Stable Agomelatine capsule medicine composition

A technology of agomelatine and composition, applied in the field of agomelatine capsule pharmaceutical composition and its preparation

Inactive Publication Date: 2011-03-30
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The present invention aims to overcome the problems of the existing agomelatine capsules, such as poor fluidity, low dissolution rate, and significant difference in loading capacity, and changes the Agomelatine capsules. Disadvantages of low dissolution rate and bioavailability of Latin capsules improve the curative effect, and the provided agomelatine capsules have good fluidity and little difference in filling capacity

Method used

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  • Stable Agomelatine capsule medicine composition
  • Stable Agomelatine capsule medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] agomelatine 15g

[0050] Mannitol 70g

[0051] Micronized silica gel 0.5g

[0052] 10% pregelatinized starch solution appropriate amount

[0053] Preparation

[0054] 1) respectively drying agomelatine and mannitol, pulverizing, and passing through a 200-mesh sieve to obtain agomelatine powder and mannitol powder respectively;

[0055] 2) Take the prescribed amount of agomelatine and mannitol, mix them evenly, then add an appropriate amount of 10% pregelatinized starch solution to make a soft material, and pass through a 20-mesh sieve to granulate to obtain wet granules of agomelatine;

[0056] 3) Dry the above wet granules of agomelatine at 60°C until the water content is less than 5% to obtain dry granules of agomelatine

[0057] 4) Pass the above-mentioned agomelatine dry granules through a 20-mesh sieve for sizing, then add a lubricant, mix well, and after passing the quality inspection, pack into capsules to obtain agomelatine capsules.

[0058] Example 2

Embodiment 2

[0060] agomelatine 30g

[0061] Mannitol 140g

[0062] Micronized silica gel 1g

[0063] 10% pregelatinized starch solution appropriate amount

[0064] Preparation

[0065] 1) respectively drying agomelatine and mannitol, pulverizing, and passing through a 200-mesh sieve to obtain agomelatine powder and mannitol powder respectively;

[0066] 2) Take the prescribed amount of agomelatine and mannitol, mix them evenly, then add an appropriate amount of 10% pregelatinized starch solution to make a soft material, and pass through a 20-mesh sieve to granulate to obtain wet granules of agomelatine;

[0067] 3) Dry the above wet granules of agomelatine at 60°C until the water content is less than 5% to obtain dry granules of agomelatine

[0068] 4) Pass the above-mentioned agomelatine dry granules through a 20-mesh sieve for sizing, then add a lubricant, mix well, and after passing the quality inspection, pack into capsules to obtain agomelatine capsules.

[0069]

[0070] Embod...

Embodiment 3

[0072] Mix agomelatine with poloxamer 188, calcium hydrogen phosphate, microcrystalline cellulose PH101, and crospovidone xl, mix well, add water to moisten, make soft material, granulate, dry, granulate, Add sucralose and magnesium stearate and pack into capsules.

[0073] The beneficial effects of the agomelatine capsules of the present invention will be described below through test examples and comparative examples.

[0074] [Test example 1] Stability investigation of product of the present invention

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Abstract

The invention discloses a stable Agomelatine capsule medicine composition which is characterized in that 1000 capsules comprise the following components of 15-30g of Agomelatine, 70-140g of mannitol, 0.5-1g of superfine silica powder and a proper amount of 10 percent pre-gelatinized starch. The invention also relates to a preparation method of an Agomelatine capsule. The Agomelatine capsule prepared by adopting the formula and the preparation method provided in the invention has the advantages of good flowability, good dissolution rate, small content uniformity, high bioavailability and good treatment effect.

Description

technical field [0001] The invention relates to a stable agomelatine capsule pharmaceutical composition and a preparation method thereof. Background technique [0002] Agomelatine, N-[2-(7-methoxy-1-naphthyl)ethyl]acetamide is a selective agonist of melatoninergic receptors. The mechanism of action is to bind to melatonin MT1 and MT2 receptors, and antagonize 5-HT2C receptors at the same time, and the two work together to play an antidepressant effect. [0003] Agomelatine is the world's first melatonin antidepressant, a new breakthrough in the field of depression treatment. Melatonin can be secreted by the pineal gland in the human body, and under normal circumstances, it can regulate the human body's circadian rhythm, including the wake-sleep cycle. Disruptions in circadian rhythms can cause mood disorders and sleep disturbances. In 1917, MeCord and Allan found that the pineal gland extract lightened the skin color of toads, and thus opened the prelude to the study of m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/165A61K47/36A61P25/24
Inventor 黄欣
Owner TIANJIN HANKANG PHARMA BIOTECH
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