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Rivaroxaban pharmaceutical composition and preparation method thereof

A technology of rivaroxaban and a composition, applied in the field of medicine, can solve the problems of extremely high production equipment requirements, high cost, and difficult industrialization implementation, and achieve the effects of high bioavailability, no allergic reaction, and stable product quality

Inactive Publication Date: 2016-04-06
TIANJIN HANRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The rivaroxaban pharmaceutical composition produced by the existing technology has extremely high requirements on the production equipment, most of which are imported from abroad, and the cost is high, so it is not easy to implement the project industrially

Method used

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  • Rivaroxaban pharmaceutical composition and preparation method thereof
  • Rivaroxaban pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The rivaroxaban pharmaceutical composition described in every 1000 tablets, its formula consists of:

[0050] Rivaroxaban 5g

[0051] Mannitol 25g

[0052] Lactose 50g

[0053] Low-substituted hydroxypropyl cellulose 70g

[0054] Magnesium stearate 2g

[0055] Coating agent 4g

[0056] Preparation Process:

[0057] 1) Preparation: dry low-substituted hydroxypropyl cellulose, lactose, and magnesium stearate at 80°C for 4 hours, and set aside;

[0058] 2) Put the prescribed amount of mannitol and rivaroxaban in a container, mix evenly, grind until the particle size is 80±10um, and set aside;

[0059] 3) Mix item 2) evenly with the prescribed amount of low-substituted hydroxypropyl cellulose and magnesium stearate;

[0060] 4) Tablet compression: adjust the appropriate hardness and tablet weight, and perform tablet compression;

[0061] 5) Coating: Prepare the prescribed amount of film coating agent with 70% ethanol to make a solution with a solid content of 10%, a...

Embodiment 2

[0065] The rivaroxaban pharmaceutical composition described in every 1000 tablets, its formula consists of:

[0066] Rivaroxaban 10g

[0067] Mannitol 50g

[0068] Lactose 100g

[0069] Low-substituted hydroxypropyl cellulose 140g

[0070] Magnesium stearate 2g

[0071] Coating agent 4g

[0072] Preparation process: with embodiment 1.

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PUM

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Abstract

The present invention discloses a rivaroxaban pharmaceutical composition, which contains rivaroxaban, mannitol, lactose, low-substituted hydroxypropyl cellulose and magnesium stearate, wherein a weight ratio of the rivaroxaban to the mannitol to the lactose is 1:5:10. The rivaroxaban pharmaceutical composition of the present invention has characteristics of good stability, product yield improving, cost reducing, industrialization achieving, good clinical application, effective dissolution improving, and significantly improved bioavailability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a rivaroxaban pharmaceutical composition and a preparation method thereof. Background technique [0002] Rivaroxaban [0003] English name: Rivaroxaban; [0004] Chemical name: 5-chloro-N-[[(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl ]-2-thiophenecarboxamide; [0005] Structural formula: [0006] [0007] Molecular formula: C 19 h 18 ClN 3 o 5 S; [0008] Molecular weight: 435.88; [0009] Indications: It is used to prevent the formation of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients after hip and knee replacement. It can also be used to prevent stroke and non-central nervous system embolism in patients with non-valvular atrial fibrillation, and reduce the risk of coronary artery syndrome recurrence. [0010] Pharmacological type: Rivaroxaban highly selectively and competitively inhibits free and bound facto...

Claims

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Application Information

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IPC IPC(8): A61K47/38A61K31/5377
Inventor 严洁
Owner TIANJIN HANRUI PHARMA
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