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A kind of sofosbuvir tablet and preparation method thereof

A Buvir tablet and preparation technology, applied in the field of Sofosbuvir tablet and its preparation, can solve the problems of high dry granulation equipment requirements, low labor efficiency, slow dissolution, etc., to improve drug stability and production efficiency High, the effect of improving the dissolution rate

Active Publication Date: 2020-04-07
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The purpose of the present invention is to solve the problems that the sofosbuvir crystal form 1 raw material in the existing sofosbuvir tablet technology meets water into a hard colloid and dissolves slowly; dry granulation has high requirements for equipment, complicated process and low labor efficiency

Method used

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  • A kind of sofosbuvir tablet and preparation method thereof
  • A kind of sofosbuvir tablet and preparation method thereof
  • A kind of sofosbuvir tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Product prescription (1000 tablets):

[0035]

[0036] Preparation Process:

[0037] (1) mix the prescribed amount of sofosbuvir and colloidal silicon dioxide evenly to obtain mixture one;

[0038] (2) Add direct-pressed mannitol, optimized microcrystalline cellulose and croscarmellose sodium to mixture 1 and mix uniformly to obtain mixture 2;

[0039] (3) Magnesium stearate is added to mixture two, blended, compressed into tablets, coated and packaged.

Embodiment 2

[0041] Product prescription (1000 tablets):

[0042]

[0043] Preparation Process:

[0044] (1) mix the prescribed amount of sofosbuvir and colloidal silicon dioxide evenly to obtain mixture one;

[0045] (2) Add direct-pressed mannitol, optimized microcrystalline cellulose and croscarmellose sodium to mixture 1 and mix uniformly to obtain mixture 2;

[0046] (3) Magnesium stearate is added to mixture two, blended, compressed into tablets, coated and packaged.

Embodiment 3

[0048] Product prescription (1000 tablets):

[0049]

[0050] Preparation Process:

[0051] (1) mix the prescribed amount of sofosbuvir and colloidal silicon dioxide evenly to obtain mixture one;

[0052] (2) Add direct-pressed mannitol, optimized microcrystalline cellulose and croscarmellose sodium to mixture 1 and mix uniformly to obtain mixture 2;

[0053] (3) Magnesium stearate is added to mixture two, blended, compressed into tablets, coated and packaged.

[0054] For the convenience of comparison with the examples, the following comparative examples are specifically listed for comparative research.

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Abstract

The invention provides a sofosbuvir tablet and a preparation method thereof. The sofosbuvir tablet comprises: 10-41% sofosbuvir accounting for the total weight of the preparation, accounting for 1-3% of the total weight of the sofosbuvir % of the first diluent, 53-86% of the second diluent, 3-10% of the total weight of the preparation, and 0.5-3.0% of the lubricant. The preparation method is a powder direct mixing tabletting method, and the specific steps are: (1) mix sofosbuvir and the first diluent uniformly to obtain a mixture one; (2) add the second diluent and a disintegrant to the mixture one Mix evenly to obtain Mixture 2; (3) Add lubricant to Mixture 2, blend, compress into tablets, coat and pack. Compared with the prior art, the present invention greatly improves the dissolution rate of the sofosbuvir preparation, has higher production efficiency and lower manufacturing cost, and can adapt to large-scale industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a sofosbuvir tablet and a preparation method thereof. Background technique [0002] Hepatitis C is a kind of viral hepatitis caused by hepatitis C virus (HCV) infection, which can lead to chronic inflammation, necrosis and fibrosis of the liver, and even hepatocellular carcinoma, which is extremely harmful to the health and life of patients. The U.S. Centers for Disease Control estimates that 4.5 million people have been infected in the U.S. alone. According to the World Health Organization, there are more than 200 million infected individuals worldwide, and at least three to four million people are infected every year. Once infected, about 20% of people clear the virus, but the remainder may carry HCV for the rest of their lives. Ten to 20 percent of chronically infected individuals eventually develop destructive cirrhosis or cancer of the liver. The viral disease is transmi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/30A61K31/7072A61K47/04A61K47/26A61K47/38A61P1/16A61P31/14
Inventor 殷殿书赵晓雷孙立杰李彪李朋飞陈雪桃张伟
Owner SHIJIAZHUANG NO 4 PHARMA
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