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目的分析DV50纳米过滤去除静注人免疫球蛋白(Human immunoglobulin for intravenous injection,IVIG)病毒时流速的影响因素。方法分别采用浊度仪、密度仪检测IVIG原液的浊度及浓度,随机选取5批浓度相近、浊度不同的IVIG原液及5批浊度相近、浓度不同的IVIG原液,分别经同一批号纳米滤芯过滤,计算平均流速;随机选取5批浊度、浓度相近的IVIG原液,经不同批号的纳米滤芯过滤,计算平均流速。结果随着制品浊度的升高,平均流速逐渐降低;制品浓度与平均流速不呈线性对应关系;不同批号的纳米滤芯,纳米平均流速相差较大。结论制品浊度对流速具有一定的影响,浓度对流速基本无影响,纳米滤芯对流速的影响最大。本实验为实际生产中控制纳米过滤去除病毒时的流速及改进生产工艺提供了参考。
Objective To analyze the influencing factors on the flow velocity of human immunoglobulin for intravenous injection (IVIG) virus removal by DV50 nanofiltration. Methods The turbidity and concentration of IVIG stock solution were measured by turbidimeter and density instrument respectively. Five groups of IVIG stock solution with similar concentration and different turbidity and 5 groups of IVIG stock solution with similar turbidity and different concentration were randomly selected. Filtration, calculate the average flow rate; randomly selected 5 sets of turbidity, concentration of similar IVIG stock solution, filtered through different batches of nano-filter to calculate the average flow rate. Results As the turbidity of the product increased, the average flow rate decreased gradually. The concentration of the product did not show a linear relationship with the average flow rate. The average flow velocities of nanofillers with different batch numbers varied greatly. Conclusion The turbidity of the product has a certain influence on the flow rate, the concentration has no effect on the flow rate, and the influence of the nano-filter on the flow rate is the greatest. This experiment for the actual production of nano-filtration control virus flow rate and improve the production process provides a reference.