目的  筛选用于人凝血因子Ⅸ（human coagulation factor Ⅸ，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半成品进行冻干和干热灭活（100 ℃处理30 min），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±1.2 IU/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%, 1.5% 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. The activity of FⅨ freeze-drying 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 of the activity between FⅨ freeze-drying product with glycine as stabilizer and without stabilizer was statistically significant (t=0.442, P= 0.002). The activity 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=-1.12, P= 0.532 for sucrose). Conclusion  1.5% arginine hydrochloride is an ideal stabilizer for dry-heating inactivation of FⅨ freeze-drying product.