基于正交试验法对舒血宁注射液溶媒配伍方案的优选

Optimization of compatibility condition of Shuxuening injection with solvent based on orthogonal test

目的考察多种因素对舒血宁注射液与溶媒配伍后稳定性的影响,选出最佳配伍方案。方法多因素选择温度、溶媒种类、溶媒用量,采用正交试验;单因素选择放置时间;以配伍溶液中主要成分槲皮素、异鼠李素、山奈素含量为指标,选出最优的配伍方案,同时按照该方案考察配伍溶液不溶性微粒变化情况。结果各因素对配伍液中主要成分含量均有影响,试验优选方案为25℃、5%葡萄糖250 ml为溶媒,放置4 h。在4 h内,配伍液不溶性微粒符合中国药典的相关规定。结论该试验优选出舒血宁注射液使用的配伍方案,为临床安全、有效地使用该药物提供依据。

Objective To study the effect of various factors on the stability of Shuxuening injection with solvent,and optimize the compatibility condition.Methods Orthogonal test was used to investigate the multifactors,including temperature,solvent type and solvent dosage.Time was chosen as the single factor.Taking the content of Quercetin,Isorhamnetin and Kaempferol as the evaluation index,the optimum compatibility condition was screened out,and the change of insoluble particles was observed.Results All the factors had effects on the content of the main components.The optimum compatibility condition was 25℃for 4 h,mixed with 250 ml 5%glucose injection.Within 4 h,the insoluble particles conformed the relevant regulation of the Chinese Pharmacopoeia.Conclusion The optimum compatibility condition of Shuxuening injection is determined,which provides a basis for the safe and effective clinical use.