摘要
目的:探讨新型硅藻土用于血液制品组份分离过滤的适用性。方法:对比新型硅藻土与传统硅藻土的电镜扫描物理结构、金属离子含量、比表面积、离心湿密度等物理表征数据,并考察其在血浆蛋白分离阶段各组份过滤效果及最终产品的质量。结果:新型硅藻土与传统硅藻土比较,具有颗粒孔隙致密、金属离子含量低、比表面积大和离心湿密度小的特点;在血浆蛋白分离阶段的过滤过程中,按照传统硅藻土用量的70%左右使用新型硅藻土时,过滤时可得到理想的滤液浊度、较快的过滤速率、更小的过滤压力和均匀的滤饼分布;所得最终产品的质量符合《中国药典》及公司内控标准。结论:新型硅藻土可替代传统硅藻土用于血液制品的规模化生产,同时降低使用量。该应用研究对于降低血液制品的生产成本和提高产品质量具有一定的实际应用价值和参考意义。
Objective: To explore an applicability of a new-type diatomite filter aid in blood plasma components separation. Methods: By comparing physical representation data of traditional diatomite and new-type diatomite, such as SEM, metal ion content, specific sur- face area, and centrifugal wet density etc. Results: Compared with traditional diatomite, the new-type diatomite particles have more clear structure, lower metal ion content, larger specific surface area and less centrifugal wet density. In the filtration process of plasma compo- nents separation, the amount of new-type diatomite was about 70% of traditional diatomite can get ideal filtrate turbidity, faster filtering rate, smaller filtration pressure and the filter cake evenly distributed. The quality of final products conforms to the "Chinese Pharma- copoeia" and the company's internal control standard. Conclusion: The new-type diatomite can be used in blood plasma products scale manufacture in place of traditional diatomite and reduce its usage. So as to lower plasma production costs and improve product quality, and these applied studies have certain practical application value.
出处
《现代生物医学进展》
CAS
2015年第7期1209-1212,1248,共5页
Progress in Modern Biomedicine
关键词
血液制品
助滤剂
硅藻土
压滤法
血浆组分
Blood products
Filter Aid
Diatomite
Filter press
Plasma components
作者简介
杨宇(1976-),男,硕士研究生,工程师,主要研究方向:生物分离工程,电话:+8602885281307,E-mail:davisyangyu@126.com
通讯作者:孟延发,E-mail:yfmeng0902@SCU.edu.cn