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Esomeprazole magnesium enteric-coated tablet containing esomeprazole magnesium pellets and preparation method of esomeprazole magnesium enteric-coated tablet

A technology of esomeprazole magnesium pellets and meprazole magnesium enteric-coated tablets, which is applied in the field of esomeprazole magnesium enteric-coated tablets and its preparation, and can solve problems such as unfavorable patients taking it

Inactive Publication Date: 2015-04-29
深圳市国源医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This process does not have the problem of enteric-coated pellets, but the tablet must be swallowed whole, which is not conducive to patients with dysphagia

Method used

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  • Esomeprazole magnesium enteric-coated tablet containing esomeprazole magnesium pellets and preparation method of esomeprazole magnesium enteric-coated tablet
  • Esomeprazole magnesium enteric-coated tablet containing esomeprazole magnesium pellets and preparation method of esomeprazole magnesium enteric-coated tablet
  • Esomeprazole magnesium enteric-coated tablet containing esomeprazole magnesium pellets and preparation method of esomeprazole magnesium enteric-coated tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Components:

[0029]

[0030] Preparation:

[0031] (1) 1500g of esomeprazole magnesium, 5000g of microcrystalline cellulose, and 900g of sodium stearyl fumarate are pulverized through a 200-mesh sieve, mixed uniformly, and another 140g of polysorbate-80 is added to 50% ethanol solution, Make a 5% solution, as a binder, for subsequent use;

[0032] (2) Add the homogeneously mixed material in (1) into the centrifugal granulator, set the parameters as preheating temperature 40°C, air inlet temperature 30°C, peristaltic pump spray speed 3 rpm, powder supply speed 60 rpm , with an atomization pressure of 0.45Mpa, pelletized, dried and set aside;

[0033] (3) Pack the isolation layer, mix 450 g of hydroxypropyl cellulose and 1 g of glyceryl monostearate, add it into 95% ethanol solution to make a 15% solution, adjust the temperature to 30 ° C, and the spray pressure to 0.5 MPa, The liquid spraying speed is 4g / s, coating the pellets in (2), drying, controlling the moist...

Embodiment 2

[0037] Components:

[0038]

[0039] Preparation:

[0040](1) Grind 3000g of esomeprazole magnesium, 3000g of microcrystalline cellulose, and 100g of sodium stearyl fumarate through a 200-mesh sieve, mix well, and take another 800.2g of polysorbate-8, and add it to 50% ethanol solution , made into a 5% solution, as a binder, for subsequent use;

[0041] (2) Add the homogeneously mixed material in (1) into the centrifugal granulator, set the parameters as preheating temperature 40°C, air inlet temperature 35°C, peristaltic pump spray speed 7 rpm, powder supply speed 70 rpm , with an atomization pressure of 0.55Mpa, pelletized, dried, and set aside;

[0042] (3) Wrap an isolation layer, mix 10 g of hydroxypropyl cellulose and 700 g of glyceryl monostearate, add in 95% ethanol solution to make a 15% solution, adjust the temperature to 36 ° C, and spray pressure to 0.6 MPa, The liquid spraying speed is 4g / s, coating the pellets in (2), drying, controlling the moisture conten...

Embodiment 3

[0046] Components:

[0047]

[0048] Preparation:

[0049] (1) 4500g of esomeprazole magnesium, 7000g of microcrystalline cellulose, and 500g of sodium stearyl fumarate are pulverized through a 200-mesh sieve, mixed uniformly, and another 300g of polysorbate-80 is added to 50% ethanol solution, Make a 5% solution, as a binder, for subsequent use;

[0050] (2) Add the homogeneously mixed material in (1) into the centrifugal granulator, set the parameters as preheating temperature 40°C, air inlet temperature 40°C, peristaltic pump spray speed 12 rpm, powder supply speed 80 rpm , atomization pressure 0.68Mpa, pelletizing, drying, standby;

[0051] (3) Pack an isolation layer, mix 800 g of hydroxypropyl cellulose and 360 g of glyceryl monostearate, add in 95% ethanol solution to make a 15% solution, adjust the temperature to 40 ° C, and spray pressure to 0.78 MPa, The liquid spraying speed is 4g / s, coating the pellets in (2), drying, controlling the moisture content of the p...

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Abstract

The invention belongs to the field of medicines and discloses an esomeprazole magnesium enteric-coated tablet containing an esomeprazole magnesium pellet and a preparation method of the esomeprazole magnesium enteric-coated tablet. The enteric-coated tablet is prepared by pressing pellets taking esomeprazole magnesium as active components, a thinner, a disintegrating agent, a lubricating agent and the like. According to the method provided by the invention, an enteric-coated pellet is firstly made into a medicine contained core pellet and then is sequentially wrapped with an insulating layer, an enteric coated layer and a wax protecting layer. According to the tablet provided by the invention, the enteric-coated pellet is wrapped with the wax protecting layer, so that the problems of acid tolerance descending caused by the breakage of the enteric coated layer during the tabletting process of the enteric-coated pellet, and disqualification in content uniformity caused by excess liquidity can be solved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an esomeprazole magnesium enteric-coated tablet containing esomeprazole magnesium pellets and a preparation method thereof. Background technique [0002] Proton pump preparation (PPI) is the drug of choice for the treatment of acid-related diseases such as peptic ulcer and gastroesophageal reflux disease. Its mechanism of action is to reduce gastric acid secretion by specifically inhibiting the proton pump of gastric parietal cells. As the first PPI drug, omeprazole has been unanimously recognized for its efficacy in treating acid-related diseases. At present, the commonly used PPIs in clinical practice include omeprazole, lansoprazole, rabeprazole, and pantoprazole. And esomeprazole 5 kinds, wherein esomeprazole is the S-optical isomer of omeprazole. [0003] A large number of clinical experiments and drug studies have confirmed that compared with other PP...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4439A61P1/04
Inventor 张晓薇郭彧张凯谢雁鸣刘华亮艾风欧石军伍彪
Owner 深圳市国源医药科技有限公司
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