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Sedative-hypnotic preparation, compound preparation, preparation method and pharmaceutical composition thereof

A compound preparation and composition technology, applied in the field of pharmaceutical preparations, can solve problems such as excessive dust and poor stability

Active Publication Date: 2014-07-16
SHANGHAI ZHONGXI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The technical problem to be solved by the present invention is to provide a sedative and hypnotic preparation, in order to overcome the poor stability of zopiclone and eszopiclone preparations in the prior art, and the defects of excessive dust in the preparation process. Preparation method and pharmaceutical composition thereof

Method used

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  • Sedative-hypnotic preparation, compound preparation, preparation method and pharmaceutical composition thereof
  • Sedative-hypnotic preparation, compound preparation, preparation method and pharmaceutical composition thereof
  • Sedative-hypnotic preparation, compound preparation, preparation method and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 and Embodiment 2

[0070] Example 1 and Example 2 Eszopiclone tablets (3mg / tablet) (unit: gram)

[0071]

[0072]

Embodiment 3

[0073] Example 3 (1mg / tablet) and Example 4 (3mg / tablet) eszopiclone tablets (unit: gram)

[0074]

[0075]

Embodiment 5 and Embodiment 6

[0076] Example 5 and Example 6 Eszopiclone Tablets (3 mg / tablet) (unit: gram)

[0077]

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PUM

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Abstract

The invention relates to a sedative-hypnotic preparation, a compound preparation, a preparation method and a pharmaceutical composition thereof. The compound preparation of the sedative-hypnotic preparation includes zopiclone or eszopiclone and a pharmaceutically acceptable auxiliary material which includes a stabilizing agent with a dosage being, by mass, 0.1%-10% of the zopiclone or the eszopiclone. The stabilizing agent is one or more of a pharmaceutically acceptable organic acid salt, a pharmaceutically acceptable organic acid buffer pair and a pharmaceutical acceptable anti-oxidant. The pharmaceutical composition of the sedative-hypnotic preparation forms a compound preparation pharmaceutical composition with other pharmaceutical active substances. The preparation method of the sedative-hypnotic preparation or the compound preparation includes carrying out a wet granulation process to the pharmaceutical composition of the sedative-hypnotic preparation or the compound preparation pharmaceutical composition. The sedative-hypnotic preparation or the compound preparation is good in stability and is excellent in dissolution rate and content uniformity. Quality of the preparations can be ensured and the preparations are suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a sedative and hypnotic preparation, a compound preparation thereof, a preparation method and a pharmaceutical composition thereof, in particular to a zopiclone or eszopiclone preparation, a compound preparation thereof, a preparation method and a pharmaceutical composition thereof thing. Background technique [0002] Eszopiclone (Eszopiclone) is a single isomer of zopiclone (zopiclone), a rapid short-acting non-benzodiazepine sedative hypnotics developed by Sepracor Corporation of the United States. Eszopiclone was launched in the United States in 2005. At that time, more than 2,000 people were involved in clinical trials for the treatment of short-term and chronic insomnia. Preclinical and clinical studies showed that the affinity of eszopiclone for benzodiazepine receptors is 50 times of eszopiclone, LD of eszopiclone 50 It is 1500mg / kg, the L-body is 300mg / kg, and t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4985A61K31/381A61K31/335A61K31/138A61K31/135A61K9/16A61P25/20
Inventor 郑斯骥张琦谭波阮圆
Owner SHANGHAI ZHONGXI PHARMA
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