High-amylose corn modified starch-based capsule and preparation method thereof

Abstract

The invention relates to the technical field of biological medicine, in particular to a high-amylose corn modified starch-based capsule and a preparation method thereof. The invention provides a high-amylose corn modified starch-based capsule. The high-amylose corn modified starch-based capsule is prepared from the following components in parts by mass: 35 to 45 parts of high-amylose hydroxypropyl corn starch, 30 to 40 parts of carboxymethyl hydroxypropyl potato starch, 25 to 35 parts of gamma-hydroxypropyl potato starch, 15 to 25 parts of gel, 2.2 to 2.8 parts of coagulant aid, 0.8 to 1.2 parts of plasticizer, 1 to 1.5 parts of nano superfine calcium carbonate, 2 to 4 parts of preservative and 1000 to 1200 parts of water. The capsule provided by the invention almost has no powder leakage phenomenon, has good stability, is not easy to break, meets the relevant standard requirements on disintegration time limit, and is suitable for industrial large-scale production and application.

Description

Technical Field

[0001] The invention relates to the technical field of biomedicine, and in particular to a high-amylose corn modified starch-based capsule and a preparation method thereof. Background Art

[0002] Capsules are divided into hard capsules and soft capsules. Hard capsules, also known as hollow capsules, are composed of a cap and a body; soft capsules are products made by processing the film-forming material and the contents at the same time.

[0003] Hard capsules are made by adding a certain amount of medicinal extracts to powder or excipients to make uniform powder or granules, filling them into hollow capsules, or directly packing medicinal powder into hollow capsules. In the production of modern Chinese medicine preparations, hard capsules have been widely used in recent years because of their relatively simple process, convenient administration, rapid onset of effect, and ability to effectively isolate the unpleasant smell of drugs.

[0004] The main component of the traditional hollow capsule shell is gelatin. Gelatin is made from animal bones and skins, which has certain hidden dangers. In addition, gelatin capsules have a high water content, become brittle when losing water, soften when absorbing water, and are prone to cross-linking and curing reactions when encountering aldehyde substances. In addition, it has certain limitations, such as being sensitive to heat and prone to oxidation and aging of proteins over a long period of time, which also affects the practicality of gelatin capsule products. Therefore, finding new materials to prepare non-gelatin capsules has become one of the current development directions of pharmaceutical excipients.

[0005] Therefore, how to provide a hard capsule product that does not contain gelatin material to replace the gelatin capsule product in the prior art is a problem that those skilled in the art urgently need to solve. Summary of the invention

[0006] The object of the present invention is to provide a high-amylose corn modified starch-based capsule and a preparation method thereof.

[0007] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0008] The invention provides a high-amylose corn modified starch-based capsule, which is prepared from the following components in parts by weight: 35-45 parts of high-amylose hydroxypropyl corn starch, 30-40 parts of carboxymethyl hydroxypropyl potato starch, 25-35 parts of gamma-hydroxypropyl potato starch, 15-25 parts of gelling agent, 2.2-2.8 parts of coagulant aid, 0.8-1.2 parts of plasticizer, 1-1.5 parts of nano-ultrafine calcium carbonate, 2-4 parts of preservative and 1000-1200 parts of water.

[0009] Preferably, the coagulant aid is potassium citrate, sodium citrate and sodium acetate; the mass ratio of potassium citrate, sodium citrate and sodium acetate is 12-18:7-11:3-5.

[0010] Preferably, the gelling agent is sodium alginate, dragon's beard gel and xanthan gum; the mass ratio of the sodium alginate, dragon's beard gel and xanthan gum is 1-3:1-3:6-10.

[0011] Preferably, the plasticizers are sorbitol and xylitol; the mass ratio of sorbitol to xylitol is 5-9:10-14.

[0012] Preferably, the preservative is methylparaben, butylparaben or ethylparaben.

[0013] The present invention also provides a method for preparing the capsule, comprising the following steps:

[0014] (1) mixing high-amylose hydroxypropyl corn starch, carboxymethyl hydroxypropyl potato starch, γ-hydroxypropyl potato starch, a gelling agent, a coagulant and water, heating and gelatinizing, and after cooling, adding a plasticizer, nano-ultrafine calcium carbonate and a preservative to obtain a glue solution, and letting it stand;

[0015] (2) placing the standing glue solution in a capsule making machine to prepare capsule blanks;

[0016] (3) After the capsule blank is dried, it is demoulded, cut, and assembled.

[0017] Preferably, the standing time in step (1) is 130 to 150 minutes.

