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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。
Objective To inject QIHANGMAO TONG as the research object, and to determine the best preparation technology before ultrafiltration impurity removal technology. Methods To investigate the removal of impurities and related substances in liquid by refrigeration, centrifugation and activated carbon adsorption combined process. The quality of Astragalus total saponin, Astragaloside Ⅳ, hydroxysafflor yellow A, the reduction rate of solid content, the protein concentration, the test results of related substances were evaluated as indexes to determine the feasibility of the impurity removal method and to optimize the process parameters. Results The optimum process parameters were refrigerated for 24 h, centrifugation time 15 min, rotation speed 5000 r / min, amount of activated carbon 0.3%, temperature 40 ℃ and adsorption time 30 min. Conclusion The combination of cold storage, centrifugation and activated carbon adsorption is effective in removing impurities such as resin and protein.