关键词: 妇科洗剂, 盐酸小檗碱, TLC, HPLC, 指纹图谱

Abstract: This study aims to establish quality-control method for gynecological lotion using thin-layer chromatography (TLC),high-performance liquid chromatography (HPLC) fingerprint analysis.TLC was used to qualitatively identify the main ingredients of Sophorae flavescentis radix, Phellodendri chinensis cortex and Cnidii fructus. HPLC was applied to determine berberine hydrochloride in gynecological lotion.HPLC was used with Wondasil C18 (250 mm×4.6 mm,5 μm) as the analytical column.The mobile phase was composed of acetonitrile-0.1% phosphric acid solution (50:50) (0.2 g sodium dodecylsulphate was added into the 100 mL mobile phase).The detection wavelength was set at 265 nm and the column temperature was 30 ℃.The same analytical column was selected for the HPLC fingerprint analysis.The mobile phase was composed of acetonitrile-0.3% phosphric acid and 0.3% diethylamine solution.The detection wavelength was set at 284 nm and the column temperature was 30 ℃.Ten batches of gynecological lotion sample were detected by the HPLC method and evaluated with Similarity Evaluation System (SES) for chromatographic fingerprint of Traditional Chinese Medicine (Version 2004A).The corresponding spots in gynecological lotion were clear and had no interference in the negative control.The calibration curve of berberine hydrochloride was in good linearity,ranging from 132.40-662.00 ng (r=0.9999).The average recovery rate was 100.97% (RSD=2.76%).Fifteen characteristic peaks were illustrated on HPLC fingerprints.The similarities of 10 batches of gynecological lotion range from 0.9490.998.HPLC fingerprint analysis was a feasible quality-control method for gynecological lotion as it provided quantitative data,higher resolution and better separation performance than TLC and HPLC.It is a promising complementary quality-control method for gynecological lotion.

Key words: gynecological lotion, berberine hydrochloride, TLC, HPLC, fingerprint