Rebamipide tablet and preparation method thereof

Abstract

The invention relates to a rebamipide tablet and a preparation method thereof, and relates to the technical field of medicines. The rebamipide tablet provided by the invention contains rebamipide and other pharmaceutically available inactive components, and the particle size D90 of the rebamipide is 3-30 [mu]m. The other pharmaceutically available inactive components comprise a diluent, a disintegrating agent, an adhesive and a lubricant. The disintegrating agent is one or two of cross linked sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone and sodium carboxymethyl starch. The dissolution curve of the rebamipide tablet is not obviously different from that of a product produced by Otsuka Pharmaceutical Co., LTD in Japan, which is an original research factory. The rebamipide tablet granulation process provided by the invention can improve the problems of difficult granulation and poor fluidity, and the preparation process is simple and controllable.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a rebamipide tablet and a preparation method thereof. Background technique [0002] Rebamipide tablets are mainly used to treat peptic ulcer, which is a frequently-occurring and common disease worldwide. Its occurrence is mainly due to the imbalance between attacking factors (gastric acid secretion) and defensive factors (including mucus mucosal barrier, mucosal blood flow and epithelial regeneration). In addition, Helicobacter pylori infection and the application of nonsteroidal anti-inflammatory drugs are two big risk factor. The current clinical treatment of such diseases is mainly through the reduction of gastric acid secretion (H receptor antagonists and proton pump inhibitors), the application of gastric mucosal protective agents (rebamipide, gefarate, sucralfate, aluminum Magnesium carbonate) and Helicobacter pylori eradication. As a new type of anti-ulcer drug, rebami...

AI Technical Summary

Problems solved by technology

The preparation method of rebamipide tablets adopts wet granulation to prepare granules, but in the granulation process, microcrystalline cellulose and hydroxypropyl cellulose with a required amount of 50% are wetted and mixed with rebamipide Finally, it needs to be sieved by the granulator before continuing to granulate. This step increases the complexity of the process

[0006] In the prior art, rebamipide has poor solubility and is not easy to disintegrate and dissolve; the raw material of rebamipide has high static electricity, low bulk density, difficulties in granulation and tableting, and the dissolution rate is inconsistent with the original drug developed by Otsuka, Japan. Leading to unstable drug quality and no guarantee of clinical effectiveness and safety in administration

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