Omeprazole pellets and preparation method thereof

Abstract

The invention discloses omeprazole pellets which comprises, by weight, 1 part of omeprazole, 27.5-55 parts of sodium bicarbonate and 0-2 parts of lubricant. The invention further discloses a preparation method of the omeprazole pellets. The preparation method includes mixing well 1 part of the omeprazole, 5-25 parts of the sodium bicarbonate and 0-0.4 part of the lubricant, and making fine particles by dry granulating; and mixing residual accessories in a formula and the made fine particles to make pellets by dry granulating, wherein the particle size of the omeprazole pellets is smaller than 65 micrometers. By the preparation method using dry granulating and two-step embedding, the technical problems that in the prior art, omeprazole with unstable crystal form is easy to degrade and discolor, degradation products increase evidently in storage, and the like are solved. The formula and the preparation method are simple and are applicable to industrial production.

Description

technical field

[0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a granule containing omeprazole and a preparation method thereof. Background technique

[0002] Generally, gastric ulcer and duodenal ulcer are collectively referred to as peptic ulcer, sometimes simply referred to as ulcer. Gastric acid (hydrochloric acid) and pepsin (a type of enzyme) that originally digest food digest their own stomach and duodenal walls, thereby damaging the mucosal tissue, which is the main cause of peptic ulcers. Experimental and clinical studies in recent years have shown that factors such as excessive gastric acid secretion, Helicobacter pylori infection, and weakened protective effect of gastric mucosa are the main links that cause peptic ulcer. Delayed gastric emptying and bile reflux, the role of gastrointestinal peptides, genetic factors, drug factors, environmental factors and mental factors are all related to the occurrence of p...

Examples

Embodiment 1

[0034] Example 1 ( Preparation process of patent GB2459393 ）

[0035] Omeprazole 40mg 1 serving

[0036] Sodium bicarbonate 1100mg 27.5 parts

[0037] Croscarmellose Sodium 30mg 0.75 parts

[0038] Sodium stearyl fumarate 10mg 0.25 parts

[0039] 1180mg

[0040] Preparation Process:

[0041] 1. Crush and sieve the raw materials;

[0042] 2. First mix the prescribed amount of micronized (particle size less than 65 μm, the same below) omeprazole (AB mixed crystal) with about half of the prescribed amount of sodium bicarbonate; then add the remaining amount of sodium bicarbonate, crosslinking Sodium carboxymethylcellulose and sodium stearyl fumarate; mix well, and fill an appropriate amount with an automatic capsule filling machine.

Embodiment 2

[0043] Example 2 ( once embedding ）

[0044] Omeprazole 40mg 1 serving

[0045] Sodium bicarbonate 1100mg 27.5 parts

[0046] Croscarmellose Sodium 30mg 0.75 parts

[0047] Sodium stearyl fumarate 10mg 0.25 parts

[0048] 1180mg

[0049] Preparation Process:

[0050] 1. Crush and sieve the raw materials;

[0051] 2. First mix the prescribed amount of processed omeprazole (AB mixed crystal) with about half of the prescribed amount of sodium bicarbonate; dry granulate to make fine particles, and then add the remaining amount of sodium bicarbonate, Dicarboxymethyl cellulose sodium and sodium stearyl fumarate; mix well, and fill an appropriate amount with an automatic capsule filling machine.

Embodiment 3

[0053] Omeprazole 40mg 1 serving

[0054] Sodium bicarbonate 1100mg 27.5 parts

[0055] Croscarmellose Sodium 30mg 0.75 parts

[0056] Sodium stearyl fumarate 10mg 0.25 parts

[0057] 1180mg

[0058] Preparation Process:

[0059] 1. Crush omeprazole (AB mixed crystal) and sodium bicarbonate separately and set aside.

[0060] 2. Weigh 1 part (the following are all by weight) of omeprazole, 10 parts of sodium bicarbonate and 0.125 parts of sodium stearyl fumarate according to the prescription, mix well; dry granulate to make fine particles; add 0.75 parts Croscarmellose sodium and the remaining prescription amount of sodium bicarbonate are mixed evenly, and dry granulated to make granules; after mixing with the remaining sodium stearyl fumarate, filling capsules is obtained.

technical field

[0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a granule containing omeprazole and a preparation method thereof. Background technique

[0002] Generally, gastric ulcer and duodenal ulcer are collectively referred to as peptic ulcer, sometimes simply referred to as ulcer. Gastric acid (hydrochloric acid) and pepsin (a type of enzyme) that originally digest food digest their own stomach and duodenal walls, thereby damaging the mucosal tissue, which is the main cause of peptic ulcers. Experimental and clinical studies in recent years have shown that factors such as excessive gastric acid secretion, Helicobacter pylori infection, and weakened protective effect of gastric mucosa are the main links that cause peptic ulcer. Delayed gastric emptying and bile reflux, the role of gastrointestinal peptides, genetic factors, drug factors, environmental factors and mental factors are all related to the occurrence of p...

Examples

Embodiment 1

[0034] Example 1 ( Preparation process of patent GB2459393 ）

[0035] Omeprazole 40mg 1 serving

[0036] Sodium bicarbonate 1100mg 27.5 parts

[0037] Croscarmellose Sodium 30mg 0.75 parts

[0038] Sodium stearyl fumarate 10mg 0.25 parts

[0039] 1180mg

[0040] Preparation Process:

[0041] 1. Crush and sieve the raw materials;

[0042] 2. First mix the prescribed amount of micronized (particle size less than 65 μm, the same below) omeprazole (AB mixed crystal) with about half of the prescribed amount of sodium bicarbonate; then add the remaining amount of sodium bicarbonate, crosslinking Sodium carboxymethylcellulose and sodium stearyl fumarate; mix well, and fill an appropriate amount with an automatic capsule filling machine.

Embodiment 2

[0043] Example 2 ( once embedding ）

[0044] Omeprazole 40mg 1 serving

[0045] Sodium bicarbonate 1100mg 27.5 parts

[0046] Croscarmellose Sodium 30mg 0.75 parts

[0047] Sodium stearyl fumarate 10mg 0.25 parts

[0048] 1180mg

[0049] Preparation Process:

[0050] 1. Crush and sieve the raw materials;

[0051] 2. First mix the prescribed amount of processed omeprazole (AB mixed crystal) with about half of the prescribed amount of sodium bicarbonate; dry granulate to make fine particles, and then add the remaining amount of sodium bicarbonate, Dicarboxymethyl cellulose sodium and sodium stearyl fumarate; mix well, and fill an appropriate amount with an automatic capsule filling machine.

Embodiment 3

[0053] Omeprazole 40mg 1 serving

[0054] Sodium bicarbonate 1100mg 27.5 parts

[0055] Croscarmellose Sodium 30mg 0.75 parts

[0056] Sodium stearyl fumarate 10mg 0.25 parts

[0057] 1180mg

[0058] Preparation Process:

[0059] 1. Crush omeprazole (AB mixed crystal) and sodium bicarbonate separately and set aside.

[0060] 2. Weigh 1 part (the following are all by weight) of omeprazole, 10 parts of sodium bicarbonate and 0.125 parts of sodium stearyl fumarate according to the prescription, mix well; dry granulate to make fine particles; add 0.75 parts Croscarmellose sodium and the remaining prescription amount of sodium bicarbonate are mixed evenly, and dry granulated to make granules; after mixing with the remaining sodium stearyl fumarate, filling capsules is obtained.

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