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本工作应“卫生部药品审评中心”的要求，建立了高效液相色谱法（ＨＰＬＣ）分析原料药ＥＣＤ的方法，并获得该中心的认可，为申报９９Ｔｃｍ－ＥＣＤ注射液新药（西）一类临床研究工作提供了关键的数据。根据ＥＣＤ的理化性质，从大量实验中得到了最佳流动相分离分析对照品Ｅ
This work should be “Ministry of Health Drug Evaluation Center,” the request established a high-performance liquid chromatography (HPLC) analysis of drug substance ECD method, and access to the center’s approval for the declaration of 99Tcm-ECD injection of new drugs Clinical research provides the key data. According to the physical and chemical properties of ECD, we got the best mobile phase separation analysis reference E