重组人粒细胞刺激因子注射液比活性的对比分析

目的评估国产重组人粒细胞刺激因子(recombinant human granulocyte colony-stimulating factor,rhG-CSF)注射液比活性的总体水平。方法收集2009及2017年国家抽验性评价部分批次rhG-CSF样品的比活性数据,并与近5年进口注册检验部分批次rhG-CSF样品进行比较分析。结果 2009部分批次rhG-CSF样品比活性均值为0. 74×10^8IU/mg,标准差为0. 10×10^8IU/mg;2017部分批次rhG-CSF样品比活性均值为0. 83×10^8IU/mg,标准差为0. 15×10^8IU/mg;进口注册批次比活性数据的均值为0. 93×10^8IU/mg,标准差为0. 17×10^8IU/mg。结论国产rhG-CSF注射液质量不断提升,与进口制品间的差距在逐渐缩小,部分企业制品的质量已达到进口药品水平。

Comparative analysis of specific activity of recombinant human granulocyte colony-stimulating factor for injection

Objective To evaluate the general level of specific activity of domestic recombinant human granulocyte colony-stimulating factor(rhG-CSF) for injection. Methods The data on specific activity of partial batches of rhG-CSF were collected from the national check-ups in 2009 and 2017, and compared with those of partial batches in control tests for license of import in recent 5 years. Results The mean specific activity of partial batches of rhG-CSF in 2009 was0. 74 × 10^8 IU/mg, with a standard deviation(SD)of 0. 10 × 10^8 IU/mg, while that in 2017 was 0. 83 × 10^8 IU/mg,with a SD of 0. 15 × 10^8 IU/mg. However, the mean specific activity of partial batches for license of import was 0. 93 ×10^8 IU/mg, with a SD of 0. 17 × 10^8 IU/mg. Conclusion The quality of domestic rhG-CSF for injection was improved continuously, of which the gap to that of imported products was narrowed. The qualities of products from partial manufacturers have reached the level of imported products.