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[2-苯氧乙醇对沙宾灭活脊髓灰质炎疫苗效力及其安全性的影响]

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

作者信息

Bian Chuan-xiu, Jiang Shu-de, Yang Jian-yong, Sun Ming-bo, Xie Ming-xue, Zhang Xin-wen, Liao Guo-yang, Li Wei-dong

机构信息

Institute of Medical Biology, Chinese Academy of Medical Science, Kunming 650118, China.

出版信息

Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi. 2007 Mar;21(1):44-6.

PMID:17429533
Abstract

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 degrees C, 37 degrees C 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 according 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.

摘要

目的

研究2-苯氧乙醇对Sabin灭活脊髓灰质炎疫苗(IPV)效力的影响。

方法

将分别含5mg或7mg 2-苯氧乙醇的Sabin IPV样品分别置于4℃、37℃保存2天和7天。采用ELISA法检测D抗原含量。然后检测小鼠和豚鼠体内的中和抗体。按照中国生物制品要求的异常毒性试验进行安全性实验。

结果

添加2-苯氧乙醇后,Sabin IPV的I、II和III型D抗原含量未发生变化。实验组和对照组小鼠及豚鼠的抗体水平无差异。观察期内动物安全。

结论

2-苯氧乙醇对Sabin IPV的效力和安全性无影响。它可作为Sabin IPV的防腐剂。

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