ABSTRACT
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, 5 μm); 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°C; 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.
