Medicinal and edible soft capsule with blood fat reducing function and preparation method of medicinal and edible soft capsule

Abstract

The invention belongs to the technical field of health-care products, and particularly relates to a medicinal and edible soft capsule with a blood fat reducing function and a preparation method of the medicinal and edible soft capsule. The medicinal and edible soft capsule with the function of reducing blood fat is prepared from a soft capsule shell and soft capsule contents, the soft capsule content comprises the following raw materials in parts by weight: 20-40 parts of red yeast rice, 20-35 parts of natto freeze-dried powder, 15-25 parts of a hawthorn extract, 10-20 parts of cassia seed polysaccharide and 3-10 parts of tea polyphenol; the soft capsule shell is prepared from a capsule shell glue solution, the capsule shell glue solution is based on HPMC and pullulan, HPMCP is fused into the capsule shell glue solution to realize enteric protection, an antioxidant and nano-silica are matched to construct a protective network, the soft capsule content mildly adjusts the microenvironment of the capsule shell, the HPMCP is assisted to be dissolved under intestinal tract conditions, and accurate release of the content is ensured; the soft capsule shell protects the effect of the contents through structural characteristics, and deliquescence or oxidation of effective components is avoided.

Description

Technical Field

[0001] The invention belongs to the technical field of health care products, and particularly relates to a medicine-food soft capsule with the function of lowering blood lipids and a preparation method thereof. Background Art

[0002] Hyperlipidemia refers to the abnormal increase in the levels of lipids such as cholesterol and triglycerides in the blood. It not only leads to atherosclerosis, but also induces a variety of chronic diseases such as coronary heart disease, cerebral infarction, fatty liver, etc., seriously affecting the patient's quality of life and life expectancy. At present, the commonly used lipid-lowering drugs in clinical practice mainly include statins, fibrates, niacin, etc. Although these drugs have certain efficacy in lowering blood lipids, long-term use is often accompanied by a series of adverse reactions, such as liver damage, muscle pain, gastrointestinal discomfort, etc., and some patients have poor tolerance to drugs and find it difficult to adhere to long-term treatment. Many studies have shown that many medicinal and edible substances such as hawthorn, cassia seed, lotus leaf, red yeast rice, etc. have significant lipid-lowering effects, are widely available, and are highly safe, making them suitable for long-term use.

[0003] However, existing lipid-lowering products using edible and medicinal substances as raw materials are relatively simple in form, mostly in the form of decoctions, powders, tablets, etc., and have problems such as poor taste, poor stability of active ingredients, and low bioavailability. Soft capsules, as a new type of preparation, can better exert their lipid-lowering effects. However, there are currently few such edible and medicinal soft capsules with lipid-lowering functions on the market, and there is still much room for improvement in terms of formula optimization and preparation process. Therefore, the development of a edible and medicinal soft capsule with a scientific and reasonable formula, a simple preparation process, a significant lipid-lowering effect, and safety and non-toxicity is of great significance for meeting people's needs for preventing and improving hyperlipidemia. Summary of the Invention

[0004] In response to the deficiencies in the prior art, the present invention provides a soft capsule that is both medicinal and edible and has the function of lowering blood lipids, and a preparation method thereof. The contents of the soft capsule of the present invention use ingredients of both medicinal and edible origin, such as red yeast rice, freeze-dried natto powder, and hawthorn extract, to synergistically regulate blood lipids in multiple dimensions. The soft capsule shell is prepared from a capsule shell colloid, which is based on HPMC and pullulan, and incorporates HPMCP to achieve enteric protection. It is combined with antioxidants and nano-silica to construct a protective network, adapt to the release of the contents, and ensure efficient fusion of the contents and the capsule shell. Multiple ingredients act synergistically on blood lipid regulation, and the capsule shell assists in the stable release of the contents, improves blood lipid indicators, alleviates liver lipid deposition, and assists in thrombolysis, with both efficacy and stability.

