医院制剂斛参增免合剂的提取工艺及质量研究

打开文本图片集

【中图分类号】R284.1 【文献标志码】A 【文章编号】1007-8517（2025）21-0033-07

DOI：10.3969/j. issn. 1007 -8517. 2025.21. zgmzmjyyzz202521008

Abstract：ObjectiveTooptimizetheextractionprocessof Hushen ZengmianMixtureandconductapreliminarystudyonitsqualitystandardMethodsTeotiuetractionprocesofHushenZengmianMixtureasoptimizedbyorthogonalestwithsagaloside IVin monarchdrugasindex.TheTCidentificationofRadixAstragali，RadixPseudostellriaeandothermedicinalmaterialsnthe preparationwasstudiedTecontentofastragalosideIVwasdetectedbyevaporativelightscaeringdetector.Techemicalfingrprints of12batchesofHushnZengmianMixturewereestablishedandanalyzedbysimilarityevaluationsoftware（2O12edition）Bycombining cluster analysis（CA）andorthogonalpartialleastsquaresdiscriminantanalysis（OPLS-DA），theclasificationandanalysisof diferentbatchesof Hushen ZengmianMixturewerecariedout.ResultsTheoptimumextractionprocesswasasfolows：thedecoction pieces weresoakedfor2hwith8times theamountofwaterforthefrsttime，and6timestheamountofwaterforthesecondandthird times，decoctingfor3times，3Omneachtime；heTLCspotsofRadixAtragaliandRadixPseudostellriaewereclearandgatie without interference. The linear range of astragaloside IV was19.577 38-978.869 μg/mL （ r=0.999 0 ）.The RSD of precision， repeatability and solution stability was less than 2% . The average recovery was 97.43% （ n=6 ），RSD % was 4，68% . The HPLC fingerprint identified 12 common peaks and identified one component as calycosin -7-0-β-D - glucopyranoside. The similarity between12batchesofsamples wasaboveO.940，andtheconsistencyand stability betwensamples weregood.The Hushen Zengmian MixturewasdividedintotwocategoriesbyCAandOPLSDA，andtwocomponentswithgreatinfluenceonthequalitydifereceof HushenZengmian Mixture werescrenedbyOPLS-DA.ConclusionTheoptimizedextractionprocessisstableandreliable，andthe contentdeterminationandtinlayeridentificationmethodareconvenientandreliable，whichcanbeusedasthequalitycontrolethod ofHushenZengmianMixture.HPLCfingerprintcanbeusedforthestabilityandconsistencyofprocessandquality，andcanbeeffec tively used for quality control and evaluation.

Key Words：Hushen Zengmian Mixture;Astragaloside; Preparation Process ; Quality Standards;Fingerprints

斛参增免合剂原处方来源于我院儿科临床经验方，全方选用贵州产的铁皮石斛和太子参[1-2]配以多味中药组方，具有滋阴清热、补气生津益胃之功，用于儿童反复呼吸道感染恢复期肺脾阴虚证疗效显著。（剩余7149字）