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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。
Purpose By improving the production process and process parameters to improve product quality. Methods The plasma of healthy human plasma was centrifuged to remove the cryoprecipitate and then subjected to 8% low temperature ethanol reaction to obtain FI precipitate. FI precipitates were extracted and dissolved, and the supernatant was filtered for S / D virus inactivation (0.3% tributyl phosphate and 1% Tween 80). After inactivation, the product was further subjected to 8% ethanol reactions twice to remove S / D reagent at the same time further purification of the product, and finally obtained F1-2 precipitation; F1-2 precipitate was extracted and dissolved, filtered and concentrated by ultrafiltration dialysis, and then formulated, sterile filtration, dispensing, lyophilization; 100 ℃ 30 min Dry heat virus inactivation. The final product purity increased by about 15%, the appearance and visible foreign body qualified, while the yield increased by about 30%. Conclusion The quality and yield of lyophilized human fibrinogen prepared by the improved process have been improved.