4代甘草酸制剂主成分异构体及有关物质含量差异分析与变化趋势

Analysis of content differences and variation trends of the principal component isomers and related substances in the four generations of glycyrrhizin preparations

目的:对国内外上市的4代甘草酸制剂中主成分和有关物质含量差异与变化趋势进行分析。方法:对样品预处理条件进行考察,并建立高效液相色谱法,对10种上市甘草酸制剂主成分及其有关物质进行含量测定,分别计算各甘草酸制剂的标示量以及18α-Gly与18β-Gly的组成比例,对制剂中各成分含量差异和变化趋势进行比较分析。结果:10种上市甘草酸类制剂标示量均符合中国药典规定,各种甘草酸制剂之间主成分及有关物质的含量以及18α-Gly与18β-Gly组成比例均存在显著性差异;进口制剂各成分总含量高于国产制剂。结论:建立的分析方法简便、灵敏,重复性好,结果准确可靠,可用于各种剂型甘草酸制剂含量检测与分析以及质量控制;分析结果可为临床用药选择及开发新的甘草酸制剂提供参考。

Objective： To analyze the content differences and variation trends of the principal component isomers and related substances in the four generations of different glycyrrhizin preparations on the domestic and foreign markets.Methods： The condition of sample pretreatment was investigated,and the HPLC analytical method was established for the simultaneous separation and detection of 18α-glycyrrhizic acid,18β-glycyrrhizinic acid,related substance A and related substance B of ten brands of glycyrrhizin preparations.The labeled amount and composition ratio of 18α-Gly and 18β-Gly of glycyrrhizin preparations were calculated.The content differences and variation trends of each component in glycyrrhizin preparations were analyzed.Results： The labeled amount of ten brands of glycyrrhizin preparations accorded with the specification in the Chinese Pharmacopoeia.The content of principal components and related substances and the composition ratio of 18α-Gly and 18β-Gly showed significance difference among different brands of glycyrrhizin preparations.The total amount of each component in imported glycyrrhizin preparations was higher than that in domestic products.Conclusion： The method is simple,sensitive,and reproducible with accurate and reliable results,which can be used for content detection of various dosage forms of glycyrrhizinate and quality control.The analysis results can provide reference for the selection of clinical medicine and new-medicine development.