鼠神经生长因子病毒灭活效果的验证  

Verification of effectiveness of virus inactivation in mouse nerve growth factor

作　　者：扈会平[1] 赵淑媛[1] 唐正均 李云富[2] 曾娟梅 孙玉龙[1] 刘兵[1] 黄剑波[1] 

机构地区：[1]丽珠集团丽珠制药厂,广东珠海519000 [2]丽珠集团疫苗工程股份有限公司,广东珠海519000

出　　处：《中国生物制品学杂志》2014年第5期709-711,715,共4页Chinese Journal of Biologicals

摘　　要：目的对鼠神经生长因子（mouse nerve growth factor,mNGF）病毒灭活工艺进行验证。方法以伪狂犬病毒（pseudorabies virus,PRV）和Sindbis病毒为指示病毒,考察辛酸钠法对mNGF原液中病毒的灭活效果,并比较灭活后与未灭活原液的mNGF活性、纯度、等电点及其-20℃贮存0、3、6个月的稳定性。结果 mNGF原液经0.3%辛酸钠、pH（5.0±0.2）、（25±1）℃灭活90 min,PRV和Sindbis病毒滴度均下降6 lgCCID50/ml以上,灭活60、90 min样品盲传3代后,均未检测出病毒。灭活后与未灭活原液的mNGF活性无差异,比活性均在5.0×10^5 AU/mg以上,蛋白纯度均为100%,等电聚焦主区带均在8.65～9.30之间;-20℃贮存0、3、6个月,蛋白纯度均为100%,比活性均无明显差异,且6个月内比活性均未明显降低。结论辛酸钠法可安全、快速、高效地灭活mNGF原液中的指示病毒及其所代表的相关病毒,保证了产品的质量及其工艺的稳定性,保障了临床用药的安全性。Objective To verify the procedure for virus inactivation in mouse nerve growth factor（mNGF）. Methods The effectiveness of sodium octanoate in inactivation of viruses in bulk of mNGF was investigated using pseudorabies virus（PRV） and Sindbis virus as indicators. The mNGF activities,purities and isoelectric points of mNGF before and after inactivation,as well as the stabilities after storage at-20 ℃ for 0,3 and 6 months,were compared. Results After the bulk of mNGF was inactivated with 0. 3% sodium octanoate at pH（5. 0 ± 0. 2）and a temperature of（25 ± 1）℃ for 90 min,both the titers of PRV and Sindbis virus decreased by more than 6 lgCCID50/ ml. However,no virus was detected in the samples inactivated for 60 and 90 min after three blind passages. The mNGF activities of bulks before and after inactivation showed no significant difference,while both the specific activities were more than 5. 0 × 10^5 AU / mg,the protein purities were 100%,the isoelectric points of major bands were 8. 65 ～ 9. 30. After storage at-20 ℃ for 0,3 and 6 months,both the purities of bulks before and after inactivation were 100%,while the specific activities showed no significant difference or decrease. Conclusion Sodium octanoate method was safe,rapid and highly effective in inactivation of indicator viruses and the relevant viruses in bulk of mNGF,which ensured the stability of product quality and procedure as well as the safety of drug in clinic.

关 键 词：神经生长因子 辛酸钠 病毒灭活 

分 类 号：R392-33[医药卫生—免疫学]