生物加工过程Issue(5)：74-79,6.DOI:10.3969/j.issn.1672-3678.2014.05.013
人凝血因子Ⅷ制剂冻干工艺
Study on freeze-drying process of human coagulation factor Ⅷ
摘要
Abstract
The freeze-drying process of human coagulation factor Ⅷ ( FⅧ) was optimized�Eutectic point was determined and the key parameters of FⅧ vacuum freeze-drying process were studied by orthogonal experiment�The optimum freeze-drying process is as follows: pre freezing at -40 ℃ for 1�5 h, main drying temperature from -40 to -33℃, then to 0℃, total time 36 h, and vacuum pressure 30 Pa. The temperature of desorption was maintained at 35 ℃, vacuum pressure was 5 Pa, and the experiment finished when the final test pressure was not changed. The FⅧby this process met the requirement of the Chinese Pharmacopoeia.关键词
冻干/人凝血因子Ⅷ/正交试验Key words
freeze-drying/human coagulation factor Ⅷ/orthogonal experiment分类
医药卫生引用本文复制引用
张丽铃,何淑琴,梁小明,黄璠..人凝血因子Ⅷ制剂冻干工艺[J].生物加工过程,2014,(5):74-79,6.基金项目
江西省重点新产品计划 （）
