HPLC法同时测定小儿奇应丸中3种成分的含量  

Simultaneous Determination of Three Ingredients in Xiaoer Qiying Pills by HPLC

作　　者：程宏辉 江涛 陈丽斯 苏锐辉 曾晨 汤迎湛 李怡芳[2] 曾利杰 王川易 CHENG Honghui;JIANG Tao;CHEN Lisi;SU Ruihui;ZENG Chen;TANG Yingzhan;LI Yifang;ZENG Lijie;WANG Chuanyi(Guangzhou Baiyunshan Jingxiutang Pharmaceutical Company Limited,Guangzhou,Guangdong 510130,China;College of Pharmacy,Jinan University,Guangzhou,Guangdong 510632,China)

机构地区：[1]广州白云山敬修堂药业股份有限公司,广东广州510130 [2]暨南大学药学院,广东广州510632

出　　处：《今日药学》2024年第5期348-351,共4页Pharmacy Today

摘　　要：目的建立小儿奇应丸中蟾毒灵、华蟾酥毒基及脂蟾毒配基含量测定的方法。方法采用Phenomenex synergi FusionRP80A C18色谱柱(250 mm×4.6 mm,4μm),流动相为乙腈-0.3%冰醋酸溶液,梯度洗脱,流速1.0 mL·min^(-1),检测波长296 nm,柱温30℃。结果蟾毒灵、华蟾酥毒基和脂蟾毒配基分别在4.140~41.40μg·mL^(-1)(r=0.9998)、4.088~40.88μg·mL^(-1)(r=1.0000)、4.020~40.20μg·mL^(-1)(r=0.9998)线性关系良好,平均加样回收率在99.42%~99.79%(RSD<1%),供试品溶液在48 h内稳定,且该方法重复性良好。结论该含量测定方法精密度及准确度高,可用于小儿奇应丸的定量分析及质量控制。OBJECTIVE To develop HPLC method for quantitative determination of bufalin,cinobufagin and resibufogenin in Xiaoer Qiying pills.METHODS A Phenomenex synergi Fusion⁃RP80A C18(250 mm×4.6 mm,4μm)was adopted with acetonitrile⁃0.3%glacial acetic acid solution as the mobile phase for gradient elution.The flow rate was 1.0 mL·min^(-1).The detection wavelength was set at 296 nm and the column temperature was 30℃.RESULTS The calibration curves showed good linear relationship in the ranges of 4.140⁃41.40μg·mL^(-1)(r=0.9998)for bufalin,4.088⁃40.88μg·mL^(-1)(r=1.0000)for cinobufagin,4.020⁃40.20μg·mL^(-1)(r=0.9998)for resibufogenin.The average recoveries were between 99.42%and 99.79%(RSD<1%).The sample solution was steady within 48 h,and this method showed good repeatability.CONCLUSION The method has high precision and accuracy and can be used for the quantitative analysis and quality control of Xiaoer Qiying pills.

关 键 词：小儿奇应丸 蟾毒灵 华蟾酥毒基 脂蟾毒配基 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]