| This thesis is about the research of biological properties equivalency of disposable infusion device under different extracting conditions. Extract the infusion device according to the 5 recommended extraction methods of infusion device in GB/T 16886.12-200510.3.1. Test the biological properties of the extraction including cytotoxictiy, intradermal reaction, acute systemic toxicity under different extraction methods using GB/T 16886 series standard. At the same time, test chemical properties of the extraction including reducing substances, pH, UV absorbance, evaporation residue and Cd ion dissolution using GB 8368-2005 standard with UV and graphite furnace atomic absorption method. DEHP was identified as a toxic component, test the dissolution of DEHP of extraction under different extracting conditions with UV method. The following conclusions can be obtained through the analysis of data:(1) The 5 extraction conditions that GB/T 16886.12-2005 recommended dose not have equivalent impact on the biological properties of the infusion device.(2) In the biology experiment process of infusion device, extraction under(37±1) °C for(72±2) h as conventional extraction is recommended, extraction under(70±2)°C for(24±2) h as strict or accelerated condition is recommended.(3) The 5extraction conditions that GB/T 16886.12-2005 recommended dose not have equivalent impact on the chemical properties of the infusion device.(4) Cd ion dissolution trend and cytotoxicity trend in the extraction of different infusion device are the same, and Cd ion dissolution can be used as a chemical characterization of chemical screening on the biological properties of infusion device materials.(5) DEHP, as an identified toxicity component of infusion device, has no significant impact on the biological performance because of its low content in the extraction, it can not be used as a chemical characterization of chemical screening on the biological properties of infusion materials. |
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