目的  分析在人凝血因子Ⅷ(human coagulation factor Ⅷ，FⅧ)层析纯化上样前增加澄清过滤对FⅧ层析效果的影响。方法  采用直接上样和澄清过滤后上样两种方式各10批次进行层析纯化，比较层析参数（流速、柱压、上样量）、洗脱液效价、洗脱液体积、洗脱液比活性、成品量及成品质量指标（效价、水分、可见异物、磷酸三丁酯残留量、聚山梨酯80残余量）。结果  经澄清过滤后上样洗脱液效价高于直接上样且差异有统计学意义（t=28.56，P=0.000），层析参数（流速、柱压、上样量）和洗脱液体积（t=0.51，P=0.310）、洗脱液比活性（t=0.56，P=0.296）差异均无统计学意义，成品产量高于直接上样且差异有统计学意义（t=23.14，P=0.000）。使用澄清过滤后，成品质量指标效价（t=0.95，P=0.183）和水分（t=1.12，P=0.145）差异无统计学意义、可见异物、磷酸三丁酯残留量、聚山梨酯80残余量符合质量标准。结论  在FⅧ层析生产过程中，增加一步澄清过滤能提高层析收率和成品收率，且对产品质量无影响。

Objective  To analyze the effect of adding clarification filtration during the preparation process of FⅧ on the chromatographic efficiency of FⅧ. Methods  Two methods, direct sample loading in 10 batches and sample loading after clarification filtration in10 batches, were used for chromatographic purification. The chromatographic parameters (flow rate, column pressure, sample amount), eluent titer, eluent volume, eluent specific activity，quantity of finished product and quality indicators (potency, moisture, appearance, visible foreign matter, tributyl phosphate residue and polysorbate 80 residue) were compared. Results  After clarification filtration, the eluent titer (t=28.56, P=0.000) was higher than that of direct sample loading, the chromatographic parameters (flow rate, column pressure, sample amount) and eluent volume (t=0.51, P=0.310)，eluent specific activity（t=0.56，P=0.296）were not significantly different, and the output of finished products (t=23.14, P=0.000) was higher than that of direct sample loading. After using clarification filtration, the titer (t=0.95, P=0.183) and moisture (t=1.12, P=0.145) were not significantly different, appearance,visible foreign matter, tributyl phosphate residue and polysorbate 80 residue were met the standard.. Conclusion During the process of chromatographic production for FⅧ, the adding of clarification filtration can promote the chromatographic efficiency and yield of finished product without affecting on the quality of the product.