Omega3 capsule with lipid-lowering and anticoagulation functions and preparation method thereof

Abstract

The invention belongs to the technical field of medical health-care food, and particularly relates to an omega3 capsule with lipid-lowering and anticoagulation functions and a preparation method of the omega3 capsule. By adopting the design that the omega3 fatty acid is coated with phospholipid, oxygenolysis of the omega3 fatty acid can be effectively avoided, meanwhile, the bioavailability of the omega3 fatty acid can be effectively improved through phospholipid coating, and the absorption efficiency of the omega3 fatty acid in intestinal tracts is enhanced. In addition, a phospholipid coating structure can also improve the auxiliary effect of omega3 anticoagulation, and is combined with nattokinase to synergistically exert thrombolysis and anticoagulation effects, so that the risk of thrombosis can be effectively reduced, blood circulation can be improved, and the phospholipid coating structure has positive significance for preventing and treating cardiovascular and cerebrovascular diseases. Besides, an enteric coating technology is adopted, so that the activity of nattokinase and omega3 fatty acid can be prevented from being damaged by gastric juice, the release efficiency of nattokinase and omega3 fatty acid in intestinal tracts is improved, and stable absorption of active ingredients is ensured.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical and health food technology, specifically relating to an ω3 capsule with both lipid-lowering and anticoagulant functions and its preparation method. Background Technology

[0002] With the improvement of people's living standards and changes in dietary structure, the incidence of hyperlipidemia and thrombosis-related diseases is increasing year by year, seriously threatening human health. Many people choose health supplements such as fish oil containing omega-3 fatty acids as nutritional supplements to regulate blood lipids and prevent cardiovascular diseases.

[0003] The DHA and EPA components in omega-3 fatty acids can lower blood lipid levels by regulating lipoprotein metabolism and inhibiting hepatic triglyceride synthesis. They also exert anticoagulant effects by intervening in platelet aggregation and coagulation factor activity. However, omega-3 fatty acids alone have the following problems: 1. Omega-3 fatty acids are lipid-soluble and require bile emulsification in the intestine to form chylomicrons for absorption. Their absorption rate is significantly affected by individual bile secretion levels, and absorption is poor in some individuals, especially the elderly and those with impaired liver and gallbladder function; 2. Simple omega-3 fatty acids themselves do not have direct anticoagulant function; they can only reduce thromboxane levels by competitively inhibiting arachidonic acid metabolism. It is generated by inhibiting platelet aggregation, and its anticoagulant effect is limited and slow to take effect.

[0004] Therefore, it is necessary to develop a compound formulation that can both improve the bioavailability of ω3 and have a synergistic anticoagulant effect. Summary of the Invention

[0005] The purpose of this invention is to provide an ω3 capsule with both lipid-lowering and anticoagulant functions, and its preparation method. By combining ω3 fatty acids with phospholipids to form a microemulsion precursor, its self-emulsification ability in the intestine is significantly enhanced, allowing for efficient absorption without relying on bile. Simultaneously, the phospholipid-coated ω3 fatty acids synergistically enhance the anticoagulant activity of the composition through their interaction with nattokinase, achieving the dual effects of rapid thrombolysis and long-lasting lipid-lowering.

[0006] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: An ω3 capsule with both lipid-lowering and anticoagulant functions is composed of a capsule shell and capsule contents. Based on 100% of the total capsule mass, the capsule contents include: 12.0-18.0% ω3 fatty acid concentrate, 0.15-0.25% nattokinase powder, 4.0-6.0% coating phospholipids, 0.4-0.6% compound antioxidants, 0.2-0.4% emulsifiers, and the balance purified water. The capsule contents are a composite suspension system of phospholipid-coated ω3 nanoemulsion and nattokinase dispersion. The capsule shell consists of: 10.0-14.0% gelatin, 5.0-7.0% glycerin, and 5.5-7.0% enteric coating powder.

[0007] Preferably, the composite antioxidant is composed of vitamin E, rosemary extract, and tea polyphenols, wherein the mass ratio of vitamin E, rosemary extract, and tea polyphenols is 3-5:2-4:1-3.

