Flupirtine maleate capsule composition and preparation method thereof

A technology of flupirtine maleate capsules and flupirtine maleate, which is applied in the field of flupirtine maleate capsule composition and its preparation, and can solve problems such as uneven mixing of raw and auxiliary materials, high production cost, and low bulk density , to achieve the effect of large-scale production, qualified product quality and improved yield

Active Publication Date: 2014-10-08
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As we all know, the bulk density of flupirtine maleate is small. After the raw materials are ultrafinely pulverized, the bulk density becomes smaller, which can easily cause uneven mixing of raw materials.
Although ultrafine pulverization can increase the dissolution of drugs to a certain extent, the process is complicated and the yield is low, resulting in high production costs

Method used

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  • Flupirtine maleate capsule composition and preparation method thereof
  • Flupirtine maleate capsule composition and preparation method thereof
  • Flupirtine maleate capsule composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Preparation Process:

[0067] (1) Screening of ingredients: Weigh the flupirtine maleate raw material and calcium hydrogen phosphate in the prescribed amount, pre-mix for 10 minutes, pass the mixed material through a 60-mesh sieve, and set aside;

[0068] (2) Mixing: add the prescribed amount of copovidone S630 to step (1), and mix for about 30 minutes;

[0069] (3) Granulation: granulation by dry granulation;

[0070] (4) Total blending: Add the prescribed amount of silicon dioxide and magnesium stearate to the granules prepared in step (3), and mix for 5 minutes;

[0071] (5) Intermediate product inspection: calculate the content of mixed particles after total blending;

[0072] (6) Calculate the loading range, fill the capsules, and use polyvinyl chloride solid pharmaceutical hard tablets and aluminum foil for pharmaceutical packaging as inner packaging materials for packaging.

Embodiment 2

[0074] Preparation process: same as the preparation process of Example 1, the mixing time in step (2) is 25 minutes.

Embodiment 3

[0076] Preparation process: same as the preparation process of Example 1, the mixing time in step (2) is 20 minutes.

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Abstract

The invention provides a flupirtine maleate capsule composition. The flupirtine maleate capsule composition contains flupirtine maleate and a solubilizer. The solubilizer is copovidone S630. The invention also provides a flupirtine maleate capsule preparation method having simple processes and quality controllability. a flupirtine maleate raw material and calcium hydrophosphate are mixed and sieved by a sieve of 60 meshes so that raw material and auxiliary material uniform mixing is guaranteed, a yield is improved and a production cost is reduced. The preparation method utilizes a dry granulation technology so that granule bulk density is large, and compared with the existing granules having small bulk density, the same weight of the granules obtained by the preparation method can be put into a small-volume capsule. The products obtained by the preparation method and the formula have qualified quality and stable drug effects and are conducive to large-scale production realization.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a flupirtine maleate capsule composition and a preparation method thereof. Background technique [0002] Flupirtine maleate, the English name is: Flupirtine Maleate, the chemical name is: 2-amino-6-[(4-fluorobenzyl)amino]pyridine-3-carbamate ethyl ester maleate, the molecular formula is: C 19 h 21 FN 4 o 6 , the molecular weight is 420.39, and the chemical structural formula is: [0003] [0004] Flupirtine maleate is a selective neuronal potassium channel opener (Selective Neuronal Potassium Channel Opener, SNEPCO), a non-opioid analgesic that acts on the central nervous system, does not produce dependence and tolerance It has triple effects of pain relief, muscle relaxation and nerve protection. It is mainly used for the treatment of various types of moderate acute pain, such as pain caused by surgery, trauma, etc., as well as headache, migraine a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/32A61K47/04A61K31/44A61P25/04A61P21/02A61P25/00
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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