炭疽噬菌体国家参考品的研制
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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 × 108PFU / 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.
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 × 108PFU / 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.
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,2010:74-76.
[2]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):1537-1538,1541.
[3]中国生物制品标准化委员会.中国生物制品规程[S].北京:化学工业出版社,2000:537-538.
[4]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.
[5]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.
[6]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(5):546-550.
[7]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.
[8]Schofield DA,Westwater C.Phage-mediated bioluminescentdetection of Bacillus anthracis[J].J Appl Microbiol,2009,107(5):1468-1478.
[9]Radnedge L,Agron PG,Hill KK,et al.Genome differences thatdistinguish Bacillus anthracis from Bacillus cereus and Bacillusthuringiensis[J].Appl Environ Microbiol,2003,69(5):2755-2764.
[2]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):1537-1538,1541.
[3]中国生物制品标准化委员会.中国生物制品规程[S].北京:化学工业出版社,2000:537-538.
[4]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.
[5]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.
[6]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(5):546-550.
[7]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.
[8]Schofield DA,Westwater C.Phage-mediated bioluminescentdetection of Bacillus anthracis[J].J Appl Microbiol,2009,107(5):1468-1478.
[9]Radnedge L,Agron PG,Hill KK,et al.Genome differences thatdistinguish Bacillus anthracis from Bacillus cereus and Bacillusthuringiensis[J].Appl Environ Microbiol,2003,69(5):2755-2764.