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Rabeprazole sodium enteric-coated micro-pellet and preparation method thereof

A technology of rabeprazole sodium and enteric-coated pellets, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., to achieve improved stability, increased stability, and efficient absorption Effect

Active Publication Date: 2012-07-11
NANJING CHANGAO PHARMA SCI & TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is still room for improvement in the stability data

Method used

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  • Rabeprazole sodium enteric-coated micro-pellet and preparation method thereof
  • Rabeprazole sodium enteric-coated micro-pellet and preparation method thereof
  • Rabeprazole sodium enteric-coated micro-pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] The present embodiment rabeprazole sodium enteric-coated pellets constitute the following table:

[0046]

[0047] Preparation:

[0048] (1) Preparation of the drug-loaded layer:

[0049] Swell HPMC in 20g of hot water, dissolve rabeprazole sodium in ethanol, and then mix the two evenly; add talcum powder and stir evenly, which is the coating solution of the drug-containing layer; then place the blank core in Prepare drug-loaded pellet cores in a centrifugal granulation coating machine or a fluidized bed;

[0050] (2) Preparation of isolation layer:

[0051] Dissolve PEG6000 and copovidone in 80% ethanol solution, then add magnesium oxide, titanium dioxide and talcum powder, and stir evenly to form the coating solution for the isolation layer; put the drug-loaded core in (1) into centrifugal granulation coating In the machine or fluidized bed, start the machine and wrap the isolation layer;

[0052] (3) Preparation of enteric-coated layer

[0053]Dissolve PEG600...

Embodiment 2

[0054] Embodiment 2 The enteric-coated pellets of rabeprazole sodium in this embodiment constitute the following table:

[0055]

[0056] The preparation method is the same as in Example 1.

Embodiment 3

[0058] The present embodiment rabeprazole sodium enteric-coated pellets constitute the following table:

[0059]

[0060]

[0061] The preparation method is the same as in Example 1.

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Abstract

The invention belongs to the field of medicament preparations, and relates to a rabeprazole sodium enteric-coated preparation and a preparation method thereof. A rabeprazole sodium enteric-coated micro-pellet disclosed by the invention comprises a blank pellet core, a medicament carrying layer, an isolating layer and an enteric-coated layer from inside to outside, wherein the weight increment of the medicament carrying layer is 10-20 percent; the weight increment of the isolating layer is 5-10 percent; the weight increment of the enteric-coated layer is 30-50 percent; the medicament carrying layer consists of rabeprazole sodium, hydroxypropyl methyl cellulose and talc powder; the isolating layer consists of copovidone, a plasticizing agent, talc powder, titanium dioxide and a stabilizing agent; the stabilizing agent is one or more of magnesium oxide, calcium oxide, sodium carbonate, sodium bicarbonate, potassium carbonate and potassium bicarbonate; and the enteric-coated layer consists of an enteric-coated material, a plasticizing agent, talc powder and titanium dioxide. The rabeprazole sodium enteric-coated micro-pellet disclosed by the invention has the effects of high solubility and high stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an enteric-coated preparation of rabeprazole sodium, a chemical drug for treating diseases such as gastric and duodenal ulcers, and a preparation method thereof. Background technique [0002] Rabeprazole sodium is a new type of proton pump inhibitor, which can be used to treat acid-related diseases, such as peptic ulcer, gastroesophageal reflux disease, Zoller-Ellison syndrome, etc. H2 receptor antagonists and proton pump inhibitors are the two most commonly used drugs for the treatment of acid-related digestive diseases. They both increase gastric pH, but proton pump inhibitors act on H+ / K+-ATPase and strongly inhibit gastric acid secretion. And to produce a large and lasting increase in gastric pH, rabeprazole sodium is the latest proton pump inhibitor. Compared with omeprazole, rabeprazole sodium has a faster onset of action and is a more effective inhib...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4439A61K47/32A61K47/38A61P1/04
Inventor 何红燕吴小涛徐丽钟雪斌宋巧莉李纬霍立茹孙晓
Owner NANJING CHANGAO PHARMA SCI & TECH CO LTD
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