[0005] The present invention provides a medicine-food soft capsule with the function of lowering blood lipids, wherein the medicine-food soft capsule with the function of lowering blood lipids is prepared from a soft capsule shell and soft capsule contents; The soft capsule comprises the following raw materials in parts by weight: 20-40 parts of red yeast rice, 20-35 parts of freeze-dried natto powder, 15-25 parts of hawthorn extract, 10-20 parts of cassia seed polysaccharide, 3-10 parts of tea polyphenols, and 3-8 parts of MCT oil (medium chain triglycerides); The soft capsule shell is prepared from a capsule shell glue solution, which includes the following raw materials in parts by weight: 40-60 parts of HPMC (hydroxypropyl methylcellulose), 25-45 parts of pullulan, 3-8 parts of HPMCP (hydroxypropyl methylcellulose phthalate), 10-25 parts of glycerin, and 0.5-3 parts of rosemary extract; The method for preparing the capsule shell glue comprises the following steps: (1) Disperse HPMCP in 50°C purified water at a ratio of 1 g HPMCP to purified water (10 mL). Stir until completely dissolved to form an enteric-coated solution. (2) HPMC and pullulan were mixed to form mixture A, and purified water at 60°C was slowly added. Glycerol and rosemary extract were added and stirred at high speed for 10 min to form a colloidal solution. (3) Slowly add the enteric colloid solution to the colloidal solution and stir magnetically at 40°C for 1 h to avoid bubble formation to form mixture B; (4) Take nano-silica and add purified water. The ratio of nano-silica to purified water is 3-5 g:50 mL. Ultrasonic dispersion is performed for 15 min to form a dispersion. The dispersion is slowly added to mixture B. The mixture is magnetically stirred at 40 °C for 30 min, and then vacuum degassed for 20 min. The mixture is then passed through a 100-mesh sieve to obtain a capsule shell glue.

[0006] Furthermore, the mass ratio of the dispersion to the mixture B is 1:20-30.

[0007] Furthermore, the red yeast rice is pretreated before use, and the specific pretreatment steps are as follows: i Take rice and soybean flour, the two are mixed in a mass ratio of 7:3, and purified water is added to adjust the water content to 40%-45%, sterilized, and cooled to obtain a sterilized matrix; ii. A 5% mass fraction of Monascus M12 seed solution was added to the sterilized matrix and allowed to ferment to form a fermentation product. On the third day of fermentation, 0.1% L-leucine was added to the fermentation product. The mixture was stirred once a day and fermentation was continued until the 12th day to obtain a fermented red yeast rice product. iii. The red yeast rice fermentation product was crushed, and a 70% ethanol solution containing 0.1% citric acid by mass was added at a ratio of 1 g: 10 mL. Ultrasonic extraction was performed, and the extraction was repeated twice. The extracts were combined, centrifuged, and the supernatant was collected; the supernatant was passed through an AB-8 resin column, and eluted with 3BV purified water and 5BV70% ethanol at a flow rate of 1.5 BV / h, and the ethanol eluate was collected. The ethanol eluate was concentrated under reduced pressure to form a red yeast rice concentrate, to which β-cyclodextrin was added, and the mass ratio of β-cyclodextrin to red yeast rice concentrate was 1:1. After dissolution, it was spray-dried to obtain the treated red yeast rice.

[0008] Furthermore, the natto freeze-dried powder is pretreated before use. The specific pretreatment process is as follows: take commercially available natto freeze-dried powder, add 1% trehalose and 0.5% glutathione according to mass fraction, place it in a three-dimensional mixer, and mix it for 20 minutes to form the pretreated natto freeze-dried powder.

[0009] The present invention also provides a method for preparing a edible and medicinal soft capsule having the function of lowering blood lipids, which specifically comprises the following steps: S1, red yeast rice, natto freeze-dried powder and hawthorn extract were sieved with an 80-mesh sieve, and cassia seed polysaccharide was sieved with a 100-mesh sieve. Then, red yeast rice, natto freeze-dried powder, hawthorn extract and cassia seed polysaccharide were dry-mixed for 15 minutes, and then tea polyphenols and MCT oil were added. The mixture was three-dimensionally mixed for 30 minutes until uniform, and then vacuum degassed to obtain the contents of the soft capsule; S2, the soft capsule contents and capsule shell glue liquid are loaded into the pill pressing machine respectively, and the pills are pressed at a glue box temperature of 50 ℃ and a filling pressure of 0.2 MPa. After initial shaping at 25 ℃ for 1 hour, they are dried at a temperature of 40 ℃ and a relative humidity of 20% for 3 hours, and then the moisture is balanced at 30 ℃. The capsule shell glue liquid is wrapped around the outside of the soft capsule contents to form a soft capsule shell, thereby obtaining a medicine-food soft capsule with lipid-lowering function.

