黄麦颗粒的质量标准研究  

Study on the Quality Standard of Huangmai Granules

作　　者：金冠钦[1] 夏玲红[1] 孙黎[1] 林厚文[1,2] 

机构地区：[1]上海交通大学医学院附属仁济医院,上海200001 [2]上海交通大学医学院,上海200025

出　　处：《中国药房》2015年第24期3410-3413,共4页China Pharmacy

基　　金：上海市科学技术委员会科研计划项目课题(No.12401900502)

摘　　要：目的：建立黄麦颗粒的质量控制方法,为该制剂的质量控制提供依据。方法：采用薄层色谱（TLC）法对黄麦颗粒中的黄芪进行鉴别,采用高效液相色谱（HPLC）法测定黄麦颗粒中的淫羊藿苷、金丝桃苷及二苯乙烯苷的含量。结果：该品TLC色谱斑点清晰,重复性好;HPLC法测定淫羊藿苷、金丝桃苷及二苯乙烯苷线性范围分别为9.969~319.0μg/ml（r=0.999 9）、12.3~196.8μg/ml（r=0.999 9）、12.64~202.2μg/ml（r=0.999 8）;精密度、稳定性、重复性试验的RSD均≤2.92%;平均加样回收率分别为95.44%、101.06%、100.51%,RSD分别为1.46%、1.90%、1.73%（n=6）。结论：该方法操作简便、重复性好、结果准确可靠,可用于黄麦颗粒的质量控制。OBJECTIVE： To establish a method for the quality control of Huangmai granules and provide reference for the quality control. METHODS： TLC was conducted to identify the Leguminosae in Huangmai granules and HPLC was used to determine the contents of icariin, hyperin and stilbene glycoside in Huangmai granules. RESULTS： The spots on TLC plates were clear with good reproducibility. The results of HPLC showed that the linear range was 9.969-319.0 μg/ml （r=0.999 9） for icariin, 12.3-196.8μg/ml（r=0.999 9） for hyperin and 12.64-202.2 μg/ml （r=0.999 8） for stilbene glycoside; RSDs of precision, stability and reproducibility tests were all no more than 2.92%; the average recoveries were respectively 95.44% （RSD=1.46%, n=6）, 101.06% （RSD=1.90%, n=6） and 100.51% （RSD=l.73%, n=6）. CONCLUSIONS： The method is simple, reproducible, accurate and reliable, and can be used for the quality control of Huangmai granules.

关 键 词：黄麦颗粒 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R284.1[医药卫生—中药学] R927.2[医药卫生—中医学]