海藻酸盐医疗器械相关标准及质量控制要点

Standards and quality control points of alginate-based medical devices

目的分析国内外海藻酸盐医疗器械的标准制订情况,讨论此类产品质量控制中需关注的重点问题。方法结合海藻酸盐在医疗器械领域的应用情况,对国内外相关标准进行调研,综合分析与海藻酸盐相关的技术指标与质量控制要点。结果海藻酸盐医用材料和医疗器械产品飞速发展,国内外相关产品标准已针对基本技术指标和检测方法进行了详细阐述。除药典外,我国已发布1项用于组织工程医疗产品的海藻酸钠标准,3项海藻酸盐相关产品标准。结论由于海藻酸盐的特殊理化性质,研究者还需要重点关注灭菌方式、产品有效期、海藻酸盐的分子量和α-L-古罗糖醛酸/β-D-甘露糖醛酸值、杂质限量。

Objective To analyze standards of alginate-based medical devices at home and abroad, and to emphasize key issues of quality control that should be concerned about. Methods Based on investigation of alginate application in medical devices and alginate-related medical standards, alginate-related technical indicators and quality control points were comprehensively analyzed. Results With the rapid development of alginate-based medical materials and medical devices, the relevant standards at home and abroad have been elaborated on the basic technical indicators and detection methods. In addition to Chinese Pharmacopoeia, China has issued one alginate standard for tissue engineering and three alginate related product standards. Conclusion Considering the special physical and chemical properties of alginate, researchers also need to focus on the sterilization method, expiry date, molecular weight, and ratio of α-Lguluronic acid to β-D-mannuronic acid of alginate, and impurity content.