药械组合产品属性界定中壳聚糖分子量与抗菌机制的关系探讨

On Relationship between Molecular Weight of Chitosan and the Antibacterial Mechanism in Jurisdictional Designation of Drug-device Combination Products

目的:针对以壳聚糖的抗菌作用为工作机制的药械组合产品,探讨其属性界定中壳聚糖分子量与抗菌机制的关系,为科学监管决策提供技术支撑。方法:通过查阅国内外文献,以分子量为研究对象,进一步区分此类产品属性界定中抗菌作用的不同机制,并提出初步建议。结果与结论:当壳聚糖的黏均分子量在100kDa及以上时,此类产品中壳聚糖通过物理阻隔作用实现抗菌目的,可认为医疗器械作用;当黏均分子量在10kDa以下时,壳聚糖通过干扰细胞新陈代谢活动实现抗菌目的,可认为药理作用;对于黏均分子量在10kDa至100kDa之间的壳聚糖抗菌作用的相关机制需在今后试验中作进一步研究。

Objective: To analyze the relationship between molecular weight of chitosan and its antimicrobial mechanism in the process of jurisdictional designation for drug-device combination products that contain chitosan and perform antibacterial function with it, so as to provide technical support for scientific regulatory supervision. Methods: By consulting relevant literature home and abroad, molecular weight was chosen as the research object to distinguish different antibacterial mechanisms in the process of jurisdictional designation, and preliminary suggestions were put forward. Results and Conclusion: When viscosity-average molecular weight of chitosan was at 100 kDa or beyond, its antibacterial function could be realized through physical barrier, which could be considered as the role of medical devices. When viscosity-average molecular weight was below 10 kDa, its antibacterial function could be realized by interfering in the metabolic activities of cells, which could be considered as the role of pharmacological effect. When viscosity-average molecular weight is between 10 kDa and 100 kDa, the mechanism of the antibacterial action of chitosan needs to be studied further in future experiments.