同种异体产品中可沥滤物分析方法研究

      Study on Analytical Method of Leachable Substances of Allogeneic Products

      • 摘要: 同种异体组织由于其来源较自体组织广泛,能够减少患者二次创伤,兼具良好的生物相容性,因此由同种异体组织制成的产品常用于临床修复治疗。在同种异体产品生产过程中引入的多种有机试剂等物质会随着临床使用过程沥滤下来进入人体,从而给患者带来不同程度的危害。因此对该类产品中可沥滤物的检测和控制非常必要。该研究在分类汇总同种异体产品中存在的可沥滤物基础上,依次从浸提液制备、已知和未知可沥滤物检测方法建立等角度进行综述,以期为同种异体产品可沥滤物研究提供研究思路。

         

        Abstract: Products made from allogeneic tissue are largely used in clinical treatment due to its wide source compared with autologous tissue, causing less secondary trauma of patients and the good biocompatibility. Various organic solvents and other substances introduced in the production process of allogeneic products will leach down into the human through clinical treatment, thus bringing varying degrees of harm to patients. Therefore, it is very necessary to detect and control the leachables in such products. Based on the classification and summary of leachable substances existing in the allogeneic products, the preparation of extract and the establishment of the detection techniques for known and unknown leachable are briefly introduced in this study, in order to provide research method for the study of leachable substances of allogeneic products.

         

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