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目的:建立速效止泻胶囊的定性定量检测方法。方法:采用TLC法鉴别速效止泻胶囊中盐酸小檗碱和拳参;采用HPLC法测定处方中盐酸小檗碱含量及拳参中绿原酸含量。盐酸小檗碱色谱条件:依利特Hypersil ODS2(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.05 mol·L-1磷酸二氢钾溶液-三乙胺(40∶60∶0.1)为流动相,流速1 mL·min-1,紫外检测波长346 nm,柱温为30℃;绿原酸色谱条件:依利特Hypersil ODS2(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.01 mol·L-1磷酸二氢钾溶液-三乙胺-磷酸(7∶93∶0.4∶0.3)为流动相,流速1 mL·min-1,紫外检测波长327 nm,柱温为30℃。结果:盐酸小檗碱和拳参薄层色谱定性鉴别特征明显;盐酸小檗碱与绿原酸含量测定,分别在2.0～6.0μg(r=0.9992)和0.1～1.8μg(r=0.9999)线性关系良好;平均回收率(n=6)分别为99.2%和102.3%,RSD分别为0.77%和1.3%。结论:本法可准确地定性、定量,有效地控制速效止泻胶囊的质量。
Objective: To establish a qualitative and quantitative detection method of quick-acting anti-diarrhea capsule. Methods: TLC method was used to identify berberine hydrochloride and fistula in quick-acting Zhixie capsule. The content of berberine hydrochloride and the content of chlorogenic acid in fistula were determined by HPLC. Berberine Hydrochloride Chromatographic conditions: Elite Hypersil ODS2 (4.6 mm × 250 mm, 5μm) column with acetonitrile-0.05 mol·L-1 potassium dihydrogen phosphate solution-triethylamine (40:60:0.1) as mobile Phase flow rate of 1 mL · min-1, UV detection wavelength of 346 nm, column temperature of 30 ℃; chlorogenic acid conditions: Elite Hypersil ODS2 (4.6 mm × 250 mm, 5μm) L-1 potassium dihydrogen phosphate solution-triethylamine-phosphoric acid (7:93:0.4:0.3) was used as the mobile phase at a flow rate of 1 mL · min-1. The UV detection wavelength was 327 nm and the column temperature was 30 ℃. Results: The chromatographic identification of berberine hydrochloride and fistifolia was significant. The contents of berberine hydrochloride and chlorogenic acid were determined respectively at 2.0-6.0μg (r = 0.9992) and 0.1-1.8μg (r = 0.9999) The average recoveries (n = 6) were 99.2% and 102.3%, respectively, with RSDs of 0.77% and 1.3%, respectively. Conclusion: This method can accurately, quantitatively and effectively control the quality of quick-acting anti-diarrhea capsule.