PVC输液器中偏苯三酸三辛酯向脂肪乳注射液中迁移量的HPLC法测定  

Determination of the Migration of Trioctyl Phthalate Released to Fat Emulsion Injection in PVC Infusion by HPLC

作　　者：张凤兰 张芳芳 顾维钧 ZHANG Feng-lan;ZHANG Fang-fang;GU Wei-jun(Shanghai Food and Drug Packaging material Control Center,Shanghai 201203,China)

机构地区：[1]上海市食品药品包装材料测试所,上海201203

出　　处：《海峡药学》2022年第2期45-47,共3页Strait Pharmaceutical Journal

基　　金：上海市包装材料与药品相容性研究专业技术服务平台(编号18DZ2292600)。

摘　　要：目的建立了高效液相色谱法测定聚氯乙烯(PVC)输液器中偏苯三酸三辛酯(TOTM)在脂肪乳注射液中的迁移量。方法使用Poroshell 120 EC-C_(18)(4.6×50 mm,2.7μm)色谱柱,以水、乙腈、异丙醇为流动相,检测波长280nm。结果TOTM在0.1045~10.4524μg·mL^(-1)浓度范围类线性关系良好(r=0.9998),平均回收率为87.95%~99.24%,相对标准偏差为0.1%~1.4%。3批次PVC输液器的检测结果显示:在37℃模拟临床使用条件下,脂肪乳注射液中TOTM的迁移量均小于1.3 mg,即小于成人的耐受摄入量(1日22 mg)。结论该方法简单、准确,可用于PVC输液器中TOTM在脂肪乳注射液中的溶出量的测定。OBJECTIVE To establish a high performance liquid chromatography(HPLC)method for the determination of the migration of trioctyl phthalate(TOTM)in polyvinyl chloride(PVC)infusion set in fat emulsion injection.METHODS Poroshell 120 EC-C_(18)(4.6×50 mm,2.7μm)column was used with water,acetonitrile and isopropanol as mobile phases,and the detection wavelength was 280nm.RESULTS The linear relationship of TOTM was good in the concentration range of 0.1045~10.4524μg·mL^(-1)(r=0.9998).The average recovery rate was 87.95%~99.24%,and the relative standard deviation was 0.1%~1.4%.The test results of this batch of PVC infusion set showed that the TOTM migration in fat emulsion injection was less than 1.3 mg under the simulated clinical use condition at 37℃,that is,less than the tolerant intake of adults(22 mg/day).CONCLUSION The method is simple and accurate,and can be used to determine the dissolution of TOTM in fat emulsion injection in PVC infusion set.

关 键 词：偏苯三酸三辛酯 脂肪乳注射液 聚氯乙烯输液器 高效液相色谱 

分 类 号：R927[医药卫生—药学]