LIQUID PREMIX PREPARATION OF POLYENE MACROLIDE ANTIBIOTICS, AND MANUFACTURING METHOD OF THE SAME

摘要

PROBLEM TO BE SOLVED: To provide a liquid premix preparation for administering polyene macrolide antibiotics to a living body which can be directly used in administration to a patient without passing through an adjusting process, and is stable when stored for a long period of time.;SOLUTION: A liquid premix preparation for administering polyene macrolide antibiotic to a living body contains (a) polyene macrolide antibiotics encapsulated in liposome, (b) pH adjuster, and (c) at least one type or more of pharmaceutically permitted non-electrolyte, and pH is adjusted to 6.0 to 7.0 by the pH adjuster in (b). The pH adjuster contains at least one selected from acetate buffer solution, phosphate buffer solution, citrate buffer solution, borate buffer solution, tartaric acid buffer solution, tris buffer solution, and phosphate buffered saline. Polyene macrolide antibiotics are Amphotericin B. A particle diameter of liposome is uniform and liposome does not contain impurities. The preparation can be used in administration in a clinical site, without passing through filtration by a filter.;COPYRIGHT: (C)2015,JPO&INPIT