浓缩当归丸质量标准的提高及阿魏酸的含量测定研究  

Standard improvement and determination of ferulic acid of concentrated Danggui pills

作　　者：徐金玲[1] 樊磊磊[1] 王雪芹[1] 张竞[1] 陈茂钦 杨秋红 XU Jingling;FAN Leilei;WANG Xueqin;ZHANG Jing;CHEN Maoqin;YANG Qiuhong(Henan Provincial Institute for Food and Drug Control,Zhengzhou 450008,China)

机构地区：[1]河南省食品药品检验所,郑州450008

出　　处：《中国药品标准》2020年第6期510-514,共5页Drug Standards of China

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

摘　　要：目的:对浓缩当归丸的质量标准进行完善和提高,将现有浓缩当归丸或者当归丸(浓缩丸)的标准进行统一。方法:采用薄层色谱法(TLC)对浓缩当归丸中当归进行定性鉴别;采用高效液相色谱法(HPLC),以阿魏酸作为检测指标,进行定量测定。结果:薄层色谱法能有限的鉴别浓缩当归丸中的当归药材,阴性无干扰;阿魏酸在1.22~39.01μg·mL-1浓度范围内线性关系良好,回归方程为Y=4.89×10^4 X-0.83×10^4,r^2=0.9999;检测限为0.25 ng,定量限为0.75 ng;平均加样回收率为99.75%,RSD为1.88%(n=6)。测定样品16批,含量测定结果在0.16~0.43 mg·g^-1之间。结论:新建立的质量标准将原有的当归药材鉴别整合,并增加了阿魏酸的含量测定项,使质量的可控性更强,实验操作性更强;建立的实验方法准确可靠,简便快捷,适用性良好,可用于该制剂的质量控制和质量评价。Objective:To improve the standard of concentrated Danggui pills and to harmonize the current standard of concentrated Danggui pills or Danggui pills(concentrated pills).Methods:Angelica in concentrated Danggui pills was identified by TLC and ferulic acid was determined by HPLC quantitatively.Results:TLC was able to identify the angelica in the concentrated Danggui pills without interference.Ferulic acid had a good linear relationship in the concentration range of 1.22-39.0μg·mL^-1.The regression equation was Y=4.89×10^4 X-0.83×10^4,r^2=0.9999.The limit of detection was 0.25 ng,the limit of quantitation was 0.75 ng.The average spiked recovery was 99.75%with RSD=1.88%(n=6).16 batches of samples were determined,and the contents were between 0.16 and 0.43 mg·g^-1.Conclusion:The established standard integrated the original identification of angelica and included the determination of ferulic acid content,which had better quality control and made experimental operation more powerful.The established method is accurate,reliable,simple and convenient,and had the good suitability.It can be used for the quality control and quality evaluation of the preparation.

关 键 词：浓缩当归丸 薄层色谱法 高效液相色谱法 质量标准 阿魏酸 

分 类 号：R921.2[医药卫生—药学]