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Omeprazole enteric coated tablet and preparation method thereof

A technology for omeprazole intestine and omeprazole, applied in the field of medicine, can solve the problems of complex process parameters, easy to produce adhesion, poor reproducibility of industrialized production and the like, achieve simple process, ensure quality and curative effect, and be easy to operate and the effect of industrial production

Pending Publication Date: 2017-09-08
济南同路医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Enteric-coated pellets have relatively high requirements on the particle size of the pellets. Adhesion is easy to occur during the process of drug application and coating. Tablet compression requires a tablet pr

Method used

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  • Omeprazole enteric coated tablet and preparation method thereof
  • Omeprazole enteric coated tablet and preparation method thereof
  • Omeprazole enteric coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Taking omeprazole enteric-coated tablets with a dose of 20 mg as an example, the formula is as follows:

[0032]

[0033] Tablet core preparation: add a certain amount of 30% ethanol solution in a suitable container, add hypromellose to stir and dissolve, sodium lauryl sulfate is dissolved in the binder and added, pass the raw and auxiliary materials through a 40 mesh sieve, add high In the shearing wet granulator, stir at 200 rpm, mix for 3 minutes, under stirring, stir at 200 rpm and cutter at 1000 rpm, gradually add the binder to make soft materials for 3-5 minutes, to obtain suitable granules, fluidized bed drying, Set the inlet air temperature to 50°C, control the moisture content of the particles to be 2.5-3.5%, and use a granulator for granulation after drying. 20%, mix the granules and the auxiliary materials with a square cone, the rotation speed is 3-5rpm, the time is 2min, and the tablet is compressed by a high-speed rotary tablet machine, the hardness is ...

Embodiment 2

[0037] Taking omeprazole enteric-coated tablets with a dose of 20 mg as an example, the formula is as follows:

[0038]

[0039] Tablet core preparation: add a certain amount of 30% ethanol solution in a suitable container, add hypromellose to stir and dissolve, sodium lauryl sulfate is dissolved in the binder and added, pass the raw and auxiliary materials through a 40 mesh sieve, add high In the shearing wet granulator, stir at 200 rpm, mix for 3 minutes, under stirring, stir at 200 rpm and cutter at 1000 rpm, gradually add the binder to make soft materials for 3-5 minutes, to obtain suitable granules, fluidized bed drying, Set the inlet air temperature to 50°C, control the moisture content of the particles to be 2.5-3.5%, and use a granulator for granulation after drying. 20%, mix the granules and the auxiliary materials with a square cone, the rotation speed is 3-5rpm, the time is 2min, and the tablet is compressed by a high-speed rotary tablet machine, the hardness is ...

Embodiment 3

[0043] Taking omeprazole enteric-coated tablets with a dose of 20 mg as an example, the formula is as follows:

[0044]

[0045] Tablet core preparation: add a certain amount of 30% ethanol solution in a suitable container, add hypromellose to stir and dissolve, sodium lauryl sulfate is dissolved in the binder and added, pass the raw and auxiliary materials through a 40 mesh sieve, add high In the shearing wet granulator, stir at 200 rpm, mix for 3 minutes, under stirring, stir at 200 rpm and cutter at 1000 rpm, gradually add the binder to make soft materials for 3-5 minutes, to obtain suitable granules, fluidized bed drying, Set the inlet air temperature to 50°C, control the moisture content of the particles to be 2.5-3.5%, and use a granulator for granulation after drying. 20%, mix the granules and the auxiliary materials with a square cone, the rotation speed is 3-5rpm, the time is 2min, and the tablet is compressed by a high-speed rotary tablet machine, the hardness is ...

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Abstract

The invention provides an omeprazole enteric coated tablet and a preparation method thereof. The omeprazole enteric coated tablet consists of a core, an isolating coating and an enteric coating, wherein alkaline stabilizing agents magnesium hydroxide and hydrotalcite are added to the core, a stable core is prepared by high-shear wet process granulation and fluid bed drying, coating is conducted by using a coating machine, the core is coated with the isolating coating for isolation for preventing the alkaline core from reacting with the enteric coating, and the weights of the enteric coating and the isolating coating are controlled so that the preparation is acid resistant for 2 hours and then is quickly dissolved out in 15 minutes in an alkaline medium, thereby ensuring the quality and curative effect of the product. The whole technical process is simple and easy for operation and industrial production.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to an omeprazole enteric-coated tablet and a preparation method thereof. Background technique [0002] Omeprazole, a proton pump inhibitor, is a lipid-soluble weakly basic drug. Mainly used for duodenal ulcer and Zollinger-Ellison syndrome, but also for gastric ulcer and reflux esophagitis; intravenous injection can be used for the treatment of acute bleeding of peptic ulcer. Combined with amoxicillin and clindamycin or with metronidazole and clarithromycin to kill Helicobacter pylori. [0003] Omeprazole is weakly alkaline and is absorbed in the duodenum after oral administration. Omeprazole is stable under neutral and alkaline conditions, with a half-life of 17 hours; easily degraded in an acidic environment, with a half-life of about 2 minutes. In order to ensure the pharmacological activity of omeprazole after taking it, the marketed products are enteric-coated preparations, including...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K47/02A61K47/38A61P1/04A61P7/04
CPCA61K9/2009A61K9/2866A61K9/2886A61K31/4439
Inventor 俞仑马华孟凡梅齐玉威郭小泉盛瑞霞阚娜
Owner 济南同路医药科技发展有限公司
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