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Abstract：Objective To establish the content determination method of berberine hydrochloride in Sifangwei capsules. Methods HPLC method was used with octadecylsilane chemically bonded silica as the filler, acetonitrile-0.05 mol/L KH2PO4 solution (25∶75) as the mobile phase, detective wavelength was 230 nm. The number of theoretical plates should not be less than 3 000. Results The content determination method has a good linear relation at the range of 0.201 6～1.008 μg (r=0.999 8). The recovery rate was 98.7%, RSD=1.24% (n=5). Conclusion The method is simple, accurate, with good separation and reproducibility, and can be used for the quality control of Sifangwei capsules.

Key words：HPLC;Sifangwei capsules;berberine hydrochloride;content determination

四方胃胶囊收载于《卫生部药品标准·中药成方制剂》第14册,功效疏肝和胃、制酸止痛,用于肝胃不和所致胃痛、胃酸过多、消化不良、胃及十二指肠溃疡者。原标准中无含量测定项,本试验采用HPLC法测定方中主要药味黄连中盐酸小檗碱的含量[1],为控制产品质量提供依据。

1 仪器与试药

日本岛津LC-10ATvp高效液相色谱仪,岛津SPD-10ATvp检测器,浙江大学智达N2000双道色谱工作站。盐酸小檗碱(中国药品生物制品检定所,批号110713- 2002087);四方胃胶囊(市售,河南百年康鑫药业有限公司,批号040201、040601、040901、041201)。乙腈为色谱纯,其余试剂均为分析纯。

2 方法与结果

2.1 色谱条件及系统适用性试验

以十八烷基硅烷键合硅胶为填充剂;以乙腈-0.05 mol/L磷酸二氢钾溶液(25∶75)为流动相,检测波长230 nm。理论板数按盐酸小檗碱计算应不低于3 000,进样量10 μL。

2.2 对照品溶液的制备

精密称取盐酸小檗碱对照品5.04 mg,加甲醇制成每1 mL含50.4 μg的溶液,即得。

2.3 供试品溶液的制备