一测多评法测定当归丸(浓缩丸)中3种成分的含量  

Simultaneous Determination of Three Chemical Components in Concentrated Danggui Pills by QAMS

作　　者：樊磊磊[1] 徐金玲[1] 娄玉霞[2] 闫洪建 FAN Lei-lei;XU Jin-ling;LOU Yu-xia;YAN Hong-jian(NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine(Chinese Materia Medica and Prepared Slices),Henan Institute for Food and Drug Control,Zhengzhou 450018,China;School of Pharmacy,Henan University of Chinese Medicine,Zhengzhou 450018,China;Zhongjing Wanxi Pharmaceutical Co.,Ltd.,Xixia 474550,China)

机构地区：[1]河南省食品药品检验所国家药品监督管理局中药材及饮片质量控制重点实验室,河南郑州450018 [2]河南中医药大学药学院,河南郑州450018 [3]仲景宛西制药股份有限公司,河南西峡474550

出　　处：《食品与药品》2022年第2期115-120,共6页Food and Drug

基　　金：2019年国家药典委员会标准制修订研究课题(编号:2019Z013)。

摘　　要：目的 建立一测多评法同时测定当归丸(浓缩丸)中阿魏酸、洋川芎内酯I和藁本内酯的含量。方法 采用液相色谱法,C_(18)色谱柱(4.6 mm×250 mm,5μm);柱温:30℃;流动相:乙腈-0.1%甲酸,梯度洗脱;流速1.0 ml/min;检测波长280 nm;进样量10μl。以藁本内酯为内参物,建立其与阿魏酸、洋川芎内酯I的相对校正因子,并将一测多评法测得的阿魏酸、洋川芎内酯I含量与外标法测定结果比较,验证该方法的可行性。结果 当归丸(浓缩丸)中3成分的浓度在相应范围内与峰面积呈良好的线性关系(r>0.9990),平均加样回收率为96.79%~98.25%,RSD为1.27%~1.69%。采用相对校正因子计算的阿魏酸、洋川芎内酯I含量值与外标法的实测值无显著差异。结论 该方法准确、可靠,可用于当归丸(浓缩丸)的质量控制。Objective To establish a method for the determination of ferulic acid, senkyunolide I and ligustilide in Concentrated Danggui Pills by quantitative analysis of multi-components by single marker(QAMS). Methods HPLC was adopted. The analysis was performed on a C_(18) column(4.6 mm×250 mm, 5 μm), with the mobile phase comprising of acetomitrile -0.1 % formic acid at a flow rate of 1.0 ml/min in a gradient elution manner. The temperature of the column was 30 ℃ and the detection wavelength was set at 280 nm. Ligustilide was used as an internal standard to calculate the relative correction factors(RCFs) of the other two constituents. The contents of ferulic acid and senkyunolide I obtained by QAMS were compared with those determined by external standard method(ESM) to verify the feasibility of QAMS. Results Three constituents showed good linear relationships between concentration and peak area in the corresponding range(r>0.9990). The average recoveries were 96.79 %-98.25 %, with RSDs of 1.27 %-1.69 %. There was no significant difference between the contents of ferulic acid and senkyunolide I calculated by RCFs and the values measured by ESM. Conclusion The method is accurate and reliable, and can be used for the quality control of Concentrated Danggui Pills.

关 键 词：当归丸(浓缩丸) 一测多评 阿魏酸 洋川芎内酯I 藁本内酯 

分 类 号：R284.1[医药卫生—中药学]