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viral safety
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  病毒安全性
     OBJECTIVE To enhance the viral safety of human immunoglobulin for intravenous injection(IVIG) products and discuss the feasibility of pasteurization of IVIG products.
     目的为了提高静脉注射人免疫球蛋白(IVIG)制品的病毒安全性,探索其巴氏灭活的可行性。
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     and safety.
     安全性指标。
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     safety.
     ·安全方面。
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     Objective:To observe the efficacy and safety of glutathione in the treatment of viral hepatitis.
     目的:观察还原性谷胱甘肽(GSH)对病毒性肝炎的疗效。
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     Viral vector shows high transfection efficiency and low safety.
     shRNA病毒表达载体的转染效率高,但安全性低。
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     Athletes and Viral Myocarditis
     运动员与病毒性心肌炎
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  viral safety
Principles of Viral Safety of Blood Products (A Review)
      
Recombinate: viral safety and final product manufacturing testing and specifications
      
Viral safety and inhibitor development associated with monoclonal antibody-purified F VIII C
      
Objective: Intravenous immunoglobulin (IVIG) preparations are derived from human pooled plasma and should fulfil high standards of purity and viral safety.
      
Second, significant efforts have been made to enhance the viral safety of IGIVs.
      
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Factor Ⅷ is an essential cofactor for normal hemostatic function.It is evident that FⅧ concentrate increases promptly the activity of FⅧ in vivo and arrestes bleeding for persons with hemophilia A (FⅧ deficiency).In the mid 80′s,new generations of plasma derived FⅧ concentrate with high purity and viral safety were developed.This review will focus on the methods of virus inactivation and the current status of FⅧ preparations from plasma or by recombinant DNA technique.

凝血因子ⅤⅢ制剂是治疗血友病甲的最主要血液制品。80年代中期发展了新一代血浆凝血因子ⅤⅢ浓制剂及基因重组凝血因子ⅤⅢ技术,不仅提高了凝血因子ⅤⅢ制剂的纯度,减少了副作用,而且降低了病毒感染的危险性。本文介绍凝血因子ⅤⅢ制剂的生产及病毒灭活工艺。

Objective To establish the method of nucleic acid testing(NAT) for transfusion-transmitted viruses of blood donors, to study the feasibility/efficacy of NAT and to estimate the current residual risk of transfusion transmitted HIV and HCV in BeijingMethods The sensitivity, reproducibility and robustness of a domestic fluorescence PCR kits for HCV RNA and HIV-1 RNA(PJ Biotech Co, Shenzhen, China) were assayed using the WHO international standards 34 373 plasma samples from seronegtive donors (with normal level...

Objective To establish the method of nucleic acid testing(NAT) for transfusion-transmitted viruses of blood donors, to study the feasibility/efficacy of NAT and to estimate the current residual risk of transfusion transmitted HIV and HCV in BeijingMethods The sensitivity, reproducibility and robustness of a domestic fluorescence PCR kits for HCV RNA and HIV-1 RNA(PJ Biotech Co, Shenzhen, China) were assayed using the WHO international standards 34 373 plasma samples from seronegtive donors (with normal level of ALT, and negative results in HBsAg, anti-HCV, anti-HIV, and Syphilis screening, collected during Feb-Oct2002) were tested for HCV and HIV-1 NAT Pools of 24 donor samples were used for NAT testing Viruses were concentrated by centrifugation and the viral RNA extraction was done using the High Pure Viral Nucleic Acid Kit (Roche, Mannheim, Germany)ResultsThe amplification system can 100% detect 50 IU/ml (n=16) HCV RNA and 50 IU/ml (n=16) HIV-1 RNA No positive HCV RNA or HIV RNA was detected in 34 373 sero-negative donorsConclusions The limited data indicate that the viral safety of blood for transfusion in Beijing is good, although the relative small sample size may not have allowed to detect the window period donors

目的 建立献血者血液混合核酸检测方法 ,调查北京现有检测体系下血液的残余风险度 ,评估核酸检测 (NAT)的必要性和可行性。方法 用世界卫生组织标准品对国产丙型肝炎病毒(HCV)和人免疫缺陷病毒 (HIV)荧光 聚合酶链反应核酸扩增检测试剂进行灵敏度、重复性和精密度试验 ;对 2 0 0 2年 2~ 10月 34373份常规血清学检测 (ALT、HBsAg、抗 HCV、抗 HIV、梅毒抗体 )合格的献血者血样进行HCVRNA和HIV 1RNA核酸扩增分析。采取 2 4人份混合血样测定 ,超离心浓缩病毒 ,Roche核酸提取柱提取病毒核酸。结果 扩增系统能 10 0 %检出 5 0IU/mlHCV及 5 0IU/mlHIV 1标准品核酸 (n =16 ) ;常规血清学检测合格的献血者血液中 ,没有检出HCV或HIVNAT阳性。结论 该核酸检测体系适用于献血者血液病毒筛查 ;北京市血液的病毒安全性已有相当高的保障。为更准确地评估NAT检测项目的可行性和必要性 ,检测标本量尚待增加。

OBJECTIVE To enhance the viral safety of human immunoglobulin for intravenous injection(IVIG) products and discuss the feasibility of pasteurization of IVIG products. METHODS We performanced a series of experiments with different protein concentrations,pH values and conductivity, and analyzed the effects on the characterizations of IVIG.RESULTS The best condition for pasteurization of IVIG was found.CONCLUSION This condition may make the effection of the characterizations of IVIG minimum.

目的为了提高静脉注射人免疫球蛋白(IVIG)制品的病毒安全性,探索其巴氏灭活的可行性。方法在不加保护剂的条件下,调整不同的蛋白浓度、pH、电导,对IVIG液体样品进行巴氏灭活,并作各种理化性质分析。结果以制品分子大小分布为主要指标,优选出蛋白浓度1.0%~1.5%、pH3.8~4.2、电导值低于0.3ms的巴氏灭活条件。结论所用条件可在不加保护剂的情况下进行巴氏灭活时,加热对静脉注射人免疫球蛋白制品性质影响最小。

 
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