Yuan Huili, Liu Wenjing, Fu Yu, Wu Jiangjie, Chen Si, Wang Xu
College of Materials Science and Engineering, Zhejiang University of Technology, Hangzhou 310014, PR China.
Key Laboratory of Plastic Modification and Processing Technology, Zhejiang Province, Zhejiang University of Technology, Hangzhou 310014, PR China.
ACS Omega. 2024 Apr 9;9(16):18599-18607. doi: 10.1021/acsomega.4c01299. eCollection 2024 Apr 23.
Carboxymethyl chitosan (CMC)-based hydrogels have great potential for clinical applications, but a critical sterilization process must be addressed to bring them to market. Compared to ethylene oxide sterilization or heat sterilization, irradiation sterilization avoids alkylation and heat damage, while available studies on γ-irradiated other polysaccharides show that solution polysaccharides are susceptible to degradation or cross-linking. Aiming at the challenges brought by the γ-irradiation process of polysaccharide aqueous solution, this paper innovatively proposes the lyophilized CMC using electron beam (EB) irradiation, which not only avoids the generation of free radicals in the irradiated water leading to the degradation and cross-linking of polysaccharides but also retains the properties of CMC in terms of gel formation, stabilization, and clinical application. We used FTIR, TG, GPC, and microbial load tests to demonstrate that lyophilized CMC did not have significant changes in structure and molecular weight after EB irradiation, complied with the requirements for sterilization, and still had gel stability, thus proving that lyophilized CMC could be used for EB irradiation and met the requirements for clinical application. Therefore, this work is expected to further advance CMC injectable hydrogels toward clinical applications and provide a new direction for the sterilization processes of other polysaccharide hydrogels.
基于羧甲基壳聚糖（CMC）的水凝胶在临床应用中具有巨大潜力，但必须解决关键的灭菌过程才能将其推向市场。与环氧乙烷灭菌或热灭菌相比，辐照灭菌可避免烷基化和热损伤，而关于γ辐照其他多糖的现有研究表明，溶液多糖易发生降解或交联。针对多糖水溶液γ辐照过程带来的挑战，本文创新性地提出采用电子束（EB）辐照冻干的CMC，这不仅避免了辐照水中产生自由基导致多糖降解和交联，还在凝胶形成、稳定性和临床应用方面保留了CMC的特性。我们通过傅里叶变换红外光谱（FTIR）、热重分析（TG）、凝胶渗透色谱（GPC）和微生物负荷测试证明，冻干的CMC在EB辐照后结构和分子量没有显著变化，符合灭菌要求，并且仍具有凝胶稳定性，从而证明冻干的CMC可用于EB辐照并满足临床应用要求。因此，这项工作有望进一步推动CMC可注射水凝胶走向临床应用，并为其他多糖水凝胶的灭菌过程提供新方向。