[0008] Preferably, the emulsifier has an HLB value of 7-9, and the emulsifier is selected from one or more of monoglycerides, sucrose esters, and polyglycerol-6-distearate.

[0009] Preferably, the total content of EPA and DHA in the ω3 fatty acid concentrate is not less than 80%, and the mass ratio of EPA to DHA is 2-3:1.

[0010] Preferably, the enzyme activity of the nattokinase powder is 2000-3000 FU / mg.

[0011] Preferably, the coating phospholipid is a soybean phospholipid modified by phospholipase A1 or A2, and the HLB of the modified soybean phospholipid is 9-10.

[0012] The preparation method of the present invention includes the following steps: S1. Using phospholipid-coated ω3 emulsion In a light-proof, nitrogen-filled mixing tank, add ω3 fatty acid concentrate, compound antioxidant, emulsifier, and the first amount of coating phospholipid according to the formula. Stir slowly and heat to 55-65℃ to completely dissolve and mix all oil-soluble components to form an oil phase. In another container, add purified water and heat to the same temperature as the oil phase. Under the stirring of a high-speed shearing machine, add the oil phase evenly to the purified water and shear emulsify to form a crude emulsion. The second amount of coating phospholipid was added to the crude emulsion and stirred continuously to disperse it completely. Then it was transferred to a high-pressure homogenizer for homogenization. After homogenization, the phospholipid-coated ω3 emulsion was obtained for later use. S2. Preparation of nattokinase dispersion Add purified water to the mixing tank, and slowly add nattokinase powder while stirring at low speed. Continue stirring until completely dispersed to form a nattokinase dispersion. S3. Preparation of capsule contents The phospholipid-coated ω3 emulsion obtained in S1 and the nattokinase dispersion obtained in S2 were mixed in proportion. Under light-proof and nitrogen-filled conditions, the two phases were uniformly dispersed by low-speed shear stirring to form a stable composite suspension system. S4. Capsule filling Prepare the capsule shell solution by mixing gelatin, glycerin and purified water in a certain proportion, heating and melting, filtering and degassing, and then setting aside for use; inject the composite suspension system obtained in S3 and the capsule shell solution into a soft capsule press and press them into soft capsules. The soft capsules are shaped and dried, then placed in a coating pan and spray-coated with an alcoholic solution or aqueous dispersion of enteric coating powder. After drying, the finished capsules are obtained.

[0013] Preferably, the first amount is 50-65% of the total mass of the coating phospholipids, and the second amount is 35-50% of the total mass of the coating phospholipids.

[0014] Preferably, the pressure of the high-pressure homogenization process in step S1 is 20-40 MPa, the number of homogenization cycles is 3-5, and the particle size of the emulsion after homogenization is 100-200 nm. The low-speed shearing and stirring speed described in step S3 is 200-400 r / min, and the stirring time is 15-30 min; In step S4, the spray rate for preparing the enteric coating is 10-20 mL / min, the inlet air temperature is 35-45℃, and the outlet air temperature is 25-35℃.

[0015] Preferably, in step S4, the setting temperature is 15-20℃ and the setting time is 20-40 min; the drying temperature is 25-30℃, the relative humidity is 30-40%, and the drying time is 12-24 h.

[0016] The advantages of this invention are: 1. This invention employs a phospholipid-coated ω3 fatty acid design, which can effectively prevent the oxidative decomposition of ω3 fatty acids. At the same time, through phospholipid coating, the bioavailability of ω3 fatty acids can be effectively improved, enhancing their absorption efficiency in the intestine and avoiding absorption problems caused by insufficient bile. It is especially suitable for people with insufficient bile secretion or weak digestive function.

