双黄连口服液指标成分体内外相关性研究

In vivo and in vitro correlation of quality control components in Shuanghuanglian Oral Liquid

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 the in vitro and in vivo HPLC fingerprint of Shuanghuanglian Oral Liquid （SOL）. Methods The chromatographic fingerprint was obtained with Welchrom C18 column （150 mm × 4.6 mm, 5μm）; The mobile phase was methanol-0.2% phosphoric acid aqueous solution, with gradient elution and segmentation variable wavelength determination; The column temperature was maintained at 30 ℃; The injection volume was 10 μL. Results Among 10 batches of samples prepared by single and different preparation methods, the overall similarity evaluation was taken using the Chromatographic Fingerprint Similarity Software for Chinese Materia Medica （Version 2004A）, and the average similarities were all above 0.93. The better in vivo and in vitro correlation of the index constituents in SOL prepared by the method of Pharmacopoeia of People ＂s Republic of China was obtained. Conclusion The method had good precision, stability, and repeatability. The standard chromatographic fingerprint established has a better representativity, and the method provides the new ideas for establishing the new evaluation system of Chinese materia medica oral preparation.