Ebstine solid oral preparation and its preparing method

Abstract

An ebastine solid oral preparation and preparation method are disclosed in the present invention. Made of ebastine, ethanol solution, cosolvent, diluent or filler, disintegrating agent, taste correcting agent, glidants or dispersing agent, effervescing agent, lubricant in proportion, its step is that firstly adding ebastine into ethanol solution, and then adding cosolvent organic acid, leading itto dissolve entirely; secondly mixing the diluent or filler, disintegrating agent, taste correcting agent, effervescing agent with dispersing agent, to obtain a mixer; third mixing the front two, preparing soft material, preparing granules, then adding disintegrating agent, effervescing agent, taste correcting agent, glidants and lubricant, tabletting or filling capsules, packing to obtain a solid oral preparation. The present invention preparing oral disintegrable tablet, dispersing tablet have short disintegrating time, good dispersing state. The obtained oral disintegrable tablet, dispersing tablet and chewing tablet have good taste and mouth feel, the obtained solid oral preparations dissolving out are all rapid. The method is easy, simple operation, without needing special equipment,and lower production cost.

Description

technical field

[0001] The present invention relates to the pharmaceutical field, more specifically to a solid oral preparation of ebastine (including orally disintegrating tablets, chewable tablets, dispersible tablets and capsules), and also to a preparation method for the solid oral preparation of ebastine. The application of ebastine solid oral preparations in the field of allergic diseases, such as urticaria, allergic rhinitis, eczema, dermatitis, prurigo, pruritus, etc. Background technique

[0002] Ebastine (EBA for short) is a new long-acting non-sedating second-generation histamine H 1 receptor antagonists. This product is mainly metabolized into carbastine (also known as caristine carebastine) in the body, which has a negative effect on histamine H 1 The receptor has a selective antagonistic effect, can inhibit the release of histamine, and has an effect on the H in the central nervous system. 1 Receptor antagonist and anticholinergic effects are weak. Preclini...

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