| 两种辅料对地塞米松磷酸钠注射液中杂质的影响 |
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| 引用本文： | 张新勇,卓静,葛雪松,孙桐.两种辅料对地塞米松磷酸钠注射液中杂质的影响[J].中国药品标准,2022,23(1):19-23. |
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| 作者姓名： | 张新勇 卓静 葛雪松 孙桐 |
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| 作者单位： | 江苏省宿迁市食品药品检验所 |
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| 摘 要： | 目的:分析对比依地酸二钠与亚硫酸氢钠对地塞米松磷酸钠注射液中杂质的影响.方法:建立地塞米松磷酸钠注射液杂质Ⅰ(C22 H30 FNa2 O11 PS)的定量分析方法,以杂质Ⅰ、地塞米松的含量和总杂质的峰面积占比来评价制剂的安全性.结果 与结论:以依地酸二钠为辅料的地塞米松磷酸钠注射液中杂质Ⅰ含量更低,总杂质也相对更少.
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| 关 键 词： | 地塞米松磷酸钠注射液 依地酸二钠 亚硫酸氢钠 杂质Ⅰ 辅料 |
Effects of two excipients on impurities in dexamethasone sodium phosphate injection |
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| Authors: | ZHANG Xinyong ZHUO Jing GE Xuesong SUN Tong |
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| Institution: | (Suqian Institutes for Food and Drug Control,Suqian 223800,China) |
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| Abstract: | Objective:To analyze and compare effects of disodium edetate and sodium bisulfite on impurities in dexamethasone sodium phosphate injection.Methods:To establish a quantitative analysis method for impurityⅠ(C22H30FNa2O11PS)in dexamethasone sodium phosphate injection,and evaluate the safety of preparations by the contents of impurityⅠand dexamethasone,as well as the peak area ratio of the total impurities.Results and conclusion:The content of impurityⅠin dexamethasone sodium phosphate injection with disodium edetate as an excipient is lower,and the total impurities are relatively less. |
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| Keywords: | dexamethasone sodium phosphate injection disodium edetate sodium bisulfite impurityⅠ excipients |
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