二苯氧乙醇对Sabin株脊髓灰质炎灭活疫苗效力的影响及安全性研究  

Effect of 2-phenoxyethanol on potency of Sabin inactivated poliomyelitis vaccine and its safety

作　　者：卞传秀[1] 姜述德[1] 杨建勇[2] 孙明波[1] 谢明学[1] 张新文[1] 廖国阳[1] 李卫东[1] 

机构地区：[1]中国医学科学院医学生物学研究所,昆明 650118 [2]卫生部北京生物制品研究所

出　　处：《中华实验和临床病毒学杂志》2007年第1期44-46,共3页Chinese Journal of Experimental and Clinical Virology

基　　金：云南省科技厅新药专项基金（2000XY05）;2003年度云南省科技厅创新人才引培项目（2003PY07）

摘　　要：目的 检测二苯氧乙醇对3价减毒株脊髓灰质炎灭活疫苗（Sabin IPV）效力的影响及其毒性。方法 将每毫升（每剂量）含二苯氧乙醇5、7mg的Sabin IPV分别放在4℃、37℃2和7d，用ELISA方法检测病毒D抗原含量，并进一步测定小鼠和豚鼠的免疫反应。按《中国生物制品规程通则异常毒性试验规程》检测其毒性。结果 含两种浓度二苯氧乙醇的Sabin IPV于37℃保存2、7d，两种疫苗中的Ⅰ、Ⅱ、Ⅲ型D抗原含量、中和抗体的效价与不含二苯氧乙醇的对照组相比，无明显差异。观察期内，小鼠和豚鼠全部健存，没有异常反应。结论 二苯氧乙醇对Sabin IPV效力没有影响，安全性好，可以作为Sabin IPV的防腐剂。Objective To investigate the effect of 2-phenoxyethanol on potency of Sabin inactivated poliomyelitis vaccine （IPV）. Methods Sabin IPV samples containing 5 mg or 7 mg 2-phenoxyethanol each dosage respectively were placed separately at 4℃ ,37℃ for 2 days and 7 days. D-antigen contents were tested with ELISA method. Then neutralizing antibodies in mice and guinea pigs were detected. The safety experiment was performed acconting to unusual toxicity test of China requirement for biological product. Results After addition of 2- phenoxyethanol,the Ⅰ,Ⅱ ,and Ⅲ D-antigen contents of Sabin IPV did not change. The antibody levels in mice and guinea pigs were not different between experimental group and control group. Animals were safe during observation period. Conclusion 2-Phenoxyethanol had no effect on potency and safety of Sabin IPV. It can be used as antiseptic for Sabin IPV.

关 键 词：防腐剂 药物 脊髓灰质炎 疫苗 灭活 

分 类 号：R686[医药卫生—骨科学]