Compound sustained-release tablet of cetirizine and pseudoephedrine and preparation method thereof

Abstract

The invention discloses a compound sustained-release tablet of cetirizine and pseudoephedrine and a preparation method thereof. The tablet comprises cetirizine or pharmaceutically acceptable cetirizine salt and pseudoephedrine or pharmaceutically acceptable pseudoephedrine salt. The preparation method comprises the steps of: preparing the pseudoephedrine or the pharmaceutically acceptable pseudoephedrine salt into a sustained-release tablet core; uniformly dispersing the cetirizine or the pharmaceutically acceptable cetirizine salt in a coating solution to coat the surface of the tablet core. Two active materials with different doses are prepared into the compound sustained-release tablet by a coating method. The preparation method solves the problems of the quick release of the cetirizine and the sustained release of the pseudoephedrine, has convenient operation and easy quality control, and is suitable for industrial production. In the tablet, more than 85% of the cetirizine is dissolved within 30 minutes, 90% of the cetirizine is dissolved out within 1 hour, and the pseudoephedrine releases medicaments in a sustained mode within 12 hours or 24 hours. The tablet is taken once or twice a day, and can reduce the administration time, better stabilize the concentration of blood medicaments and reduce adverse effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a compound cetirizine pseudoephedrine slow-release tablet and a preparation method thereof. Background technique [0002] Allergic rhinitis is a common disease. Statistics show that the incidence of allergic diseases in my country is as high as 37.3%, among which the patients who have suffered from allergic rhinitis have reached 1-2%, up to 4%. The resulting nasal congestion, airflow obstruction, rhinorrhea, sneezing, chronic pharyngitis, nasal cavity or sinus compound infection seriously affect people's physical and mental health. Cetirizine Sustained Release Tablets is a compound preparation of cetirizine hydrochloride and pseudoephedrine hydrochloride, developed by Belgian UCB Company, and launched in the United States in August 2001 for the treatment of allergic rhinitis; it is the only one approved in the United States for the treatment of allergies. Prescription combinatio...

AI Technical Summary

Problems solved by technology

[0010] These processes are relatively cumbersome and uncontrollable in production

Compressing double-layer tablets requires a special double-layer tablet press, and the tablets are larger and costly, and the slow-release layer may affect the release of the immediate-release layer

On the other hand, the pseudoephedrine sustained-release layer adopts hydrogels such as hypromellose as the main sustained-release material, but pseudoephedrine is very water-soluble, and it is difficult to control the sudden release of pseudoephedrine only with hydrogel as the sustained-release material. Even if erodible materials such as glyceryl monostearate are added as blockers in the prescription, it is easy to cause problems such as tablet sticking, spots on the surface, and poor hardness.

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