[0018] Preferably, the gelatinization temperature in step (1) is 72-78°C.

[0019] Preferably, the gelatinization time in step (1) is 80 to 90 minutes.

[0020] Preferably, the temperature in step (1) is lowered to 42-46°C.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] The present invention uses various types of modified starches as capsule raw materials. The presence of various types of hydroxypropyl starch increases the viscosity of the mixed components, is easy to shape, has high product stability, and reduces the sensitivity of the raw materials to the production environment during the production process. In particular, the addition of gamma-hydroxypropyl potato starch makes the colloid have higher viscosity, greater cold water solubility and better film-forming properties, so that the prepared capsules have excellent performance, good stability, are not easy to break, have stable quality, and the raw material price is cheap and the cost is low.

[0023] The present invention also adds a gelling agent to the raw materials of the capsule, which can improve the film-forming property of the capsule, and the coagulant can promote the coagulation process after the capsule is formed, and improve the plasticity of the capsule. The plasticizer can improve the plasticity and ductility of the capsule. The nano-ultrafine calcium carbonate can improve the compatibility of the formula system and play a role in toughening and strengthening. In addition, only when the types of the raw materials of the gelling agent, the coagulant and the plasticizer are selected in the present invention, can the best technical effect be achieved.

[0024] The capsule provided by the present invention has almost no powder leakage, good stability, is not easy to break, and the disintegration time limit also meets the requirements of relevant standards, and is suitable for factory-scale large-scale production and application. DETAILED DESCRIPTION

[0025] The invention provides a high-amylose corn modified starch-based capsule, which is prepared from the following components in parts by weight: 35-45 parts of high-amylose hydroxypropyl corn starch, 30-40 parts of carboxymethyl hydroxypropyl potato starch, 25-35 parts of γ-hydroxypropyl potato starch, 15-25 parts of gelling agent, 2.2-2.8 parts of coagulant, 0.8-1.2 parts of plasticizer, 1-1.5 parts of nano-ultrafine calcium carbonate, 2-4 parts of preservative, and 1000-1200 parts of water; preferably, 37-43 parts of high-amylose hydroxypropyl corn starch, 32-38 parts of carboxymethyl hydroxypropyl potato starch, 27-33 parts of γ-hydroxypropyl potato starch, 17-23 parts of gelling agent, 2.3-2.7 parts of coagulant, 0.9-1.2 parts of plasticizer. 1.1 parts, nano-ultrafine calcium carbonate 1.1-1.4 parts, preservative 3 parts, water 1100 parts; further preferably 39-41 parts of high-amylose hydroxypropyl corn starch, 34-36 parts of carboxymethyl hydroxypropyl potato starch, 29-31 parts of γ-hydroxypropyl potato starch, 19-21 parts of gelling agent, 2.4-2.6 parts of coagulant, 1 part of plasticizer, 1.2-1.3 parts of nano-ultrafine calcium carbonate, 3 parts of preservative, water 1100 parts; more preferably 40 parts of high-amylose hydroxypropyl corn starch, 35 parts of carboxymethyl hydroxypropyl potato starch, 30 parts of γ-hydroxypropyl potato starch, 20 parts of gelling agent, 2.5 parts of coagulant, 1 part of plasticizer, 1.3 parts of nano-ultrafine calcium carbonate, 3 parts of preservative, water 1100 parts.

[0026] In the present invention, the coagulant aid is potassium citrate, sodium citrate and sodium acetate; the mass ratio of potassium citrate, sodium citrate and sodium acetate is 12-18:7-11:3-5; preferably 13-17:8-10:4; more preferably 14-16:9:4; more preferably 15:9:4.

[0027] In the present invention, the gelling agent is sodium alginate, dragon's beard gel and xanthan gum; the mass ratio of the sodium alginate, dragon's beard gel and xanthan gum is 1-3:1-3:6-10; preferably 2:2:7-9; more preferably 2:2:8.

[0028] In the present invention, the plasticizers are sorbitol and xylitol; the mass ratio of sorbitol to xylitol is 5-9:10-14; preferably 6-8:11-13; more preferably 7:12.

[0029] In the present invention, the preservative is methyl parahydroxybenzoate, butyl parahydroxybenzoate or ethyl parahydroxybenzoate; preferably methyl parahydroxybenzoate.

