输液包装对静脉滴注用药Ⅰ期临床试验的影响因素分析  

Analysis of the factors of infusion bag on the phaseⅠclinical trials of intravenous medicine

作　　者：朱昶宇 邹静[2] 唐梅[2] 颜婷[2] 周杨林[2] 蒲艳[2] 左慧英 童荣生 ZHU Chang-yu;ZOU Jing;TANG Mei;YAN Ting;ZHOU Yang-lin;PU Yan;ZUO Hui-ying;TONG Rong-sheng(Personalized Drug Therapy Key Laboratory of Sichuan Province,School of Medicine,University of Electronic Science and Technology of China,Chengdu 610072,Sichuan Province,China;Department of Pharmacy,Sichuan Academy of Medical Sciences·Sichuan Provincial People’s Hospital,Chengdu 610072,Sichuan Province,China)

机构地区：[1]电子科技大学医学院个体化药物治疗四川省重点实验室,四川成都610072 [2]四川省医学科学院·四川省人民医院药学部,四川成都610072

出　　处：《中国临床药理学杂志》2020年第19期3151-3153,3168,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的通过比较输液包装的相关因素差异,为临床试验输液瓶选择提供参考。方法通过紫外-可见分光光度法、光阻法和静脉血压模拟法比较A、B、C、D、E 5种输液包装在透光性能、不溶性微粒和排液性能3个方面的差异,并对结果进行分析。结果输液B、C、D、E具有良好的透光性能,便于试验过程中查对药液情况;输液A、B、C、D在穿刺前后,不溶性微粒水平相当,显著优于输液E,在胶塞穿刺操作过程中,会引入大量微粒;输液A、B、C作为全密闭式输液产品,其中输液B、C自排液平稳,输液A输注排液时间延长。结论在Ⅰ期临床试验过程中,应当充分考虑输液包装可能带来的影响,选择适合Ⅰ期临床试验的输液包装对于保证试验的顺利完成有十分重要的意义。Objective To provide reference for the selection of infusion bottles in clinical trials by comparing the relevant factors of infusion bag.Methods By ultraviolet-visible spectrophotometry,photoresist and venous blood pressure simulation,we compared the differences of A,B,C,D,E five kinds of infusion bag in light trasmission,insoluble particles,discharge performance,and the results were analyzed.Results Infusion B,C,D and E had good light transmittance,which was convenient to check the condition of drug solution during the clinical trials.Before and after the puncture,the level of insoluble particles in infusion A,B,C and D was similar,which was significantly better than that in infusion E.During the operation of rubber plug puncture,a large number of particles would be introduced.Infusion A,B and C were used as completely closed infusion products,in which infusion B and C had stable collapsible dripping speed.On the other hand,the collapsible dripping speed of infusion A,which will slow down in the later part of the trial,was not stable.Conclusion In the course of phaseⅠclinical trials,full consideration should be given to the possible effects of infusion bag,and it is very important to choose suitable infusion packaging suitable for phaseⅠclinical trials to ensure the successful completion of the trial.

关 键 词：Ⅰ期临床试验 输液包装 透光性 不溶性微粒 自排液 

分 类 号：R97[医药卫生—药品]