CAJ | 학술논문

目的：对含纳米成分的医疗器械中纳米分散体系的建立方式及受试品的稳定性进行评估。方法：通过对纳米颗粒团聚形成原因和理化分散方法的比较，确定建立分散体系的要素，通过粒度观测等方法对分散体系的稳定性进行评估。结果：在进行含纳米成分医疗器械的检测时，应根据生产者的建议准备分散体系，建立分散体系的方法应被详细记录以保证其重现性。结论：受试品的稳定性对于获取具有代表性和可重复性的结果尤为重要，在分散方法评估过程中应根据每个受试品的个性，对具体案例进行具体分析和具体量化。
목적：대함납미성분적의료기계중납미분산체계적건립방식급수시품적은정성진행평고。방법：통과대납미과립단취형성원인화이화분산방법적비교，학정건립분산체계적요소，통과립도관측등방법대분산체계적은정성진행평고。결과：재진행함납미성분의료기계적검측시，응근거생산자적건의준비분산체계，건립분산체계적방법응피상세기록이보증기중현성。결론：수시품적은정성대우획취구유대표성화가중복성적결과우위중요，재분산방법평고과정중응근거매개수시품적개성，대구체안례진행구체분석화구체양화。
Objective:To evaluate the methods of nano-dispersion systems and the stability of samples in medical devices.Methods: By analyzing the cause of agglomeration and comparing kinds of methods to orient the elements of nano-dispersion Systems and the evaluation means. Results: To obtain the repetitive results, the foundation methods of nano-dispersion systems should be recorded in detail and all the following tests should be based on it.Conclusion: The constitution and evaluation of a dispersion system in obtaining representative and reproducible results in biological evaluation is very important and should be studied case by case.