Omeprazole enteric-coated pellet and preparation process thereof

An omeprazole intestinal and preparation technology technology, which is applied in the directions of microcapsules, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Influence, low yield of industrialized production, etc., to achieve the effect of smooth and round appearance, controllable product quality, and reduction of broken fine powder

Active Publication Date: 2022-03-01
HAINAN HAILING CHEMIPHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the stability of omeprazole is poor, and its structure contains the chemical structure of sulfonyl benzimidazole, which is a weakly basic compound, which is easily affected by the external environment and degrades to produce impurities, reducing the content of the main drug.
Especially under acidic and light conditions, omeprazole is very easy to decompose quickly, and its hydrophobicity is strong, and its compatibility with reagents such as liquids is poor, resulting in low industrial production yield and difficult quality control in the p

Method used

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  • Omeprazole enteric-coated pellet and preparation process thereof

Examples

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Example Embodiment

[0027] Example 1

[0028] A preparation process for omeprazole enteric-coated pellets, comprising the steps of:

[0029] (1) Slow-release protective solution: Mix the modified polylactic acid solution and ethyl cellulose aqueous dispersion, and stir at 20°C for 50 minutes to obtain the slow-release protective solution;

[0030] (2) Mannitol solution: mannitol is dissolved in purified water to obtain a mannitol solution;

[0031] (3) Ball core: Dry mix omeprazole and microcrystalline cellulose for 10 minutes, add simethicone, and cut at 2000r / min for 12 minutes to obtain a wet and soft material, which is put into an extrusion spheronizer to prepare Granules, with 400r / min, time is 2min, get ball core;

[0032] (4) Coated ball core: Preheat the fluidized bed, pour the ball core into the multi-functional fluidized bed, set the coating operating conditions as the rotating speed is 50r / min, the fan frequency is 35Hz, and the air inlet temperature is 33°C , turn on the blower to ...

Example Embodiment

[0034] Example 2

[0035] A preparation process for omeprazole enteric-coated pellets, comprising the steps of:

[0036] (1) Slow-release protective solution: mix the modified polylactic acid solution and ethyl cellulose aqueous dispersion, and stir at 30°C for 60 minutes to obtain the slow-release protective solution;

[0037] (2) Mannitol solution: mannitol is dissolved in purified water to obtain a mannitol solution;

[0038] (3) Ball core: Dry mix omeprazole and microcrystalline cellulose for 10-15 minutes, add simethicone, cut at 3000r / min for 15 minutes to obtain wet and soft material, put the wet and soft material into the extrusion spheronizer Carry out granulation, with 500r / min, time is 3min, obtains ball core;

[0039](4) Coated ball core: Preheat the fluidized bed, pour the ball core into the multi-functional fluidized bed, set the coating operation conditions as the rotating speed is 60r / min, the fan frequency is 45Hz, and the air inlet temperature is 40°C , tu...

Example Embodiment

[0041] Example 3

[0042] A preparation process for omeprazole enteric-coated pellets, comprising the steps of:

[0043] (1) Slow-release protective solution: mix the modified polylactic acid solution and ethyl cellulose aqueous dispersion, and stir at 25°C for 55 minutes to obtain the slow-release protective solution;

[0044] (2) Mannitol solution: mannitol is dissolved in purified water to obtain a mannitol solution;

[0045] (3) Ball core: Dry mix omeprazole and microcrystalline cellulose for 12 minutes, add simethicone, and cut at 2500r / min for 15 minutes to obtain a wet and soft material, which is put into an extrusion spheronizer to prepare Granules, with 450r / min, the time is 2min, get ball core;

[0046] (4) Coated ball core: Preheat the fluidized bed, pour the ball core into the multi-functional fluidized bed, set the coating operation conditions as the speed is 55r / min, the fan frequency is 40Hz, and the air inlet temperature is 36°C , turn on the blower to prehe...

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Abstract

The invention provides an omeprazole enteric-coated pellet and a preparation process thereof. The preparation process comprises the following steps: mixing a modified polylactic acid solution and an ethyl cellulose aqueous dispersion, and stirring to obtain a slow-release protection solution; dissolving mannitol in purified water to obtain a mannitol solution; the preparation method comprises the following steps: dry-mixing omeprazole and microcrystalline cellulose, adding dimeticone, shearing, extruding and rounding to obtain pellet cores; the preparation method comprises the following steps: alternately spraying a sustained-release protective solution and a mannitol solution on a pellet core, drying to obtain a coated pellet core, dissolving hydroxypropyl methyl cellulose and talcum powder in purified water, stirring to obtain an enteric coating solution, spraying the enteric coating solution on the coated pellet core, and drying after spraying to obtain the omeprazole enteric pellet. By adopting the unique omeprazole enteric-coated pellet preparation process, the pellet has the advantages of large drug loading capacity, smooth and round appearance, no fine powder, no cracking, no broken pellet, good pellet formability, high yield, good in-vitro release degree, stable quality, simple production process and controllable product quality.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to an omeprazole enteric-coated pellet and a preparation process thereof. Background technique [0002] Omeprazole is a proton pump inhibitor developed in Sweden, which can inhibit the excessive secretion of gastric acid, so it is often used to treat peptic ulcer. However, omeprazole has poor stability. Its structure contains the chemical structure of sulfonyl benzimidazole, which is a weakly basic compound, and is easily affected by the external environment to degrade and produce impurities, reducing the content of the main drug. Especially under acidic and light conditions, omeprazole is very easy to decompose quickly, and its hydrophobicity is strong, and its compatibility with reagents such as liquids is poor, resulting in low industrial production yield and difficult quality control in the production process. There are differences in the quality of finished produc...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/4439A61K47/38A61K47/34A61K47/26A61K47/02A61P1/04
CPCA61K9/5015A61K9/5047A61K9/5031A61K9/501A61K31/4439A61P1/04
Inventor 蔡亲韩勇
Owner HAINAN HAILING CHEMIPHARMA CORP
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