LIQUIDIC FORMULATION FOR ORAL ADMINISTRAION COMPRISING AMBROXOL, LEVODROPROPIZINE AND BUFFER, AND METHOD FOR PREPARING THE SAME

摘要

PURPOSE: An oral liquid medicine is provided to prevent the change of quality by changes according to time since the storage stability is excellent, and to have high drug compliance, thereby being used as a medicine for acute and chronic cough. CONSTITUTION: An oral liquid medicine comprises Ambroxol or pharmaceutically acceptable salt thereof, Levodropropizine or pharmaceutically acceptable salt thereof, and a buffer in the aqueous medium and has a pH of 4.5-5.5. A manufacturing method of the oral liquid medicine comprises: a step of dissolving the pharmaceutically acceptable diluting agent in the aqueous medium; a step of adjusting the pH of the mixture as 4.5 to 5.5 using the buffer; a step of adding the Ambroxol or pharmaceutically acceptable salt thereof, the Levodropropizine or pharmaceutically acceptable salt thereof to the mixture and dissolving; and a step of adding the aqueous medium to the mixture. [Reference numerals] (AA) Stress condition 4 weeks; (BB) Stress condition 2 weeks