Sedative hypnotic pharmaceutical preparation and its preparation method

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 medicines, in particular to a sedative-hypnotic drug 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 people in the world are troubled by insomnia, and the occurrence of insomnia increases with age. Its treatment has attracted more and more people's attention. [0003] In the past, sedative and hypnotics were divided into barbiturates, benzodiazepines and other classes according to their chemical structures. Barbiturates include phenobarbital, pentobarbital and secobarbital, etc.; Azepines include diazepam (stable), nitrazepam (nitrosazepam), flurazepam (flurazepam), clonazepam (clonazepam), lorazepam (clorazepam), espresso Azolam (Solam), Triazolam, Etizolam, Alprazolam (Jiajingan), Midazolam (Sumianan), etc.; other types include chloral hydrate, meprobamate, methaqual...

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 In the preparation process of some such solid preparations, due to the use of mechanical pulverization, there are many defects such as dust, potential safety hazards, cumbersome operation, high cost, and large pollution and loss. A new eszopiclone is provided. Or zopiclone preparation and preparation method thereof

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