不同普通血浆制剂相关质量指标的对比分析  

Related quality indexes of different common plasma products:A comparative study

作　　者：兰静 平娜娜 张嫄[1] 彭鹏[1] 丁谨 张雅莉[1] 刘娜 徐华[1] LAN Jing;PING Nana;ZHANG Yuan;PENG Peng;Ding Jin;ZHANG Yali;LIU Na;XU Hua(Shaanxi Blood Center,Xi'an 710000,China)

机构地区：[1]陕西省血液中心,陕西西安71000022

出　　处：《中国输血杂志》2021年第10期1144-1146,共3页Chinese Journal of Blood Transfusion

基　　金：西安市卫生和计划委员会2021年科研项目(2021yb10)。

摘　　要：目的探讨不同来源的普通血浆制剂中血浆总蛋白(TP)含量、凝血因子Ⅷ(FⅧ)活性及纤维蛋白原(Fib)含量的差异,为普通血浆制剂相关质量标准的建立及细化提供依据。方法试验涉及的样品包括全血来源的冰冻血浆与去冷沉淀冰冻血浆以及去白细胞全血来源的冰冻血浆与去冷沉淀冰冻血浆;血浆总蛋白含量(TP含量)采用双缩脲法进行测定;FⅧ活性(FⅧ∶C)与Fib含量均采用凝固法进行测定。结果全血来源冰冻血浆、全血来源去冷沉淀冰冻血浆、去白细胞全血来源冰冻血浆与去白细胞全血来源去冷沉淀冰冻血浆的TP含量分别为(59.64±4.78)g/L、(58.09±4.18)g/L、(52.20±3.57)g/L与(51.89±1.50)g/L,FⅧ∶C分别为(109.63±43.38)%、(27.06±7.09)%、(71.83±21.64)%与(21.66±3.86)%,Fib含量分别为(2.19±0.39)g/L、(1.30±0.24)g/L、(2.04±0.37)g/L与(1.22±0.15)g/L。两两进行比较,除去白细胞全血来源冰冻血浆与去白细胞全血来源去冷沉淀冰冻血浆的TP含量无显著性差异外,其他普通血浆制剂的TP含量均存在明显差异(P<0.05);4种普通血浆制剂的FⅧ∶C存在明显差异(P<0.05);去冷沉淀冰冻血浆中的Fib含量均显著低于冰冻血浆中的Fib含量(P<0.05),其他普通血浆制剂的Fib含量则无明显差异。结论普通血浆制剂的TP含量、FⅧ∶C与起始血液及制备过程密切相关,建议据此进一步细化普通血浆制剂的质量标准;应考虑制定去冷沉淀冰冻血浆的有关质量标准以及临床适应症。Objective To explore the difference of total protein(TP)content,coagulation factor VIII(FⅧ)activity and Fib content in different common plasma products,and to further provide basis for the establishment and refinement of relevant quality standards of common plasma products.Methods Samples involved in the experiment included frozen plasma and cryoprecipitated frozen plasma derived from whole blood and eukocyte-depleted whole blood.The TP content determination was carried out by biuret method.The FⅧactivity(FⅧ:C)and Fib content were determined by coagulation method.Results The TP content(g/L)in frozen plasma and cryoprecipitated frozen plasma derived from whole blood and eukocyte-depleted whole blood were 59.64±4.78 vs 58.09±4.1 vs 52.20±3.57 vs 51.89±1.50,respectively,and the FⅧ:C(%)were 109.63±43.38 vs 27.06±7.09 vs 71.83±21.64 vs 21.66±3.86,,and the Fib content(g/L)were 2.19±0.39 vs 1.30±0.24 vs 2.04±0.37 vs1.22±0.15,respectively.There was a significant difference in TP content between other common plasma products(P<0.05)while similar between frozen plasma and cryoprecipitated frozen plasma derived from eukocyte-depleted whole blood(P>0.05).There was significant difference in FⅧ:C among four common plasma products(P<0.05).The Fib content of cryoprecipitated frozen plasma was significantly lower than that of frozen blood,and there was no significant difference in Fib content among other common plasma products(P>0.05).Conclusion The TP content and FⅧ:C of common plasma products are closely related to the initial blood and preparation process.It is suggested that the quality standard of common plasma products should be further refined,and the establishment of cryoprecipitated frozen plasma relevant quality standard and clinical indications should be considered.

关 键 词：普通血浆制剂 血浆总蛋白 凝血因子Ⅷ 纤维蛋白原 质量标准 

分 类 号：R457.14[医药卫生—治疗学]