注射用益气复脉(冻干)与果糖注射液的配伍稳定性考察  

Compatible stability of Yiqi Fumai lyophilized injection with fructose injection

作　　者：吕芳[1] 叶正良[2] 李德坤[2] 刘君动[1] 杨悦武 周大铮[2] 

机构地区：[1]天津中医药大学,天津300193 [2]天津天士力之骄药业有限公司,天津300402

出　　处：《天津中医药》2013年第3期175-178,共4页Tianjin Journal of Traditional Chinese Medicine

基　　金：国家科技重大专项"重大新药创制"资助项目(2010ZX09502-004)

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。[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.

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 

分 类 号：R942[医药卫生—药剂学]