壳聚糖季铵盐微球作为注射疫苗佐剂的安全性评价

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.

Security Evaluation of N-(2-Hydroxy)propyl-3-trimethylammonium Chitosan Chloride Microspheres as Parenteral Vaccine Adjuvant

The safety evaluation of N-(2-hydroxy)propyl-3-trimethylammonium chitosan chloride (HTCC) microspheres as parenteral vaccine adjuvant was carried out in mice, rats, guinea pigs, rabbits. Mouse acute toxicity test showed that they have a high tolerance for over 50 times given clinical dose (5.0 mg/dose). Even high dosage of microspheres was injected in SD rats for many times, no pathological changes were found in their organ. The symptoms of mice in abnormal toxicity test were normal after injection. And the weight of mice increased significantly. In allergy test, no allergic reaction and symptoms were found in guinea pigs. And no fester and suppuration were found in muscle stimulation test. In the hemolysis results, red blood cell did not aggregate. All the tests proved good security of the HTCC microspheres.