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An enteric-coated tablet containing D-rabeprazole or a pharmaceutically acceptable salt thereof, and a preparation method therefor

A technology of dex-rabeprazole and rabeprazole, which is applied in the field of enteric-coated tablets containing dex-rabeprazole or its pharmaceutically acceptable salts and its preparation, can solve the problem that the degradation of rabeprazole cannot be guaranteed , adverse reactions and other problems, to achieve the effect of convenient operation, good stability and simple preparation process

Inactive Publication Date: 2013-07-17
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the powder mixture, the degradation of rabeprazole during the production process cannot be guaranteed
[0007] CN 101134036A discloses a pharmaceutical composition comprising 10-80 parts of rabeprazole and 100-5000 parts of sodium bicarbonate, but a large amount of alkaline buffer can also cause adverse reactions

Method used

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  • An enteric-coated tablet containing D-rabeprazole or a pharmaceutically acceptable salt thereof, and a preparation method therefor
  • An enteric-coated tablet containing D-rabeprazole or a pharmaceutically acceptable salt thereof, and a preparation method therefor
  • An enteric-coated tablet containing D-rabeprazole or a pharmaceutically acceptable salt thereof, and a preparation method therefor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1: Preparation of dex-rabeprazole enteric-coated tablets

[0033] Tablet prescription:

[0034] D-Rabeira Sodium

1 copy

Mannitol

4 parts

Crospovidone

0.2 parts

Sodium carbonate

1 copy

Concentrated ammonia solution (pH 9.0)

Appropriate amount

Magnesium stearate

0.05 parts

[0035] The raw and auxiliary materials are all passed through a 100-mesh sieve, mixed evenly, an appropriate amount of concentrated ammonia solution (pH 9.0) is added, granulated, dried at 50°C, granulated through a 20-mesh sieve, magnesium stearate is added, and tabletted to obtain tablet cores.

[0036] Coating formula:

[0037] Gastric coating powder 10g

[0038] 50% ethanol solution 100g

[0039] Disperse the stomach-soluble coating powder in 50% ethanol solution, stir evenly, coat the tablet core, increase the weight by 7%, and obtain (1).

[0040] Enteric coating formula:

[0041] Enteric coating powder 20...

Embodiment 2

[0044] Example 2: Preparation of dex-rabeprazole enteric-coated tablets

[0045] Tablet prescription:

[0046] Dexrabeprazole Sodium

1 copy

lactose

20 copies

Sodium carboxymethyl starch

4 parts

magnesium oxide

10 copies

Aqueous sodium hydroxide solution (pH 11.0)

Appropriate amount

Magnesium stearate

2 copies

[0047] The raw and auxiliary materials are all passed through a 100-mesh sieve, mixed evenly, an appropriate amount of sodium hydroxide solution (pH 11.0) is added, granulated, dried at 50°C, granulated through a 20-mesh sieve, magnesium stearate is added, and tabletted to obtain tablet cores.

[0048] Coating formula:

[0049] Gastric coating powder 10g

[0050] 50% ethanol solution 100g

[0051] Disperse the gastric-soluble coating powder in 50% ethanol solution, stir evenly, coat the tablet core, increase the weight by 6%, and obtain (1).

[0052] Enteric coating formula:

[0053] Enter...

Embodiment 3

[0056] Example 3: Preparation of dex-rabeprazole enteric-coated tablets

[0057] Tablet prescription:

[0058] Dexrabeprazole Sodium

1 copy

Mannitol

12 copies

Sodium carboxymethyl starch

2 copies

magnesium oxide

5 copies

Concentrated ammonia solution (pH 10.5)

Appropriate amount

Magnesium stearate

0.5 parts

[0059] The raw and auxiliary materials are all passed through a 100-mesh sieve, mixed evenly, an appropriate amount of concentrated ammonia solution (pH 10.5) is added, granulated, dried at 40°C, granulated through a 20-mesh sieve, magnesium stearate is added, and tabletted to obtain tablet cores.

[0060] Coating formula:

[0061] Gastric coating powder 10g

[0062] 50% ethanol solution 100g

[0063] Disperse the stomach-soluble coating powder in 50% ethanol solution, stir evenly, coat the tablet core, increase the weight by 7%, and obtain (1).

[0064] Enteric coating formula:

[0065] Enteri...

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PUM

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Abstract

The present invention relates to an enteric-coated tablet containing D-rabeprazole or a pharmaceutically acceptable salt thereof, and a preparation method therefor. The tablet comprises a tablet core and a coating layer. The tablet core is prepared by using the D-rabeprazole or the pharmaceutically acceptable salt thereof, and pharmaceutically acceptable excipients through a wet granulation process, wherein the binder used in the wet granulation process has a pH of 9-14. The tablet of the invention has good stability, and the preparation method is simple and easy to operate, thus being suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of western medicine preparations, in particular to an enteric-coated tablet containing dex-rabeprazole or a pharmaceutically acceptable salt thereof and a preparation method thereof. Background technique [0002] Rabeprazole is a second-generation proton pump inhibitor that specifically inhibits parietal cell H + , K-ATPase system to block the final step of gastric acid secretion, the effect is dose-dependent, and can inhibit the secretion of basic gastric acid and gastric acid secretion under stimulation. Rabeprazole includes two optical isomers, left-handed and right-handed. The actual active ingredient used is a racemic mixture, but experiments have shown that the pharmacological effects of the right-handed isomer are significantly stronger than those of the left-handed and racemic. The minimum effective dose of the conformation is smaller than that of the racemate, and the metabolic half-life is longer,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4439A61P1/04
Inventor 郝贵周郭增光
Owner SHANDONG NEWTIME PHARMA
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