经典名方当归补血汤物质基准的质量标准研究  

Quality Standards of Danggui Buxue Decoction

作　　者：谢晓林 李娟[2] 张德柱 马钊 梁承远[2] 凌梅 乔乖萍 惠楠[2] XIE Xiaolin;LI Juan;ZHANG Dezhu;MA Zhao;LIANG Chengyuan;LING Mei;QIAO Guaiping;HUI Nan(Shaanxi Panlong Pharmaceutical Group Co.,Ltd,Xi′an 710021,China;Shaanxi University of Science&Technology,Xi′an 710021,China)

机构地区：[1]陕西盘龙药业集团股份有限公司,西安710021 [2]陕西科技大学,西安710021

出　　处：《世界中医药》2023年第11期1541-1546,共6页World Chinese Medicine

基　　金：陕西省创新能力支撑计划项目(2020PT-033)——陕西省古代经典名方开发与应用共享平台;陕西省技术创新引导计划项目(2020CGXNG-044)——复方醋酸棉酚片质量标准提升及临床用途拓展产业化研究;陕西省科技厅重点研发计划项目(2020ZDLSF03-10)——盘龙七片上市再评价研究。

摘　　要：目的:建立经典名方当归补血汤的质量标准。方法:应用薄层色谱鉴别方法,以对照药材、阿魏酸、藁本内酯以及黄芪甲苷为对照,建立当归补血汤物质基准的定性鉴别方法。采用高效液相色谱法测定当归补血汤中阿魏酸以及毛蕊异黄酮葡萄糖苷的含量,采用NewmateTM C18(250 mm×4.6 mm,5μm)色谱柱,以乙腈-0.2%甲酸为流动相进行洗脱,流速0.5 mL/min,检测波长分别为316 nm和260 nm。结果:薄层色谱鉴别方法专属性良好,斑点清晰。阿魏酸、毛蕊异黄酮葡萄糖苷分别在进样量为10~200μg、5~50μg范围内线性关系良好,相关系数均>0.999;平均加样回收率分别为100.64%和92.62%,相对标准偏差(RSD)均<3%。15批样品中阿魏酸和毛蕊异黄酮葡萄糖苷含量分别在0.068%~0.109%和0.057%~0.092%范围内。结论:建立的方法准确可靠,可作为当归补血汤的质量控制标准。Objective:To establish the quality standard of the classical prescription Danggui Buxue Decoction.Methods:Thin-layer chromatography(TLC)was used for the identification of the benchmark substances with the reference medicinal materials,ferulic acid,ligustilide,and astragaloside as the references.High performance liquid chromatography(HPLC)was employed to determine the content of ferulic acid and calycosin glucoside in the decoction.The NewmateTM C18(4.6 mm×250 mm,5μm)column was used for gradient elution with acetonitrile-0.2%formic acid as the mobile phase at a flow rate of 0.5 mL/min.The detection wavelengths were set at 316 nm and 260 nm,respectively.Results:The TLC method showed good specificity with clear spots.The calibration curves were linear within the range of 10~200μg for ferulic acid and 5~50μg for calycosin glucoside,with the correlation coefficients above 0.999.The average recovery was 100.64%for ferulic acid and 92.62%for calycosin glucoside,with the relative standard deviations(RSDs)below 3%.The content of ferulic acid and calycosin glucoside in 15 batches of samples was 0.068%~0.109%and 0.057%~0.092%,respectively.Conclusion:The established method is accurate and reliable and can be used as a standard for the quality control of Danggui Buxue Decoction.

关 键 词：当归补血汤 阿魏酸 毛蕊异黄酮葡萄糖苷 藁本内酯 黄芪甲苷 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R284[医药卫生—中药学]