[0030] The present invention also provides a method for preparing the capsule, comprising the following steps:

[0031] (1) mixing high-amylose hydroxypropyl corn starch, carboxymethyl hydroxypropyl potato starch, γ-hydroxypropyl potato starch, a gelling agent, a coagulant and water, heating and gelatinizing, and after cooling, adding a plasticizer, nano-ultrafine calcium carbonate and a preservative to obtain a glue solution, and letting it stand;

[0032] (2) placing the standing glue solution in a capsule making machine to prepare capsule blanks;

[0033] (3) After the capsule blank is dried, it is demoulded, cut, and assembled.

[0034] In the present invention, the standing time in step (1) is 130 to 150 min; preferably 134 to 146 min; more preferably 138 to 142 min; and more preferably 140 min.

[0035] In the present invention, the gelatinization temperature in step (1) is 72-78°C, preferably 73-77°C, more preferably 74-76°C, and more preferably 75°C.

[0036] In the present invention, the gelatinization time in step (1) is 80 to 90 min, preferably 82 to 88 min, more preferably 84 to 86 min, and more preferably 85 min.

[0037] In the present invention, the temperature in step (1) is lowered to 42-46°C, preferably 43-45°C, and more preferably 44°C.

[0038] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0039] Example 1

[0040] A high-amylose corn modified starch-based capsule is prepared from the following components in parts by weight: 35 parts of high-amylose hydroxypropyl corn starch, 30 parts of carboxymethyl hydroxypropyl potato starch, 25 parts of gamma-hydroxypropyl potato starch, 15 parts of gelling agent, 2.2 parts of coagulant aid, 0.8 parts of plasticizer, 1 part of nano-ultrafine calcium carbonate, 2 parts of preservative, and 1000 parts of water.

[0041] The coagulant aids are potassium citrate, sodium citrate and sodium acetate, with a mass ratio of 12:7:3.

[0042] The gelling agent is sodium alginate, dragon's beard glue and xanthan gum, and the mass ratio is 1:1:6.

[0043] The plasticizers are sorbitol and xylitol, with a mass ratio of 5:10.

[0044] The preservative is butyl paraben.

[0045] The preparation method of the capsule comprises the following steps:

[0046] (1) Mixed sol: High amylose corn hydroxypropyl starch, carboxymethyl hydroxypropyl potato starch, γ-hydroxypropyl potato starch, gelling agent, coagulant aid and water are mixed in proportion, stirred evenly and placed in a water bath set at 72°C to gelatinize the starch, while stirring and keeping warm. After 80 minutes, the mixture is taken out and cooled to 42°C, and a plasticizer, nano-ultrafine calcium carbonate and preservative are added. After stirring evenly, a gel solution is formed, which is allowed to stand for 130 minutes to remove bubbles in the gel solution.

[0047] (2) Dipping in glue to make blanks: Place the glue liquid in a fully automatic capsule making machine, and immerse the mold rod of the capsule mold lubricated with lubricating oil into the glue liquid to prepare capsule blanks.

[0048] (3) Drying: The capsule blank is dried using flowing cold air. After the capsule blank is dried, it is demolded and the cap and body are collected separately in medicinal low-density polyethylene bags.

[0049] (4) Cutting: The capsule cap and body blank are added to the cutting machine for cutting respectively, and then the cut capsule cap and body are collected in different transfer bags, marked and set aside.

[0050] (5) Fitting: The cut capsule cap and body are respectively poured into the A and B hoppers of the automatic fitting machine for automatic fitting. After fitting, the empty capsules are collected in a transfer bag.

[0051] (6) Light inspection and packaging: Place the capsules on the light inspection table and remove capsules with black spots, sand holes, flower heads, lace, bubbles, cracks, deformations and other problems. After sorting, qualified hollow capsules are packaged and put into storage.

[0052] Example 2

[0053] A high-amylose corn modified starch-based capsule is prepared from the following components in parts by weight: 45 parts of high-amylose hydroxypropyl corn starch, 40 parts of carboxymethyl hydroxypropyl potato starch, 35 parts of γ-hydroxypropyl potato starch, 25 parts of gelling agent, 2.8 parts of coagulant, 1.2 parts of plasticizer, 1.5 parts of nano-ultrafine calcium carbonate, 4 parts of preservative, and 1200 parts of water.

[0054] The coagulant aids are potassium citrate, sodium citrate and sodium acetate, with a mass ratio of 18:11:5.

[0055] The gelling agent is sodium alginate, dragon's beard gum and xanthan gum, and the mass ratio is 3:3:10.

[0056] The plasticizers are sorbitol and xylitol, with a mass ratio of 9:14.

[0057] The preservative is ethyl paraben.

