茵栀黄护肝颗粒制备工艺及质量标准的研究  

Preparation Process and Quality Analysis of Yinzhihuang Hugan Granules

作　　者：李小伟 栗进才[2] 陈云飞 张松 刘旭东 葛君 LI Xiaowei;LI Jincai;CHEN Yunfei;ZHANG Song;LIU Xudong;GE Jun(Mengcheng County Hospital of Chinese Medicine,Mengcheng 233500,China;Bozhou Vocational and Technical College,Bozhou 236800,China)

机构地区：[1]安徽省蒙城县中医院,安徽蒙城233500 [2]亳州职业技术学院,安徽亳州236800

出　　处：《中国民族民间医药》2021年第17期47-52,共6页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：安徽省高校科学研究项目(项目编号:KJ2018ZD065)。

摘　　要：目的:研究茵栀黄护肝颗粒的制备工艺及质量标准。方法:以成型性、溶化性、吸湿性为指标,通过单因素试验优选茵栀黄护肝颗粒的最佳制备工艺;采用薄层色谱法(TLC)对茵栀黄护肝颗粒中佛手、栀子和黄连进行定性鉴别;运用高效液相色谱仪(HPLC)测定栀子苷含量,流动相乙腈-0.2%磷酸水溶液(10∶90),检测波长238 nm。结果:最佳制备工艺为稠膏∶糊精∶糖粉(1∶0.8∶2.4),干燥温度70℃。佛手、栀子和黄连的薄层色谱,斑点清晰且阴性无干扰;栀子苷在0.2052~0.4788μg(R^(2)=0.9984)浓度范围内呈良好的线性关系,平均回收率99.19%(RSD=0.13%),栀子苷含量不得少于0.45 mg/g。结论:本实验制备工艺可行,建立的质量控制方法专属性强、重复性好,可用于控制茵栀黄护肝颗粒的质量。Objective To study the preparation process and quality standards of Yin zhihuang Hugan Granules.Methods With formability,solubility and hygroscopicity as indicators,the optimal preparation process of Yin zhihuang Hugan granules was optimized by single factor tests;Thin-layer chromatography(TLC)was used for qualitative identification of gardeniae fructus,fingered citron and coptis chinensis in Yin zhihuang Hugan granules;High Performance Liquid Chromatography(HPLC)was adopted to determine the content of gardenoside with mobile phase of acetonitrile-0.2%phosphoric acid water(10∶90)and detection wavelength of 238 nm.Result The optimal preparation process was thick paste:dextrin:powdered sugar(1∶0.8∶2.4),dryingtemperature at 70℃.Spots of gardeniae fructus,fingered citron and coptis chinensis on TLC plates were clear without interference by the blank reference;Gardenoside showed a good linear relationship in the concentration range of 0.2052~0.4788μg(R^(2)=0.9984),with an average recovery rate of 99.19%(RSD=0.13%),and the content of gardenoside should not less than 0.45 mg·g^(-1).Conclusion The preparation process of this experiment is feasible,and the quality control method established has strong specificity and good repeatability,which can be used to control the quality of Yin zhihuang Hugan granules.

关 键 词：制备工艺 质量标准 栀子 佛手 黄连 

分 类 号：R282.6[医药卫生—中药学]