首页|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

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

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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 C18柱(250 mm x4.6 mm,5 μm),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 2.099 2~3.271 6,0.111 6~0.192 0,2.918 9~3.450 3,0.474 8~0.783 8,0.221 0~0.805 4,0.194 6~0.996 4,0.534 2~1.705 1 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.
Quality evaluation of Huricha-6 Flavored Pills based on fingerprint combined with quantitative analysis of multi-components by single marker
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 C18(250 mm x4.6 mm,5 μm)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 2.099 2~3.271 6,0.111 6~0.192 0,2.918 9~3.450 3,0.474 8~0.783 8,0.221 0~0.805 4,0.194 6~0.996 4,and 0.534 2~1.705 1 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.

Huricha-6 Flavored Pillgallic acidHPLCfingerprintquantitative analysis of multi-components by single marker

孙倩男、渠晓艳、郭宝凤

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内蒙古自治区药品检验研究院中蒙药标准研究实验室,呼和浩特 010020

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

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(6)
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