[0010] Compared with the prior art, the present invention has the following beneficial effects: The food-drug soft capsule with the function of lowering blood lipids of the present invention is prepared from the content of the soft capsule and the soft capsule shell. The content of the soft capsule selects the food-drug ingredients that are scientifically compatible to form a synergistic system for regulating blood lipids in multiple dimensions. Red yeast rice is matched with natto freeze-dried powder to play a core blood lipid-lowering role by inhibiting the synthesis of endogenous cholesterol, and to assist in regulating blood lipid indicators from the perspective of improving blood status. Hawthorn extract promotes lipid decomposition, Cassia seed polysaccharide participates in the regulation of blood lipid metabolism, and tea polyphenols reduce lipid peroxidation through antioxidant effect, thereby achieving a comprehensive improvement of dyslipidemia. At the same time, homemade red yeast rice improves the biosynthesis efficiency of active ingredients by optimizing the fermentation matrix and fermentation conditions, and the subsequent extraction and purification process accurately retains the effective ingredients and reduces impurity interference; natto freeze-dried powder is treated with a composite protective agent and packed with nitrogen, which effectively maintains the stability of the active ingredients, ensuring that it is not easily inactivated during storage, providing a guarantee for the continued performance of the efficacy. The shell gel provides a protective structure that adapts to the soft capsule's contents. The colloidal network formed by HPMC and pullulan imparts excellent film-forming properties and flexibility to the shell. Glycerol, as a plasticizer, further balances the shell's physical properties, preventing embrittlement or sticking during storage and use. The introduction of HPMCP imparts enteric solubility to the shell, protecting it from the damaging effects of gastric fluid on the contents, ensuring intestinal release of the active ingredients and enhancing bioavailability. The addition of antioxidants and nano-silica creates a dual protective system. The antioxidant inhibits oxidation reactions within the shell and its contents. The nano-silica optimizes the shell structure, reducing oxygen transmission rate and the impact of the external environment on the active ingredients. This, in conjunction with the antioxidant components of the contents, maintains the overall stability of the soft capsule. The acidic components of the soft capsule contents gently modulate the shell's microenvironment, aiding the dissolution of HPMCP under intestinal conditions and ensuring precise release of the contents. The polysaccharides in the soft capsule contents form hydrogen bonds with the HPMC in the shell, enhancing the shell's stability and minimizing delamination or leakage. On the contrary, the capsule shell protects the efficacy of the contents through its structural characteristics. Its good barrier properties reduce the impact of moisture, oxygen, etc. on the contents, preventing the effective ingredients from deliquescing or oxidizing; the enteric properties provide protection for ingredients that are sensitive to gastric acid, solving the problem of some active ingredients being easily inactivated in the stomach, and improving the utilization efficiency of the effective ingredients. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 This is a graph showing the in vitro thrombolytic performance of the edible and medicinal soft capsules with the lipid-lowering function prepared by the present invention; Figure 2 This is the Oil Red O staining of mouse liver according to the present invention. DETAILED DESCRIPTION

[0012] In order to enable those skilled in the art to better understand the technical solution of the present invention and to make the above-mentioned features, purposes and advantages of the present invention more clearly understood, the present invention is further described below in conjunction with examples. The examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention.

[0013] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those familiar to those skilled in the art. Furthermore, any methods and materials similar or equivalent to those described herein can be applied to the present invention. The preferred embodiments and materials described herein are for illustrative purposes only and are not intended to limit the scope of this application.

[0014] In the following examples, unless otherwise specified, conventional methods are used; the materials used in the following examples, unless otherwise specified, are all new materials purchased from the market.

[0015] Example 1: This example provides a food-drug soft capsule with a lipid-lowering function, wherein the food-drug soft capsule with a lipid-lowering function is prepared from a soft capsule shell and soft capsule contents; The soft capsules contain the following raw materials in parts by weight: 20 parts of red yeast rice, 20 parts of freeze-dried natto powder, 15 parts of hawthorn extract, 10 parts of cassia seed polysaccharide, 3 parts of tea polyphenols, and 3 parts of MCT oil; The soft capsule shell is prepared from a capsule shell glue solution, which includes the following raw materials in parts by weight: 40 parts of HPMC, 25 parts of pullulan, 3 parts of HPMCP, 10 parts of glycerol, and 0.5 parts of rosemary extract; The method for preparing the capsule shell glue comprises the following steps: (1) Disperse HPMCP in 50°C purified water at a ratio of 1 g HPMCP to purified water (10 mL). Stir until completely dissolved to form an enteric-coated solution. (2) HPMC and pullulan were mixed to form mixture A, and purified water at 60°C was slowly added. The mixture was stirred at a high shear speed of 2000 rpm for 30 min, and glycerol and rosemary extract were added. The mixture was stirred for 10 min to form a colloidal solution. (3) Slowly add the enteric colloid solution to the colloidal solution and stir magnetically at 40°C for 1 h to avoid bubble formation to form mixture B; (4) Take nano-silica and add purified water. The ratio of nano-silica to purified water is 3 g:50 mL. Ultrasonic dispersion is performed for 15 min to form a dispersion. The dispersion is slowly added to mixture B. The mass ratio of the dispersion to mixture B is 1:20. The mixture is magnetically stirred at 40 °C for 30 min, then vacuum degassed for 20 min, and then passed through a 100-mesh sieve to obtain a capsule shell glue.

