病毒灭活血浆中MB残留量检测Determination of residual methylene blue in plasma after virus inactivation
杨春晖,边国慧,阳红,梁启忠,周群刚,李长清
YANG Chun-hui,BIAN Guo-hui,YANG Hong,LIANG Qi-zhong,ZHOU Qun-gang,LI Chang-qing
摘要(Abstract):
目的检测病毒灭活处理血浆中亚甲蓝(methylene blue,MB)残留量。方法将4家采供血机构(A、B、C、D)提供的血浆样品经2个不同型号的一次性病毒灭活装置处理后,采用固相萃取方法分别提取病毒灭活血浆及标准品中MB,利用高效液相色谱法检测MB含量。结果 4家采供血机构病毒灭活血浆MB平均残留量分别为(0.29±0.11)、(0.26±0.09)、(0.09±0.03)和(0.10±0.02)μmol/L。两种不同型号滤器对MB的滤除率分别为91%和73%,差异有统计学意义(P<0.01)。结论目前我国病毒灭活血浆中MB残留量基本符合质量要求,但不同的采供血机构及不同滤器处理的血浆样品间MB残留量仍存在明显差异。
Objective To determine the residual methylene blue(MB)content in plasma after virus inactivation. Methods Plasma samples from four blood centers(A,B,C and D)were treated by disposable virus inactivation apparatuses of two types. The MB in plasma after virus inactivation and standard were extracted by solid phase extraction column,and determined by high performance liquid chromatography(HPLC). Results The residual methylene blue in plasma from four blood centers were(0. 29 ± 0. 11),(0. 26 ± 0. 09),(0. 09 ± 0. 03) and(10 + 0. 02) μmol / L respectively. The removal rates of MB by two types of filters were 91% and 73% respectively,which showed significant difference(P <0. 01). Conclusion The residual MB content in domestic plasma after virus inactivation basically met the requirements for quality control,which showed significant difference in those from various blood centers and those treated by various filters.
关键词(KeyWords):
血浆;病毒灭活;MB;残留量
Plasma;Virus inactivation;MB;Residual content
基金项目(Foundation): 卫生部行业专项(20092008)
作者(Author):
杨春晖,边国慧,阳红,梁启忠,周群刚,李长清
YANG Chun-hui,BIAN Guo-hui,YANG Hong,LIANG Qi-zhong,ZHOU Qun-gang,LI Chang-qing
DOI: 10.13200/j.cnki.cjb.000863
参考文献(References):
- [1]Prowse CV.Component pathogen inactivation:a critical review[J].Vox Sang,2013,104(3):183-199.
- [2]Mertes PM,Demoly P,Alperovitch A,et al.Methylene bluetreated plasma:an increased allergy risk[J].J Allergy Clin Immunol,2012,130(3):808-812.
- [3]The people's Republic of China National Quality Standard.Quality requirements for whole blood and blood components.GB18469-2012[S].Chinese Standard Press,2012.(in Chinese)中华人民共和国国家质量标准.全血及成分血质量要求.GB18469-2012[S].中国标准出版社,2012.
- [4]Sills MR,Zinkham WH.Methylene blue-induced Heinz body hemolytic anemia[J].Arch Pediatr Adolesc Med,1994,148(3):306-310.
- [5]Porat R,Gilbert S,Magilner D.Methylene blue-induced phototoxicity:an unrecognized complication[J].Pediatrics,1996,97(5):717-721.
- [6]Lozano M,Cid J,Muller TH.Plasma treated with methylene blue and light:clinical efficacy and safety profile[J].Transfus Med Rev,2013,27(4):235-240.
- [7]Riggert J,Humpe A,Legler TJ,et al.Filtration of methylene blue-photooxidized plasma:influence on coagulation and cellular contamination[J].Transfusion,2001,41(1):82-86.
- [8]Politis C,Kavallierou L,Hantziara S,et al.Haemovigilance data on the use of methylene blue virally inactivated fresh frozen plasma with the Theraflex MB-Plasma System in comparison to quarantine plasma:11 years'experience[J].Transfus Med,2014,24(5):316-320.
- [9]Council of Europe.Guide to the preparation,use and quality assurance of blood components,recommendation No.R(95)15(17th ed)[S].Strasbourg:EDQM,2013.
- [10]于建华,孙庶丽,王明静,等.病毒灭活血浆中有效成分及亚甲蓝残留量的研究[J].中国卫生检验杂志,2010,20(6):1541,1576.