Acotiamide tablet and preparation method

Abstract

The invention discloses an acotiamide tablet and a preparation method. The acotiamide tablet comprises the following components in percentage by weight: 10-50% of acotiamide, 30-80% of a filling agent, 3-20% of a disintegrant, 0.5-1% of a lubricant and 0.2-2.5% of a corrigent. The preparation method comprises the following steps of performing micronization on the acotiamide and the filling agent, and controlling the particle size to be 0.5-20 [mu]m; dissolving the fine powder prepared in the former step and a part of the disintegrant with an ethanol solution so as to obtain a soft material, and pelleting by using a sieve of 24 meshes; drying the prepared fine granules at 50-70 DEG C, and shaping the granules by using a sieve of 20 meshes; sequentially adding the rest disintegrant, the corrigent and the lubricant into the dry granules, performing total blending for two times, namely mixing for the first time before the lubricant is added, and mixing for the second time after the lubricant is added, and tableting while an intermediate is detected to be qualified, thereby obtaining the acotiamide tablet. The acotiamide tablet disclosed by the invention is a coated common tablet which is used for treating functional dyspepsia and is rapid in medicine absorption, high in bioavailability, convenient to take and small in side effect.

Description

technical field [0001] The present invention relates to a pharmaceutical preparation for treating functional dyspepsia, specifically a tablet, including coated or uncoated ordinary tablets, chewable tablets and orally disintegrating tablets. Background technique [0002] Functional dyspepsia (FD), also known as dyspepsia, refers to a group of unpleasant symptoms such as epigastric pain, epigastric distention, early satiety, belching, loss of appetite, nausea, and vomiting. clinical syndrome. Symptoms are persistent or recurring for more than one month or more than twelve weeks in the past twelve months. FD is the most common clinical functional gastrointestinal disease. [0003] Acotiamide is the world's first approved treatment for functional dyspepsia. [0004] Dyspepsia symptoms are common and significantly reduce the quality of life of patients, most of whom have functional dyspepsia (FD). According to survey data, indigestion symptoms of the general population in We...

AI Technical Summary

Problems solved by technology

According to the survey data, nearly 40% of the general population in western countries have dyspepsia symptoms, which significantly reduces the quality of life

A small part of the population is caused by gastric ulcer, which can be treated by eradicating Helicobacter pylori. About 20% of the symptomatic population is gastroesophageal reflux disease, which can be effectively treated by proton pump inhibitors, but most of the dyspepsia population belongs to FD. Treatment of FD remains challenging

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