[0017] 2. The phospholipid coating structure can also enhance the auxiliary effect of ω3 anticoagulation, and in combination with nattokinase, it synergistically exerts a thrombolytic and anticoagulant effect, which can effectively reduce the risk of thrombosis, improve blood circulation, and has positive significance for the prevention and treatment of cardiovascular and cerebrovascular diseases. Furthermore, this invention uses enteric coating technology, which can avoid gastric juice damaging the activity of nattokinase and ω3 fatty acids, improve their release efficiency in the intestine, and ensure the stable absorption of active ingredients. Attached Figure Description

[0018] Figure 1 This represents the average concentration of ω3 in the blood of each group in the control experiment.

[0019] Figure 2 This represents the average cumulative amount of ω3 in each tissue during the control experiment.

[0020] Figure 3 The following are the performance indicators of the coating materials in the control experiment, where (a) is the average particle size, (b) is the PDI value, and (c) is the centrifugal stratification rate.

[0021] Figure 4 The performance indicators of each group of coating materials in the control experiment are shown in (a) for particle size change rate after 14 days of storage and (b) for stratification rate after 14 days of storage. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions 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. The embodiments of the present invention described and shown herein can generally be arranged and designed in various different configurations.

[0023] Example 1 This embodiment discloses a composite soft capsule of ω3 fatty acid and nattokinase, with a total capsule weight of 1.0g, including 0.24g of capsule shell and 0.76g of capsule contents.

[0024] The capsule shell consists of: 0.12g gelatin, 0.06g glycerin, and 0.060g enteric coating powder.

[0025] The capsule contents include: 0.15g of ω3 fatty acid concentrate, 0.002g of nattokinase, 0.05g of soybean lecithin for coating, 0.005g of compound antioxidant, 0.003g of emulsifier, and 0.55g of purified water.

[0026] The ω3 fatty acid concentrate contains no less than 80% EPA and DHA, with a mass ratio of EPA to DHA of 2:1. The nattokinase powder has an enzyme activity of 2000 FU / mg. The coating phospholipid is soybean phospholipid modified by phospholipase A2, with an HLB of 9.5.

[0027] The compound antioxidant consists of vitamin E, rosemary extract, and tea polyphenols in a mass ratio of 3:2:1. The emulsifier is polyglycerol-6-distearate, HLB=9.

[0028] The preparation method of the present invention includes the following steps: S1. Using phospholipid-coated ω3 emulsion In a light-proof, nitrogen-filled mixing tank, add ω3 fatty acid concentrate, compound antioxidant, emulsifier and 50% of coating phospholipid according to the formula. Stir slowly and heat to 55°C to completely dissolve and mix all oil-soluble components to form an oil phase. In another container, purified water is added and heated to 55°C. Under the stirring of a high-speed shearing machine, the oil phase is evenly added to the purified water, and shearing emulsification is performed to form a crude emulsion. Add 50% of the coating phospholipid to the crude emulsion and stir continuously to disperse it completely. Then transfer it to a high-pressure homogenizer and homogenize it three times under a pressure of 20 MPa to obtain a phospholipid-coated ω3 emulsion with a particle size of 100-150 nm for later use. S2. Preparation of nattokinase dispersion Add purified water to the mixing tank, and slowly add nattokinase powder while stirring at low speed. Continue stirring until completely dispersed to form a nattokinase dispersion. S3. Preparation of capsule contents The phospholipid-coated ω3 emulsion obtained in S1 was mixed with the nattokinase dispersion obtained in S2 in a certain proportion, and stirred at 200 r / min for 30 min under light-proof and nitrogen-filled conditions to form a composite suspension system. S4. Capsule filling Gelatin, glycerin and purified water were mixed and heated to melt, then filtered to remove bubbles; the composite suspension system and capsule shell solution were injected into a press to compress into soft capsules; the capsules were set at 15℃ for 40 minutes, washed, and then dried at 25℃ and 30% relative humidity for 24 hours. The soft capsules were placed in a coating pan and coated with an enteric coating powder alcohol solution by spraying at a rate of 10 mL / min, an inlet air temperature of 35°C, and an outlet air temperature of 25°C. After drying, the finished product was obtained.

