摘要
目的通过对蒲茵护肝颗粒进行薄层鉴别、定量测定,建立合理可行的质量控制方法。方法参照2015年版《中华人民共和国药典》(四部)通则相关方法,建立鉴别蒲茵护肝颗粒中牡丹皮、白芍、黄芪的薄层色谱法;采用YMC ODS色谱柱(4.6 mm×250 mm,5μm),柱温30℃,以0.05%磷酸水溶液-乙腈为流动相进行梯度洗脱,流速为1.0 m L/min,在324 nm波长处检测原儿茶醛、绿原酸、咖啡酸、丹酚酸B和芍药苷含量,进样量为10μL。结果薄层鉴别方法专属性强,能够有效鉴别牡丹皮、白芍、黄芪;定量测定方法学考察结果表明,原儿茶醛、绿原酸、咖啡酸、丹酚酸B和芍药苷进样质量在0.314~3.14μg、0.218~2.18μg、0.210~2.10μg、0.392~3.92μg、0.540~5.40μg范围内与峰面积呈良好的线性关系,加样回收率分别为97.12%、98.46%、97.53%、96.98%、97.43%。结论建立的薄层鉴别和HPLC含量测定方法简单易行,结果准确可靠,可有效用于蒲茵护肝颗粒的质量控制。
Objective To establish the reasonable method for quality control and standard for Puyin Hugan Granules through identification and quantitative determination.Methods With reference to general principles of Chinese Pharmacopoeia 2015 version,TLC method to identify Moutan Cortex,Paeoniae Radix alba,and Astragali Radix in Puyin Hugan Granules was set up.HPLC assay was carried out on a column of YMC ODS(4.6 mm×250 mm,5μm).The mobile phase was acetonitrile-0.05%phosphoric acid solution with gradient elution at a flow rate of 1 mL/min.The injection volume was 10μL.The contents of protocatechuic aldehyde,chlorogenic acid,caffeic acid,salvianolic acid B and paeoniflorin were determined at 324 nm wavelength.The column temperature was 30℃.Results The TLC identification method was specific,and could effectively identify Moutan Cortex,Paeoniae Radix alba,and Astragali Radix.Methodology of quantitative measurement results indicated that protocatechuic aldehyde,chlorogenic acid,caffeic acid,salvianolic acid B and paeoniflorin showed good linear correlations in the range of 0.314–3.14μg,0.218–2.18μg,0.210–2.10μg,0.392–3.92μg,and 0.540–5.40μg,respectively.The recovery rates were 97.12%,98.46%,97.53%,96.98%,and 97.43%,respectively.Conclusion The TLC and HPLC method is simple and easy to operate,and the results are accurate and reliable.It can be used for the quality control of Puyin Hugan Granules.
作者
杨烨
郑艳萍
李伟东
蔡宝昌
YANG Ye;ZHENG Yan-ping;LI Wei-dong;CAI Bao-chang(Zhongda Hospital,Southeast University,Nanjing 210009,China;Nanjing Haichang Chinese Medicine Group Co.Ltd.,Nanjing 210061,China;Jiangsu Haisheng Pharmaceutical Co.Ltd,Nanjing 210061,China)
出处
《中国中医药信息杂志》
CAS
CSCD
2018年第8期75-79,共5页
Chinese Journal of Information on Traditional Chinese Medicine
基金
江苏省科技项目-社会发展-面上项目(BE2016626)
作者简介
通讯作者:郑艳萍,E-mail:zyp611@163.com。
