Pellet type pantoprazole sodium enteric capsule and preparation method thereof

A technology of pantoprazole sodium and enteric-coated capsules, applied in the field of medicine, can solve the problems of insufficient release of active ingredients, easy degradation of active ingredients, large gastrointestinal irritation, etc., and achieves improved bioavailability, good curative effect reproducibility, The effect of improving solubility

Inactive Publication Date: 2015-05-27
ZHEJIANG CHANGDIAN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Existing pantoprazole sodium enteric-coated capsules have problems such as poor acid resistance, easy degradation of active ingredients, poor stability, large irritation to the stomach, or insufficient and timely release of active ingredients, and low utilization rate.

Method used

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  • Pellet type pantoprazole sodium enteric capsule and preparation method thereof
  • Pellet type pantoprazole sodium enteric capsule and preparation method thereof
  • Pellet type pantoprazole sodium enteric capsule and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0027] A micropill type pantoprazole sodium enteric-coated capsule is a sustained-release preparation, and the micropill type pantoprazole sodium enteric-coated capsule is composed of a capsule shell and pantoprazole sodium mixed uniformly contained in the capsule shell. Composition of azole sodium pellets, pantoprazole sodium pellets are blank ball core, main drug layer, isolation layer, enteric-coated layer successively from inside to outside, main drug layer weight is 14% of blank ball core, and isolation layer weight is 9% of the total weight of the blank core and the main drug layer, and the weight of the enteric layer is 28% of the total weight of the blank core, the main drug layer and the isolation layer, wherein 40% of the pantoprazole sodium pellets are outside the enteric layer Also coat the pigment layer, the pigment layer weight is 0.5% of the total weight of the blank ball core, the main drug layer, the isolation layer and the enteric layer, the diameter of the bl...

Embodiment 2

[0039] A micropill type pantoprazole sodium enteric-coated capsule is a sustained-release preparation, and the micropill type pantoprazole sodium enteric-coated capsule is composed of a capsule shell and pantoprazole sodium mixed uniformly contained in the capsule shell. Composition of azole sodium pellets, pantoprazole sodium pellets are blank ball core, main drug layer, isolation layer, enteric-coated layer successively from inside to outside, main drug layer weight is 20% of blank ball core, and isolation layer weight is 9.3% of the total weight of the blank core and the main drug layer, and the weight of the enteric layer is 29% of the total weight of the blank core, the main drug layer and the isolation layer, wherein 45% of the pantoprazole sodium pellets are outside the enteric layer Also coat the pigment layer, the pigment layer weight is 0.7% of the total weight of the blank ball core, the main drug layer, the isolation layer and the enteric coating layer, the diameter...

Embodiment 3

[0051] A micropill type pantoprazole sodium enteric-coated capsule is a sustained-release preparation, and the micropill type pantoprazole sodium enteric-coated capsule is composed of a capsule shell and pantoprazole sodium mixed uniformly contained in the capsule shell. Composed of azole sodium pellets, the pantoprazole sodium pellets are successively blank core, main drug layer, isolation layer, enteric-coated layer from inside to outside, the weight of the main drug layer is 30% of the blank core, and the isolation layer Weight is 9.5% of the total weight of blank ball core and main drug layer, and the weight of enteric layer is 30% of blank ball core, main drug layer and isolation layer total weight, wherein the pantoprazole sodium pellets of 50% are in enteric coat Also coat pigment layer outside the layer, the weight of pigment layer is 0.8% of the total weight of blank ball core, main drug layer, isolation layer and enteric coating layer, the diameter of blank ball core ...

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Abstract

The invention discloses a pellet type pantoprazole sodium enteric capsule and a preparation method thereof. The pellet type pantoprazole sodium enteric capsule is a sustained-release preparation composed of a capsule shell and uniformly mixed pantoprazole sodium pellets held in the capsule shell; the pantoprazole sodium pellet from inside to outside in turn comprises a blank pellet core, a main drug layer, an isolation layer and an enteric layer, wherein the weight of the main drug layer is 14-55% of that of the blank pellet core, the weight of the isolation layer is 9-10% of that of the total weight of the blank pellet core and the main drug layer, the weight of the enteric layer is 28-32% of that of the total weight of the blank pellet core, the main drug layer and the isolation layer; 40-60% of that of the pantoprazole sodium pellet is coated with a pigmented layer on the outside of the enteric layer; the weight of the pigmented layer is 0.5-1% of that of the total weight of the blank pellet core, the main drug layer, the isolation layer and the enteric layer; the diameter of the blank pellet core is 0.8-1.0 mm; the granularity of the pantoprazole sodium pellet is 14-20 mesh; each capsule contains 20-40 mg of the pantoprazole sodium. The pellet type pantoprazole sodium enteric capsule has the advantages of acidproof, rapid release and stable.

Description

technical field [0001] The invention relates to a pantoprazole sodium enteric-coated capsule and a preparation method thereof, in particular to a pellet-type pantoprazole sodium enteric-coated capsule and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Pantoprazole sodium, its chemical name is: 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl-1H-benzimidazole sodium Salt, molecular formula: C 16 h 14 f 2 N 3 NaO 4 S, molecular weight: 405.36. [0003] Pantoprazole sodium is a new generation of proton pump inhibitors after omeprazole and lansoprazole that can effectively inhibit the secretion of gastric acid. Its main pharmacological action is through the H of gastric parietal cells + / K + -ATPase, the proton pump, inhibits gastric acid secretion and treats acid disorders and Helicobacter pylori infection. Pantoprazole sodium is a benzimidazole compound containing a sulfinyl group, easily soluble ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/4439A61K47/38A61P1/04
Inventor 陈宇东李传丰来杭佳廖衍刘春波
Owner ZHEJIANG CHANGDIAN PHARMA
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