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建立一种冷深沉凝血因子的制备方法,确保产品质量符合预期要求。取筛选预备的保存期内的新鲜冰冻血浆,循环水浴,并将初始温度控制在15℃,定期观察水温,在30 min内水温达到4℃,然后维持4℃水温30 min,在4℃无菌条件下分离出沉淀在血浆中的冷不溶解物质并在1 h内冻结。以纤维蛋白原和Ⅷ因子含量为质控项目。结果36袋制品的纤维蛋白原和Ⅷ因子含量均符合国家要求并好于原方法,临床使用效果良好。此方法优于原传统方法,可推广应用。
To establish a method for the preparation of cold and deep coagulation factors to ensure product quality in line with expectations. Fresh frozen plasma and circulating water bath were prepared during the screening period, and the initial temperature was controlled at 15 ℃. The water temperature was observed regularly. The water temperature reached 4 ℃ within 30 min, then the water temperature was maintained at 4 ℃ for 30 min. Under conditions of separation of the precipitation of the plasma in the cold insoluble material and frozen within 1 h. Fibrinogen and Ⅷ factor content for quality control projects. Results The content of fibrinogen and factor Ⅷ in 36 bags of products all met the requirements of the state and was better than the original method, and the clinical effect was good. This method is superior to the original traditional method, which can be popularized and applied.