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Medicinal composition for treating gastrointestinal disorders as well as preparation method and application thereof

A technology for gastrointestinal diseases and compositions is applied in the field of pharmaceutical compositions for the treatment of gastrointestinal diseases and the field of preparation thereof, which can solve the problems of affecting the stability and curative effect of preparations, accelerating the decomposition of sodium azulene sulfonate, destroying the molecular structure and the like, so as to improve the stability of medicines. The effect of high stability, convenient clinical application and easy disintegration

Active Publication Date: 2011-07-06
SICHUAN GUOKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But currently there are only tablets (including buccal tablets), granules (including compound granules) and eye drops and other preparations
The active ingredient sodium azulene sulfonate has a certain decomposing property under heat and light irradiation, and usually has a certain hygroscopicity, and the latter is heavier, which accelerates the decomposition of sodium azulene sulfonate and destroys its molecular structure. , the decomposition products are mainly impurities such as guaiazulene; the light test proves that after the sodium azulene sulfonate raw material is irradiated under strong light for 10 days, an obvious decomposition product guaiazulene impurity peak will appear after the main peak on the high performance liquid chromatography, thereby Affect the stability and curative effect of its preparation to a great extent

Method used

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  • Medicinal composition for treating gastrointestinal disorders as well as preparation method and application thereof
  • Medicinal composition for treating gastrointestinal disorders as well as preparation method and application thereof
  • Medicinal composition for treating gastrointestinal disorders as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The preparation of embodiment 1 pharmaceutical tablet of the present invention

[0024] prescription:

[0025] Sodium azulene sulfonate 2.0g

[0026] Sodium bicarbonate 130.0g

[0027] Starch 42.0g

[0028] Dextrin 25.0g

[0029] Menthol 0.3g

[0030] Magnesium stearate 0.6g

[0031]

[0032] Makes 1000 pieces

[0033] operate:

[0034] Weigh the crushed and sieved 80-mesh sodium azulene sulfonate, sodium bicarbonate, starch, dextrin according to the prescription amount, mix thoroughly with the equal volume incremental mixing method, and then crush and sieve. Take an appropriate amount of starch (this starch amount includes the recipe amount starch), add distilled water and heat to make a 10% starch slurry, add the mixed powder to make a soft material, granulate with a 20-mesh sieve, dry at 60°C for 4 hours, and collect the granules. Add magnesium stearate, spray menthol, mix well, granulate with 18 mesh sieve, and compress into tablets. ...

Embodiment 2

[0035] Embodiment 2 Pharmaceutical auxiliary material NaHCO of the present invention 3 Study on the Stability of Sodium Azulene Sulfonate Tablets

[0036] According to the structural characteristics of sodium azulene sulfonate, it can undergo a decomposition reaction, and the decomposition products mainly include guaiazulene and sodium salt. This decomposition reaction is a chemical dynamic equilibrium. Decomposition products, as impurities, affect the stability and curative effect of the preparation to a large extent.

[0037] The inventors have found in practice that after adding sodium bicarbonate, the chemical balance is reversed, which achieves the purpose of inhibiting its decomposition and improves the stability of the product.

[0038] 1. Materials and methods

[0039] 1.1. Drugs:

[0040] Sodium azulene sulfonate (C 15 h 17 NaO 3 S.1 / 2H 2 O) 20g of raw materials, the batch number of the raw material drug is 091201, and different amounts of NaHCO are added with ...

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Abstract

The invention provides a medicinal composition for treating gastrointestinal disorders, and the medicinal composition is prepared from the following main components in parts by weight: 0.5 to 10 parts of sodium azulene sulfonate and 20 to 300 parts of sodium bicarbonate. The invention also provides a preparation method and application of the medicinal composition. The medicinal composition can achieve the medical effect of synergy by compatibly using the sodium azulene sulfonate and the sodium bicarbonate, has stable quality and strong controllability, has the functions of light protection, damp prevention and the like, and can cover defect taste of the medicament, so that decomposition of the medicament can be prevented or retarded, and the medicament stability is improved to ensure the curative effect of the medicament is exerted better. The medicinal composition is easily disintegrated and quickly absorbed, is convenient for clinical application, and provides a novel option for clinical treatment.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating gastrointestinal diseases and a preparation method thereof. Background technique [0002] Sodium azulene sulfonate is often used in the treatment of gastric ulcer, duodenal ulcer, gastritis and bacterial enteritis, etc. It has definite curative effect and mild side effects. But there are only preparations such as tablets (containing buccal tablets), granules (containing compound granules) and eye drops at present. The active ingredient sodium azulene sulfonate has a certain decomposing property under heat and light irradiation, and usually has a certain hygroscopicity, and the latter is heavier, which accelerates the decomposition of sodium azulene sulfonate and destroys its molecular structure. , the decomposition products are mainly impurities such as guaiazulene; the light test proves that after the sodium azulene sulfonate raw material is irradiated under strong light for 10 days, ...

Claims

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Application Information

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IPC IPC(8): A61K31/185A61K33/00A61P1/04A61P1/00A61P31/04
Inventor 石万棋左志国邓聪史成刚徐琨
Owner SICHUAN GUOKANG PHARMA
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