医用敷料类产品体表创面吸收评价

      Introduction to the Evaluation of In Vitro Transdermal Absorption Test for Medical Devices

      • 摘要: 体表创面吸收试验是评估医疗器械活性成分经皮肤吸收行为的关键方法,可提供医疗器械或其浸提物经体表吸收程度、速率及途径的信息,为评估医疗器械的安全有效性提供重要支持性证据。体表创面吸收试验适用于与创面直接接触的医用敷料类医疗器械,随着近年来我国重组胶原蛋白等新型敷料产品的迅速发展,体表创面吸收评价在医疗器械临床前评价中发挥着更加重要的作用。该文将系统探讨体表创面吸收技术在医用敷料类产品评价中的技术要点、监管标准与发展趋势,为相关产品的研发与评价提供参考。

         

        Abstract: In vitro transdermal absorption testing is a key method for evaluating the transdermal absorption behavior of active ingredients in medical devices. It can provide information on the degree, rate, and pathway of transdermal absorption of medical devices or their extracts, offering important supportive evidence for assessing the safety and effectiveness of medical devices. The in vitro transdermal absorption test is suitable for medical dressing devices that come into direct contact with wounds. With the rapid development of new dressing products such as recombinant collagen in China in recent years, the evaluation of surface wound absorption skin plays an important role in the preclinical evaluation of medical dressing products. This review will systematically explore the technical points, regulatory standards, and development trends of surface wound absorption technology in the evaluation of medical devices, providing a reference for the research, development, and evaluation of medical dressing products.

         

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