甘草酸二铵磷脂复合物注射剂灭菌方法筛选与灭菌工艺验证

Screening and validation on sterilization method and process of diammonium glycyrrhizinate phospholipid complex injection

目的筛选适合甘草酸二铵磷脂复合物注射剂的灭菌方法,并对灭菌工艺进行验证。方法浓配法制备甘草酸二铵磷脂复合物注射剂,分别采用流通蒸汽、高压蒸汽和辐射灭菌法进行灭菌处理,通过测定甘草酸二铵含量、注射液的过氧化值和磷脂复合物的粒径对灭菌方法进行筛选,并采用无菌检查和热原检查法验证所确定的高压灭菌工艺。结果流通蒸汽和高压灭菌法对甘草酸二铵磷脂复合物注射剂的含量、过氧化值和粒径无明显影响,辐射灭菌可导致含量下降、过氧化值增高。无菌检查显示注射剂经高压灭菌处理后均无菌生长,热原检查显示家兔体温升高均低于0.6℃,表明确定的灭菌工艺符合要求。结论高压蒸汽灭菌法适用于甘草酸二铵磷脂复合物注射剂的灭菌,且灭菌工艺可靠。

Objective To select the sterilization method suitable for the injection of Diammonium glycyrrhizinate phospholipid complex,and to verify the sterilization process. Methods Diammonium glycyrrhizinate phospholipid complex injections were prepared by concentrated method,and were sterilized by the methods of flowing steam,autoclaving and radiation,respectively. The appropriate sterilization method was determined by evaluating the contents of Diammonium glycyrrhizinate,the peroxide values of the injections and the particle sizes of Diammonium glycyrrhizinate phospholipid complex. The sterile examination and pyrogen test were carried out to validate the determined sterilization method. Results The flowing steam and autoclaving had no significant effect on the contents,peroxide values and particle sizes of Diammonium glycyrrhizinate phosphate complex. The radiation sterilization method decreased the content and increased the peroxide values. There was no bacterial growth in the sterile examination,and the temperature elevated lower than 0. 6 ℃ in the pyrogen test,indicating that the determined sterilization process met the requirements. Conclusion The autoclaving method is appropriate for the sterilization of the Diammonium glycyrrhizinate phospholipid complex injection,and the sterilization process is reliable.