction at a temperature of 65℃ and a power of 200 W for 40 min. The remaining raw materials and preparation methods are the same as in Example 2. Comparative Example 9 (without plant extracts)

[0036] Unlike Example 2, the composition does not contain plant extracts, and the missing amounts are made up with natural vitamin E and vitamin C in a mass ratio of 25:15.

[0037] The remaining raw materials and preparation methods are the same as in Example 2. Comparative Example 10 (excluding natural vitamin E and vitamin C)

[0038] Unlike Example 2, the composition does not contain vitamin E and vitamin C, and the missing amounts are made up with an equal amount of plant extracts.

[0039] The remaining raw materials and preparation methods are the same as in Example 2. Effect test Test Example 1: Toxicity Test

[0040] 1.1 Twenty mice (half male and half female) were selected for each group for acute oral toxicity testing: The compositions of each example and each comparative example were administered by gavage at a dose of 10 g / kg·bw twice daily, and the mice's vital signs were observed. Results: The maximum tolerated dose (MTD) was greater than 20 g / kg·bw in all cases, indicating that the mice were non-toxic.

[0041] 1.2 Forty mice (half male and half female) were selected for each group and fed for 30 days. The compositions from each example and comparative example were used. The recommended human dose was 0.5 g / person / day. Three dosage groups were established at 30, 60, and 120 times the recommended human dose: 0.25 g / kg·bw / d, 0.5 g / kg·bw / d, and 1.0 g / kg·bw / d. A blank control group of 0 g / kg·bw / d was also included. The test samples were mixed into the basal diet and fed to the mice for 30 consecutive days. Daily observations were made for any signs of toxicity or death. At the end of the experiment, hematological, blood biochemical, and organ coefficient indicators were observed, and pathological examinations were performed. All results were within the normal range, indicating safety and non-toxicity. Test Example 2: Test on the protective effect on the cardiovascular and cerebrovascular systems

[0042] This experiment used a mixed hyperlipidemia animal model to detect the lipid-lowering function of the coenzyme Q10-containing composition of this invention, thereby evaluating the protective efficacy of the coenzyme Q10-containing product of this invention on the cardiovascular and cerebrovascular systems. The experimental method is as follows: 1. Principle Feeding animals with diets containing cholesterol, sucrose, lard, and sodium cholate can create animal models of lipid metabolism disorders. Then, administering test samples to the animals can detect the effects of the test samples on hyperlipidemia and determine the effects of the test samples on lipid absorption, lipoprotein formation, lipid degradation, or excretion.

[0043] 2. Instruments and reagents Dissection instruments, spectrophotometer, automated biochemical analyzer, and reagent kits for measuring cholesterol, sodium cholate, serum total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C).

[0044] 3. Animal selection Healthy adult male SPF-grade SD rats were selected, with 10 rats in each group.

[0045] 4. High-fat model feed Add 20wt% sucrose, 10wt% lard, 1.2wt% cholesterol, and 0.2wt% sodium cholate to the basic feed, along with appropriate amounts of casein, dicalcium phosphate, and limestone. Except for crude fat, the moisture, crude protein, crude fat, crude fiber, crude ash, calcium, phosphorus, and calcium-to-phosphorus ratio of the high-fat model feed must all meet the national standards for maintenance feed.

[0046] 5. Dosage grouping and administration time of test samples The experiment included Examples 1-4, Comparative Examples 1-10, a blank control group, and a model control group. The test samples were administered for 30 days.

[0047] 6. Experimental Procedure 6.1 Adaptation period Rats were fed a basic diet under the barrier system for 7 days for acclimatization. The feeding conditions were: temperature 22±2℃, relative humidity 50~60%RH, 12h automatic light-dark cycle, free access to food and water. At the end of the acclimatization period, the weight was 200±20g.

[0048] 6.2 Modeling period Rats were randomly divided into two groups based on body weight: a control group of 10 rats fed a basal diet and a model group of 150 rats fed a high-fat diet. Body weight was measured weekly. After two weeks of the high-fat diet, rats in both the control and model groups were deprived of food, and blood was collected from their tails. Serum was separated as soon as possible after blood collection, and serum TC, TG, and HDL-C levels were measured. Based on TC levels, the model group was randomly divided into 15 subgroups (Examples 1-4, Comparative Examples 1-10, and the model control group), with 10 rats in each subgroup. There were no significant differences in TC, TG, and HDL-C among the subgroups. However, compared with the control group, all subgroups in the model group showed significant increases in TC and TG, and significant decreases in HDL-C, indicating successful modeling.

