甘地颗粒质量标准研究  

Study on Quality Standard of Gandi Granules

作　　者：朱红岩 李弥 张颖[1] 张艳红 樊敏伟 徐阿晶[1] 张健[1] ZHU Hong-yan;LI Mi;ZHANG Ying;ZHANG Yan-hong;FAN Min-wei;XU A-jing;ZHANG Jian(Department of Clinical Pharmacy,Xinhua Hospital Affiliated to School of Medicine of Shanghai Jiao Tong University,Shanghai 200092,China;National Research Center of Pharmaceutical Engineering Technology of Traditional Chinese Medicine-Shanghai Chinese Medicine Pharmaceutical Technology Co.,Ltd.,Shanghai 201203,China)

机构地区：[1]上海交通大学医学院附属新华医院临床药学部,上海200092 [2]国家中药制药工程技术研究中心-上海中药制药技术有限公司,上海201203

出　　处：《食品与药品》2024年第6期570-575,共6页Food and Drug

摘　　要：目的建立甘地颗粒的质量标准。方法通过薄层色谱法(TLC)定性鉴别甘地颗粒中的黄芪、黄芩、山茱萸、地黄4味药材;通过高效液相色谱法(HPLC)测定甘地颗粒中黄芩苷、马钱苷两个指标成分的含量。结果黄芪、黄芩、山茱萸、地黄供试品图谱中,在与对照药材或对照品图谱相应的位置上显相同颜色的斑点,且阴性对照无干扰。黄芩苷、马钱苷质量浓度分别在8.98~143.64μg/ml(r=0.999)、5.63~153.53μg/ml(r=0.9999)范围内与峰面积呈良好的线性关系,平均加样回收率(n=6)分别为92.68%(RSD=0.25%)、94.84%(RSD=0.54%),初步拟定甘地颗粒中有效成分黄芩苷的含量不低于18 mg/g,马钱苷的含量不低于1.2 mg/g。结论本研究所建立的甘地颗粒质量标准简便易行,TLC和HPLC方法准确、专属性强、重复性好,可用于甘地颗粒的质量控制。Objective To establish the quality standard of Gandi Granules.Methods Thin layer chromatography(TLC)was used to qualitatively identify Astragali Radix,Scutellariae Radix,Corni Fructus and Rehmanniae Radix in Gandi Granules.High performance liquid chromatography(HPLC)was used to determine the contents of baicalin and loganin in Gandi Granules.Results In TLC chromatograms of Astragali Radix,Scutellariae Radix,Corni Fructus and Rehmanniae Radix,the same color spots were shown in the corresponding positions of chromatograms of reference herbs or reference substances,and negative control had no interference.The linearities of baicalin and loganin were in the concentration range of 8.98-143.64μg/ml(r=0.999)and 5.63-153.53μg/ml(r=0.9999),respectively.The average recoveries(n=6)were 92.68%(RSD=0.25%)and 94.84%(RSD=0.54%),respectively.The contents of baicalin and loganin in Gandi Granules were not less than 18 mg/g and 1.2 mg/g,respectively.Conclusion The quality standard of Gandi Granules established in this study is simple and easy to operate.The TLC and HPLC methods are accurate,specific and reproducible,and can be used for the quality control of Gandi Granules.

关 键 词：甘地颗粒 质量标准 薄层色谱法 高效液相色谱法 黄芩苷 马钱苷 

分 类 号：R284.1[医药卫生—中药学]