| 摘要 |
<P>PROBLEM TO BE SOLVED: To provide a method of manufacturing a liposome preparation capable of grasping in real time the variation of the chemical content or the elimination rate of unwanted material etc. in the liposome solution during the process and manufacturing the liposome preparation by comparing it with a standard lot previously measured. <P>SOLUTION: In an outer liquid substitution process for a liposome preparation, a liposome preparation is manufactured by circulating required times the processes (1) in which an outer liquid substantially containing no unwanted material is supplied to an outer liquid containing unwanted material in the liposome preparation solution, (2) in which at least a part of the outer liquid containing unwanted material is ultrafiltrated and discharged as a waste liquid while (1) is carried out and (3) in which liposome preparation solution is returned to a vessel. In this method of manufacturing a liposome preparation, the solution containing liposome is not taken out of the system and the information regarding the concentration of the preparation in the solution is measured at multiple times in a lot and compared with the values previously measured about the standard lot, and the variation of manufacturing condition from the standard lot is grasped. <P>COPYRIGHT: (C)2013,JPO&INPIT |