[0049] 6.3 Test Sample Administration After grouping, the blank control group continued to be given the basal diet; the Example 1-4 groups, Comparative Examples 1-10 groups, and the model control group continued to be given the high-fat model diet, and the Example 1-4 groups and Comparative Examples 1-10 groups were given 0.5 g / kg·bw of the Coenzyme Q10-containing composition of Example 1-4 and Comparative Examples 1-10 by oral gavage daily; at the end of the experiment, blood was collected from the tail without fasting, and serum was separated as soon as possible after blood collection to measure serum TC, TG, and HDL-C levels. The results were taken as mean ± standard deviation, as shown in Table 1. Table 1. Effects of Coenzyme Q10-containing compositions on serum TC, TG, and HDL-C levels.

[0050] Note: The symbol indicates that the model control group is compared with the blank control group, p < 0.05; # indicates that Examples 1-4 are compared with the model control group, p < 0.05; ▲ indicates that Comparative Examples 1-10 are compared with Example 2, p < 0.05.

[0051] Comparing the test results of Examples 1-4 and the model control group in Table 1, it can be seen that the coenzyme Q10-containing composition prepared in this invention has a good auxiliary lipid-lowering effect and helps protect cardiovascular and cerebrovascular health. Furthermore, comparing the test results of Example 1 with those of Examples 2-4, it can be seen that the addition of plant extracts and composite emulsifiers can significantly improve the cardiovascular and cerebrovascular protective efficacy of the composition.

[0052] By comparing the test results of Example 2 and Comparative Examples 1-6 in Table 1, it can be seen that the type of fermentation bacteria and the ratio of live bacteria used in the preparation of plant extracts will affect the performance of plant extracts, thereby affecting the efficacy of the coenzyme Q10-containing composition. When the fermentation bacteria of the types specified in this invention are used for fermentation at a specific ratio of live bacteria, the composition has better cardiovascular and cerebrovascular protection effects. This may be because the type of fermentation bacteria and the ratio of live bacteria will affect the synergistic metabolic relationship between strains, the generation efficiency of active metabolites, etc., thereby affecting the composition of active ingredients in the fermentation products, and further affecting the cardiovascular and cerebrovascular health benefits of the composition.

[0053] By comparing the test results of Example 2 and Comparative Examples 7-8 in Table 1, it can be seen that the extraction solvent used in the preparation of plant extracts also affects the performance of plant extracts, thereby affecting the efficacy of the coenzyme Q10-containing composition. When the eutectic solvent with the specific composition of the present invention is used for extraction, the composition has better cardiovascular and cerebrovascular health benefits. This may be because the eutectic solvent selected in the present invention can not only completely extract the active ingredients of the mixed fermentation product, but the eutectic solvent itself can also have a synergistic effect with each active ingredient, thereby maximizing the efficacy of the composition.

[0054] By comparing the test results of Example 2 and Comparative Examples 9-10 in Table 1, it can be seen that when the composition lacks plant extracts (Comparative Example 9) or natural vitamin E and vitamin C (Comparative Example 10), the health benefits of the composition for cardiovascular and cerebrovascular health are reduced. This may be because in the coenzyme Q10-containing composition prepared in this invention, coenzyme Q10, plant extracts, natural vitamin E, and vitamin C have a synergistic protective effect on cardiovascular and cerebrovascular health. Test Example 3: Immunity-Boosting Efficacy Test

[0055] NK cells are multifunctional immune cells that play a crucial role in the body's immune protection. This invention uses a lactate dehydrogenase assay to detect the effect of a coenzyme Q10-containing composition on NK cell activity, thereby evaluating the immune-enhancing efficacy of the coenzyme Q10-containing product of this invention. The experimental methods are as follows: Healthy adult SPF-grade SD rats were selected and acclimatized for 7 days using a basal diet under a barrier system. The conditions were: temperature 22±2℃, relative humidity 50-60%RH, 12-hour automatic light-dark cycle, and free access to food and water. At the end of the acclimatization period, the rats weighed 200±20g. Ten rats were placed in each group. Groups 1-4 (Examples 1-4) and 1-10 (Comparative Examples 1-10) were administered 0.5g / kg body weight of the Coenzyme Q10-containing combination via oral gavage daily. The blank control group was administered an equal volume of physiological saline via gavage. This administration was continued for 30 days. All groups had normal food and water. After the last gavage, the rats were fasted for 12 hours and sacrificed using the cervical spine dehiscence method. NK cell activity was measured.

