目的 建立苦参配方颗粒的质量控制标准。方法 采用薄层色谱（TLC）法鉴别苦参配方颗粒中苦参碱、槐定碱和氧化苦参碱。采用高效液相色谱（HPLC）法测定苦参配方颗粒中苦参碱和氧化苦参碱，色谱条件为Lichrospher-5NH2色谱柱（250 mm×4.6 mm，5 μm）；流动相：乙腈–无水乙醇–3%磷酸溶液（80∶10∶10）；体积流量：1.0 mL/min；柱温：30 ℃；检测波长：220 nm；进样量：10 μL。结果 苦参碱、槐定碱和氧化苦参碱在TLC色谱图中相应的位置上显相同的斑点。苦参碱在0.15～1.58 μg、氧化苦参碱在0.17～1.68 μg呈良好的线性关系，回收率分别为98.3%、101.5%，RSD值分别为1.35%、1.73%。结论 该方法快速、灵敏、准确，可用于苦参配方颗粒的质量控制

Objective To establish the quality control method of Sophorae Radix Dispensing Granule. Methods Matrine, sophoridine and oxymatrine in Sophorae Radix Dispensing Granule were identified by TLC method. Matrine and oxymatrine were determined by HPLC method on Lichrospher-5NH2 column (250 mm×4.6 mm, 5 μm). The mobile phase was acetonitrile-ethanol-3% phosphate solution (80:10:10) with flow rate at 1.0 mL/min. The detection wavelength was 220 nm and column temperature was 30 ℃ with injection volume of 10 μL. Results Matrine, sophoridine, and oxymatrine showed the same spots at different locations in TLC chromatograms. Linear ranges of matrine and oxymatrine were 0.15—1.58 μg and 0.17—1.68 μg, respectively. And their average recoveries were 98% and 103% with RSD values of 1.35% and 1.73%. Conclusion The established method is rapid, sensitive, and accurate, and could be used for the quality control of Sophorae Radix Dispensing Granule.