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新型避光输液器的药物相容性及安全性评价
引用本文:黄昕,沈圃毅,施睿,单楠,宋旻昕,沈卫阳.新型避光输液器的药物相容性及安全性评价[J].海峡药学,2014(12):62-65.
作者姓名:黄昕  沈圃毅  施睿  单楠  宋旻昕  沈卫阳
作者单位:1. 江苏省淮安市妇幼保健院药剂科淮安223002
2. 南京师范大学附属中学南京210003
3. 中国药科大学理学院,药物质量与安全预警教育部重点实验室 南京,210009
基金项目:中国药科大学大学生创新项目资助(No.02640557)。
摘    要:目的研究避光输液器在临床输注过程中与药物的相互作用以及安全性问题。方法通过对硝普钠、氟罗沙星以及盐酸阿扎司琼3种光敏性药物用避光输液器进行模拟临床输液试验,对流经输液器前后的药液的各项指标进行检测,并对增塑剂TOTM以及避光着色剂在输液过程中的迁移进行检测。结果药物溶液在光照条件下经过避光输液器前后各项指标并无明显变化。增塑剂TOTM与避光着色剂在输液过程中有微量溶出。结论避光输液器与试验药物相容性良好,输液管路中的TOTM与避光着色剂有微量溶出,应用一次性避光式输液器输注光敏感型药物安全可靠。

关 键 词:避光输液器  相容性  增塑剂  避光着色剂

Studies on the Safety EvaIuation and Drug CompatibiIity of the New Type Light-resistant Infusion Sets
Institution:HUANG Xin, SHEN Pu-yi, SHI Rui, SONG Min-xing, SHEN Wei-yang ( 1. Pharmacy Department of Jiangsu Huai'an Maternal and Child Health Hospital Huaian 223002, China;2. The affiliated senior high school of Nanjing Normal University, Nanjing 2]0003, China ;3. School of Sciences of China Pharmaceutical University, Key Laboratory of Drug Quality Control and Pharmacovigilance Ministry of Education, Nanjing 210009, China)
Abstract:OBJECTIVE To discuss the interaction between drugs and the light-resistant infusion sets in the process of clinical infusion for the safety evaluation and drug Compatibility test. METHODS Three light-sensitive drugs(Sodium Nitroprusside, Fleroxacin and Azasetron Hydrochloride) were used to simulate clinical operation by lightproof infusion device, and various targets of the drug before and after infusing and the release of the plasticizer TOTM and the light-resistant colorants had also been determinated. RESULTS No obvious changes can be observed in the drug solution before and after the infusion process, with trace plasticizer TOTM and the light-resistant colorants released. CONCLUSION The light-resistant infusion sets are effective and compatible with the drugs. The trace re- lease of plasticizer and light-resistant colorantsit proves the safety of light-resistant infusion sets for clinical operation.
Keywords:Light-resistant infusion sets  Compatibility  Plasticizer  Light-resistant colorant
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