妇科千金胶囊与妇科千金片指纹图谱的建立及其比较分析.docx

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妇科千金胶囊与妇科千金片指纹图谱的建立及其比较分析

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粟倩唐洁张鹏廖颖妍谢菁琛龚云林丽美

〔摘要〕目的建立妇科千金胶囊与妇科千金片的指纹图谱，为两者鉴别与质量评价提供实验依据。方法采用高效液相色谱法对40批妇科千金胶囊与40批妇科千金片进行测定，结合聚类分析、模式识别分析、相似度评价等对其进行比较。结果首次建立了妇科千金胶囊与妇科千金片的指纹图谱，共确定了23个共有峰，指认出了穿心莲内酯和脱水穿心莲内酯两个成分。聚类分析以及模式识别分析均可以明显地将其分为两类，并确定了穿心莲内酯为千金胶囊与妇科千金片的差异性成分。结论该方法重复性好、准确率高，结合各类分析方法可以明确地区分妇科千金胶囊与妇科千金片，可用于对妇科千金胶囊与妇科千金片进行质量控制与评价。

〔关键词〕妇科千金胶囊;妇科千金片;指纹图谱;聚类分析;模式判别

〔〕R284.1????〔文献标志码〕A????〔〕doi：10.3969/j.issn.1674-070X.2021.08.010

EstablishmentandComparativeAnalysisofFingerprintChromatogramofFuke

QianjinCapsuleandTablet

SUQian1，2，TANGJie1，2，ZHANGPeng2，3，LIAOYingyan1，2，XIEJingchen1，2，GONGYun2，3*，LINLimei1，2*

（1.SchoolofPharmacy，HunanUniversityofChineseMedicine，Changsha，Hunan410208，China;2.KeyLaboratoryforQualityEvaluationofBulkHerbsofHunanProvince，Changsha，Hunan410208，China;3.ZhuzhouQianjinPharmaceuticalCo.，Ltd，Zhuzhou，Hunan412007，China）

〔Abstract〕ObjectiveToestablishthefingerprintsofFukeQianjinCapsuleandFukeQianjinTablet，soastoprovideexperimentalevidencefortheiridentificationandqualityevaluation.MethodsHighperformanceliquidchromatographicmethodwasdevelopedtoestablishthefingerprintof40batchesFukeQianjinCapsuleand40batchesFukeQianjinTabletandthequalityassessmentwasachievedbyclusteranalysis，patternrecognitionanalysisandsimilarityevaluation.ResultsItwasthefirsttimetoestablishtheHPLCcharacteristicfingerprintsofFukeQianjinCapsuleandFukeQianjinTablet.Therewere23commonpeaksinthefingerprints.Twocomponentswereidentifiedasandrographolideanddehydratedandrographolidebycomparingwithreferencestandards.80batchesofdifferentcapsulesandtabletswereobviouslydividedintotwogroupsbyclusteranalysisandpatternrecognitionanalysisandtheresultsofclassificationwereconsistent，andandrographolideweredeterminedasthemaindifferentchemicalcomponentsofFukeQianjinCapsuleandF