生物制品生产中助滤剂硅藻土的应用  

The Use of Filter Aid Diatomaceous Earth in the Production of Biological Products

作　　者：文光芬 胡国保 时凯 姜永平 WEN Guangfen;HU Guobao;SHI Kai;JIANG Yongping(Sinopharm Guizhou Biopharmaceuticals Co.,Ltd,Kaili 556011,China)

机构地区：[1]国药集团贵州生物制药有限公司,贵州凯里556011

出　　处：《山东化工》2025年第6期190-192,共3页Shandong Chemical Industry

摘　　要：硅藻土是一种硅质岩石,主要由古代硅藻的遗骸所组成。其化学成分以SiO_(2)为主,可用SiO_(2)·nH_(2)O表示。硅藻土因其高比表面积和多孔结构,能够有效吸附和过滤药品生产中的杂质。其具有良好的化学稳定性和热稳定性,能够在各种环境下保持稳定的过滤性能,在药品生产过程中广泛应用。本文对药品生产过程中使用硅藻土作为助滤剂的主要工艺因素进行研究梳理,进一步明确硅藻土在作为助滤剂的同时,在生物因子控制方面也发挥了重要作用。需要根据具体的产品和工艺特性,选择合适的硅藻土产品,必要时还需要对硅藻土辅料进行预处理或改性。Diatomaceous earth is a type of siliceous rock mainly composed of the remains of ancient diatoms.Its chemical composition is mainly SiO_(2),which can be represented by SiO_(2)·nH_(2)O.Diatomaceous earth,due to its high specific surface area and porous structure,can effectively adsorb and filter impurities in drug production.It has good chemical and thermal stability and can maintain stable filtration performance in various environments.Widely used in drug production and biopharmaceutical processes.This study summarizes the main process factors of using diatomaceous earth as a filter aid in biopharmaceutical processes,further clarifying that diatomaceous earth plays an important role in controlling biological factors while serving as a filter aid.To maintain,it is necessary to select suitable diatomaceous earth products based on specific product and process characteristics,and if necessary,pre-treatment or modification of diatomaceous earth excipients is also necessary.

关 键 词：硅藻土 生物制药 生物因子 助滤剂 

分 类 号：TU991.24[建筑科学—市政工程] X703[环境科学与工程—环境工程]