医用聚乳酸材料的化学等同性研究

Research on Chemical Equivalence Characteristics of Polylactic Acid in Medical Devices

摘要: 通过间接合成法合成聚乳酸，按标准GB/T 16886.18-2011选择符合聚乳酸化学表征的参数和方法，对国产和进口聚乳酸进行严谨全面的比较分析，证明国产和进口聚乳酸的化学等同性，证实国产聚乳酸的安全使用性，结合《医疗器械生物学评价和审查指南》为国产聚乳酸在植入级医疗器械应用上提供技术依据。

Abstract: Polylactic acid is synthesized indirectly by the polymerization method, according to the standard GB/T 16886.18-2011, the evaluation parameters and methods about chemical characterization of polylactic acid have been established. By using rigorous and comprehensive comparative analysis, the chemical equivalency of domestic and imported polylactic acid materials has been proved, along with the "Medical Device Biology Evaluation and Review Guide", paving the way of using domestic polylactic acid in implantable medical devices.