[0029] Example 2 This embodiment discloses a composite soft capsule of ω3 fatty acid and nattokinase, with a total capsule weight of 1.0g, including 0.265g of capsule shell and 0.735g of capsule contents.

[0030] The capsule shell consists of: 0.14g gelatin, 0.07g glycerin, and 0.055g enteric coating powder.

[0031] The capsule contents include: 0.14g of ω3 fatty acid concentrate, 0.0025g of nattokinase, 0.06g of soybean lecithin for coating, 0.006g of compound antioxidant, 0.004g of emulsifier, and 0.5225g of purified water.

[0032] The ω3 fatty acid concentrate contains at least 80% EPA and DHA, with a mass ratio of EPA to DHA of 3:1. The nattokinase powder has an enzyme activity of 3000 FU / mg. The coating phospholipid is soybean phospholipid modified by phospholipase A1, with an HLB of 9. The compound antioxidant consists of vitamin E, rosemary extract, and tea polyphenols in a mass ratio of 5:4:3. The emulsifier is sucrose ester with an HLB of 9.

[0033] The preparation method of the present invention includes the following steps: S1. Using phospholipid-coated ω3 emulsion In a light-proof, nitrogen-filled mixing tank, add ω3 fatty acid concentrate, compound antioxidant, emulsifier and 65% of coating phospholipid according to the formula. Stir slowly and heat to 65°C to completely dissolve and mix all oil-soluble components to form an oil phase. In another container, purified water is added and heated to 65°C. Under the stirring of a high-speed shearing machine, the oil phase is evenly added to the purified water, and shearing emulsification is performed to form a crude emulsion. Add 35% of the coating phospholipid to the crude emulsion and stir continuously to disperse it completely. Then transfer it to a high-pressure homogenizer and homogenize it 5 times under a pressure of 40 MPa to obtain a phospholipid-coated ω3 emulsion with a particle size of 100-150 nm for later use. S2. Preparation of nattokinase dispersion Add purified water to the mixing tank, and slowly add nattokinase powder while stirring at low speed. Continue stirring until completely dispersed to form a nattokinase dispersion. S3. Preparation of capsule contents The phospholipid-coated ω3 emulsion obtained in S1 was mixed with the nattokinase dispersion obtained in S2 in a certain proportion, and stirred at 400 r / min for 30 min under light-proof and nitrogen-filled conditions to form a composite suspension system. S4. Capsule filling Gelatin, glycerin and purified water were mixed and heated to melt, then filtered to remove bubbles; the composite suspension system and capsule shell solution were injected into a press to compress into soft capsules; the capsules were set at 20℃ for 40 minutes, washed, and then dried at 30℃ and 30% relative humidity for 24 hours. The soft capsules were placed in a coating pan and coated with an enteric coating powder alcohol solution by spraying at a rate of 20 mL / min, an inlet air temperature of 45°C, and an outlet air temperature of 35°C. After drying, the finished product was obtained.

[0034] Example 3 This embodiment discloses a composite soft capsule of ω3 fatty acid and nattokinase, with a total capsule weight of 1.0g, including 0.22g of capsule shell and 0.78g of capsule contents.

[0035] The capsule shell consists of: 0.10g gelatin, 0.05g glycerin, and 0.07g enteric coating powder.

[0036] The capsule contents include: 0.16g of ω3 fatty acid concentrate, 0.0015g of nattokinase, 0.04g of soybean lecithin for coating, 0.004g of compound antioxidant, 0.002g of emulsifier, and 0.5725g of purified water.

[0037] The preparation method in this embodiment is the same as that in Example 1.

[0038] Example 4 This embodiment discloses a composite soft capsule of ω3 fatty acid and nattokinase, with a total capsule weight of 1.0g, including 0.255g of capsule shell and 0.745g of capsule contents.

[0039] The capsule shell consists of: 0.13g gelatin, 0.065g glycerin, and 0.06g enteric coating powder.

[0040] The capsule contents include: 0.17g of ω3 fatty acid concentrate, 0.002g of nattokinase, 0.055g of soybean lecithin for coating, 0.003g of compound antioxidant, 0.003g of emulsifier, and 0.512g of purified water.

