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Rapid-release compound omeprazole tablet and preparation method thereof

A technology of omeprazole tablets and omeprazole, which is applied in the direction of pill delivery, digestive system, drug combination, etc., and can solve the problems of highly unstable acid and affecting the rapid treatment of drugs, etc.

Inactive Publication Date: 2012-11-28
HUATUO MEDICINES CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Omeprazole is highly unstable to acid and is easy to degrade and denature in acidic and neutral media. Considering the stability, the enteric coating layer can protect omeprazole from contact with acidic gastric juice, but it also affects the rapid treatment of drugs the goal of

Method used

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  • Rapid-release compound omeprazole tablet and preparation method thereof
  • Rapid-release compound omeprazole tablet and preparation method thereof
  • Rapid-release compound omeprazole tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Tablet core prescription: divided into two specifications of omeprazole 20mg and 40mg, the prescriptions of the two specifications in the tablet core remain unchanged except for omeprazole.

[0031]

[0032] Tablet core preparation method:

[0033] 1. Weigh omeprazole, sodium bicarbonate, magnesium hydroxide, hydroxypropyl cellulose, and croscarmellose sodium according to the prescription amount, add an appropriate amount of water, granulate, and dry at 50°C until the water content is less than 2.0%. , Determination of intermediate content.

[0034] 2. According to the prescription composition and content determination results, convert the dosage of hard sodium fumarate and add it to the dry granules. Mix well and compress into tablets.

[0035] For the sample prepared in Example 1, measure the content, dissolution rate and related substances of omeprazole, and the content of sodium bicarbonate and magnesium hydroxide. And investigate the increase of omeprazole-re...

Embodiment 2

[0041] Tablet core prescription: same as embodiment 1.

[0042]

[0043] Tablet core preparation method:

[0044] 1. Weigh sodium bicarbonate, magnesium hydroxide and polymer material hydroxypropyl cellulose according to the prescription amount, add appropriate amount of water, granulate, dry at 50°C until the water content is less than 2.0%, crush the granules, and pass through a 60-mesh sieve.

[0045] 2. Take omeprazole and other auxiliary materials according to the prescription amount, mix them with the prepared granules in an equal amount increasing method, and compress into tablets.

[0046] Table 2 Determination results of compound omeprazole tablets (Example 2)

[0047]

[0048] In Example 2, before mixing with omeprazole, first mix sodium bicarbonate and magnesium hydroxide evenly, then mix evenly with hydroxypropyl cellulose, then granulate with water, dry at 50°C, and control the moisture content of the granules to be less than 2.0 %, and ensure that the gra...

Embodiment 3

[0051] Tablet core prescription: omeprazole 20 mg is used as the screening basis for disintegrant dosage.

[0052]

[0053] Tablet core preparation method:

[0054]1. Weigh sodium bicarbonate, magnesium hydroxide and polymer material hydroxypropyl cellulose according to the prescription amount, add appropriate amount of water, granulate, dry at 50°C until the water content is less than 2.0%, crush the granules, and pass through a 60-mesh sieve.

[0055] 2. Take omeprazole and other auxiliary materials according to the prescription amount, mix them with the prepared granules in an equal amount increasing method, and compress into tablets.

[0056] Table 3 Determination results of compound omeprazole tablets (Example 3)

[0057] Measurement items

A

B

C

Dissolution (%)

88.2

92.4

96.6

[0058] In Example 3, further studies were conducted on the amount of disintegrant in the formulation. Croscarmellose sodium is selected as the d...

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Abstract

The invention relates to a rapid-release compound omeprazole tablet and a preparation method thereof; the tablet contains effective amounts of omeprazole, sodium bicarbonate and magnesium hydroxide, and selectively contains or does not contain one or more than one pharmaceutically accepted auxiliary material; the tablet is characterized in that the tablet contains a proton pump inhibitor of omeprazole, contains antacids of sodium bicarbonate and magnesium hydroxide which can neutralize gastric acid and change the pH environment in gastric juice, and also contains one or more than one of pharmaceutical auxiliary materials of hydroxy propyl cellulose, cross-linked sodium carboxymethyl cellulose, and sodium stearyl fumaryl. The tablet of the invention can effectively prevent degradation of omeprazole caused by acidic substances in gastric juice, and unexpectedly reach the purpose of rapid disintegration of the drug.

Description

technical field [0001] The present invention relates to pharmaceutical preparation technology. More specifically, the present invention relates to a preparation method of an immediate-release compound tablet containing omeprazole, sodium bicarbonate and magnesium hydroxide. Background technique [0002] Omeprazole (Omeprazole), the chemical name is 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfoxide}- 1H-benzimidazole, the structural formula is as follows: [0003] [0004] Omeprazole is a benzimidazole proton pump inhibitor, which can inhibit the proton pump in the gastric parietal cell membrane (H + ,K + -ATPase system), so that the H+ in the cell wall cannot be transported to the gastric juice, thereby inhibiting the secretion of gastric acid. Omeprazole is widely used in the treatment of reflux esophagitis, gastrinoma, and gastric and duodenal ulcers. Since omeprazole is easily degraded in an acidic environment, in order to maintain its pharmacolog...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4439A61K47/38A61P1/04
Inventor 李宏良宋杏花王守旭郑家富吴刘胜彭秀忠刘书彬徐晓燕朱杨超曾艳
Owner HUATUO MEDICINES CO LTD
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