Preparation method of agomelatine solid preparation

A solid preparation and carrier technology, which is applied in the field of medicine, can solve the problems of reducing production efficiency and cumbersome production, and achieve the effects of simple method, saving cost and production time, and good in vitro dissolution performance

Active Publication Date: 2013-03-27
ZHEJIANG HUAHAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the micronization of drugs requires special airflow pulverization equipment, which is cumbersome in production and requires quality control of drug particle size, which reduces production efficiency.

Method used

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  • Preparation method of agomelatine solid preparation
  • Preparation method of agomelatine solid preparation
  • Preparation method of agomelatine solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Preparation of the composition of agomelatine:

[0024] Weigh 10 g of crystal form II agomelatine and 20 g of crospovidone (model Kollidon CL) and mix them evenly, then add them to an oven at 160° C. for 10 minutes, take them out and pass through a sieve to cool.

Embodiment 2

[0026] Preparation of the composition of agomelatine:

[0027] Weigh 100 g of agomelatine of crystal form VI and 300 g of crospovidone (model Kollidon CL-M) and add them to a jacketed granulator for granulation. The temperature is set at 105° C. and stirred for 5 minutes. Take out and sieve to cool.

Embodiment 3

[0029] Preparation of the composition of agomelatine:

[0030] Weigh 10 g of crystal form II agomelatine and 40 g of crospovidone (Polyplasdone XL) and mix them evenly, then add them to an oven at 140° C. for 10 minutes, take them out and pass through a sieve to cool.

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PUM

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Abstract

The invention provides a preparation method of an agomelatine solid preparation. The preparation method comprises the steps of mixing agomelatine or pharmaceutically acceptable salts with polyvinylpolypyrrolidone; hot-melting the mixture to prepare particles; and mixing the particles with other pharmaceutically acceptable carriers to be tabletted or filled to form capsules. The agomelatine solid preparation prepared by the method is stable and controllable in quality and high in dissolution.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of agomelatine solid preparation. Background technique [0002] Agomelatine tablets (agomelatine tablets) were developed by the French company Servier, the specification is 25mg, and its trade name is Weixin, and the trade name is It is mainly used for the treatment of adult depression. It was approved for marketing by the European Union in February 2009. It is the world's first melatonin receptor agonist antidepressant. Its molecular structural formula is as follows: [0003] [0004] Agomelatine is almost insoluble in hydrochloric acid solution at pH 2.0, acetate buffer at pH 4.5, phosphate buffer at pH 6.8 and water, so it is necessary to improve its dissolution rate in the preparation process to enhance its biological properties. Utilization. [0005] Drugs with poor solubility have brought technical difficulties in the development of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/48A61K9/16A61K31/165A61K47/32A61P25/24
CPCA61K9/1635A61K9/48A61K9/20A61K9/16A61K9/2027A61K47/32A61K31/165A61P25/24
Inventor 彭俊清徐彪曹宇陈梁杨专余慧李艳艳
Owner ZHEJIANG HUAHAI PHARMA CO LTD
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