注射用丹参(冻干)中糖和糖醇类成分的定性定量分析

Analysis of sugars and sugar alcohols in freeze-dried Dan-Shen injection

目的:研究建立注射用丹参(冻干)中糖和糖醇成分定性、定量分析的方法。方法:以l-甲基咪唑作溶剂和催化剂,盐酸羟胺和乙酸酐为肟化和乙酰化试剂,将注射用丹参(冻干)样品中的糖类成分乙酰化后,再利用GC-MS联用技术进行定性和定量分析。结果:对注射用丹参(冻干)中所含8个糖和糖醇成分进行了结构确证,并对其中6个成分的含量进行了测定,6个成分的线性关系良好(r≥0.9995),平均回收率在95.77%～104.4%之间。结论:本法操作简便、灵敏、准确,可用于注射用丹参(冻干)中糖和糖醇成分的质量控制。

Objective：To establish a method for the determination of sugars and sugar alcohols in freeze-dried Dan-Shen injection.Methods：1-Methylimidazole was used as solvent and catalyst,hydroxylamine hydrochloride and acetic anhydride were used as reagent for oximization and acetylation.The products of the derivation reaction were separated effectively by gas chromatography with a capillary column,and structurally identified and characterized by GC-MS.Results：The structures of 8 sugars and sugar alcohols were identified and characterized by GC-MS in freeze-dried Dan-Shen injection,the content of six of them were determined.The calibration curve showed a good linear（r≥0.9995）.The average recoveries were within 95.77%-104.4%.Conclusi on：The method is simple,accurate,reliable and applicable for the determination of sugars and sugar alcohols in freeze-dried Dan-Shen injection.