重组C因子法检测细菌内毒素的方法适用性研究
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摘要
目的考察重组C因子法的品种适用性,以加快该方法的推广。方法选取有代表性的6个典型品种,每个品种3个批次,进行重组C因子法干扰试验,并经过国内4个实验室进行复核验证。以回收率为评价指标,以2015年版《中国药典》为评价标准,总结4个实验室应用该方法产生的问题和解决策略。结果 6个品种18个批次在验证实验室和3个复核实验室的回收率结果均在《中国药典》要求的50%～200%范围内,符合干扰试验要求;该方法应用中的常见问题和解决策略共有7项21条。结论重组C因子法在国内4个实验室对6个典型品种具有较好的品种适用性。
Objective To investigate the variety applicability of the recombinant factor C method, in order to accelerate its popularization.Methods 6 representative varieties with 3 batches of each variety were selected for interference test by recombinant factor C method,which was verified by 4 laboratories in China.With the recovery rate as the evaluation index,and Chinese Pharmacopoeia(2015 edition) as the evaluation standard,the problems and solutions generated by the application of the method were summarized in a total of 4 laboratories.Results The recovery results of 18 batches of 6 varieties in the verification laboratory and 3 review laboratories were within the range of 50%-200% required by Chinese Pharmacopoeia,and met the interference test requirements.The common problems and solutions in the application process were classified into 7 categories and 21 items.Conclusion The recombinant factor C method has good applicability to 6 typical varieties in 4 laboratories in China.
Objective To investigate the variety applicability of the recombinant factor C method, in order to accelerate its popularization.Methods 6 representative varieties with 3 batches of each variety were selected for interference test by recombinant factor C method,which was verified by 4 laboratories in China.With the recovery rate as the evaluation index,and Chinese Pharmacopoeia(2015 edition) as the evaluation standard,the problems and solutions generated by the application of the method were summarized in a total of 4 laboratories.Results The recovery results of 18 batches of 6 varieties in the verification laboratory and 3 review laboratories were within the range of 50%-200% required by Chinese Pharmacopoeia,and met the interference test requirements.The common problems and solutions in the application process were classified into 7 categories and 21 items.Conclusion The recombinant factor C method has good applicability to 6 typical varieties in 4 laboratories in China.
引文
[1]BOLDEN JS,SMITH KR.Application of recombinant Factor Creagent for the detection of bacterial endotoxins in pharmaceutical products[J].Pda J Pharm Sci Technol,2017,71(5):405-412.
[2]廖永岩,叶富良.中国鲎资源已告危急[J].中国水产,2000(10):12.
[3]陈秋明.厦门海域中国鲎资源的研究与保护[J].环境科学与管理,2009,34(6):9-11.
[4]祁静,刘涛,李珍,等.Bac-to-Bac/BmNPV杆状病毒在家蚕幼虫中表达重组鲎C因子[J].生物工程学报,2014,30(10):1594-1601.
[5]王影影,齐兴梅,刘涛,等.基于蛋白质反式剪接在大肠杆菌中表达鲎C因子CES多肽[J].基因组学与应用生物学,2013,32(6):707-712.
[6]张轶岭,祁静,张春,等.昆虫细胞表达鲎C因子内毒素活性检测的研究[J].生物技术,2017,27(5):478-483.
[7]王东宁,刘杰武,陈琳,等.东方鲎C因子的分段克隆及表达[J].生物化学与生物物理学报:英文版,2002,34(1):77-82.
[8]裴宇盛,蔡彤,高华.细菌内毒素检查新方法进展[J].药物分析杂志,2014,34(3):392-395.
[9]ABATE W,SATTAR AA,LIU J,et al.Evaluation of recombinant factor C assay for the detection of divergent lipopolysaccharide structural species and comparison with Limulus amebocyte lysate-based assays and a human monocyte activity assay[J].Journal of Medical Microbiology,2017,66(7):888-897.
[10]CAI T,PEI YS,ZHANG GL,et al.Establishment of the 8th National standard of Endotoxin[J].Journal of Chinese Pharmaceutical Sciences,2017,26(10):771-774.
