洗涤血小板制备及相关质量功能指标的研究

Study on Preparation of Washed Platelets and Related Quality Function Indexes

目的:研究制备满足临床需求的高质量洗涤血小板血液成分。方法:以去白细胞混合浓缩血小板和单采去白细胞血小板为起始血液,通过无菌接驳的方式,采取离心、分离和洗涤,用生理盐水100 mL完成1~2次的静态洗涤,并用200 mL生理盐水对沉淀物进行悬浮、静置、解聚等,并最终制备成洗涤血小板。结果:经质量检测,两种起始血液制备的洗涤血小板在容量、血小板计数、白细胞残留量、红细胞混入量、血浆蛋白质含量、pH值质量指标上均符合国家相关标准要求,在血小板聚集、血小板黏附、血小板氧分压、血小板二氧化碳分压辅助指标的表现上,二者大体一致。结论:在现有标准、技术等框架下,血站行业制备的洗涤血小板质量可靠,可向临床提供洗涤血小板,在适宜条件下可应用于临床治疗。

Objective:To investigate and prepare high-quality blood components for washed platelets that meet the clinical needs.Methods:Leukocyte-reduced pooled platelet concentrates and leukocyte-reduced apheresis platelets were used as initial blood,through sterile connection ways,they were centrifuged,separated and washed,followed by 1~2 static washing with 100 mL of physiological saline,and then the sediments were suspended with 200 mL physiological saline,placed,depolymerized and eventually prepared into washed platelets.Results:Through quality detection,the washed platelets prepared with two kinds of initial blood conformed to the requirements of the relevant national standards in terms of the volume,platelet count,leukocyte residue,red blood cell count,plasma protein content and pH value quality indicators,they showed equivalent performance in the platelet aggregation,platelet adhesion,O2 partial pressure,CO2 partial pressure auxiliary indicators.Conclusion:Under the current standard,technology and other frames,the quality of washed platelets prepared in blood station industry is reliable and can be provided for clinical practice and used in clinical treatment under suitable conditions.