摘要
在热原不合格的白蛋白制品中，加入血浆蛋白Ｃｏｈｎ分部ＩＶ－１、ＩＶ－４组份进行热变性沉淀去除热原。经处理后，热原检测（兔法）表明，４批平均降温０．４７℃回收率为７２．５％，白蛋白５７％５０ｈ的热稳定性试验合格。其它常规检测项目均符合生物制品规程要求。
A hot denatured precipitation process was carried out by adding Cohn fraction IV-1 and IV-4 to pyrogenic albumin. The pyrogen level of the treated product was reduced 0.47℃ on average from 4 batches with 72.5% recovery,and the heat stability test under 57℃ during 50h was up to the standard, while the other items of routine determination were all met with the requirements specified for biological product standard.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
1996年第12期537-539,共3页
Chinese Journal of Pharmaceuticals
关键词
热原去除工艺
白蛋白
血浆蛋白
pyrogen, progenic albumin, Cohn fraction IV-1 and IV-4
