注射用灯盏花素与注射用转化糖的配伍稳定性考察

Study of Compatible Stability of Breviscapine for Injection and Invert Sugar for Injection

目的考察注射用灯盏花素与注射用转化糖在0.9%氯化钠注射液中的稳定性并进行分析。方法观察并测定灯盏花素与转化糖在0.9%氯化钠注射液中配伍后室温放置6 h内的微粒、外观及pH,并采用高效液相色谱法测定配伍液室温放置6 h内的含量变化。结果与配伍0 h比较,配伍液放置6 h内的外观、色泽及含量均无明显变化,pH略有变化,微粒不符合2010年版《中国药典》规定。配伍液中灯盏花乙素含量在6 h内保持在95%以上。结论注射用灯盏花素与注射用转化糖在0.9%氯化钠注射液中不宜配伍。

Objective To investigate and analyze the stability of Breviseapine for Injection and Invert Sugar for Injection in the combi- nation of 0.9 % Sodium Chloride Injection. Methods The microparticles, external appearance and pH value of the compatible mixture solution placed in the room temperature for 6 h were measured. The content change of compatible solution placed in the room tempera- ture for 6 h was determined by HPLC. Results No significant differences in the appearance,color and contents within 6 h after mixing were noted between 0 h and within 6 h for the mixture, the pH value had slight change and the microparticles were inconformity with the stipulation in the China Pharmacopeia （edition 2010）. The content of breviscapine in the compatible solution maintained above 95% within 6 h. Conclusion Breviscapine for Injection and Invert Sugar for Injection are inappropriately compatible with 0. 9 % Sodium Chloride Injection.