整形用注射填充物的临床前理化评价

      Preclinical Physicochemical Evaluation of Injectable Fillers for Plastic Surgery

      • 摘要: 整形用注射填充物在美容整形领域应用广泛,其安全性与有效性至关重要。为了保证产品的安全性、有效性,科学、严谨、充分、规范地开展临床前理化评价不可或缺。按照原材料进行划分,整形用注射填充物可分为透明质酸钠类、胶原蛋白类和聚酯类等,不同材料的评价项目和指标存在差异。临床前理化评价不仅包含通用理化项目评价,如有效成分含量、pH值、渗透压、重金属总量、微量元素等,同时还需针对不同材料的特殊性开展相应的评价项目,如透明质酸钠凝胶的交联度、胶原蛋白产品的胶原含量及聚酯类产品的共聚率等。文中不仅简要介绍了部分通用评价项目的试验方法,还针对部分尚未有成熟方法或现有方法有改进空间的评价项目进行了详细的介绍,旨在为整形用注射填充物的研发、质量控制提供参考,助力提升整形用注射填充物的安全性与有效性。

         

        Abstract: Injectable fillers for plastic surgery are widely used in the field of aesthetic plastic surgery, and their safety and effectiveness are of vital importance. To ensure the safety and effectiveness of the products, it is indispensable to conduct scientific, rigorous, comprehensive and standardized preclinical physicochemical evaluations. According to the raw materials, injectable fillers for plastic surgery can be classified into sodium hyaluronate type, collagen type and polyester type, etc. The evaluation items and indicators for different materials vary. Preclinical physicochemical evaluation not only includes general physicochemical project evaluation, such as the content of active ingredients, pH value, osmotic pressure, total heavy metal content, trace elements, etc., but also needs to carry out corresponding evaluation items according to the particularity of different materials, such as the crosslinking degree of sodium hyaluronate gel, the collagen content of collagen products and the copolymerization rate of polyester products. This article not only briefly introduces the test methods of some general evaluation items, but also provides detailed introductions to some evaluation items that have no mature methods or have room for improvement in existing methods, aiming to provide references for the research and development and quality control of injectable fillers for plastic surgery, and help improve the safety and effectiveness of injectable fillers for plastic surgery.

         

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