[0041] The preparation method in this embodiment is the same as that in Example 1.

[0042] This invention includes a control experiment on the absorption rate of ω3 fatty acids coated with phospholipids to verify the effect of phospholipid coating on improving the bioavailability of ω3 fatty acids.

[0043] Healthy SD rats, weighing 200-250g, with equal numbers of males and females, were randomly divided into three groups of 10 rats each. They were fed standard feed and had free access to water. The experiment began 3 days after the rats acclimatized to the environment.

[0044] Experimental group: Phospholipid-coated ω3 emulsion was prepared according to the steps in S1 of Example 1 and fed to the animals.

[0045] Control group 1: Feeded directly with pure ω3 raw materials, without any other treatment.

[0046] Control group 2: The phospholipids used in step S1 of Example 1 were replaced with cyclodextrin, and a cyclodextrin-coated ω3 emulsion was prepared for feeding.

[0047] All groups were administered the drug via gavage once daily for 7 consecutive days. On day 7, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours after administration, 0.5 mL of blood was collected from the orbital venous plexus of rats. The serum was separated by centrifugation and frozen at -20°C. Subsequently, the rats were sacrificed, and the liver, brain, and adipose tissue were rapidly separated, rinsed with physiological saline, dried, and frozen.

[0048] The samples were treated with methanol extraction and then quantitatively detected by HPLC.

[0049] The results are as follows: Table 1. Average concentration of ω3 in blood

[0050] Table 2. Average cumulative amount of ω3 in each tissue

[0051] like Figure 1As shown in Table 1, the phospholipid-coated ω3 emulsion in the experimental group resulted in significantly higher blood ω3 concentrations at all time points compared to control groups 1 and 2. The AUC of the experimental group was 328.6 μg·h / mL, which was 2.1 times that of control group 1 and 1.44 times that of control group 2, indicating that phospholipid coating can significantly increase the total amount and duration of ω3 absorption in vivo.

[0052] like Figure 2 As shown in Table 2, the experimental group had the highest ω3 accumulation in the liver, brain, and adipose tissue among the three groups, reaching 168.5 μg / g, 83.2 μg / g, and 245.7 μg / g, respectively, representing an increase of 80-91% compared to control group 1. Although the tissue accumulation in control group 2 was higher than that in control group 1, it was significantly lower than that in the experimental group. In conclusion, the serum AUC and tissue accumulation in the experimental group were significantly higher than those in the two control groups, and all differences between groups were statistically significant (P<0.01), demonstrating that phospholipid coating can effectively improve the absorption and bioavailability of ω3.

[0053] Meanwhile, the present invention conducts a comparative experiment to test the anticoagulation effect of the scheme, the method of which is as follows: Healthy SD rats, weighing 200-250g, with equal numbers of males and females, were randomly divided into five groups of 10 rats each. They were fed standard feed and had free access to water. The experiment began after 3 days of acclimatization.

[0054] Experimental group: The contents of the capsules prepared in the steps of Example 1 were administered by gavage.

[0055] Blank control group: Administered an equal volume of physiological saline by gavage.

[0056] Control group 3: The patient was given pure ω3 fatty acid concentrate by gavage at the same dose as the experimental group.

[0057] Control group 4: Nattokinase dispersion was administered by gavage at the same dose as the nattokinase in the experimental group.

[0058] Control group 5: No phospholipid coating was performed; instead, ω3 fatty acid concentrate was directly mixed with nattokinase and administered by gavage.

[0059] All groups were administered the medication by gavage once daily for 7 consecutive days. The dosage of ω3 was calculated as 150 mg / kg body weight and the dosage of nattokinase was calculated as 2 mg / kg body weight.

[0060] Two hours after the last administration on day 7, 5 mL of blood was collected from the rat's abdominal aorta and placed in a sodium citrate anticoagulant tube. The plasma was then centrifuged at 3000 r / min for 10 min and separated for later use.

