The invention provides a
mesalazine enteric-coated tablet composition with a four-layer
coating system and a preparation method of the
mesalazine enteric-coated tablet composition, and belongs to thefield of medicines. The composition is formed by combining a
mesalazine tablet core and four
layers of coatings, wherein the coatings sequentially comprise a first layer, a second layer, a third layerand a fourth layer from inside to outside, wherein the first layer is an
isolation layer; the second layer is a slow-release casing layer; the third layer is a positioning acid-resistant layer; and the fourth layer is a
moisture-proof layer. A second method for determining the
dissolution rate by adopting the appendix of the
Chinese pharmacopoeia is adopted, the release rate of the product is determined at 50rpm, and the release behavior should be as follows: the release rate is less than 10% in a
dissolution medium with the pH value of 1.0 for 2h, then the product is transferred into a 7.4 medium, the release rate is 10-30% in 45min, the release rate is 50-75% in 75min and the release rate is 85% or above in 105min. The product is slowly released in intestines, most of the medicines canreach colons and act on inflammatory mucous membranes,
prostaglandin synthesis causing
inflammation and formation of
inflammatory mediator leukotriene are inhibited, and the product has a remarkable anti-inflammatory effect on intestinal wall
inflammation and particularly has a good effect on inflammatory intestinal wall connective tissues.