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Capsule containing flupirtine maleate and preparation method thereof

A technology of flupirtine maleate and capsules, which is applied in the field of medicine, can solve the problems of difficult storage, poor stability, and low dissolution rate, and achieve the effect of convenient product storage and enhanced stability

Inactive Publication Date: 2012-12-26
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Flupirtine maleate is easily degraded when exposed to light, and is not easy to store
Through long-term research, we have found that the currently commercially available flupirtine maleate capsules have a short shelf life, poor stability, and low dissolution rate. After a period of storage, the content of active ingredients decreases and impurities increase.

Method used

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  • Capsule containing flupirtine maleate and preparation method thereof
  • Capsule containing flupirtine maleate and preparation method thereof
  • Capsule containing flupirtine maleate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Embodiment 1, flupirtine maleate capsule prescription:

[0055]

[0056] Process:

[0057] 1) pass the calcium hydrogen phosphate through a 100-mesh sieve, and set aside;

[0058] 2) pulverize flupirtine maleate through a 600-mesh sieve, and set aside;

[0059] 3) mix flupirtine maleate with calcium hydrogen phosphate and 10g silicon dioxide, and 10g magnesium stearate;

[0060] 4) Put the above-mentioned obtained material in a dry granulator to make a dry material, and break it into dry granules through a swing granulator;

[0061] 5) passing the gained dry particles through 24 mesh and 80 mesh stainless steel sieves successively, collecting the part above the 80 mesh sieves as qualified particles;

[0062] 6) Add additional auxiliary materials crospovidone, 10g silicon dioxide, and 3g magnesium stearate to the above materials, and mix well;

[0063] 7) Capsule.

Embodiment 2

[0064] Embodiment 2, flupirtine maleate capsule prescription:

[0065]

[0066] Process:

[0067] 1) Pass calcium hydrogen phosphate through a 100-mesh sieve and set aside;

[0068] 2) Pulverize the flupirtine maleate through a 600-mesh sieve and set aside;

[0069] 3) Mix flupirtine maleate with calcium hydrogen phosphate, 10g silicon dioxide, and 10g magnesium stearate;

[0070] 4) Put the above-mentioned obtained material in a dry granulator to make a dry material, and crush it into dry granules through a swing granulator;

[0071] 5) Pass the obtained dry particles through 24-mesh and 80-mesh stainless steel screens in turn, and collect the part above the 80-mesh screen as qualified particles;

[0072] 6) Add external auxiliary materials crospovidone, 10g silicon dioxide, 3g magnesium stearate to the above materials, and mix well;

[0073] 7) Capsules.

Embodiment 3

[0074] Embodiment 3, flupirtine maleate capsule prescription:

[0075]

[0076] 1) Pass calcium hydrogen phosphate through a 100-mesh sieve and set aside;

[0077] 2) Pulverize the flupirtine maleate through a 600-mesh sieve and set aside;

[0078] 3) Mix flupirtine maleate with calcium hydrogen phosphate, 20g silicon dioxide, and 20g magnesium stearate;

[0079] 4) Put the above-mentioned obtained materials in a dry granulator to make dry materials, and crush them into dry granules through a swing granulator;

[0080] 5) Pass the obtained dry particles through 24-mesh and 80-mesh stainless steel screens in turn, and collect the part above the 80-mesh screen as qualified particles;

[0081] 6) Add external auxiliary materials crospovidone, 20g silicon dioxide, 6g magnesium stearate to the above materials, and mix well;

[0082] 7) Capsules.

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Abstract

The invention relates to a medicinal composition containing flupirtine maleate and a preparation method of the medicinal composition containing flupirtine maleate. The flupirtine maleate composition provided by the invention contains dried solid particles containing flupirtine maleate and a pharmaceutically acceptable adjuvant which is not contained in the particles. The composition is high in storage stability.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a capsule containing flupirtine maleate and a preparation method thereof. Background of the invention [0002] Flupirtine maleate (Katadolon®; ethyl 2-amino-6-[(4-fluorobenzyl)amino]pyridine-3-carbamate) is a centrally acting non-opioid analgesic. The structure is as follows: [0003] [0004] Flupirtine, in the form of the maleate salt, has been used successfully for many years in the treatment of, for example, neuralgia, pain associated with degenerative joint diseases, headaches and postoperative pain. According to DE4122166AI, flupirtine maleate can also be used as a medicament for the control of disorders or pathological symptoms which are based on muscle tension or are the result of muscle tension. [0005] Flupirtine maleate is easily degraded when exposed to light, and is not easy to store. Through long-term research, we found that the currently commercially avai...

Claims

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Application Information

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IPC IPC(8): A61K31/44A61P25/04A61P29/02
Inventor 董凯李宝齐王瑞卿
Owner TIANJIN CHASE SUN PHARM CO LTD
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