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目的建立双黄连口服液体内外HPLC指纹图谱。方法色谱柱为Welchrom C18柱(150 mm×4.6 mm,5μm),流动相为甲醇-0.2%磷酸水溶液,梯度洗脱,分段变波长测定;柱温30℃;进样量10μL。结果利用中药色谱指纹图谱相似度软件2004A版,对每种制备方法各10批次样品和不同制备方法进行整体相似度评价,结果相似度平均值均大于0.93。药典法制备的双黄连口服液3种指标成分体内外相关性良好。结论该方法精密度、稳定性和重复性良好,所建立的对照指纹图谱具有较好的代表性,该方法为建立中药口服制剂新的评价体系提供了思路。
Objective To establish an HPLC fingerprint of Shuanghuanglian oral liquid. Methods The column was Welchrom C18 column (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol-0.2% phosphoric acid solution and eluted with gradient elution. The column temperature was 30 ℃ and the injection volume was 10 μL. Results According to the software of TCM chromatographic fingerprinting similarity 2004A, the overall similarity of 10 batches of each preparation method and different preparation methods were evaluated. The average similarity values were all greater than 0.93. Shuanghuanglian oral solution prepared by the pharmacopoeia of three indicators of good correlation in vitro and in vivo. Conclusion The method has good precision, stability and repeatability. The established control fingerprinting has good representativeness. This method provides a new idea for establishing a new evaluation system of traditional Chinese medicine oral preparations.