苦碟子注射液与常用溶媒配伍的稳定性研究

目的:通过考察苦碟子注射液与常用溶媒的配伍变化,指导临床合理使用苦碟子注射液。方法:将苦碟子注射液与常用溶媒(灭菌注射用水、5%葡萄糖注射液、10%葡萄糖注射液、0.9%氯化钠注射液、复方氯化钠注射液)配伍,定时考察配伍后溶液的外观、pH、不溶性微粒及质量浓度变化情况。结果:室温4 h内,配伍后混合液外观及pH均无明显改变;光照对溶液颜色无明显影响;灭菌注射用水、5%葡萄糖注射液、10%葡萄糖注射液、0.9%氯化钠注射液作为溶媒的不溶性微粒数目均符合2010年版《中国药典》规定;与常用溶媒配伍后,只有与10%葡萄糖注射液配伍时,总黄酮质量浓度未见明显变化。结论:10%葡萄糖注射液为苦碟子注射液最佳溶媒。

Compatible Stability of Kudiezi Injection in Commonly Used Solvents

OBJECTIVE：To guide rational use of Kudiezi injection in the clinic by studying the compatibility of Kudiezi injection in commonly used solvents. METHODS：Kudiezi injection was combined with commonly used solvents（Sterilized water for injection,5% Glucose injection,10% Glucose injection,0.9% Sodium chloride injection,Compound sodium chloride injection）.The property of mixture was examined,including appearance,pH,insoluble particle and content. RESULTS：The appearance and pH of mixture had no obvious change at room temperature for 4h;the sun light had no effect on the color of mixture;the number of insoluble particle in Kudiezi injection compatibility with Sterilized water for injection,5% Glucose injection,10% Glucose injection,0.9% Sodium chloride injection was in line with the requirement of Chinese Pharmacopoeia（2010 edition）. The content of total flavonoids only 10% Glucose injection had no significant change after mixed with Kudiezi injection. CONCLUSIONS：10%Glucose injection is the best solvent for Kudiezi injection.