蒙药红花益肝丸的质量标准研究  

Study on Quality Standard of Mongolian Medicine Honghua Yigan Wan

作　　者：布音 祁峰 陈苏依勒 BU Yin;QI Feng;CHEN Suyile(Preparation Center,Alxa League Mongolian Hospital,Alxa League Inner Mongolia 750300,China)

机构地区：[1]阿拉善盟蒙医医院制剂中心,内蒙古阿拉善盟750300

出　　处：《中国卫生标准管理》2023年第16期101-105,共5页China Health Standard Management

基　　金：中央本级重大增减支项目(2060302);内蒙古自治区人民政府蒙医药标准化项目(2021-〔MB025〕)。

摘　　要：目的建立红花益肝丸的鉴别方法及有效成分的检测方法,为红花益肝丸质量标准提升提供参考。方法运用显微鉴别法对红花益肝丸中的西红花、木香、毛诃子、丁香进行显微鉴别,选用薄层色谱法对红花益肝丸中的丁香酚进行定性分析,采用高效液相色谱法对红花益肝丸中的栀子苷含量进行定量分析。结果显微特征明显,薄层色谱中,斑点清晰,无明显干扰斑点,可用于定性鉴别;高效液相色谱法在栀子苷在0.2234~0.8190μg范围内与峰面积呈良好的线性关系(r=0.9999),栀子苷平均回收率为98.8%。结论所建立的方法专属性强、重现性好、灵敏度高,可以用于红花益肝丸的质量控制。Objective To establish identification method and detection method of the effective components for Honghua Yigan Wan,and provide reference for the improvement of the quality standard of Honghua Yigan Wan.Methods Microscopic identification was used for qualitative determination of Xihonghua,Muxiang,Maokezi and Dingxiang in Honghua Yigan Wan.Thin layer chromatography was applied for identification of eugenol in the prescription,and high performance liquid chromatography was used for quantitative determination of geniposide.Results The microscopic features are obvious,the spots are clear in TLC,and there are no obvious interference spots,which can be used for qualitative identification.At the same time,a good linearity of geniposide was shown in range of 0.2234-0.8190μg(r=0.9999)with the HPLC.The average recovery was 98.8%.Conclusion The methods in this research are strong specificity,good reproducibility,and with high sensitivitycan.It can be used for quality control of Honghua Yigan Wan.

关 键 词：质量控制 薄层色谱 丁香酚 高效液相色谱 含量测定 栀子苷 

分 类 号：R927[医药卫生—药学]