Sedative hypnotic pharmaceutical preparation and its preparation method

A pharmaceutical preparation, sedation and hypnosis technology, applied in the pharmaceutical field, can solve the problems of unsatisfactory drug dissolution characteristics, large pollution and loss, and cumbersome operation

Active Publication Date: 2013-01-02
SHANGHAI ZHONGXI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved by the present invention is to overcome the large particle size of the pharmaceutical active ingredient eszopiclone or zopiclone in the existing eszopiclone or zopiclone solid preparations, which makes the dissolution characteristics of the drug not ideal, and the current

Method used

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  • Sedative hypnotic pharmaceutical preparation and its preparation method
  • Sedative hypnotic pharmaceutical preparation and its preparation method
  • Sedative hypnotic pharmaceutical preparation and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0037] Example 2 Eszopiclone capsule (3mg / capsule) formulation and preparation method (unit: g)

[0038] The granules (including magnesium stearate and 1 / 3 sodium starch glycolate) before tabletting in Example 1 were passed through a 30-mesh sieve, mixed evenly, and then packed into capsules.

Embodiment 3

[0039] Example 3 Zopiclone tablet (2.5mg / tablet) formula and preparation method (unit: g)

[0040]

[0041]

Embodiment 4

[0042] Example 4 Eszopiclone tablets (2mg / tablet) (unit: grams)

[0043]

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PUM

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Abstract

The invention discloses a preparation method of a sedative hypnotic pharmaceutical preparation. The preparation method includes the steps of dissolving active ingredient dexzopiclone or zopiclone in acidifier-containing acidic solution to give drug-containing acidic solution, and then performing wet granulation with the obtained drug-containing acidic solution, basifier and adjuvant. The acidifier is hydrochloric acid, and the basifier is sodium hydroxide. One or more of organic weak acid, acid salt and conjugate base of organic weak acid are added before or during the addition of the basifier. The invention also discloses the sedative hypnotic pharmaceutical preparation prepared by the method. The inventive preparation method has no potential safety hazard, simple and convenient operation, low pollution and loss, low cost, and good process controllability. The obtained pharmaceutical preparation has excellent dissolution and stability, and lower related substance content.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a sedative and hypnotic pharmaceutical preparation containing eszopiclone or zopiclone and a preparation method thereof. Background technique [0002] There are relatively serious sleep disorders in modern society. Nearly 1 / 4 of the world's people suffer from insomnia, and the incidence of insomnia increases with age. More than 50% of the elderly complain about easy and early awakening, insomnia and Its treatment is getting more and more attention. [0003] In the past, sedative-hypnotic drugs were divided into barbiturates, benzodiazepines and others according to their chemical structures. Barbiturates include phenobarbital, pentobarbital and secobarbital; benzodiazepines Nitroazepines include Diazepam (Valium), Nitrazepam (Nazepam), Flurazepam (Fluazepam), Clonazepam (Clonazepam), Lorazepam (Clonazepam), Essence Zolam (Sullen), Triazolam, Etizolam, Alprazolam (Jiajing), Midazolam (Sum...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/16A61K9/20A61K9/48A61K31/4985A61P25/20
Inventor 郑斯骥张琦袁少卿周敏周晓兰
Owner SHANGHAI ZHONGXI PHARMA
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