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马来酸桂哌齐特冻干制剂制备及质量稳定性研究 被引量:3

Study on Lyophilized Preparation of Cinepazide Maleate and Its Quality Stability
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摘要 采用浓度为80 g.L-1的马来酸桂哌齐特溶液制备冻干制剂。结果表明,甘露醇为赋形剂时冻干制剂稳定性最好,在甘露醇浓度为160 g.L-1时制备的马来酸桂哌齐特冻干制剂主体含量≥99.0%、杂质含量≤0.2%、平均含水量≤1.0%。 The lyophilized preparation of cinepazide maleate is prepared with 80 g ·L^-1 of cinepazide maleate solution. It is found that the stability of lyophilized preparation is optimum with mannitol as excipient and the best mannitol concentration is 160 g ·L^-1. For the obtained lyophilized preparation, the content of cinepazide maleate is more than 99.0% ,the content of impurity is less than 0.2%, and the average content of water is less than 1.0 %.
出处 《化学与生物工程》 CAS 2009年第6期48-50,共3页 Chemistry & Bioengineering
关键词 马来酸桂哌齐特 冷冻干燥 稳定性 赋形剂 cinepazide maleate freeze drying stability excipient
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