利湿通淋颗粒中小檗碱和益母草碱的质量控制

建立了利湿通淋颗粒中小檗碱和益母草碱的质量控制方法。采用Diamonsil C18柱（250 mm×4.6 mm，5 μm ），以乙腈-0.1%磷酸溶液（体积比为50:50），且每100 mL加十二烷基硫酸钠0.1 g溶液为流动相，流速为1.0 mL/min，检测波长为265 nm测定小檗碱的含量；采用Diamonsil C18色谱柱（250 mm×4.6 mm，5 μm），以乙腈-0.4%辛烷磺酸钠的0.1%磷酸溶液（体积比为24:76）为流动相，流速为1.0 mL/min，检测波长为277 nm测定益母草碱的含量。结果显示，小檗碱在0.052～0.520 μg质量范围内(r= 0.999 6)，益母草碱在0.039 6～0.396 0μg质量范围内(r=0.999 1)，进样量与峰面积均呈良好的线性关系。小檗碱的加样回收率为98.51%～102.1%，相对标准偏差为2.08%（n=6）；益母草碱的加样回收率为99.90%～102.6%，相对标准偏差为1.13%（n=6）。该含量测定方法专属性强、重现性好、操作简便，可用于利湿通淋颗粒的质量控制。

Quality control of berberine and leonurine in Lishitonglin Granules

A quality control method to quantify berberine and leonurine in Lishitonglin Granules via HPLC was established.The content of berberine was determined using the Diamonsil-C18 chromatographic column (250 mm×4.6 mm,5 μm) and acetonitrile-0.1% phosphoric acid(50:50,V/V)solution with 0.1 g sodium dodecyl sulfate per 100 mL of the solution as the mobile phase. The flow rate was 1.0 mL/min, and the detection wavelength was 265 nm. The content of leonurine was determined using the Diamonsil-C18 chromatographic column(250 mm×4.6 mm,5 μm).The mobile phase was acetonitrile-0.1% phosphoric acid solution (24:76, V/V) containing 0.4% sodium octane sulfonate. The flow rate was 1.0 mL/min, and the detection wavelength was 277 nm. The results showed that berberine was linear in the range of 0.052~0.520 μg(r=0.999 6) and leonurine was linear in the range of 0.039 6~0.396 0 μg (r=0.999 1). Further, there was a good linear relationship between injection volume and peak area. The recovery rate of berberine was 98.51%~102.1%, with relative standard deviation(RSD) of 2.08% (n=6).The recovery rate of leonurine was 99.90%~102.6%, with RSD of 1.13% (n=6). The established method has high specificity, good reproducibility, and ease of operation and can be used for the quality control analysis of Lishitonglin Granules.