Tablets containing escitalopram oxalate and preparation method thereof

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to escitalopram oxalate tablets and a preparation method thereof capable of ensuring stable quality. According to the preparation method, an escitalopram oxalate raw material with the median diameter of not less than 300 microns is used, and auxiliary materials include magnesium stearate and other components, wherein the weight percentage of magnesium stearate in the tablets is less than 0.1%. The preparation method effectively solves the problems of poor raw material fluidity, high sticking tendency and non-uniform mixing of materials, and also solves the problem that compatibility between magnesium stearate and active ingredients is poor, causing increase of related substances. The method has the advantages of easy operation and easy industrialization, and the obtained tablets are high in content uniformity and stable in quality within the valid period.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an escitalopram oxalate tablet and a preparation method for ensuring its quality is stable within the valid period. Background technique [0002] Escitalopram oxalate tablets (escitalopram oxalate), developed by Lundbeck, Denmark, was approved by the FDA in 2002, and was approved by the CFDA in 2005, and was launched in China in 2005. It is an oral serotonin reuptake inhibitor; its structural formula is as follows : [0003] [0004] The patent CN02815031 of Yuanyan Lingbei in China discloses a method for preparing escitalopram oxalate raw material with a median particle size of 40-200um, and uses this raw material for direct powder compression or capsule filling, but the raw material The crystal form needs to be prepared by a specific process; [0005] WO03 / 011278A1 patent mentions that when the direct compression process is adopted, if the difference between t...

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Problems solved by technology

[0007] CN 104523638 discloses a wet granulation process for preparing escitalopram oxalate tablets. It is mentioned that when the powder is directly compressed into tablets, the raw materials are prone to sticking due to high static electricity. The inventor also confirmed this in actual operation. Phenomenon, which once led to the failure of normal production;

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