Dabigatran-containing solid dispersion and preparation method as well as application thereof

A technology of solid dispersion and dabigatran etexilate, applied in the field of medicine, can solve problems such as difficulty in ensuring the exertion of drug efficacy, and achieve the effects of improving drug bioavailability, accelerating dissolution rate, and improving water solubility

Inactive Publication Date: 2015-05-27
QINGDAO HUANGHAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, it is difficult to guarantee the efficacy of the common dispersion preparation

Method used

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  • Dabigatran-containing solid dispersion and preparation method as well as application thereof
  • Dabigatran-containing solid dispersion and preparation method as well as application thereof
  • Dabigatran-containing solid dispersion and preparation method as well as application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Mix and grind 3g of dabigatran etexilate and 20g of povidone K30 for 10min, add the resulting mixture into 100mL of anhydrous methanol and stir for 15min, transfer the obtained solution to a rotary evaporator for rotary evaporation, and wait until it is concentrated to 10mL Take it out and place it in an oven to dry for 4 hours, and the obtained solid is crushed and passed through an 80-mesh sieve to obtain a solid dispersion containing dabigatran etexilate benzenesulfonate.

Embodiment 2

[0036] 5g dabigatran etexilate mesylate, 10g povidone K30, and 10g povidone K90 were dissolved in absolute ethanol, and then the solution was spray-dried by spray drying equipment to obtain a composite solid dispersion, and further After drying for 1 hour, the residual solvent was removed, and the obtained solid was passed through an 80-mesh sieve to obtain a solid dispersion containing dabigatran etexilate mesylate.

Embodiment 3

[0038] Measure 200mL of anhydrous methanol, add 3ml of Tween 80, 30g of polyethylene glycol 2000, fully shake and dissolve, then add 5g of dabigatran etexilate, stir for about 20min, pour the obtained solution into a rotary evaporator, and concentrate to 15ml When it is taken out, it is dried in an oven, and the obtained solid is pulverized and passed through an 80-mesh sieve to obtain a solid dispersion of dabigatran etexilate butanedisulfonate.

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Abstract

The invention belongs to the technical field of medicines and specifically discloses a dabigatran-containing solid dispersion and a preparation method as well as application thereof. The solid dispersion comprises a dabigatran-containing active substance and a carrier material, wherein the hydrophilic high-molecular polymer accounts for 20%-98% of mass of the solid dispersion and the carrier material is a hydrophilic high-molecular polymer. The preparation of the solid dispersion is low in cost and excellent in technical reproducibility.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a solid dispersion containing dabigatran etexilate and its preparation and application. Background technique [0002] Atrial fibrillation (AF) is the most common arrhythmia disease clinically. The investigation shows that the prevalence of atrial fibrillation in my country is as high as 0.77%, and the prevalence shows a trend of increasing significantly with age. With the increasingly prominent problem of population aging in my country, the prevalence of atrial fibrillation will continue to increase. Cardiogenic stroke (mainly ischemic stroke) is the most serious complication of atrial fibrillation, with a high rate of death and disability. Therefore, stroke prevention is very important for patients with atrial fibrillation. The basis of stroke prevention is anticoagulant therapy. Warfarin is the oral anticoagulant drug with the most abundant clinical evidence and the most comm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/4439A61K47/34A61K47/32A61P7/02A61K47/10
Inventor 牟琳琳闫敏李普成刘晓华胡杰
Owner QINGDAO HUANGHAI PHARM CO LTD
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