粉针剂用注射用水初溶的必要性及其稳定性浅析  

Necessity and stability of initial dissolution of water for injection for powder injection

作　　者：肖莉娜[1] 张建中[1] XIAO Li’na;ZHANG Jianzhong(Pharmacy Intravenous Admixture Service,Zhongshan Hospital,Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学附属中山医院静脉用药调配中心,上海200032

出　　处：《上海医药》2022年第7期78-81,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:提高我院粉针剂药物用注射用水初溶后的稳定性。方法:对我院2020年所有针剂品种进行回顾并统计,其中对粉针剂用注射用水初溶及初溶后的药物稳定性进行分析。结果:发现在粉针剂药物说明书中要求使用注射用水进行初溶的药物品种有53个,占总品种的13%,其目的包括增加粉针剂药物的溶解度、避免输液pH对粉针剂药物溶解造成不稳定结果、避免盐析现象、避免美拉德反应、防止产生同离子效应、防止输液中可能产生不溶性微粒、防止溶血现象的发生。结论:粉针剂药物溶解是制备加药输液稳定性的一个重要步骤,正确使用注射用水对其进行初溶是药学人员必须掌握的专业技能。Objective:To improve the stability of water for injection for powder injection in our hospital.Methods:All varieties of drug injections in our hospital in 2020 were reviewed and statistically analyzed,in which the initial dissolution of water for injection for powder and the drug stability after initial dissolution were analyzed.Results:It was found that there were 53 drug varieties that require the use of water for injection for initial dissolution in the powder injection drug instructions,accounting for 13%of the total varieties,the purpose of which was to increase the solubility of the powder for injection,avoid the salting-out phenomenon,the Maillard reaction and the unstable results caused by the pH value of the infusion solution,and prevent the generation of the same ion effect and the insoluble particles in the infusion solution and the occurrence of hemolysis.Conclusion:Drug dissolution of powder injection is an important step in the stability of drug infusion preparation.Proper use of water for injection for initial dissolution is a professional skill that pharmaceutical personnel must master.

关 键 词：粉针剂 注射用水 初溶 稳定性 

分 类 号：R926[医药卫生—药学] R952