人参次苷H滴丸定性与定量方法研究  

Qualitative and quantitative study for secondary ginsenoside H dripping pills

作　　者：张兰兰[1,2] 高文远[1] 宋兆辉[2] 蔡楠[2] 黄芝娟[2] 

机构地区：[1]天津大学药物科学与技术学院,天津300072 [2]天津天士力集团现代中药研究所,天津300410

出　　处：《中国新药杂志》2011年第9期774-776,802,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2008ZX09401-006)

摘　　要：目的：建立人参次苷H滴丸质量控制方法。方法：采用薄层色谱法同时鉴别人参皂苷Rh1和Rh2;采用香草醛冰醋酸-高氯酸比色法测定总皂苷含量;采用高效液相色谱法测定人参皂苷Rh1和Rh2含量。结果：人参皂苷Rh1和Rh2样品分离较好,薄层色谱斑点清晰;总皂苷含量测定的平均回收率为98.81%,线性范围为0.056~0.448 mg.mL-1;人参皂苷Rh1线性回归方程y=6 462.7x＋2.073 5,当进样量在0.208~4.16μg范围内,与其峰面积呈线性,r=0.9997;人参皂苷Rh2线性回归方程y=9867.2x＋0.1204,当进样量在1.148~22.96μg范围内,与其峰面积呈线性,r=0.999 9。结论：建立的人参次苷H滴丸质控方法准确、专属性及重现性好且快速简便,可用于该制剂的质量控制。Objective：To study the quality control methods for secondary ginsenoside H dripping pills.Methods：Ginsenosides,Rh1 and Rh2,were simultaneously identified by thin layer chromatography（TLC）.The contents of Rh1 and Rh2 were determined by high performance liquid chromatography（HPLC）.Results：Rh1 and Rh2 in samples were separated.The TLC spots were clear.The equation of linear regression was as follows：y=6 462.7x＋2.073 5（Rh1） and y=9 867.2x＋0.120 4（Rh2）.Rh1 and Rh2 showed a good linear relationship in the range of 0.208~4.16 μg（Rh1） and 1.148~22.96 μg（Rh2）.Conclusion：The method developed is highly specific,precise and accurate.It is suitable for the quality control of secondary ginsenoside H dripping pills.

关 键 词：人参次苷H滴丸 人参皂苷RH1 人参皂苷RH2 

分 类 号：R914.1[医药卫生—药物化学]