低温乙醇工艺各组分血浆蛋白含量检测分析

Determination and analysis of plasma protein content of each component in low-temperature-ethanol process

目的分析低温乙醇工艺分离血浆蛋白过程中各组分特定蛋白的含量,评价现有工艺能力,为后续工艺改良和产品质量提升提供支持。方法生产过程中,对每一步血浆蛋白分离产生的组分沉淀和上清进行取样,检测各种血浆蛋白含量,分析不同血浆蛋白在分离制作过程中的动态变化。结果在现有工艺条件下,人血白蛋白收率较高,各步骤损失较少;IgG在FⅢ制作过程中有超过20%的损失;IgA和可能导致IgG裂解的纤溶酶原均主要在FⅢ制作过程中被去除;FⅠ、FⅣ和FⅢ制作工序可实现不同血浆蛋白的选择性分离。结论现有低温乙醇工艺可以实现人血白蛋白的高收率生产,而人免疫球蛋白类制品收率在FⅢ制作过程损失较大,但FⅢ制作过程可有效去除IgA和纤溶酶原。

Objective To analyze the content of specific proteins of each component in the process of plasma protein separation by the low-temperature-ethanol technique,so as to evaluate the availability of current technique and provide supports for subsequent technique optimization and product quality improvement.Methods During the production process,the precipitation and supernatant producedin plasma protein separation were sampled,the content of each plasma protein was determined,and the dynamic changes of each plasma protein during the process of separation and preparation were analyzed.Results Under the current process conditions,the yield of human albumin was relatively high with low loss in each step,while IgG loss was more than 20%during the FⅢproduction.Moreover,IgA and plasminogen that could cause IgG lysis were mainly removed during the production of FⅢ.The production processes of FⅠ,FⅣand FⅢcould realize the selective separation of different plasma proteins.Conclusion The current low-temperature-ethanol technique could achieve high yield production of human albumin,while the yield of human immunoglobulin products underwent great loss,The IgA and plasminogen can be effectively removed in the production process of FⅢ.