Starch-based capsules and methods of making the same

Abstract

This invention relates to a starch-based capsule and its preparation method, belonging to the field of starch-based capsule processing technology. The starch-based capsule is prepared by using a soluble support framework to support a starch film-forming material. The soluble support framework is fabricated by 3D printing and includes a capsule cap frame and a capsule body frame. After assembly, the capsule cap frame and capsule body frame form a closed storage space for storing dry powder. Using a 3D-printed soluble support framework provides stable support for the capsule, effectively avoiding the problems of deformation, powder leakage, and premature disintegration of traditional starch capsules, improving the storage stability and transportation safety of the capsule, and extending the product's shelf life. The film-forming quality is excellent and the film has good toughness: modified starch combined with cellulose, glycerin, and other additives, and then plasticized with sorbitol, gives the starch film good flexibility and mechanical strength, making it less prone to cracking. At the same time, the dense film layer effectively isolates external moisture and oxygen, protecting the contents from deliquescence and oxidation.

Description

Technical Field

[0001] This invention belongs to the field of starch-based capsule processing technology, specifically relating to a starch-based capsule and its preparation method. Background Technology

[0002] Starch-based capsules are made from plant-based raw materials such as pharmaceutical-grade hydroxypropyl methylcellulose (HPMC) and tapioca starch through physical extraction. They are characterized by the absence of preservatives, wide range of storage conditions, and stable capsule shells under varying temperature and humidity conditions. Furthermore, the production process leaves no paraben-like preservative residues, providing an alternative for vegetarians.

[0003] However, traditional starch-based capsules lack an independent support system and rely solely on the film-forming properties of starch to maintain their structure. The capsule shell has low strength and poor toughness, making it prone to deformation and cracking during storage and transportation. In particular, when storing dry powder contents, powder leakage is likely to occur. Furthermore, the capsule shell has poor water and acid resistance, making it prone to deliquescence in humid environments and rapid swelling and disintegration in acidic gastric environments, thus failing to stably protect the contents. Summary of the Invention

[0004] The purpose of this invention is to provide a starch-based capsule and its preparation method in order to solve the above-mentioned problems.

[0005] The present invention achieves the above objectives through the following technical solutions:

[0006] This invention provides a starch-based capsule, which is prepared by a soluble support framework supporting a starch film-forming material. The soluble support framework is fabricated by 3D printing and includes a capsule cap frame and a capsule body frame. After the capsule cap frame and capsule body frame are assembled, a closed storage space is formed inside for storing dry powder.

[0007] The raw materials for preparing the soluble support framework, by weight, include: 35-45 parts HPMCE5, 2-4 parts titanium dioxide, 3-5 parts polyethylene glycol, 50-65 parts purified water, 0.5-1 parts magnesium stearate, and 0.1 parts sodium benzoate; the raw materials for preparing the starch film-forming material include: 40-55 parts modified sweet potato starch, 8-16 parts cellulose powder, 0.1-0.5 parts urea, 1-3 parts glycerol, 1-3 parts papain, 2-4 parts malic acid, and 80-100 parts deionized water.

[0008] As a further optimization of the present invention, the preparation process of the soluble support skeleton is as follows: (i) HPMCE5 and titanium dioxide are added to purified water, stirred evenly and then left to stand for 1-3 hours to obtain a pre-mixed solution;

[0009] (ii) Add polyethylene glycol, magnesium stearate and sodium benzoate to the pre-mixed liquid in sequence, heat to 40°C, stir at 1000-1200r / min for 1-2h, degas under vacuum for 20-45min, and let stand at 25°C for 12-16h to obtain printing paste.

[0010] (iii) Add the printing paste to the 3D printer, the printing extrusion speed is 2-5mm / s, the nozzle moving speed is 2-5mm / s, the nozzle diameter is 0.2-0.4mm, and print the cap frame and the body frame in sequence. After printing, dry it to a moisture content of 5-8%, assemble the cap frame and the body frame to obtain a soluble support skeleton.

[0011] As a further optimization of the present invention, the preparation process of the starch film-forming material is as follows: Modified sweet potato starch is added to deionized water and stirred to form a uniform starch solution. The solution is heated in a water bath to 45-55°C, papain is added, and the mixture is stirred at a constant temperature for 30-60 minutes to enzymatically hydrolyze the starch. The temperature is maintained at 45-55°C, and urea, glycerol, and malic acid are added sequentially and stirred at 120 r / min for 15-20 minutes. After stirring, cellulose powder is added and stirred at 120 r / min for 15-20 minutes. The temperature is raised to 75-85°C and stirred at a constant temperature for 30-45 minutes to obtain the starch film-forming material.

