六味颈康胶囊质量标准的建立  

Establishment of Quality Standard for Liuwei Jingkang Capsules

作　　者：范桂强 宋更申 路伦 郝江涛 

机构地区：[1]衡水市食品药品检验检测中心,河北衡水053000 [2]河北省药品检验研究院 [3]河北省深州市医院

出　　处：《中国药师》2016年第8期1605-1608,共4页China Pharmacist

摘　　要：目的:建立六味颈康胶囊质量标准。方法:用TLC法对处方中白芍、甘草、续断、粉葛进行定性鉴别;用HPLC法测定其主要活性成分葛根素、芍药苷、甘草苷、甘草酸铵的含量,色谱柱为ZORBAX SB-C18柱(250 mm×4.6 mm,5μm);流动相为乙腈-0.1%磷酸水溶液,进行梯度洗脱;流速为1.0 ml·min^(-1);柱温为30℃;检测波长为0~7 min、在250 nm波长下检测葛根素,7~10 min在232 nm波长下检测芍药苷,10~14 min在276 nm波长下检测甘草苷,14 min在250 nm波长下检测甘草酸铵;进样量为10μl。结果:TLC法可鉴别白芍、甘草、续断、粉葛的特征斑点且阴性样品无干扰,4个有效成分的线性范围分别为:葛根素2.644~26.440μg·ml^(-1)(r=0.999 9)、芍药苷65.200~652.000μg·ml^(-1)(r=0.999 2)、甘草苷12.620~126.200μg·ml^(-1)(r=0.999 9)、甘草酸铵13.280~132.800μg·ml^(-1)(r=0.998 9),平均加样回收率分别为98.74%,99.24%,98.69%,98.19%,RSD分别为0.71%,0.40%,0.78%,0.84%(n=6)。结论:该方法简便、准确、灵敏度高、重复性好,可有效控制六味颈康胶囊的产品质量。Objective：To establish the quality standard for Liuwei Jingkang capsules.Methods：TLC was used for the identification of Radices Paeoniae Alba,Licorice,Radix Dipsaci and Radix Puerariae Thomsonii.The contents of puerarin,peoniflorin,liquiritin and ammonium glycyrrhetate were determined by HPLC.A Zorbax SB-C_（18）（250 mm ×4.6 mm,5μm） column was used.The mobile phase consisted of acetonitrile and water containing 0.1%hydrochloric acid at a flow rate of 1.0 ml·min^（-1） with gradient elution.The column temperature was 30℃.Puerarin was detected at 250 nm（0-7 min）,peoniflorin was detected at 232 nm（7-10 min）,liquiritin was detected at 276 nm（10-14 min） and ammonium glycyrrhetate was detected at 250nm（14-40 min）,and the injection volume was10 μl.Results：The TLC spots were clear with good resolution and without interference from negative samples.There was good linear relationship between the concentration of puerarin,peoniflorin,liquiritin and ammonium glycyrrhetate and peak area within the concentration range of 2.644-26.440 μg·ml^（-1）（r=0.999 9）,65.200-652.000 μg·ml^（-1）（r=0.999 2）,12.620-126.200 μg·ml^（-1）（r=0.999 9） and 13.280-132.800 μg·ml^（-1）（r=0.998 9）.The average recovery（RSD） was 98.74%（0.71%）,99.24%（0.40%）,98.69%（0.78%） and 98.19%（0.84%）,respectively（n=6）.Conclusion：The established method is accurate,highly sensitive and well reproducible,which can be used for the determination of main components in Liuwei Jingkang capsules to control the quality.

关 键 词：六味颈康胶囊 质量控制 薄层色谱法 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]