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Medicinal composition of agomelatine-containing enteric-coated tablets

A technology of composition and enteric-coated tablet, applied in the field of medicine

Inactive Publication Date: 2012-12-19
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this invention has a certain effect on improving bioavailability, it cannot solve the fundamental problem only by this method

Method used

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  • Medicinal composition of agomelatine-containing enteric-coated tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Enteric-coated tablet containing 2 mg agomelatine

[0035] The first five of the following substances were blended together, wet granulated, dried and sized. The granules are then mixed with magnesium stearate and compressed in batches of 100 mg tablets each using a rotary tablet press.

[0036]

[0037] Isolation gown

[0038] Povidone 30g

[0039] water 500g

[0040] Process: a, the povidone of prescription quantity is dissolved in the water of prescription quantity,

[0041] b. Preheat the plain tablets in the coating pan so that the temperature of the tablet bed is 40°C.

[0042] c. Coating is completed at a speed of 3ml / min.

[0043] Enteric coating layer

[0044]

[0045] Process: a. Disperse the Eudragit S of the prescribed amount in 30g of water,

[0046] B, sodium hydroxide solution (1mol / l) is dripped under stirring condition to complete, and continue to stir for 30 minutes,

[0047] c, add triethyl citrate and talcum powder of prescription quant...

Embodiment 2

[0051] Enteric-coated tablet containing 3 mg agomelatine

[0052] The first five of the following substances were blended together, wet granulated, dried and sized. The granules were then mixed with silicon dioxide and compressed in batches of 150 mg tablets each using a rotary tablet press.

[0053]

[0054] Isolation gown

[0055] Hypromellose (50cp) 30g

[0056] water 1000g

[0057] Process: a, the hypromellose of prescription quantity is dissolved in the water of prescription quantity,

[0058] b. Preheat the plain tablets in the coating pan so that the temperature of the tablet bed is 40°C.

[0059] c. Coating is completed at a speed of 3ml / min.

[0060] Enteric coating layer

[0061]

[0062] Process: a. Mix the components in the prescription according to the prescription amount for later use,

[0063] b. Preheat the above-mentioned coated tablets in a coating pan so that the tablet bed temperature is 40°C,

[0064] c. Coating at a speed of 4ml / min, samplin...

Embodiment 3

[0066] Enteric-coated tablet containing 5 mg agomelatine

[0067] The raw and auxiliary materials are mixed, and a rotary tablet press is used for direct tablet compression, and a batch of tablets with a quality of 200 mg per tablet is pressed.

[0068]

[0069] Isolation gown

[0070] Hypromellose (50cp) 50g

[0071] Ethanol 600g

[0072] water 1400g

[0073] Process: a, the hypromellose of prescription quantity is dissolved in the 30% ethanol of prescription quantity,

[0074] b. Preheat the plain tablets in the coating pan so that the temperature of the tablet bed is 40°C.

[0075] c. Coating is completed at a speed of 3ml / min.

[0076] Enteric coating layer

[0077]

[0078] Process: a. Dissolve Eudragit L100 in ethanol,

[0079] b, add triethyl citrate and talcum powder of prescription quantity, make coating solution for subsequent use,

[0080] d. Preheat the above-mentioned coated tablets in a coating pan so that the tablet bed temperature is 40°C

[0081...

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Abstract

The invention relates to a medicinal composition of agomelatine-containing enteric-coated tablets. The medicinal composition is mainly composed of a medicine-containing tablet portion and an enteric coating portion, wherein the content of an active component-agomelatine is 1 mg-50 mg. The enteric-coated tablets provided by the invention can be used for treating depression and anxiety, have the functions of adjusting sleeping rhythms and biological clocks, and have the advantages of low content of the main medicine and high bioavailability.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a medicinal composition of enteric-coated tablets of agomelatine containing antidepressant and anti-anxiety effects. Background technique [0002] Agomelatine has the functions of antidepressant, anti-anxiety, regulating sleep rhythm and regulating biological clock. It is not only the first melatonin (MT1, MT2) receptor agonist, but also 5-hydroxytryptamine (5-HT2C) receptor antagonist. The structural formula is as follows: [0003] [0004] Molecular formula: C 15 h 17 N0 2 [0005] Molecular weight: 243.30. [0006] Agomelatine has antidepressant effect and does not increase the concentration of 5-HT in the synaptic cleft. occurrence of drug side effects. Patients with depression often have difficulty falling asleep, early awakening, or changes in sleep rhythm. Polysomnography often shows decreased slow wave sleep (SWS), increased rapid eye movement slee...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/30A61K31/165A61K47/38A61K47/36A61K47/32A61P25/24A61P25/22A61P25/20
Inventor 李洪起王博任晓文连潇嫣
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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