[0012] As a further optimization of the present invention, the modified sweet potato starch is obtained by fermentation and oxidation of sweet potato starch;

[0013] The specific steps of the fermentation process are as follows: (i) Sweet potato starch is mixed with deionized water and heated to 30-37°C. Lactobacillus acidophilus powder and yeast powder are added and stirred at 30-50 r / min for 6-8 hours. After stirring, Bifidobacterium longum powder is added, and the mixture is mixed evenly and allowed to stand for 12-16 hours. The supernatant is poured off, and the mixture is washed 2-3 times with clean water. After settling, the water is skimmed off and the mixture is dehydrated using a cloth bag to obtain wet starch.

[0014] The specific steps of the oxidation treatment are as follows: (i) Mixing deionized water with wet starch and mixing well to obtain starch milk;

[0015] (ii) Adjust the pH of the starch milk to 9.0-11.0 using sodium hydroxide. Add sodium hypochlorite dropwise to the starch milk at 25-40℃ and stir at 350 r / min for 1-2 h. After stirring, add 5-10% dilute hydrochloric acid to adjust the pH to 6.5-7.0. Add tea polyphenols, anthocyanins and curcumin, and stir at 120 r / min for 15-25 min to obtain modified sweet potato starch milk.

[0016] (iii) The modified sweet potato starch milk was washed with deionized water until neutral, dried at 40-50℃ and pulverized to obtain modified sweet potato starch.

[0017] As a further optimization of the present invention, the mass ratio of sweet potato starch, deionized water, Lactobacillus acidophilus powder, yeast powder and Bifidobacterium longum powder in the fermentation process is 0.5:1.2:0.05:0.04:0.08.

[0018] As a further optimization of the present invention, the mass ratio of deionized water to wet starch in the oxidation treatment is 1:0.4; the mass ratio of starch milk, sodium hypochlorite, tea polyphenols, anthocyanins and curcumin is 1:0.05:0.02:0.01:0.03.

[0019] This invention also provides a method for preparing starch-based capsules, comprising the following steps:

[0020] S1. Immerse the soluble support skeleton in the starch film-forming material. After 2-3 minutes, vertically lift the soluble support skeleton at a constant speed of 1-2 mm / s and hang it vertically for 30-60 seconds. Then transfer it to an environment of 30-35℃ and vacuum degree -0.06MPa to dry for 2-4 hours to obtain the pre-made shell film.

[0021] S2, immerse the pre-made shell membrane in a 10% sorbitol aqueous solution for 3-5 seconds, remove it and use filter paper to absorb excess liquid on the surface, and dry it in an environment of 35-40℃ and vacuum degree -0.05MPa for 4-6 hours to obtain starch-based capsules.

[0022] The beneficial effects of this invention are as follows: This invention uses a 3D-printed soluble support skeleton to provide stable support for the capsule, effectively avoiding the problems of easy deformation, powder leakage, and premature disintegration of traditional starch capsules, improving the storage stability and transportation safety of the capsule, and extending the product's shelf life; it produces a high-quality, resilient film: modified starch combined with cellulose, glycerin, and other additives, and then plasticized with sorbitol, gives the starch film good flexibility and mechanical strength, making it less prone to brittleness. At the same time, the dense film layer effectively isolates external moisture and oxygen, protecting the contents from deliquescence and oxidation; it is suitable for various dry powder contents (such as vitamins, probiotics, and traditional Chinese medicine powders), especially suitable for functional ingredients that are sensitive to gastric acid and require colon-targeted release, solving the problem of limited application scenarios for traditional starch capsules. Detailed Implementation

[0023] The present application will now be described in further detail. It should be noted that the following specific embodiments are only used to further illustrate the present application and should not be construed as limiting the scope of protection of the present application. Those skilled in the art can make some non-essential improvements and adjustments to the present application based on the above application content.

[0024] Unless otherwise specified, all methods used in this invention are conventional methods known to those skilled in the art, and all reagents and materials used are commercially available products.

[0025] Example 1: Modified sweet potato starch was obtained from sweet potato starch through fermentation and oxidation.