[0016] The red yeast rice is pretreated before use, and the specific pretreatment steps are: i. Rice and soybean flour were mixed in a mass ratio of 7:3, and the water content was adjusted to 40% with purified water. The mixture was sterilized at 120°C for 30 min and cooled to 28°C to obtain a sterilized matrix. ii. A 5% mass fraction of Monascus M12 seed solution was added to the sterilized matrix and allowed to ferment at 25°C and a relative humidity of 80% to form a fermentation product. On the third day of fermentation, 0.1% L-leucine was added thereto, the mixture was stirred once a day, and fermentation was continued until the 12th day to obtain a Monascus fermentation product. iii. The red yeast rice fermentation product was crushed, and a 70% ethanol solution containing 0.1% citric acid by mass was added at a ratio of 1 g:10 mL. Ultrasonic extraction was performed at 200 W and 50°C for 30 min. The extraction was repeated twice, the extracts were combined, centrifuged at 4000 rpm for 15 min, and the supernatant was collected; the supernatant was passed through an AB-8 resin column with a diameter-to-height ratio of 1:8, and eluted with 3BV purified water and 5BV70% ethanol at a flow rate of 1.5 BV / h, and the eluate was collected. The eluate was concentrated under reduced pressure at -0.08 MPa and 50°C to a solid content of ≥50% to obtain a red yeast rice concentrate. β-cyclodextrin was added at a mass ratio of 1:1 between the red yeast rice concentrate and β-cyclodextrin. After dissolution, the mixture was spray-dried at 170°C inlet air and 75°C outlet air to obtain the treated red yeast rice.

[0017] The natto freeze-dried powder was pretreated before use. The specific pretreatment process was as follows: commercially available natto freeze-dried powder was taken, 1% trehalose and 0.5% glutathione were added according to the mass fraction, placed in a three-dimensional mixer, and mixed at a speed of 25 rpm for 20 minutes to form the pretreated natto freeze-dried powder.

[0018] This embodiment also provides a method for preparing a medicinal and edible soft capsule having the function of lowering blood lipids, which specifically comprises the following steps: S1: Red yeast rice, natto freeze-dried powder, and hawthorn extract were sieved with an 80-mesh sieve, and cassia seed polysaccharide was sieved with a 100-mesh sieve. Red yeast rice, natto freeze-dried powder, hawthorn extract, and cassia seed polysaccharide were then dry-mixed for 15 minutes. Tea polyphenols and MCT oil were then added and three-dimensionally mixed for 30 minutes until uniform. The mixture was then vacuum-degassed for 10 minutes at -0.05 MPa and 25°C to obtain the contents of the soft capsule. S2, the soft capsule contents and capsule shell glue liquid are loaded into the pill pressing machine respectively, and the pills are pressed at a glue box temperature of 50 ℃ and a filling pressure of 0.2 MPa. After initial shaping at 25 ℃ for 1 hour, they are dried at a temperature of 40 ℃ and a relative humidity of 20% for 3 hours, and then the moisture is balanced at 30 ℃. The capsule shell glue liquid is wrapped around the outside of the soft capsule contents to form a soft capsule shell, thereby obtaining a medicine-food soft capsule with lipid-lowering function.

