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Esomeprazole sodium enteric-coated preparation and preparation method thereof

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

Active Publication Date: 2016-05-11
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

In the existing technology for preparing esomeprazole sodium enteric-coated tablets, during the production process or during the product storage process, the properties of the intermediate product or the finished tablet core change, turning reddish or red, and the impurities exceed the standard. Hidden danger

Method used

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  • Esomeprazole sodium enteric-coated preparation and preparation method thereof
  • Esomeprazole sodium enteric-coated preparation and preparation method thereof
  • Esomeprazole sodium enteric-coated preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-6

[0122] Preparation method (method 1):

[0123] ①Mix esomeprazole sodium, 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 , 20-mesh sieve for granulation, add the remaining hydroxypropyl cellulose and magnesium stearate, mix well, and compress into tablets.

[0124] ② Coating: Dissolve and disperse the ingredients of each coating layer with 80% ethanol solution, sieve, mix well, and coat separately.

[0125] ③ After the coating is completed, dry the coated tablet until the water content is less than 1%, and pack it.

Embodiment 7-12

[0127] Preparation method (method 2):

[0128]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 esomeprazole sodium, remaining hydroxypropyl cellulose and magnesium stearate, mix well, and compress into tablets.

[0129] ② Coating: Dissolve and disperse the ingredients of each coating layer with 80% ethanol solution, sieve, mix well, and coat separately.

[0130] ③After the coating is completed, dry the coated tablet until the water content is less than 1%, and pack it.

[0131]

[0132]

[0133]

[0134] (2) Implementation example of two-layer coating

Embodiment 13-14

[0136] Preparation method (method 1):

[0137] ①Mix esomeprazole sodium, 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 , 20-mesh sieve for granulation, add the remaining hydroxypropyl cellulose and magnesium stearate, mix well, and compress into tablets.

[0138] ② Coating: Dissolve and disperse the ingredients of each coating layer with 80% ethanol solution, sieve, mix well, and coat separately.

[0139] 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 medicine, and in particular relates to an enteric-coated preparation of proton pump inhibitor esomeprazole sodium and a preparation method thereof. The property of esomeprazole sodium is very unstable, and preparation or improper storage can degrade rapidly, change color, directly affect the curative effect of medicine and drug safety, in order to solve the above problem, the enteric-coated preparation of the present invention is with esomeprazole sodium as The main drug is prepared by three-layer coating, and the three-layer coating layers from the inside to the outside are: alkaline protective layer, isolation layer, and enteric-coated layer; wherein: the alkaline protective layer includes film-forming agent, lubricant, Sunscreen agent, alkaline stabilizer, solvent, the pH value of the coating solution is 8.0-13.0; the isolation layer includes film-forming agent, lubricant, plasticizer, sunscreen agent, solvent, and the pH value of the coating solution is 7.0-8.0 ; The enteric layer includes a film-forming agent, a plasticizer, a lubricant, a sunscreen, a stabilizer, and a solvent, and the pH value of the coating solution is 5.0-6.0. The invention has the characteristics of short product production cycle and little influence from environment, temperature, 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 and a preparation method of esomeprazole sodium, a proton pump inhibitor. Background technique [0002] The chemical structural formula of esomeprazole sodium is: [0003] [0004] Chemical name: Sodium 5-methoxy-2-((S)-(4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl-1H-benzimidazole. [0005] Esomeprazole is a proton pump inhibitor (PPI), which is the left-handed isomer of omeprazole. It is the first PPI developed into an optical isomer. It was approved for marketing in the United States and European countries in 2001. In 2003 It was launched in my country in 2009. Due to its strong and long-lasting acid inhibitory effect and certain protective effect on gastric mucosa, it is currently the drug of choice for the treatment of acid-related diseases. [0006] Esomeprazole sodium is unstable under acidic conditions and enters the stomach where ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K31/4439A61P1/04
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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