输注器具产品药物相容性研究概述An overview on drug compatibility of infusion sets
叶成红,骆红宇,沈永
YE Chenghong,LUO Hongyu,SHEN Yong
摘要(Abstract)：
药物相容性指的是由于药物与所接触的材料、容器等发生作用而对药物的治疗而产生的相互影响,包括材料的可提取物、浸出物以及由于其相互作用给药品质量及使用功能带来的风险。对于输注器具类产品而言,药物相容性也是该类产品安全性研究的重要方面和产品审评的重要关注点,其主要包括输注器具对药物的吸附和输注器具中某些添加剂、单体等可溶出物的迁移进入药液两个作用。研究发现,不同材料的输注器具产品对不同浓度、不同种类的药物具有不同的药物相容性,一定程度上影响了输液的效果和安全。文章简要概述了常见材料的输注器具产品的药物相容性研究进展,为企业更好地选择合适材料开发相关产品并进行注册申报以及指导临床合理用药提供参考。
Objective Drug compatibility refers to the interaction between drug and its contact materials,containers,etc. including the extractable or leachable materials,and the interaction which will bring the risks to the quality of the drug and the function of the products. For infusion sets,drug compatibility is also an important aspect of product safety research and an important focus of product review. It mainly includes two functions: the absorption of drugs by infusion sets and the migration of soluble substances such as additives and monomers of the polymer into the liquid. It is found that infusion sets products with different materials have different drug compatibility with different concentrations and different kinds of drugs,which affects the effect and safety of infusion to a certain extent. This article briefly summarizes the progress of drug compatibility research on infusion sets products made of different materials,and provides references for enterprises to select better suitable materials to develop related products and to register and declare them and guide clinical rational drug use.
关键词(KeyWords)：
输注器具;药物相容性;概述
infusion sets;drug compatibility;overview
基金项目(Foundation):
作者(Author):
叶成红,骆红宇,沈永
YE Chenghong,LUO Hongyu,SHEN Yong
DOI: 10.14066/j.cnki.cn21-1349/r.2018.10.014
参考文献(References)：
- [1]王学芬,陈祖坚,闫超.中国与欧美药品包装材料相容性研究规范[J].广州化工,2014,42(5):31-33.
- [2]刘言.药品包装材料与药物相容性研究的现状及展望[J].天津药学,2013,25(5):56-59.
- [3]国家食品药品监督管理总局.关于发布化学药品注射剂与药用玻璃包装容器相容性研究技术指导原则(试行)的通告(2015年第40号)[OL]. http://samr. cfda. gov. cn/WS01/CL0087/126004. html.
- [4] ALLWOOD M C. Drug Interactions with plastics and their biological consequences[S]. Netherlands,1988:157-162.
- [5]沈亦红.一次性输液器药物相容性及安全性分析[J].医疗装备,2012,25(8):1-4.
- [6]徐帆,杨伶俐,毛盼盼,等.大输液包装材质与注射用药物相容性研究进展与思考[J].中国护理管理,2014,23(20):91-94.
- [7]余强,李佳宁,郭亮,等.输液器材质对输注药物吸附作用的研究进展[J].中国护理管理,2016,16(6):862-864.
- [8]黎玉伦,宋伏虎,洪小英,等.医用塑料对药物吸附作用的研究[J].医学综述,2008,14(6):930-932.
- [9]奚廷斐,王春仁.邻苯二甲酸辛酯增塑聚氯乙烯医疗器械的安全性评价[J].中国医疗器械信息,2005,11(2):27-30.
- [10]宋晓峰,魏光辉.医用塑料增塑剂DEHP安全性研究及对策[J].国外医学,2005,32(6):358-361.
- [11]王佳,董四君.邻苯二甲酸二乙基己酯(DEHP)毒理与健康效应研究进展[J].生态毒理学报,2012,7(1):25-34.
- [12]蒋磊,徐维平,芮贝贝,等.邻苯二甲酸二乙基己酯体内代谢和毒性机制研究进展[J].中国药业,2015,24(5):1-4.
- [13]郑卫. PVC输液器与药物相容性研究综述[J].中国食品药品监管,2010(8):68-71.
- [14]徐翠玲,贾铭婧,崔钰琪. PVC输液器与20种药物的相容性[J].中国医药工业杂志,2015,46(8):879-885.
- [15]敖薪,李峥.聚氯乙烯输液器对3种药物吸附作用的研究[J].中华护理杂志,2006,41(9):785-788.
- [16]JIN S E,YOU S,JEON S,et al. Diazepam sorption to PVC-and non-PVC-based tubes in administration sets w ith quantitative determination using a high-performance liquid chromatographic method[J]. International Journal of Pharmaceutics,2016,506(1/2):414-419.
- [17]方旻,曲亚南,谢新艺,等.聚氨酯输液器对三种药物的吸附研究[J].中国医疗器械信息,2013,19(3):56-57.
- [18]TRELEANO A,WOLZ G,BRANDSCH R,et al. Investigation into the sorption of nitroglycerin and diazepam into PVC tubes and alternative tube materials during application[J]. International Journal of Pharmaceutics,2009,(369):30-37.
- [19]辛凤鲜,薛云燕. TPE输液器药物相容性探讨[J].中国医疗器械信息,2011,17(2):34-37.
- [20]张恩娟,陈琳,黄林清. PVC与TPE输液器对3种药物的吸附研究[J].中国药房,2007,18(7):F508-510.