[0019] Example 2: This example provides a food-drug soft capsule with a lipid-lowering function, wherein the food-drug soft capsule with a lipid-lowering function is prepared from a soft capsule shell and soft capsule contents; The soft capsules contain the following raw materials in parts by weight: 30 parts of red yeast rice, 25 parts of freeze-dried natto powder, 20 parts of hawthorn extract, 15 parts of cassia seed polysaccharide, 5 parts of tea polyphenols, and 5 parts of MCT oil; The soft capsule shell is prepared from a capsule shell glue solution, which includes the following raw materials in parts by weight: 50 parts of HPMC, 35 parts of pullulan, 5 parts of HPMCP, 15 parts of glycerin, and 2 parts of rosemary extract; The method for preparing the capsule shell glue comprises the following steps: (1) Disperse HPMCP in 50°C purified water at a ratio of 1 g HPMCP to purified water (10 mL). Stir until completely dissolved to form an enteric-coated solution. (2) HPMC and pullulan were mixed to form mixture A, and purified water at 60°C was slowly added. The mixture was stirred at a high shear speed of 2000 rpm for 30 min, and glycerol and rosemary extract were added. The mixture was stirred for 10 min to form a colloidal solution. (3) Slowly add the enteric colloid solution to the colloidal solution and stir magnetically at 40°C for 1 h to avoid bubble formation to form mixture B; (4) Take nano-silica and add purified water. The ratio of nano-silica to purified water is 4 g:50 mL. Ultrasonic dispersion is performed for 15 min to form a dispersion. The dispersion is slowly added to mixture B. The mass ratio of the dispersion to mixture B is 1:25. The mixture is magnetically stirred at 40 °C for 30 min, then vacuum degassed for 20 min, and then passed through a 100-mesh sieve to obtain a capsule shell glue.

[0020] The red yeast rice is pretreated before use, and the specific pretreatment steps are: i. Rice and soybean flour were mixed in a mass ratio of 7:3, and purified water was added to adjust the moisture content to 45%. The mixture was sterilized at 121°C for 30 min and cooled to 28°C to obtain a sterilized matrix. ii. A 5% mass fraction of Monascus M12 seed solution was inoculated into the sterilized matrix and allowed to ferment at 28°C and a relative humidity of 85% to form a fermentation product. On the third day of fermentation, 0.1% L-leucine was added thereto. The mixture was stirred once daily and fermentation was continued until the 12th day to obtain a Monascus fermentation product. iii. The red yeast rice fermentation product was crushed, and a 70% ethanol solution containing 0.1% citric acid by mass was added at a ratio of 1 g:10 mL. Ultrasonic extraction was performed at 200 W and 50 ° C for 30 min. The extraction was repeated twice, the extracts were combined, centrifuged at 4000 rpm for 15 min, and the supernatant was collected; the supernatant was passed through an AB-8 resin column with a diameter-to-height ratio of 1:8 and a flow rate of 2BV / h, and eluted with 3BV purified water and 5BV70% ethanol at a flow rate of 1.5 BV / h, and the ethanol eluate was collected. The ethanol eluate was concentrated under reduced pressure at -0.08 MPa and 50 ° C to a solid content of ≥50% to form a red yeast rice concentrate. β-cyclodextrin was added at a mass ratio of 1:1 between the red yeast rice concentrate and β-cyclodextrin. After dissolution, the mixture was spray-dried at 170 ° C inlet and 75 ° C outlet to obtain the treated red yeast rice.

[0021] The natto freeze-dried powder was pretreated before use. The specific pretreatment process was as follows: commercially available natto freeze-dried powder was taken, 1% trehalose and 0.5% glutathione were added according to the mass fraction, placed in a three-dimensional mixer, and mixed at a speed of 25 rpm for 20 minutes to form the pretreated natto freeze-dried powder.

[0022] This embodiment also provides a method for preparing a medicinal and edible soft capsule having the function of lowering blood lipids, which specifically comprises the following steps: S1: Red yeast rice, natto freeze-dried powder, and hawthorn extract were sieved with an 80-mesh sieve, and cassia seed polysaccharide was sieved with a 100-mesh sieve. Red yeast rice, natto freeze-dried powder, hawthorn extract, and cassia seed polysaccharide were then dry-mixed for 15 minutes. Tea polyphenols and MCT oil were then added and three-dimensionally mixed for 30 minutes until uniform. The mixture was then vacuum-degassed for 10 minutes at -0.08 MPa and 25°C to obtain the contents of the soft capsule. S2, the soft capsule contents and capsule shell glue liquid are loaded into the pill pressing machine respectively, and the pills are pressed at a glue box temperature of 50 ℃ and a filling pressure of 0.2 MPa. After initial shaping at 25 ℃ for 1 hour, they are dried at a temperature of 40 ℃ and a relative humidity of 20% for 3 hours, and then the moisture is balanced at 30 ℃. The capsule shell glue liquid is wrapped around the outside of the soft capsule contents to form a soft capsule shell, thereby obtaining a medicine-food soft capsule with lipid-lowering function.

