荜铃胃痛颗粒的质量标准研究

Quality standard for Biling Weitong Granules

目的：研究荜铃胃痛颗粒（延胡索，大黄，黄连等）的质量标准。方法：采用薄层色谱法对延胡索、大黄、黄连、吴茱萸、荜澄茄进行定性鉴别；采用RP-HPLC法对盐酸小檗碱进行定量分析。色谱柱为cm柱（ODS，250mm×4．6mm，5μm），流动相为乙睛-0．02mol／L的磷酸二氢钾（用磷酸调节pH至3．0）（25：75），检测波长为347nm，流速1．0mL／min。结果：薄层斑点清晰，阴性对照无干扰；盐酸小檗碱在0．04132-0．6198μg范围内有良好的线性关系（r=0．9999），平均回收率为101．93％，RSD=0．60％（n=6）。结论：方法简便可行，结果准确可靠，可作为本产品的质量控制方法。

AIM： To establish the quality standard of Biling Weitong Granules （Rhizoma Corydalis, Radix et Rhizoma Rhei, Rhizoma Couidis, etc. ）. METHODS： Rhizoma Corydalis, Radix et Rhizoma Rhei, Rhizoma Cop- tidis, Fructus Evodiae, Fructus Litseae were identified by TLC. The content of berberine hydrochloride was deter- mined by RP-HPLC Cls column（ODS, 250 mm x4.6 ram, 5 μm） was used as chromatographic column. The acetonitrile-0.02 mol/L potassium dihydrogen phosphate （Adjust with phosphoric acid to a pH of 3.0） （25：75） was used as mobile phase. The detection wavelength was at 347 nm. The flow rate was kept to 1. 0 mL/min. RESULTS： The TLC sports developed were fairly clear, and the blank test showed no interference. The linearity of berberine hydrochloride was good in the range of 0. 041 32-0. 619 8 μg（ r = 0. 999 9）. The average recovery of berberine hydrochloride was 101.93%, RSD = 0.60% （n = 6）. CONCLUSION ： The method is simple, reliable, accurate and can be applied as the quantity control method of Biling Weitong Granules.