[0026] The specific steps of the fermentation process are as follows: sweet potato starch is mixed with deionized water and heated to 30°C. Lactobacillus acidophilus powder and yeast powder are added and stirred at 30 r / min for 6 hours. After stirring, Bifidobacterium longum powder is added, mixed evenly, and allowed to stand for 12 hours. The supernatant is discarded, washed twice with clean water, allowed to settle, and then the water is skimmed off. The mixture is dehydrated using a cloth bag to obtain wet starch (the mass ratio of sweet potato starch, deionized water, Lactobacillus acidophilus powder, yeast powder, and Bifidobacterium longum powder is 0.5:1.2:0.05:0.04:0.08).

[0027] The specific steps of the oxidation treatment are as follows: (i) Mix deionized water and wet starch, and the resulting starch milk is obtained by mixing well (the mass ratio of deionized water to wet starch is 1:0.4).

[0028] (ii) The pH of the starch milk was adjusted to 9.0 using sodium hydroxide. Sodium hypochlorite was added dropwise to the starch milk at 25°C and stirred at 350 r / min for 1 h. After stirring, 5% dilute hydrochloric acid was added to adjust the pH to 6.5. Tea polyphenols, anthocyanins and curcumin were added and stirred at 120 r / min for 15 min to obtain modified sweet potato starch milk (the mass ratio of starch milk, sodium hypochlorite, tea polyphenols, anthocyanins and curcumin was 1:0.05:0.02:0.01:0.03).

[0029] (iii) The modified sweet potato starch milk was washed with deionized water until neutral, dried at 40°C and pulverized to obtain modified sweet potato starch;

[0030] The preparation process of starch film-forming material is as follows: 40 parts of modified sweet potato starch are added to 80 parts of deionized water and stirred to form a uniform starch solution. The solution is heated to 45°C in a water bath, 1 part of papain is added, and the mixture is stirred at a constant temperature for 30 min to enzymatically hydrolyze the starch. The temperature is maintained at 45°C. 0.1 parts of urea, 1 part of glycerol and 2 parts of malic acid are added sequentially and stirred at 120 r / min for 15 min. After stirring, 8 parts of cellulose powder are added and stirred at 120 r / min for 15 min. The temperature is raised to 75°C and stirred at a constant temperature for 30 min to obtain the starch film-forming material.

[0031] The preparation process of the soluble support framework is as follows: (i) 35 parts HPMCE5 and 2 parts titanium dioxide are added to 50 parts purified water, stirred evenly and left to stand for 1 hour to obtain a pre-mixed solution.

[0032] (ii) Add 3 parts polyethylene glycol, 0.5 parts magnesium stearate and 0.1 parts sodium benzoate to the pre-mixed liquid in sequence, heat to 40°C, stir at 1000 r / min for 1 h, degas under vacuum for 20 min, and let stand at 25°C for 12 h to obtain printing paste.

[0033] (iii) Add the printing paste to the 3D printer, the printing extrusion speed is 2mm / s, the nozzle moving speed is 2mm / s, the nozzle diameter is 0.2mm, print the cap frame and the body frame in sequence, after printing, dry it to a moisture content of 5%, assemble the cap frame and the body frame to obtain a soluble support skeleton.

[0034] The soluble support framework includes a cap frame and a body frame. After assembly, the cap frame and body frame form a closed storage space inside for storing dry powder. The soluble support framework is immersed in starch film-forming material. After 2 minutes, the soluble support framework is vertically lifted out at a constant speed of 1 mm / s, suspended vertically for 30 seconds, and then transferred to an environment of 30°C and vacuum degree of -0.06 MPa to dry for 2 hours to obtain a pre-made shell film.

[0035] The pre-made shell membrane was immersed in a 10% sorbitol aqueous solution for 3 seconds, and after being removed, excess liquid on the surface was absorbed with filter paper. It was then dried in an environment of 35°C and vacuum degree of -0.05MPa for 4 hours to obtain starch-based capsules.

[0036] Example 2: Modified sweet potato starch was obtained from sweet potato starch through fermentation and oxidation.

[0037] The specific steps of the fermentation process are as follows: sweet potato starch is mixed with deionized water and heated to 35°C. Lactobacillus acidophilus powder and yeast powder are added and stirred at 40 r / min for 7 h. After stirring, Bifidobacterium longum powder is added, mixed evenly, and allowed to stand for 14 h. The supernatant is discarded, washed twice with clean water, allowed to stand and settle, and then the water is skimmed off. The mixture is dehydrated using a cloth bag to obtain wet starch (the mass ratio of sweet potato starch, deionized water, Lactobacillus acidophilus powder, yeast powder and Bifidobacterium longum powder is 0.5:1.2:0.05:0.04:0.08).

[0038] The specific steps of the oxidation treatment are as follows: (i) Mix deionized water and wet starch, and the resulting starch milk is obtained by mixing well (the mass ratio of deionized water to wet starch is 1:0.4).

