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Pantoprazole sodium enteric capsule composition and preparation method thereof

A technology for pantoprazole sodium and enteric-coated capsules is applied in the field of pharmaceutical preparations, which can solve the problems of high substance content, complex preparation process, poor long-term storage stability, etc., and achieves high storage stability, high medication safety, and related substances. low content effect

Active Publication Date: 2017-01-25
HEBEI IDEAL & HIGHTECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, based on prescription composition, preparation process and other reasons, the pantoprazole sodium enteric-coated capsules in the prior art still have high content of related substances, poor long-term storage stability, and complicated preparation process (such as CN104523648A adopts a double-separation layer design) And other issues

Method used

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  • Pantoprazole sodium enteric capsule composition and preparation method thereof
  • Pantoprazole sodium enteric capsule composition and preparation method thereof
  • Pantoprazole sodium enteric capsule composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0085]Embodiment 1-4 pantoprazole sodium enteric-coated capsule of the present invention

[0086] prescription:

[0087]

[0088] Note: In Examples 1 and 2, the weight ratio of povidone K30, trisodium phosphate and talcum powder in the drug-loaded layer is 3:5:5, and the hydroxypropyl methylcellulose E5 and polyethylene glycol in the isolation layer The weight ratio of 6000 is 10:1, and the weight ratio of polyethylene glycol 6000, titanium dioxide and talcum powder in the enteric coating layer is 1:1:0.5.

[0089] Preparation:

[0090] (1) Preparation of blank pellet cores

[0091] Using the coating granulator and atomizing spray technology, the sucrose, starch and 40% sucrose syrup (binder) in the core layer of the blank pellets were made into blank pellet cores of 18-24 mesh.

[0092] (2) Preparation of drug-loaded pellets

[0093] Dissolve povidone k30 and trisodium phosphate in the drug-loaded layer in purified water; add pantoprazole sodium under dark conditions t...

experiment example

[0100] Experimental example Study on the quality and storage stability of pantoprazole sodium enteric-coated capsules

[0101] Get the pantoprazole sodium enteric-coated capsule that embodiment 1-4 makes, commercially available pantoprazole sodium enteric-coated capsule, and the pantoprazole sodium enteric-coated pellet capsule prepared by CN104523648A embodiment 1, at 40 Stored for 12 months under the conditions of ℃±2℃ and relative humidity of 75%±5%, the test results of the percentage content of related substances are as follows:

[0102] Month 0:

[0103]

[0104] 3rd month:

[0105]

[0106] 6th month:

[0107]

[0108] 12th month:

[0109]

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Abstract

The invention provides a pantoprazole sodium enteric capsule composition and a preparation method thereof. A pantoprazole sodium enteric capsule provided by the invention is prepared from pantoprazole, starch, saccharose, 40% sugar syrup, povidone K30, trisodium phosphate, talcum powder, hydroxypropyl methyl cellulose E5, polyethylene glycol 6000, eudragit L30D-55, titanium dioxide and sodium hydroxide. The pantoprazole sodium enteric capsule composition has the advantages of low content of relevant substances, high storage stability, high drug use safety, simple preparation process, suitability for industrial production and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pantoprazole sodium enteric-coated capsule composition and a preparation method thereof. Background technique [0002] Pantoprazole Sodium (Pantoprazole Sodium) is a proton pump inhibitor of water-soluble weakly basic drugs, which is easy to concentrate in an acidic environment, so it can be specifically distributed in the secretory tubules of gastric mucosal parietal cells after oral administration, and here It is converted into the active form of sulfenamide in a high-acid environment, and then irreversibly combines with the sulfhydryl group of H+, K+-ATPase (also known as proton pump) in the secretory membrane of parietal cells through disulfide bonds to generate sulfenamide and The complex of the proton pump, thereby inhibiting the enzyme activity, blocking the last step of gastric acid secretion, so it has a strong and long-lasting inhibitory effect on ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K31/4439A61K47/38A61K47/32A61K47/10A61K47/02A61P1/04
CPCA61K9/501A61K9/5026A61K9/5031A61K9/5047A61K9/5078A61K31/4439
Inventor 张云升韩盼盼胡庆敏夏彤
Owner HEBEI IDEAL & HIGHTECH PHARMA
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