玄槐止痛颗粒的质量标准研究  

Quality Control of Xuanhuai Zhitong Granules

作　　者：张浩怡 熊悦悦 张鹤鸣 ZHANG Haoyi;XIONG Yueyue;ZHANG Heming(Guangdong Provincial Engineering Research center for Dietary Supplement,Key Laboratory of Brain Cognition and Education Science,Ministry of Education,Institute of Brain Science and Rehabilitation Medicine,South China Normal University,Guangzhou 510631 Guangdong,China)

机构地区：[1]脑认知与教育科学教育部重点实验室,广东省中药保健食品工程技术研究中心,华南师范大学脑科学与康复医学研究院,广东广州510631

出　　处：《中药新药与临床药理》2021年第7期1024-1029,共6页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：广州市科技计划项目(201605100954069)。

摘　　要：目的建立玄槐止痛颗粒的质量标准。方法采用薄层色谱法对玄槐止痛颗粒中大黄、黄柏、救必应、槐花进行定性鉴别;高效液相色谱法测定大黄中芦荟大黄素、大黄酸、大黄素、大黄酚和大黄素甲醚5种蒽醌类成分的含量。结果薄层色谱方法专属性强,准确简便;含量测定方法准确,无阴性干扰。大黄中芦荟大黄素、大黄酸、大黄素、大黄素甲醚和大黄酚的含量分别为2.334、3.315、1.943、7.373、0.778μg·g^(-1),且在各自线性范围内线性关系良好(r分别为0.9999、0.9998、0.9997、0.9999、0.9999),平均加样回收率分别为98.54%(RSD=1.12%)、98.34%(RSD=0.58%)、98.05%(RSD=1.03%)、98.17(RSD=0.77%)、97.25%(RSD=1.13%)。结论所建立的鉴别方法和含量测定方法能有效控制玄槐止痛颗粒的质量,方法专属性强、准确度高、可重复性好,可为该制剂的质量控制提供参考。Objective To establish the quality standard for Xuanhuai Zhitong Granules.Methods TLC was used for the qualitative identification of Phellodendron,Rhubarb,Ilex rotunda Thunb,and Sophora japonica.High performance liquid chromatography(HPLC)was adopted in the content determination of five anthraquinones included aloe-emodin,rhein,emodin,chrysophanol and emodin mono methyl ether in rhubarb.Results TLC spots for different herbs were all clear,accurate and simple.The established method for quantitative determination were accurate with no negative interference.The contents of five anthraquinones in rhubarb,the aloe-emodin,rhein,emodin,emodin mono methyl ether and chrysophanol were respectively 2.334,3.315,1.943,7.373,0.778μg·g^(-1),and showed good linear relationships within their own ranges(r were 0.9999,0.9998,0.9997,0.9999,0.9999,respectively),and the average recoveries were 98.37%(RSD=2.80%),99.13%(RSD=1.20%),98.09%(RSD=1.54%),98.63(RSD=2.13%),97.94%(RSD=1.56%).Conclusion The established methods were both accurate,with strong specificity and repeatability,which can be used for the quality control of Xuanhuai Zhitong Granules and provide an experimental basis for further research.

关 键 词：薄层色谱法 反相高效液相色谱法 质量控制 玄槐止痛颗粒 蒽醌类 

分 类 号：R284.1[医药卫生—中药学]