甘草酸二铵磷脂复合物水针剂的制备和初步稳定性研究

目的：制备甘草酸二铵磷脂复合物水针剂,并考察其初步稳定性。方法：采用浓配法制备水针剂,热压法灭菌。以平均粒径、粒度分布和Zeta电位为主要指标考察小针剂的物理稳定性,以含量测定、有关物质为主要指标考察小针剂化学稳定性。结果：所研制的甘草酸二铵磷脂复合物小针剂可耐受热压灭菌,并且高温、光照实验和30℃加速实验显示注射剂粒径均匀,电位稳定,含量和有关物质未发生明显变化。结论：甘草酸二铵磷脂复合物注射剂制备工艺简单,终端灭菌方法可靠,并且具有良好的理化稳定性。

Study On Preparation and Stability of Diammonium Glycyrrhizinate Phospholipid Complex Injection

Objective：To study the preparation and stability of diammonium glycyrrhizinate phospholipid complex injection. Methods： Small volume injection was prepared and sterilized by high-pressure sterilization. Particle size, size distribution and zeta potentia1 were applied as physical stability parameters, besides, drug content and related substances were recognized as chemical stability parameters. Results： Diammonium glycyrrhizinate phospholipid complex injection could tolerant high-temperature and pressure sterilization. According to the stability parameters, the injection remained stable after high temperature, illumination, and 3 months duration under 30℃.Conclusion： The small volume injection of Diammonium glycyrrhizinate phospholipid complex was simple to prepare, terminal sterilization, and stable to store.