PROBLEM TO BE SOLVED: To provide a method for producing granulated particles capable of stably holding a chemically unstable bioactive substance over a long period by a simple and highly safe method.SOLUTION: The method for producing the granulated particles by charging additive particles into a jetting fluidized bed granulation apparatus, and spraying a liquid obtained by formulating an aqueous solution of a stabilizer, a binder and the bioactive substance particles while keeping the fluidized state, includes adding 2-18 pts.wt. of the stabilizer, the binder and the bioactive substance particles dissolved or suspended in water to 1 pt.wt. of the additive particles charged to the jetting fluidized bed apparatus and spray it to produce the granulated particles. A high-quality tablet rapidly disintegrable in the oral cavity can be produced by using the granulated particles produced by the method.COPYRIGHT: (C)2011,JPO&INPIT【課題】化学的に不安定な生理活性物質を長期に亘り安定に保持できる造粒物を、簡便かつ安全性の高い方法での製造する方法を提供する。【解決手段】添加剤粒子を噴流流動層造粒装置に仕込み、流動状態を保ちながら、安定化剤水溶液、結合剤及び生理活性物質粒子を配合した液を噴霧する造粒物の製造法において、噴流流動層装置に仕込まれる添加剤粒子1重量部に対して、水に溶解もしくは懸濁した安定化剤、結合剤および生理活性物質粒子を2重量部~18重量部をスプレー添加することにより造粒物を製造する方法。この方法で製造した造粒物を用いると、高品質の口腔内速崩壊錠を製造することができる。【選択図】図1
