一测多评法测定8个银翘解毒系列制剂中的7种酚酸类成分的含量_王俊俊

一测多评法测定8个银翘解毒系列制剂中的7种酚酸类成分的含量王俊俊1, 张俐2, 郭青2*, 寇俊萍1, 余伯阳1, 谷丹华1

(1. 中国药科大学, 江苏南京 211198; 2. 江苏省食品药品监督检验研究院, 江苏南京 210008)

摘要: 建立8个银翘解毒系列制剂中君药金银花所含的7种酚酸类成分(新绿原酸、绿原酸、隐绿原酸、咖啡酸、异绿原酸B、异绿原酸A、异绿原酸C) 的一测多评统一方法。首先, 采用HPLC以绿原酸为内参物, 建

立绿原酸与其他6种酚酸类成分的相对校正因子 (RCF), 并用不同浓度、不同色谱柱、不同HPLC验证其耐用

性, 利用金银花提取物作随行对照定位各待测色谱峰。然后利用RCF计算8个不同银翘解毒系列制剂样品中其

他6种酚酸类成分的含量, 并与外标法的测定结果进行比较, 对该方法进行可行性验证。结果表明, 所建立的平

均相对校正因子的耐用性良好 (RSD在0.80%～2.56%), 一测多评法测定样品中的酚酸类成分的含量与外标法

的含量测定结果一致(相对平均偏差<0.93%)。因此, 一测多评法可以成功应用于8个银翘解毒系列制剂中金银

花的酚酸类成分的定量控制。

关键词: 一测多评; 相对校正因子; HPLC; 银翘解毒制剂; 绿原酸; 酚酸

中图分类号: R917 文献标识码:A 文章编号: 0513-4870 (2015) 04-0480-06

Quantitative analysis of seven phenolic acids in eight Yinqiao Jiedu

serial preparations by quantitative analysis of multi-components

with single-marker

WANG Jun-jun1, ZHANG Li2, GUO Qing2*, KOU Jun-ping1, YU Bo-yang1, GU Dan-hua1

(1. China Pharmaceutical University, Nanjing 211198, China;

2. Jiangsu Institute for Food and Drug Control, Nanjing 210008, China)

Abstract: The study aims to develop a unified method to determine seven phenolic acids (neochlorogenic acid, chlorogenic acid, 4-caffeoylquinic acid, caffeic acid, isochlorogenic acid B, isochlorogenic acid A and

isochlorogenic acid C) contained in honeysuckle flower that is the monarch drug of all the eight Yinqiao Jiedu serial preparations using quantitative analysis of multi-components by single-marker (QAMS). Firstly,

chlorogenic acid was used as a reference to get the average relative correction factors (RCFs) of the other phenolic acids in ratios to the reference; columns and instruments from different companies were used to validate

the durability of the achieved RCFs in different levels of standard solutions; and honeysuckle flower extract was used as the reference substance to fix the positions of chromatographic peaks. Secondly, the contents of

seven phenolic acids in eight different Yinqiao Jiedu serial preparations samples were calculated based on the

RCFs durability. Finally, the quantitative results were compared between QAMS and the external standard (ES) method. The results have showed that the durability of the achieved RCFs is good (RSD during 0.80%−

2.56%), and there are no differences between the quantitative results of QAMS and ES (the relative average

deviation<0.93%). So it can be successfully used to the quantitative control of honeysuckle flower principally

prescribed in Yinqiao Jiedu serial preparations.

收稿日期: 2014-10-16; 修回日期: 2014-12-02.

*通讯作者 Tel: 86-25-86632807, E-mail: guoqing850@