解毒利湿合剂质量标准研究

Study on Quality Standard for Jiedulishi Mixture

目的建立解毒利湿合剂的质量标准。方法采用TLC法对方中紫花地丁、川牛膝、黄柏、牡丹皮进行定性鉴别。用HPLC法测定绿原酸的含量。色谱柱:Amethyst C_(18)-H柱(250 mm×4.6 mm,5μm),流动相:乙腈-0.4%磷酸溶液(10∶90),流速:1.0 ml/min,检测波长:327 nm,柱温:30℃。结果 TLC斑点清晰、分离度好、阴性无干扰。绿原酸在4.045～258.88μg/ml范围内,线性关系良好(r=0.999 9),平均加样回收率99.40%,RSD=1.50%(n=6)。结论该方法简单、准确、重复性好,可用于控制解毒利湿合剂质量。

Abstaract: Objective To establish the quality standard for Jiedulishi Mixture. Methods TLC is used to identify Herba Violae, Cyathulae Radix, Phellodendri Chinensis Cortex, Moutan Cortex. The content of chlorogenic acid is determined by HPLC. The Amethyst C18-H column(250 mm × 4.6 mm, 5 μm)is used, acetonitrile-0.4 % phosphoric acid(10 : 90)as the mobile phase.The flow rate is 1.0 ml/min, and the detection wavelength is 327 nm, and column temperature is 30 ℃. Results The TLC spots are clear with good resolution and without interference from the negative samples. The linear range of chlorogenic acid is 4.045 ~ 258.88 μg/ml(r = 0.999 9), the average recovery rate is 99.40 %, and RSD is 1.50 %(n = 6). Conclusion The method is simple, accurate and reproducible,which can be used in the quality control of Jiedulishi Mixture.