葡聚糖磁性复合微粒的辐照灭菌研究

Study on the radiation sterilization of dextran composite magnetic nanoparticles

为满足葡聚糖磁性复合微粒临床无菌应用要求,采用60Coγ射线对该微粒进行辐照灭菌处理,考察吸收剂量为9 kGy、15 kGy和25 kGy时对其物理化学性质的影响,并对灭菌微粒进行无菌检查及方法验证。结果表明:该磁性复合微粒在3种吸收剂量下均表现出良好的稳定性,其物理化学性质均未出现明显变化;经辐照灭菌的微粒达到10-1的无菌保证水平,已建立的无菌检查方法可靠。

Dextran composite magnetic nanoparticles （DCMn） were expected to be a magnetically-targeted carrier for clinical anticancer drug delivery. The feasibility of sterilization of the DCMn using 60Co γ-rays irradiation was investigated with different absorbed doses of 9 kGy, 15 kGy, and 25 kGy. A sterility test for the particles and the validation of test was performed. The DCMn showed excellent stability with the investigated irradiation dosage range. The test results showed that irradiation did not influence the physicochemical properties of DCMn, and the radiated DCMn reached the 101 sterilization level and the sterility test was stable and reliable.