Alginate hard capsule disintegrable at different positions in gastrointestinal tract

An alginate, gastrointestinal tract technology, applied in the directions of capsule delivery, food forming, medical preparations of inactive ingredients, etc., can solve the problems of delayed disintegration, low ionic strength, insufficient degree of de-crosslinking, etc. Achieve the effects of low cost, simple preparation method and good damp-heat stability

Active Publication Date: 2012-09-12
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

Due to the lack of enzymes to digest and degrade alginate in the human body, the disintegration of alginate hard capsules in the body mainly relies on ion exchange to form partially soluble alginate, but the ionic strength and pH in the human digestive tract vary from person to person, even if it is The environment in the digestive tract of the same person is different at different times and in different physical conditions, resulting in serious individual d

Method used

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  • Alginate hard capsule disintegrable at different positions in gastrointestinal tract
  • Alginate hard capsule disintegrable at different positions in gastrointestinal tract
  • Alginate hard capsule disintegrable at different positions in gastrointestinal tract

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1 Colon Dissolving Hard Capsule 1

[0029] Table 1

[0030]

[0031] (1) Glue preparation: slowly dissolve 10g of high-viscosity sodium alginate and 100g of glycerin in 890g of water, and let it stand to remove air bubbles after the dissolution;

[0032] (2) Glue dipping: slowly pour the glue into the dipping tank, and automatically dip the glue through the hard capsule shell mold;

[0033] (3) Preparation and curing of the curing liquid: the curing liquid is an aluminum chloride aqueous solution with a concentration of 30% by mass, spray the curing liquid and rinse the mold for 6 seconds, so that the dipping liquid in the mold is cured into alginate gel capsules;

[0034] (4) Post-processing: the alginate gel capsule is subjected to the conventional hard capsule shell process of drying, shelling, cutting, fastening, light inspection, and sterilization to obtain the alginate hard capsule shell;

[0035] (5) Capsule filling: Fill 0.5 g of starch as an activ...

Embodiment 2

[0038] Example 2 Colon Dissolving Hard Capsule 2

[0039] Table 2

[0040]

[0041](1) Glue preparation: slowly dissolve 10g of high-viscosity sodium alginate, 50g of sorbitol and 200g of polyvinylpyrrolidone in 740g of water, and decompress to remove air bubbles after the dissolution;

[0042] (2) Glue dipping: slowly pour the glue into the dipping tank, and automatically dip the glue through the hard capsule shell mold;

[0043] (3) Preparation and curing of the curing liquid: the curing liquid is an aqueous solution of ferric chloride with a concentration of 10% by mass. Spray and rinse the mold for 30 seconds with the curing liquid, so that the dipping liquid in the mold is solidified into alginate gel capsules;

[0044] (4) Post-processing: the alginate gel capsule is subjected to the conventional hard capsule shell process of drying, shelling, cutting, fastening, light inspection, and sterilization to obtain the alginate hard capsule shell;

[0045] (5) Capsule fil...

Embodiment 3

[0048] Example 3 Enteric Dissolving Hard Capsules

[0049] table 3

[0050]

[0051] (1) Glue preparation: Slowly dissolve 100g of ultra-low viscosity sodium alginate, 50g of glycerin and 100g of polyethylene glycol 6000 in 750g of water, and let stand to remove air bubbles after dissolution;

[0052] (2) Glue dipping: slowly pour the glue into the dipping tank, and automatically dip the glue through the hard capsule shell mold;

[0053] (3) Preparation and curing of the curing liquid: the curing liquid is an aqueous solution of ferric chloride with a mass percent concentration of 2%, and the pH is adjusted to 3.0 with hydrochloric acid, and the curing liquid is soaked in the mold for 1 minute, so that the dipping glue in the mold is cured into Alginate gel capsules;

[0054] (4) Post-processing: the alginate gel capsule is subjected to the conventional hard capsule shell process of drying, shelling, cutting, fastening, light inspection, and sterilization to obtain the al...

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Abstract

Disclosed is an alginate hard capsule disintegrable at different positions in gastrointestinal tract. Processing steps include preparing glue solution, glue solution dipping, solidifying, drying, drawing out, cutting, fastening, optical testing and sterilizing of glue solution and capsule filling. The glue solution is prepared by dissolving univalent alginate, plasticizer and pore former in water, wherein the pore former is a polymer film-forming material, glycerin and sorbitol serve as the plasticizer; the solidifying is that dipped gel solution is made into alginate gel capsule by means of ionic cross-linking or acidulating, wherein solidifying solution is multivalent metal ion water solution or acid solution; and finally active ingredients and disintegrating accelerator are filled in hard capsule shells to obtain finished products, wherein the disintegrating accelerator is a substance which can be in precipitation reaction or complexation with multivalent metal ions. The alginate hard capsule is widely applied to different disintegrating environments in the gastrointestinal tract and disintegrable in vivo at different speeds to release the active ingredients and has the advantages of high hydrothermal stability, simple preparation method and low cost.

Description

technical field [0001] The invention relates to a capsule for medicine and health food packaging, in particular to a hard capsule prepared from alginate gel as the main raw material. Background technique [0002] Hard capsules are made by filling a certain amount of medicinal material extracts with medicinal powder or auxiliary materials into uniform powder or granules, or by filling the medicinal material powder directly into hollow capsules. The production process is relatively simple, It has the advantages of convenient taking, fast onset of effect, and ability to effectively isolate the bad smell of medicines. [0003] At present, gelatin is mostly used as raw material for capsule shells at home and abroad, but because it is an animal-derived material, there is a risk of animal disease transmission and other food safety issues, and some chemical groups in gelatin are easily combined with aldehyde-containing substances. The chemical reaction of the drug ingredients will...

Claims

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Application Information

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IPC IPC(8): A61K47/36A61K9/48A23P1/04A23L1/29A23L33/00A23P10/30
Inventor 张文辉
Owner 南京健辉生物科技有限公司
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