Desloratadine capsule and preparation method thereof

A technology of desloratadine and loratadine, applied in the field of medicine, can solve the problems of unstable and effective loratadine, increased production cost, large amount of excipients, etc., achieve simple and effective prescription process, and avoid oxygen contact , improve the effect of instability

Active Publication Date: 2014-07-30
GUANGDONG JIUMING PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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  • Desloratadine capsule and preparation method thereof
  • Desloratadine capsule and preparation method thereof
  • Desloratadine capsule and preparation method thereof

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Embodiment Construction

[0025] The embodiment of the present invention provides a desloratadine capsule, which is composed of the raw material desloratadine as the active ingredient and auxiliary materials, and the components are as follows:

[0026]

[0027] The preparation method of above-mentioned desloratadine capsule, reference figure 1 shown, including the following steps:

[0028] S1 Dissolving part of the pregelatinized starch in water to prepare an aqueous solution of pregelatinized starch, adjusting the pH value to 7-8 with sodium bicarbonate solution;

[0029] S2 desloratadine is crushed into fine powder with GF30-III pulverizer, and placed in a boiling granulation dryer. The desloratadine fine powder is sprayed into the pregelatinized starch aqueous solution under boiling state to make the pregelatinized starch Coating desloratadine fine powder with gelatinized starch and drying simultaneously to obtain desloratadine pharmaceutical composition coated with pregelatinized starch;

[00...

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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...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/4545A61K47/36A61P37/08A61P11/02A61P27/02A61P17/00
Inventor 管小明
Owner GUANGDONG JIUMING PHARMA
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