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

发布时间：2018-12-18 00:59

【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。
[Abstract]:Objective: to investigate the stability of Danhong injection and citicoline sodium injection in two common solutes (0.9% sodium chloride injection and 5% glucose injection). Methods: the characters, the number of insoluble particles and pH of Danhong injection and citicoline sodium injection were observed and determined in a certain period (4 h) after compatibility between Danhong injection and citicoline sodium injection. The contents of main components (Danshensu, protocatechualdehyde, caffeic acid, p-coumaric acid, rosemary acid, Salvianolic acid B and citicoline sodium) in Danhong injection and citicoline sodium injection were determined by UPLC. Results: the color of Danhong injection and citicoline sodium injection mixed with citicoline sodium in two kinds of solutes were all brown clear and transparent liquid, pH was relatively stable within 4 hours, and the number of insoluble particles was up to the standard. When the solvent was 0.9% sodium chloride injection, the content of caffeic acid in Danhong injection decreased to 50% within 4 h, and the other components had no obvious change and were relatively stable. When the solvent was 5% glucose injection, the content of each component had no obvious change and was relatively stable. Conclusion: Danhong injection and citicoline sodium injection can be used in 0.9% sodium chloride injection and 5% glucose injection, but 5% glucose injection is the preferred solvent.
【作者单位】：河南中医药大学第一附属医院;
【基金】：河南省科技攻关项目(102102310077)
【分类号】：R969.2

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