[0039] (ii) The pH of the starch milk was adjusted to 10.0 using sodium hydroxide. Sodium hypochlorite was added dropwise to the starch milk at 30°C and stirred at 350 r / min for 1.5 h. After stirring, 8% dilute hydrochloric acid was added to adjust the pH to 6.5. Tea polyphenols, anthocyanins and curcumin were added and stirred at 120 r / min for 20 min to obtain modified sweet potato starch milk (the mass ratio of starch milk, sodium hypochlorite, tea polyphenols, anthocyanins and curcumin was 1:0.05:0.02:0.01:0.03).

[0040] (iii) The modified sweet potato starch milk was washed with deionized water until neutral, dried at 45°C and pulverized to obtain modified sweet potato starch;

[0041] The preparation process of starch film-forming material is as follows: 50 parts of modified sweet potato starch are added to 90 parts of deionized water and stirred to form a uniform starch solution. The solution is heated to 50°C in a water bath, 2 parts of papain are added, and the mixture is stirred at a constant temperature for 45 minutes to enzymatically hydrolyze the starch. The temperature is maintained at 50°C. 0.3 parts of urea, 2 parts of glycerol and 3 parts of malic acid are added sequentially and stirred at 120 r / min for 18 minutes. After stirring, 12 parts of cellulose powder are added and stirred at 120 r / min for 18 minutes. The temperature is raised to 80°C and stirred at a constant temperature for 35 minutes to obtain the starch film-forming material.

[0042] The preparation process of the soluble support framework is as follows: (i) 40 parts HPMCE5 and 3 parts titanium dioxide are added to 55 parts purified water, stirred evenly and left to stand for 2 hours to obtain a pre-mixed solution.

[0043] (ii) Add 4 parts polyethylene glycol, 0.8 parts magnesium stearate and 0.1 parts sodium benzoate to the pre-mixed liquid in sequence, heat to 40°C, stir at 1100 r / min for 1.5 h, degas under vacuum for 30 min, and let stand at 25°C for 14 h to obtain printing paste.

[0044] (iii) Add the printing paste to the 3D printer, the printing extrusion speed is 3mm / s, the nozzle moving speed is 3mm / s, the nozzle diameter is 0.3mm, print the cap frame and the body frame in sequence, after printing, dry it to a moisture content of 7%, assemble the cap frame and the body frame to obtain a soluble support skeleton.

[0045] The soluble support framework includes a cap frame and a body frame. After assembly, the cap frame and body frame form a closed storage space inside for storing dry powder. The soluble support framework is immersed in starch film-forming material. After 2 minutes, the soluble support framework is vertically lifted out at a constant speed of 1 mm / s and suspended vertically for 45 seconds. Then, it is transferred to an environment of 32°C and vacuum degree of -0.06 MPa to dry for 3 hours to obtain a pre-made shell film.

[0046] The pre-made shell membrane was immersed in a 10% sorbitol aqueous solution for 4 seconds, and after being removed, excess liquid on the surface was absorbed with filter paper. It was then dried in an environment of 37°C and vacuum degree of -0.05MPa for 5 hours to obtain starch-based capsules.

[0047] Example 3: Modified sweet potato starch was obtained from sweet potato starch through fermentation and oxidation.

[0048] The specific steps of the fermentation process are as follows: sweet potato starch is mixed with deionized water and heated to 37°C. Lactobacillus acidophilus powder and yeast powder are added and stirred at 50 r / min for 8 hours. After stirring, Bifidobacterium longum powder is added, mixed evenly, and allowed to stand for 16 hours. The supernatant is discarded, washed three times with clean water, allowed to settle, and then the water is skimmed off. The mixture is dehydrated using a cloth bag to obtain wet starch (the mass ratio of sweet potato starch, deionized water, Lactobacillus acidophilus powder, yeast powder, and Bifidobacterium longum powder is 0.5:1.2:0.05:0.04:0.08).

[0049] The specific steps of the oxidation treatment are as follows: (i) Mix deionized water and wet starch, and the resulting starch milk is obtained by mixing well (the mass ratio of deionized water to wet starch is 1:0.4).

[0050] (ii) The pH of the starch milk was adjusted to 11.0 using sodium hydroxide. Sodium hypochlorite was added dropwise to the starch milk at 40°C and stirred at 350 r / min for 2 h. After stirring, 10% dilute hydrochloric acid was added to adjust the pH to 7.0. Tea polyphenols, anthocyanins and curcumin were added and stirred at 120 r / min for 25 min to obtain modified sweet potato starch milk (the mass ratio of starch milk, sodium hypochlorite, tea polyphenols, anthocyanins and curcumin was 1:0.05:0.02:0.01:0.03).

