珍母丸质量标准研究

Study on Quality Standard of Zhenmu Pills

关键词:  珍母丸  质量标准  高效液相色谱法  薄层色谱法  显微鉴别

Key words:  Zhenmu pills  quality standard  HPLC  TLC  microscopic identification

摘要:

目的 建立珍母丸的质量标准。方法 采用显微鉴别方法对枸杞子、珍珠母的显微鉴别进行描述，采用薄层色谱法对香附、山茱萸、赤芍进行定性鉴别；采用HPLC测定赤芍中芍药苷的含量，色谱柱为Accurasil C₁₈（250 mm×4.6 mm，5 μm），以乙腈-0.2%磷酸溶液（15∶85）为流动相，流速为1.0 mL·min^-1，检测波长为230 nm，进样量为10 μL。结果 显微、薄层色谱有较强的专属性，赤芍中芍药苷在0.193~2.415 μg内线性关系良好（r=0.999 5），平均回收率为101.56%，RSD为1.45%（n=6）。结论 本方法操作简便，重复性好，可作为珍母丸的质量控制方法。

Abstract:

OBJECTIVE To establish the quality standard for Zhenmu Pills. METHODS Microscopic identification method was used to identify Lycii Fructus and Margaritifera Concha. TLC was adopted to identify Cyperi Rhizoma, Corni Fructus and Paeoniae Radix Rubra. The content of paeoniflorin in Paeoniae Radix Rubra was determined by HPLC. The chromatographic separation was carried out on an Accurasil C₁₈(250 mm×4.6 mm, 5 μm) column. The mobile phase consisted of acetonitrile-0.2% phosphoric acid solution(15:85) at a flow rate of 1.0 mL·min^-1. The detection wavelength was 230 nm and the injection volume was 10 μL. RESULTS Microscopic identification method and TLC had strong specificity. The linear range was 0.193-2.415 μg(r=0.999 5). The average recovery was 101.56% with the RSD of 1.45%(n=6). CONCLUSION The method is simple and good repeatability, which can be used as the quality control method for Zhenmu Pills.