| 正气片质量标准研究 |
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| 引用本文： | 姜艳艳,张正光,徐翼舟. 正气片质量标准研究[J]. 药学服务与研究, 2009, 9(5): 352-355 |
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| 作者姓名： | 姜艳艳 张正光 徐翼舟 |
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| 作者单位： | 1. 上海和黄药业有限公司质量保证部,上海,200331
2. 上海和黄药业有限公司技术中心,上海,200331 |
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| 摘 要： | 目的：建立正气片的质量标准。方法：采用TLC法鉴别正气片中的木香、甘草和厚朴,并用HPLC法对橙皮苷进行定量分析。结果：TLC法可以鉴别出木香、甘草和厚朴。HPLC检测橙皮苷的线性范围为0.05～0.75μg,线性方程为Y=1190.2X＋0.7771,r=0.9999。该方法回收率为（99.81±2.15）%（n=9）,精密度、重复性和稳定性良好。结论：本研究建立的方法专属性强,重现性好,准确、可靠,可有效控制正气片的质量。
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| 关 键 词： | 正气片 质量标准 薄层色谱法 色谱法 高压液相 含量测定 |
Study on the quality control standard for Zhengqi tablet |
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| JIANG Yan-yan,ZHANG Zheng-guang,XU Yi-zhou. Study on the quality control standard for Zhengqi tablet[J]. Pharmaceutical Care and Research, 2009, 9(5): 352-355 |
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| Authors: | JIANG Yan-yan ZHANG Zheng-guang XU Yi-zhou |
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| Affiliation: | 1. Department of Quality Assurance, Shanghai Hutchison Pharmaceutical Co. L.td. , Shanghai 200331, China; 2. The Technology Centre, Shanghai Hutchison Pharmaceutical Co. Ltd. , Shanghai 200331, China) |
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| Abstract: | Objective：To establish the quality control standard for Zhengqi tablet which contains Radix Aucklandiae,Radix Et Rhizoma Glycyrrhizae,Cortex Magnoliae Officinalis and Pericarpium citri reticulatae,etc.Methods：Radix Aucklandiae,Radix Et Rhizoma Glycyrrhizae and Cortex Magnoliae Officinalis were identified by TLC method.HPLC was used for quantitative determination of hesperidin.Results：Radix Aucklandiae,Radix Et Rhizoma Glycyrrhizae and Cortex Magnoliae Officinalis could be identified by TLC method. The linear range of hesperidin was 0.05 0, 75 ,g The average recovery was （99.81 ± 2.15 ）% （n=9）.The precision, repeatability and stability of the method were good. Conclusion：The method is specific,repeatable,accurate and reliable. It can be used for quality control of Zhengqi tablets. |
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| Keywords: | Zhengqi tablets quality standard thin layer chromatography chromatography high pressure liquid content determination |
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