Objective To evaluate the safety of TOTM, this study carried on the research on the drug compatibility between fat emulsion injection and PVC disposable infusion set plasticized with DEHP and TOTM, and provided acceptable support for safety evaluation of PVC infusion apparatus of different plasticizers. Methods After simulating clinical conditions, collecting the fat emulsion injection runs by the PVC disposable infusion set at different time point, and adopting HPLC to test, the adsorption properties of soybean oil and plasticizer migration was inspected between the two infusions. We established a HPLC approach to detect the content of both DEHP and TOTM in the fat emulsion injection. Results The soybean oil in fat emulsion injection was absorbed differently in the two tubes. The rate of change of the soybean oil concentration within 4 h is 87.5% to 92.0% in the infusion which was used DEHP as plasticizer. The absorption of the infusion to soybean oil which was used TOTM as plasticizer increased with the time. Relative to zero time concentration, the rate of change of the soybean oil concentration in the infusion which was used TOTM as plasticizer reached 98.4% to 99.6% in the first two hours, almost no absorption. After two hours, the rate of change of the soybean oil concentration reached 47.9% to 52.0% compared to the concentration of zero time. Obvious absorption of soybean oil began after 2h since TOTM was used. In plasticizer migration test the migration of DEHP was not detected while the migration of TOTM was detected when fat emulsion injection flew through the infusion from 30min to 60min. Conclusions This method evaluates the two plasticizers, TOTM and DEHP, on its drug compatibility of PVC disposable infusion set and fat emulsion injection.
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