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目的提高单位面积纳米膜过滤静注人免疫球蛋白的载量。方法采用正交实验设计方法,配制不同静注人免疫球蛋白浓度、pH值、电导率、保护剂浓度的制品进行纳滤膜过滤,记录6 h过滤总量,用spss 16.0分析结果。结果 4.0 mg/mL人免疫球蛋白;pH值6.0;电导率:5.3 ms/cm,保护剂浓度:20 mmol/L是所研究因素最佳组合,能使20 nm纳米膜的载量提高至11.6 kg/m2。结论通过优化制品组成条件可以提高静注人免疫球蛋白过滤载量,进而降低生产过程中纳滤膜过滤成本。
Objective To improve the per unit area of nano-membrane filtration of intravenous immunoglobulin load. Methods The products of different concentrations of human immunoglobulin, pH value, conductivity and protectant concentration were prepared by nanofiltration using orthogonal experimental design method. The total amount of filtration was recorded for 6 h and the results were analyzed by spss 16.0. Results 4.0 mg / mL human immunoglobulin; pH 6.0; conductivity 5.3 ms / cm; protective agent concentration 20 mmol / L was the best combination of the studied factors, which could increase the loading of 20 nm nanofilm to 11.6 kg / m2. Conclusion By optimizing the composition of the product conditions can increase the intravenous immunoglobulin filtration load, thus reducing the cost of nanofiltration membrane in the production process.