摘要
目的:研究不同条件对异甘草酸镁注射液的稳定性影响,为提高异甘草酸镁注射液的质量控制及中药注射剂稳定性研究提供必要理论依据和技术支持。方法:采用高效液相色谱(HPLC)结合紫外可见分光光度计研究pH、温度、金属离子以及与临床常用注射液(5%葡萄糖注射液、10%葡萄糖注射液、0.9%氯化钠注射液、乳酸环丙沙星注射液)配伍时,对异甘草酸镁注射液的稳定性影响。结果:异甘草酸镁注射液与3种注射液配伍后,5h内pH值、含量、可见异物等考察指标均无明显变化,与乳酸环丙沙星注射液配伍有白色絮状沉淀产生,强酸条件下有明显降解;部分金属离子对其稳定性也有影响。结论:异甘草酸镁注射液可与3种常用注射液稳定配伍,强酸、高温、部分金属离子对其稳定性也有不同的影响,这将为异甘草酸镁注射液的临床用药提供参考。
Objective:To study the effects of different conditions on the stability of magnesium isoglycyrrhizinate injection,and provide the necessary theoretical basis and technical support for improving the quality control of magnesium isoglycyrrhizinate injection and the stability of traditional Chinese medicine injection.Methods:The effects of pH,temperature,metal ions and their compatibility with common clinical injections(5%glucose injection,10%glucose injection,0.9%sodium chloride injection and ciprofloxacin lactate injection)on the stability of magnesium isoglycyrrhizinate injection were studied by HPLC and UV-Vis methods.Results:After magnesium isoglycyrrhizinate injection was compatible with three kinds of injection,the pH value,content and visible foreign body had no obvious change within 5 hours.White flocculent precipitation was produced when it was compatible with ciprofloxacin lactate injection,and it was degraded obviously under strong acid condition.Some metal ions also affected it.Conclusion:Magnesium isoglycyrrhizinate injection can be compatible with three commonly used injection stably.Strong acid,high temperature and some metal ions also have different effects on its stability,which will provide reference for clinical medication of Magnesium isoglycyrrhizinate injection.
作者
郑富香
徐艳霞
李超
王一丹
任晓亮
ZHENG Fu-xiang;XU Yan-xia;LI Chao;WANG Yi-dan;REN Xiao-liang(College of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China)
出处
《中国现代中药》
CAS
2019年第8期1094-1098,共5页
Modern Chinese Medicine
基金
国家自然科学基金青年科学基金项目(81803955)
关键词
异甘草酸镁注射液
稳定性
PH
温度
离子
配伍
Magnesium Isoglycyrrhizinate Injection
stability
pH
temperature
ion
compatibility
