基于HPLC指纹图谱结合多组分含量测定评价痛风立安胶囊质量

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【中图分类号】R284 【文献标志码】A 【文章编号】1007－8517（2025）20-0037-08

DOI： 10.3969/j .issn.1007-8517.2025.20.zgmzmjyyzz202520009

Abstract：ObjectiveToestablishtheHPLCfingerprintof Tongfeng Li'ancapsulesandconductquantitative analysisof itssixcomponents，and comprehensively evaluate its quality.Methods The chromatography was carred out on a Gemini -NX L18 column （4.6 mm × 250 mm， 5μm ），with the mobile phase composed of acetonitrile（A） -0.2% formic acid solution（B）by gradient elution ata flow rate of 1mL⋅min-1 . The column temperature was set at 35qC ，and the detection wavelength was 25O nm. For the common peaks，SPSS 20.0was employedforsimilarityclusteranalysis （HCA），andprincipalcomponentanalysis （PCA）.HPLC wasutilizedtodeterine thecontentsofmagganin，soazinidine，polydati，PsylidineD，osinicacidandemodininGfangliancapsules.ResultsTeHfingerprintofTongfengLi’ancapsuleswas established.Thesimilarityof1Obatchesofsampleswas greaterthanO.96.36commonpeaks wereidentified，and6commonpeakswererecognized.TheanalysisresultsofHCAandPCAindicatedthatthe1bathesofsamples presentedcertaindiferensadwerediviedintoteecategories：teproductiosamplesiwereclassfedsategryhepro duction samples in 2021 were category I ，and the production samples in 2O22 were category III. Three principal components were extractedithePCAanalysis，andthevarianceinterpretationrateofeachprincipalcomponentwasusedastheweightforlinearweighted scores.Amongthe1Obatchesofsamples，thecomprehensivescoreofbatchnumber2106O3wassuperiortothatof heotherbatches.In the10batchesofsamples，thecontentsofmaggianin，isoazinidine，polydati，PsylidineD，rosinicacidandemodinwere0.2340 0.5139 mg/capsule，0.0603-0.1712mg/capsule，0.4867-1.2274 mg/capsule，0.1865-0.4784 mg/capsule，0.0188-0.2026 mg/ capsule，andO.08530.1418g/capsule，respectively.heresultsoftemetodolgicalinvestigationweresatisfactory.Cocusion TheestablishedHPLCfingerprintanalysismethodcombinedwithultiomponentcontentdeteminationissimple，stable，eliableand reproducible，which can provide a theoretical basis for evaluating the quality of Tongfeng Li'an capsules.

Keywords：Tongfeng Li’an Capsules；Fingerprints；HCA；PCA；Multicomponent Content Determination

痛风立安胶囊是广西国际壮医医院风湿病科名壮医李凤珍总结的壮药经验方，由肿节风、虎杖、忍冬藤、透骨草、甘草等八味药材组成，具有清热毒、除湿毒、祛风毒、消肿痛，调水道，通龙路、火路的功效，用于风湿热毒所致的隆芡（痛风）[1-3]，疗效确切，且无不良反应，在我院风湿病专科使用广泛[4]，2020 年被评为广西十大中药民族药院内制剂。（剩余7715字）