大柴胡颗粒质量标准研究  

Quality standard for Dachaihu Granules

作　　者：胡颖菲[1] 陆兔林[1] 毛春芹[1] 吴皓[1] 弓晓东[1] 周云中 王菊[1] 张星[1] 

机构地区：[1]南京中医药大学药学院,江苏南京210046 [2]南通精华制药股份有限公司,江苏南通226005

出　　处：《中成药》2013年第1期68-73,共6页Chinese Traditional Patent Medicine

基　　金：江苏省科技成果转化专项资金(BA2010094)

摘　　要：目的建立大柴胡颗粒(柴胡、黄芩、大黄、枳实、芍药等)的质量标准。方法采用薄层色谱法鉴别方中黄芩、大黄、枳实、白芍四味饮片,高效液相色谱法对柚皮苷、橙皮苷、新橙皮苷和黄芩苷进行定量测定,采用Kro-masil C18色谱柱,乙腈-0.2%醋酸水为流动相,梯度洗脱,检测波长280nm。结果 TLC斑点清晰,分离度良好,阴性无干扰;柚皮苷进样量在0.193 8～3.8760μg范围内呈现良好的线性关系,相关系数r=0.9990;橙皮苷进样量在0.109 6～2.1920μg范围内呈现良好的线性关系,相关系数r=0.999 9;新橙皮苷进样量在0.128 7～2.574 0μg范围内呈现良好的线性关系,相关系数r=0.9999;黄芩苷进样量在0.452 5～9.0504μg范围内呈现良好的线性关系,相关系数r=0.9999,4个待测成分的方法平均回收率分别为99.94%、95.83%、97.46%和98.94%(RSD<3%)。结论定性定量方法简便、结果准确可靠、专属性强,所建标准可用于大柴胡颗粒的质量控制。AIM To establish the quality standard for Dachaihu Granules （Bupleuri Radix, Scutellariae Radix, Rhei Radix et Rhizoma, Aurantii Fructus immaturus and Paeoniae Radix alba, etc. ）. METHODS TLC was used for the qualitative identification of Scutellariae Radix, Rhei Radix et Rhizoma, Aurantii Fructus immaturus and Paeoniae Radix alba. HPLC was used to simultaneously determine the contents of naringin, hesperidin, neohesperidin and baicalin. The samples were separated on a Kromasil Cls （250 mm×4.6 mm, 5 μm） column by a gradient elution using acetonitrile-0. 2% acetic acid as the mobile phase and detection wavelength was set at 280 nm. RESULTS TLC spots were clear and well-separated without negative interference. HPLC experiment showed good linear relationships at the ranges of 0. 193 8-3. 876 0 μg for naringin （r =0. 999 0） , 0. 109 6-2. 192 0 μg for hesperidin （ r = 0. 999 9 ）, 0. 128 7-2. 574 0 μg for neohesperidin （ r = 0. 999 9 ）, 0. 452 5-9. 050 4 μg for baicalin （ r = 0. 999 9）. In addition, the average recoveries were 99.94% , 95.83% , 97.46% and 98.94% , respectively （ RSD 〈 3% ）. CONCLUSION The method is simple, accurate and reliable with good precision. It can be used for the quality control of Dachaihu Granules.

关 键 词：大柴胡颗粒 柚皮苷 橙皮苷 新橙皮苷 黄芩苷 TLC HPLC 质量标准 

分 类 号：R927.2[医药卫生—药学]