摘要
目的:考察冻干保护剂(甘氨酸)含量对人凝血因子Ⅷ产品质量及稳定性的影响.方法:将甘氨酸含量分别调整至2～20 g/L,参考相关标准对产品外观、效价、比活性等指标进行比较,筛选合适的冻干保护剂添加量;对按照优选处方生产的人凝血因子Ⅷ开展长期稳定性试验(2～8℃,3年),按照相关标准检测产品稳定性.结果:确定冻干人凝血因子Ⅷ的冻干保护剂(甘氨酸)含量为12 g/L,通过长期稳定性试验,3年后产品各项指标(外观、可见异物、真空度、水分含量、pH值、人凝血因子Ⅷ效价、比活性等)符合质量标准,产品稳定.结论:确定的冻干处方下,产品质量良好,且人凝血因子Ⅷ稳定性良好,可用于大批量生产.
Abstract
Objective:To investigate the effect of lyophilized protective agent(glycine)content of human coagulation factor Ⅷ on product quality and stability.Methods:The glycine content is adjusted to 2 to 20 g/L,and the appearance,potency,specific activity and other indexes of the products are compared with the relevant standards,and the appropriate lyophilized protective agent addition is screened.Long-term stability test(2 to 8℃,3 years)is carried out for human coagulation factor Ⅷ produced according to the preferred prescription,and the stability of the product is tested according to relevant standards.Results:The lyophilized protective agent(glycine)content of lyophilized human coagulation factor Ⅷ is determined to be 12 g/L,and after long-term stability test,the product met the quality standards after 3 years(appearance,visible foreign body,vacuum,moisture content,pH value,human coagulation factor Ⅷ potency,specific activity,etc.),and the product is stable.Conclusion:Under the confirmed lyophilized formulation,the product quality is good,and the stability of human coagulation factor Ⅷ is good,which can be used for mass production.
NETL
NSTL
维普
万方数据