Carbinoxamine sustained-release orally disintegrating tablets and preparation method thereof

Abstract

The invention relates to carbinoxamine sustained-release orally disintegrating tablets and a preparation method thereof. The carbinoxamine sustained-release orally disintegrating tablets are prepared from the following components in percentage by weight: 10%-60% of carbinoxamine and active components thereof, 10%-40% of auxiliary materials with sustained releasing effect and 30%-80% of other auxiliary materials. The carbinoxamine sustained-release orally disintegrating tablets are characterized in that (1) the orally disintegrating tablets are prepared by pressing medicine-containing sustained-release pills and the auxiliary materials; (2) each medicine-containing pill comprises a pill core containing the carbinoxamine and the active components thereof, and a sustained-release coating layer in sequence from inside to outside; (3) the releasing of medicines is controlled through the sustained-release coating layer; and (4) the orally disintegrating tablets are prepared and are convenient to orally take, so that the medicine utilization compliance of patients is improved. The pill cores are prepared by mainly adopting an extruding rolling method and a fluidized bed is used for coating; and then the auxiliary materials are added and the mixture is pressed to prepare the orally disintegrating tablets. The medicine-containing pills are uniformly covered with sustained-release coating materials so that the medicines are slowly and uniformly released and the time to peak is delayed; and the plasma drug concentration keeps stable and the medicine administration frequency is reduced, so that the compliance of the patients can be improved. Furthermore, the prepared orally disintegrating tablets can improve the compliance of the patients with difficulty in swallowing, such as children and old people, and have remarkable preparation advantages.

Description

technical field [0001] The invention belongs to the technical field of drug sustained-release preparations, in particular to a sustained-release orally disintegrating tablet containing an active ingredient carbixamine or a pharmaceutically acceptable salt thereof and a preparation method thereof. Background technique [0002] Carbinoxamine is a class of ethanolamine antihistamine drugs with mild sedative effects. It has been proven safe and effective in the past few years and has been widely used in countries all over the world. There are many compound preparations containing carbinoxamine, including solid sustained-release drugs . [0003] Carbinoxamine is very effective in treating allergies in children and is often used to relieve symptoms of anaphylaxis, colds, and coughs. The standard of carbinoxamine maleate ordinary tablet is 4mg, and patients need to take the medicine 3-4 times a day to provide sufficient blood concentration and ensure good therapeutic effect. In a...

AI Technical Summary

Problems solved by technology

[0007] The technical scheme adopted in the present invention is: firstly, the drug-containing pellets are prepared by using the sustained-release matrix material, and then the drug-containing pellets are coated with the sustained-release coating film to realize the two-way control of the drug release rate by the framework and the film control, so as to continuously At the same time, the slow-release coating layer contains gastric adhesive materials, which can effectively increase the gastric residence time of the preparation, thereby improving the bioavailability of the drug. Finally, add diluents, disintegrating agents, flavoring and corrective agents, and auxiliary agents. Auxiliary ingredients such as fluid lubricants are compressed into orally disintegrating tablets. This dosage form can be directly disintegrated and dispersed in the mouth without water delivery, which effectively solves the problem of swallowing difficulties for children and middle-aged and elderly patients. The characteristics of high utilization can improve the medication compliance of patients

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