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黄连羊肝丸质量标准的研究

Study on the Quality Standard of Huanglian Yanggan Pill

【作者】 吴阳

【导师】 郭伟英;

【作者基本信息】 辽宁医学院 , 药物分析学, 2011, 硕士

【摘要】 目的本论文建立了反相高效液相色谱法同时测定黄连羊肝丸中黄芩苷及盐酸小檗碱的含量并进行方法学考察,还增加了多药味的鉴别,并讨论了黄芩苷的提取方法以及对其含量进行了测定,以便更好的控制其质量,保证临床用药的安全,有效。方法应用正相薄层色谱法对黄连羊肝丸中的密蒙花、木贼、柴胡进行了鉴别。还应用了反相高效液相色谱法,检测了黄连羊肝丸中黄芩苷和盐酸小檗碱的含量,并进行了方法学验证,表明此方法符合含量测定的要求。结果高效液相色谱法含量测定其结果为:黄芩苷、盐酸小檗碱的回归方程分别为:Y= 7.885×104X-1.560×105, r=0.9999, Y= 9.618×104X-1.847×104 , r= 0.9999,黄芩苷和盐酸小檗碱分别在16.0~80.0μg·mL-1 ( r = 0.9999)、1.1~9.9μg·mL-1 ( r = 0.9999)线性关系良好,平均加样回收率( n = 9)分别为100.2%和100.9%。应用薄层色谱法对黄连羊肝丸中的木贼、柴胡进行了鉴别,可得出薄层色谱供试品色谱中,在与对照药材或对照品相应的位置上,显相同颜色的斑点;在与空白样品相应的位置上,不显相同颜色的斑点。分离效果好,没有其它干扰。结论本文采用高效液相色谱法同时测定黄连羊肝丸中黄芩苷和盐酸小檗碱的含量以及应用了薄层色谱法对黄连羊肝丸中的几味药材进行鉴别,方法简便。灵敏度高、重复性好,对于提升黄连羊肝丸质量标准提供了科学依据。

【Abstract】 ObjectiveThis paper established the HPLC determination of baicalin and berberine hydrochloride in the HuanglianYanggan pills and studied methodology, it has added more traditional Chinese medicinal materials identifying. Discussing the extraction of baicalin and its methodology has been investigated, in order to better control its quality and ensure clinical drug safe and effective.MethodsBy using normal-phase thin layer chromatography,Buddleja, Horsetail, and Bupleurum were identified in HuanglianYanggan pill. The application of Reversed phase high performance liquid chromatograph detect berberine baicalin and berberine hydrochloride determination in the HuanglianYanggan pill and conducted method validation, this method comply with the requirements of determination.ResultsHPLC determination of the results are that the linear range for baicalin and berberine hydrochloride was respectively 16.0~80.0μg·mL-1 ( r = 0.9999) , and 1.1~9.9μg·mL-1 ( r = 0.9999) , and the average recoveries ( n = 9) were 100.2% and 100.9%. I choose TLC to identify Horsetail and Bupleurum in HuanglianYanggan pill.Results TLC indicated that identified herbs could show the same color pot as the control herbs or contrast in the same position. Good separation affects no other interference. ConclusionsIn this paper, Simultaneous determination of baicalin and berberine hydrochloride content in HuanglianYanggan pill by HPLC, also several kinds of medicinal herbs were identified.This method is simple, sensitive, and reproducible, for enhancing quality standards of Huanglian Yanggan pill provides scientific basis.

  • 【网络出版投稿人】 辽宁医学院
  • 【网络出版年期】2012年 01期
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