摘要
目的研制炭疽鉴别试验及炭疽活疫苗纯菌检查用炭疽噬菌体国家参考品。方法制备炭疽噬菌体参考品,建立噬菌体参考品效价质量标准,组织4个实验室对该参考品进行协作验证,并对参考品稳定性进行分析。结果研制的炭疽噬菌体国家参考品,其效价质量标准应不低于1.0×108PFU/ml;经协作验证,该参考品可有效鉴别3批炭疽活疫苗;该参考品在4℃条件下稳定性较好,37℃稳定性较差。结论研制的炭疽噬菌体国家参考品已被国家有关部门正式批准,可用于炭疽鉴别试验及炭疽活疫苗纯菌检查。
Objective To prepare the national reference for phage of Bacillus anthracis, which is used for identity test and bacterial purity test on live anthrax vaccine. Methods The reference for phage of B. anthracis was prepared, of which the quality standard for titer was established. The reference was cooperatively verified by four laboratories, of which the stability was analyzed. Results The quality standard for titer of prepared national reference was not less than 1. 0×108 PFU/ml. Cooperative verification showed that three batches of live anthrax vaccine were identified effectively with the reference. The reference was stable at 4℃ while less stable at 37℃. Conclusion The established national reference for phage of B. anthracis has been approved by state departments concerned and may be used for identity test and bacterial purity test on live anthrax vaccine.
出处
《中国生物制品学杂志》
CAS
CSCD
2013年第9期1325-1327,共3页
Chinese Journal of Biologicals
基金
国家药典会2010版药典标准提高课题(1026)
