目的：建立安舒液的质量标准。方法采用薄层色谱法对制剂中地肤子、黄柏进行定性鉴别。采用高效液相色谱法对制剂中盐酸小檗碱、盐酸黄柏碱含量进行测定，ZORBAX SB-C18柱（4.6 mm×250 mm，5µm）分离，以乙腈0.1%磷酸（1000 mL加50µL二乙胺）为流动相梯度洗脱，流速1.0 mL/min，检测波长284 nm。结果薄层色谱分别检出黄柏中的盐酸黄柏碱、盐酸小檗碱及地肤子中的地肤子皂苷 Ic。盐酸小檗碱线性关系为Y＝23.109X－30.548（r2＝0.9998），加样回收率RSD＝2.97%，表明盐酸小檗碱进样量在0.0505～2.5250µg范围内有良好的线性关系；盐酸黄柏碱线性关系为Y＝10.038X－2.4466（r2＝0.9999），加样回收率RSD＝1.24%，表明盐酸黄柏碱进样量在0.0500～2.5000µg范围内有良好的线性关系。结论该方法准确、快速、稳定、可靠，重复性好，可用于安舒液的质量控制及评价。%Objective To establish quality standards forAnshu Liquid.Methods Phellodendri Chinensis Cortex and Kochiae Fructus were qualitatively identified by TLC method. The contents of berberine hydrochloride and phellodendrine hydrochloride in the preparation were determined by HPLC method. The chromatographic column was ZORBAX SB-C18 (4.6 mm×250 mm, 5μm); the mobile phase was acetonitrile-0.1% phosphoric acid (0.5% diethylamine) gradient elution; the flow rate was 1.0 mL/min; the detection wavelength was 284 nm.Results Berberine hydrochloride and phellodendrine hydrochloride in Phellodendri Chinensis Cortex and saponin Ic in Kochiae Fructus were detected by TLC method. The linear relationship of berberine hydrochloride in the preparation was Y=23.109X−30.548,r2=0.999 8, RSD=2.97%, showing that the linear range of berberine hydrochloride was 0.050 5– 2.525 0 µg. The linear relationship of phellodendrine hydrochloride in the preparation wasY=10.038X−2.446 6, r2=0.999 9, RSD=1.24%, showing that the linear range of phellodendrine hydrochloride was 0.050 0–2.500 0 µg. Conclusion The method is accurate, rapid, stable and reliable, with good reproducibility, which can be used for the quality control and evaluation ofAnshu Liquid.
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