含红花的伤科跌打系列制剂中6种红色染色物检测方法研究

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【中图分类号】R284.1 【文献标志码】A 【文章编号】1007-8517（2026）01-0051-04

DOI:10. 3969/j. issn. 1007 -8517. 2026. 01. zgmzmjyyzz202601011

ResearchonDetection of Six RedDyes in Carthami Flos-containingShangke Dieda Preparation

XU Jia CAI Hao* WANG Xiaoyu Shantou Institute for Drug Control of Guangdong Province，Shantou 515O41，China

Abstract：ObjectiveToestablishaHPLC methodforthesimultaneousdeterminationofsixreddyes（namelysunsetyellw，carmine，auramineI,acidred73，eryhrosineandazorubine），addedinCarthamiFlos-containingShngkeDiedaPreparationMet ods The samples were ultrasonically extracted with 70% ethanol，separated on a Kromasil 100-2.5C18 （ 100mm×4.6m n，2.5 （20 μm ），gradient elution with acetonitrile and 0.05mol⋅mL-1 ammonium acetate. Results The detection limit of this method was 0.0018-0.0022μg⋅mL-1 ，the recovery rate was 95.37%-101.48%，and the relative standard deviation（RSD）was all less than 1.2% .Conclusion This methodisrapid，simple,andcost-efective，which cansimultaneouslydetectthe sixreddyes in traumaticinjurypreparatios.ItprovidescertaintechnicalreferencesforthesupervisionandcontrolofillgalstaininginCnespatet medicines.

Keywords:Carthami Flos；Shangke Dieda Preparation；HPLC；Staining；Red Dyes

伤科跌打系列制剂由红花、大黄、地黄等22味中药组成，其系列制剂主要包括伤科跌打片、伤科跌打丸、伤科跌打胶囊等剂型，具有活血散瘀、消肿止痛的功效，用于跌打损伤、伤筋动骨、瘀血肿痛、闪腰岔气[1-2]。（剩余6807字）