[0023] Example 3: This example provides a food-drug soft capsule with a lipid-lowering function, wherein the food-drug soft capsule with a lipid-lowering function is prepared from a soft capsule shell and soft capsule contents; The soft capsules contain the following raw materials in parts by weight: 40 parts of red yeast rice, 35 parts of freeze-dried natto powder, 25 parts of hawthorn extract, 20 parts of cassia seed polysaccharide, 10 parts of tea polyphenols, and 8 parts of MCT oil; The soft capsule shell is prepared from a capsule shell glue solution, which includes the following raw materials in parts by weight: 60 parts of HPMC, 45 parts of pullulan, 8 parts of HPMCP, 25 parts of glycerin, and 3 parts of rosemary extract; The method for preparing the capsule shell glue comprises the following steps: (1) Disperse HPMCP in 50°C purified water at a ratio of 1 g HPMCP to purified water (10 mL). Stir until completely dissolved to form an enteric-coated solution. (2) HPMC and pullulan were mixed to form mixture A, and purified water at 60°C was slowly added. The mixture was stirred at a high shear speed of 2000 rpm for 30 min, and glycerol and rosemary extract were added. The mixture was stirred for 10 min to form a colloidal solution. (3) Slowly add the enteric colloid solution to the colloidal solution and stir magnetically at 40°C for 1 h to avoid bubble formation to form mixture B; (4) Take nano-silica and add purified water. The ratio of nano-silica to purified water is 5 g:50 mL. Ultrasonic dispersion is performed for 15 min to form a dispersion. The dispersion is slowly added to mixture B. The mass ratio of the dispersion to mixture B is 1:30. The mixture is magnetically stirred at 40 °C for 30 min, then vacuum degassed for 20 min, and then passed through a 100-mesh sieve to obtain a capsule shell glue.

[0024] The red yeast rice is pretreated before use, and the specific pretreatment steps are: i. Rice and soybean flour were mixed in a mass ratio of 7:3, and the water content was adjusted to 45% with purified water. The mixture was sterilized at 130°C for 30 min and cooled to 30°C to obtain a sterilized matrix. ii. A 5% mass fraction of Monascus M12 seed solution was inoculated into the sterilized matrix and allowed to ferment at 28°C and a relative humidity of 85% to form a fermentation product. On the third day of fermentation, 0.1% L-leucine was added thereto. The mixture was stirred once daily and fermentation was continued until the 12th day to obtain a Monascus fermentation product. iii. The red yeast rice fermentation product was crushed, and a 70% ethanol solution containing 0.1% citric acid by mass was added at a ratio of 1 g:10 mL. Ultrasonic extraction was performed at 200 W and 50 ° C for 30 min. The extraction was repeated twice, the extracts were combined, centrifuged at 4000 rpm for 15 min, and the supernatant was collected; the supernatant was passed through an AB-8 resin column with a diameter-to-height ratio of 1:8 and a flow rate of 2BV / h, and eluted with 3BV purified water and 5BV70% ethanol at a flow rate of 1.5 BV / h, and the ethanol eluate was collected. The ethanol eluate was concentrated under reduced pressure at -0.08 MPa and 50 ° C to a solid content of ≥50% to form a red yeast rice concentrate. β-cyclodextrin was added at a mass ratio of 1:1 between the red yeast rice concentrate and β-cyclodextrin. After dissolution, the mixture was spray-dried at 170 ° C inlet and 75 ° C outlet to obtain the treated red yeast rice.

[0025] The processing process of the natto freeze-dried powder is as follows: commercially available natto freeze-dried powder is taken, 1% trehalose and 0.5% glutathione are added according to the mass fraction, placed in a three-dimensional mixer, and mixed at a speed of 25 rpm for 20 minutes to form pretreated natto freeze-dried powder.

[0026] This embodiment also provides a method for preparing a medicinal and edible soft capsule having the function of lowering blood lipids, which specifically comprises the following steps: S1: Red yeast rice, natto freeze-dried powder, and hawthorn extract were sieved with an 80-mesh sieve, and cassia seed polysaccharide was sieved with a 100-mesh sieve. Red yeast rice, natto freeze-dried powder, hawthorn extract, and cassia seed polysaccharide were then dry-mixed for 15 minutes. Tea polyphenols and MCT oil were then added and three-dimensionally mixed for 30 minutes until uniform. The mixture was then vacuum-degassed for 10 minutes at -0.1 MPa and 25°C to obtain the contents of the soft capsule. S2, the soft capsule contents and capsule shell glue liquid are loaded into the pill pressing machine respectively, and the pills are pressed at a glue box temperature of 50 ℃ and a filling pressure of 0.2 MPa. After initial shaping at 25 ℃ for 1 hour, they are dried at a temperature of 40 ℃ and a relative humidity of 20% for 3 hours, and then the moisture is balanced at 30 ℃. The capsule shell glue liquid is wrapped around the outside of the soft capsule contents to form a soft capsule shell, thereby obtaining a medicine-food soft capsule with lipid-lowering function.

