减少雷贝拉唑钠输液中不溶性微粒的配制方法优化  

Optimization for the dispensing methods of reducing insoluble particles in rabeprazole sodium intravenous infusion

作　　者：杨婷[1] 高申[1] YANG Ting;GAO Shen(Department of Pharmacy,Changhai Hospital,Second Military Medical University,Shanghai 200433,China)

机构地区：[1]第二军医大学长海医院药学部,上海200433

出　　处：《药学服务与研究》2018年第2期114-116,共3页Pharmaceutical Care and Research

摘　　要：目的:考察影响雷贝拉唑钠输液中不溶性微粒数量的因素,确定其最佳配制方法。方法:取时间、光照、初溶液体积和西林瓶内压力4个影响因素,采用L8(24)正交设计,筛选雷贝拉唑钠注射剂的最优配制方法。结果:4种因素对雷贝拉唑钠冻干粉针剂静脉输液成品中不溶性微粒数均有显著影响,最优配制模式为:以10ml的0.9%氯化钠注射液作为初溶液,配制时西林瓶内压力为负压75kPa,避光条件,配制后1h使用。在优化的配制模式下,不溶性微粒数减少为传统模式的约1/20。结论:采用优化模式配制的雷贝拉唑钠输液能显著减少其中不溶性微粒数。Objective:To explore the influential factors of insoluble particle number in the rabeprazole sodium intravenous infusion,so as to establish the optimal dispensing method.Methods:Time flight intensity,volume of first infusion and internal pressure of vial were selected as the 4 influential factors.Orthogonal design Ls(24)was applied to establish the optimal dispen-sing method.Results:The four factors had obvious influence on insoluble particle number in the rabeprazole sodium intravenous infusion.The optimal dispensing mode was as follows:the drug powder was initially dissolved in 10 ml 0.9%sodium chloride injection,with a negative pressure of 75 kPa in vial,without light,and the infusion was put to use 1 h after dispensing.The num-ber of insoluble particles in intravenous infusion by optimal mode was about 1/20 of that by traditional mode.Conclusion:Insol-uble particle number in the rabeprazole sodium intravenous infusion was significantly reduced by the optimal dispensing mode.

关 键 词：雷贝拉唑钠注射剂 不溶性微粒 配制方法 正交设计 

分 类 号：R917[医药卫生—药物分析学]