摘要
目的:考察左亚叶酸钠注射液在不同pH值条件下的稳定性。方法:配制不同pH值的左亚叶酸钠注射液,滤膜过滤除菌后,采用高效液相法测定含量和有关物质。结果:pH值在6.0~9.0范围内变化时,制剂的外观、含量和已知杂质均无明显变化,但pH 6.0与pH 9.0时的总杂质相对其他pH偏大。在pH6.5,pH 7.5和pH 8.5这3个pH条件下60℃放置5 d后,随pH值升高,已知杂质和总杂质均呈下降趋势。结论:为保证制剂的长期稳定性良好,配液时的pH范围宜控制在7.5~8.5。
Objective: To investigate the stability of disodium levofolinate injection at different pHs. Methods:Disodium levofolinate injection of different pHs was prepared,and bacteria was eliminated by membrane filtration. HPLC method was utilized to determine levofolinate and its related substances. Results:The changes of appearance,content of disodium levofolinate and known impurities were not obvious when the pH varied within the range of 6.0 - 9.0. The content of total impurity was higher injection was stored at 60 ℃ for 5 days at pH 6.5, pH 7.5 descended with pH value rising. Conclusion:To assure the atpH6.0 and pH9.0 than at other pHs. When the and pH 8.5, the known impurities and total impurity long-term stability of disodium levofolinate injection, the pH should be controlled within 7.5 - 8.5 when preparing the infection .
出处
《中国新药杂志》
CAS
CSCD
北大核心
2017年第24期2995-2998,共4页
Chinese Journal of New Drugs