人参茸芝胶囊的质量控制研究

tudy on quality control for Renshen Rongzhi capsules

中文关键词:  人参茸芝胶囊  薄层色谱法  高效液相色谱法  质量控制

英文关键词:Renshen Rongzhi capsules  thin layer chromatography  high performance liquid chromatography  quality control

中文摘要:

      目的 建立人参茸芝胶囊中人参、灵芝孢子粉的定性鉴别和标志性成分人参皂苷和灵芝酸A含量测定的方法。方法 用薄层色谱法(thin layer chromatography, TLC)定性鉴别人参茸芝胶囊中人参、灵芝孢子粉; 用高效液相色谱法(high performance liquid chromatography, HPLC)测定人参皂苷和灵芝酸A的含量。结果 薄层鉴别荧光斑点清晰, 分离度好, 阴性对照无干扰; 人参皂苷在0.5~50 μg范围内呈良好的线性关系, 平均回收率在98.53%~102.53%之间, 相对标准偏差(RSD)在0.84%~1.83%之间; 灵芝酸A的线性范围0.0006~0.06 mg/mL(r2=0.9998), 平均回收率为98.80%, RSD为0.89%。结论 所建立的人参、灵芝孢子粉定性鉴别、标志性成分人参皂苷和灵芝酸A定量检测方法可用于人参茸芝胶囊的质量控制。

英文摘要:

      Objective To establish the methods to qualitatively identify the ginseng and Ganoderma lucidum spore powder, and determine the ginsenosides and ganoderic acid A in the Renshen Rongzhi capsules. Methods Qualitative identification of ginseng and ganoderma spore in Renshen Rongzhi capsules was carried out by thin layer chromatography (TLC). Ginsenosides and Ganoderma acid A were determined by high per-formance liquid chromatography (HPLC). Results The TLC spots were clear with high resolution, and the blank test showed no interference. The linear range of ginsenosides was 0.5~50 μg, the average recovery was between 98.53%~102.53%, and the relative standard deviation (RSD) was between 0.84%~1.83%. The linear range of ganoderma acid A was 0.0006~0.06 mg/mL (r2=0.9998), the average recovery was 98.80%, and the RSD was 0.89%. Conclusion The qualitative and quantitative analysis methods are applicable for the quality control of Renshen Rongzhi capsules.