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Pantoprazole sodium enteric micro-pellet capsules and preparation method thereof

A technology of pantoprazole sodium enteric and soluble pellets, which can be used in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve problems such as poor stability

Inactive Publication Date: 2015-04-22
FUZHOU MINHAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The object of the present invention is to provide a kind of pantoprazole sodium enteric-coated micropill capsule and preparation method thereof, aim to solve the problem of poor stability of existing pantoprazole sodium enteric-coated micropill capsule, thereby improving the safety of product sex and bioavailability

Method used

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  • Pantoprazole sodium enteric micro-pellet capsules and preparation method thereof
  • Pantoprazole sodium enteric micro-pellet capsules and preparation method thereof
  • Pantoprazole sodium enteric micro-pellet capsules and preparation method thereof

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preparation example Construction

[0056] The preparation method of described pantoprazole sodium enteric-coated pellet capsule, comprises the following steps:

[0057] Each component is weighed according to the weight ratio of the components of each layer;

[0058] 1) Preparation of the main drug layer:

[0059] Under the condition of stirring, add hydroxypropyl methylcellulose into purified water, after completely dissolving, add sodium carbonate, pantoprazole sodium, sodium lauryl sulfate, Tween-80 in sequence, and get the main drug layer after stirring evenly Coating solution;

[0060] Place the blank pellet core in a pellet coating machine, and coat it with the main drug layer coating solution to obtain pellets containing the main drug layer;

[0061] 2) Wrap the first isolation layer:

[0062] Under the condition of stirring, add hydroxypropyl methylcellulose into purified water, after completely dissolving, add talcum powder, sodium carbonate, titanium dioxide in turn, after stirring evenly, grind in ...

Embodiment 1

[0078] A kind of preparation of pantoprazole sodium enteric-coated pellet capsule:

[0079] By weight, weigh the following components:

[0080] Main drug layer:

[0081] blank core

35.89 copies

Pantoprazole Sodium

5.82 copies

Hypromellose

1.75 servings

Sodium carbonate

0.40 servings

Sodium dodecyl sulfate

0.35 parts

Tween 80

0.70 servings

purified water

50 copies

[0082] First isolation layer:

[0083] Hypromellose

3.90 servings

Talc powder

0.20 servings

Sodium carbonate

0.03 parts

Titanium dioxide

0.70 servings

purified water

40 copies

[0084] Second isolation layer:

[0085] Hypromellose

3.90 servings

Talc powder

0.20 servings

Titanium dioxide

0.70 servings

[0086] purified water

40 copies

[0087] Enteric layer:

[0088] triethyl citrate ...

Embodiment 2

[0109] A kind of preparation of pantoprazole sodium enteric-coated pellet capsule:

[0110] By weight, weigh the following components:

[0111] Main drug layer:

[0112] blank core

35 copies

Pantoprazole Sodium

5.5 servings

Hypromellose

2 copies

Sodium carbonate

0.3 parts

Sodium dodecyl sulfate

0.4 parts

Tween 80

0.6 parts

purified water

40 copies

[0113] First isolation layer:

[0114] Hypromellose

3.5 servings

Talc powder

0.25 parts

Sodium carbonate

0.025 copies

Titanium dioxide

0.75 parts

purified water

30 copies

[0115] Second isolation layer:

[0116] Hypromellose

4.5 servings

Talc powder

0.25 parts

[0117] Titanium dioxide

0.75 parts

purified water

30 copies

[0118] Enteric layer:

[0119] triethyl citrate

1 copy

Talc powder...

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Abstract

The invention discloses pantoprazole sodium enteric micro-pellet capsules and a preparation method thereof. The micro-pellet capsules comprise a main medicine layer, a first isolation layer, a second isolation layer, an enteric layer, a pigment layer and a capsule layer from inside to outside. The micro-pellet capsules comprise the first and second isolation layers to ensure that an environment pH value of pantoprazole sodium can be slowly transited to a slightly acidic environment of the enteric layer, and under the protection of the enteric layer and two isolation layers, pantoprazole sodium and an enteric layer material with acidity can still exist stably under the condition of being placed for a long time, so that the stability of products can be ensured. Meanwhile, the preparation method disclosed by the invention is simple to operate, high in production efficiency, low in equipment investment and low in product cost.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pantoprazole sodium enteric-coated pellet capsule 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 ea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4439A61K47/38A61K47/32A61P1/04A61P1/18
Inventor 陈家煊
Owner FUZHOU MINHAI PHARMA
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