[0058] The preparation method of the capsule comprises the following steps:

[0059] (1) Mixed sol: High amylose corn hydroxypropyl starch, carboxymethyl hydroxypropyl potato starch, γ-hydroxypropyl potato starch, gelling agent, coagulant aid and water are mixed in proportion, stirred evenly and placed in a water bath set at 78°C to gelatinize the starch, stirred and kept warm, taken out after 90 minutes and cooled to 46°C, plasticizer, nano-ultrafine calcium carbonate and preservative are added, stirred evenly to form a gel solution, and allowed to stand for 150 minutes to remove bubbles in the gel solution.

[0060] (2) Dipping in glue to make blanks: Place the glue liquid in a fully automatic capsule making machine, and immerse the mold rod of the capsule mold lubricated with lubricating oil into the glue liquid to prepare capsule blanks.

[0061] (3) Drying: The capsule blank is dried using flowing cold air. After the capsule blank is dried, it is demolded and the cap and body are collected separately in medicinal low-density polyethylene bags.

[0062] (4) Cutting: The capsule cap and body blank are added to the cutting machine for cutting respectively, and then the cut capsule cap and body are collected in different transfer bags, marked and set aside.

[0063] (5) Fitting: The cut capsule cap and body are respectively poured into the A and B hoppers of the automatic fitting machine for automatic fitting. After fitting, the empty capsules are collected in a transfer bag.

[0064] (6) Light inspection and packaging: Place the capsules on the light inspection table and remove capsules with black spots, sand holes, flower heads, lace, bubbles, cracks, deformations and other problems. After sorting, qualified hollow capsules are packaged and put into storage.

[0065] Example 3

[0066] A high-amylose corn modified starch-based capsule is prepared from the following components in parts by weight: 40 parts of high-amylose hydroxypropyl corn starch, 35 parts of carboxymethyl hydroxypropyl potato starch, 30 parts of gamma-hydroxypropyl potato starch, 20 parts of gelling agent, 2.5 parts of coagulant, 1 part of plasticizer, 1.3 parts of nano-ultrafine calcium carbonate, 3 parts of preservative, and 1100 parts of water.

[0067] The coagulant aids are potassium citrate, sodium citrate and sodium acetate, with a mass ratio of 15:9:4.

[0068] The gelling agent is sodium alginate, dragon's beard glue and xanthan gum, and the mass ratio is 2:2:8.

[0069] The plasticizers are sorbitol and xylitol, with a mass ratio of 7:12.

[0070] The preservative is methyl paraben.

[0071] The preparation method of the capsule comprises the following steps:

[0072] (1) Mixed sol: High amylose corn hydroxypropyl starch, carboxymethyl hydroxypropyl potato starch, γ-hydroxypropyl potato starch, gelling agent, coagulant aid and water are mixed in proportion, stirred evenly and placed in a water bath set at 76°C to gelatinize the starch, stirred and kept warm, taken out after 86 minutes and cooled to 45°C, plasticizer, nano-ultrafine calcium carbonate and preservative are added, stirred evenly to form a gel solution, and allowed to stand for 143 minutes to remove bubbles in the gel solution.

[0073] (2) Dipping in glue to make blanks: Place the glue liquid in a fully automatic capsule making machine, and immerse the mold rod of the capsule mold lubricated with lubricating oil into the glue liquid to prepare capsule blanks.

[0074] (3) Drying: The capsule blank is dried using flowing cold air. After the capsule blank is dried, it is demolded and the cap and body are collected separately in medicinal low-density polyethylene bags.

[0075] (4) Cutting: The capsule cap and body blank are added to the cutting machine for cutting respectively, and then the cut capsule cap and body are collected in different transfer bags, marked and set aside.

[0076] (5) Fitting: The cut capsule cap and body are respectively poured into the A and B hoppers of the automatic fitting machine for automatic fitting. After fitting, the empty capsules are collected in a transfer bag.

[0077] (6) Light inspection and packaging: Place the capsules on the light inspection table and remove capsules with black spots, sand holes, flower heads, lace, bubbles, cracks, deformations and other problems. After sorting, qualified hollow capsules are packaged and put into storage.

[0078] Experimental Example 1

[0079] Performance Testing

[0080] In order to verify the performance of the capsule, the performance of the capsule was tested.

[0081] 1. Capsule tightness test: Take 100 capsules produced in each test group, pinch the two ends of the capsules with the thumb and index finger, rotate and pull them apart to check whether there is adhesion, deformation or rupture, then fill them with talcum powder, put on the cap, and drop them vertically from a height of 1m onto a wooden board with a thickness of 2cm to check whether there is any powder leakage.

