论文部分内容阅读
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5d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 at pH 6.0 and pH 9.0 than at other pHs.When the injection was stored at 60 ℃ for 5 days at pH 6.5,pH 7.5 and pH 8.5,the known impurities and total impurity descended with pH value rising.Conclusion:To assure the long-term stability of disodium levofolinate injection,the pH should be controlled within 7.5 ～ 8.5 when preparing the infection.