左卡尼汀注射液包材选择对灭菌稳定性的影响

Effect of packaging materials on the chemical stability of L-carnitine injection during sterilization processes

目的优化左卡尼汀注射液的灭菌条件,明确包材在注射液灭菌中的重要作用。方法将自制的左卡尼汀注射液封装于不同材质的安瓿瓶中,采用不同条件进行灭菌后,用高效液相色谱法分析其中杂质的含量。结果左卡尼汀注射液适宜的湿热灭菌参数为121℃20 min,包装材料中的硅元素会加速杂质2(5H)-呋喃酮的产生。结论灭菌过程会使左卡尼汀注射液有不同程度的降解,建议采用低硼硅安瓿瓶包装,121℃湿热灭菌时,灭菌时间不宜超过20 min。

Objective To find out the important role of packaging materials on the chemical stability of L-camitine injections. Methods Locally prepared L-carnitine injection was packed in ampoules with different materials. The related substances were determined with an HPLC method after the sterilization under different conditions. Results The sterilization should be conducted at 121 ℃ for 20 min. The silicon element accelerated the generation of the 2 （5H）-furanone. Conclusion L-carnitine injection is degraded in the sterilization process and the silicon element of the packaging materials may reduce the stability of L-carnitine injection. We recommend low borosilicate ampoules and sterilizing for no more than 20 min.