[11]蔡彤,张媛,贺庆,等.体外人外周血单个核细胞热原检测法用于ACYW135群脑膜炎球菌多糖疫苗的方法学研究[J].科技导报,2017,35(17):88-91.
[12]裴宇盛,蔡彤,张国来,等.细菌内毒素检查法超标结果的处理方法[J].科技导报,2017,35(10):71-75.
[13]裴宇盛,蔡彤,张国来,等.紫杉醇脂质体中细菌内毒素的检测(英文)[J].中国药学:英文版,2018(6):436-441.
[14]PEI Y,CAI T,GAO H,et al.Comparison of result judgment algorithm of test for interfering factors in the bacterial endotoxins test among Chinese,Japanese,European,American,and Indian pharmacopeias[J].Chinese Medical Journal,2014,127(15):2784-2788.
[15]PEI Y,CAI T,GAO H,et al.Five simple models for interfering factors test of bacterial endotoxins test[J].Chinese Medical Journal,2014,127(18):3344-3346.
[16]许明哲,黄宝斌,杨青云,等.分析方法确认内容介绍[J].药物分析杂志,2015,35(1):183-189.
[2]廖永岩,叶富良.中国鲎资源已告危急[J].中国水产,2000(10):12.
[3]陈秋明.厦门海域中国鲎资源的研究与保护[J].环境科学与管理,2009,34(6):9-11.
[4]祁静,刘涛,李珍,等.Bac-to-Bac/BmNPV杆状病毒在家蚕幼虫中表达重组鲎C因子[J].生物工程学报,2014,30(10):1594-1601.
[5]王影影,齐兴梅,刘涛,等.基于蛋白质反式剪接在大肠杆菌中表达鲎C因子CES多肽[J].基因组学与应用生物学,2013,32(6):707-712.
[6]张轶岭,祁静,张春,等.昆虫细胞表达鲎C因子内毒素活性检测的研究[J].生物技术,2017,27(5):478-483.
[7]王东宁,刘杰武,陈琳,等.东方鲎C因子的分段克隆及表达[J].生物化学与生物物理学报:英文版,2002,34(1):77-82.
[8]裴宇盛,蔡彤,高华.细菌内毒素检查新方法进展[J].药物分析杂志,2014,34(3):392-395.
[9]ABATE W,SATTAR AA,LIU J,et al.Evaluation of recombinant factor C assay for the detection of divergent lipopolysaccharide structural species and comparison with Limulus amebocyte lysate-based assays and a human monocyte activity assay[J].Journal of Medical Microbiology,2017,66(7):888-897.
[10]CAI T,PEI YS,ZHANG GL,et al.Establishment of the 8th National standard of Endotoxin[J].Journal of Chinese Pharmaceutical Sciences,2017,26(10):771-774.
[11]蔡彤,张媛,贺庆,等.体外人外周血单个核细胞热原检测法用于ACYW135群脑膜炎球菌多糖疫苗的方法学研究[J].科技导报,2017,35(17):88-91.
[12]裴宇盛,蔡彤,张国来,等.细菌内毒素检查法超标结果的处理方法[J].科技导报,2017,35(10):71-75.
[13]裴宇盛,蔡彤,张国来,等.紫杉醇脂质体中细菌内毒素的检测(英文)[J].中国药学:英文版,2018(6):436-441.
[14]PEI Y,CAI T,GAO H,et al.Comparison of result judgment algorithm of test for interfering factors in the bacterial endotoxins test among Chinese,Japanese,European,American,and Indian pharmacopeias[J].Chinese Medical Journal,2014,127(15):2784-2788.
[15]PEI Y,CAI T,GAO H,et al.Five simple models for interfering factors test of bacterial endotoxins test[J].Chinese Medical Journal,2014,127(18):3344-3346.
[16]许明哲,黄宝斌,杨青云,等.分析方法确认内容介绍[J].药物分析杂志,2015,35(1):183-189.
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