对用于包被冠状动脉支架的抗CD34单克隆抗体的生物学指标的质量控制研究

目的: 对鼠源抗CD34单克隆抗体的结合活性以及包被在冠状动脉支架上的抗体量和牢固度等技术指标进行评价。 方法: 采用流式细胞术测定抗CD34单克隆抗体结合KG-1a细胞的活性;酶联免疫显色方法测定支架上抗体包被量;体外模拟冲刷方法测定支架上抗体牢固度;采用显微镜计数方法测定包被抗CD34抗体支架体外捕获CD34(+)细胞的能力。 结果: 在抗CD34 McAb浓度为1 μg·mL^-1时,细胞平均阳性率为96.34%;支架上抗体含量为50.97 ng·cm^-2,而且体外模拟冲刷后支架上抗体含量无显著变化;包被抗CD34单抗的冠状动脉支架捕获细胞数为4万个·cm^-2。 结论: 该方法可用于体外检测抗CD34单克隆抗体包被冠状动脉支架的生物学参数。

Objective: To evaluate the biological parameters of anti-CD34 monoclonal antibody(McAb) used for coating coronary stents. Methods: KG-1a cell binding activity of anti-CD34 McAb was evaluated with flow cytometric methods;Coated quantity of McAb on coronary stents was measured with ELISA;The binding firmness of McAb was evaluated with wash simulation method;The CD34(+) KG-1a cell capture ability of anti-CD34 McAb coated on coronary stents was measured with microscope counting method. Results: When KG-1a cell was treated with 1 μg·mL^-1 anti-CD34 McAb,the FITC positive ratio of KG-1a cell was 96.34%;the content of McAb in coronary stent was 50.97 ng·cm^-2;the content of McAb in coronary stent did not change significantly when the wash simulation treatment was applied;the coronary stents coated with anti-CD34 McAb could capture 4×10⁴ KG-1a cells each square centimeter. Conclusion: The methods employed above can efficiently evaluate the biological parameters of anti-CD34 McAb used for coating coronary stent.