蒙药嘎日西散质量标准研究  

Study on Quality Standard of Garixi Powder

作　　者：特格喜白音 敖登其木格 田吉 王海荣 Tegexibaiyin;Aodengqimuge;TIAN Ji;WANG Hairong(Pharmaceutical Laboratory of Inner Mongolia International Mongolian Hospital,Hohhot 010065,China)

机构地区：[1]内蒙古自治区国际蒙医医院药物实验室,呼和浩特010065

出　　处：《世界中医药》2021年第19期2871-2875,共5页World Chinese Medicine

基　　金：蒙药新药研发及药物实验室的建设项目(2016YJS14);蒙药新药研发及产业化创新团队项目(内组通字[2015]56号);2017年内蒙古自治区人民政府蒙医药标准化项目(2017-009)。

摘　　要：目的:建立蒙药嘎日西散的质量标准。方法:采用显微鉴别法对制剂中大黄、诃子、土木香、黑冰片、豆蔻、荜茇、山柰、石榴8味药材进行定性鉴别,选取薄层色谱法对制剂中荜茇、大黄及连翘3味药材进行定性鉴别,采用理化鉴别法对制剂中面碱进行定性鉴别,采用高效液相色谱法测定蒙药嘎日西散中游离大黄酚含量。结果:显微鉴别特征明显;薄层鉴别的色谱斑点清晰,阴性对照无干扰,专属性强。高效液相色谱法大黄酚进样量在47.45~1898 ng范围内呈良好的线性关系,r=1,平均回收率为97.08%,RSD为1.12%(n=6)。结论:本实验建立的分析方法准确、稳定、重复性好,适用于蒙药嘎日西散的质量控制。Objective:To establish quality standards for Garixi Powder.Methods:Microscopic identification was used for qualitative determination of rhubarb,fructus chebulae,elecampane inula root,black borneol,fructus amomi rotundus,piperis longi,rhizoma kaempferiae and punica granatum.Thin layer chromatography was applied for qualitative determination of piperis longi,rhubarb,and fructus forsythiae.Physical and chemical identification was used for qualitative determination of sodium carbonate decahydrate.High performance liquid chromatography was used for quantitative determination of free chrysophanol in thepowder.Results:The microscopic determination features were obvious and exclusive.TLC chromatographic spots were clear,and there was no interference for negative samples.A good linearity of chrysophanol was shown in range of 47.45~1898 ng(r=1)with high performance liquid chromatography.The average recovery of chrysophanol was 97.08%,and the RSD was 1.12%(n=6).Conclusion:The methods in this research are simple,sensitive,accurate,and with good reproducibility.It can be used for quality control of Garixi Powder.

关 键 词：嘎日西散 显微鉴别法 薄层色谱法 高效液相色谱法 大黄酚 含量测定 质量标准 

分 类 号：R29[医药卫生—民族医学] R289.5[医药卫生—中医学]