DV50纳米过滤去除静注人免疫球蛋白中的病毒时流速的影响因素

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。

Influencing factors of velocity during removal of virus in human immunoglobulin for intravenous injection by DV50 nanofiltration

Objective To analyze the influencing factors of velocity during removal of virus in human immunoglobulin for intravenous injection(IVIG)by DV50 nanofiltration.Methods The turbidity and concentration of bulk of IVIG were determined by turbidimeter and densimeter respectively.Five batches of bulks with similar concentrations and different turbidities,as well as five batches of bulks with similar turbidities and different concentrations,were subjected to nanofiltration by using the filter elements of the same batch,and the mean velocity was calculated.Another five batches of bulks with similar turbidities and concentrations were subjected to nanofiltration by using the filter elements of different batches,and the mean velocity was calculated.Results The mean velocity decreased with the increasing turbidity of bulk,while showed no linear relationship to the concentration.The mean velocity of nanofil-tration by using various filter elements showed significant difference.Conclusion The turbidity of product showed a certain influ-ence,while the concentration showed no significant difference,on velocity.However,the filter element showed significant influence on velocity.The study provided a reference to controlling the velocity during removal of virus by nanofiltration and improving the pro-duction procedure of IVIG.