目的 建立苦參配方顆粒的質(zhì)量控制標(biāo)準(zhǔn)。方法 采用薄層色譜（TLC）法鑒別苦參配方顆粒中苦參堿、槐定堿和氧化苦參堿。采用高效液相色譜（HPLC）法測(cè)定苦參配方顆粒中苦參堿和氧化苦參堿，色譜條件為L(zhǎng)ichrospher-5NH2色譜柱（250 mm×4.6 mm，5 μm）；流動(dòng)相：乙腈–無(wú)水乙醇–3%磷酸溶液（80∶10∶10）；體積流量：1.0 mL/min；柱溫：30 ℃；檢測(cè)波長(zhǎng)：220 nm；進(jìn)樣量：10 μL。結(jié)果 苦參堿、槐定堿和氧化苦參堿在TLC色譜圖中相應(yīng)的位置上顯相同的斑點(diǎn)。苦參堿在0.15～1.58 μg、氧化苦參堿在0.17～1.68 μg呈良好的線性關(guān)系，回收率分別為98.3%、101.5%，RSD值分別為1.35%、1.73%。結(jié)論 該方法快速、靈敏、準(zhǔn)確，可用于苦參配方顆粒的質(zhì)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.