复方甘草酸铵注射液质量标准研究

Study on the Quality Standard of Compound Ammonium Glycyrrhizinate Injection

目的:完善和提高复方甘草酸铵注射液的质量标准。方法:采用高效液相色谱法对主要成分甘草酸铵进行定性鉴别并测定其含量和有关物质,并对其质量标准进行了整体提高。结果:该质量标准鉴别项、有关物质项专属性强;并且同时适用于三种同类注射液的质量控制。结论:本文方法可用于复方甘草酸铵注射液的质量控制。

Objective：To improve the quality standard of Compound Ammonium Glycyrrhizinate Injection. Method：Develop an HPLC method for determination of the contents of Ammonium Glycyrrhizinate and its related substances. Result： The identification, related substances and assay methods were accurate and with good linearity, and it also apply to the three similar injections. Conclusion：The improved quality standards can control the quality of this product effectively.