蒙花锚肝宁片质量标准研究  

Quality standard of Menghuamao Ganning tablets

作　　者：问静 韩达斌 汪永明 王永晶 祁彦凯 刘海青 刘学良 WEN Jing;HAN Da-bin;WANG Yong-ming;WANG Yong-jing;QI Yan-kai;LIU Hai-qing;LIU Xue-liang(Qinghai Center for Drug Evaluation and Inspection,Xining 810007)

机构地区：[1]青海省药品审评核查中心,西宁810007

出　　处：《中南药学》2023年第10期2715-2719,共5页Central South Pharmacy

基　　金：青海省基础研究项目(No.2020-ZJ-747)。

摘　　要：目的建立蒙花锚肝宁片的鉴别及含量测定方法。方法采用薄层色谱(TLC)法对椭圆叶花锚有效成分1-羟基-3,4,5-三甲氧基酮和熊果酸进行定性鉴别,采用高效液相色谱(HPLC)法测定蒙花锚肝宁片中有效成分木犀草素、1-羟基-3,4,5-三甲氧基酮和当药苷的含量。结果在TLC色谱中,1-羟基-3,4,5-三甲氧基酮和熊果酸色谱鉴别斑点清晰,且阴性样品无干扰;HPLC测定木犀草素、1-羟基-3,4,5-三甲氧基酮和当药苷三种成分分别在0.0028~0.0560μg、0.0715~1.430μg、0.0020~0.0402μg内与峰面积呈良好的线性关系,平均加样回收率在96.76%~99.26%(RSD<1.3%)。结论该方法专属性强,简便可行,灵敏度高,能有效的控制蒙花锚肝宁片的内在质量。Objective To improve the quality standards of Menghuamao Ganning tablets.Methods l-hydroxy-3,4,5-trimethoxyxanthon,and ursolic acid in Menghuamao Ganning tablets were identified by thin layer chromatography(TLC).Luteolin,l-hydroxy-3,4,5-trimethoxyxanthon,ursolic acid,and sweroside in Menghuamao Ganning tablets were determined by high performance liquid chromatography(HPLC).Results The spots in the thin layer chromatography were clear,and the negative control had no interference.The injection mass of luteolin,l-hydroxy-3,4,5-trimethoxyxanthon and sweroside showed a good linear relationship with the peak area in the range of 0.0028~0.0560μg,0.0715~1.430μg and 0.0020~0.0402μg,respectively.The average recoveries were 96.76%~99.26%(RSD<1.3%).Conclusion The method is simple,accurate and sensitive,which can be used for the quality control of Menghuamao Ganning tablets.

关 键 词：蒙花锚肝宁片 薄层色谱法 高效液相色谱法 1-羟基-3 4 5-三甲氧基酮 熊果酸 木犀草素 当药苷 

分 类 号：R283[医药卫生—中药学] R917[医药卫生—中医学]