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作 者:刘毅[1] 刘晓强 李选堂 姚晓 郭贤辉 林兰[1] LIU Yi;LIU Xiao-qiang;LI Xuan-tang;YAO Xiao;GUO Xian-hui;LIN Lan(National Institutes for Food and Drug Control,Bejing 102629,China;Changzhou Institute for Drug Control,Changzhou 213002,China)
机构地区:[1]中国食品药品检定研究院,北京102629 [2]江苏省常州市药品检验所,常州213002
出 处:《中国新药杂志》2024年第2期194-197,共4页Chinese Journal of New Drugs
摘 要:目的:考察引起盐酸溴己新注射剂临床应用吸附性丢失的因素.方法:采用析因实验设计,考察给药途径中输液容器、输液器相关因素引起的主药含量变化以确认临床应用过程中的吸附性丢失情况.结果:玻璃瓶材质的输液容器几乎无吸附影响,输液软袋、生理盐水溶媒影响较突出,聚氯乙烯输液器(PVC)影响较大.结论:建议本品输液优选玻璃瓶包装的葡萄糖注射液,以降低给药剂量的丢失.Objective:To investigate the factors causing adsorbable loss of bromhexine hydrochloride injections in clinical application.Methods:Factorial experimental design was used to investigate the changes of active pharmaceutical ingredient content caused by the factors related to the infusion containers and infusion sets in the administration route to confirm the loss of adsorption during clinical application.Results:In regard of the adsorbable loss of active pharmaceutical ingredient,the glass infusion container had almost no effect,the infusion soft bag and normal saline solvent had significant effects,and the polyvinyl chloride infusion set had a greater effect.Conclusion:It is suggested that glucose injection packaged in glass bottle be preferred for infusion of bromhexine hydrochloride injections to reduce the adsorbable loss of active pharmaceutical ingredient.
关 键 词:注射用盐酸溴己新 盐酸溴己新葡萄糖注射液 盐酸溴己新注射液 吸附性 临床应用
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