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一次性使用避光延长管中增塑剂DEHP向模拟药液迁移情况 预览

Migration of plasticizer DEHP in disposable light proof tube to simulated solution
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摘要 因一次性使用避光延长管中聚乙烯粒料中加入了一定比例的邻苯二甲酸二辛酯(DEHP),过量的DEHP进入人体可能会有一定的影响。本实验使用水和不同浓度乙醇溶液来模拟不同极性的药物通过一次性避光延长管,并模拟临床输液情况,从而动态制备相应的模拟溶液。根据增塑剂在不同溶剂中溶解度的大小,分别采取浓缩或稀释的手段将DEHP转移至甲醇溶液中,采用气相色谱法进行试验。以保留时间定性,以外标法定量。经一系列方法学验证,说明该方法准确可靠,且操作简单,大量减少有机溶剂的使用,安全、环保、有效。从模拟试验数据可见随着溶剂极性的降低,一次性使用避光延长管中DEHP向溶液的迁移量逐渐递增,因此在输液过程中,使用极性小的药物时应尽量避免使用此类物质。 Due to the addition of a certain proportion of plasticizer dioctyl phthalate(DEHP) to the polyethylene pellets in the disposable light proof tubes, the excess of DEHP may have a certain effect on the human body. In this experiment, water and different concentrations of ethanol solutions are used for simulating drugs with different polarities to flow through disposable light proof tube, and the situation of clinical infusion is simulated for preparing the corresponding simulated solutions. According to the solubility of the plasticizer in different solvents, DEHP is transferred to the methanol solution by concentration or dilution.The gas chromatography was used for test. The retention time is qualitative, while the external standard method is quantified.Through a series of methodological verifications, the proposed method greatly reduces the use of organic solvents, and is proved to be accurate, reliable, simple to operate, safe, environmentally friendly and effective. The simulation test data showed that with the decrease of the polarity of the solvent, the migration of DEHP to the solution in the disposable tubes is gradually increasing.Therefore, in the process of infusion, the use of such substances should be avoided as much as possible when the drugs with small polarity are used.
作者 曾念利 ZENG Nianli( Sichuan Institute of Food and Drug Inspetion, Chengdu 611730, China)
出处 《中国医学物理学杂志》 CSCD 2018年第6期729-733,共5页 Chinese Journal of Medical Physics
关键词 一次性使用避光延长管 邻苯二甲酸二辛酯 模拟药液 气相色谱 迁移情况 disposable light proof tube dioctyl phthalate simulated solution gas chromatograph migration
作者简介 曾念利,初级工程师,研究方向:药品包装材料检验和药品与包材相容性,E—mail:2440384931@qq.com
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