Paroxetine mesylate tablet core, and preparation method of coated tablet of paroxetine mesylate

Abstract

The invention provides a paroxetine mesylate tablet core, and a preparation method of a coated tablet of paroxetine mesylate. Each paroxetine mesylate tablet core comprises 10 to 40mg of active pharmaceutical ingredient paroxetine mesylate, 20 to 90% of a water insoluble filler, 10 to 60% of a water soluble filler, 3 to 30% of a disintegrating agent, 0 to 10% of an adhesive, and 0.1 to 10% of a flow aid and a lubricant. The paroxetine mesylate tablet core is prepared via wet-method granulation or spray granulation of the ingredients above, and tabletting. The invention also provides the preparation method of the paroxetine mesylate coated tablet. A coating material is opacifying agent-containing opadry or a coating powder composed of 0.5 to 4% of a film forming agent, 0.1 to 2% of a plasticizer, 0.1 to 1% of a colouring agent, 0.1 to 2% of an opacifier, and 0.1 to 1% of a lubricant. The paroxetine mesylate tablet core is subjected to coating using a coating liquid prepared from the coating material. The ingredients of the coating material are commonly used; the preparation method is stable; film coating is capable of covering bitter taste and hemp taste of the main drug, increasing light stability, and improving compliance of patients and stability of preparations. The coated tablet prepared via the preparation method is qualified and stable.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical preparation of an oral coated tablet containing paroxetine mesylate as the main drug. The tablet adopts commonly used auxiliary materials and adopts a conventional wet granulation process. The preparation method is simple, the operation is convenient, the quality and stability of the pharmaceutical preparation are improved, the application range is wide, and it is suitable for large-scale production. Background technique [0002] Paroxetine is a phenylpiperidine derivative, a selective 5-HT reuptake inhibitor, and belongs to the class of antidepressant drugs such as citalopram, fluoxetine, sertraline, and clomipramine, and is widely used clinically. In the treatment of depression, it has no obvious effect on other transmitters at the usual dose. It increases the concentration of 5-HT in the synaptic cleft by preventing the reabsorption of 5-HT, ther...

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