Novel prescription composition and preparation method of paroxetine hydrochloride enteric controlled release tablet

Abstract

The invention relates to a novel prescription and a preparation method of an oral paroxetine hydrochloride enteric controlled release tablet. The paroxetine hydrochloride enteric controlled release tablet consists of a double-layer core and an enteric coating, wherein the enteric coating enables active pharmaceutical ingredients to release in a fixed position at the lower end of the small intestine; the double-layer core controls the constant release speed of a medicine; the core consists of two layers, wherein one layer is a corroded blockage layer free of the active ingredients and is used for limiting the liquid permeation on the surface of a matrix, and another layer is a medicine-containing layer of a hydrophilic matrix; and when an aqueous medium enters a hydrophilic layer containing the active ingredients, a polymer can be hydrated and gelled, and thus a screen is constructed for the active ingredients to release and disperse from a preparation. The oral paroxetine hydrochloride enteric controlled release tablet is high in medicine release performance and completely meets the requirement on zero-order release. A controlled release material of a corroded layer is a mixture of docosanoic acid glycerol ester and / or ethyecellulose based on the mass ratio of 5: 1 to 1: 5; and the material adopted in the hydrophilic matrix layer is HPMC (Hydroxy Propyl Methyl Cellulose) series, and K4M is preferable.

Description

technical field

[0001] The invention discloses a preparation and a preparation method of paroxetine hydrochloride enteric-coated controlled-release tablets for oral administration, which belong to the technical field of medicine. Background technique

[0002] Paroxetine hydrochloride is a selective serum reuptake inhibitor (SSRI) type antidepressant, its antidepressant effect is similar to that of tricyclic antidepressants (TCA), and its side effects are significantly less than TCA, It belongs to the third generation of new antidepressant drugs. GlaxoSmithKline (China) Investment Co., Ltd. has launched Paroxetine immediate-release tablets in China in 1996 for the treatment of major depressive disorder. However, the adverse reactions of paroxetine immediate-release tablets are relatively large, mainly manifested as nausea and headache. This is because paroxetine tablets may cause the increase of 5-HT in the synapses of the peripheral nerves of the duodenum, stimulate the 5-...

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