Mosapride citrate granules and preparation method thereof

Abstract

The invention discloses mosapride citrate granules and a preparation method thereof, and relates to a granule agent containing polyethylene glycol, hydroxypropyl cellulose and mosapride citrate. The granule agent uses hydroxypropyl cellulose as carriers, uses polyethylene glycol as solubilizer, and then is combined with pharmacy acceptable auxiliary materials, dissolving experiments show that mosapride citrate is basically all dissolved at the moment of 5 min, acceleration experiments show that the stability of mosapride citrate is high, and the preparation technology is simple and suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a granule of mosapride citrate and a preparation method thereof. Background technique [0002] Mosapride Citrate (Mosapride Citrate), the chemical name is 4-amino-5-chloro-2-ethoxy-N-[[4-(4-fluorobenzyl)-2-morpholinyl]methanol Base] benzamide citrate, white or off-white crystalline powder, odorless, slightly bitter, melting point 143-145°C. It was developed by Dainippon Pharmaceutical Co., Ltd. and filed a compound patent application with Japan on April 30, 1986. It is easily soluble in dimethylformamide and pyridine, slightly soluble in methanol, insoluble in 95% ethanol, and insoluble in water. Or ether, mainly used for functional dyspepsia with heartburn, belching, nausea, vomiting, early satiety, upper abdominal distension and other gastrointestinal symptoms, the drug can enhance gastrointestinal motility, but does not affect gastric acid secr...

AI Technical Summary

Problems solved by technology

For example, the slow-release tablet is affected by many factors such as pressure and powder fluidity during tablet compression, which brings many difficulties to the investigation of the best process in the later stage; the slow-release coated tablet has poor stability because it is difficult to accurately control the coating thickness; Capsules are affected by materials, and it is often difficult to achieve a uniform effect for capsule shells from different manufacturers, with large differences in release between batches and poor reproducibility, etc.

[0010] Therefore, as far as the current prior art is concerned, it is impossible to provide a mosapride citrate granule with good stability, high dissolution rate, small release difference between batches and simple preparation process.

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