PHARMACEUTICAL COMPOSITION CONTAINING EPERISONE WITH IMPROVED STABILITY OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND A PREDETERMINED ACIDIFIER

摘要

PURPOSE: A pharmaceutical composition containing eperisone with improved stability or a pharmaceutically acceptable salt thereof, and a predetermined acidifier is provided to effectively suppress the generation of related materials by adding the predetermined acidifier and to enable long-term maintenance of drug efficacy, thereby being applied to a pharmaceutical industry.;CONSTITUTION: A pharmaceutical composition contains eperisone or a pharmaceutically acceptable salt thereof, an acidifier, and a pharmaceutically acceptable excipient. Eperisone or the pharmaceutically acceptable salt is eperisone hydrochloride. The pH concentration of the pharmaceutical composition is pH 1-5 when the pharmaceutical composition is dissolved or dispersed in 10-20 mL of water. The acidifier is selected among organic acids and a mixture thereof. The organic acids are selected among alginic acid, phosphoric acid, sulfuric acid, hydrochloric acid, boric acid, hydrobromic acid, and a mixture thereof. The pharmaceutically acceptable excipient is selected among a dispersing agent, a disintegrant, a binder, a lubricant, and a mixture thereof.;COPYRIGHT KIPO 2013;[Reference numerals] (AA) Acceleration condition; (BB) Related material; (C1) Example 1; (C2) Example 2; (DD) Comparative example 1