[0051] (iii) The modified sweet potato starch milk was washed with deionized water until neutral, dried at 50°C and pulverized to obtain modified sweet potato starch;

[0052] The preparation process of starch film-forming material is as follows: 55 parts of modified sweet potato starch are added to 100 parts of deionized water and stirred to form a uniform starch solution. The solution is heated to 55°C in a water bath, 3 parts of papain are added, and the mixture is stirred at a constant temperature for 60 min to enzymatically hydrolyze the starch. The temperature is maintained at 55°C. 0.5 parts of urea, 3 parts of glycerol and 4 parts of malic acid are added sequentially and stirred at 120 r / min for 20 min. After stirring, 16 parts of cellulose powder are added and stirred at 120 r / min for 20 min. The temperature is raised to 85°C and stirred at a constant temperature for 45 min to obtain the starch film-forming material.

[0053] The preparation process of the soluble support framework is as follows: (i) 45 parts HPMCE5 and 4 parts titanium dioxide are added to 65 parts purified water, stirred evenly and left to stand for 3 hours to obtain a pre-mixed solution.

[0054] (ii) Add 5 parts polyethylene glycol, 1 part magnesium stearate and 0.1 parts sodium benzoate to the pre-mixed liquid in sequence, heat to 40°C, stir at 1200 r / min for 2 h, degas under vacuum for 45 min, and let stand at 25°C for 16 h to obtain printing paste.

[0055] (iii) Add the printing paste to the 3D printer, the printing extrusion speed is 5mm / s, the nozzle moving speed is 5mm / s, the nozzle diameter is 0.4mm, print the cap frame and the body frame in sequence, after printing, dry it to a moisture content of 8%, assemble the cap frame and the body frame to obtain a soluble support skeleton.

[0056] The soluble support framework includes a cap frame and a body frame. After assembly, the cap frame and body frame form a closed storage space inside for storing dry powder. The soluble support framework is immersed in starch film-forming material. After 3 minutes, the soluble support framework is vertically lifted out at a constant speed of 2 mm / s and suspended vertically for 60 seconds. Then, it is transferred to an environment of 35°C and vacuum degree of -0.06 MPa to dry for 4 hours to obtain a pre-made shell film.

[0057] The pre-made shell membrane was immersed in a 10% sorbitol aqueous solution for 5 seconds, and after removal, excess liquid on the surface was absorbed with filter paper. It was then dried in an environment of 40°C and vacuum degree of -0.05MPa for 6 hours to obtain starch-based capsules.

[0058] Comparative Example 1

[0059] The preparation process of starch film-forming material is as follows: 50 parts of sweet potato starch are added to 90 parts of deionized water and stirred to form a uniform starch solution. The solution is heated to 50°C in a water bath, 2 parts of papain are added, and the mixture is stirred at a constant temperature for 45 minutes to enzymatically hydrolyze the starch. The temperature is maintained at 50°C. 0.3 parts of urea, 2 parts of glycerol and 3 parts of malic acid are added sequentially and stirred at 120 r / min for 18 minutes. After stirring, 12 parts of cellulose powder are added and stirred at 120 r / min for 18 minutes. The temperature is raised to 80°C and stirred at a constant temperature for 35 minutes to obtain the starch film-forming material.

[0060] The preparation process of the soluble support framework is as follows: (i) 40 parts HPMCE5 and 3 parts titanium dioxide are added to 55 parts purified water, stirred evenly and left to stand for 2 hours to obtain a pre-mixed solution.

[0061] (ii) Add 4 parts polyethylene glycol, 0.8 parts magnesium stearate and 0.1 parts sodium benzoate to the pre-mixed liquid in sequence, heat to 40°C, stir at 1100 r / min for 1.5 h, degas under vacuum for 30 min, and let stand at 25°C for 14 h to obtain printing paste.

[0062] (iii) Add the printing paste to the 3D printer, the printing extrusion speed is 3mm / s, the nozzle moving speed is 3mm / s, the nozzle diameter is 0.3mm, print the cap frame and the body frame in sequence, after printing, dry it to a moisture content of 7%, assemble the cap frame and the body frame to obtain a soluble support skeleton.

