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目的建立洁阴洗剂的质量标准。方法采用薄层色谱法对洁阴洗剂中苦参、黄柏、虎杖、野菊花、淫羊藿进行定性鉴别;应用高效液相色谱法测定蛇床子素的含量,色谱条件为:Kromasil100-5C18(150mm×4.6mm)色谱柱,流动相:甲醇-水(65∶35),流速:1.0 mL.min-1,检测波长:322 nm,柱温:25℃。结果薄层色谱法能准确鉴别出制剂中的苦参、黄柏、虎杖、野菊花、淫羊藿,空白对照结果无干扰;蛇床子素与其他成分分离完全,峰形良好。蛇床子素在0.02～0.17μg范围内线性关系良好(r=0.9993)。平均加样回收率为100.4%,RSD为0.89%(n=6)。结论所建立的方法简便、准确、重现性好,可作为该制剂的质量控制方法。
Objective To establish the quality standard of Jieyin lotion. Methods TLC, HPLC, HPLC were used to determine the content of Osthol. The chromatographic conditions were as follows: Kromasil 100-5C18 ( 150 mm × 4.6 mm). The mobile phase consisted of methanol-water (65:35), flow rate 1.0 mL · min-1, detection wavelength 322 nm and column temperature 25 ℃. Results TLC was able to accurately identify the preparations of Sophora, Phellodendri, Polygonum cuspidatum, wild chrysanthemum, Epimedium, blank control without interference; osthole completely separated from other components, the peak shape is good. Osthole in the 0.02 ~ 0.17μg range of good linear relationship (r = 0.9993). The average recovery was 100.4% with a RSD of 0.89% (n = 6). Conclusion The method is simple, accurate and reproducible. It can be used as a quality control method for this preparation.