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以小鼠、大鼠、豚鼠、家兔等为动物模型,对壳聚糖季铵盐微球作为注射疫苗佐剂进行安全性评价.结果表明,小鼠急性毒性实验中50倍临床拟给药剂量(5.0 mg/只)下动物耐受性良好;大鼠重复毒性实验中即使50倍高剂量多次注射微球,动物各组织器官仍无病理性变化;异常毒性实验中小鼠给药后体征正常、体重明显增加,壳聚糖微球注射豚鼠后未见过敏反应及症状;家兔注射部位未发生肌肉组织溃烂、化脓等,佐剂未引起红细胞溶血.
The safety evaluation of chitosan quaternary ammonium salt microspheres as vaccine adjuvant in mice, rats, guinea pigs and rabbits was carried out. The results showed that in mice acute toxicity experiment 50 times clinical drug administration The animals were well tolerated at the dose of 5.0 mg / animal. In the repeated toxicity test of rats, the tissues and organs of the animals were still not pathologically changed even though the microspheres were injected 50 times in a high dose. The signs of the mice in the abnormal toxicity test Normal, weight increased significantly, no allergic reactions and symptoms were observed in the chitosan microspheres injected into guinea pigs. Muscle tissue ulceration and suppuration were not found in the injection site of rabbits. The adjuvant did not cause erythrocyte hemolysis.