不同保护剂对人凝血因子Ⅸ制品干热灭活的活性影响  

Effect of different stabilizers on the dry-heating inactivation of human coagulation factor Ⅸ

作　　者：杨虎虎 刘志远 吴菲菲 刘兆路 菅长永 

机构地区：[1]山东泰邦生物制品有限公司研发中心,泰安271000

出　　处：《国际生物制品学杂志》2016年第2期63-65,共3页International Journal of Biologicals

摘　　要：目的筛选用于人凝血因子Ⅸ（human coagulation factorⅨ，FⅨ）干热灭活的保护剂。方法分别将质量分数为1．0％、1．5％和3．0％的甘氨酸、盐酸精氨酸、甘露醇和蔗糖溶液作为保护剂加入同一批次FⅨ半成品，对含不同保护剂的FⅨ半成品进行冻干和于热灭活（100℃处理30min），测定干热灭活前后FⅨ冻干制品的活性。结果干热灭活后，以1．5％盐酸精氨酸作为保护剂的FⅨ冻干制品的活性最高，平均55．5±1．2IU／ml，回收率达100．2％；甘氨酸对FⅨ具有一定的保护作用，含甘氨酸保护剂的FⅨ冻干制品与不含保护剂的FⅨ冻干制品间的活性差异有统计学意义（t=0．442，P=0．002）；含甘露醇（t=0．030，P=0．325）或蔗糖（t=-1．120，P=0．532）保护剂的FⅨ冻干制品与不含保护剂的FⅨ冻干制品间的活性差异均无统计学意义。结论1．5％盐酸精氨酸是FⅨ冻干制品干热灭活的理想保护剂。Objective To select a stabilizer for dry-heating inactivation of human coagulation factor Ⅸ （FⅨ）. Methods 1.0%, 1.5M and 3.0% glycine, arginine hydrochloride, mannitol and sucrose solutions were added respectively as stabilizers into the same batch of FIX intermediate. FⅨ intermediates with different stabilizers were freeze-dried and dry-heating inactivated（100℃, 30 min）. The activity of FⅨ freeze-dryirig product was measured before and after dry-heating inactivation. Results After dry- heating inactivation, the activity of FIX freeze-drying product with 1. 5% arginine hydrochloride as stabilizer was the highest, average 55. 5 ＋ 1.2 IU/ml, and the recovery of FⅨ freeze-drying product reached 100. 2%. Glycine had protection for FⅨ freeze-drying product, and the difference between the activities of F℃ freeze-drying product with glycine as stabilizer and without stabilizer was statistically significant （t=0. 442, P= 0. 002）. The activity difference between FIX freeze-drying product with mannitol or sucrose as stabilizer and without stabilizer was not statistically significant （t = 0. 030, P=0.325 for mannitol, and t =- 1. 120, P= 0. 532 for sucrose）. Conclusion 1. 5% arginine hydrochloride is lan ideal stabilizer for dry-heating inactivation of FⅨ freeze-drying product.

关 键 词：因子Ⅸ 病毒灭活 辅药 盐酸精氨酸 

分 类 号：TQ464[化学工程—制药化工]