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开光复明片质量标准的研究

A Study on Quality Control Methods of Kaiguangfuming Tablets

【作者】 王艳君

【导师】 张振中; 刘伟;

【作者基本信息】 郑州大学 , 药物分析, 2007, 硕士

【摘要】 随着中药现代化的进程,越来越多的现代科学技术被应用到了中药提取、生产、质量控制等各个方面。在对开光复明片的质量标准研究过程中,为了提供开光复明片的有效的质量控制方法,笔者对开光复明片的各主要成分进行了由定性到定量的全面研究。采用现代薄层层析(TLC)技术对栀子、黄连、黄柏、大黄、冰片分别进行了色谱鉴别,结果表明,用TCL技术鉴别此五味主药,方法的专属性强,重现性好,操作简便;用高效液相色谱(HPLC)法测定了黄芩苷的含量,并制定了开光复明片质量标准(草案)。HPLC法测定黄芩苷的含量,C=0.0028+7.01×10-6Area,在4.95μg/ml~49.5μg/ml间,进样量与峰面积值有很好的线性关系,r=0.9999,平均回收率为99.3%,RSD%为1.25%(n=5),测定准确快速,灵敏度高,重复性强。由此证明,本质量标准可以很好的对开光复明片的质量进行控制,完全可以作为开光复明片的质量控制标准。

【Abstract】 With the modernization of Chinese traditional medicine, more and more new science and technology have been used into varieties of the production processes of Chinese traditional medicine, ranging from abstraction, production, identification and quality control etc.To study the effective quality control method of Kaiguangfuming tablets, we have researched the main components of this product in both qualitation and quantitation. The modern technology TLC was used for the identification of Gardenia ,Coptis,Phellodendron amurense,rhubarb and Borneol. The results proved that TLC for identification these five ingredients was highly specific with clear spots and high efficiency. HPLC was used in assay the baicalin in baical skullcap root in order to enact the quality specification. The results show that regression equation was C=0.0028+7.01×l0-6Area with r=0.9999 in linear range of 4.95~49.5μg/ml .The mean recovery was 99.3% with RSD being 1.25%.In conclusion, the method appeared to be simple, quick, sensitive, accurate,reproducible and can be used to control the quality of Kaiguangfuming tablets effectively.

【关键词】 开光复明片薄层鉴别高效液相色谱法黄芩苷
【Key words】 Kaiguangfuming tabletsTLCBaicalinHPLC
  • 【网络出版投稿人】 郑州大学
  • 【网络出版年期】2007年 04期
  • 【分类号】R286.0
  • 【被引频次】2
  • 【下载频次】123
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