丹红注射液与维生素B_6注射液的配伍稳定性研究

Compatible stability of Danhong injection mixed with vitamin B_6 injection

目的：研究丹红注射液与维生素B_6注射液在5%葡萄糖注射液（5%GS）、0.9%氯化钠注射液（0.9%NS）中的配伍稳定性。方法：采用超高效液相色谱法测定丹红注射液与维生素B_6注射液配伍后放置0,1,4 h内丹参素钠、原儿茶醛、咖啡酸、对香豆酸、迷迭香酸和丹酚酸B及维生素B_6的含量变化;采用不溶性微粒检测仪、酸度计测定配伍后放置0,0.5,1,2,4 h不溶性微粒数及p H值,并观察外观变化。结果：丹红注射液与维生素B_6注射液配伍在5%GS、0.9%NS中均为黄褐色,澄清透明液体,4 h内无明显变化;不溶性微粒数及p H值均在药典规定的范围之内;在4 h内,以5%GS为溶媒时,丹红注射液的6种有效成分及维生素B_6的含量无明显变化;以0.9%NS为溶媒时,丹红注射液中6种有效成分的含量保持在94%~106%范围内,维生素B_6在1 h时检测不到。结论：丹红注射液与维生素B_6注射液可在5%GS中配伍使用,不能以0.9%NS为溶媒进行配伍。

Objective： To investigate the compatible stability of Danhong injection mixed with vitamin B_6 injection in two kinds of solutions（ 5% glucose injection and 0. 9% sodium chloride injection）. Methods： UPLC was used to detect the content change（ salvianic acid A sodium,protocatechuic aldehyde,caffeic acid,p-coumaric acid,rosmarinic acid,salvianolic acid B,and isosorbide mononitrate） of the mixture within 4 h after mixing. The amount of insoluble particles,p H value,and appearance were also observed. Results： Neither the appearance and p H value and the amount of insoluble particles had obvious changes. No significant difference was found in the contents of salvianic acid A sodium,protocatechuic aldehyde,caffeic acid,p-coumaric acid,rosmarinic acid and salvianolic acid B in two kinds of solutions after Danhong injection mixed with vitamin B_6 injection. Vitamin B_6 was also stable in 5% glucose injection within 4 h,but was not detected in 0. 9% sodium chloride injection after mixing. Conclusion： Danhong injection can be mixed with vitamin B_6 injection in 5% glucose injection within 4 h after mixing,but not in 0. 9% sodium chloride injection.