| 野牡丹止痢片的质量标准 |
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| 引用本文： | 周劲康,林锦锋,钟丽琴,连晓吟.野牡丹止痢片的质量标准[J].中国药师,2009,12(5):593-595. |
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| 作者姓名： | 周劲康 林锦锋 钟丽琴 连晓吟 |
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| 作者单位： | 1. 广东省药品检验所,广州,510310;曼秀雷敦(中国)药业有限公司
2. 广东省药品检验所,广州,510310 |
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| 摘 要： | 目的：建立野牡丹止痢片的质量标准。方法：采用TLC法对野牡丹进行鉴别；用HPLC法对野牡丹中没食子酸进行含量测定，色谱柱：Thermo BDS HYPERSIL C18（250mm×4．6mm，5μm），流动相：甲醇-0．1％甲酸（5：95），检测波长：272nm，流速：1．0ml·min^-1。结果：本品鉴别薄层色谱特征明显；没食子酸线性范围0．12～1．6μg（r=0．9999），平均回收率为100．6％（RSD=1．3％，11=9）。结论：鉴别和含量测定方法准确可行，重复性好，可作为药品标准控制野牡丹止痢片的质量。
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| 关 键 词： | 野牡丹止痢片 没食子酸 质量标准 |
Quality standard for Yemudan Zhili Tablets |
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| Zhou Jinkang,Lin Jinfeng,Zhong Liqin,Lian Xiaoyin.Quality standard for Yemudan Zhili Tablets[J].China Pharmacist,2009,12(5):593-595. |
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| Authors: | Zhou Jinkang Lin Jinfeng Zhong Liqin Lian Xiaoyin |
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| Institution: | Zhou Jinkang, Lin Jinfeng , Zhong Liqin , Lian Xiaoyin ( 1. Gongdong Institute for Drug Control, Guangzhou 510310, China; 2. Mentholatum(China) Pharmaceutical Co. , Ltd. ) |
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| Abstract: | Objective： To establish the quality standard for Yemudanzhili Tablets. Method： TLC was performed to identify Radix Melastomatis Candidi; HPLC was used to determine the content of gallic acid. The Thermo BDS HYPERSIL C18 eolumn（250mm × 4.6 mm,5 μm） was used, the mobile phase consisted of methanol - 0.1% formic acid （ 5： 95 ）, the detection wavelength was at 272nm; and the flow rate was 1.0ml·min^-1. Result： Radix Melastomatis Candidi was identified;Gallic acid showed a good linearity within the range of 0.12 -1.6μg（ r = 0.999 9 ）, the average recovery was 100.6% and RSD was 1.3 % （n = 9）. Conclusion： This method is simple, accurate and repeatable, and suitable for the quality control of Yemudanzhili tablets. |
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| Keywords: | Yemudanzhili Tablets Gallic acid Quality standard |
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