冷沉淀凝血因子制备工艺的改进

Improvement on Method in Making the Cryoprecipitated Antihemophilic Factor

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 of making the cryoprecipitated antihemophilic factor,the fresh frozen plasma was defrosted in circulating water bath at the inital temperature 15℃ followed by adjusting tempera-ture to 4℃ in 30min,and then the temperature of 4℃ maintained for 30min.The cold insoluble substances precipitated in the plasma were separated out under 4℃sterile conditions,which were frozen in 1h immediately.The contents of fibrinogen and Ⅷ factor were taken as the projects of quality control.All quality-indexes of 36 bags of product were superior to those of the original methods,which conformed to the national demands,and also acquired a good clinical use.The method was better than the traditional methods,and can be adopted in practical application.