注射用曲札茋苷与常用输液配伍稳定性研究

Quzhazhigan for Injection with Common Infusion Compatibility Test

目的观察注射用曲札茋苷与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液在4种条件下配伍的稳定性。方法将注射用曲札茋苷分别与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液配伍后,放置于室温、低温2~8℃避光、室温避光、室温强光照（4500lx±500lx）条件下。采用高效液相色谱法测定含量、降解产物,同时测定p H值、外观。结果注射用曲札茋苷与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液配伍后在低温2~8℃避光、室温避光条件下0~8h内其外观、p H值及含量、降解产物均无显著性改变。结论研究提示注射用曲札茋苷与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液配伍后在低温2~8℃避光、室温避光条件下较为稳定,实验结果可供临床配伍使用参考。

Objective To investigate the stability of compatible Quzhazhigan for injection with 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, under four conditions. Methods Quzhazhigan for injection was mixed with 5% and 10% glucose infusions, and 0.9% sodium chloride Injection at the room temperature, 2-8℃ in dark, room temperature in dark, room temperature in strong light conditions, within 8h after which the changes of appearance, pH value, the changes of degradation products and the changes of Quzhazhigan contents in them were determined by HPLC. Results There are no significant changes in appearance, pH value of the mixture solutions, degradation products and Quzhazhigan contents in them within 8h after they were prepared at the 2~8℃ in dark, room temperature in dark conditions. Conclusion The test that prompts Quzhazhigan for injection can be mixed with the 3 infusions for clinical use within 8h at the 2-8℃ in dark, room temperature in dark conditions. And its are available for clinical use compatibility reference.