紫锥菊口服液质量评价

Study and Evaluation of Quality Control of Echinacea Purpurea Oral Liquid

摘要:

目的: 完成紫锥菊口服液质量研究与评价。方法: 采用硅胶GF₂₅₄预制板,以乙酸乙酯-甲酸-水(6:0.5:1)的上层溶液为展开剂,进行TLC定性鉴别;以Agilent Eclipse XDB-C₁₈色谱柱(4.6 mm×250 mm,5 μm),流动相乙腈-0.3%磷酸水溶液梯度洗脱,流速1.2 mL·min^-1,检测波长330 nm,柱温35℃,进样量10 μL,进行HPLC含量测定;同时对指标pH、相对密度进行质量研究。结果: 紫锥菊口服液有良好的薄层鉴别特征;有效成分菊苣酸含量在0.004~0.128 g·L^-1,进样量与其色谱峰峰面积呈良好的线性关系(r=0.999 9),平均加样回收率101.13%,RSD 1.41%。结论: TLC定性鉴别,操作简便,重复性好。HPLC含量测定方法简便、快速、准确。所建立的方法可用于柴锥菊口服液质量控制。

Abstract:

Objective: To establish the quality standard and evaluation of Echinacea Purpurea oral liquid. Method: TLC test was based on silica gel plate with the upper solution of ethyl acetate-acetic acid-water (6:0.5:1) as mobile phase. The analytical column was Agilent Eclipse XDB-C₁₈(4.6 mm×250 mm, 5 μm) with acetonitrile and 0.3% phosphoric acid as mobile phase in gradient mode;the flow rate was 1.2 mL·min^-1;the detecting wavelength was set at 330 nm;the column temperature was set at 35℃ and the injection volume was 10 μL. At the same time, pH and relative density were determined. Result: Characteristic of Echinacea Purpurea oral liquid was clear. The linear range of cichoric acid was 0.004-0.128 g·L^-1(r=0.999 9), and the average recovery was 101.13% with RSD 1.41%. Conclusion: The method to identify cichoric acid is simple and has a great repeatability. The method to detemine the content of cichoric acid in Echinacea Purpurea oral liquid is simple, accurate with a good reproducibility. So the TLC and HPLC methods can be used for the quality of the oral liquid.