目的 建立鹿茸中胰岛素样生长因子-1（IGF-1）的超滤浓缩工艺。方法 以鹿茸冻干粉为原料，采用超滤技术对IGF-1的超滤浓缩工艺进行考察。以聚醚砜（PES）膜和改性PES膜进行对比研究，考察截留相对分子质量、压力、pH值等因素对鹿茸冻干粉超声提取液超滤浓缩过程的影响，并对超滤膜的清洗方法进行考察，得出适宜的工艺条件。结果 最优工艺条件为截留相对分子质量：PES膜4 000，改性PES膜5 000；压力为0.3 MPa，pH值为12。在此条件下，PES膜IGF-1回收率达到68.32%，蛋白质回收率达到69.20%；改性PES膜IGF-1回收率达到57.17%，蛋白质回收率达到87.43%。采用4种不同的方法对超滤膜进行清洗，结果表明，超滤膜在0.4% NaOH-0.1% NaClO溶液中浸泡24 h，PES膜膜通量恢复率达到98.65%，改性PES膜膜通量恢复率达到93.75%，膜通量接近完全恢复。结论 采用优化的超滤浓缩技术能够达到浓缩分离IGF-1的目的。该工艺操作简单、稳定，超滤膜易于清洗，回收率高，具有工业化生产应用价值。

Objective To establish the ultrafiltration process of concentrating insulin-like growth factor-1 (IGF-1) from Cervi Cornu Pantotrichum (CCP). Methods The ultrafiltration technique was utilized to concentrate the IGF-1 with CCP freeze-dried powder as raw material. The polyethersulfone (PES) membrane and modified PES membrane were compared and studied. The effects of relative molecular weight cutoff (RMWCO), pressure, and pH value on IGF-1 ultrafiltration process were investigated. Furthermore, the cleaning methods were investigated, and the optimal conditions were obtained. Results The optimal conditions were as follows: The RMWCO of PES membrane was 4 000, the RMWCO of modified PES membrane was 5 000, the pressure was 0.3 MPa, and the pH value was 12. The recovery rate of IGF-1 and protein reached 68.32% and 69.20%, respectively by the PES membrane, while the recovery rate of IGF-1 and protein reached 57.17% and 87.43% respectively by the modified PES membrane. Four different methods were employed to clean the membrane. The results showed that the membrane immersed in 0.4% NaOH-0.1% NaClO solution for 24 h was the appropriate cleaning method, by which the PES membrane permeation flux recovery rate could reach 98.65% and the modified PES membrane permeation flux recovery rate could reach 93.75%. Conclusion The IGF-1 could be easily concentrated and separated using the ultrafilter condensing technique. The process is easy and stable, and the membrane is easy to be cleaned and has high recovery rate, which has the high potential of industrial production and application.

国家“十一五”重大新药创制科技重大专项综合性新药研究开发技术大平台项目（2009ZX09301-008）