[0056] Target cells (YAC-1 cells) were passaged 24 hours before the experiment, and the cell concentration was adjusted to 5 × 10⁻⁶. 5 Spleens were aseptically harvested after rat sacrifice, and spleen cell suspensions were prepared as effector cells, with the cell concentration adjusted to 2 × 10⁶ cells / mL. 7 Target cells / mL. 100 μL each of target cells and effector cells were added to a U-shaped 96-well culture plate; 100 μL each of target cells and culture medium were added to the target cell spontaneous release well; 100 μL each of target cells and 1% NP-40 were added to the target cell maximum release well; each of the above was set up with three parallel wells, and cultured in a 37℃, 5% CO2 incubator for 4 h, then the 96-well culture plate was incubated at 1500 r·min. -1 Centrifuge for 5 min, and transfer 100 μL of supernatant from each well to a flat-bottomed 96-well culture plate. Simultaneously add 100 μL of LDH substrate solution. React for 3-10 min depending on room temperature, adding 1 mol·L⁻¹ of the supernatant to each well. -1 30 μL of HCl was added, and the optical density (OD) was measured at 490 nm using a microplate reader. NK cell activity was calculated using the following formula, and the results were taken as mean ± standard deviation, as shown in Table 2. NK cell activity (%) = (OD of reaction well - OD of spontaneous release well) / (OD of maximum release well - OD of spontaneous release well) × 100%; Table 2 Effects of Coenzyme Q10-containing Compositions on NK Cell Activity ; Note: a indicates that Examples 1-4 are compared with the blank control group, and p < 0.05; b indicates that Comparative Examples 1-10 are compared with Example 2, and p < 0.05.

[0057] Comparing the test results of Examples 1-4 and the blank control group in Table 2, it can be seen that the coenzyme Q10-containing composition prepared in this invention can improve NK cell activity and has a good effect on enhancing immunity. Furthermore, comparing the test results of Example 1 and Examples 2-4, it can be seen that the addition of plant extracts and compound emulsifiers can significantly improve NK cell activity and enhance immunity.

[0058] By comparing the test results of Example 2 and Comparative Examples 1-6 in Table 2, it can be seen that the type of fermentation bacteria and the ratio of live bacteria used in the preparation of plant extracts will significantly affect the effect of the composition on enhancing NK cell activity. When the fermentation bacteria of the type specified in this invention are used for fermentation at a specific ratio of live bacteria, the composition has a better immune-enhancing effect.

[0059] By comparing the test results of Example 2 and Comparative Examples 7-8 in Table 2, it can be seen that the extraction solvent used in preparing the plant extract also affects the effect of the composition on enhancing NK cell activity. When the eutectic solvent of the specific composition of the present invention is used for extraction, the composition has a better immune-enhancing effect.

[0060] By comparing the test results of Example 2 and Comparative Examples 9-10 in Table 2, it can be seen that when the composition lacks plant extracts (Comparative Example 9) or natural vitamin E and vitamin C (Comparative Example 10), the composition's immune-enhancing effect is reduced. This may be because in the coenzyme Q10-containing composition prepared in this invention, coenzyme Q10, plant extracts, natural vitamin E, and vitamin C have a synergistic immune-enhancing effect.

[0061] Finally, it should be noted that the above embodiments and comparative examples are only used to illustrate the technical solutions of the present invention and not to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A composition containing coenzyme Q10, characterized in that, By weight, including but not limited to the following components: Coenzyme Q10: 25-30 servings; Natural Vitamin E: 20-30 servings; Vitamin C: 10-20 servings; Vegetable oil: 400-450 parts; The vegetable oil is at least one of olive oil, perilla seed oil, and walnut oil.

2. The coenzyme Q10-containing composition according to claim 1, characterized in that, Based on parts by weight, the coenzyme Q10-containing composition further includes the following components: Plant extract: 20-25 parts; Compound emulsifier: 25-40 parts; The plant extract is prepared by using hawthorn, kudzu root, and schisandra as raw materials, and then by mixed fermentation with Lactobacillus pentosus, Bacillus coagulans and Bifidobacterium infantis, followed by extraction with a low eutectic solvent. The composite emulsifier is composed of lecithin and sodium caseinate in a mass ratio of 1:1 to 3.

3. The coenzyme Q10-containing composition according to claim 2, characterized in that, The method for preparing the plant extract includes the following steps: S1. Take dried hawthorn, kudzu root and schisandra, grind them into powder and pass them through a 40-60 mesh sieve. Mix the hawthorn powder, kudzu root powder and schisandra powder together, add 10-20 times the weight of purified water, boil and cool to room temperature to obtain the mixture. S2. Based on the mass of the mixture, add 1-2 wt% glucose, 0.05-0.1 wt% yeast powder, 0.01-0.05 wt% K2HPO4, and 0.01-0.05 wt% MgSO4·7H2O, mix well, and sterilize at 121℃ for 15-25 min to obtain the fermentation substrate. S3. Inoculate the fermentation substrate with a mixed inoculum consisting of Lactobacillus pentosus, Bacillus coagulans and Bifidobacterium infantis, and sterilize at high temperature after anaerobic fermentation to obtain the fermentation product. S4. After mixing glucose, citric acid and deionized water, stir under a water bath at 50-60°C until a transparent liquid is formed, which is the eutectic solvent. Mix the fermentation product obtained in step S3 with the eutectic solvent and then perform ultrasonic extraction. S5. After ultrasonic extraction, centrifuge, take the supernatant and filter it through a 0.22μm filter membrane, freeze-dry until the water content is ≤5wt%, and the plant extract is obtained.

