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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 investigate the stability of Danhong injection and Citicoline sodium injection in the compatibility of two common vehicles (0.9% sodium chloride injection and 5% glucose injection) for their clinical rational use reference. Methods: The changes of traits, insoluble particles and p H within a certain period of time (4 h) after the combination of Danhong injection and citicoline sodium injection in two kinds of common solvents were observed and determined. The determination of Danhong injection by UPLC The contents of main components (Danshensu, protocatechuic aldehyde, caffeic acid, p-coumaric acid, rosmarinic acid, salvianolic acid B and citicoline sodium) in liquid and citicoline sodium injection were measured. Results: The color of Danhong injection and citicoline sodium injection in two kinds of media were clear yellow transparent liquid, pH was relatively stable within 4 h, the number of insoluble particles were in line with the standard; the solvent was 0.9% Sodium chloride injection, the mass fraction of caffeic acid in Danhong injection was reduced to <50% in 4 h, the content of other components did not change obviously and was relatively stable. When the solvent was 5% dextrose injection, the content of each component was none Significantly changed and relatively stable. Conclusion: Danhong injection and citicoline sodium injection can be used in 0.9% sodium chloride injection and 5% glucose injection compatibility, but the preferred 5% glucose injection as the vehicle.