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基于指纹图谱和一测多评法评价胡日查六味丸质量的研究

Quality evaluation of Huricha-6 Flavored Pills based on fingerprint combined with quantitative analysis of multi-components by single marker
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摘要 目的:通过指纹图谱结合一测多评(QAMS)方法评价胡日查六味丸(Huricha-6 Flavored Pill,Huricha-6)的质量。方法:采用HPLC法,使用Thermo HYPERSIL PREP HS C_(18)柱(250 mm×4.6 mm,5μm),以乙腈-0.1%磷酸水溶液梯度洗脱,检测波长230 nm,柱温35℃,流速1.0 mL·min^(-1)。结果:建立了Huricha-6的HPLC指纹图谱,确定了21个共有峰,并指认了7个共有峰包括没食子酸、紫丁香苷、羟基红花黄色素A、鞣花酸、甘松新酮、木香烃内酯、去氢木香内酯。通过相似度评价系统评价6批Huricha-6的指纹图谱,相似度计算均>0.9。以没食子酸为内参物,建立了可同时测定紫丁香苷、羟基红花黄色素A、鞣花酸、甘松新酮、木香烃内酯、去氢木香内酯含量的QAMS法。上述7种成分QAMS法与外标法的测定结果无显著差异。6批Huricha-6中没食子酸、紫丁香苷、羟基红花黄色素A、鞣花酸、甘松新酮、木香烃内酯、去氢木香内酯的质量浓度分别为2.0992~3.2716,0.1116~0.1920,2.9189~3.4503,0.4748~0.7838,0.2210~0.8054,0.1946~0.9964,0.5342~1.7051 mg·g^(-1)。结论:HPLC指纹图谱评价和QAMS法结合控制Huricha-6的质量,该方式经济可行、结果准确、重复性良好。 Objective:To establish a comprehensive assessment system for Huricha-6 Flavored Pills(Huricha-6)through integrating quantitative analysis of multi-components by single marker and fingerprint.Methods:HPLC analysis was performed on a Thermo HYPERSIL PREP HS C_(18)(250 mm×4.6 mm,5μm)column maintained at 35℃ and gradiently eluted with acetonitrile-0.1% phosphoric acid aqueous solution as mobile phase.The detection wavelength was 230 nm and the flow rate was 1.0 mL·min^(-1).Results:The fingerprints of six batches of Huricha-6 were comprehensively analyzed with similarity evaluation and principal component analysis.Furthermore,by using gallic acid as internal reference standard,QAMS was established to determine the contents of syringin,hydroxysafflor yellow A,ellagic acid,nardosinone,costunolide,and dehydrocostus lactone in Huricha-6.The fingerprint of Huricha-6 was established and 21 common peaks were calibrated.Seven common peaks were identified,including gallic acid,syringin,hydroxysafflor yellow A,ellagic acid,nardosinone,costunolide,and dehydrocostus lactone.The fingerprints analysis showed that the similarity of six batches of preparations was greater than 0.9.There was no significant difference in the contents of syringin,hydroxysafflor yellow A,ellagic acid,nardosinone,costunolide,and dehydrocostus lactone between the quantitative results of external standard method(ESM)and QAMS method.The contents of the seven main components were 2.0992~3.2716,0.1116~0.1920,2.9189~3.4503,0.4748~0.7838,0.2210~0.8054,0.1946~0.9964,and 0.5342~1.7051 mg·g^(-1),respectively.Conclusion:The fingerprint and the QAMS method of Huricha-6 were established to provide an economic and accurate method to evaluate the quality of Huricha-6.
作者 孙倩男 渠晓艳 郭宝凤 SUN Qian-nan;QU Xiao-yan;GUO Bao-feng(Chinese and Mongolian Medicine Standard Research Laboratory,Inner Mongolia Institute for Drug Control,Huhehot 010020,China)
出处 《中国新药杂志》 CAS CSCD 北大核心 2024年第6期605-612,共8页 Chinese Journal of New Drugs
关键词 胡日查六味丸 没食子酸 高效液相色谱法 指纹图谱 一测多评法 Huricha-6 Flavored Pill gallic acid HPLC fingerprint quantitative analysis of multicomponents by single marker
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