Lansoprazole intestine solution capsule and its preparation method

Abstract

The invention discloses a lansoprazole enteric liquid capsule which has a simple manufacturing process, avoids water from being led in during the manufacturing process, and has good storage stability and a manufacturing method. The lansoprazole enteric liquid capsule consists of lansoprazole, dispersant, edible vegetable oil, magnesium oxide or magnesium carbonate, an emulsifier, poloxamer, animal and vegetable glue, and sodium citrate. After being mixed uniformly, raw materials enter into a colloid mill, and then the raw materials are infused into a hollow capsule, and polyacrylic resin ethanol solution is used as the sealing material to sleeve and seal the infused capsule. The invention suspends the lansoprazole into hydrophobic excipient oil, forms a protective film around the lansoprazole powder, does not lead in water during the manufacturing process, avoids the degradation of the lansoprazole, does not need to wrap an isolation layer and an enteric coating, and has short production cycle, simple production process, low cost, and good product quality and stability.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a manufacturing method thereof, in particular to lansoprazole enteric solution liquid capsule and a manufacturing method thereof. Background technique [0002] Lansoprazole chemical name: 2[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole , English name: Lansoprazole Liquid Filled Enteric-coated capsules. Molecular formula: C 16 h 14 f 3 N 3 o 2 S, molecular weight: 369.37, chemical structure: [0003] [0004] Lansoprazole is a proton pump in gastric parietal cells (H + , K + -ATPase) inhibitor, its mechanism of action is that after the drug is absorbed, it is transferred to the acid-secreting tubules of the parietal cells of the gastric mucosa, and under acidic conditions, it is converted into an active body structure. This active substance interacts with the proton pump (H + , K + -ATPase) SH group combination, thereby inhibiting the activity of th...

AI Technical Summary

Problems solved by technology

[0007] Because the raw material of lansoprazole is unstable to temperature and humidity, when the lansoprazole agent is directly filled into capsules, it will absorb moisture and degrade during storage and use in the future, so generally it cannot be directly filled into hollow capsules

In the above coating process, the lansoprazole agent needs to be coated with isolation layer and enteric coating for multiple times. Due to the introduction of water in the process, the partial degradation of lansoprazole is caused, and the process is complicated and the cost is high.

In order to avoid the introduction of moisture in the process, organic solvents can be used for the coating binder and coating materials, but the production conditions of the workshop require explosion-proof facilities, and the dust pollution and organic reagent pollution generated during the production process will have a certain impact on the health of the operators. The impact on the environment is also more serious

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