[0061] Prothrombin time (PT), activated partial thromboplastin time (APTT), and thrombin time (TT) in plasma were measured using a fully automated coagulation analyzer. Simultaneously, plasma thromboxane was measured using an ELISA kit. ( ), 6-keto-prostaglandin ( )content.

[0062] The test results are as follows: Table 3 Coagulation Physiological Indicators

[0063] As shown in Table 3, the experimental group showed significant prolongations in all three coagulation parameters: PT, APTT, and TT. The level has decreased significantly. The significantly elevated levels indicate that the compound preparation has a stronger antithrombotic effect. A direct comparison between the control group (5) and the experimental group reveals that the experimental group significantly reduced... The levels were statistically significant (P<0.01), indicating that the combined use of ω3 fatty acid concentrate and nattokinase has a synergistic antithrombotic effect.

[0064] In this invention, a comparative experiment was conducted on the selection of coating materials for ω3. Unmodified soybean lecithin (HLB=4) and commercially available polyglycerol fatty acid ester (HLB=9) were selected for comparison with Example 1.

[0065] Experimental group: A2 catalytically modified soybean phospholipids were selected as the coating phospholipids, with an HLB value of 9.5; Control group 6: Unmodified soybean lecithin (HLB=4) was used as the coating material; Control group 7: Commercially available polyglycerol fatty acid ester (HLB=9) was used as the coating material.

[0066] Three parallel samples were set up in each group, and the emulsion was prepared according to the following steps.

[0067] Experimental methods: Each group prepared emulsions according to steps S1-S3 in Example 1. The average particle size and PDI value of the emulsions were detected by a laser particle size analyzer. Each sample was tested 3 times and the average value was taken. 10 mL of emulsion was placed in a centrifuge tube and centrifuged at 3000 r / min for 30 min. The stratification was observed and the stratification rate was calculated. Then the emulsion was sealed and stored in a 25℃ constant temperature incubator for 14 days. On the 14th day, the particle size change rate and stratification rate were detected.

[0068] The test results are as follows: Table 4 Test results of coating materials

[0069] As shown in Table 4 and Figure 3-4 As shown, the average particle size of the emulsion in the experimental group was only 135 nm, and the PDI value was <0.2, which was far superior to that of control group 6 (particle size 382 nm, PDI=0.45) and control group 7 (particle size 186 nm, PDI=0.27). This indicates that the modified phospholipid can significantly reduce the emulsion particle size, improve dispersion uniformity, and form a stable nanoemulsion system. The centrifugal stratification rate of the experimental group was only 2.1%, significantly lower than that of control group 6 (18.6%) and control group 7 (7.8%), proving that the emulsifying and coating effect of the modified phospholipid can enhance the emulsion's resistance to centrifugal sedimentation and prevent oil-water stratification. After 14 days of storage, the particle size change rate of the experimental group was only 8.5%, and the stratification rate was 5.3%, both significantly better than the two control groups, indicating that the modified phospholipid can maintain the stability of the emulsion for a long time and effectively prevent ω3 aggregation and precipitation.

[0070] The above are merely preferred embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. An ω3 capsule with both lipid-lowering and anticoagulant functions, characterized in that, Composed of a shell and capsule contents; based on 100% of the total capsule weight: The capsule contents include: 12.0-18.0% ω3 fatty acid concentrate, 0.15-0.25% nattokinase powder, 4.0-6.0% coating phospholipids, 0.4-0.6% compound antioxidants, 0.2-0.4% emulsifiers, and the balance purified water; the capsule contents are a composite suspension system of phospholipid-coated ω3 nanoemulsion and nattokinase dispersion; The capsule shell consists of: 10.0-14.0% gelatin, 5.0-7.0% glycerin, and 5.5-7.0% enteric coating powder.

2. The ω3 capsule with both lipid-lowering and anticoagulant functions according to claim 1, characterized in that, The compound antioxidant is composed of vitamin E, rosemary extract, and tea polyphenols, and the mass ratio of vitamin E, rosemary extract, and tea polyphenols is 3-5:2-4:1-3.

