中国药业2018，Vol.27Issue(21)：9-11,3.DOI:10.3969/j.issn.1006-4931.2018.21.003
不同增溶剂对鱼金注射液稳定性的影响
Effect of Different Solubilizer on Stability of Yujin Injection
摘要
Abstract
Objective To investigate the stability of Yujin Injection prepared with different solubilizer. Methods Yujin Injections were prepared with hydroxypropyl-β-cyclodextrin, sulfobutyl-β-cyclodextrin or methyl-β-cyclodextrin as solubilizers respectively. The appearance, insoluble particles, visible foreign matter, pH, methyl-n-nonanone, bornyl acetate and linalool were taken as evaluation indexes to investigate the influencing factors of Yujin Injection (light, high temperature, low temperature, freezing and thawing) and accelerate stability at 40 ℃. Results The appearance, visible foreign matter and insoluble particles of Yujin Injections prepared by hydroxypropyl-β-cyclodextrin and methyl-β-cyclodextrin were in line with the provisions. There was no significant change in methyl n-nonyl ketone, bornyl acetate and linalool content. After six months of accelerated test, the insoluble particles of Yujin Injection prepared by sulfobutyl-β-cyclodextrin were increased, the solution turned slightly milky white. Conclusion Hydroxypropyl-β-cyclodextrin and methyl-β-cyclodextrin have good solubilization effect, the Yujin Injections prepared with them have good stability. However, sulfobutyl-β-cyclodextrin is not suitable for the solubilization of Yujin Injection.关键词
羟丙基-β-环糊精/磺丁基-β-环糊精/甲基-β-环糊精/影响因素试验/加速稳定性/鱼金注射液Key words
hydroxypropyl-β-cyclodextrin/sulfobutyl-β-cyclodextrin/methyl-β-cyclodextrin/influencing factor test/accelerated stability/Yujin Injection分类
医药卫生引用本文复制引用
何俊婷,张芳侠,曹爱兰,王景峰,惠选柱..不同增溶剂对鱼金注射液稳定性的影响[J].中国药业,2018,27(21):9-11,3.基金项目
陕西省科学技术研究发展计划项目[2015SF2-06] （）
