| abstract |
PURPOSE: To provide a coating material for the production of enteric granule effective for releasing a large amount of a physiologically active substance such as living lactobacillus cells in the intestines without being influenced with gastric juice to exhibit sufficient physiological activity and, nevertheless, having excellent long-term storage stability. n CONSTITUTION: The objective coating material has a composite layer composed of (A) a layer containing oil and fat and an excipient and having a role to stabilize the granule over a long period and (B) a layer containing a protein soluble in hydrated alcohol, preferably zein having excellent gastric juice resistance and having a role to stabilize the granulation object under low-pH condition. Since the coating material does not dissolve in the gastric juice and starts to dissolve in the intestines, the enteric granule produced by coating an enteric physiologically active substance, etc., with the coating material exhibits the above effects. The granule can be continuously produced in a mass using conventional granulation apparatus. n COPYRIGHT: (C)1992,JPO&Japio |