[0063] The soluble support framework includes a cap frame and a body frame. After assembly, the cap frame and body frame form a closed storage space inside for storing dry powder. The soluble support framework is immersed in starch film-forming material. After 2 minutes, the soluble support framework is vertically lifted out at a constant speed of 1 mm / s and suspended vertically for 45 seconds. Then, it is transferred to an environment of 32°C and vacuum degree of -0.06 MPa to dry for 3 hours to obtain a pre-made shell film.

[0064] The pre-made shell membrane was immersed in a 10% sorbitol aqueous solution for 4 seconds, and after being removed, excess liquid on the surface was absorbed with filter paper. It was then dried in an environment of 37°C and vacuum degree of -0.05MPa for 5 hours to obtain starch-based capsules.

[0065] Comparative Example 2

[0066] Modified sweet potato starch is obtained by oxidizing sweet potato starch;

[0067] The specific steps of the oxidation treatment are as follows: (i) Mixing deionized water with sweet potato starch, and mixing well to obtain starch milk (the mass ratio of deionized water to wet starch is 1:0.4).

[0068] (ii) The pH of the starch milk was adjusted to 10.0 using sodium hydroxide. Sodium hypochlorite was added dropwise to the starch milk at 30°C and stirred at 350 r / min for 1.5 h. After stirring, 8% dilute hydrochloric acid was added to adjust the pH to 6.5. Tea polyphenols, anthocyanins and curcumin were added and stirred at 120 r / min for 20 min to obtain modified sweet potato starch milk (the mass ratio of starch milk, sodium hypochlorite, tea polyphenols, anthocyanins and curcumin was 1:0.05:0.02:0.01:0.03).

[0069] (iii) The modified sweet potato starch milk was washed with deionized water until neutral, dried at 45°C and pulverized to obtain modified sweet potato starch;

[0070] The preparation process of starch film-forming material is as follows: 50 parts of modified sweet potato starch are added to 90 parts of deionized water and stirred to form a uniform starch solution. The solution is heated to 50°C in a water bath, 2 parts of papain are added, and the mixture is stirred at a constant temperature for 45 minutes to enzymatically hydrolyze the starch. The temperature is maintained at 50°C. 0.3 parts of urea, 2 parts of glycerol and 3 parts of malic acid are added sequentially and stirred at 120 r / min for 18 minutes. After stirring, 12 parts of cellulose powder are added and stirred at 120 r / min for 18 minutes. The temperature is raised to 80°C and stirred at a constant temperature for 35 minutes to obtain the starch film-forming material.

[0071] The preparation process of the soluble support framework is as follows: (i) 40 parts HPMCE5 and 3 parts titanium dioxide are added to 55 parts purified water, stirred evenly and left to stand for 2 hours to obtain a pre-mixed solution.

[0072] (ii) Add 4 parts polyethylene glycol, 0.8 parts magnesium stearate and 0.1 parts sodium benzoate to the pre-mixed liquid in sequence, heat to 40°C, stir at 1100 r / min for 1.5 h, degas under vacuum for 30 min, and let stand at 25°C for 14 h to obtain printing paste.

[0073] (iii) Add the printing paste to the 3D printer, the printing extrusion speed is 3mm / s, the nozzle moving speed is 3mm / s, the nozzle diameter is 0.3mm, print the cap frame and the body frame in sequence, after printing, dry it to a moisture content of 7%, assemble the cap frame and the body frame to obtain a soluble support skeleton.

[0074] The soluble support framework includes a cap frame and a body frame. After assembly, the cap frame and body frame form a closed storage space inside for storing dry powder. The soluble support framework is immersed in starch film-forming material. After 2 minutes, the soluble support framework is vertically lifted out at a constant speed of 1 mm / s and suspended vertically for 45 seconds. Then, it is transferred to an environment of 32°C and vacuum degree of -0.06 MPa to dry for 3 hours to obtain a pre-made shell film.

[0075] The pre-made shell membrane was immersed in a 10% sorbitol aqueous solution for 4 seconds, and after being removed, excess liquid on the surface was absorbed with filter paper. It was then dried in an environment of 37°C and vacuum degree of -0.05MPa for 5 hours to obtain starch-based capsules.

[0076] Comparative Example 3

[0077] Modified sweet potato starch is made from sweet potato starch through fermentation.

[0078] The specific steps of the fermentation process are as follows: sweet potato starch is mixed with deionized water and heated to 35°C. Lactobacillus acidophilus powder and yeast powder are added and stirred at 40 r / min for 7 h. After stirring, Bifidobacterium longum powder is added, mixed evenly, and allowed to stand for 14 h. The supernatant is discarded, washed twice with clean water, allowed to stand and settle, and then the water is skimmed off. The mixture is dehydrated using a cloth bag to obtain modified sweet potato starch (the mass ratio of sweet potato starch, deionized water, Lactobacillus acidophilus powder, yeast powder and Bifidobacterium longum powder is 0.5:1.2:0.05:0.04:0.08).