[0027] The difference between Comparative Example 1 and Example 2 is that no freeze-dried natto powder is added, and the rest is exactly the same as Example 2.

[0028] The difference between Comparative Example 2 and Example 1 is that a traditional alum capsule shell is used, and the rest of the parts are exactly the same as Example 2.

[0029] Experimental example: Lipid-lowering performance test: Male mice were purchased and housed at 24°C and 50% relative humidity under specific pathogen-free conditions. All mice were fed a standard laboratory diet with free access to water and acclimated for one week. Ten mice were assigned to a standard diet and 50 mice to a high-fat diet (78.8% basal feed, 1% cholesterol, 10% lard, 10% egg yolk powder, 0.2% bile salt) for four weeks. Six groups (n=10) of mice on the high-fat diet were then randomly assigned to be fed the lipid-lowering soft capsules prepared in Examples 1-3 and Comparative Examples 1-2 of the present invention. The remaining group was fed a high-fat diet as a high-fat model group. Ten mice on a standard diet were fed a standard diet as a control group. The test was conducted by gavage.

[0030] Oral gavage was performed every morning for four consecutive weeks. During the experiment, the mice were weighed weekly. The mice were divided into the following groups: control group, Example 1-3 groups, and Comparative Example 1-2 groups. Serum parameters were measured using HDL-C, LDL-C, TC, and TG kits. Liver enzyme activity was measured using CAT and T-SOD kits, and liver tissue protein concentration was measured using a BCA kit. The results are reported in Table 1.

[0031] Table 1

[0032] Note: a indicates a significant difference compared with the control group (P<0.05), b indicates a significant difference compared with the high-fat model group (P<0.05) As shown in the results in Table 1, the edible and medicinal soft capsules with the lipid-lowering function prepared in Examples 1-3 of the present invention can significantly reduce the contents of TC, TG and LDL-C, indicating that the edible and medicinal soft capsules with the lipid-lowering function prepared in the present invention can reduce the risk of cholesterol deposition in blood vessels, reduce blood triglycerides, and reduce the risk of fat accumulation; and can well improve the HDL-C content, indicating that the increase in good cholesterol is beneficial to the transport of cholesterol and the optimization of blood lipids; the soft capsule shell prepared in the present invention assists the stable release of the soft capsule contents, and by optimizing the release environment, allows the soft capsule contents to better play the role of lowering blood lipids, effectively regulate blood lipids, and improve hyperlipidemia.

[0033] Figure 1 The in vitro thrombolysis performance test was conducted using an in vitro thrombolysis method. The results showed that when the soft capsules prepared by the present invention were used and had the function of lowering blood lipids, the blood clots had a high dissolution efficiency, while when no natto freeze-dried powder was added, the blood clots were basically not dissolved, indicating that the addition of natto freeze-dried powder can effectively assist in lowering blood clots. Figure 2The results showed that the lipid droplet area of ​​the liver tissue cells of mice in the high-fat model group was large and widely distributed, indicating that the high-fat diet caused a large amount of lipid deposition in the liver and severe fat accumulation; compared with comparative examples 1-2, the lipid droplet area of ​​Example 2 group was significantly smaller and lipid deposition was reduced, indicating that the medicinal and edible soft capsules with lipid-lowering function prepared by the present invention have a good improvement effect on liver fat accumulation.

[0034] In summary, the medicinal and edible soft capsules of the present invention with the function of lowering blood lipids, in terms of raw material formula, select scientific formulations of medicinal and edible ingredients, and coordinate multiple ingredients such as red yeast rice and natto freeze-dried powder to construct a multi-dimensional blood lipid regulation system, which improves dyslipidemia from multiple pathways such as inhibiting cholesterol synthesis and promoting lipid decomposition; in terms of raw material processing technology, homemade red yeast rice is used to optimize the fermentation and extraction process, and natto freeze-dried powder is protected to enhance the stability and efficacy of the active ingredients; the capsule shell glue is given enteric and protective properties through reasonable raw material matching and preparation technology, which adapts to the contents and improves bioavailability; the contents and the capsule shell work in a two-way manner to ensure stable efficacy; the overall preparation process achieves efficient fusion of the contents and the capsule shell. Experimental verification shows that the soft capsule can effectively regulate blood lipid indicators, improve liver fat accumulation, and assist in thrombolysis, and has both blood lipid-lowering efficacy and product stability and safety, providing an innovative solution for the development of medicinal and edible lipid-lowering products with broad application prospects.

