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An enteric coated mini-pill of pantoprazole sodium

A technology of pantoprazole sodium and enteric-coated pellets is applied in the directions of non-active ingredients such as medical preparations, digestive systems, organic active ingredients, etc., and can solve the problems of low stability of pellets, difficult industrialization of the preparation process, and the like, To achieve the effect of benefiting labor protection, reducing the chance of drug contamination, and improving efficiency

Active Publication Date: 2006-12-27
HANGZHOU ZHONGMEI HUADONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to overcome the low stability of the pellets in the prior art, the deficiencies that the preparation process is difficult to industrialize, provide a more stable pantoprazole sodium enteric-coated pellets, and provide an industrializable preparation method at the same time

Method used

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  • An enteric coated mini-pill of pantoprazole sodium
  • An enteric coated mini-pill of pantoprazole sodium

Examples

Experimental program
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Effect test

preparation example Construction

[0037] 1. Preparation of ball core

[0038] 1. Preparation of medicinal liquid,

Embodiment 1

[0040] Use a clean stainless steel bucket to accurately weigh about 340g of ethanol, add 25g of PVP, and stir while adding, until the PVP is completely dissolved and the solution becomes clear and transparent. Add approximately 440 g of the former powder of pantoprazole sodium into the prepared PVP solution, stir while adding, and continue to stir for 10 minutes, pass through a 60-mesh sieve, and remove solid matter greater than 60 mesh. Put the solution less than 60 mesh in another clean stainless steel barrel, and use Na 2 Adjust the pH value to 11 with CO3 and set aside. The raw material concentration of the solution is 50%.

Embodiment 2

[0042] Pantoprazole Sodium 440g

[0043] HPMC 120g

[0044] Lactose 800g

[0045] Purified water 1310g

[0046] Adjust the pH to 13 with 4% NaOH, and the solution concentration is 15%.

[0047] The preparation method is the same as in Example 1.

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Abstract

The invention discloses pantoprazole sodium enteric pellets which comprise cores containing pantoprazole sodium and enteric coating containing cellulose substances. The invention also discloses the process for preparing the cores. The invention realize higher preparation stability and facilitated mass production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to pantoprazole sodium enteric-coated pellets. Background technique [0002] Pantoprazole sodium (pantoprazole sodium) is a proton pump inhibitor developed and marketed by German Becton Pharmaceuticals. It is widely used in various acid-related diseases, such as duodenal ulcer, gastric ulcer, moderate and severe Reflux esophagitis, etc., and has the advantages of high curative effect, short course of treatment, good tolerance and low recurrence rate. [0003] At present, enteric-coated tablets and ordinary enteric-coated capsules are widely used in China. They are single-dose drugs. The reproducibility of the enteric-coated effect is not good, and it is easy to cause excessive local concentration to stimulate the gastric mucosa. The enteric-coated pellets can increase the contact area between the drug and the gastrointestinal tract, so that the drug can be completely abso...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/4439A61K47/38A61K47/02A61K47/10A61P1/04
Inventor 姚忠立鄢丰车宝军
Owner HANGZHOU ZHONGMEI HUADONG PHARMA
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