PURPOSE: To provide the subject lyophilized preparation having good redissolubility, not depositing crystals, having good storage stability and substantially not producing decomposed products, by adding a nonvolatile acid and/or a salt thereof.
CONSTITUTION: A lyophilized preparation used for preparing injection solutions contains (A) 4'-demethylepipodophyllotoxy-9-(4,6-o-ethylidene-2-dimethylamino-2- deoxy-β-D-glucopyranoside) hydrochloride (ethoposide-2-dimethylamino compound), (B) a non-volatile acid such as inorganic acid, 6C hydroxycarboxylic acid, 4C dicarboxylic acid (particulary desirably phosphoric acid) and/or salts thereof, preferably alkali metal salts, and further optionally (C) a saccharide such as 5-6C sugar alcohol or disaccharide as a stabilizer in an A:B:C ratio of 10-95:5-50:0-80, especially 30-50:20-30:0-50, each % by weight.
OKUMA TAKAAKI