| Multi-layer coextrusion bags is widely applied in packing various injections.However,the antioxidant contained in the multi-layer coextrusion bags may greatly dissolve out,threatening the health of human.Therefore,the studies on the dissolution of the antioxidant in the multi-layer coextrusion bag for infusion in different injections or solvents are necessary.As the main material of the multi-layer coextrusion bag for infusion is the polypropylene polymer materials,it may cause the certain adsorption effect on the main components of the packaged medicament or the antioxidants dissolution.The main component,auxiliary material and other materials in medicament might be adsorbed into the gap of the polymer materials,resulting the reduction of main component in medicament.Thus,the studies on the adsorption effect of the multi-layer coextrusion bag for infusion on different medicaments are also significant.As the study referring the compatibility of acanthopanax senticosus injection and multi-layer coextrusion for infusion is deficient in recent years,the objective of the paper is studying the adsorption effect of the multi-layer coextrusion bag for infusion on the acanthopanax senticosus injection,the migration of antioxidants in the acanthopanax senticosus injection and the extraction of antioxidants with acanthopanax senticosus injection and 0.9%sodium chloride injection,providing certain theoretical support for the application of multi-layer coextrusion bag for infusion on packing the acanthopanax senticosus injection.Firstly,it carries out the methodological verification which verifies the accuracy of the experimental method.It includes specificity experiment,stability experiment,precision experiment,detection limit and quantitative limit,linear relationship experiment and accuracy experiment.Secondly,it launches the extraction experiment which extracts antioxidants from the multi-layer coextrusion bag for infusion with the acanthopanax senticosus injection and 0.9%sodium chloride injection for confirming the types of antioxidants and measuring the actual value of each antioxidant.The conditions and environment for extraction experiment should be consistent with the sterilization environment.The time should be slightly longer than the time for sterilization.Thirdly,it implements the migration experiment which mainly reserches the migration of antioxidants in the acanthopanax senticosus and 0.9%sodium chloride injection packed with the multi-layer coextrusion bag for infusion under conventional conditions.The acanthopanax senticosus and 0.9%sodium chloride injection packed with the multi-layer coextrusion bag for infusion are put in the place with accelerated test conditions(25?±2?;Relative humidity 60%±10%)for six months and in the place with long-term test conditions(6?±2?,Relative humidity 60%±10%)for nine months.Furthermore,it evaluates the values of antioxidants in samples at different phases of the experiment according to the requirements.Fourthly,it carries out the adsorption experiment and stability study.The adsorption experiment mainly investigates whether the multi-layer coextrusion bag for infusion results in the adsorption effect on the main components of the acanthopanax senticosus injection,while the stability study mainly researches the stability of acanthopanax senticosus packed by the multi-layer coextrusion bag for infusion.The acanthopanax senticosus injection packed with the multi-layer coextrusion bag for infusion and the acanthopanax senticosus injection in an inert packing container are put in the place with accelerated test conditions(25?2?;Relative humidity 60%±10%)for six months and in the place with long-term test conditions(6?±2?,Relative humidity 60%±10%)for nine months.It will evaluate the relevant indexes at different phases of the experiment according to the requirements.The indexes include the volume of flavonoids,pH,properties,insoluble particles and visible particles.Experimental result:The multi-layer coextrusion bag for infusion contains four antioxidants(antioxidant 168,330,1010 and 1076).The values of antioxidants conform to relevant standards.The antioxidants will not migrate into the acanthopanax senticosus injection under sterilization and conventional conditions.The multi-layer coextrusion bag for infusion does not have obvious adsorption effect on the acanthopanax senticosus injection.The pH,properties,insoluble particles and visible particles in long term and accelerated experiments conform to relevant standards.Conclusion:The experiment can effectively prove the excellent compatibility between the multi-layer coextrusion bag for infusion and the acanthopanax senticosus injection.it is safe and reliable to pack the acanthopanax senticosus injection with the multi-layer coextrusion bag for infusion. |
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