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Apixaban dropping pill and preparation method thereof

A technology for apixaban and dropping pills is applied in the field of pharmaceutical preparations and their preparation, which can solve the problems of heavy and difficult taste, large dosage, slow onset of effect, etc., and achieves easy absorption, uniform drug dispersion, dissolution and absorption accelerated effect

Inactive Publication Date: 2015-04-22
TIANJIN KANGRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Most of the existing apixaban drugs are tablets, which have the disadvantages of large dosage, heavy taste, difficult to swallow, and slow onset of action. The process suitable for the new drug dosage form has also become an important issue of current research

Method used

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  • Apixaban dropping pill and preparation method thereof

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preparation example Construction

[0021] The invention provides an apixaban drop pill and a preparation method thereof. In the method, apixaban is used as the main raw material, and polyethylene glycol and other substrates are added in a certain proportion, and prepared through specific processes and equipment. made. details as follows:

[0022] (1) Prescription: Apixaban + matrix

[0023] Base: Contains polyethylene glycol (1500, 2000, 4000, 6000, 8000, 10000, 20000), polyoxyl 40 stearate, beta cyclodextrin, poloxamer, sodium carboxymethyl starch, One or more components of stearic acid, sodium stearate, glycerin gelatin, glyceryl monostearate, shellac, polyoxyethylene monostearate, polyether.

[0024] The weight ratio of apixaban to base is 1:(1-60).

[0025] (2) Preparation process: the specific implementation steps are as follows:

[0026] The first step is to mix apixaban with the matrix according to a certain ratio.

[0027] The second step is to use water bath, oil bath or other heating methods to h...

Embodiment 1

[0041] Prescription: Apixaban 0.5g; PEG4000 5g;

[0042] PEG8000 25g; 1000 capsules in total.

[0043] Preparation method: Mix apixaban, PEG4000, and PEG8000 evenly, heat in a water bath to make it completely melt, pour the molten liquid into the material funnel of the dripping pill making machine, keep it warm at 80°C, select the drip nozzle, and drop it into the In simethicone oil at -5°C, after molding, filter, separate, and wipe clean to obtain.

Embodiment 2

[0045] Prescription: Apixaban 1g; PEG1500 5g;

[0046] PEG6000 25g; 1000 capsules in total.

[0047] Preparation method: Mix apixaban, PEG1500, and PEG6000 evenly, heat in a water bath to melt completely, pour the molten liquid into the material funnel of the dripping pill making machine, keep it warm at 80°C, select the drip nozzle, and drop it into the In simethicone oil at -5°C, after molding, filter, separate, and wipe clean to obtain.

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Abstract

The invention discloses an apixaban dropping pill for preventing thrombotic diseases and a preparation method of the apixaban dropping pill. The preparation method comprises the steps of with apixaban as a raw material, adding a matrix according to a prescription, and uniformly mixing to obtain a mixed material; heating the mixed material to be molten, and uniformly stirring to obtain a mixture; placing the mixture into a special pill dropping machine; and dropping pills into a condensing agent at a proper speed to condense to form the apixaban dropping pill. The apixaban dropping pill is high in bioavailability, capable of rapidly releasing drugs, high in effect taking speed and drug stability and convenient to take; in addition, the consumption of auxiliary materials is reduced, the production process is simple, the preparation method is easy to operate, the weight difference is small, and the production cost is reduced; and no dust is generated, and labor protection can be favorably realized.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, specifically an apixaban dropping pill and a preparation method thereof. Background technique [0002] Apixaban (Apixaban, trade name Eliquis) is an oral selective activated factor Xa inhibitor. Apixaban is the third new oral anticoagulant to be marketed after dabigatran and rivaroxaban. It has been approved in Europe for the prevention of venous thromboembolic events in patients undergoing elective hip or knee replacement surgery. [0003] Of the three oral anticoagulants approved in Europe, rivaroxaban and apixaban performed better in the RECORD and ADVANCE trials, respectively, compared with enoxaparin, the current standard of care for the prevention of venous thromboembolism after orthopedic surgery. Highlight advantages. Apixaban, jointly developed by Pfizer and Bristol-Myers Squibb, will lead the market for stroke-prevention vascular thinners due to its "be...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4545A61K47/34A61K47/42A61K47/44A61K47/12A61P7/02
Inventor 黄四周李明亮王琦
Owner TIANJIN KANGRUI PHARMA
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