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过程工程学报 ›› 2016, Vol. 16 ›› Issue (4): 647-653.DOI: 10.12034/j.issn.1009-606X.215427

• 生化工程专栏 • 上一篇    下一篇

壳聚糖季铵盐微球作为注射疫苗佐剂的安全性评价

吴晶晶1,吴楠2,岳华2,吴兴兰3,中西秀树1,高晓冬1,马光辉2   

  1. 1. 江南大学生物工程学院
    2. 中国科学院过程工程研究所生化工程国家重点实验室
    3. 北京石油化工学院所生化工程国家重点实验室
  • 收稿日期:2015-12-28 修回日期:2016-03-28 出版日期:2016-08-20 发布日期:2016-10-10
  • 通讯作者: 吴晶晶 anyuejingyou@163.com

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

WU Jing-jing 1,WU Nan 2,YUE Hua 2,WU Xing-lan 3,NAKANISHI Hideki 1,GAO Xiao-dong 1,MA Guang-hui 4   

  1. 1. School of Biotechnology, Jiangnan University
    2. National Key Lab. Biochemical Engineering, Institute of Process Engineering, Chinese Academy of Science
    3. Beijing Institute of Petrochemical Technology
    4. State Key Lab. Biochem. Eng., Inst. Process Eng., Chinese Academy of Sciences
  • Received:2015-12-28 Revised:2016-03-28 Online:2016-08-20 Published:2016-10-10
  • Contact: WU Jing-jing anyuejingyou@163.com

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被引次数

3

摘要： 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.

关键词: 壳聚糖季铵盐, 微球, 疫苗佐剂, 安全性

Abstract: 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.

Key words: N-(2-hydroxy)propyl-3-trimethylammonium chitosan chloride, microspheres, vaccine adjuvant, security evaluation

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