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A kind of rivaroxaban tablet for prevention and treatment of embolism disease and preparation method thereof

A technology of rivaroxaban and embolism, applied in pharmaceutical preparations for the prevention and treatment of embolism diseases, tablets containing rivaroxaban and its preparation field, which can solve the problem that the tablet does not achieve the expected effect, poor drug dissolution, etc. problems, to achieve the effect of easy operation, simple preparation method and easy labor protection

Active Publication Date: 2018-03-23
SHANGHAI XUDONG HAIPU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Micronization treatment of rivaroxaban is the most commonly used technical means to solve the problem of poor dissolution of the drug in the prior art. However, due to the characteristics of the raw material itself and some defects in the micronization technology, the prepared tablets did not meet the expected results. Effect

Method used

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  • A kind of rivaroxaban tablet for prevention and treatment of embolism disease and preparation method thereof
  • A kind of rivaroxaban tablet for prevention and treatment of embolism disease and preparation method thereof
  • A kind of rivaroxaban tablet for prevention and treatment of embolism disease and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032]

[0033] Preparation:

[0034] (1) Add rivaroxaban into the mixture of Span 80 and polyoxyethylene hydrogenated castor oil, heat in a water bath at 40°C-50°C, stir until dissolved, and set aside;

[0035] (2) Add kaolin into the mixed solution of step (1), continue to stir, mix evenly, cool to room temperature, and pass through a 20-mesh sieve for subsequent use;

[0036] (3) Mix the drug-containing granules prepared in step (2) with the prescribed amount of pregelatinized starch, crospovidone, silicon dioxide, and magnesium stearate, and punch tablets with a shallow arc with a diameter of 9 mm to obtain the product.

Embodiment 2

[0038]

[0039] Preparation:

[0040] (1) Add rivaroxaban into the mixture of Span 80 and polyoxyethylene hydrogenated castor oil, heat in a water bath at 40°C-50°C, stir until dissolved, and set aside;

[0041] (2) Add kaolin into the mixed solution of step (1), continue to stir, mix evenly, cool to room temperature, and pass through a 20-mesh sieve for subsequent use;

[0042] (3) Mix the drug-containing granule prepared in step (2) with the prescribed amount of microcrystalline cellulose, croscarmellose sodium, silicon dioxide, and magnesium stearate, and punch the tablet with a shallow arc with a diameter of 10 mm. Instantly.

Embodiment 3

[0044]

[0045] Preparation:

[0046] (1) Add rivaroxaban into the mixture of Span 80 and polyoxyethylene hydrogenated castor oil, heat in a water bath at 40°C-50°C, stir until dissolved, and set aside;

[0047] (2) Add kaolin into the mixed solution of step (1), continue to stir, mix evenly, cool to room temperature, and pass through a 20-mesh sieve for subsequent use;

[0048] (3) Mix the drug-containing granules prepared in step (2) with the prescribed amount of pregelatinized starch, sodium carboxymethyl starch, silicon dioxide, and sodium stearate fumarate, and punch the tablet with a shallow arc with a diameter of 11 mm. Instantly.

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Abstract

The invention discloses rivaroxaban tablets for preventing and treating embolismic diseases and a preparing method thereof. The tablets are made by tableting a mixture of pharmaceutical-containing granules and other pharmaceutically acceptable auxiliaries; the pharmaceutical-containing granules contain rivaroxaban, span-80, polyoxyethylene hydrogenated castor oil and kaolin. The rivaroxaban tablets dissolve out fast, higher than 90% in 5min, and meanwhile, dissolution stability is good, and a preparing process is simple.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pharmaceutical preparation for preventing and treating embolic diseases, in particular to a tablet containing rivaroxaban and a preparation method thereof. Background technique [0002] The chemical name of Rivaroxaban is 5-chloro-nitrogen-((5S)-2-oxo-3-[-4-(3-oxo-4-morpholinyl)phenyl]-1,3- Oxazolidine-5-yl-2-thiophene-carboxamide, the structural formula is as follows: [0003] [0004] Molecular formula: C 19 h 18 ClN 3 o 5 S molecular weight: 435.89 [0005] The drug is the world's first oral direct factor Xa inhibitor jointly developed by Bayer Pharmaceuticals and Johnson & Johnson. It was approved for marketing in Canada and the European Union on September 15, 2008 and October 1, 2008. The trade name is Xarelto. Rivaroxaban is a low molecular weight oral anticoagulant with high selectivity and direct inhibitory factor Xa, which is us...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/5377A61K47/44A61P7/02
Inventor 郭文荣翁建平
Owner SHANGHAI XUDONG HAIPU PHARMA
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