Desloratadine capsule and preparation method thereof

Abstract

The invention discloses a desloratadine capsule and a preparation method thereof. The desloratadine capsule is prepared from desloratadine as an active ingredient and auxiliary materials. The desloratadine capsule comprises 6% of desloratadine, 30-50% of microcrystalline cellulose, 20-40% of calcium hydrogen phosphate, 10-30% of pregelatinized starch and 1-5% of talcum powder. According to the preparation method, a pregelatinized starch aqueous solution having alkalescence coats desloratadine by a spray drying method and the pregelatinized starch effectively wrap desloratadine so that moisture absorption and contact with oxygen in air are effectively avoided, instability of desloratadine in an acid environment is effectively overcome and good stability of a desloratadine preparation is realized. The preparation method has simple and effective processes and is suitable for industrial production.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a stable desloratadine capsule and a preparation method thereof. Background technique [0002] Desloratadine is clinically used for seasonal and perennial allergic rhinitis, allergic conjunctivitis, and urticaria. Desloratadine is a new generation of antihistamine drugs. The drug has a fast onset of action and a long duration of action. It not only has antihistamine effect, but also has anti-inflammatory activity. It has obvious effects on eliminating congestion and relieving wheals. Nervous system side effects, no cardiotoxicity, no drug interactions. [0003] Desloratadine oral preparations currently on the market at home and abroad have a variety of dosage forms: such as tablets, syrups, dry suspensions, and dispersible tablets. However, desloratadine is unstable in high temperature, high humidity, exposure to air and acidic conditions. The technical personnel of pharmacy are trying...

AI Technical Summary

Problems solved by technology

This wrapping method cannot wrap desloratadine completely, additional β-cyclodextrin and polyethylene glycol 6000

[0008] Chinese patent CN101548959B discloses that desloratadine is wet mixed with dissolved β-cyclodextrin and polyethylene glycol 6000 and dried to achieve the purpose of wrapping desloratadine, but it cannot be completely wrapped

[0009] Although the above-mentioned patents can solve the problem of a certain aspect of desloratadine instability, there is no effective method for completely solving the instability of desloratadine.

And the above-mentioned patents all have the same problem, that is, the process is cumbersome, there are many types of excipients in the prescription, and the amount of excipients used is relatively large, which will inevitably lead to the difficulty of industrial production and the increase of production costs.

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