平行六波长高效液相色谱指纹谱评价二妙丸质量  

Parallel Six Wavelength HPLC Fingerprint Quality Evaluation of Ermiao Pills

作　　者：詹丹丹 张颖 孙国祥[2] 

机构地区：[1]大兴安岭地区食品药品检验检测所,黑龙江加格达奇165000 [2]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《黑龙江医药》2012年第4期518-520,共3页Heilongjiang Medicine journal

摘　　要：目的:建立了二妙丸的平行六波长高效液相色谱指纹谱,并采用均值法整合平行六波长下样品的定性定量全信息,用系统指纹定量法鉴定11批二妙丸整体质量,为二妙丸在质量控制方面提供全面客观的评价方法。方法:采用高效液相色谱法,以盐酸小檗碱为参照物峰,在254nm、265nm、284nm、305nm、326nm和340nm下检测,分别确定了53个、54个、51个、57个、53个和47个共有指纹峰,建立了二妙丸的平行六波长高效液相色谱指纹谱,以均值法整合六波长下各样品的定性定量全信息。结果:用系统指纹定量法鉴定出S2,S6,S10(为Ⅰ级)质量最好;S7、S8、S9(为Ⅱ级)质量很好;S5,S11(为Ⅲ级)质量好;S1、S3、S4(为Ⅴ级)质量中等。结论:不同波长下的样品的指纹图谱所反映的质量级有很大差异。平行六波长指纹谱能较全面地反映二妙丸的质量信息,可以为二妙丸的质量控制方面提供参考。Objective：To establish a Ermiao pills parallel six wavelength high performance liquid chromatographic fingerprint spectrum,and the mean value method integrating parallel six wavelength for samples of qualitative and quantitative information,by systematic quantified fingerprint method for the identification of the 11 batch of EMWs overall quality,for Ermiao pills in terms of quality control to provide a comprehensive and objective evaluation method.Methods：uses the highly effective liquid phase chromatography,with berberine hydrochloride as a reference peak,at 254 nm,265 nm,284 nm,305 nm,326 nm and 340nm detection,respectively,were identified in 53,54,51,57,53 and 47 common fingerprint peaks,built by EMW PSW-HPLC fingerprints,to mean the method integrating six wavelength under various samples of qualitative and quantitative information.Results：by systematic quantified fingerprint method to identify S2,S6,S10（for class I）the best quality;S7,S8,S9（Level II）of good quality;S5,S11（III）of good quality;S1,S3,S4（V-grade）quality medium.Conclusion：Different wavelengths of the sample fingerprint reflect the quality level has very big difference.Parallel six wavelength fingerprint spectrum can reflect the Ermiao pills on the quality of information,can provide Ermiao pill quality control reference.

关 键 词：二妙丸 平行六波长高效液相色谱指纹图谱 共有指纹峰 质量控制 均值法 

分 类 号：R927.2[医药卫生—药学]