A Study On The Compatibility Between Three Injections Such As Propofol And Infusion Apparatus Of Different Materials

Background: With the improvement of living standards and health awareness,people’s increasing emphasis on medical and health care has made the safety of infusion equipment used for clinical intravenous infusion have received widespread attention.Objective: To reseach the compatibility between the infusion apparatus of three commercially available materials（PVC,non-phthalene,TPE）and the three drugs of propofol medium and long chain fat emulsion injection,levocarnitine injection and dexmedetomidine hydrochloride injection,and the safety assessment of relevant leachables,and to make the recommendation of clinical rational drug use and choice of infusion apparatus.Methods: Extreme leaching or intensive leaching method simulates the leaching environment under the harshest clinical conditions（dynamic extraction at 75°C for 24h）to the greatest extent,and analyzes the extraction of elemental magazines and organic matter for each component of the disposable infusion apparatus;Based on the extraction results,combined with the material information of the production of infusion apparatus,the possible leachables（DEHP,TOTM,antioxidant 1076,330,1010,168,168*,styrene and cyclohexanone）were established to detect the detection method,simulated the clinical infusion method,and conducted an interaction study（migration test and adsorption test）on propofol medium and long chain fat emulsion injection,levocarnitine injection,dexmedetomidine hydrochloride injection and PVC,non-phthalene,TPE material infusion apparatus（migration test and adsorption test）,Analyze the compatibility and safety of drugs with infusion devices.Results:1.Extraction studies: In the detection of elemental impurities,the elemental detection results did not exceed the control threshold.In the organic extract detection,cyclohexanone was detected below the PDE;the test results of other organic extracts did not exceed the SCT.Among the compounds of special concern,the detection results of nitrosamines and nitrosamines were less than 0.01μg/g,the detection results of polycyclic aromatic hydrocarbons were below the detection limit,and the detection results of 2-mercaptobenzothiazole were less than 0.1μg/g.2.Compatibility study of infusion apparatus:（1）Propofol medium and long chain fat emulsion injection with 0.9% sodium chloride injection / 5% glucose injection,and the compatibility test of PVC material,nonphthalene PVC and TPE material infusion device,DEHP was detected in the two compatible liquids of PVC material,and the material had a strong adsorption capacity of the main components in the two compatible liquids,which dropped to 63.58% and 54.59% in 24 hours;the two matched liquids in non-phthalene and TPE material infusion apparatus were not detected DEHP,TOTM,antioxidants 1010,antioxidants 330,antioxidants 1076,antioxidants 168 and antioxidants 168*,cyclohexanone and styrene,no change in p H and content,indicating that propofol medium/long chain fat emulsion injection is incompatible with PVC infusion apparatus,and has good compatibility with non-phthalene and TPE material infusion apparatus.（2）Levocarnitine injection is compatible with water for injection,and in the compatibility test with PVC material,non-phthalene PVC,TPE material infusion infusion apparatus,DEHP,TOTM,antioxidants 1010,antioxidants 330,antioxidants 1076,antioxidants 168 and antioxidants 168*,cyclohexanone and styrene,p H and content did not change,indicating that the compatibility of levocarnitine injection with PVC,nonphthalene,TPE three materials of infusion apparatus is good.（3）Dexmedetomidine hydrochloride was compatible with 0.9% sodium chloride injection,and in the compatibility test of PVC material,non-phthalene PVC,TPE material infusion apparatus,cyclohexanone was detected after 4h of the compatibility liquid using PVC material,and with the time measurement,the leaching of cyclohexanone increased（not exceeding the AET）,the content decreased after 12 h,the content dropped to 89.97%,and the p H changed slightly;the two matched liquids in the non-ph-o-benzene and TPE infusion apparatus were not detected DEHP,TOTM,antioxidants 1010,antioxidants 330,antioxidants 1076,antioxidants 168 and antioxidants 168*,cyclohexanone and styrene,p H and content did not change,indicating that dexmedetomidine hydrochloride injection has poor compatibility with PVC infusion devices and good compatibility with nonphthalene and TPE infusion apparatus.Conclusion:1.The detection methods of DEHP and TOTM,antioxidants 1010,antioxidants 330,antioxidants 1076,antioxidants 168 and antioxidants 168*,cyclohexanone and styrene established in this thesis have high sensitivity,low detection limit,high precision and good reproducibility,and can be used for the detection and control of DEHP and other leachables in medical plastics by infusion equipment manufacturers.2.The results of the compatibility of infusion apparatus show that the compatibility of propofol medium and long chain fat emulsion injection and PVC material infusion apparatus is poor,and clinically it should be avoided as much as possible to avoid the use of PVC material infusion apparatus infusion of fatty milk such as propofol medium and long chain fat emulsion,and the selection of TPE material infusion apparatus is the first choice for propofol medium/long chain fat emulsion injection and other fat emulsion preparations.3.Levocarnitine injection has good compatibility with PVC,non-phthalaldehyde PVC and TPE material infusion equipment.4.The compatibility between Dexmedetomidine hydrochloride injection and PVC infusion apparatus,the cyclohexanone was detected more than 4 hours.the clinical use of Dexmedetomidine hydrochloride injection should try to avoid the use of PVC infusion apparatus,if necessary,should be controlled within 4 hours.