| 摘要 |
PURPOSE: To obtain an aseptic infusible powder without deteriorating the stability and quality of an antibiotic substance by spray-drying a solution of an antibiotic substance in a circulating inert gas atmosphere in the presence of a salt-forming agent. CONSTITUTION: An antibiotic substance, preferably aβ-lactam antibiotic substance (e.g. ampicillin or piperacillin) is dissolved at a concentration of 1-50wt.%, preferably 8-25wt.% in an aqueous mixture consisting of <=80vol.% of water, methanol or ethanol, 70vol.% of acetone and 50vol.% of isopropyl alcohol in the presence of a salt-forming agent (e.g. sodium hydroxide or sodium salt of the alcohol used in the composition). The solution is subjected to ultrasonic treatment and degassing treatment and spray-dried in a circulating inert gas atmosphere to obtain the objective powder. The spray-drying is carried out at a solution temperature of 50-550 deg.C, preferably 150-240 deg.C and an extracted powder temperature of 90-200 deg.C, preferably 95-130 deg.C.
|
