摘 要：目的 以注射用芪红脉通为研究对象，确定制剂工艺超滤前最佳除杂技术。方法 考察冷藏、离心、活性炭吸附组 合工艺对药液中杂质及有关物质的去除情况。以黄芪总皂苷、黄芪甲苷、羟基红花黄色素A（HSYA）的质量浓度、固含物 减少率、蛋白质质量浓度、有关物质检查结果等为评价指标，确定除杂方法的可行性并优化工艺参数。结果 最佳工艺参数 为冷藏24 h，离心时间15 min、转速5 000 r/min，活性炭用量0.3%、温度40 ℃、吸附时间30 min、原药液pH 值。结论 冷 藏、离心和活性炭吸附组合工艺除杂效果显著，可有效去除树脂、蛋白质等杂质。

Abstract: Objective To determine the best impurity removal technology before ultrafiltration, taking Qihongmaitong injection as the research object. Methods To investigated the removal of impurities and related substances by the combined process of refrigeration, centrifugation, and activated carbon adsorption. Adopting the content of effectual ingredients, solids reduction efficiency, protein content and related substances inspection as the evaluation index to determine the feasibility of the method and optimize the process parameters. Results The experiment showed that the best process parameters were: refrigerated 24 h, centrifugated 15 min, speed 5 000 r/min, activated carbon dosage 0.3%, temperature 40 ℃, adsorpted time of 30 min, the original solution pH value. Conclusion The impurity effect of refrigeration, centrifugation and activated carbon adsorption is significant, which can effectively remove the resin, protein. and other impurity.

基金项目：科技部重大新药创制项目“中药治疗心脑血管疾病有效成分组（群）的创新药物孵化基地”（2011ZX09401-097）