Gastric dissolve type tablet containing olanzapine and preparation method for gastric dissolve type tablet

Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to a gastric dissolve type tablet containing olanzapine and a preparation method for the gastric dissolve type tablet. The gastric dissolve type tablet containing olanzapine comprises the following components in parts by weight: 10-20 parts of olanzapine, 20-30 parts of hydroxypropyl-beta-cyclodextrin, 10-30 parts of microcrystalline cellulose, 3-5 parts of croscarmellose sodium, 8-12 parts of pregelatinized starch, 6-10 parts of sorbitan fatty acid ester, 5-8 parts of magnesium hydroxide, 3-6 parts of xylitol, 3-5 parts of sodium alginate, 2-4 parts of tapioca starch, 1-3 parts of kaolin, 3-5 parts of a lubricant and 2-6 parts of a coating material. The gastric dissolve type tablet, prepared according to the preparation method, is high in dissolving-out speed, the preparation is stable in quality, no remarkable moisture absorption phenomenon is generated when the gastric dissolve type tablet is placed for a long time, a wet granulation step is omitted through tabletting by adopting a direct compression method, the gastric dissolve type tablet has the outstanding advantages of saving time, saving energy, being simple in technology, and being less in working procedures, the stability of the tablet is beneficial for being enhanced, and the gastric dissolve type tablet is suitable for being widely popularized and applied.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an olanzapine stomach-soluble tablet and a preparation method thereof. Background technique [0002] Olanzapine is indicated for the acute phase and maintenance treatment of schizophrenia and other psychosis with severe positive and / or negative symptoms. Olanzapine also relieves secondary affective symptoms common in schizophrenia and related disorders. For initial curative effect, continued treatment is required. Olanzapine is an antipsychotic with pharmacological effects on multiple receptor systems. Animal experiments have shown that olanzapine has affinity for multiple receptors such as 5-HT, dopamine D, α-adrenaline, and histamine H. Animal behavior studies have shown that olanzapine has 5-HT, dopamine and cholinergic antagonism, which is consistent with its receptor binding. Olanzapine has a greater affinity for the 5-HT2 receptor in vitro and in viv...

AI Technical Summary

Problems solved by technology

[0003] Due to the nature of olanzapine itself is sensitive to moisture, easy to change color, metastable in various crystalline and amorphous forms, and easy to degrade after being made into tablets, it is not suitable for preparation by wet granulation tableting technology

At the same time, when wet granulation is used to prepare olanzapine stomach-soluble tablets, there are many production steps, large energy consumption, large material loss, long production cycle, and the introduction of water during the production process, resulting in unstable quality of the finished product during long-term storage.