HPLC法测定皮肤病血毒片中7种成分的含量  

Determination of seven components in Pifubingxuedu tablet by HPLC method

作　　者：史志辉 肖会敏[2] 何悦[2] 刘洋[3] 刘海月 杨旭[2] 王四旺[2] 

机构地区：[1]陕西君碧莎制药有限公司,陕西咸阳712000 [2]第四军医大学药学院新药研发中心,陕西西安710032 [3]陕西中医药大学,陕西咸阳712046

出　　处：《药学实践杂志》2017年第5期427-432,共6页Journal of Pharmaceutical Practice

摘　　要：目的建立同时测定皮肤病血毒片中7种成分含量的HPLC方法。方法采用Kromasil C18柱(250 mm×4.6mm,5μm);流动相:乙腈-0.5%磷酸水溶液,梯度洗脱法;流速:0.8 ml/min;PDA检测器,检测波长:245、325、403nm。结果皮肤病血毒片中绿原酸、羟基红花色素A、芍药苷、连翘酯苷A、阿魏酸、小檗碱和甘草酸分别在10.00~200.00,4.00~80.00,20.00~400.00,4.00~80.00,3.00~60.00,10.00~200.00和10.00~200.00μg/ml范围内呈良好的线性关系;各成分平均回收率均在95%~105%之间,RSD<2%。10批制剂中绿原酸、羟基红花色素A、芍药苷、连翘酯苷A、阿魏酸、小檗碱和甘草酸的平均含量(mg/片)与RSD(%)分别为0.299 5,2.25;0.700 0,1.33;0.429 2,1.21;0.039 1,2.34;0.014 8,2.23;0.209 0,2.06和0.272 7,2.68。结论该方法准确可靠、简便快速,适用于皮肤病血毒片的质量控制。Objective To establish a HPLC method for simultaneous determination of seven constituents in Pifubingxuedu tablet.Methods The determination was performed on Kromasil-C18 column （4.6 mm ＆#215; 250 mm, 5 μm）.The mobile phase was acetonitrile-0.5% phosphoric acid aqueous solution with a flow rate of 0.8ml/min.The detector was PDA and detection wavelength was set at 245,325,403 nm, respectively.Results A method has been established for the determination of chlorogenic acid, hydroxy Safflower Pigment A, paeoniflorin, forsythiaside A, ferulic acid, berberine and glycyrrhizin acid in one run by HPLC.Their average contents and RSD in each Pifubingxuedu tablet were 0.299 5 mg/tablet （2.25%）;0.700 0 mg/tablet（1.33%）;0.429 2 mg/tablet （1.21%）;0.039 1 mg/tablet （2.34%）;0.014 8 mg/tablet（2.23%）;0.209 0 mg/tablet （2.06%）;0.272 7 mg/tablet （2.68%）, respectively.Conclusion The established method is simple, convenient, accurate and reliable.It is suitable for the quality control of Pifubingxuedu tablet.

关 键 词：皮肤病血毒片 高效液相色谱 绿原酸 羟基红花色素A 芍药苷 连翘酯苷A 小檗碱 甘草酸 

分 类 号：R917[医药卫生—药物分析学]