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Cetilistat tablet and preparation method

A celistat and tablet technology, applied in the field of pharmaceutical manufacturing, can solve problems such as unqualified dissolution rate, unqualified product quality stability inspection, tableting and splitting, etc.

Inactive Publication Date: 2015-10-14
刘小斌 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, during the research process of Selistat Tablets, we found that if the prescription and production process of Selistat Tablets are not well controlled, there will be problems such as tablet splitting and poor compressibility. At the same time, the dissolution rate is unqualified, resulting in bioavailability. Low, product quality stability inspection failed

Method used

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  • Cetilistat tablet and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Selistat Tablets (Prescription Quantity 1000 Tablets)

[0015] Selistat Tablets (Prescription Quantity 1000 Tablets)

[0016]

[0017] Preparation process: Weigh the prescribed amount of celistat, mannitol, microcrystalline cellulose, and croscarmellose sodium, mix well, weigh the prescribed amount of high-substituted hydroxypropyl cellulose and add it to 80% ethanol Solution, stirring to dissolve completely, used as adhesive to connect to the fluidized bed. Add the mixture into the fluidized bed, turn on the fan to keep the mixture in suspension, add binder to make wet granules, and dry for 30 minutes. Take out the granules, add the prescribed amount of magnesium stearate, mix evenly, measure the content of the granules, and press into tablets according to the content of the granules. Finished product testing. The packaging is vested.

Embodiment 2

[0019] Selistat Tablets (Prescription Quantity 1000 Tablets)

[0020]

[0021] Preparation process: Weigh the prescribed amount of celistat, mannitol, microcrystalline cellulose, and croscarmellose sodium, mix well, weigh the prescribed amount of high-substituted hydroxypropyl cellulose and add it to 80% ethanol Solution, stirring to dissolve completely, used as adhesive to connect to the fluidized bed. Add the mixture into the fluidized bed, turn on the fan to keep the mixture in suspension, add binder to make wet granules, and dry for 30 minutes. Take out the granules, add the prescribed amount of magnesium stearate, mix evenly, measure the content of the granules, and press into tablets according to the content of the granules. Finished product testing. The packaging is vested.

Embodiment 3

[0023] Selistat Tablets (Prescription Quantity 1000 Tablets)

[0024]

[0025]

[0026] Preparation process: Weigh the prescribed amount of celistat, mannitol, microcrystalline cellulose, and croscarmellose sodium, mix well, weigh the prescribed amount of high-substituted hydroxypropyl cellulose and add it to 80% ethanol Solution, stirring to dissolve completely, used as adhesive to connect to the fluidized bed. Add the mixture into the fluidized bed, turn on the fan to keep the mixture in suspension, add binder to make wet granules, and dry for 30 minutes. Take out the granules, add the prescribed amount of magnesium stearate, mix evenly, measure the content of the granules, and press into tablets according to the content of the granules. Finished product testing. The packaging is vested.

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Abstract

The invention provides a cetilistat tablet and a preparation method and belongs to the field of medicines. The cetilistat tablet includes cetilistat, mannitol, microcrystalline cellulose, magnesium stearate, crosslinked sodium carboxymethylcellulose and high-substituted hydroxypropyl cellulose, wherein the weight ratios of the cetilistat, the mannitol, the microcrystalline cellulose, the crosslinked sodium carboxymethylcellulose, the high-substituted hydroxypropyl cellulose to the magnesium stearate are 1:0.5-5:1-2:0.1-2:0.1-0.5:0.1-1. The preparation method includes the steps of pelletization in a fluidized bed, mixing and tabletting. The invention solves the problem of poor tabletting effect, low dissolution rate and poor stability of the cetilistat tablet. The cetilistat tablet is improved in bioavailability and curative effects and is better in treatment effects.

Description

technical field [0001] The invention relates to a medicine prescription and a preparation method for treating obesity and type 2 diabetes, and belongs to the field of pharmaceutical manufacturing, in particular to a selistat tablet and a preparation method. Background technique [0002] Obesity has become a global chronic disease. There are currently nearly 90 million obese people in the United States. Obesity rates have also risen rapidly in European countries in recent years. The latest foreign data show that the proportion of overweight / obese people in the European population is as high as 38-50%, and the proportion of obese women in Europe exceeds that of men. In fact, not only European and American countries, but also many countries including China, India, Japan, Brazil, Russia and Southeast Asian countries, the national obesity rate is also rising sharply. According to statistics released by my country's relevant departments, the overweight ratio of adults in my cou...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/536A61K47/38A61K47/10A61P3/04
Inventor 刘小斌吴鹏程
Owner 刘小斌
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