鼠疫噬菌体国家参考品的研制

目的采用鼠疫噬菌体国家参考品研制鼠疫鉴别及鼠疫活疫苗纯菌检查。方法制备鼠疫噬菌体参考品，建立噬菌体效价质量标准，对参考品进行协作验证，并对参考品进行稳定性分析。结果研制的鼠疫噬菌体国家参考品，其效价质量标准应不低于10^-7，该参考品在-20℃条件下具有较好的稳定性，在37℃条件下稳定性较差。结论研制的鼠疫噬菌体国家参考品已被国家有关部门正式批准，可用于鼠疫鉴别诊断及鼠疫活疫苗纯菌检验。

Preparation of national reference on the phage for Yersinia pestis

Objective To establish national reference on phage for Yersinia pestis. Methods The reference used for identity test and bacterial purity test of plague vaccine were prepared. Quality standard of titer was established through identity test and bacte- rial purity test. Reference on the phage was evaluated by four professional laboratories to test three batches of plague vaccine. Fi- nally, the stability of reference was tested by measuring titer of phage. Results National reference on the phage for Yersinia pes- tis was established. Quality standard of titer was not less than 10-7. The titer of phage stored stably at minus 20 degrees Celsius, while was not stable at 37 degrees Celsius. Conclusion The established national reference material of phage for Yersinia pestis may be used ifor quality control of plague vaccine.