复方鹿仙草片质量控制方法的简化与提高研究  

Improvement in quality control method for Compound Luxiancao Tablet

作　　者：韩桂茹[1] 张鹏 安丽娜 申玉龙 

机构地区：[1]河北省药品检验所,河北石家庄050011 [2]承德燕峰药业有限责任公司,河北承德067600

出　　处：《中成药》2012年第2期272-277,共6页Chinese Traditional Patent Medicine

摘　　要：目的为制定简便、快捷的复方鹿仙草片(苦参、鹿仙草、土茯苓、九香虫,黄药子和天花粉等)质量控制方法,对原方法进行了简化与提高研究。方法在5块薄层板上鉴别了苦参、鹿仙草、土茯苓、九香虫,黄药子和天花粉。采用反相高效液相法,以乙腈-甲醇-0.1%磷酸(1.5∶4∶94.5)作为流动相,同时测定了复方鹿仙草片中苦参碱和氧化苦参碱。结果通过方法学考察,苦参碱的进样量在0.043 5～1.087 5μg,与峰面积呈良好的线性关系(r=0.999 97);氧化苦参碱的进样量在0.051 5～1.946μg,与峰面积呈良好的线性关系(r=0.999 99)。苦参碱的平均回收率为99.09%,RSD为1.39%(n=9);氧化苦参碱的平均回收率为100.18%,RSD为2.08%(n=9)。TLC鉴别阴性无干扰。结论简化和提高后的复方鹿仙草片质量标准,简便、快捷、实用。AIM To establish a simple and rapid method for the quality control of Compound Luxiancao Tablet（Sophorae flavescentis Radix,Balanophorae involucratae Herba,Smilacis glabrae Rhizoma,Aspongopus,Dioscoreae bulbifeerae Rhizoma and Trichosanthis Radix,etc.） to improve the current quality control.METHODS Sophorae flavescentis Radix,Balanophorae involucratae Herba,Smilacis glabrae Rhizoma,Aspongopus,Dioscoreae bulbifeerae Rhizoma and Trichosanthis Radix were identified by TLC on five thin-layer chromatographic plates.The contents of matrine and oxymatrine in Compound Luxiancao Tablet were determined by using a mixture of acetonitrile,methanol and 0.1% phosphoric（1.5∶ 4∶ 94.5） as the mobile phase by RP-HPLC.RESULTS The methodological study showed that a good linear correlation existed in the ranges of 0.043 5-1.087 5 μg（r=0.999 97） for matrine and 0.051 5-1.946 μg（r=0.999 99） for oxymatrine.The average recoveries of matrine and oxymatrine were 99.09% and 100.18%,respectively.RSDs were 1.39%（n=9） and 2.08%（n=9）,respectively.The negative sample did not have interference on TLC identification.CONCLUSION The method in the improvement in quality standard of Fufang Luxiancao Tablet is simple,rapid and feasible.

关 键 词：复方鹿仙草片 TLC HPLC 苦参碱 氧化苦参碱 质量控制 

分 类 号：R927.2[医药卫生—药学]