毕军,黄坤斌,聂中越
BI Jun~1,HUANG Kun-bin~1,NIE Zhong-yue~2(1.Guangdong Center for Drug Evaluation & Certification

• 1:广东省药品审评认证中心
• 2:广东省药品审评认证中心
• 3:深圳市人民医院 广州510080
• 4:广州510080

摘要(Abstract)：

目的建立五更清肠溶片中补骨脂素的含量测定方法。方法HypersilODS C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(45∶55),检测波长为246 nm。结果补骨脂素在12.5~125μg.m l-1范围内,浓度与峰面积值呈良好线性关系,r=0.9996,平均加样回收率为98.12%,RSD=1.8%。结论本方法简便,重复性好,可用于五更清肠溶片的质量控制。
Objective To establish a method for determinating the content of Psoralen in Wugengqing Enteric-coated Tablets.Method HPLC method was used,the separation was performed on Hypersil ODS C_(18)(250 mm×4.6 mm,5 μm),methyl-water(45∶55) as mobile phase and quantified by ultraviolet detection with wavelength at 246 nm.Result The range of calibration curve was 12.5～125 μg·ml~(-1),r=0.9996,average recovery rate was 98.12%,and RSD was 1.8%.Conclusion This method is simple,accurate and reproducible for the quality control of Wugengqing enteric-coated tablet.

关键词(KeyWords)： 五更清肠溶片;补骨脂素;HPLC-UV
wugengqing enteric-coated tablets;psoralen;HPLC-UV

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基金项目(Foundation):

作者(Author): 毕军,黄坤斌,聂中越
BI Jun~1,HUANG Kun-bin~1,NIE Zhong-yue~2(1.Guangdong Center for Drug Evaluation & Certification

参考文献(References)：

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• [2]金世元,王琦.中药饮片炮制研究与临床应用[M].北京:化学工业出版社,2004:412.
• [3]国家药典委员会.中国药典(2005年版)一部[S].北京:化学工业出版社,2005:129.