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Pradaxa dropping pill and preparation method thereof

A technology of dabigatran etexilate and dropping pills, which is applied in the field of pharmaceutical preparations and its preparation, can solve the problems of slow onset of action, heavy taste, and large dosage, and achieve faster dissolution and absorption, easy absorption, and drug dispersion uniform 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 dabigatran etexilate drugs are tablets, which have the disadvantages of large dosage, heavy taste, difficult to swallow, slow onset of effect, etc. Therefore, it is the need of current clinical treatment to seek new preparation types of this class of drugs. Developing a process suitable for new pharmaceutical forms has also become an important issue in current research

Method used

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  • Pradaxa dropping pill and preparation method thereof

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preparation example Construction

[0021] The invention provides a dabigatran etexilate dripping pill and a preparation method thereof. In the method, taking dabigatran etexilate as the main raw material, according to a certain ratio, adding substrates such as polyethylene glycol, after passing through specific processes and equipment Prepared by processing. details as follows:

[0022] (1) Prescription: dabigatran etexilate + 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 dabigatran etexilate and substrate is 1: (1-60).

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

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

Embodiment 1

[0042] Prescription: Dabigatran etexilate 0.5g; PEG4000 5g;

[0043] PEG8000 25g; 1000 capsules in total.

[0044] Preparation method: mix dabigatran etexilate, PEG4000 and PEG8000 evenly, heat in a water bath to make it 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 Put it in simethicone oil at -5°C, after forming, filter, separate, and wipe clean to get it.

Embodiment 2

[0046] Prescription: Dabigatran etexilate 1g; PEG1500 5g;

[0047] PEG6000 25g; 1000 capsules in total.

[0048] Preparation method: Mix dabigatran etexilate, PEG1500, and PEG6000 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 Put it in simethicone oil at -5°C, after forming, filter, separate, and wipe clean to get it.

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Abstract

The invention discloses a pradaxa dropping pill serving as an anticoagulant and a preparation method of the pradaxa dropping pill. The preparation method comprises the steps of with pradaxa 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 pradaxa dropping pill. The pradaxa 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, in particular to a dabigatran etexilate dropping pill and a preparation method thereof. Background technique [0002] Dabigatran etexilate is the latest generation of oral anticoagulant direct thrombin inhibitors (DTIs) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Dabigatran etexilate can provide effective, predictable, and stable anticoagulant effect, and at the same time, there are few drug interactions, no drug-food interactions, and no routine coagulation function monitoring or dose adjustment is required. [0003] Dabigatran etexilate is another new type of oral anticoagulant drug approved by the US Food and Drug Administration after warfarin. It is a non-peptide thrombin inhibitor, which specifically and selectively blocks thrombin (free or bound) activity to exert anticoagulant effect. It has the chara...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4439A61P7/02
Inventor 黄四周李明亮王琦
Owner TIANJIN KANGRUI PHARMA
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