Pharmaceutical composition making pregabalin as active ingredient, its preparation method and uses

A technology of pregabalin, active ingredients, used in drug combination, pill delivery, nervous system diseases, etc., can solve problems such as lack of sedation

Inactive Publication Date: 2006-07-26
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In addition, studies of the drug in the treatment of neuropathic pain have shown that in various mouse models of neuropathic pain, including intrathecal injection of P-or-NMDA neuron receptors, carrageenan and formalin-induced Pain model, pregabalin was at least twice as effective as gabapentin in relieving pain, but had no sedative effect

Method used

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  • Pharmaceutical composition making pregabalin as active ingredient, its preparation method and uses

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1 pregabalin tablet

[0017] components

Dosage

Pregabalin

microcrystalline cellulose

pregelatinized starch

CMS-Na

Micropowder silica gel

Magnesium stearate

95% ethanol

Co-made

25g

60g

30g

5.0g

2.5g

2.5g

Appropriate amount

1000 pieces

[0018] Preparation:

[0019] Pass pregabalin, microcrystalline cellulose, and pregelatinized starch through an 80-mesh sieve. After mixing evenly, add 95% ethanol in an appropriate amount to make a soft material, granulate with a 20-mesh sieve, dry, granulate with a 18-mesh sieve, and add CMS- Na, micropowder silica gel, magnesium stearate, mix evenly, and press a suitable die into a tablet to obtain the product.

Embodiment 2

[0020] Embodiment 2: Pregabalin Capsules

[0021] components

Dosage

Pregabalin

starch

50g

30g

[0022] Dextrin

5% PVP-k 30 ethanol solution

PPVP

Talc powder

10g

Appropriate amount

2.0g

2.0g

[0023] Preparation:

[0024] Pass pregabalin, starch and dextrin through 80-mesh sieve respectively, after mixing evenly, add 5% PVP-k 30 ethanol solution (about 60 ml) to make soft material, granulate with 24-mesh sieve, dry, and 24-mesh sieve granules, add the prescribed amount of PPVP and talcum powder, mix evenly, and put it into a suitable capsule shell.

Embodiment 3

[0025] Embodiment 3: pregabalin dispersible tablet

[0026] components

Dosage

Pregabalin

microcrystalline cellulose

Mannitol

CMS-Na

PPVP

lemon zest

aspartame

Talc powder

50% ethanol

Co-made

75g

80g

120

18g

3g

6g

3g

2.5g

Appropriate amount

1000 pieces

[0027] Preparation:

[0028] Pass pregabalin, microcrystalline cellulose, and mannitol through 80-mesh sieve respectively, after mixing evenly, add appropriate amount of 50% ethanol solution to make soft material, granulate with 24-mesh sieve, dry, granulate with 20-mesh sieve, add disintegrant CMS-Na, PPVP, lemon essence, aspartame, talcum powder, mixed evenly and pressed into tablets to obtain.

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PUM

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Abstract

The invention relates to a medicinal composition with pregabalin as the active constituent, its preparing process and use, which comprises pregabalin as the medicinal active constituent, as well as pharmaceutically acceptable auxiliary materials, The composition can be used for treating peripheral nerve pain and epilepsy, and can be prepared into the forms of tablets, capsules, dispersible tablets, granules, soft capsules, chewable tablets, buccal tablets, buccal tablets or other oral preparations.

Description

technical field [0001] The invention relates to a pharmaceutical composition with pregabalin as an active ingredient, a preparation method and application thereof, and belongs to the technical field of medicine. Background technique [0002] Epilepsy is a chronic disease in which the sudden abnormal discharge of brain neurons leads to transient brain dysfunction. Due to the different parts involved in the abnormal discharge of neurons, it can be manifested as seizures of motor, sensory, autonomic, conscious and mental disorders. It is one of the common clinical symptoms caused by many reasons. According to the domestic epidemiological survey, its incidence rate is about 1‰ of the population, and its prevalence is about 5‰ of the population. [0003] The chemical name of pregabalin is (3S)-3-(Aminomethyl)-5-methylhexanoic acid and its chemical structure is [0004] [0005] Experiments have found that pregabalin can bind to the α2γ-subunit gabapentin binding site on the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/197A61K9/20A61K9/48A61P25/08A61P25/02
Inventor 严轶东
Owner FUKANGREN BIO PHARMA
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