Capsule for treating ulcerative colitis

Abstract

An object of the present invention is to obtain a capsule for treating ulcerative colitis which, when a capsule containing indigo is orally administered, acts more effectively than conventional ones and has less side effects of hepatotoxicity by not easily disintegrating in the stomach and small intestine but only in the large intestine. The present invention relates to a capsule for treating ulcerative colitis which disintegrates locally in the large intestine, comprising a drug-containing content, a protective layer coating the content and a film formed outside the protective layer, which are arranged concentrically, wherein the content is a content in which indigo, which is a drug for treating ulcerative colitis, is dispersed or dissolved, and the film is locally disintegrated in the large intestine.

1 . A capsule for treating ulcerative colitis which disintegrates locally in the large intestine, comprising a drug-containing content, a protective layer coating the content and a film formed outside the protective layer, which are arranged concentrically,
 wherein   the content is a content in which indigo is dispersed or dissolved, the indigo being a drug for treating ulcerative colitis,   the protective layer contains an oily substance,   the film is a film which chitosan powder is dispersed in a film base material of a natural water-soluble polymer, and   the natural water-soluble polymer is a mixture of a first natural water-soluble polymer and a second natural water-soluble polymer, the first natural water-soluble polymer is composed of one or a mixture of at least two selected from the group consisting of gelatin, carrageenan, starch, agar, pullulan, modified starch, alginic acid and mannan, and the second natural water-soluble polymer is composed of one or a mixture of at least two selected from the group consisting of pectin, gellan gum and curdlan.   
     
     
         2 . The capsule for treating ulcerative colitis according to  claim 1 , wherein the film further contains a plasticizer. 
     
     
         3 . The capsule for treating ulcerative colitis according to  claim 1 , wherein the chitosan powder is of animal origin or plant origin, and amount of the chitosan powder falls within the range of 1 to 27% by mass, and amount of the second natural water-soluble polymer falls within the range of 1 to 24% by mass, based on the total weight of the dried film. 
     
     
         4 . The capsule for treating ulcerative colitis according to  claim 1 , wherein the film base material of the natural water-soluble polymer is a mixture of gelatin and pectin. 
     
     
         5 . The capsule for treating ulcerative colitis according to  claim 1 , which has been treated with an acidic solution in advance. 
     
     
         6 . The capsule for treating ulcerative colitis according to  claim 1 , wherein one selected from the group consisting of the content, the protective layer and the film or a combination thereof further contains an adherable substance to an epithelial of large intestine, a substance increasing residence time in the large intestine or a combination thereof. 
     
     
         7 . The capsule for treating ulcerative colitis according to  claim 1 , wherein an adherable substance to an epithelial of large intestine, a substance increasing residence time in the large intestine or a combination thereof is allowed to be present on the outer surface of the film. 
     
     
         8 . The capsule for treating ulcerative colitis according to  claim 1 , comprising the content which contains indigo powder and an adherable substance to an epithelial of large intestine,
 wherein the indigo powder is blended or coated with the adherable substance to the epithelial of the large intestine.   
     
     
         9 . The capsule for treating ulcerative colitis according to  claim 1 , which is for oral administration. 
     
     
         10 . The capsule for treating ulcerative colitis according to  claim 1 , which is administrated in amount of indigo per adult (60 kg) of 0.05 to 120 mg/day. 
     
     
         11 . The capsule for treating ulcerative colitis according to  claim 1 , which is administrated in amount of indigo per adult (60 kg) of 0.05 to 20 mg/day.