注射用七叶皂苷与地塞米松注射液配伍稳定性研究

 目的 在4、25、37 ℃下研究地塞米松磷酸钠注射液和七叶皂苷钠粉针的配伍稳定性。方法 将地塞米松磷酸钠注射液、七叶皂苷钠粉针按照临床用药浓度分别溶解于5%葡萄糖注射液和0.9%氯化钠注射液中，比较配制溶液后0、1、2、4、8、12 h时地塞米松磷酸钠、七叶皂苷A和七叶皂苷B的含量变化、pH值、不溶性微粒数、外观。结果 在4、25 ℃条件下，12 h内，两种药物配伍稳定性良好，在37 ℃时两种药物配伍稳定性较差。结论 地塞米松磷酸钠注射液和七叶皂苷钠粉针溶液可以配伍使用，配伍后应于阴凉处储存，并于12 h内输注完毕。

Compatibility and Stability of Dexamethasone Sodium Phosphate Combined with Sodium Aescinate in Infusion Solutions

OBJECTIVE To investigate the stability of mixture (compatibility) of dexamethasone sodium phosphate injection and sodium aescinate injection at 4 ℃， room temperature and 37 ℃.METHODS The dexamethasone sodium phosphate injection and sodium aescinate for injection were dissolved into 5% glucose injection and 0.9% sodium chloride injection based on the instruction of concentration from clinical medicine respectively， and then a mixture of these two compounds with the same concentration mentioned above was produced. The contents of dexamethasone sodium phosphate and aescinate (A and B) dissolved in 5% glucose injection and 0.9% sodium chloride injection were determined by HPLC respectively after the preparation of the solution for 0， 1， 2， 4， 8 and 12 h. Moreover， the mixture was analyzed to determine the content of dexamethasone sodium phosphate， aescinate A and B. Finally， the correlative pH and number of indiscerptible particles in these six solutions were also investigated in corresponding time points during the 12 h. RESULTS High stability of the mixture of two drugs was shown with the storage temperature at 4 ℃ within 12 h. However， with the storage temperature at 37 ℃， the mixture of two drugs was unstable.CONCLUSION The mixture of dexamethasone sodium phosphate injection and sodium aescinate injection for clinical medicine should be stored under low temperature and injected within 12 h.