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KMID : 0369819940240030109
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Jorunal of Korean Pharmaceutical Sciences
1994 Volume.24 No. 3 p.109 ~ p.113
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Stabilization of Doxorubicin Hydrochloride in Injections
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이상철/Lee SC
남상철/김춘성/신현종/백우현/Nam SC/Kim CS/Shin HJ/Paik WH
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Abstract
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Effects of various formulation factors using L8 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∼8?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?C. From the results of L8 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.
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KEYWORD
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Doxorubicin hydrochloride, Stabilization, L8 orthogonal arrays, Antioxidant, Chelating agent
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