Stabilization of Doxorubicin Hydrochloride in Injections

염산 독소루비신 주사액의 안정화

Effects of various formulation factors using $L_8$ orthogonal arrays with the stability of doxorubicin hydrochloride injections(DHls) were investigated. The degradation of DHI may be occured by pH, temperature, light and metal ions. It is known that DHI should be stored on refrigerated condition of $4{\sim}8^{\circ}C$ because of its unstability on the room temperature. The employed factors were sodium chloride as isotonic solution, sodium bisulfite or sodium pyrosulfite as an antioxidant, disodium edetate as a chelating agent, methyl parahydroxybenzoate as a dissolution time shortening agent, and hydrochloric acid or citric acid as a pH adjusting agent at $22^{\circ}C$. From the results of $L_8$ orthogonal arrays, an optimal formula, including sodium chloride, disodium edetate, sodium bisulfite and hydrochloric acid, was obtained and the shelf-life of the formula was determined as 560 days approximately.