Evaluation Of Drug Compatibility Of New Type Infusion

PVC material is the main material for the production of infusion. To meet the clinical requirements, medical plasticizers is usually added during the production of PVC to achieve better flexibility of the final product-DEHP is the most widely used plasticizier. Because PVC infusion will absorb the pharmaceutical solution and may migrate to the liquid within human body, which is a potential risk and may jeopardize the patients’ safety. Therefore, manufacturers began producing infusion adding low-risk plasticizers (such as TOTM), or other non-PVC materials (such as TPE) infusion to replace the PVC infusion.This thesis is divided into four chapters, in the first chapter, by querying the database, summarize the toxicological data of the medical plasticizers which are most commonly used.In the second chapter, using HPLC to detective the concentration changing of pharmaceutical in the liquid which were through the three kind of infusion. Test results show that, pharmaceutical adsorption is basically the same in both PVC infusions. Two kinds of PVC infusions are adsorbed esters drugs. In the TPE infusion, the concentration of the pharmaceutical liquid is not a significant change.In the third chapter, to simulate clinical situation, nitroglycerin solution, isosorbidemononitrate solution and 45% ethanol aqueous solution were allowed to transfuse through both types of tubes, respectively, and were collected at multiple time points for a quantitative determination of the plasticizers content using HPLC. Plasticizer was found in neither the nitroglycerin nor the isosorbidemononitrate solutions. Both TOTM and DEHP were detected in the ethanol water simulation solution, and the content of TOTM was higher than DEHP. The migration of DEHP was not detected when fat emulsion injection flows through the infusion, and while the migration TOTM was detected from 30 to 60 minutes. By contrast toxicology data, even higher dissolution, TOTM is still safey because of lower toxicity.In the last chapter, using the Gas chromatography-mass spectrometry for the qualitative detection of TPE material can extract performed, identified 23 kinds of additives and their degradation products in the leachate. Of these 23 substances, there are several substances potentially harmful to humans. Therefore, it should increase the detection of TPE material, to ensure the safety of the product.The results of this paper laid a foundation for further compatibility tests between the pharmaceutical liquids and the infusions. Evaluation of existing data for new infusion is not perfect, it requires not only the efforts of regulators, but also need each transfusion medical device manufacturer of efforts in order to better ensure the safety of patients using medical devices.