Preparation method of premixed auxiliary material for dispersible tablet

Abstract

The invention discloses a preparation method of a premixed auxiliary material for a dispersible tablet. The method comprises the following steps of: dispersing cross-linked polyvidone and silicon dioxide into 75 percent ethanol by taking microcrystalline cellulose as a mother nucleus, and spraying onto the microcrystalline cellulose; and spraying and drying simultaneously to obtain the premixed auxiliary material suitable for the dispersible tablet. The method has the technical effects that: the premixed auxiliary material for the dispersible tablet is spherulite-shaped, and the angle of repose is smaller than 30 degrees, so that the premixed auxiliary material is extremely easy to mix uniformly with a raw material of the dispersible table, the mixing time is reduced, and dust in a production process is greatly reduced; and moreover, the cross-linked polyvidone is embedded into microcrystalline cellulose, and the hygroscopic property of the cross-linked polyvidone is lowered according to the water-retaining property of the microcrystalline cellulose, so that the humidity requirement of a production environment is greatly lowered, and the preparation of a dispersible table with superior quality is facilitated.

Description

technical field [0001] The invention relates to a preparation method of a premixed auxiliary material, in particular to a preparation method of a premixed auxiliary material for a dispersible tablet. Background technique [0002] Dispersible tablets refer to tablets that can quickly disintegrate and evenly disperse in water. Compared with ordinary tablets, they have the advantages of rapid disintegration, quick effect, convenient administration, and high bioavailability. Its production process is to blend raw materials with diluent microcrystalline cellulose, disintegrant crospovidone, glidant silicon dioxide, etc., mix evenly, and then directly compress the powder into tablets. [0003] Because crospovidone, a commonly used disintegrant for dispersible tablets, has strong hygroscopicity and poor fluidity, it requires high humidity control in the production environment during the powder mixing process (requires humidity to be less than 40%), and cross-linking often occur...

AI Technical Summary

Problems solved by technology

[0003] Due to the strong hygroscopicity and poor fluidity of crospovidone, a disintegrant commonly used in dispersible tablets, the requirements for humidity control in the production environment are very high during the powder mixing process (required humidity is less than 40%), and cross-linking often occurs during the production process The hygroscopicity of povidone causes the tablet to be sticky and punchy, causing the appearance of the tablet to be numb, and the tablet hardness is not enough, which affects the product quality of the dispersible tablet

In addition, there are many auxiliary materials used in the production of dispersible tablets, which require a long mixing time to mix evenly with the raw materials. On the one hand, the production efficiency is low, and on the other hand, the large dust is not good for the clean production of medicines.