[0082] 2. Friability test: Take 100 capsules produced by each test group and put them in a watch glass. Dry them in an oven at 40°C for 24 hours, then take them out and put them into a glass tube standing upright on a 2-cm thick wooden board. Drop a 20-g cylindrical weight freely from the glass mouth to observe whether the capsules are broken and calculate the friability rate (friability rate = number of broken capsules / number of test capsules × 100%).

[0083] 3. Disintegration time test: Take 100 capsules produced by each test group for testing, fill them with talcum powder as the content, and measure the disintegration time in simulated gastric fluid at a temperature of (37±1)℃ and pH=1.1. Record the average time required for the capsules of each test group from the beginning of disintegration to complete disintegration.

[0084] 4. Loss on drying: 100 capsules produced in each test group were tested. The cap and body were separated and dried at 130°C for 90 minutes. The loss on drying was calculated.

[0085] Among them, the method of Example 3 was used as the experimental group;

[0086] Control group 1: other methods are the same as those of Example 3, except that the γ-hydroxypropyl potato starch is replaced by an equal amount of high-amylose hydroxypropyl corn starch.

[0087] Control group 2: other methods are the same as those of Example 3, except that both carboxymethyl hydroxypropyl potato starch and γ-hydroxypropyl potato starch are replaced by an equal amount of high-amylose hydroxypropyl corn starch.

[0088] Control group 3: other methods are the same as those of Example 3, except that only potassium citrate is used as a coagulant aid.

[0089] Control group 4: other methods are the same as those of Example 3, except that only xanthan gum is used as the gelling agent.

[0090] Control group 5: other methods are the same as those of Example 3, except that only xylitol is used as the plasticizer.

[0091] The test results are shown in Table 1.

[0092] Table 1. Capsule performance test results

[0093]

[0094] It can be seen from the contents recorded in Table 1 that the capsules prepared by the experimental group of the present invention meet the requirements of relevant standards, and no powder leakage occurs during the experiment. The capsules have good stability and are not easy to break. The disintegration time also meets the requirements of relevant standards.

[0095] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A high-amylose corn modified starch-based capsule, characterized in that: The invention is prepared from the following components in parts by weight: 35-45 parts of high-amylose hydroxypropyl corn starch, 30-40 parts of carboxymethyl hydroxypropyl potato starch, 25-35 parts of gamma-hydroxypropyl potato starch, 15-25 parts of gelling agent, 2.2-2.8 parts of coagulant, 0.8-1.2 parts of plasticizer, 1-1.5 parts of nano-ultrafine calcium carbonate, 2-4 parts of preservative and 1000-1200 parts of water.

2. The capsule according to claim 1, characterized in that The coagulant aids are potassium citrate, sodium citrate and sodium acetate; the mass ratio of the potassium citrate, sodium citrate and sodium acetate is 12-18:7-11:3-5.

3. The capsule according to claim 1, characterized in that The gelling agent is sodium alginate, dragon's beard glue and xanthan gum; the mass ratio of the sodium alginate, dragon's beard glue and xanthan gum is 1-3:1-3:6-10.

4. The capsule according to claim 1, characterized in that The plasticizers are sorbitol and xylitol; the mass ratio of sorbitol to xylitol is 5-9:10-14.

5. The capsule according to claim 1, characterized in that The preservative is methylparaben, butylparaben or ethylparaben.

6. The method for preparing the capsule according to any one of claims 1 to 5, characterized in that: The steps include: (1) mixing high-amylose hydroxypropyl corn starch, carboxymethyl hydroxypropyl potato starch, γ-hydroxypropyl potato starch, a gelling agent, a coagulant and water, heating and gelatinizing, and after cooling, adding a plasticizer, nano-ultrafine calcium carbonate and a preservative to obtain a glue solution, and letting it stand; (2) placing the standing glue solution in a capsule making machine to prepare capsule blanks; (3) After the capsule blank is dried, it is demoulded, cut, and assembled.

7. The preparation method according to claim 6, characterized in that: The standing time in step (1) is 130 to 150 minutes.

8. The preparation method according to claim 6, characterized in that: The gelatinization temperature in step (1) is 72-78°C.

9. The preparation method according to claim 6, characterized in that: The gelatinization time in step (1) is 80 to 90 minutes.

10. The preparation method according to claim 6, characterized in that: Step (1) is cooling to 42-46°C.

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