HPLC法同时检查华蟾素片中蟾毒灵、华蟾酥毒基及酯蟾毒配基限量和测定蟾蜍噻咛的含量  

Simultaneous Identification of Bufalin、Cinobufagin and Recibufogenin in Huachansu Tablets and Determination of Toad Thiophene-making by HPLC

作　　者：吴毅 许妍 赵雯 孟晓伟[2] 

机构地区：[1]江西省食品药品检验所,南昌330029 [2]江西中医学院

出　　处：《中国药事》2012年第1期53-56,共4页Chinese Pharmaceutical Affairs

摘　　要：目的采用HPLC法对华蟾素片中有毒成分蟾毒灵、华蟾酥毒基及酯蟾毒配基进行限量检查;并利用HPLC法测定其有效成分蟾蜍噻咛的含量。方法限量检查:色谱柱为Agela C18柱,流动相为乙腈-0.5%磷酸二氢钾溶液(50∶50)(用磷酸调节pH为3.2),检测波长为296nm。含量测定:色谱柱为Kromasil C18柱,流动相为乙腈-水(10∶90),检测波长为226nm。结果在与蟾毒灵、华蟾酥毒基及酯蟾毒配基对照品色谱峰相同的保留时间处,5批样品出现的色谱峰面积之和小于对照品峰面积之和。蟾蜍噻咛在0.1045～1.0448μg范围内呈良好的线性关系,r=0.9998;平均回收率为98.9%,RSD=1.6%;每片含量不得少于0.15mg。结论方法快速、准确、重复性好,可用于华蟾素片质量标准的控制。Objective A HPLC method was established for the simultaneous identification of bufalin,cinobufagin and recibufogenin in Huachansu tablets and determination of toad thiophene-making by HPLC.Methods The identification method was separated on Agela C18 column,acetonitrile and 0.5% potassium dihydrogen phosphate（50∶50）（use the phosphoric acid adjusted to pH=3.2）as mobile phase.The detection wavelength was at 296 nm.The determination method was separated on Kromasil C18 column,acetonitrile and water（10∶90）as mobile phase.The detection wavelength was at 226 nm.Results 5 batches of samples appeared that the sum of chromatograph peak area of bufalin,cinobufagin and recibufogenin was smaller than the sum of peak area of the corresponding standard references.Toad thiophene-making was linear in the range of 0.1045~1.0448μg.The recovery was 98.9%,and RSD was 1.6%.The content of each tablet was not less than 0.15mg.Conclusion The methods were rapid,accurate and reproducible,and can be used for the quality control of Huachansu Tablets.

关 键 词：华蟾素片 蟾毒灵 华蟾酥毒基 酯蟾毒配基 蟾蜍噻咛 HPLC 

分 类 号：R284[医药卫生—中药学] R927.2[医药卫生—中医学]