冻干人纤维蛋白原质量提高的研究

Technology research on lyophilized human fibrinogen

目的通过调整生产工艺和工艺参数来提高产品的质量。方法健康人血浆化浆后采用离心方法去除冷沉淀,然后进行8%低温乙醇反应获得FI沉淀。FI沉淀进行抽提溶解,过滤后上清进行S/D病毒灭活(0.3%磷酸三丁酯和1%的吐温80);灭活后制品再进行2次8%乙醇反应以去除S/D试剂同时对制品进一步纯化,最终获得F1-2沉淀;对F1-2沉淀进行抽提溶解,过滤后超滤透析浓缩,再进行配制、除菌过滤,分装、冻干;冻干结束进行100℃30 min干热病毒灭活。结果最终的制品的纯度提高了15%左右,外观和可见异物合格,同时收率提高了30%左右。结论用改进工艺后的工艺制备的冻干人纤维蛋白原的质量和收率都得到了提高。

Objective To improve the quality of the products by adjusting the process and parameters. Methods Centrifuge was used to remove the cold precipitates from plasma, and then ethanol was added to 8% concentration at a low temperature. FI precipitates were obtained. Precipitated F1 was dissolved by extraction buffer. Filtration began S/D virus inactivation （0. 3% tributyl phosphate and 1% of tween 80）. Inactivated products removed S/D reagent by 8% ethanol reaction, and further purification products were obtained. In the end, precipitates F1-2 were obtained. Fibrinogen was extracted from F1-2 precipitates and filtrates. Later, the products underwent uhrafihration, enrichment, preparation, aseptic filtration, packing and freeze-dried method. After freeze-drying, the products began to inactivate virus with the dry-freeze method of 100 ℃ for 30 min. Results The purity of the products increased by 15%. The appearance and visible foreign matter were qualified. The yield also increased by 30%. Conclusion The quality and the yield of lyophilized human fibrinogen were improved using the improved process.