一测多评法同时测定逍遥丸中6种指标性成分的研究  

Determination of Six Index Components in Xiaoyao Pills by Quantitative Analysis of Multi-components by Single Marker

作　　者：董永华[1] 尹创[2] Dong Yonghua;Yin Chuang(Department of Pharmacy,Wanbei Coal-electricity Corporation General Hospital,Anhui Suzhou 234000, China;Suzhou Food and Drug Control Institute, Anhui Province)

机构地区：[1]皖北煤电集团总医院药剂科,安徽宿州234000 [2]安徽省宿州市食品药品检验所

出　　处：《中国药师》2018年第5期930-933,共4页China Pharmacist

摘　　要：目的:建立一测多评(QAMS)的方法用来测定逍遥丸中6种成分的含量。方法:以甘草酸为参照物,采用HPLC法,以Kromasil C_(18)色谱柱(250 mm×4.6 mm,5μm);流动相为乙腈(A)-0.1%磷酸水溶液(B)为流动相,梯度洗脱:0~10 min,5%A;10~25 min,5%A→15%A;20~70 min,15%A→60%A;流速:1.0 ml·min^(-1);检测波长:280 nm;柱温:35℃;进样量:10μl。应用QAMS法的方法测定6种指标性成分之间的相对校正因子,分别采用外标法和一测多评法测定逍遥丸中的6种指标性成分的含量,并对2种方法计算结果进行对比分析,以验证一测多评法的实用性与稳定性。结果:建立QAMS法用于测定逍遥丸中6种指标性成分的含量,并对6批逍遥丸进行测定,其计算值与测定值的差异无统计学意义(P>0.05)。结论:QAMS法用于测逍遥丸中6种指标性成分的含量,方法简单、有效、结果准确,可用于逍遥丸的质量控制,并为后续的一测多评的研究提供参考价值。Objective： To develop a method of quantitative analysis of multi-components by single marker （QAMS） for six active constituents in Xiaoyao pills. Methods： Using glycyrrhizic acid as the reference, an HPLC method with a Kromasil C^8 column （250 mm×4.6 mm,5μm） was applied,the mobile phase was acetonitrile （A） -0.1% phosphoric acid solution （B） with gradient elution （0-10 min,5 % A;10-25 min,5 % →20 % A;20-70 min,15 % → 60 % A and 40-60 min,60 % A）. The detection wavelength was 280nm,the column temperature was 35℃ and the injection volume was 10 μl. The relative correction factors among the six index components were detected by QAMS. The contents of the six index components were determined by an external standard method and QAMS to compare the results obtained from the two different methods and verify the practicability and stability of QAMS. Results： The established QAMS was used to determine the six index components in Xiaoyao pills,and totally 6 batches of Xiaoyao pills were determined. There were no significant differences in the calculated values and the determined ones （P 〉 0.05）. Conclusion： The QAMS method is simple,effective and accurate in determining the contents of the six index components in Xiaoyao pills ,which can be used for the quality control of Xiaoyao pills and provide reference for the further study.

关 键 词：一测多评法 逍遥丸 绿原酸 芍药苷 甘草苷 阿魏酸 甘草酸 Z-藁本内酯 

分 类 号：R917[医药卫生—药物分析学]