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Sodium bicarbonate enteric capsule and preparation method thereof

A sodium bicarbonate enteric and sodium bicarbonate technology, applied in the field of sodium bicarbonate enteric-coated capsules and the preparation thereof, can solve problems such as adverse effects, achieve neutralization of uric acid, avoid adverse reactions in the stomach, effectively neutralize uric acid and The effect of intestinal protection

Active Publication Date: 2021-03-12
BLOOMAGE BIOTECHNOLOGY CORP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Aiming at the problem that the excipients in the current sodium bicarbonate enteric solution have adverse effects on the active ingredients, the invention provides a sodium bicarbonate enteric-coated capsule and a preparation method thereof

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 Preparation of sodium bicarbonate enteric-coated capsules

[0028] (1) Add the capsule skin material consisting of 15g of hypromellose phthalate (HPMCP), 1.5g of curdlan gum and 1.0g of xanthan gum into 100mL of water, raise the temperature to 80°C, and keep it for 60min , continue stirring; then lower the temperature to 50°C and keep warm until the glue has no bubbles and is transparent; dip the glue and use a mold to make a 70mg / capsule hollow capsule;

[0029] (2) Polyacrylic acid resin latex, triethyl citrate, microcrystalline cellulose and talcum powder are dissolved in ethanol with a volume fraction of 60% to make an enteric coating solution; in the enteric coating solution , the mass percentage of polyacrylic acid resin latex is 16%, the mass percentage of triethyl citrate is 5%, the mass percentage of microcrystalline cellulose is 2%, and the mass percentage of talcum powder is 8%;

[0030] Immerse the empty capsules in the enteric coating solution, ...

Embodiment 2

[0054] Example 2 Preparation of sodium bicarbonate enteric-coated capsules

[0055] (1) Add the capsule skin material consisting of 12g of hypromellose phthalate, 2.0g of curdlan gum and 1.0g of xanthan gum into 60mL of water, raise the temperature to 80°C, keep it for 60min, and keep stirring ; then lower the temperature to 50°C and keep warm until the glue has no bubbles and is transparent; dip the glue and use a mold to make a hollow capsule of 106 mg / capsule;

[0056] (2) Dissolve polyacrylic acid resin emulsion and cellulose acetate phthalate in ethanol with a volume fraction of 50% to make an enteric coating solution; in the enteric coating solution, the mass of polyacrylic acid resin is 100% The content of cellulose acetate phthalate is 18%, and the mass percentage of cellulose acetate phthalate is 15%;

[0057] Immerse the empty capsules in the enteric coating solution, keep for 8 seconds, take them out, and dry them at 30°C and RH 60%-70% for 40 minutes to prepare 12...

Embodiment 3

[0059] Example 3 Preparation of sodium bicarbonate enteric-coated capsules

[0060] (1) Add the capsule skin material consisting of 20g of hypromellose phthalate, 1.5g of curdlan gum and 0.5g of xanthan gum into 100mL of water, raise the temperature to 85°C, keep it for 40min, and keep stirring ; then lower the temperature to 50°C and keep warm until the glue has no bubbles and is transparent; dip the glue and use a mold to make a 90mg / capsule hollow capsule;

[0061] (2) Dissolve polyvinyl acetate phthalate and hydroxypropylmethylcellulose acetate in ethanol with a volume fraction of 70% to make an enteric coating solution; in the enteric coating solution, poly The mass percentage of vinyl acetate phthalate is 20%, and the mass percentage of hydroxypropyl methylcellulose acetate contains 6%;

[0062] Immerse the empty capsules in the enteric coating solution, keep for 10 seconds, take them out, and dry them at 25°C and RH 60%-70% for 20 minutes to obtain 97mg / capsules of ent...

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Abstract

The invention belongs to the technical field of medicinal preparation processing, and particularly relates to a sodium bicarbonate enteric capsule and a preparation method thereof. The preparation method of the sodium bicarbonate enteric capsule comprises the following steps: adding a capsule shell material suitable for alkaline contents into water, heating and stirring to obtain a solution, and dipping with glue to obtain a hollow capsule shell; dipping the hollow capsule in an enteric coating solution, and drying to obtain an enteric hollow capsule shell; filling the content containing sodium bicarbonate, coating a sealing material solution at the sleeved part of the capsule, and drying to obtain the sodium bicarbonate enteric capsule. The capsule shell material suitable for the alkalinecontents is prepared from the following raw materials in parts by weight: 10-20 parts of hydroxypropyl methyl cellulose phthalate, 1-2 parts of curdlan and 0.5-1.5 parts of xanthan gum. According tothe invention, the enteric hollow capsule is filled with the alkaline contents, so adverse reactions of the stomach can be avoided, and the effects of neutralizing uric acid and protecting the intestinal tract can be more effectively realized; and compared with the coating by a spraying technology, the enteric hollow capsule has less influence on the contents.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparation processing, and in particular relates to a sodium bicarbonate enteric-coated capsule and a preparation method thereof. Background technique [0002] Gout, also known as "hyperuricemia", is a disorder of purine metabolism and belongs to arthritis. Gout is a disorder in the metabolism of purine substances in the human body. The synthesis of uric acid increases or the excretion decreases, resulting in hyperuricemia. When the blood uric acid concentration is too high, uric acid is deposited in the joints, cartilage and kidneys in the form of sodium salt, causing tissue foreign bodies. Inflammation, ie gout. Gout can cause kidney damage, including gouty nephropathy, acute obstructive nephropathy and urinary calculi. In addition, when the blood uric acid in the human body is excessively elevated and exceeds its saturation, white crystals are precipitated in certain parts of the body....

Claims

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Application Information

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IPC IPC(8): A61K33/00A61K9/48A61K47/38A61K47/36A61K47/32A61P19/06
CPCA61K33/00A61K9/4891A61K9/4816A61K47/38A61K47/36A61K47/32A61P19/06
Inventor 刘文庆董杰杰田昕王静郭学平
Owner BLOOMAGE BIOTECHNOLOGY CORP LTD
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