| 摘要: |
| [目的] 考察注射用益气复脉(冻干)在室温(25±1)℃下与果糖注射液配伍的稳定性。[方法] 模拟临床用药浓度, 将注射用益气复脉(冻干)8瓶, 分别用注射用水溶解后转注入5%果糖注射液250 mL中, 混合均匀后, 在室温(25±1)℃下考察6 h内配伍液的色泽、澄清度、pH值、不溶性微粒、紫外全波长扫描图谱、总皂苷变化情况, 并采用高效液相色谱法测定皂苷及五味子醇甲的含量, 同时考察皂苷及木脂素的指纹图谱变化情况。[结果] 在室温(25±1)℃下, 0～6 h配伍液的色泽、性状、pH值、不溶性微粒、紫外全波长扫描图谱、皂苷、五味子醇甲含量、皂苷及木脂素指纹图谱均无明显变化。[结论] 注射用益气复脉(冻干)与果糖注射液配伍, 在室温(25±1)℃下6 h内配伍稳定。 |
| 关键词: 注射用益气复脉(冻干) 果糖注射液 配伍 稳定性 高效液相色谱法 |
| DOI：10.11656/j.issn.1672-1519.2013.03.17 |
| 分类号: |
| 基金项目:国家科技重大专项“重大新药创制”资助项目(2010ZX09502-004). |
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| Compatible stability of Yiqi Fumai lyophilized injection with fructose injection |
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LV Fang1, YE Zheng-liang2, LI De-kun2, LIU Jun-dong1, YANG Yue-wu2, ZHOU Da-zheng2
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1.Tianjin University of TCM,Tianjin 300193,China;2.Tianjin Tasly Pride Pharmaceutical Company Limited,Tianjin 300402,China
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| Abstract: |
| [Objective] To investigate the compatible stability of Yiqi Fumai lyophilized injection with fructose injection at room temperature(25±1)℃。 [Methods] At room temperature(25±1)℃, 8 bottles of Yiqi Fumai lyophilized injection were added into 250 mL fructose injection. The appearance and color, pH value of mixture, insoluble particle, the ultraviolet wavelength scanning mapping, saponins in 6 h were observed. The content of ginsenosides and schisandrin was determined by HPLC, and the fingerprint of ginsenosides and lignans was investigated. [Results] At room temperature(25±1)℃, there were no changes in appearance, color, pH value, insoluble particle, the ultraviolet wavelength scanning graph, the content of saponins and schisandrin, the fingerprint of ginsenosides and lignans of mixture within 0~6 h. [Conclusion] At room temperature(25±1)℃, the compatibility of Yiqi Fumai lyophilized injection with fructose injection is stable within 6 h. |
| Key words: Yiqi Fumai lyophilized injection fructose injection compatibility stability HPLC |
