| 元胡止痛片的质量控制研究 |
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| 引用本文： | 刘瑞新,王青晓.元胡止痛片的质量控制研究[J].中国药品标准,2010,11(5):343-346. |
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| 作者姓名： | 刘瑞新 王青晓 |
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| 作者单位： | [1]河南中医学院第一附属医院药学部,郑州450000 [2]河南省食品药品检验所,郑州450003 |
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| 摘 要： | 目的：元胡止痛片的质量控制研究。方法：收集10批不同厂家、批号的元胡止痛片，经过全面、规范的方法学验证，建立HPLC法控制元胡止痛片中延胡索乙素的含量。结果：延胡索乙素在5．09—71．23μg·mL^-1时，质量浓度与峰面积积分值呈良好的线性关系（r=0．99997），平均回收率为97．94％（RSD=2．10％）；含量限度定为每片含延胡索乙素（C21H25NO4）不得少于75μg。结论：该方法简便、快速、准确，能有效控制元胡止痛片的内在质量。
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| 关 键 词： | 元胡止痛片 延胡索乙素 HPLC 含量测定 |
Study on Quality Control of Yuanhuzhitong Tablets |
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| Authors: | Liu Rui-xin and Wang Qing-xiao |
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| Institution: | 1. The First Affiliated Hospital of Henan College of T. C. M. , Zhengzhou 450000; 2. Henan Provincial Institute of Food and Drug Control, Zhengzhou 450003 ) |
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| Abstract: | Objective： To study on quality control of Yuanhuzhitong Tablets. Methods： 10 batches of Yuanhuzhitong Tablets from different companies were collected, and the HPLC concentration determination method of tetrahydropalmatine in Yuanhuzhitong Tablets was established after comprehensive and standardized methodology validation. Results： The linear detection ranges of tetrahydropalmatine were 5. 09 - 71.23 μg· mL^ -1 （ r = 0. 999 97 ）, and the average recovery was 97.94% （ RSD 2. 10% ） ; The content of tetrabydropalmatine shall not be less than 75μg per tablet. Conclusion： This method is convenient, rapid and accurate, which could be used for quality control of Yuanhuzhitong Tablets. |
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| Keywords: | Yuanhuzhitong Tablets Tetrahydropalmatine HPLC Determination of Concentrations |
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