[0079] The preparation process of starch film-forming material is as follows: 50 parts of modified sweet potato starch are added to 90 parts of deionized water and stirred to form a uniform starch solution. The solution is heated to 50°C in a water bath, 2 parts of papain are added, and the mixture is stirred at a constant temperature for 45 minutes to enzymatically hydrolyze the starch. The temperature is maintained at 50°C. 0.3 parts of urea, 2 parts of glycerol and 3 parts of malic acid are added sequentially and stirred at 120 r / min for 18 minutes. After stirring, 12 parts of cellulose powder are added and stirred at 120 r / min for 18 minutes. The temperature is raised to 80°C and stirred at a constant temperature for 35 minutes to obtain the starch film-forming material.

[0080] The preparation process of the soluble support framework is as follows: (i) 40 parts HPMCE5 and 3 parts titanium dioxide are added to 55 parts purified water, stirred evenly and left to stand for 2 hours to obtain a pre-mixed solution.

[0081] (ii) Add 4 parts polyethylene glycol, 0.8 parts magnesium stearate and 0.1 parts sodium benzoate to the pre-mixed liquid in sequence, heat to 40°C, stir at 1100 r / min for 1.5 h, degas under vacuum for 30 min, and let stand at 25°C for 14 h to obtain printing paste.

[0082] (iii) Add the printing paste to the 3D printer, the printing extrusion speed is 3mm / s, the nozzle moving speed is 3mm / s, the nozzle diameter is 0.3mm, print the cap frame and the body frame in sequence, after printing, dry it to a moisture content of 7%, assemble the cap frame and the body frame to obtain a soluble support skeleton.

[0083] The soluble support framework includes a cap frame and a body frame. After assembly, the cap frame and body frame form a closed storage space inside for storing dry powder. The soluble support framework is immersed in starch film-forming material. After 2 minutes, the soluble support framework is vertically lifted out at a constant speed of 1 mm / s and suspended vertically for 45 seconds. Then, it is transferred to an environment of 32°C and vacuum degree of -0.06 MPa to dry for 3 hours to obtain a pre-made shell film.

[0084] The pre-made shell membrane was immersed in a 10% sorbitol aqueous solution for 4 seconds, and after being removed, excess liquid on the surface was absorbed with filter paper. It was then dried in an environment of 37°C and vacuum degree of -0.05MPa for 5 hours to obtain starch-based capsules.

[0085] Performance testing

[0086] According to the method for dissolution and release determination in General Chapter 0931 of Part IV of the 2025 edition of the Chinese Pharmacopoeia, the release performance of starch-based capsules prepared by the methods of Examples 1-3 and Comparative Examples 1-3 was tested. Dry powdered vitamin D was filled into the sealed storage space of the starch-based capsules. The test results are shown in Table 1.

[0087] Table 1

[0088]

[0089] As can be seen from the table above, after 2 hours in simulated gastric acid solution, the release rate of the starch-based capsules in Examples 1-3 was only 7%-8%, exhibiting extremely low release levels. This indicates that the capsules are structurally stable and have good acid resistance under simulated gastric acid conditions, effectively preventing premature release of contents in the stomach. After 4 hours in simulated colonic solution, the release rate of Examples 1-3 rapidly increased to 94%-96%, enabling rapid and complete release of contents and demonstrating good colon-targeted release characteristics. In contrast, Comparative Examples 1-3 showed a release rate as high as 16%-25% after 2 hours in simulated gastric acid solution, indicating significant premature release in the stomach and poor acid resistance. After 4 hours in simulated colonic solution, the final release rate of Comparative Examples 1-3 was only 82%-87%, indicating incomplete release. The overall release behavior differed significantly from that of the Examples.

[0090] The embodiments described above are merely examples of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention.

