血管内皮生长因子抑制剂结合活性试验两种结果分析方法比较

Comparison of Two Methods for Analyzing the Results of Vascular Endothelial Growth Factor Inhibitors Binding Activity Assays

目的:对血管内皮生长因子抑制剂(VEGF Trap)结合活性试验两种结果分析方法进行比较,以考察两者的差异。方法:采用固定剂量的VEGF与系列稀释的VEGF Trap处理之后,检测未结合的VEGF的量,分别以未结合的VEGF量对VEGF Trap浓度梯度和未结合的VEGF检测板的OD值对VEGF Trap浓度梯度进行四参数方程拟合,两种方法计算该产品的结合活性。结果:两种方法均满足试验有效性条件,且血管内皮生长因子抑制剂供试品和标准品的半数抑制浓度(IC50)均分别为3.68和3.6pmoL·L-1,供试品的结合活性为102%。结论:证明了两种分析方法得到的结果完全一致。为同类产品结合活性计算方法的选择提供借鉴。

Objective: To compare the two methods for analyzing the results of vascular endothelial growth factor inhibitors binding activity assays. Methods: After a fixed amount of VEGF was applied to serially dilute VEGF Trap, the amount of unbound VEGF was detected. The two methods were used to calculate the binding activity of the products. One was the four-parameter equation fitting of the concentration gradient of VEGF Trap with the unbound VEGF amount, and the other was the four-parameter equation fitting of the concentration gradient of VEGF Trap with the OD value of the unbound VEGF detection plate. Results: Both methods met the test validity conditions, and the half inhibitory concentration(IC50) of the vascular endothelial growth factor inhibitors’ tested samples and the standard substance was 3.68 and 3.6 pmoL·L-1 respectively. The binding activity of the tested samples was 102%. Conclusion: The results obtained by the two methods are identical,which provide references for selecting methods for calculating the binding activity of similar products.