人血白蛋白质量评价与研究
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摘要
目的考察人血白蛋白的质量现状及存在问题。方法对33个生产企业153批次人血白蛋白,依据法定质量标准进行检验;同时开展了人细小病毒B19筛查、杂蛋白研究及铝离子含量影响因素等3个方面的探索性研究;对检验及探索性研究所得的结果进行统计分析,综合评价人血白蛋白的质量现状。结果 153批样品按法定标准检验,合格率为100. 0%。探索性研究显示,33个生产企业60批样品中B19 DNA残留阳性率为0; 27个生产企业28批样品中共鉴定出23种其他血浆蛋白;铝离子含量变化与玻璃瓶、枸橼酸浓度及存放均存在相关性。结论法定检验及探索性研究结果显示,本品的总体质量状况较好。但存放期间铝离子含量仍有明显增加,建议继续对铝离子增长影响因素进行研究。
OBJECTIVE To understand the quality status and problems of human albumin. METHODS A total of 153 batchs human albumin samples from 33 manufacturers were analyzed according to the legal quality standard. Three exploratory researches on human parvovirus B19 screening,protein impurity and influencing factors of alum inumion content were conducted. RESULTS The qualified rate of the 153 batches of samples was 100. 0%. The positive rate of B19 DNA in 60 batches from 33 manufacturers was zero.Twenty-three types of other plasma protein were identified in 28 batches of samples from 27 manufacturers. The increase in aluminum contents was related with glass bottle and citrate ion content. CONCLUSION The overall quality of human albumin is good. However,the content of aluminium ion increases significantly during storage. It is suggested to conduct further study on the influencing factors of aluminium ion content.
OBJECTIVE To understand the quality status and problems of human albumin. METHODS A total of 153 batchs human albumin samples from 33 manufacturers were analyzed according to the legal quality standard. Three exploratory researches on human parvovirus B19 screening,protein impurity and influencing factors of alum inumion content were conducted. RESULTS The qualified rate of the 153 batches of samples was 100. 0%. The positive rate of B19 DNA in 60 batches from 33 manufacturers was zero.Twenty-three types of other plasma protein were identified in 28 batches of samples from 27 manufacturers. The increase in aluminum contents was related with glass bottle and citrate ion content. CONCLUSION The overall quality of human albumin is good. However,the content of aluminium ion increases significantly during storage. It is suggested to conduct further study on the influencing factors of aluminium ion content.
引文
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[14]MENDITTO A,SARDELLI R,LANZIERI G,et al.Time-dependent increase of aluminium in human albumin solutions:the role of initial citrate content[J].Vox Sang,2001,80(2):121.
[15]WANG M L,XIAO L,ZHAO H,et al.Determination of citrate ion content and analysis of related factors of aluminum content in human albumin products[J].Chin Pharm J(中国药学杂志),2018,53(5):379-382.
[16]The 2017 Annual Report of Biological Products Lot Release(2017年生物制品批签发年报)[EB/OL].[2018-09-30].http://www.nicpbp.org.cn/CL0012/10838.html.
[2]KOBAYASHI K.Summary of recombinant human serum albumin development[J].Biologicals,2006,34(1):55-57.
[3]ZHANG D,CHEN B.Trend and preliminary analysis of the polymer in the human albumin production process[J].Chin J Blood Transfus(中国输血杂志),2016,29(9):909-912.
[4]PAN C Y,SHI D,MIAO M Y,et al.Active products of kinin system[J].Chem Life(生命的化学),2008,28(5):629-632.
[5]CHEN T W,HU M M.Preliminary study on reducing PKA in human albumin products[J].Chin Med Biotechnol(中国医药生物技术),2013,8(6):463-465.
[6]GALLINELLA G.Parvovirus B19 achievements and challenges[J].ISRN Virol,2013,http://dx.doi.org/10.5402/2013/898730.
[7]SCHMIDT I,BLMEL J,SEITZ H,et al.Parvovirus B19 DNAin plasma pools and plasma derivatives[J].Vox Sang,2001,81(4):228-235.
[8]PAVLIK I,HORVATHOVA A,BARTOSOVA L,et al.IS900RFLP types of Mycobacterium avium subsp.paratuberculosis in faeces and environmental samples on four dairy cattle farms[J].Veter Med,2010,55(1):1-9.
[9]DALY P,CORCORAN A,MAHON B P,et al.High-sensitivity PCR detection parvovirus B19 in plasma[J].J Clin Microbiol,2002,40(6):1958-1962.
[10]HOU J F,WANG M,MA Q P.Determination of human parvovirus B19 DNA in source plasma and blood products[J].Chin JBiol(中国生物制品学杂志),2012,25(8):1043-1044.
[11]ZENG F X,HE P D,LI Y J,et al.Investigation of the prevalence of human parvovirus B19 DNA in source plasma[J].Chin J Blood Transfusi(中国输血杂志),2015,28(2):162-165.
[12]ZENG F X,ZHANG Y,YU D,et al.Analysis of ability of cold ethanol fractionation process in removel of human parvovirus B19[J].Chin J Biol(中国生物制品学杂志),2016,29(11):1215-1217.
[13]WANG M L,XIAO L,LIANG W Y,et al.Information statistics and discussion the results of aluminumion content determination of retention samples of human albumin[J].Chin Pharm J(中国药学杂志),2018,53(2):145-153.
[14]MENDITTO A,SARDELLI R,LANZIERI G,et al.Time-dependent increase of aluminium in human albumin solutions:the role of initial citrate content[J].Vox Sang,2001,80(2):121.
[15]WANG M L,XIAO L,ZHAO H,et al.Determination of citrate ion content and analysis of related factors of aluminum content in human albumin products[J].Chin Pharm J(中国药学杂志),2018,53(5):379-382.
[16]The 2017 Annual Report of Biological Products Lot Release(2017年生物制品批签发年报)[EB/OL].[2018-09-30].http://www.nicpbp.org.cn/CL0012/10838.html.