目的 考察不同截留相对分子质量聚砜材质中空纤维超滤膜及板式超滤膜对热毒宁注射液脱炭液的超滤效果。方法 以超滤前后绿原酸转移率、栀子苷转移率、指纹图谱相似度、细菌内毒素、蛋白质、草酸盐、树脂的去除情况为考察指标，优化热毒宁注射液脱炭液的纯化工艺。结果 聚砜材质截留相对分子质量10 000的中空纤维膜对热毒宁注射液脱炭液中草酸盐及树脂有明显去除效果，聚砜材质截留相对分子质量5 000的板式膜能够100%去除药液中的细菌内毒素。结论 采用2级超滤膜联用技术能够保障热毒宁注射液的制剂稳定性及临床使用安全性。

Objective To investigate the ultrafiltration effect of polysulfone hollow fiber ultrafiltration membrane and polysulfone plate ultrafiltration membrane with relative molecular weight by different cut-off on the decarburization fluid of Reduning Injection. Methods The transfer rates of chlorogenic acid and geniposide, fingerprint similarity, and removal of bacterial endotoxin, protein, oxalate, and resin before and after ultrafiltration were used as inspect indicators to optimize the purification technology for the decarburization fluid of Reduning Injection. Results The obvious effect of polysulfone hollow fiber ultrafiltration membrane with the relative molecular weight 10 000 on oxalate and resin in the decarburization fluid of Reduning Injection was observed. Bacterial endotoxin (100%) in the decarburization fluid of Reduning Injection was removed by the polysulfone plate ultrafiltration membrane with the relative molecular weight 5 000. Conclusion The stability and the preparation safety of Reduning Injection could be ensured by the two stage combination of the ultrafiltration membrane technology.

科技部“973计划”新药研制过程化学机理（中药制药过程控制技术模式和方式研究，2010CB735604）