Medicinal composition for treating thrombus

A composition and drug technology, applied in the direction of drug combination, medical preparations containing active ingredients, sugar-coated pills, etc., can solve the problems of short validity period and achieve good dissolution and stability effects

Inactive Publication Date: 2010-12-22
北京德众万全医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Patent CN200780042978.2 mentions that the storage method of the prasugrel pharmaceutical composition is in a container filled with nitrogen and air and / or moisture impermeable, because exposing prasugrel to air and / moisture for a long time will cause Certain degradation associated with stability and further resulting in a shorter shelf life

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] prescription:

[0022] Raw materials

Dosage (mg)

Prasugrel Hydrobromide

6.08

Mannitol

66.9

microcrystalline cellulose

44

Low-substituted hydroxypropyl cellulose

10

hypromellose

1.7

Magnesium stearate

1.3

Opadry

Appropriate amount

[0023] Preparation Process:

[0024] 1. Add prasugrel hydrobromide, mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and hypromellose in equal amounts, and mix them uniformly to obtain mixture 1;

[0025] 2. Perform dry granulation of mixture 1 to obtain granule 1;

[0026] 3. Add magnesium stearate to the prepared granule 1 and mix well.

[0027] 4. Compress the mixed granules into tablets and coat them.

Embodiment 2

[0029] prescription:

[0030] Raw materials

Dosage (mg)

Prasugrel Hydrobromide

12.16

Mannitol

53.42

microcrystalline cellulose

35

Croscarmellose Sodium

6

[0031] hypromellose

1.5

Glyceryl behenate

1.2

Sucrose Stearate

1.2

Opadry

Appropriate amount

[0032] Preparation Process:

[0033] 1. Add prasugrel hydrobromide, mannitol, microcrystalline cellulose, croscarmellose sodium, and hypromellose in equal amounts, and mix uniformly to obtain mixture 1;

[0034] 2. Perform dry granulation of mixture 1 to obtain granule 1;

[0035] 3. Add glyceryl behenate and sucrose stearate into the prepared granule 1, and mix well.

[0036] 4. Compress the mixed granules into tablets and coat them.

Embodiment 3

[0038] prescription:

[0039] Raw materials

Dosage (mg)

Prasugrel Hydrobromide

12.16

Mannitol

53.42

microcrystalline cellulose

35

Low-substituted hydroxypropyl cellulose

6

hypromellose

1.5

Glyceryl behenate

1.2

Sucrose Stearate

1.2

Opadry

Appropriate amount

[0040] Preparation Process:

[0041] 1. Add prasugrel hydrobromide, mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and hypromellose in equal amounts, and mix them uniformly to obtain mixture 1;

[0042] 2. Perform dry granulation of mixture 1 to obtain granule 1;

[0043] 3. Add glyceryl behenate and sucrose stearate into the prepared granule 1, and mix well.

[0044] 4. Compress the mixed granules into tablets and coat them.

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PUM

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Abstract

The invention provides a solid medicinal composition containing prasugrel bromate for treating thrombus. The composition has the advantages of good stability, convenient operation, transportation and storage, wide application range and suitability for scale production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a solid pharmaceutical composition containing prasugrel hydrobromide for treating thrombus. Background technique [0002] Prasugrel is a new hemostatic drug of the thienopyridine class. It is a prodrug that forms an active molecule after metabolism in the body, and binds to the platelet P2Y12 receptor to exert anti-platelet aggregation activity. Clinical studies have proved that prasugrel has a better anticoagulant effect than clopidogrel, and can reduce the combined risk of heart attack, stroke, and death due to heart disease by 20%. Drug resistance and bioavailability, toxicity is also low. [0003] On July 10, 2009, the U.S. FDA approved the marketing application of the new thrombosis prevention drug prasugrel (Effient) jointly developed by Eli Lilly and Daiichi Pharmaceutical Sankyo Co., Ltd., for the prevention of percutaneous coronary artery disease. Patients with...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4365A61P7/02
Inventor 张晓
Owner 北京德众万全医药科技有限公司
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