Composition containing flupirtine maleate and preparation method of composition

A technology of flupirtine maleate and a composition is applied in the field of compositions containing flupirtine maleate and its preparation, and can solve the problems of no obvious changes, unstable raw materials, etc. The effect of good fluidity and stable quality

Inactive Publication Date: 2017-12-01
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The purpose of the present invention is to provide a composition containing flupirtine maleate, which solves the problem of unstable raw materials under light and high humidity conditions. The quality of the product of the present invention is stable, and the content of flupirtine maleate and related impurities And the dissolution rate has no obvious change, and the in vitro dissolution behavior is consistent with the flupirtine maleate capsules of the German AWD company, reducing the risk of differences in clinical efficacy between the two. The process of the present invention is simple, which is beneficial to the realization of industrial production

Method used

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  • Composition containing flupirtine maleate and preparation method of composition
  • Composition containing flupirtine maleate and preparation method of composition
  • Composition containing flupirtine maleate and preparation method of composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Prescription (1000 capsules)

[0045]

[0046] Preparation process: pulverize flupirtine maleate with a pulverizer, and the particle size distribution range of flupirtine maleate after pulverization is d(0.9)=10-16 μm, d(0.5)=5-7 μm, in order according to the prescription quantity Weigh anhydrous calcium hydrogen phosphate, crospovidone xl-10, silicon dioxide and flupirtine maleate into the mixer, mix for 15 minutes, add the mixed raw and auxiliary materials into the dry granulator to granulate, and use 0.6mm stencil for granulation, weigh povidone k30, magnesium stearate and the prepared granules according to the prescription, add them to the mixer and mix them for 5 minutes, measure the content of the granules, calculate the loading according to the content of the granules, and fill them with automatic capsules machine 2 # Empty capsules are filled, and the filling volume is controlled within ±5%.

Embodiment 2

[0048] Prescription (1000 capsules)

[0049]

[0050]

[0051] Preparation process: pulverize flupirtine maleate with a pulverizer, and the particle size distribution range of flupirtine maleate after pulverization is d(0.9)=10-16 μm, d(0.5)=5-7 μm, in order according to the prescription quantity Weigh anhydrous calcium hydrogen phosphate, crospovidone xl-10, silicon dioxide and flupirtine maleate into the mixer, mix for 15 minutes, add the mixed raw and auxiliary materials into the dry granulator to granulate, and use 0.6mm stencil for granulation, weigh povidone k30, magnesium stearate and the prepared granules according to the prescription, add them to the mixer and mix them for 5 minutes, measure the content of the granules, calculate the loading according to the content of the granules, and fill them with automatic capsules machine 2 # Empty capsules are filled, and the filling volume is controlled within ±5%.

Embodiment 3

[0053] Prescription (1000 capsules)

[0054]

[0055] Preparation process: pulverize flupirtine maleate with a pulverizer, the particle size distribution range of flupirtine maleate after pulverization is d(0.9)=16 μm, d(0.5)=7 μm, and take anhydrous Calcium hydrogen phosphate, crospovidone xl-10, silicon dioxide and flupirtine maleate are added to the mixer, mixed for 15 minutes, and the mixed raw and auxiliary materials are added to the dry granulator to granulate, using a 0.6mm mesh plate Carry out granulation, take povidone k30, magnesium stearate and the obtained granules according to the prescription amount and add them to the mixer and mix for 5 minutes, detect the granule content, calculate the loading according to the granule content, and use a full-automatic capsule filling machine 2 # Empty capsules are filled, and the filling volume is controlled within ±5%.

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Abstract

The invention relates to composition containing flupirtine maleate and a preparation method of the composition. The composition is prepared from raw materials in percentage by weight as follows: 25%-35% of flupirtine maleate, 50%-70% of a diluent, 1.5%-4.5% of a disintegrating agent, 1.5%-4.5% of a flow aid, 0.5%-1.5% of a cosolvent and 0.5%-1.5% of a lubricant. The problem that the raw materials are unstable under illumination and high-humidity conditions is solved. The composition is stable in quality, the content of flupirtine maleate, related impurities and dissolution rate have no remarkable change, the in-vitro dissolution behavior is consistent with that of flupirtine maleate capsules from the German AWD company, the risk of clinical effect difference is reduced, the process is simple, and realization of industrial production is facilitated.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a composition containing flupirtine maleate and a preparation method thereof. Background technique [0002] Flupirtine maleate, English name: FlupirtineMaleate, chemical name: 2-amino-6-[(4-fluorobenzyl)amino]pyridine-3-carbamate ethyl ester maleate, molecular formula: C 15 h 17 FN 4 o 2 ·C 4 h 4 o 4 , the molecular weight is 420.40, and the chemical structural formula is: [0003] [0004] Flupirtine maleate is a selective neurogenic potassium channel opener, a non-opioid analgesic that acts on the central nervous system, does not produce dependence and tolerance, and is mainly used for various types of Treatment of moderate acute pain, such as pain caused by surgery, trauma, etc., as well as headache, migraine and abdominal cramps. [0005] Flupirtine Maleate Capsules is a new type of non-opioid painkiller developed by German AWD Compa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/44A61K47/32A61P25/00
CPCA61K9/1635A61K9/1694A61K31/44
Inventor 苗得足赵亮王克成
Owner REYOUNG PHARMA
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