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Fast releasing solid omeprazole prepn and its prepn process

A solid preparation, omeprazole technology, applied in the field of pharmaceutical preparations, can solve problems such as gastrointestinal damage

Inactive Publication Date: 2007-06-06
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is also generally believed that sodium hydroxide is a strong base, and if the dosage is not well controlled, it will cause damage to the gastrointestinal tract.

Method used

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  • Fast releasing solid omeprazole prepn and its prepn process
  • Fast releasing solid omeprazole prepn and its prepn process
  • Fast releasing solid omeprazole prepn and its prepn process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Common tablets each containing omeprazole 10 mg and sodium hydroxide 350 mg were prepared.

[0063] The prescription is:

[0064] Omeprazole 1g

[0065] Sodium hydroxide 35g

[0066] Aluminum magnesium carbonate 100g

[0067] Total weight 136g

[0068] The preparation process is: (Operation in dark place, humidity control and temperature control, the same below)

[0069] Raw and auxiliary materials are pulverized through 80 mesh sieves, and the omeprazole, sodium hydroxide and aluminum magnesium carbonate of prescription quantity are taken and mixed evenly, and directly compressed into tablets, and 100 fast-disintegrating tablets are made altogether, each containing omeprazole 10mg, Sodium hydroxide 350mg, tablet diameter 1.6cm, hardness 4-5kg, store in a dry and low temperature place.

Embodiment 2

[0071] Prepare fast-disintegrating tablets each containing 10 mg of omeprazole and 400 mg of sodium hydroxide.

[0072] The prescription is:

[0073] Omegra 1g

[0074] Sodium hydroxide 40g

[0075] Calcium hydrogen phosphate 54g

[0076] Croscarmellose Sodium 15g

[0077] 2% Povidone Alcohol Solution QS

[0078] Total weight 110g

[0079] The preparation process is: (Operation in dark place, humidity control and temperature control, the same below)

[0080] Raw and auxiliary materials are crushed through an 80-mesh sieve, weighed omeprazole, sodium hydroxide, calcium hydrogen phosphate and 50% of the prescribed amount of croscarmellose sodium and mixed evenly, add 2% povidone alcohol solution Appropriate amount, granulate with a 24-mesh sieve, dry at 40°C for 5 hours, granulate with a 30-mesh sieve, add 50% of the prescription amount of croscarmellose sodium, mix evenly, and press into tablets to make a total of 100 rapidly disintegrating tablets , each tablet contains...

Embodiment 3

[0083] Each chip containing 20 mg of omeprazole and 600 mg of sodium hydroxide was prepared.

[0084] The prescription is:

[0085] Omeprazole 2g

[0086] Sodium hydroxide 60g

[0087] Cyclodextrin 30g

[0088] Cross-linked polyvinylpyrrolidone 40g

[0089] 2% Povidone Alcohol Solution QS

[0090] Total weight 100g

[0091] The preparation process is: (operation in dark place, the same below)

[0092] Raw and auxiliary materials are pulverized through 80 mesh sieves, and the omeprazole of prescription quantity, the sodium hydroxide of 50% prescription quantity and the cross-linked polyvinylpyrrolidone of 50% prescription quantity are taken by weighing, and the medicine-containing pill core is prepared, and the hydrogen of 50% prescription quantity is added. The sodium oxide, the cyclodextrin of the prescribed amount and the cross-linked polyvinylpyrrolidone of 50% of the prescribed amount are mixed uniformly, and directly compressed into tablets. Pack 100 chips, each co...

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Abstract

The present invention relates to medicine preparation, and is especially one kind of fast releasing solid omerprazole preparation and its preparation process. The present invention combines omerprazole with certain amount of sodium hydroxide, and the medicine preparation can neutralize gastric acid and the medicine may be absorbed effectively. Certain amount of sodium hydroxide can neutralize gastric acid without causing gastrointestinal damage.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an instant-release solid preparation of omeprazole and a preparation method thereof. Background technique [0002] Omeprazole (OPZ) is the first clinical proton pump inhibitor, which irreversibly inhibits H + -K + -ATPase activity, thereby blocking the last link of gastric acid secretion, because of its remarkable acid-suppressing effect, and its safety and reliability, it is widely used in clinical practice. [0003] Omeprazole is unstable under acidic conditions, and it is easily degraded in the stomach when it is taken directly orally. At present, intravenous injection or oral enteric-coated solid preparations are mostly used clinically. For example: Chinese patent CN200410017827.X describes omeprazole enteric-coated granule preparation, which contains: active ingredient ball core, film isolation layer and enteric coating layer; Chinese patent CN96193594. Enteric-...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/48A61K31/4439A61K47/04A61P1/04
Inventor 朱家壁杨燕
Owner CHINA PHARM UNIV
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