【摘要】 目的 建立健脾祛湿丸（浓缩丸）的质量标准。方法 对全方药味分别进行薄层色谱（TLC）鉴别；采用高效液相色谱（HPLC）法测定落新妇苷、盐酸小檗碱、丹酚酸B的含量。结果 土茯苓和黄柏、苦参、连翘、茯苓、白术、丹参、薏苡仁、白花蛇舌草的TLC图谱斑点清晰，分离度好，阴性对照无干扰。落新妇苷、盐酸小檗碱、丹酚酸B质量浓度分别在0.02～0.10 mg/mL,0.176～0.88 mg/mL,0.014 4～0.072 mg/mL范围内与峰面积线性关系良好（r=0.999 4,0.999 4,0.999 8,n=5），精密度、稳定性、重复性试验结果的RSD均小于2.0%；平均加样回收率分别为99.38%,101.53%,100.82%,RSD分别为1.94%,0.69%,1.31%(n=6)。结论 该研究所建质量标准操作快速简便，结果准确，可用于健脾祛湿丸（浓缩丸）的质量控制。更多还原

【Abstract】 Objective To establish the quality standards of Jianpi Qushi Pills(concentrated pills).MethodsThin LayerChromatography(TLC) was used for the identification of the herbal ingredients in the formula;High-Performance Liquid Chromatography(HPLC) was employed to determine the content of astilbin,berberine hydrochloride and salvianolic acid B.ResultsThe TLC chromatograms of the herbs,including Smilacis Glabrae Rhizoma and Phellodendri Chinensis Cortex,Poria,CoicisSemen,Atractylodis Macrocephalae Rhizoma,Sophorae Flavescentis Radix,Forsythiae Fructus,Herba Hedyotidis,Salviae MiltiorrhizaeRadix et Rhizoma,showed clear spots with good separation,and no interference from the negative control. The linear ranges ofastilbin,berberine hydrochloride and Salvianolic acid B were 0. 02 to 0.10 mg/m L,0.176 to 0.88 mg/m L,and 0.014 4 to0.072 mg/m L,respectively(r =0.999 4,0.999 4,0.999 8,n=5). The results of precision,stability,and repeatability testsshowed that the relative standard deviations(RSDs) were all less than 2. 0%. The average recovery rates were 99. 38%,101. 53%,and 100. 82%,with RSDs of 1.94%,0.69%,and 1.31%(n=6),respectively.ConclusionThe established quality standards aresimple,quick,and accurate,and can be used for quality control of Jianpi Qushi Pills(concentrated pills).更多还原