丹红注射液与胞磷胆碱钠注射液在2种常用溶媒中的配伍稳定性  

Investigation of Compatible Stability of Danhong Injection Combined with Citicoline Sodium Injection in Two Commonly Used Solvents

作　　者：李学林[1] 李伟霞[1] 赵娅[1] 唐进法[1] 张辉[1] 曹英杰[1] 孟祥乐[1] 

机构地区：[1]河南中医药大学第一附属医院,郑州450000

出　　处：《中国实验方剂学杂志》2017年第3期6-9,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：河南省科技攻关项目(102102310077)

摘　　要：目的:考察丹红注射液与胞磷胆碱钠注射液在2种常用溶媒(0.9%氯化钠注射液和5%葡萄糖注射液)中配伍后的稳定性,为二者的临床合理使用提供参考。方法:观察并测定丹红注射液与胞磷胆碱钠注射液在2种常用溶媒中配伍后一定时间段内(4 h)性状、不溶性微粒数和p H的变化;采用UPLC测定丹红注射液和胞磷胆碱钠注射液中主要成分(丹参素、原儿茶醛、咖啡酸、对香豆酸、迷迭香酸、丹酚酸B和胞磷胆碱钠)的含量变化。结果:丹红注射液与胞磷胆碱钠注射液在2种溶媒中配伍后的颜色均为棕黄色澄清透明液体,4 h内p H相对稳定,不溶性微粒数均符合标准;溶媒为0.9%氯化钠注射液时,丹红注射液中咖啡酸的质量分数在4 h内降低至<50%,其余成分含量无明显变化且相对稳定;溶媒为5%葡萄糖注射液时,各成分含量无明显变化且相对稳定。结论:丹红注射液与胞磷胆碱钠注射液可在0.9%氯化钠注射液和5%葡萄糖注射液中配伍使用,但首选5%葡萄糖注射液为溶媒。Objective： To observe the compatible stability of Danhong injection combined with citicoline sodium injection（DHI ＋ CSI） in two commonly used solvents（0. 9% sodium chloride injection and 5% glucose injection）. Method： The characters,p H values and insoluble particles of DHI ＋ CSI in two solvents were observed and determined. The content changes of main compounds including danshensu,protocatechuic aldehyde,caffeic acid,p-coumaric acid,rosmarinic acid,salvianolic acid B and citicoline sodium in DHI and CSI were determined by UPLC. Result： The characters of DHI ＋ CSI in the two commonly used solvents were brown,clarify and transparent liquid; p H values within 4 h were relatively stable; the numbers of insoluble particles were in the range of standards in 2015 edition of Chinese Pharmacopoeia. When the solvent was 0. 9% sodium chloride injection,the content of caffeic acid reduced more than 50%; there were no significant changes of the contents of other compounds,and the contents of them were relatively stable within 4 h. When the solvent was 5% glucose injection,there were no significant changes of the contents of seven compounds in DHI and CSI,and the contents of them were relatively stable within 4 h. Conclusion： DHI and CSI can be combined in 0. 9% sodium chloride injection and 5% glucose injection,and 5% glucose injection is preferred as the solvent.

关 键 词：丹红注射液 胞磷胆碱钠注射液 配伍 不溶性微粒 咖啡酸 丹酚酸B 

分 类 号：R283.6[医药卫生—中药学] R284.1[医药卫生—中医学]