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Enteric solid preparation using pantoprazole sodium as major ingredients and preparation method thereof

A technology of pantoprazole sodium and solid preparations, which is applied in the field of enteric-coated solid preparations with pantoprazole sodium as the main component and its preparation, and can solve the problems of patients being easily bitten and losing their enteric properties

Inactive Publication Date: 2010-07-21
北京利乐生制药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, both of them have the characteristics of being easily bitten by the patient and losing their enteric properties when taking them. Ordinary enteric-coated capsules are prone to such phenomena.

Method used

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  • Enteric solid preparation using pantoprazole sodium as major ingredients and preparation method thereof
  • Enteric solid preparation using pantoprazole sodium as major ingredients and preparation method thereof
  • Enteric solid preparation using pantoprazole sodium as major ingredients and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Pellet composition:

[0023]

[0024] Isolation layer components:

[0025]

[0026] Enteric coating layer components:

[0027]

[0028] Preparation Process:

[0029] 1. Take pantoprazole sodium 1.5 hydrate, microcrystalline cellulose, crospovidone, polyvinylpyrrolidone, and sodium carbonate and mix them uniformly by equal addition method, then add soft material made of Tween 80, and add to centrifuge In the granulator, the pellet core containing the drug is produced by centrifugal granulation technology, with a diameter of 1.0 mm.

[0030] 2. Take each component of the isolation layer, prepare a coating solution according to the prescription, and coat it on the surface of the pill core by fluidized coating technology.

[0031] 3. Take each component of the enteric coating layer, prepare a swirling solution according to the prescription, and further coat it on the surface of the isolation layer by fluidized coating technology.

[0032] 4. Gained enteric-coat...

Embodiment 2

[0034] Pellet composition:

[0035]

[0036] Isolation layer components:

[0037]

[0038] Enteric coating layer components:

[0039]

[0040] Preparation Process:

[0041] 1. Take pantoprazole sodium 1.5 hydrate, sucrose, crospovidone, polyvinylpyrrolidone, and sodium carbonate and mix them uniformly by equal addition method, then add Tween 80 soft material, and add it to the centrifugal granulator In , the pellet core with a diameter of 1.5mm was generated by centrifugal granulation technology.

[0042] 2. Take each component of the isolation layer, prepare a coating solution according to the prescription, and coat it on the surface of the pill core by fluidized coating technology.

[0043] 3. Take each component of the enteric coating layer, prepare a swirling solution according to the prescription, and further coat it on the surface of the isolation layer by fluidized coating technology.

[0044] 4. Gained enteric-coated pellets are packed into capsules, each ...

Embodiment 3

[0046] Pellet composition:

[0047]

[0048] Isolation layer components:

[0049]

[0050] Enteric coating layer components:

[0051]

[0052] Preparation Process:

[0053] 1. Take pantoprazole sodium 1.5 hydrate, crospovidone, polyvinylpyrrolidone, and sodium carbonate and use the equal-volume incremental method to fully mix them evenly, and then layer them on the surface of the blank sucrose core by layering to generate pills containing core. The diameter is about 1.5mm.

[0054] 2. Take each component of the isolation layer, prepare a coating solution according to the prescription, and coat it on the surface of the pill core by fluidized coating technology.

[0055] 3. Take each component of the enteric coating layer, prepare a swirling solution according to the prescription, and further coat it on the surface of the isolation layer by fluidized coating technology.

[0056] 4. Gained enteric-coated pellets are divided into 1000 bags, each bag of 0.22g, contain...

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Abstract

The invention provides an enteric solid preparation using pantoprazole sodium as major ingredients and a preparation method thereof. The invention relates to an enteric solid preparation using pantoprazole sodium or hydrate thereof as active ingredients and a preparation method thereof. The invention aims at providing a novel pantoprazole sodium preparation for a large number of patients and medical personnel, and the novel pantoprazole sodium preparation fully exerts the medicine curative effect, reduces the adverse effect, is convenient for children and old people to take in a decrement way, is convenient to carry, store and transport, and is suitable for large-scale production. The invention uses the pantoprazole sodium or the hydrate thereof as the active ingredients, some accessory ingredients of specified types are proportionally added into the ingredients for being prepared into enteric grains or micropills according to the process provided by the invention, and the ingredients can be further prepared into dry suspension preparations or capsules.

Description

technical field [0001] An enteric-coated solid preparation with pantoprazole sodium as the main component and a preparation method thereof. The invention relates to an enteric-coated solid preparation with pantoprazole sodium and pharmaceutically acceptable salts or hydrates thereof as active ingredients for treating digestive tract diseases, preferably peptic ulcer, and a preparation method thereof. Background technique [0002] Pantoprazole sodium is the third listed H drug after omeprazole and lansoprazole + / K + ATP magnesium inhibitor, the indication is acute duodenal ulcer and gastric ulcer and the relief of moderate to severe reflux esophagitis. It was first successfully developed by BykGulden pharmaceutical company in Germany. It was first launched in 1994. Listed in Switzerland, the trade name is "Pantoloc". As soon as the drug was launched on the market, it was favored by clinicians from all over the world because of its good curative effect and excellent safety...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/4439A61K9/14A61K9/54A61P1/04A61P1/00
Inventor 李宝齐
Owner 北京利乐生制药科技有限公司
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