Claims

1. A starch-based capsule, characterized in that, The starch-based capsule is prepared by supporting starch film-forming material with a soluble support framework. The soluble support framework is made by 3D printing. The soluble support framework includes a capsule cap frame and a capsule body frame. After the capsule cap frame and capsule body frame are assembled, a closed storage space is formed inside for storing dry powder. The raw materials for preparing the soluble support framework, by weight, include: 35-45 parts HPMCE5, 2-4 parts titanium dioxide, 3-5 parts polyethylene glycol, 50-65 parts purified water, 0.5-1 parts magnesium stearate, and 0.1 parts sodium benzoate; the raw materials for preparing the starch film-forming material include: 40-55 parts modified sweet potato starch, 8-16 parts cellulose powder, 0.1-0.5 parts urea, 1-3 parts glycerol, 1-3 parts papain, 2-4 parts malic acid, and 80-100 parts deionized water. The modified sweet potato starch is obtained by fermentation and oxidation of sweet potato starch; The specific steps of the fermentation process are as follows: sweet potato starch is mixed with deionized water, heated to 30-37℃, Lactobacillus acidophilus powder and yeast powder are added, and stirred at 30-50 r / min for 6-8 h. After stirring, Bifidobacterium longum powder is added, mixed evenly, and allowed to stand for 12-16 h. The supernatant is poured off, washed with clean water 2-3 times, allowed to stand and settle, and then the water is skimmed off. The wet starch is obtained by dehydration using a cloth bag. The specific steps of the oxidation treatment are as follows: (i) Mixing deionized water with wet starch and mixing well to obtain starch milk; The pH of the starch milk was adjusted to 9.0-11.0 using sodium hydroxide. Sodium hypochlorite was added dropwise to the starch milk at 25-40℃ and stirred at 350 r / min for 1-2 h. After stirring, 5-10% dilute hydrochloric acid was added to adjust the pH to 6.5-7.

0. Tea polyphenols, anthocyanins and curcumin were added and stirred at 120 r / min for 15-25 min to obtain modified sweet potato starch milk. Modified sweet potato starch was obtained by washing the modified sweet potato starch milk with deionized water until neutral, drying it at 40-50℃, and pulverizing it. The preparation process of the starch film-forming material is as follows: Modified sweet potato starch is added to deionized water and stirred to form a uniform starch solution. The solution is heated in a water bath to 45-55°C, papain is added, and the mixture is stirred at a constant temperature for 30-60 minutes to enzymatically hydrolyze the starch. The temperature is maintained at 45-55°C. Urea, glycerol, and malic acid are added sequentially and stirred at 120 r / min for 15-20 minutes. After stirring, cellulose powder is added and stirred at 120 r / min for 15-20 minutes. The temperature is raised to 75-85°C and stirred at a constant temperature for 30-45 minutes to obtain the starch film-forming material. The preparation process of the soluble support skeleton is as follows: (i) HPMCE5 and titanium dioxide are added to purified water, stirred evenly and then allowed to stand for 1-3 hours to obtain a pre-mixed solution. (ii) Add polyethylene glycol, magnesium stearate and sodium benzoate to the pre-mixed liquid in sequence, heat to 40°C, stir at 1000-1200r / min for 1-2h, degas under vacuum for 20-45min, and let stand at 25°C for 12-16h to obtain printing paste. (iii) Add the printing paste to the 3D printer, the printing extrusion speed is 2-5mm / s, the nozzle moving speed is 2-5mm / s, the nozzle diameter is 0.2-0.4mm, and print the cap frame and the body frame in sequence. After printing, dry it to a moisture content of 5-8%, assemble the cap frame and the body frame to obtain a soluble support skeleton.

2. The starch-based capsule according to claim 1, characterized in that, In the fermentation process, the mass ratio of sweet potato starch, deionized water, Lactobacillus acidophilus powder, yeast powder, and Bifidobacterium longum powder is 0.5:1.2:0.05:0.04:0.

08.

3. A starch-based capsule according to claim 1, characterized in that, In the oxidation treatment, the mass ratio of deionized water to wet starch is 1:0.4; the mass ratio of starch milk, sodium hypochlorite, tea polyphenols, anthocyanins and curcumin is 1:0.05:0.02:0.01:0.

03.

4. A method for preparing a starch-based capsule according to any one of claims 1-3, characterized in that, Includes the following steps: S1. Immerse the soluble support skeleton in the starch film-forming material. After 2-3 minutes, vertically lift the soluble support skeleton at a constant speed of 1-2 mm / s and hang it vertically for 30-60 seconds. Then transfer it to an environment of 30-35℃ and vacuum degree -0.06MPa to dry for 2-4 hours to obtain the pre-made shell film. S2, immerse the pre-made shell membrane in a 10% sorbitol aqueous solution for 3-5 seconds, remove it and use filter paper to absorb excess liquid on the surface, and dry it in an environment of 35-40℃ and vacuum degree -0.05MPa for 4-6 hours to obtain starch-based capsules.

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