醒脑静注射液与不同输液配伍的稳定性

Stability of Xingnaojing injection in combination with different infusions

目的考察醒脑静注射液分别与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液、葡萄糖氯化钠注射液配伍后的稳定性。方法采用2015版《中国药典》规定的光阻法分别考察在0.0、0.5、1.0、2.0、4.0、8.0 h内,醒脑静注射液按说明书中的用量与4种输液配伍后所产生不溶性微粒数量,以及上述时间内pH值的变化。结果醒脑静注射液与4种输液配伍后的外观、pH值无明显变化。醒脑静注射液与10%葡萄糖注射液、葡萄糖氯化钠注射液配伍后≥10μm不溶性微粒数符合药典标准;与0.9%氯化钠注射液、5%葡萄糖注射液配伍后≥10μm不溶性微粒数平均值符合药典标准。与4种输液配伍后≥25μm不溶性微粒数符合药典标准。结论建议选用溶媒为5%葡萄糖注射液或10%葡萄糖注射液。临床科室在使用醒脑静注射液时,在前30 min应慢滴,应在4.0 h内滴注完毕。

Objective To investigate the stability of Xingnaojing injection in combination with 0.9%sodium chloride injection,5%glucose injection,10%glucose injection,and glucose and sodium chloride injection.Methods The changes of insoluble particles and pH values in the combination of xingnaojing injection with the above four infusion solutions in 0.0,0.5,1.0,2.0,4.0,and 8.0 h were studied by light blockage methods specified in the Chinese Pharmacopoeia(2015).Results After the combination of Xingnaojing injection with the above four solutions,there were no significant changes in the appearance and pH value.When Xingnaojing injection was mixed with 10%glucose injection and glucose and sodium chloride injection,the number of insoluble particles≥10μm met the standard.The average number of≥10μm insoluble particles in Xingnaojing injection after the combination with 0.9%sodium chloride injection and 5%glucose injection met the standard.The numbers of insoluble particles≥25μm in all the solutions met the requirement.Conclusion The more suitable solvents for Xingnaojing injection are 5%or 10%glucose injection.When clinically using Xingnaojing injection,the infusion should be dropped slowly in the first 30 minutes,and finished within 4 hours.