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Enteric-coated preparation of rabeprazole sodium and preparation method thereof

A technology of rabeprazole sodium and enteric-coated preparations, which is applied in the field of medicine, can solve the problems of hidden quality and safety hazards, excessive impurities, etc., and achieve the effect of stable product quality and short production cycle

Active Publication Date: 2015-02-11
成都迪康药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Impurities exceed the standard, and there are quality and safety hazards

Method used

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  • Enteric-coated preparation of rabeprazole sodium and preparation method thereof
  • Enteric-coated preparation of rabeprazole sodium and preparation method thereof
  • Enteric-coated preparation of rabeprazole sodium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-6

[0121] Preparation method (method 1):

[0122] ①Mix rabeprazole sodium with magnesium oxide, mannitol, and 2 / 3 hypromellose evenly, add ethanol solution of hypromellose to make soft material, granulate with 20 mesh sieve, and dry below 50°C. Sieve through a 20-mesh sieve, add the remaining hydroxypropyl cellulose and magnesium stearate, mix well, and press into tablets.

[0123] ② Coating: Dissolve and disperse the ingredients of each coating layer with 80% ethanol solution, sieve, mix well, and coat separately.

[0124] ③After the coating is completed, dry the coated tablet until the water content is less than 1%, and pack it.

Embodiment 7-12

[0126] Preparation method (method 2):

[0127]① Mix magnesium oxide, mannitol, and 2 / 3 hypromellose evenly, add hypromellose ethanol solution to make soft material, granulate with 24 mesh sieve, dry below 50°C, granulate with 24 mesh sieve, Add rabeprazole sodium, remaining hydroxypropyl cellulose and magnesium stearate, mix well, and compress into tablets.

[0128] ② Coating: Dissolve and disperse the ingredients of each coating layer with 80% ethanol solution, sieve, mix well, and coat separately.

[0129] ③After the coating is completed, dry the coated tablet until the water content is less than 1%, and pack it.

[0130]

[0131]

[0132] (2) Implementation example of two-layer coating

Embodiment 13-14

[0134] Preparation method (method 1):

[0135] ① Mix rabeprazole sodium with magnesium oxide, mannitol, and 2 / 3 hypromellose evenly, add ethanol solution of hypromellose to make a soft material, granulate with a 20-mesh sieve, and dry below 50°C. Sieve through a 20-mesh sieve, add the remaining hydroxypropyl cellulose and magnesium stearate, mix well, and press into tablets.

[0136] ② Coating: Dissolve and disperse the ingredients of each coating layer with 80% ethanol solution, sieve, mix well, and coat separately.

[0137] ③After the coating is completed, dry the coated tablet until the water content is less than 1%, and pack it.

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Abstract

The invention belongs to the field of medicines and in particular relates to an enteric-coated preparation of rabeprazole sodium, a proton pump inhibitor and a preparation method thereof. The properties of rabeprazole sodium are very unstable and rabeprazole sodium can be quickly degraded and discolored if rabeprazole sodium is prepared or stored improperly, thus directly affecting the curative effects and medication safety of the medicine. In order to solve the problems, the enteric-coated preparation is prepared by using rabeprazole sodium as the main medicine and adopting three layers of coatings, wherein the three coating layers are respectively an alkaline protective layer, an isolation layer and an enteric-coated layer from inside to outside; the alkaline protective layer comprises film forming agents, lubricating agents, light-screening agents, alkaline stabilizing agents and solvents and the pH value of the coating solution is 8.0-13.0; the isolation layer comprises film forming agents, lubricating agents, plasticizers, light-screening agents and solvents and the pH value of the coating solution is 7.0-8.0; the enteric-coated layer comprises film forming agents, plasticizers, lubricating agents, light-screening agents, stabilizing agents and solvents and the pH value of the coating solution is 5.0-6.0. The enteric-coated preparation has the characteristics of short product production cycle and less influence caused by environments, temperatures, humidity and dust pollution.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to an enteric-coated preparation of proton pump inhibitor rabeprazole sodium and a preparation method thereof. Background technique [0002] The chemical structural formula of rabeprazole sodium is: [0003] [0004] Chemical name: 2-[{4-(3-methoxypropoxy)-3-methylpyridin-2-yl}-methylsulfinyl]-1 hydrogen-benzimidazole sodium salt. [0005] Rabeprazole sodium is a new generation of benzimidazole substitute after omeprazole and lansoprazole, and it is a strong inhibitor of the proton pump in the parietal cell tip secretion membrane. Rabeprazole sodium specifically inhibits H + -K + - The activity of ATPase, which is a key enzyme in gastric acid production, has an inhibitory effect on basal gastric acid and gastric acid secretion caused by stimulation. Rabeprazole sodium is suitable for gastric ulcer, duodenal ulcer, erosive gastroesophageal reflux disease, and Helicobacter py...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4439A61P1/04A61P31/04
Inventor 彭守明周桂梅晁锐
Owner 成都迪康药业股份有限公司
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