原料血浆冷沉淀提取工艺过程质量控制

Quality Control in the Process of Cryoprecipitation Extraction

目的:对原料血浆冷沉淀提取工艺过程进行质量控制,保证血浆安全和冷沉淀质量合格。方法:采用双缩脲法检测血浆和冷沉淀蛋白含量。用DR45密度计检测冷沉淀提取前后血浆密度。采用薄膜过滤法检查冷沉淀提取前后血浆微生物限度。采用SDS-聚丙烯酰胺凝胶电泳法和电泳扫描法,分析血浆中白蛋白和Ig G百分含量。采用ACL7000全自动凝血分析仪检测凝血因子Ⅱ、Ⅶ、Ⅸ、Ⅹ和Ⅷ效价。检测分析冷沉淀的质量。结果:冷沉淀提取前后血浆蛋白、密度、微生物限度、凝血因子Ⅷ效价明显下降,但血浆中白蛋白、Ig G以及凝血因子Ⅱ、Ⅶ、Ⅸ和Ⅹ效价无明显变化。5批冷沉淀中FⅧ的收获率均值为61.8%,其质量符合制备人凝血因子Ⅷ的标准。结论:通过对冷沉淀提取工艺过程的质量控制,有效保证了血浆和冷沉淀的质量。

Objective： To ensure the quality of plasma and cold precipitation by quality control in the process of cryoprecipitation extraction. Methods： The contents of plasma protein before and after cryoprecipitation extraction were determined by using biuret. The plasma density before and after cryoprecipitation extraction were detected by using DR45 density meter. The plasma albumin and Ig G level before and after cryoprecipitation extraction were evaluated by using SDS- polyacrylamide gel electrophoresis and electrophoretic scanning method. The human coagulation factor Ⅱ, Ⅶ, Ⅸ, Ⅹ and Ⅷ titer before and after cryoprecipitation extraction were analyzed by using ACL7000 automatic blood coagulation analyzer. In addition, the quality of cryoprecipitation was also detected and analyzed. Results： Plasma protein, dentity, human coagulation factor Ⅷ titer and microbial limit decreased obviously after cryoprecipitation extraction. However, plasma albumin and Ig G level, human coagulation Ⅱ, Ⅶ, Ⅸ and Ⅹ titer exhibited no obvious change. The average recovery rate of F Ⅷ in the five batches of cryoprecipitation was 61.8%. The quality of cryoprecipitation was suitable for producing the human coagulation factor Ⅷ. Conclusion： The quality of cold plasma and precipitation was ensured by quality control inthe process of cryoprecipitation extraction.