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中药色谱指纹图谱评价方法的不确定度和可靠度研究 被引量:7

Uncertainty and reliability in chromatographic fingerprint of traditional Chinese medicine
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摘要 目的建立中药指纹图谱不确定度和可靠度评价理论并用其评价二妙丸(Ermiao Wan,EMW)HPLC指纹图谱的不确定度和可靠度。方法采用RP-HPLC法测定EMW-HPLC指纹图谱,以系统指纹定量法综合评价12批EMW质量。结果以盐酸小檗碱(berberine hydrochloride,BBR)为参照物峰,确定55个共有指纹峰,建立了EMW-HPLC指纹图谱。用不确定度和可靠度评价EMW-HPLC对照指纹图谱和12批样品指纹图谱,EMW-HPLC对照指纹图谱的定性可靠度和定量可靠度均>0.95,表明对照指纹图谱反映的化学指纹数量和含量分布比例以及整体含量的可靠性很高。S2、S3和S7的定性和定量可靠度依次升高,表明其反映的化学指纹数量分布和含量分布与整体含量的可信性依次增强。质量为Ⅲ级的S8的定性定量可靠度均为0.98,而质量为Ⅱ级的S2的定性定量可靠度均为0.92,表明中药质量高低与可靠度不一定相关。结论所建立的不确定度评价方法能准确反映中药指纹图谱所代表质量的变动性,可靠度评价方法可准确评价对照指纹图谱和单批指纹图谱所表征的中药质量的定性和定量信息的可靠程度。 Objective To develop the evaluation theory for uncertainty and reliability in traditional Chinese medicine(TCM) chromatographic fingerprints and to evaluate the uncertainty and reliability of high performance liquid chromatography(HPLC) fingerprints of Eermiao Wan(EMW).Methods The chromatographic fingerprints were determined by reversed-phase HPLC,in which the systematic quantified fingerprint method was employed to comprehensively evaluate the quality of 12 batches of EMW.Results Fifty-five common peaks were marked by choosing berberine hydrochloride(BBR) peak as the referential peak and EMW-HPLC-FPs were established.The uncertainty and reliability of EMW referential fingerprint(RFP) and 12 batches of sample fingerprints were evaluated.The qualitative reliability and quantitative reliability(QRQR) of EMW-HPLC-RFP were more than 0.95,which showed the reliability of the chemical fingerprint quantity,the distribution proportion and the overall content reflected by RFP was very high.The QRQR of S2,S3 and S7 increased hierarchically,indicating each qualitative and quantitative information was more reliable than the former.The QRQR of quality grade Ⅲ S8 was 0.98,while the QRQR of quality grade Ⅱ S2 was 0.92,which indicated there was no correlation between the TCM quality grade and the magnitude of reliability.Conclusion The evaluation of uncertainty can accurately reflect the variance in TCM fingerprints,and that of reliability may exactly estimate the reliability degree of qualitative and quantitative information in both RFP and each sample fingerprint.
出处 《中南药学》 CAS 2011年第5期366-371,共6页 Central South Pharmacy
基金 国家自然科学基金重大研究计划课题(编号:90612002)
关键词 二妙丸 HPLC指纹图谱 不确定度 可靠度 系统指纹定量法 Eermiao Wan; HPLC fingerprint; uncertainty; reliability; systematic quantified fingerprint method;
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