基于超滤技术的甘草酸二铵注射液工艺研究

Study of Preparing Diammonium Glycyrrhizinate Injection Based on Ultrafiltration

目的:研究超滤技术应用于甘草酸二铵注射液时的适用性以及细菌内毒素的去除。方法:以pH值、温度、浓度和超滤膜截留分子质量4因素进行正交试验,采用HPLC法和动态浊度法分别检测甘草酸二铵注射液超滤前后有效成分及细菌内毒素,分别计算透过率和去除率。结果:正交试验结果表明各因素对甘草酸二铵透过率无显著性影响,且超滤可以有效的去除细菌内毒素。结论:甘草酸二铵的超滤适用性好,超滤技术可以用于去除甘草酸二铵注射液中的细菌内毒素,为制备工艺的优选提供依据,提高制剂质量和用药安全性。

Objective ： To investigate the ultrafiltration technique for the applicability and the removal of bacterial endotoxins of diammonium glycyrrhizinate injection. Methods ： The pH value, temperature, concentration and membrane pore size were selected as 4 factors for orthogonal text. The content for effectual components and bacterial endotoxins were detected by HPLC and kenitic-turbidimetry respectively, and then calculated the transmittance and removal for each. Results ： 0rthogonal test showed that the 4 factors on the transmittance of diammonium glycyrrhizinate had not significant impact, ~/nd ultrafiltration can effectively remove bacterial endotoxins. ConcIusion： The applicability of ultrafihration of diammonium glycyrrhizinate iv good. Utrafiltration technique can be used to remove bacterial endotoxins in diammonium glycyrrhizinate injection, which could provide the basis for the optimum preparation and improve the quality and the safty of medication.