[0035] The present invention and its embodiments are described above. Such description is not restrictive. The drawings show only one embodiment of the present invention, and actual applications are not limited thereto. In short, if a person skilled in the art is inspired by the above, and does not deviate from the purpose of the present invention, any method and embodiment similar to the technical solution without creative design shall fall within the scope of protection of the present invention.

Claims

1. A food-drug soft capsule with blood lipid lowering function, characterized in that: It consists of a soft capsule shell and soft capsule contents; The soft capsule comprises the following raw materials in parts by weight: 20-40 parts of red yeast rice, 20-35 parts of freeze-dried natto powder, 15-25 parts of hawthorn extract, 10-20 parts of cassia seed polysaccharide, 3-10 parts of tea polyphenols, and 3-8 parts of MCT oil; The soft capsule shell is prepared from a capsule shell glue solution, which comprises the following raw materials in parts by weight: 40-60 parts of HPMC, 25-45 parts of pullulan, 3-8 parts of HPMCP, 10-25 parts of glycerin, and 0.5-3 parts of rosemary extract; The method for preparing the capsule shell glue comprises the following steps: (1) Disperse HPMCP in purified water and stir until dissolved to form an enteric-coated solution; (2) HPMC and pullulan are mixed to form mixture A, purified water is added, high-speed shear stirring is performed, glycerin and rosemary extract are added, and stirring is continued to form a colloidal solution; (3) Slowly add the enteric colloid solution into the colloidal solution and stir magnetically to form a mixture B; (4) Take nano-silica, add purified water, and ultrasonically disperse to form a dispersion liquid, add the dispersion liquid to mixture B, stir magnetically, and then vacuum degas and sieve to obtain a capsule shell glue liquid.

2. The edible and medicinal soft capsule with the function of lowering blood lipids according to claim 1, characterized in that: In step (1), the ratio of the HPMCP to purified water is 1 g:10 mL; in step (2), the ratio of the mixture A to purified water is 1 g:5 mL.

3. The edible and medicinal soft capsule with blood lipid lowering function according to claim 1, characterized in that: In step (4), the ratio of the nano-silica to purified water is 3-5 g:50 mL, and the mass ratio of the dispersion to mixture B is 1:20-30.

4. The edible and medicinal soft capsule with blood lipid lowering function according to claim 1, characterized in that: The red yeast rice is pretreated before use, and the specific pretreatment steps are: i Take rice and soy flour, mix the two, add purified water to a water content of 40%-45%, sterilize, and cool to obtain a sterilized matrix; ii. Take Monascus M12 seed solution, access to the sterilized matrix, allowed to ferment to form a fermentation product, to which L-leucine was added during fermentation, and fermentation was continued to obtain a fermented red yeast rice; iii. The red yeast rice fermentation product is crushed, an ethanol solution containing citric acid is added, ultrasonic extraction is performed, the extraction is repeated, the extracts are combined, centrifuged, the supernatant is collected, the supernatant is eluted, the eluate is collected, the eluate is concentrated under reduced pressure, and then β-cyclodextrin is added thereto, dissolved and then spray-dried to obtain the treated red yeast rice.

5. The edible and medicinal soft capsule with the function of lowering blood lipids according to claim 4, characterized in that: In step i, the mass ratio of the rice to the soybean powder is 7:3; in step iii, the amount ratio of the red yeast rice fermentation product to the ethanol solution is 1 g:10 mL.

6. The edible and medicinal soft capsule with blood lipid lowering function according to claim 1, characterized in that: The natto freeze-dried powder is pretreated before use. The specific pretreatment process is: taking commercial natto freeze-dried powder, adding trehalose and glutathione according to the mass fraction, and mixing to form the pretreated natto freeze-dried powder.

7. A method for preparing the edible and medicinal soft capsules having the function of lowering blood lipids according to any one of claims 1 to 6, characterized in that: The specific steps include: S1, sieving red yeast rice, natto freeze-dried powder, hawthorn extract, and cassia seed polysaccharide separately, then dry-mixing the red yeast rice, natto freeze-dried powder, hawthorn extract, and cassia seed polysaccharide, adding tea polyphenols and MCT oil, mixing, and then vacuum degassing to obtain the contents of the soft capsule; S2, forming the soft capsule contents and the capsule shell glue into pellets, setting the shape, and drying, and wrapping the capsule shell glue on the outside of the soft capsule contents to form a soft capsule shell, thereby obtaining a medicine-food soft capsule with the function of lowering blood lipids.

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