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目的制备合适的甘草酸二铵磷脂复合物注射液,并考察其初步稳定性。方法以粒径、过氧化值、pH为指标,分别考察了不同种类溶媒和pH值对注射液稳定性的影响。通过影响因素实验的结果确定最佳处方,并对最适处方进行加速实验。结果以5%葡萄糖注射液为溶媒的处方在高温60℃和强度4 500 Lx光照下放置10 d理化性质没有发生明显变化,且初步加速实验也显示出良好的稳定性。结论甘草酸二铵磷脂复合物葡萄糖注射液质量稳定,粒径符合肝脏靶向性要求。
Objective To prepare an appropriate injection of diammonium glycyrrhizinate phospholipid complex and investigate its initial stability. Methods The effects of different kinds of solvents and pH on the stability of injection were investigated by particle size, peroxide value and pH. According to the results of the influencing factor experiment, the best prescription was determined and the optimal prescription was accelerated. Results The results showed that there was no obvious change in the physicochemical properties of the prescriptions with 5% dextrose injection for 10 days under the conditions of high temperature of 60 ℃ and intensity of 4 500 Lx, and the preliminary acceleration tests also showed good stability. Conclusion Glycyrrhizin phospholipid complex glucose injection has stable quality and particle size in line with the requirements of liver targeting.