| 摘要 |
PURPOSE:To obtain a microcapsule type sustained release pharmaceutical preparation having a fine and uniform particle diameter without requiring the fractionating and particle size regulating operation and a method for producing the pharmaceutical preparation. CONSTITUTION:The objective microcapsule type sustained release pharmaceutical preparation has an enclosed substance containing a physiologically active substance and an outer shell substance formed from a biocompatible high molecular substance having biodegradability and/or in vivo histocompatibility, <=150mum maximum particle diameter, 5-100mum average particle diameter and <=50% coefficient of variation. Furthermore, the objective method for producing this microcapsule type sustained release pharmaceutical preparation is to make a salt substance at 0.1 M concentration to the saturated concentration present in an outer layer in a secondary emulsifying step in preparing a W/O type emulsion from an aqueous solution containing the physiologically active substance and a solution containing the biocompatible high molecular substance in an organic solvent, then secondarily emulsifying the resultant W/O type emulsion with an aqueous solution of a water-soluble high molecular substance, preparing a W/O/W type emulsion and further preparing the objective microcapsule type sustained release pharmaceutical preparation. |
