Mesalazine oral controlled release medicine composition

Abstract

The invention relates to a mesalazine oral colon-targeted sustained release medicine composition which is characterized by containing: (a) a sustained release table core containing mesalazine or medicinal salts or solvates thereof and hydrophilic stroma, wherein the mesalazine or the medicine salts thereof are dispersed in the hydrophilic stroma; and (b) a coating wrapped outside the table core and containing acid-resistant materials; wherein the one-hour release of the composition in simulated intestinal fluid with the pH of 7.2 is less than 20 percent, the four-hour release thereof is 30-60 percent, and the eight-hour release thereof is greater than 70 percent. The composition has simple manufacturing process and low cost, slowly releases the mesalazine in small intestines and colons, and achieves the colon-targeted medicine delivery once a day and the local curative effect.

Description

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, in particular to a colon-targeted slow-release pharmaceutical composition for oral administration of mesalazine, a controlled-release tablet core containing mesalazine or its pharmaceutically acceptable salt or its solvate and a hydrophilic matrix, and the tablet core is coated with One layer of coating contains an acid-resistant material, and the composition releases less than 20% in 1 hour, 30-60% in 4 hours, and more than 70% in 8 hours in simulated intestinal fluid with pH 7.2. The composition gradually releases mesalamine in the small intestine and colon, and is used for treating colitis with intestinal targeted administration once a day. Background technique

[0002] Inflammatory bowel disease is a general term for ulcerative conjunctivitis and Crohn's disease, which together affect 0.5-1.0% of the western population, with more than 1 million patients in the United States and more...

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