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Title:: Comparison for phthalic acid diethyl ethyl ester and rimellitic acid three dioctyl released from PVC disposable infusion set

作者:: 李永贵1; 2; 王菲菲3; 崔燕1; 2; 马丽霞2; 纪青1; 2; 陈峰4; 尹弢1; 2△; 王晶1; 2△; 1.山东省药学科学院山东省化学药物重点实验室，济南 250101；2.山东省药学科学院山东省医用高分子材料重点实验室，济南 250101；3.中国大冢制药有限公司，天津 300382；4.华润山东医药有限公司，济南 250118

Author(s):: LI Yonggui1; 2; WANG Feifei3; CUI Yan1; 2; MA Lixia2; JI Qing1; 2; CHEN Feng4; YIN Tao1; 2; WANG Jing1; 2; 1.Shandong Academy of Pharmaceutical Sciences，Shandong Provincial Key Laboratory of Chemical Drug, Jinan 250101，China；2.Shandong Academy of Pharmaceutical Science，Shandong Provincial Key Laboratory of Biomedical Polymers，Jinan 250101；3.China Otsuka Pharmaceutical Co.，Ltd，Tianjin 300382，China；4.China Resources Shandong Pharmaceutial Co.，Ltd，Jinan 250118

Keywords:: Plasticizer; Phthalic acid diethyl ethyl ester; Rimellitic acid three dioctyl; Migration; Disposable polyvinyl chloride infusion set

摘要:: 本研究通过对比研究邻苯二甲酸二乙基乙酯（phthalic acid diethyl ethyl ester，DEHP）和偏苯三酸三辛酯（rimellitic acid three dioctyl，TOTM）在不同药液中的溶出量，为安全使用DEHP或TOTM增塑的一次性使用聚氯乙烯（polyvinyl chloride，PVC）输液器提供依据。选用氯化钠注射液、单硝酸异山梨酯注射液、紫杉醇注射液、乙醇水溶液模拟临床滴注，分别收集通过两种输液器后的药液，采用高效液相色谱法（HPLC）检测药液中DEHP或TOTM的溶出量。结果显示，在氯化钠注射液、单硝酸异山梨酯注射液中未检出DEHP，在紫杉醇注射液、乙醇水溶液中有检出。在氯化钠注射液、单硝酸异山梨酯注射液和紫杉醇注射液中未检出TOTM，在乙醇水溶液中有少量检出。说明在临床上输注药物，选择合适材质的一次性使用PVC输液器非常有必要。

Abstract:: We provided the basis of safe use for disposable PVC infusion set plasticized with DEHP and TOTM by the contrastive study about the dissolution of phthalic acid diethyl ethyl ester（DEHP） and rimellitic acid three dioctyl（TOTM）in different drugs.We simulated clinical drip with sodium chloride injection, isosorbide mononitrate injection, paclitaxel injection, ethanol aqueous solution, and collected the liquid respectively through two kinds of infusion set, used HPLC to test the dissolubility respectively .the DEHP was not checked out in sodium chloride injection, isosorbide mononitrate injection ，but was checked out in taxol injection, ethanol aqueous solution；the TOTM was not checked out in sodium chloride injection, isosorbide mononitrate injection and paclitaxel injection ，but a small amount of TOTM was checked out in the ethanol aqueous solution.So it is necessary to chose the appropriate PVC infusion set for clinical.