Soft capsule with different disintegrating modes and preparation method thereof

A technology of soft capsules and capsule cores, which is applied in the field of medicine to achieve the effect of complete functions

Active Publication Date: 2018-04-20
南京健辉生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The inventor once provided a method for making alginate soft capsules, see Chinese Patent: A Preparation Method for Alginate Soft Capsules (Application Number: CN200910027900.4, Publication Number: CN101564667A), and Chinese Patent: A Package Preparation method of alginate soft capsules with suspension of functional substances (application number: CN201110347884.4, publication number: CN102379859A), the alginate soft capsules produced by the above method

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0055] Example 1

[0056] Capsule core liquid preparation: the oil phase is 90 g of liquid paraffin, the water phase is 0.1 g of Tween 80, 1 g of calcium chloride is dissolved in 8.9 g of water, and the oil phase is slowly added to the water phase under rapid stirring at 1000 rpm , Forming an oil-in-water emulsion.

[0057] Soft capsule drip system: Dissolve 1 gram of commercially available ultra-high viscosity sodium alginate in 999 grams of deionized water to form a capsule liquid, and drip the capsule core liquid into the capsule liquid through a dripper with an inner diameter of 2 mm. Stir for 30 minutes in the cyst-forming liquid that is sodium alginate solution.

[0058] Soft capsule formation and cross-linking degree adjustment: filter out the obtained capsule core droplets and the soft capsule that has formed calcium alginate gel coating layer, wash with water, and dry at room temperature. The capsule core liquid is dehydrated and de-emulsified to form a spherical soft capsu...

Example Embodiment

[0059] Example 2

[0060] Prepare the following solution: 1 g of trisodium citrate, dissolved in 79 g of deionized water, add 20 g of ethanol, stir to form a homogeneous solution, soak the soft capsule for external force crushing obtained in Example 1 into the solution for 1 minute, and then filter out Air-dried to obtain a spherical soft capsule, the content of which is liquid paraffin, the diameter of the soft capsule is 5 mm, the loading amount is 50 mg, and it is an orally disintegrating soft capsule.

Example Embodiment

[0061] Example 3

[0062] The following solution was prepared: 5 grams of sodium chloride was dissolved in 95 grams of deionized water. The soft capsule for external force crushing obtained in Example 1 was immersed in the solution for 5 minutes, filtered out after soaking, and dried to obtain a spherical soft capsule. The content is liquid paraffin. The diameter of the soft capsule is 5 mm, and the loading capacity is 50 mg. Disintegrate soft capsule inside.

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Abstract

The invention relates to the field of medicine, and provides a soft capsule with different disintegrating modes. The soft capsule comprises a wall material and a content. The wall material is made ofsodium alginate which is formed through crosslinking of polyvalent metal ions in different degrees, the purpose that the soft capsule is disintegrated in different positions of human body alimentary canal can be achieved by controlling shifting of the polyvalent metal ions, adjusting the crosslinking degree of sodium alginate and adding aerogenic components into the wall material. The invention further provides a preparation method of the soft capsule with different disintegrating modes. The soft capsule provided by the invention can achieve oral disintegrating, gastric disintegrating, small intestinal disintegrating, colon disintegrating and external force smashing and disintegrating, can be suitable for the requirements for content disintegrating of different groups under different states and with different demands. In addition, a series of methods for preparing the soft capsule capable of achieving different disintegrating modes are simple and practicable, and suitable for large-scale production, and the cost is low.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a soft capsule with different disintegration modes and a preparation method thereof. Background technique [0002] Soft capsule is a commonly used dosage form in the pharmaceutical industry. It is welcomed by users because of its advantages of convenient use, convenient carrying, quantitative use, and high bioavailability. However, the rubber skin of soft capsules is generally composed of materials such as gelatin or starch. These materials are all hot-melt materials, that is to say, these materials control the process of rubber forming and digestive tract release according to the temperature. Therefore, this type of soft capsule is generally used for instant dissolution. The surface of the soft capsule is re-wrapped with enteric-coated materials or chemical cross-linking agents harmful to the human body are used. On the one hand, this type of soft capsule has a single functio...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/36A61K47/02
CPCA61K9/4808A61K9/4816A61K9/4833A61K47/02A61K47/36
Inventor 张文辉
Owner 南京健辉生物科技有限公司
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