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Sofosbuvir tablet and preparation method thereof

A technology of buvir tablet and tablet core, applied in the field of sofosbuvir tablet and its preparation, achieves the effects of reducing production cost, simple and mature production process, and high yield

Active Publication Date: 2017-05-17
JIANGSU COBEN PHARMA CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the above-mentioned technical problems, the present invention provides a Sofosbuvir tablet and a preparation method thereof. The method is simpler and more convenient, suitable for large-scale production and the current situation of China's domestic pharmaceutical equipment, and the preparation process does not cause the active ingredient Sophie There is no material compaction and granulation difficulty due to the change of Buwet crystal form. The finally obtained tablet has stable quality, simple process, high yield and good stability, and is suitable for industrial batch production.

Method used

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  • Sofosbuvir tablet and preparation method thereof
  • Sofosbuvir tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Product prescription (1000 tablets):

[0043]

[0044] making process:

[0045] ① Raw material drug pretreatment: pass the sofosbuvir raw material through 80 mesh, and set aside;

[0046] ②Preparation of adhesive solution: make povidone K90 into 2% solution with water, set aside;

[0047] ③ Mixing of raw and auxiliary materials: Take the formula amount of sofosbuvir, microcrystalline cellulose, mannitol, and croscarmellose sodium, and place them in a high-shear mixing granulator and mix evenly (stirring paddle: 120rpm, 10min );

[0048]④Granulation: add 2% povidone K90 solution to granulate (spraying time: 4min; stirring speed: 150rpm; shearing speed: 1200rpm), dry (60°C, control material moisture ≤ 3.5%), granulate (40 mesh );

[0049] ⑤Total mixing: put the sorted granules and formula amount of micropowder silica gel in the mixing machine and mix evenly (speed: 15rpm, 2min);

[0050] ⑥ Tablet compression: place the granules in a high-speed rotary tablet press,...

Embodiment 2

[0053] Product prescription (1000 tablets):

[0054]

[0055]

[0056] making process:

[0057] ① Raw material pretreatment: pass the sofosbuvir raw material through 80 meshes, and set aside;

[0058] ②Preparation of adhesive solution: make povidone K30 into a 5% solution with water, and set aside;

[0059] ③ Mixing of raw and auxiliary materials: Take the formula amount of sofosbuvir, microcrystalline cellulose, pregelatinized starch, and crospovidone, and mix them evenly in a high-shear mixing granulator (stirring paddle: 120rpm, 10min) ;

[0060] ④Granulation: Add 5% povidone K30 solution to granulate (spraying time: 4min; stirring speed: 150rpm; shearing speed: 1200rpm), dry (60°C, control material moisture ≤ 3.5%), granulate (20 mesh );

[0061] ⑤Total mixing: put the sorted granules and formula amount of micropowder silica gel in the mixing machine and mix evenly (speed: 15rpm, 2min);

[0062] ⑥ Tablet compression: place the granules in a high-speed rotary tab...

Embodiment 3

[0065] Product prescription (1000 tablets):

[0066]

[0067] making process:

[0068] ① Raw material pretreatment: pass the sofosbuvir raw material through 80 meshes, and set aside;

[0069] ②Adhesive solution preparation: make povidone K30 into 8% solution with water, set aside;

[0070] ③Mixing of raw and auxiliary materials: take the formulated amount of sofosbuvir, microcrystalline cellulose, pregelatinized starch, mannitol, and 1 / 2 the formulated amount of croscarmellose sodium, place in high-shear mixing and granulate Mix evenly in the machine (stirring paddle: 120rpm, 10min);

[0071] ④Granulation: Add 5% povidone K30 solution to granulate (spraying time: 4min; stirring speed: 150rpm; shearing speed: 1200rpm), dry (60°C, control material moisture ≤ 3.5%), granulate (20 mesh );

[0072] ⑤ Blending: Put the sorted granules, the magnesium stearate of the recipe amount and 1 / 2 the croscarmellose sodium of the recipe amount in the blender and mix evenly (speed: 15rpm...

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Abstract

The invention discloses a sofosbuvir tablet and preparation method thereof. The sofosbuvir tablet comprises a tablet core and a film coating layer, wherein the tablet core is prepared from active ingredients and pharmaceutically acceptable accessories through a wet granulation process; the active ingredient is sofosbuvir crystal type 6, the accessories comprise a filling agent, a disintegrating agent, an adhesive and a lubricant; the tablet core comprises the following components by weight percent: 25%-70% of sofosbuvir crystal type 6, 20%-65% of a filling agent, 1%-10% of a disintegrating agent, 0.5%-3% of a lubricant, and 0.25%-5% of an adhesive. The preparation method of the sofosbuvir tablet provided by the invention is simple and convenient, is suitable for large-scale production andthe current situation of domestic pharmaceutical equipment in China, the change of the active component sofosbuvir crystal type cannot be caused in the preparation process, the conditions of materialhardening and difficult granulation are avoided; the finally obtained tablet is stable in quality, simple in process, high in yield, good in stability, and suitable for industrial batch production.

Description

technical field [0001] The invention relates to a sofosbuvir tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Hepatitis C is caused by hepatitis C virus (HCV), a systemic infectious disease mainly caused by liver damage. The symptoms of acute infection are not obvious, and it is easy to become chronic. The self-healing rate of chronic hepatitis C patients is very low. About 10.0%-20.0% of HCV-infected patients develop liver cirrhosis within 20 years of infection, and about 5.0%-7.0% of cases eventually die of liver cirrhosis or liver cancer. Hepatitis C has become an important cause of end-stage liver disease in Europe, America, Japan and other countries. The recurrence rate of hepatitis C is high, especially in chronic patients, which brings a heavy economic burden to patients, families and society. [0003] Sofosbuvir (also translated as Sofosbuvir, English name Sofosbuvir, trade name S...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/36A61K31/7072A61K47/38A61P1/16A61P31/14
CPCA61K9/2054A61K9/2059A61K9/2866A61K31/7072
Inventor 蒋善会游金宗史磊潘世浩
Owner JIANGSU COBEN PHARMA CO LTD
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