目的 考察香丹注射液制剂过程中超滤工艺对原儿茶醛、丹参素钠的透过率和除杂率的影响，评价香丹注射液制备过程中超滤工艺的适用性并进行膜超滤过程优化设计。方法 采用正交试验方法，以药液温度、pH值、超滤膜截留相对分子质量和膜进出口压差作为影响因素，通过检测超滤前后药液中原儿茶醛、丹参素钠的量和药液固含量，优选超滤过程的工艺参数。结果 药液温度、pH值和进出口压差3个因素对原儿茶醛、丹参素钠综合透过率和除杂率无显著影响，而超滤膜截留相对分子质量因素对其有显著的影响（P＜0.01）。结论 优选的超滤工艺适用性好。

Objective To explore the effect of ultrafiltration technology in the preparation of Xiangdan Injection on transmittance and impurity removal rates of protocatechuic aldehyde (PA) and sodium danshensu (SD), to evaluate its applicability, and to optimize the ultrafiltration technology. Methods Taking the solution temperature, pH value, intercept relative molecular weight of ultrafiltration membrane, membrane import and export pressure difference of ultrafiltration membrane as influence factors, the process parameters of the ultrafiltration were optimized by detecting the contents and solid contents of PA and SD before and after the ultrafiltration. Results The three factors of temperature, pH value, and import and export pressure difference have no significant influence on the transmittance of PA and SD, and the removal rate of impurity. The intercept relative molecular weight of ultrafiltration membrane has the significant influence (P < 0.01). Conclusion The optimized ultrafiltration conditions are feasible for the preparation of Xiangdan Injection.

国家“重大新药创制”——现代中药创新集群与数字制药技术平台（2013ZX09402203）