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Starch film-forming composition, soft capsule shell and application of soft capsule shell in soft capsule

A composition and soft capsule technology, which is applied in the field of medicine and dietary supplement manufacturing, can solve the problems that soft capsules do not have enteric-coated effect, and achieve stable enteric-coated effect, simple ingredients, and good formability

Pending Publication Date: 2022-06-28
SIRIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

EP3010492A1 discloses a mixture containing high acyl gellan gum, starch and plasticizer, and the soft capsules prepared from this mixture do not have enteric effect

Method used

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  • Starch film-forming composition, soft capsule shell and application of soft capsule shell in soft capsule
  • Starch film-forming composition, soft capsule shell and application of soft capsule shell in soft capsule
  • Starch film-forming composition, soft capsule shell and application of soft capsule shell in soft capsule

Examples

Experimental program
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preparation example Construction

[0048] Soft capsule shells can be prepared from the starch film-forming compositions of the present invention by conventional techniques. For example, the preparation method may include: sol, pelletizing and drying steps. The sol step may include pre-mixing and dispersing the gellan gum and the plasticizer uniformly, adding to an appropriate amount of water under stirring, heating and stirring at 60-98° C. until the gellan gum is dissolved; adding starch, continuing to heat and stirring at 60-98° C. until the starch dissolves; remove the bubbles to get the glue. The pill pressing step may include using a soft capsule production line to transport the glue into the plastic box of the soft capsule filling machine, and the glue is cooled on the surface of the drum to form a rubber skin, which is compressed and formed by packaging and filling, and can be further shaped in a rotating cage. The prepared soft capsule shells were tested to be enteric and had excellent formability.

...

Embodiment 1-8

[0085] Soft capsule shells were prepared using the formulations in Tables 2 and 3 and the above-mentioned method, and the rubber skin strength index, toughness index and molding adhesion index and enteric property were determined according to the above method.

[0086] Table 2: Formulations and measurement results of the starch film-forming compositions of Examples 1-8

[0087]

[0088] Table 3: Formulations and measurement results of the starch film-forming compositions of Comparative Examples 1-9

[0089]

[0090] √ not cracked, × cracked, / not tested.

Embodiment 1

[0091] Embodiment 1-6 adopts potassium hydroxide as pH adjuster, and makes soft capsule with the composition of partially deacylated gellan gum, starch, glycerin and water, wherein potassium, The total content of sodium is 245, 254, 276, 356 and 463mg / 100g, all lower than 500mg / 100g, and the comprehensive evaluation of molding is 5, 5, 5, 4.4 and 3.2, all higher than 3.0, suitable for soft capsules However, the pH of the 1% soft capsule shell aqueous solution in Example 1 is 5.91 (6.0. The soft capsules of Examples 2-6 have enteric coating effects, but the examples The comprehensive evaluation of molding of 6 is 2.6 (less than 3.0), the molding viscosity is poor, and the risk of oil leakage is high, which affects the large-scale production of soft capsules.

[0092] Embodiments 7 and 8 adopt sodium hydroxide and calcium hydroxide as pH regulators, and the comprehensive evaluation of its molding is respectively 5 and 3, which are higher than 3.0, and are suitable for large-scal...

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Abstract

The invention provides a starch film-forming composition, a soft capsule shell and application of the soft capsule shell in a soft capsule. The invention provides a starch film-forming composition. The starch film-forming composition comprises 1-8 wt% of gellan gum, 16-45 wt% of starch, 10-35 wt% of a plasticizer and 0.01-0.2 wt% of an alkaline pH regulator, wherein the starch film-forming composition further comprises water; and wherein the alkaline pH regulator makes the pH value of 1% of a soft capsule shell aqueous solution prepared from the starch film-forming composition be 6 lt; the pH value is less than or equal to 8, and the total content of potassium and sodium elements in the soft capsule shell is less than 500mg / 100g; and wherein each repeating unit of the gellan gum comprises from 25% to 40% acetyl residues, and the gellan gum has a single gel temperature. The soft capsule prepared from the starch film-forming composition disclosed by the invention is good in film-forming property, good in toughness and good in forming property, and has an enteric-coated effect.

Description

technical field [0001] The invention belongs to the field of manufacture of medicines and dietary supplements, and in particular relates to a starch composition and the application of the starch composition in vegetable soft capsules. Background technique [0002] Soft capsules refer to the direct coating of quantitative liquid medicines and nutritional ingredients, or to dissolve or disperse solid medicines and nutritional ingredients with suitable excipients to make solutions, suspensions, emulsions or semi-solids, sealed in spherical or elliptical shapes. capsules in soft capsules. Soft capsules can be prepared into enteric soft capsules according to the properties of the drug. Especially for substances such as fats, fatty acids and probiotics that are greatly affected by gastric juice, enteric soft capsules can be prepared to improve the absorption and transformation efficiency of the contents, reduce the decomposition of functional substances, and make the functional s...

Claims

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Application Information

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IPC IPC(8): C08L3/08C08L3/06C08L5/00C08K5/053C08J5/18A61K9/48A61K47/36A23P10/30A23L29/30A23L29/00
CPCC08J5/18A61K9/4816A61K47/36A23P10/30A23L29/30A23L29/015A23L29/035A23L29/37C08J2303/08C08J2403/06C08J2405/00C08K5/053A23V2002/00A23V2200/224A23V2250/5054A23V2250/5118A23V2250/6406A23V2250/1578A23V2250/1614A23V2250/16
Inventor 陈洁伟李绪发方素琼
Owner SIRIO PHARMA CO LTD
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