4. The coenzyme Q10-containing composition according to claim 3, characterized in that, In step S1, the hawthorn powder, kudzu root powder, and schisandra powder are mixed in a mass ratio of 1:0.5-0.7:0.2-0.

3.

5. The coenzyme Q10-containing composition according to claim 3, characterized in that, In step S2, based on the mass of the mixture, add 1.5 wt% glucose, 0.07 wt% yeast powder, 0.03 wt% K2HPO4, and 0.02 wt% MgSO4·7H2O.

6. The coenzyme Q10-containing composition according to claim 3, characterized in that, In step S3, the preservation number of *Lactobacillus pentosaceus* is CCTCC NO: M2023711, the preservation number of *Bacillus coagulans* is CCTCC NO: M2017813, and the preservation number of *Bifidobacterium infantis* is CGMCC NO. 1.15639. The inoculum amount of the mixed bacterial agent is 3-6% v / v of the fermentation substrate, and the effective viable count of the mixed bacterial agent is 1.8 × 10⁻⁶. 7 ~2.5×10 7 The effective viable count ratio of Lactobacillus pentosus, Bacillus coagulans, and Bifidobacterium infantis is 1:0.3-0.7:1.2-1.

5. The anaerobic fermentation temperature is 35-37℃ and the time is 48-72h. The high-temperature instantaneous sterilization is sterilization at 135-140℃ for 5-10s.

7. The coenzyme Q10-containing composition according to claim 3, characterized in that, In step S4, the molar ratio of glucose, citric acid, and deionized water is 1:2 to 4:2.5 to 5, the volume ratio of fermentation product to eutectic solvent is 1:4 to 10, and the ultrasonic extraction temperature is 60 to 70°C, the power is 180 to 220 W, and the time is 30 to 50 min; in step S5, the centrifugation speed is 4000 to 5000 rpm, and the time is 18 to 22 min.

8. A product containing coenzyme Q10, characterized in that, The product is a soft capsule composed of a capsule shell and a coenzyme Q10-containing composition as described in any one of claims 2 to 7.

9. The product containing coenzyme Q10 according to claim 8, characterized in that, The capsule shell, by weight, includes, but is not limited to, the following components: 50-120 parts gelatin, 35-40 parts glycerin, 0.1-1 parts titanium dioxide, 3-10 parts caramel color, and 50-120 parts purified water.

10. The method for preparing the product containing coenzyme Q10 according to claim 9, characterized in that, Includes the following steps: (1) Preparation of the coenzyme Q10-containing composition: Coenzyme Q10 and natural vitamin E are added to vegetable oil and stirred until completely dissolved in a water bath at 65-75°C. Plant extract, vitamin C, and compound emulsifier are added and stirred evenly. The mixture is then homogenized at 5000-10000 rpm for 2-5 minutes and degassed under vacuum at -0.07MPa to -0.1MPa until no bubbles are present, thus obtaining the coenzyme Q10-containing composition. (2) Preparation of capsule shell solution: Titanium dioxide and 1 / 2 volume of purified water are mixed evenly and passed through a colloid mill to obtain titanium dioxide solution. Then caramel color is added and mixed evenly to obtain pigment solution. Gelatin, glycerin and the remaining purified water are mixed and heated to 70-80℃. Stir until the gelatin dissolves. Then vacuum degassing is performed at -0.07MPa to -0.1MPa until no bubbles are present. The mixture is passed through a 120-mesh sieve. Pigment solution is added and mixed evenly. The mixture is kept warm at 55-65℃ for later use. (3) Capsule pressing: The coenzyme Q10-containing composition obtained in step (1) and the capsule shell solution obtained in step (2) are pressed into soft capsules; wherein the capsule shell thickness of the soft capsule is 0.7±0.05mm and each soft capsule contains 500mg of the composition; (4) Setting: Set for 1 to 2.5 hours at a temperature of 18 to 26°C and a relative humidity of 25 to 30%; (5) Drying: Dry at a temperature of 20-30℃ and a relative humidity of 18-22% for 20-30 hours; (6) Selecting capsules: Remove substandard soft capsules that are irregularly shaped, leaking oil, or have bubbles; (7) Packaging: The qualified soft capsules are bottled and sealed to obtain products containing coenzyme Q10.

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