避光型聚氨酯输液器中紫外线吸收剂UV-P的溶出性质研究  

Study on the Migration Properties of Ultraviolet Absorbent UV-P in Light-Resistant TPU Infusion Device

作　　者：崔萍 曹庆丰 丁逸梅 CUI Ping;CAO Qing-feng;DING Yi-mei(Jiangsu Provincial Institute of Material Medica,Nanjing 211816,China;School of Pharmaceutical Sciences,Nanjing Tech University,Nanjing 211816,China)

机构地区：[1]江苏省药物研究所有限公司,江苏南京211816 [2]南京工业大学药学院,江苏南京211816

出　　处：《塑料科技》2024年第8期126-131,共6页Plastics Science and Technology

摘　　要：文章建立了避光型热塑性聚氨酯输液器中紫外线吸收剂UV-P迁移量的高效液相色谱检测方法,对一次性使用聚氨酯输液器中紫外线吸收剂UV-P的溶出性质进行研究。以6种不同类型的注射液模拟临床使用条件,经聚氨酯输液器输注后进高效液相色谱仪进行分析。采用Kromasil C18色谱柱,以甲醇-水(90∶10)为流动相,339 nm为检测波长。结果表明:UV-P在0.061 4~1.638 0 mg/L质量浓度范围内线性关系良好(r=0.999 9),各输液平均加标回收率均在97.51%~101.10%,相对标准偏差(RSD)小于2%,信噪比大于3,检测下限为0.020 48 mg/L。文章建立的方法灵敏度高、重复性好,适合对聚氨酯输液器中UV-P的溶出量进行检测。This paper established a high performance liquid chromatography(HPLC)method for the determination of ultraviolet absorber UV-P in an light resistant thermoplastic polyurethane infusion device,and to carry out the research on the dissolution of ultraviolet absorber UV-P from disposable TPU infusion device.Six different types of injections were used to simulate the clinical application conditions,and after infusion with a light resistant TPU infusion device,they were analyzed by high-performance liquid chromatography.Kromasil C18 column was adopted,the mobile phase consisted of methanol-water(90∶10),the detection wavelength was 339 nm.The resuls show that calibration curves of UV-P are linear over the range of 0.0614~1.6380 mg/L(r=0.9999),the average recoveries are both betwen 97.91%and 101.10%,the relative standard deviation is less than 2%,the signal-to-noise ratio is greater than 3,and the values of quantitation limit is 0.02048 mg/L.The method is sensitive and good repeatability,which is suitable for the detection of UV-P dissolution in TPU infusion device.

关 键 词：避光型聚氨酯输液器 紫外线吸收剂UV-P 溶出 高效液相色谱法 

分 类 号：O657.72[理学—分析化学]