三益丹质量标准的建立  

Study on the Quality Standard for Sanyidan

作　　者：田欢 李晔[2] 张红[2] 陈志永 刘洋[2] 孙婷婷[2] 赵锋 Tian Huan;Li Ye;Zhang Hong;Chen Zhiyong;Liu Yang;Sun Tingting;Zhao Feng(Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712046,China;Shaanxi Academy of Traditional Chinese Medicine;Xi'an Traditional Chinese Medicine Hospital)

机构地区：[1]陕西中医药大学,陕西咸阳712046 [2]陕西省中医药研究院 [3]西安市中医医院

出　　处：《中国药师》2019年第5期919-922,共4页China Pharmacist

基　　金：陕西省科技厅统筹创新工程计划项目(编号:2016KTCL03-14);西安市科技计划项目[编号:2017122SF/YXO13(137)]

摘　　要：目的:建立三益丹丸剂的质量控制方法。方法:采用TLC法鉴别制剂中血竭、人工麝香、人工牛黄、延胡索、西洋参;采用高效液相色谱仪与蒸发光散射检测器联用技术(HPLC-ELSD)同时测定三益丹中胆酸、猪去氧胆酸、人参皂苷Rb1的含量。采用高效液相色谱仪与蒸发光散射检测器联用技术(HPLC-ELSD),色谱柱为岛津Inert Sustain C_(18)柱(250 mm×4. 6 mm,5μm),0. 1%甲酸水溶液-乙腈,梯度洗脱;流速:1 ml·min^(-1),柱温:30℃,进样量:10μl;同时测定三益丹中胆酸、猪去氧胆酸、人参皂苷Rb_1的含量。结果:TLC鉴别的相应斑点清晰,且阴性对照无干扰;含量测定胆酸、猪去氧胆酸、人参皂苷Rb_1分别在1. 791～8. 955μg(r=0. 999 5),1. 102～5. 508μg(r=0. 999 6),1. 092～4. 680μg(r=0. 999 9)质量范围内与峰面积成良好的线性关系,平均加样回收率分别为98. 10%、98. 24%、100. 13%,RSD分别为1. 90%、3. 30%、3. 40%(n=6)。结论:本法操作简便,结果准确、重现性好,可用于三益丹的质量控制。Objective:To establish the quality standard for Sanyidan.Methods:Dragon’s blood,Artificial musk,Artificial CowBezoar,Corydalis Rhizoma and American Ginseng in the preparation were identified by TLC,and the contents of cholic acid,hyodeoxycholic acid and ginsenoside Rb1 were simultaneously determined by HPLC-ELSD.While the cholic acid,hyodeoxycholic acid,and ginsenoside Rb1 were simultaneously determined by HPLC-ELSD,the column was a Inert Sustai C18(250 mm×4.6 mm,5μm),the column was 0.1%phosphoric acid-acetonitrile with gradient elution,the flow rate was 1.0 ml·min^-1,the column temperature was 30℃and the injection volume was 10μl.Results:The TLC spots were clear without any interference from the negative control;the calibration curve of cholic acid,hyodeoxycholic acid and ginsenoside Rb1 was linear within the range of 1.791-8.955μg,1.102-5.508μg and1.092-4.680μg,respectively.The average recovery was 98.10%,98.24%and 100.13%with the RSD of 1.90%,3.30%and3.40%(n=6),respectively.Conclusion:The method is simple,accurate and reproducible,which can be used for the quality control of Sanyidan.

关 键 词：三益丹 薄层鉴别法 含量测定 质量标准 

分 类 号：TQ460.72[医药卫生—药物分析学]