3. The ω3 capsule with both lipid-lowering and anticoagulant functions according to claim 1, characterized in that, The emulsifier has an HLB value of 7-9 and is selected from one or more of monoglycerides, sucrose esters, and polyglycerol-6-distearate.

4. An ω3 capsule with both lipid-lowering and anticoagulant functions according to claim 1, characterized in that, The total content of EPA and DHA in the ω3 fatty acid concentrate is not less than 80%, and the mass ratio of EPA to DHA is 2-3:

1.

5. An ω3 capsule with both lipid-lowering and anticoagulant functions according to claim 1, characterized in that, The enzyme activity of the nattokinase powder is 2000-3000 FU / mg.

6. An ω3 capsule with both lipid-lowering and anticoagulant functions according to claim 1, characterized in that, The coating phospholipid is selected from soybean phospholipids modified by phospholipase A1 or A2, and the HLB of the modified soybean phospholipids is 9-10.

7. A method for preparing an ω3 capsule with both lipid-lowering and anticoagulant functions as described in claim 1, characterized in that, Includes the following steps: S1. Using phospholipid-coated ω3 emulsion In a light-proof, nitrogen-filled mixing tank, add ω3 fatty acid concentrate, compound antioxidant, emulsifier, and the first amount of coating phospholipid according to the formula. Stir slowly and heat to 55-65℃ to completely dissolve and mix all oil-soluble components to form an oil phase. In another container, add purified water and heat to the same temperature as the oil phase. Under the stirring of a high-speed shearing machine, add the oil phase evenly to the purified water and shear emulsify to form a crude emulsion. The second amount of coating phospholipid was added to the crude emulsion and stirred continuously to disperse it completely. Then it was transferred to a high-pressure homogenizer for homogenization. After homogenization, the phospholipid-coated ω3 emulsion was obtained for later use. S2. Preparation of nattokinase dispersion Add purified water to the mixing tank, and slowly add nattokinase powder while stirring at low speed. Continue stirring until completely dispersed to form a nattokinase dispersion. S3. Preparation of capsule contents The phospholipid-coated ω3 emulsion obtained in S1 and the nattokinase dispersion obtained in S2 were mixed in proportion. Under light-proof and nitrogen-filled conditions, the two phases were uniformly dispersed by low-speed shear stirring to form a stable composite suspension system. S4. Capsule filling Prepare the capsule shell solution by mixing gelatin, glycerin and purified water in a certain proportion, heating and melting, filtering and degassing, and then setting aside for use; inject the composite suspension system obtained in S3 and the capsule shell solution into a soft capsule press and press them into soft capsules. The soft capsules are shaped and dried, then placed in a coating pan and spray-coated with an alcoholic solution or aqueous dispersion of enteric coating powder. After drying, the finished capsules are obtained.

8. The method for preparing an ω3 capsule with both lipid-lowering and anticoagulant functions according to claim 7, characterized in that, The first dosage is 50-65% of the total mass of the coating phospholipids, and the second dosage is 35-50% of the total mass of the coating phospholipids.

9. A method for preparing an ω3 capsule with both lipid-lowering and anticoagulant functions according to claim 7, characterized in that, The high-pressure homogenization process in step S1 is carried out at a pressure of 20-40 MPa, and the number of homogenization cycles is 3-5. The particle size of the emulsion after homogenization is 100-200 nm. The low-speed shearing and stirring speed described in step S3 is 200-400 r / min, and the stirring time is 15-30 min; In step S4, the spray rate for preparing the enteric coating is 10-20 mL / min, the inlet air temperature is 35-45℃, and the outlet air temperature is 25-35℃.

10. A method for preparing an ω3 capsule with both lipid-lowering and anticoagulant functions according to claim 7, characterized in that, The setting temperature in step S4 is 15-20℃, and the setting time is 20-40 min; the drying temperature is 25-30℃, the relative humidity is 30-40%, and the drying time is 12-24 h.

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