鼠疫噬菌体国家参考品的研制
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摘要
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。
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 bacterial purity test. Reference on the phage was evaluated by four professional laboratories to test three batches of plague vaccine. Finally,the stability of reference was tested by measuring titer of phage. Results National reference on the phage for Yersinia pestis 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 for quality control of plague vaccine.
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 bacterial purity test. Reference on the phage was evaluated by four professional laboratories to test three batches of plague vaccine. Finally,the stability of reference was tested by measuring titer of phage. Results National reference on the phage for Yersinia pestis 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 for quality control of plague vaccine.
引文
[1]国家药典委员会.中华人民共和国药典(三部)[S].北京:中国医药科技出版社,2010,71-73.
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[4]黄至澄,王世文,李恪梅,等.不动杆菌属噬菌体分离及其裂解谱分析[J].中华医院感染学杂志,2009,19(3):268-270.
[5]苏胜兵,马红霞,徐凤宇.噬菌体在细菌性疾病诊断和治疗中的应用[J].中国兽医科学,2011,41(05):546-550.
[6]万学勤,唐冬生,刘爱平,等.幽门螺杆菌毒性噬菌体分离纯化及模拟治疗研究[J].南方医科大学学报,2011,31(2):304-307.
[7]Schofield DA,Westwater C.Phage-mediated bioluminescent detection of Bacillus anthracis[J].J Appl Microbiol,2009,107(5):1468-1478.
[8]魏东,李恪梅,王国治.应用噬菌体进行炭疽疫苗纯菌检查方法的建立[J].国际检验医学杂志,2012,33(13):1537-1538.
[9]邹艳波,迟秀娟,赵斌.鼠疫噬菌体试纸方法的研究[J].中国地方病防治杂志,2008,23(5):331-332.
[2]中国生物制品标准化委员会.中国生物制品规程[S].北京:化学工业出社,2000,533-534.
[3]吴俐健,张含玉,王笑歌,等.噬菌体生物扩增法检测结核性液体标本的临床应用价值[J].山西医药杂志,2011,40(4):336-338.
[4]黄至澄,王世文,李恪梅,等.不动杆菌属噬菌体分离及其裂解谱分析[J].中华医院感染学杂志,2009,19(3):268-270.
[5]苏胜兵,马红霞,徐凤宇.噬菌体在细菌性疾病诊断和治疗中的应用[J].中国兽医科学,2011,41(05):546-550.
[6]万学勤,唐冬生,刘爱平,等.幽门螺杆菌毒性噬菌体分离纯化及模拟治疗研究[J].南方医科大学学报,2011,31(2):304-307.
[7]Schofield DA,Westwater C.Phage-mediated bioluminescent detection of Bacillus anthracis[J].J Appl Microbiol,2009,107(5):1468-1478.
[8]魏东,李恪梅,王国治.应用噬菌体进行炭疽疫苗纯菌检查方法的建立[J].国际检验医学杂志,2012,33(13):1537-1538.
[9]邹艳波,迟秀娟,赵斌.鼠疫噬菌体试纸方法的研究[J].中国地方病防治杂志,2008,23(5):331-332.