Mosapride citrate tablet and preparation method thereof

Abstract

The invention discloses a mosapride citrate tablet and a preparation method thereof. The preparation method comprises the following steps: dissolving mosapride citrate glacial acetic acid; adding mesoporous silica and carrying out uniform mixing under stirring; then adding an aqueous sodium hydroxide solution into a solution obtained in the previous step under stirring; allowing a compound of mosapride citrate and mesoporous silica to be precipitated and carrying out filtering and drying; then mixing the dried compound with a filler and a disintegrating agent and carrying out granulation and drying; and adding a lubricant into dry particles and then carrying out tabletting. Compared with the prior art, the mosapride citrate tablet prepared in the invention can be rapidly dissolved out in water, and the preparation method is simple in process and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a mosapride citrate tablet 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. The melting point is 143-145°C. Soluble in dimethylformamide and pyridine, slightly soluble in methanol, insoluble in 95% ethanol, insoluble in water or ether. [0003] Mosapride citrate is a new third-generation gastric motility drug, 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 secretion, and has no side effects such as extrapyramidal reaction and diarrhea, and is well tol...

AI Technical Summary

Problems solved by technology

But because mosapride citrate is an insoluble drug, it is almost insoluble in water, often encounters the problem that the dissolution rate is low or even unqualified in the actual production of mosapride citrate oral solid preparation; and because citric acid The content of mosapride in the preparation is low, and it is difficult to fully mix during preparation. When performing dissolution testing, there are often problems of high and low, and large differences in dissolution between tablets

When there is an urgent need for quick-acting and high-efficiency preparations in clinical practice, solving the problem of low bioavailability of insoluble drugs due to low solubility and slow dissolution has always been a major problem in the pharmaceutical industry

But the process is relatively cumbersome

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