【摘要】 采用ＤＥＡＥ－ＳｅｐｈａｄｅｘＡ５０和ＤＥＡＥ－ＳｅｐｈａｒｏｓｅＣＬ－６Ｂ凝胶从人血浆中吸附制备经Ｓ／Ｄ病毒灭活处理后的ＰＣＣ制品，ＤＥＡＥ洗脱液经Ｓ／Ｄ处理（０．３％磷酸三丁脂和１％Ｔｗｅｎ８０，６～８ｈ，２４℃）后，使所加入具有感染剂量（＞１０６）的标志病毒ＶＳＶ、Ｓｉｎｄｂｉｓ、ＨＩＶ均被有效灭活；ＰＣＣ制品中Ⅱ、Ⅶ、Ⅸ、Ⅹ因子的比活性（Ｕ／ｍｇ）分别为０．７９９±０．３４９、０．３４３±０．２５２、０．７４７±０．３４８、０．５８０±０．１９９（ｎ＝７），均比传统ＰＣＣ提高１．５～２．５倍（其中ＦⅨ∶Ｃ的比活性提高有显著性，ｔ＝３．１０５，Ｐ＜０．０１），同时也优于国内同类制品（ｔ＝２．３６０，Ｐ＜０．０５），对其杂蛋白（ＡＴ－Ⅲ、Ｆｎ、ＰＫＡ、Ｐｌｇ、ⅧＲ∶Ａｇ抗Ａ、抗Ｂ凝集素）的分析也反映出ＰＣＣ纯度有所提高。ＳＤＳ－ＰＡＧＥ、ＩＥ、ＣＩＥ电泳图谱及ＨＰＬＣ层析图谱证实上述结果，ＰＣＣ中ＴＮＢＰ残留量≤１０μｇ／ｍｌ，Ｔｗｅｅｎ８０残留量≤１００μｇ／ｍｌ，均在安全范围内。更多还原

【Abstract】 OF ORIGINAL ARTICLES Prothrombin Complex Concentrate Prepared by Modified GelAdsorption Method$$$$ Yu Rong,et al (Institute of Blood Transfusion,Chinese Academy of Medical Sciences & Peking Union Medical College) Abstract The prothrombin complex concentrate,viruses in which were inactivatedly treated by solvent/detergent,was adsorbatedly prepared from human plasma,using DEAE sephadex A50 and DEAE sepharose CL 6B gels.The DEAE eluate was incubated with SD mixture 0.3% tri (n buty 1)phosphate(TNBP) and 1% Tween 80 for 6～8h at 24℃,so the added indicant viruses in the eluate,such as VSV,Sindbis and HIV with infective dose>10 6,were effectively inactivated.The specific activity of factors Ⅱ,Ⅶ,Ⅸ,Ⅹ in the prothrombin complex concentrate products( n =7) was 0.799±0.349,0.346±0.252,0.747±0.348,0.580±0.199U/mg,respectively.Obviously,their specific activity was higher than that of traditional prothrombin complex concentrates by 1.5～2.5 times (among them,the specific activity of FⅨ∶C was improved significantly, t=3.105,P <0.01),and in the meantime,its quality was better than other prothrombin complex concentrate products prepared domestically ( t=2.360,P <0.05).Analysis of impure proteins such as AT Ⅲ,FN,PKA,Plg,anti A and anti B hemagglutinins showed that its purity was improved.The SDS PAGE,IE,CIE and HPLC also demonstrated the mentioned above results.The residual level of TNBP and Tween 80 in the prothrombin complex concentrate was <10 μg/ml and 100μg/ml,respectively,and fell within the safe range.更多还原