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S-pantoprazole sodium enteric-coated tablet and preparation method thereof

A technology of pantoprazole sodium and enteric-coated tablets, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of large coefficient of variation and poor stability, and achieve stability Excellent performance, small coefficient of variation, good curative effect and stability

Active Publication Date: 2014-08-06
GUANGDONG HUANAN PHARMACEUTICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The object of the present invention is to: provide a kind of S-pantoprazole sodium enteric-coated tablet, aim at solving the problems such as poor stability of existing S-pantoprazole sodium enteric-coated tablet, the coefficient of variation of stripping out etc.

Method used

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  • S-pantoprazole sodium enteric-coated tablet and preparation method thereof
  • S-pantoprazole sodium enteric-coated tablet and preparation method thereof
  • S-pantoprazole sodium enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The preparation of embodiment one S-pantoprazole sodium enteric-coated tablet

[0024] 1. Chip core

[0025] Material name

Dosage

S-pantoprazole sodium sesquihydrate

22.55mg

microcrystalline cellulose

27mg

Mannitol

63mg

Cross-linked polyvinylpyrrolidone

4mg

magnesium oxide

7mg

2% hypromellose 50% ethanol solution

0.6mg

Magnesium stearate

0.91mg

[0026] 2. Isolation layer

[0027] Opadry 17K69000

12g

double distilled water

88g

[0028] 3. Enteric-coated layer

[0029] Opadry 93O36628

20g

double distilled water

80g

[0030] The preparation of tablet core: get the S-pantoprazole sodium sesquihydrate of recipe quantity, microcrystalline cellulose, mannitol, cross-linked polyvinylpyrrolidone, magnesium oxide, cross 80 mesh sieves and mix; Add 2 50% ethanol solution of % hypromellose, passed through a 20-mesh sie...

Embodiment 2

[0034] The preparation of embodiment two S-pantoprazole sodium enteric-coated tablets

[0035] 1. Chip core

[0036] Material name

Dosage

S-pantoprazole sodium sesquihydrate

22.55mg

microcrystalline cellulose

45mg

Mannitol

45mg

Sodium carboxymethyl starch

8mg

magnesium oxide

7mg

2% hypromellose 50% ethanol solution

0.6mg

Magnesium stearate

0.91mg

[0037] 2. Isolation layer

[0038] Opadry 17K69000

12g

double distilled water

88g

[0039] 3. Enteric-coated layer

[0040] Opadry 93O36628

20g

double distilled water

80g

[0041] The preparation of tablet core: get the S-pantoprazole sodium sesquihydrate of recipe quantity, microcrystalline cellulose, mannitol, sodium carboxymethyl starch, magnesium oxide, cross 80 mesh sieves and mix; Add 2 50% ethanol solution of % hypromellose, passed through a 20-mesh sieve to granu...

Embodiment 3

[0045] The preparation of embodiment three S-pantoprazole sodium enteric-coated tablets

[0046] 1. Chip core

[0047] Material name

Dosage

S-pantoprazole sodium sesquihydrate

22.55mg

microcrystalline cellulose

27mg

Mannitol

63mg

Sodium carboxymethyl starch

8mg

magnesium oxide

7mg

2% hypromellose 50% ethanol solution

0.6mg

Magnesium stearate

0.91mg

[0048] 2. Isolation layer

[0049] Opadry 17K69000

12g

double distilled water

88g

[0050] 3. Enteric-coated layer

[0051] Opadry 93O36628

20g

double distilled water

80g

[0052] The preparation of tablet core: get the S-pantoprazole sodium sesquihydrate of recipe quantity, microcrystalline cellulose, mannitol, sodium carboxymethyl starch, magnesium oxide, cross 80 mesh sieves and mix; Add 2 50% ethanol solution of % hypromellose, passed through a 20-mesh sieve to gra...

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Abstract

The invention is applicable to the field of pharmaceutic preparations, and provides an S-pantoprazole sodium enteric-coated tablet and a preparation method thereof. The enteric-coated tablet is prepared by wrapping an S-pantoprazole sodium tablet core with an isolated layer and an enteric layer; the tablet core comprises the following components by weight percent: 15-20% of S-pantoprazole sodium, 60-75% of filler, 0.2-1% of binder, 2-8% of disintegrant, 4-10% of stabilizer and 0.2-1% of lubricating agent, wherein the weight gain of the isolated layer is 1-10% of weight of the tablet core; the weight gain of the enteric layer is 8-18% of the weight of the tablet core. By adopting the S-pantoprazole sodium enteric-coated tablet provided by the invention, not only can the problem of an unstable storage process be solved, but also the drug disintegration time can be shortened, and the problem of a large digestion variable coefficient is improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an S-pantoprazole sodium enteric-coated tablet and a preparation method thereof. Background technique [0002] Pantoprazole sodium is a proton pump inhibitor, which can specifically inhibit the H+, K+-ATPase on the secretory microtubules formed by the apical membrane of parietal cells and the tubular vesicles in the cytoplasm, causing irreversible inhibition of the enzymes. Thereby effectively inhibiting the secretion of gastric acid, not only can non-competitively inhibit gastric acid secretion caused by gastrin, histamine, and choline, but also inhibit part of the basic gastric acid secretion that is not affected by choline or H2 receptor blockers. Effectively reduce gastric acid secretion, for the treatment of duodenal ulcer, gastric ulcer, reflux esophagitis and Zoller-Ellison syndrome, especially for ulcer with bleeding, vomiting or inability to eat, intractable ul...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/4439A61K47/26A61K47/36A61K47/38A61K47/32
Inventor 谢称石操锋秦超叶琼仙原素杜静
Owner GUANGDONG HUANAN PHARMACEUTICAL GROUP CO LTD
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