目的:建立适用于重组人纽表位肽12体外质量控制的生物学活性测定方法，用于该制品的生物学活性评价。方法: 采用小鼠，比较不同品系、给药浓度、给药周期等条件下应用ELISA方法检测出的小鼠相应抗体水平，确定最佳实验条件，以建立相应的体外活性测定方法。结果: FVB/N转neu基因小鼠 (TgN MMTVneu 202 Mul，Jackson Lab.，USA)对重组人纽表位肽12的反应存在量——效关系，并确定了最佳测定条件和给药剂量，用抗体阳转百分率作为评价指标，样品测定重复性较好,CV%值为6.7%(n=4)，结果可靠。结论: 已建立的FVB/N转neu基因小鼠测定重组人纽表位肽12生物学活性的方法可用于重组人纽表位肽12生物学活性的常规评价。

Objective:To establish a sensitive and effective bioassay method for in vitro evaluation of biological activity of recombinant human neu epitope peptide 12. Methods:Mice were used in the test. By comparing results of antibody for an ELISA in different species of mouse, including dosage and production intervals of immunization and parameters, an in vitro bioassay protocol was formulated. Results:According to dose-response curve of recombinant human neu epitope peptide 12 on FVB transgenic mice(TgN MMTVneu 202 Mul，Jackson Lab.，USA), the optimal reaction time and dosage were determined. The results were accurate, and objective, and had good reproducibility, CV% is 6.7% (n=4); the percentage of positive mice were used for biological activity evaluation of recombinant human neu epitope peptide 12. Conclusion:The established method of using FVB transgenic mice to test the recombinant human neu epitope peptide 12 bioactivity can be used in routine control of the biological activity evaluation of recombinant human neu epitope peptide 12.

国家高技术发展计划项目（863计划）资助（合同编号： 2001AA215071）