Abstract

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Title:: Migration of plasticizer DEHP in disposable light proof tube to simulated solution

Author(s):: ZENG Nianli; Sichuan Institute of Food and Drug Inspetion, Chengdu 611730, China

Keywords:: ; Keywords: disposable light proof tube; dioctyl phthalate; simulated solution; gas chromatograph; migration

Abstract:: Abstract: 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.