摘要
目的建立平行多波长色谱指纹谱均值法(PMW-FP-AM)的不确定度和可靠度评价理论,并用以评价单批二妙丸(Ermiao Wan,EMW)平行六波长指纹谱均值法(PSW-FP-AM)结果与均值法(AM)对应标准谱的不确定度和可靠度。方法采用RP-HPLC法测定二妙丸平行六波长HPLC指纹图谱(EMW-PSW-HPLC-FP),以均值法和系统指纹定量法综合鉴定11批EMW质量。结果以小檗碱为参照物峰,分别确定53(254nm)、54(265nm)、51(284nm)、57(305nm)、53(326nm)和47(340nm)个共有指纹峰,建立了EMW-PSW-HPLC-FP。用PSW-FP-AM鉴定S2、S6和S10(Ⅰ级)质量最好,S7、S8和S9(Ⅱ级)质量很好,S5和S11(Ⅲ级)质量好,S1、S3和S4(Ⅵ级)质量一般。评价出EMW-PSW-FP-AM对应标准的定性定量及均化性可靠度均>0.97,表明标准谱反映的化学指纹数量和含量分布比例与整体含量信息的可靠度极高。S2、S5、S6、S7、S8、S9和S10的定性定量信息可靠度(0.918～0.984)极高,S11定性定量信息可靠;S1、S3和S4的定性定量信息的可靠度(0.778～0.881)中等。结论所建立方法能准确反映PMW-FP-AM结果所代表质量信息的不确定性,评价PMW-FP-AM标准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。
Abstract： Objective To set up the theories of uncertainty and reliability （U＆R） in average method （AM） of paral- lel multiple wavelength （PMW） chromatographic fingerprints （PMW-FP-AM） of traditional Chinese medicine and eval- uate the U＆R of the corresponding referential fingerprints （RFP） and each batch of Ermiao Wan （EMW） detected under the parallel six wavelengths for high performance liquid chromatography fingerprints （PSW-HPLC-FP） by AM. Methods The chromatographic fingerprints were determined by reversed-phase HPLC under PSW, in which the AM and systematic quantified fingerprint method （SQFM） were used to comprehensively evaluate the quality of 11 batches of EMWs. Results Atotalof53 （254 nm）, 54 （265 nm）, 51 （284 rim）, 57 （305 nm）, 53 （326 nm）, and47 （340 nm） common peaks were respectively marked with berberine peak as the referential peak and EMW-PSW-FPs were established. As the same time S2, S6, and S10 （grade Ⅰ） were identified as having the best quality; S7, S8, and S9 （gradeⅡ） with better quality; S5 and S11 （grade Ⅲ） with good quality; S1, S3 and S4 （gradeⅥ） common quality by PSW-FP-AM. The reliabilities （all over 0. 97） of EMW-PSW-FP-AM corresponding norm were reliable, which showed the information of fingerprint quantity and distribution proportion, and the overall contents reflected quality by RFP were highly reliable. The reliability （0. 918-0. 984） in qualitative and quantitative information for S2,S5, S6, S7, S8, S9, and S10 was classified as very high, that of Sll was reliable, while that （0. 778-0. 881） of S1, S3 and S4 was moderate. Conclusion The evaluation method of uncertainties in PMW-FP-AM can accurately reflect the varia- tions in the quality of traditional Chinese medicine, and those of reliahilities would exactly calculate the degrees of reliabilities of qualitative and quantitative information included in the RFP and each sample fingerprint by PMW-FP-AM.
出处
《中南药学》
CAS
2011年第12期924-929,共6页
Central South Pharmacy
基金
国家自然科学基金重大研究计划课题(No.90612002)
关键词
二妙丸
平行多波长色谱指纹图谱
均值法
系统指纹定量法
不确定度
可靠度
Ermiao Wan
parallel multiple wavelength chromatographic fingerprints
average method
systematicquantified fingerprint method
uncertainty
reliability
