人凝血酶原复合物制备工艺中吸附用凝胶使用次数研究  

Cycle times of adsorption gel used in the preparation of human prothrombin complex

作　　者：张安山 韩祥东 尹云云 陈桂珍 雷晨瑶 刘晓 郭广兆 ZHANG Anshan;HAN Xiangdong;YIN Yunyun;CHEN Guizhen;LEI Chenyao;LIU Xiao;GUO Guangzhao(LanzhouLansheng Plasmaderived Biotherapies Co Ltd,Lanzhou 730046,China)

机构地区：[1]兰州兰生血液制品有限公司,甘肃兰州730046

出　　处：《中国输血杂志》2020年第11期1161-1163,共3页Chinese Journal of Blood Transfusion

摘　　要：目的研究DEAE Sephadex A-50凝胶使用次数。方法将同一批次DEAE Sephadex A-50凝胶连续使用5次,检测DEAE Sephadex A-50凝胶吸附前后血浆中凝血因子Ⅱ、Ⅶ、Ⅸ、Ⅹ效价、吸附前凝胶内毒素、pH和外观,进而评价凝胶质量。结果同一批次DEAE Sephadex A-50连续4次吸附人混合血浆,与第1次吸附结果进行比较,血浆中凝血因子Ⅱ、Ⅸ、Ⅹ3种因子吸附效率均为100%,凝血因子Ⅶ吸附效率(71±6)%(P>0.05);凝胶内毒素检测合格,pH在7.0±0.4范围内。随着吸附次数增加,凝胶颜色加深,由白灰偏白逐渐变为白灰偏灰。同一批次DEAE Sephadex A-50使用第5次时,凝血因子Ⅸ吸附效率为80%,吸附效率降低。结论同一批次DEAE Sephadex A-50凝胶连续使用4次,其吸附能力、凝胶内毒素和pH均符合要求,凝胶颜色逐渐加深。Objective To study the cycle times of DEAE Sephadex A-50 gel.Methods The same batch of DEAE Sephadex A-50 gel was used for 5 times in succession, and the quality of gel was evaluatedin terms of the titer of coagulation factor Ⅱ,Ⅶ, ⅨandⅩbefore and after the application of gel, as well asthe endotoxin, pH and appearance of it before application. Results The same batch of DEAE Sephadex A-50 adsorbed human plasma for 4 consecutive times, and then compared with the results after the first adsorption.The adsorption efficiency of coagulation factor Ⅱ, Ⅸ and Ⅹ in plasma were 100%, the adsorption efficiency of FⅦ was(71±6)%, and there was no significant difference in the adsorption results among each factor(P>0.05). The test results of gel endotoxin satisfied the quality criteria and the pH was within the range of 7.0±0.4.With the increase of adsorption times, the gel color deepened and gradually changed from white gray to gray. In the 5 th consecutive application, the adsorption efficiency of coagulation factor Ⅸ decreased to 80%.Conclusion The adsorption capacity, gel endotoxin and pH of the same batch of DEAE Sephadex A-50 gel used consecutively for 4 times all met the requirements,and the gel color gradually deepened.

关 键 词：DEAE Sephadex A-50 人凝血酶原复合物 使用次数 

分 类 号：R457.1[医药卫生—治疗学] TQ464[医药卫生—临床医学]