基于阿魏酸和羟基红花黄色素A含量的肤痒颗粒质量评估  

Quality Analysis of Fuyang Granule Based on Determination of Ferulic Acid and Hydroxysafflor Yellow A

作　　者：欧贝丽 邹燕 龚秋翼 施文禧 OU Beili;ZOU Yan;GONG Qiuyi;SHI Wenxi(Jiaxing Food,Drug and Product Quality Inspection and Testing Institute,Zhejiang Jiaxing 314000,China)

机构地区：[1]嘉兴市食品药品与产品质量检验检测院,浙江嘉兴314000

出　　处：《中国医药导刊》2023年第8期842-846,共5页Chinese Journal of Medicinal Guide

基　　金：浙江省药品监管系统科技计划项目[项目编号:2022012,项目名称:肤氧颗粒质量标准提升与质量标志物(Q-marker)的预测]。

摘　　要：目的:建立超高效液相色谱-二极管阵列测定肤痒颗粒中阿魏酸和羟基红花黄色素A含量的方法,以此评估市场上51批次肤痒颗粒的质量状况。方法:采用Waters BEH-C_(18)(2.1 mm×100 mm,1.7μm)色谱柱,以甲醇-乙腈(26∶2)、0.7%磷酸溶液为流动相,梯度洗脱,流速为0.2 mL·min^(-1),柱温为40℃,波长322 nm(阿魏酸)、401 nm(羟基红花黄色素A)。结果:阿魏酸与羟基红花黄色素A分离度良好,阿魏酸在1.01~40.04μg·mL^(-1)、羟基红花黄色素A在2.01~80.21μg·mL^(-1)浓度范围内与峰面积线性关系良好,r 2均大于0.9990。阿魏酸与羟基红花黄色素A的加标回收率分别为98.6%、98.9%。51批次肤痒颗粒的阿魏酸和羟基红花黄色素A的含量分布差异较大,个别批次未检出羟基红花黄色素A。结论:目前市场上的肤痒颗粒质量差异较大,个别产品质量堪忧,原有标准有待提升。本方法准确、快速,可用于肤痒颗粒中阿魏酸和羟基红花黄色素A的含量测定,可更加有效控制肤痒颗粒的质量。Objective:To analyze the quality and the problems of fuyang granule,after establishing an UPLC-PDA method for determination of ferulic acid(FA)and hydroxysafflor yellow A(HYA).Methods:A Waters BEH-C_(18)(2.1 mm×100 mm,1.7μm)column was used for separation,with a column temperature at 40℃,a flow rate of 0.2 mL·min^(-1).The detection wavelength was set at 401 nm(HYA)and 322 nm(FA).The mobile phase consisted of Methanol-acetonitrile(26∶2)and 0.7%phosphoric acid solution,radient elution.Results:FA and HYA showed good linear relationships with their peak areas in the ranges of 1.01-40.04μg·mL^(-1),and 2.01-80.21μg·mL^(-1),respectively.And the correlation coefficients were all more than 0.9990.The average recoveries were 98.6%,98.9%,respectively.51 batches of fuyang granule were determined.1 batch was negative of HYA and some caused attention because of its poor quality.Conclusion:The method is rapid and accurate,and can be effectively used for the quality control of Fuyang Granules.

关 键 词：肤痒颗粒 阿魏酸 羟基红花黄色素A 超高效液相 质量评估 

分 类 号：R284.1[医药卫生—中药学]