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Pantoprazole sodium enteric-coated tablet and preparation method thereof

A technology of pantoprazole sodium plain tablets and pantoprazole sodium, which is applied in the field of biomedicine, can solve the problems of long disintegration time of pantoprazole sodium enteric-coated tablets, unstable storage process, etc., and reduce the labor force of workers Strength, low production cost, and reasonable composition

Active Publication Date: 2013-04-03
SHIJIAZHUANG HUAXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The invention provides a pantoprazole sodium enteric-coated tablet capable of solving technical problems such as long disintegration time of the existing pantoprazole sodium enteric-coated tablet and instability during storage, and provides the product of the enteric-coated tablet Preparation

Method used

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  • Pantoprazole sodium enteric-coated tablet and preparation method thereof
  • Pantoprazole sodium enteric-coated tablet and preparation method thereof
  • Pantoprazole sodium enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Plain Tablet Prescription:

[0042]

[0043]

[0044] Formulation of coating solution for isolation layer:

[0045]

[0046] Formulation of enteric layer coating solution:

[0047]

[0048] Preparation:

[0049] (1) Pass pantoprazole sodium through an 80-mesh sieve, crush the pH regulator through an 80-mesh sieve, and pass the filler through a 60-mesh sieve for later use;

[0050] (2) Weigh the prescribed amount of pantoprazole sodium, filler, disintegrant (internal added part), and pH regulator into the wet granulator, and mix for 5 minutes until uniform;

[0051] (3) Add an appropriate amount of 10% povidone K30 aqueous solution (adjust the pH value to 11.0) to make a soft material, granulate with a 20-mesh sieve, dry, and granulate through a 18-mesh sieve for later use;

[0052] (4) Add the prescribed amount of lubricant and disintegrant (additional part) to the granules, mix for 15 minutes until uniform, and press into tablets;

[0053] (5) Wrap the ...

Embodiment 2

[0056] Plain Tablet Prescription:

[0057]

[0058] Formulation of coating solution for isolation layer:

[0059]

[0060] Formulation of enteric layer coating solution:

[0061]

[0062] Preparation::

[0063] (1) Pass pantoprazole sodium through an 80-mesh sieve, crush the pH regulator through an 80-mesh sieve, and pass the filler through a 60-mesh sieve for later use;

[0064] (2) Weigh the prescribed amount of pantoprazole sodium, filler, disintegrant, and pH regulator into the wet granulator, and mix for 5 minutes until uniform;

[0065](3) Add an appropriate amount of 10% povidone K30 aqueous solution (adjust the pH value to 8.0) to make soft materials, granulate with a 20-mesh sieve, dry, and granulate through a 18-mesh sieve for later use;

[0066] (4) Add the prescribed amount of lubricant to the granules, mix for 15 minutes until uniform, and press into tablets;

[0067] (5) Wrap the isolation layer and increase the weight by 1.0%;

[0068] (6) Wrap the...

Embodiment 3

[0070] Plain Tablet Prescription:

[0071]

[0072] Formulation of coating solution for isolation layer:

[0073]

[0074] Formulation of enteric layer coating solution:

[0075]

[0076] Preparation::

[0077] (1) Pass pantoprazole sodium through an 80-mesh sieve, crush the pH regulator through an 80-mesh sieve, and pass the filler through a 60-mesh sieve for later use;

[0078] (2) Weigh the prescribed amount of pantoprazole sodium, filler, disintegrant (internal added part), and pH regulator into the wet granulator, and mix for 5 minutes until uniform;

[0079] (3) Add an appropriate amount of 10% povidone K30 aqueous solution to make a soft material, granulate with a 20-mesh sieve, dry, and granulate through a 18-mesh sieve for later use;

[0080] (4) Add the prescribed amount of lubricant and disintegrant (additional part) to the granules, mix for 15 minutes until uniform, and press into tablets;

[0081] (5) Wrap the isolation layer and increase the weight b...

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PUM

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Abstract

The invention provides a pantoprazole sodium enteric-coated tablet and a preparation method thereof. The pantoprazole sodium enteric-coated tablet comprises a pantoprazole sodium tablet, an isolated layer and an enteric-coated layer, wherein the pantoprazole sodium tablet comprises main drug pantoprazole sodium and auxiliaries; and the auxiliaries include a filler, a disintegrant, a lubricating agent, an adhesive, a pH regulating agent, and the like. The pantoprazole sodium enteric-coated tablet accelerates the disintegration time of the pantoprazole sodium enteric-coated tablet and solves the problem of drug instability during a storage period.

Description

technical field [0001] The invention relates to the technical field of biomedicine, and relates to an enteric-coated tablet and a preparation method thereof, in particular to a pantoprazole sodium enteric-coated tablet and a preparation method thereof which have undergone process research and verification. Background technique [0002] Pantoprazole Sodium Enteric-Coated Tablets are developed by Nycomyn, Germany. Pantoprazole is the third proton pump inhibitor in the world after omeprazole and lansoprazole, and is mainly used for the treatment of duodenal and gastric ulcer and relief of moderate to severe reflux esophagitis. It was listed in South Africa for the first time in 1994, and it was launched in China in 2001 under the product name "Pantoroc". [0003] Pantoprazole is a benzimidazole derivative that inhibits gastric acid secretion by specifically binding to the proton pump on gastric parietal cells. Pantoprazole is activated in the acidic secretion tubules of gastr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4439A61P1/04
Inventor 张云张硕王敏郭卿马海波李明海
Owner SHIJIAZHUANG HUAXIN PHARMA
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